Operative versus non-operative treatment for clavicle fracture
医学论文英文摘要的写作
英文标题的写作-注意事项 英文标题的写作 注意事项
2.尽量选用特指词和关键词 尽量选用特指词和关键词 一个含意常有多种表达方式 肝癌：hepatocarcinoma, liver cancer/ carcinoma, 肝癌： hepatic cancer/ carcinoma, liver/ hepatic neoplasm 望文生义 ：congenital skin webbed fingers syndactyly of fingers
A postmortem study of 64 vagus nerves from 32 children up to 1 year of age was done to determine the incidence of ectopic parathyroid tissue. The segments of nerve (average length, 2.6 cm), including the entire ganglion nodosum, were examined using a combination of step and serial sectioning. Discrete solitary collections of ectopic parathyroid chief cells were seen in 6% of vagus nerves and ranged in diameter from 162 to 360 micron. Confirmation of the nature of the cells was based on the presence of abundant glycogen and positive immunoreactivity for chromogranin and parathormone. The possible significance of intravagal parathyroid tissue is briefly discussed.
考研英语急救50词
hesitate
v.实现，取得
achieve
n.结论
conclusion
v.逆转，彻底改变
reverse
n.情形，状况
situation
n.消费者，顾客
consumer
v.-ing写
writing
n.目的
purpose
n.建议
suggestion
n.道歉
apology
adv.真诚地；诚实地
sincerely
n.环境；外界；围绕
environment
n.政府；治理
government
n.协调；和谐
harmony
n.想象力
imagination
adj.必不可少的；必须的
indispensable
n.必要性；必然性
necessity
n.哲学；哲理；人生观
philosophy
adj.心理的；心理学的
psychological
n.现象
phenomenon
v.描绘
depict/portray
adv.首先
initially
adj.有利的，有好处的
advantageous/beneficial/favorable
n.态度
attitude
n.挫折
setback
n.自制力；纪律
discipline
n.进步，提升
advancement
vt.加快；促进
accelerate
adj.明智的；可取的aFra bibliotekvisable
v.影响
influence/impact2/effect
n.竞争
2016年04月急性冠脉综合征治疗新药临床研究指导原则.(英文版)
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom1 April 2016 1 EMA/CHMP/207892/20152 Committee for medicinal products for human use (CHMP)3 Guideline on clinical investigation of new medicinal 4products for the treatment of acute coronary syndrome 5(CPMP/EWP/570/98) 6Draft7 Draft agreed by Cardiovascular Working PartyFebruary 2016 Adopted by CHMP for release for consultation1 April 2016 Start of public consultation 27 April 2016 End of consultation (deadline for comments)31 October 2016 8 This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the 9 treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' 10 (CPMP/EWP/570/98). 1112 Comments should be provided using this template . The completed comments form should be sent to CVSWPSecretariat@ema.europa.eu .13Keywords Acute coronary syndrome, STE-ACS, NSTE-ACS, guideline, CHMP1415Table of contents16Executive summary (4)171. Introduction (background) (4)182. Scope (5)193. Legal basis and relevant guidelines (5)204. Choice of efficacy criteria (endpoints) (6)214.1. All-cause mortality and CV mortality (6)224.2. New myocardial infarction (6)234.3. Revascularisation (6)244.4. Unstable angina pectoris necessitating hospitalisation (6)254.5. Stent thrombosis (6)264.6. Stroke (7)274.7. Left ventricular function and heart failure (7)284.8. Composite endpoints (7)294.9. Endpoints in fibrinolysis studies (7)305. Methods to assess efficacy (how to measure the endpoints) (8)315.1. Mortality (8)325.2. New myocardial infarction (8)335.3. Revascularisation (8)345.4. Unstable angina pectoris necessitating hospitalisation (8)355.5. Stent thrombosis (8)365.6. Ventricular function and heart failure (9)375.7. Angiographic endpoints (9)386. Selection of patients (9)396.1. Study population (9)406.1.1. STE-ACS (ST elevation acute coronary syndrome) (9)416.1.2. NSTE-ACS (Non-ST elevation acute coronary syndrome) (9)426.1.3. Unstable angina (9)436.2. Inclusion criteria for the therapeutic studies (10)446.3. Exclusion criteria for the therapeutic studies (10)456.4. Risk Stratification (10)466.5. Special populations (11)476.5.1. Older patients (11)487. Strategy and design of clinical trials (11)497.1. Clinical pharmacology (11)507.2. Therapeutic exploratory studies (12)517.2.1. Objectives (12)527.2.2. Design (12)537.3. Confirmatory Therapeutic Studies (12)547.3.1. Objectives (12)557.3.2. Background therapy (12)567.3.3. Choice of comparator (13)577.3.4. Duration of clinical studies (13)587.3.5. Analyses and subgroup analysis (13)598. Safety aspects (14)608.1. Bleedings (14)618.2. All-cause mortality (15)628.3. Thrombocytopenia (15)638.4. Rebound effect (15)648.5. Effects on laboratory variables (15)658.6. Effects on concomitant diseases (15)66References (16)6768Executive summary6970Two CHMP Guidelines have been previously developed to address clinical investigations of new71medicinal products for the treatment of acute coronary syndrome (ACS): (I) the CHMP points toconsider (PtC) on the clinical investigation of new medicinal products for the treatment of acute7273coronary syndrome without persistent ST-segment elevation (CPMP/EWP/570/98), published in 2000 74[1], and (II) the CHMP PtC on the clinical development of fibrinolytic products in the treatment of75patients with ST segment elevation myocardial infarction (CPMP/EWP/967/01), published in 2003 [2].76Since their finalisation, major developments have taken place in the definitions, diagnosis,77interventions and management of ACS, as reflected in the relevant European Society of Cardiology78(ESC) clinical practice guidelines (3, 4). Currently, an update of the above mentioned CHMP Guidelines 79is considered necessary to take these new developments into consideration based on literature review 80and experience gained with medicinal products intended for treatment during the acute phase and81beyond. The present update includes the following changes: 1) guidance addressing both ST-segment 82elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction83(NSTEMI), as well as unstable angina (UA), 2) update in their definitions, 3) risk stratification using84different scoring systems, 4) investigated endpoints, and 5) clinical developments of new medicinal85products beyond the acute stage, including agents other than antiplatelets and anticoagulants.1. Introduction (background)8687Cardiovascular diseases are currently the leading cause of death in industrialized countries and also 88expected to become so in emerging countries by 2020 [3, 4]. Among these, coronary artery disease 89(CAD) is the most prevalent manifestation and is associated with high mortality and morbidity. ACS 90has evolved as a useful operational term to refer to any constellation of clinical symptoms that are91compatible with acute myocardial ischemia. It encompasses (STEMI), NSTEMI, and UA.92ACS represents a life-threatening manifestation of atherosclerosis. It is usually precipitated by acute 93thrombosis induced by a ruptured or eroded atherosclerotic coronary plaque, with or without94concomitant vasoconstriction, causing a sudden and critical reduction in blood flow. In the complex95process of plaque disruption, inflammation was revealed as a key pathophysiological element. Non-96atherosclerotic aetiologies are rare e.g. such as arteritis and dissection.97The leading symptom of ACS is typically chest pain. Patients with acute chest pain and persistent (>20 min) ST-segment elevation have ST-elevation ACS (STE-ACS) that generally reflect an acute total9899coronary occlusion. Patients with acute chest pain but without persistent ST-segment elevation have 100rather persistent or transient ST-segment depression or T-wave inversion, flat T waves, pseudo-101normalization of T waves, or no ECG changes. At presentation, based on the measurement of102troponins, it is possible to further discriminate between the working diagnosis of non-ST-elevation ACS 103(NSTE-ACS) and unstable angina.104NSTE-ACS is more frequent than STE-ACS [5] with an annual incidence around 3 per 1000 inhabitants, 105but varying between countries [6]. Hospital mortality is higher in patients with STEMI than among 106those with NSTEMI (7% vs. 3–5%, respectively), but at 6 months the mortality rates are very similar 107in both conditions (12% and 13%, respectively) [5,7,8]. Long term follow-up shows that death rates 108were higher among patients with NSTE-ACS than with STE-ACS, with a two-fold difference at 4 years[8]. This difference in mid- and long-term evolution may be due to different patient profiles, since 109110NSTE-ACS patients tend to be older with more co-morbidities, especially diabetes and renal failure.2. Scope111112The aim of this guideline is to provide guidance when performing trials to develop medicinal products 113in the management of ACS. The primary goals of therapy for patients with ACS are to:1. Treat acute, life-threatening complications of ACS, such as serious arrhythmias, pulmonary 114115oedema, cardiogenic shock and mechanical complications of acute myocardial infarction (AMI). [9] 1162. Reduce the amount of myocardial necrosis that occurs in patients with AMI, thus preserving 117left ventricular (LV) function, preventing heart failure (HF), and limiting other cardiovascular118complications.1193. Prevent major adverse cardiac events like death, non-fatal myocardial infarction (MI), andneed for urgent revascularization.120121The focus in this Guideline concerns mainly the medical treatment of ACS (treatment goals 2 and 3). 122The choice of interventional procedures [percutaneous coronary intervention (PCI) or coronary artery 123bypass graft CABG)] falls outside the scope of this guideline.3. Legal basis and relevant guidelines124125This guideline has to be read in conjunction with the introduction and general principles and parts I 126and II of the Annex I to Directive 2001/83 as amended.127Pertinent elements outlined in current and future EU and ICH guidelines, should also be taken into 128account, especially those listed below:129•Dose-Response Information to Support Drug Registration (ICH E4; CPMP/ICH/378/95).130•Statistical Principles for Clinical Trials (ICH E9; CPMP/ICH/363/96).131•Choice of Control Group and Related Issues in Clinical Trials (ICH E10; CPMP/ICH/364/96).132•Points to consider on an Application with 1) Meta-analyses 2) One pivotal study133(CPMP/EWP/2330/99).134•Points to consider on multiplicity issues in clinical trials (CPMP/EWP/908/99).135•Investigation of subgroups in confirmatory clinical trials (EMA/CHMP/539146/2013).136•The Extent of Population Exposure to Assess Clinical Safety for Drugs (ICH E1A;137CPMP/ICH/375/95).138•Pharmacokinetic Studies in Man (3CC3A).139•Studies in Support of Special Populations: Geriatrics (ICH E7 CHMP/ICH/379/95) and related Q&A 140document (EMA/CHMP/ICH/604661/2009).141•Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95).142•Reporting the Results of Population Pharmacokinetic Analyses (CHMP/EWP/185990/06).143•Reflection paper on the extrapolation of results from clinical studies conducted outside the EU to 144the EU-population (EMEA/CHMP/EWP/692702/2008).145•Draft Guideline on clinical investigation of medicinal products for the treatment of chronic heart 146failure (EMA/392958/2015 )•Guideline on clinical investigation of medicinal products for the treatment of acute heart failure147148(CPMP/EWP/2986/03 Rev. 1)4. Choice of efficacy criteria (endpoints)149150Definitions of clinical endpoints in confirmatory trials should be in line with the relevant clinical151guidelines to facilitate interpretation of the results, to allow comparisons across clinical studies and to 152extrapolate to clinical practice. Endpoints should be centrally adjudicated by a blinded committee. The 153following endpoints are relevant to the investigation of efficacy in patients with ACS.4.1. All-cause mortality and CV mortality154155As one of the goals of treatment of ACS is reduction of mortality, this is an important endpoint to156measure. There is an ongoing debate around the use of all-cause versus cardiovascular mortality in 157cardiovascular (CV) trials. All cause mortality is the most important endpoint in clinical trials for the 158estimation of the benefit-risk balance of a drug, in particular when investigating newer medicinal159products with possible safety issues. On the other hand, CV mortality is more specifically linked to the 160mode of action of CV medicinal products/intervention and is especially relevant when the earliest part 161of the follow up is assessed. The choice is also dependent on the objective of the study i.e. in non-162inferiority trials, CVmortality may be preferred while in superiority trials all cause mortality is usually 163used. In fibrinolysis studies, all cause mortality is preferred (see section 4.9).164As such, one of the two mortality endpoints should be included as a component of the primary165endpoint, with the other investigated as a key secondary endpoint.4.2. New myocardial infarction166167New onset MIis a relevant endpoint in studies of ACS and should always be investigated. The definition 168of MI has evolved through the years; at the time of drafting of this Guideline, the third universal169definition of MI is applicable [10]. Criteria of MI are the same as those used to define the index event 170(see below).4.3. Revascularisation171172Some clinical trials have included revascularization endpoints (PCI or CABG) as part of the primary 173composite with conflicting results [11, 12]. Such endpoints are considered more relevant tointerventional studies, and in the scope of this Guideline, their inclusion as a primary endpoint should 174175be clearly justified and their assessment pre-defined and systematically assessed.4.4. Unstable angina pectoris necessitating hospitalisation176177Unstable angina has been investigated in ACS clinical trials. Due to the varying definitions used, the 178associated subjectivity and the influence of local clinical practice, this endpoint is not encouraged to be 179included in the composite primary endpoint.4.5. Stent thrombosis180181Stent thrombosis (ST) is a rare event that can have fatal consequences. ST has been captured in some 182registration studies, but not consistently in the primary endpoint (PEP). The investigation of ST as part 183of the primary endpoint is not encouraged due to the uncertainty of the clinical relevance of all184captured events, except for the "definite" subcategory. Another category identified by the timing isintra-procedural stent thrombosis (IPST), which is a rare event indicating the development of occlusive 185186or non-occlusive new thrombus in or adjacent to a recently implanted stent before the PCI procedure is187completed. Some recent studies [13,14] show that these events may be of prognostic value. As such they should also be collected and presented as secondary endpoint but not included in the analysis of 188189ST.4.6. Stroke190191Stroke should be defined by a generally accepted definition [15]. Clinical studies in ACS have used192non-fatal stroke in the primary endpoint , including any types of strokes. However it is preferred to193include only ischemic strokes in the primary endpoint, as this is the true measure of efficacy;194haemorrhagic stroke should be included as a safety endpoint. An ischaemic stroke with haemorrhagic195conversion should be considered as “primary ischaemic”. The subgroup of “undefined strokes” should196be as small as possible in order to be able to properly assess the effect of the study treatment. In case 197all types of strokes are included in the primary endpoint, a sensitivity analysis including only ischemic198stroke should be submitted.4.7. Left ventricular function and heart failure199Some medicinal products such as modulators of reperfusion injury or inflammation, or gene/cell200201therapy are developed to improve myocardial function and reduce the occurrence of HF. In these202cases, measurement of myocardial function could be a relevant endpoint to investigate the mechanismof action. In phase III studies, these endpoints can be investigated as secondary endpoints to support 203204the clinical endpoints. Occurrence of HF should be considered as a clinical endpoint in phase III studies205aimed at showing benefit in long-term cardiovascular outcome. All-cause mortality and long term206follow-up are mandatory in studies with novel interventions.4.8. Composite endpoints207Due to the rather low incidence of cardiovascular events during the follow-up period after the acute 208209phase of the ACS, composite endpoints consisting of relevant components are acceptable, both as210primary and secondary endpoints. The composite of CV death, non-fatal MI and non-fatal stroke (Major211Adverse Cardiovascular Events, [MACE]) has commonly been used in registration studies, with non-212fatal strokes showing limited contribution to the results. As such, it is preferred to investigate the213composite of death and non-fatal MI in confirmatory studies; non-fatal ischaemic stroke could beincluded in the composite if justified. Sometimes different definitions of MACE are being used with214215novel therapies [16], that should be justified when used in place of MACE. The inclusion of less216objective and clinically derived outcomes in the same composite is generally not encouraged, as they217may either drive the efficacy or dilute the results. In case these endpoints are included they have to be218stringently defined, and adjudicated. Each component of the primary composite endpoint should be219analysed as secondary endpoint.220The net clinical benefit that includes both benefit and safety issues of the studied drug may be used as221a secondary endpoint to be evaluated if it contributes to the discussion on the benefit-risk balance of222the studied drug.4.9. Endpoints in fibrinolysis studies223224In fibrinolysis studies, angiographic studies using the TIMI (Thrombolysisi in Myocardial Infarction)perfusion grades as evaluation criteria are often used. However, complete recanalization cannot be 225226considered as a surrogate for survival when assessing fibrinolytic drugs, as some medicinal productsproviding higher complete recanalization rates than alteplase, failed to demonstrate additional survival 227228benefit. For this reason, all cause mortality is the most relevant endpoint or a combined endpoint as 229previously discussed (see 4.1). Secondary endpoints such as heart failure hospitalisations, left230ventricular function, ventricular arrhythmias, the need for rescue recanalization (emergent and/or231planned) should also be considered and justified.5. Methods to assess efficacy (how to measure the232endpoints)2335.1. Mortality234235Definition of CV death should be clearly defined, in line with acceptable standards [17]. It is mandatory 236to report and centrally adjudicate all mortality data where survival is an endpoint of the study.237Assessment of cardiovascular mortality will require censoring of other “types” of mortality, which may 238complicate its interpretation, in particular when non-CV deaths are in high proportion.5.2. New myocardial infarction239240The diagnostic of MI is based on the detection of a rise and/or fall of cardiac biomarker values241[preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference 242limit (URL). All MIs should be collected and also classified by their different sub types (i.e,243spontaneous, secondary to an ischemic imbalance, related to PCI, related to ST or CABG) [10]. This is 244particularly important considering the different prognostic values of each type of MI. For the same 245reason and to support the clinical relevance of post procedural MIs, these events should be presented 246with higher cut-off values (≥ 5 and ≥10x upper level of normal ULN, in case of CK-MB or ≥70x ULN of 247cTn) [18]. These higher cut-off values can also help in diagnosing MIs in the setting of elevated248baseline biomarkers, which is a problematic situation. In such cases, serial measurements of the249biomarkers are necessary, in addition to new ECG changes or signs of worsening of cardiac function, 250e.g. HFor hypotension [18].5.3. Revascularisation251252The underlying cause of revascularization should be identified: restenosis, ST or disease progression. 253In the latter case target vessel revascularization (TVR) could be included. Early target lesion eventsafter revascularization (before 30 days) are more likely to be caused by an angiographic complication 254255and should preferably be included as safety endpoint (see ST).5.4. Unstable angina pectoris necessitating hospitalisation256257When investigated, robust definitions should be employed. In order to support the seriousness of the 258event it should also be shown that it has led to a revascularisation procedure. Since a medicinalproduct that prevents death and/or new MI might result in more patients suffering from UA, the259260analysis of this endpoint should take into account censoring issues as well.5.5. Stent thrombosis261262ST should be collected and classified as definite, probable and possible in line with acceptable263definitions [19]. In addition, the timing of ST should be documented (acute, sub-acute, late and very 264late), as risk factors and clinical sequels differ with timing.5.6. Ventricular function and heart failure265266Investigation of cardiac function should follow state of the art methods. This can include among others 267measurement of ventricular function by isotopic method and/or by cardiac magnetic resonance imaging 268and/or echocardiography. Investigation of HFshould follow the relevant CHMP guidelines.5.7. Angiographic endpoints269270Angiograms should undergo central blinded reading. In principle, the rate of TIMI 3 flow (complete 271revascularization) of the infarct related artery at 90 minutes is considered the most relevant272angiographic endpoint, as it has been shown to correlate with an improved outcome in terms of273mortality and left ventricular function. An earlier evaluation of the patency pattern (i.e. 30 and 60274minutes) may provide important information on the speed of recanalization. Whatever is the time-point 275selected as primary outcome, it must be properly justified and pre-specified in the clinical trial.6. Selection of patients2766.1. Study population277The definition of the different ACS subtypes should be based on current guidelines/universal definition 278279of MI including STEMI and NSTEMI as well as UA [3, 4, 10].6.1.1. STE-ACS (ST elevation acute coronary syndrome)280281In patients with acute chest pain and persistent (>20 min) ST-segment elevation on ECG the282diagnostic of STE-ACS is made [3]. This condition generally reflects an acute total coronary occlusion.Most patients will ultimately develop an ST-elevation myocardial infarction (STEMI) with the criteria of 283284acute myocardial infarction described before [see 5.2].6.1.2. NSTE-ACS (Non-ST elevation acute coronary syndrome)285286In patients with acute chest pain but no persistent ST-segment elevation the diagnostic of NSTE-ACS is 287made [4]. ECG changes may include transient ST-segment elevation, persistent or transient ST-288segment depression, T-wave inversion, flat T waves or pseudo-normalization of T waves or the ECG 289may be normal. The clinical spectrum of non-ST-elevation ACS (NSTE-ACS) may range from patients 290free of symptoms at presentation to individuals with ongoing ischaemia, electrical or haemodynamic 291instability or cardiac arrest. The pathological correlate at the myocardial level is cardiomyocyte292necrosis (NSTEMI) or, less frequently, myocardial ischaemia without cell loss (UA). Currently, cardiac 293troponins play a central role in establishing a diagnosis and stratifying risk, and make it possible to 294distinguish between NSTEMI and UA[4].6.1.3. Unstable angina295296Unstable angina (UA) is defined as myocardial ischemia at rest or minimal exertion in the absence of 297cardiomyocytes necrosis, i.e. without troponin elevation. Among NSTE-ACS population, the higher298sensitivity of troponin has resulted in an increase in the detection of MI [4]; the diagnosis of UAis less 299frequently made.6.2. Inclusion criteria for the therapeutic studies300301Inclusion of both STEMI and NSTEMI and/or NSTE-ACS patients in the same clinical trial (or not)302should be justified based on the mechanism of action of the investigated product and the proposed 303time of intervention. If both subgroups are investigated in the same trial, both subgroups should be 304well represented. For interventions aimed at post-acute and longer term phases (secondary305prevention or plaque stabilisation) it may be justified to address both conditions in the same clinical 306trial. Time of inclusion of the patients in relation to the index event should be set and adequately307discussed a priori.308Patients with unstable angina represent a different risk category and prognosis that necessitates309different interventions than NSTEMI patients. However, during the acute presentation of NSTE-ACS it may be difficult to discriminate NSTEMI from UA so both groups have been included in some clinical 310311studies. In general, the investigation of interventions in these patients is encouraged, but preferably in 312separate clinical trials.If fibrinolysis is considered, inclusion criteria should be in line with the current treatment guidelines 313314concerning the inclusion for fibrinolysis [3].6.3. Exclusion criteria for the therapeutic studies315316If the patients do not fulfil the above criteria for ACS they should be excluded from the ACS studies. 317Other life-threatening conditions presenting with chest pain, such as dissecting aneurysm,318myopericarditis or pulmonary embolism may also result in elevated troponins and should always be 319considered as differential diagnoses [4].320If drugs interfering with the haemostatic system are tested, patients with a significant risk of bleeding 321(e.g. recent stroke, recent bleeding, major trauma or surgical intervention) and/or a propensity to 322bleed (e.g. thrombocytopenia, clotting disturbances, intracranial vascular diseases, peptic ulcers,323haemophilia) should be excluded from participation in the clinical studies.324Attention should be paid to the time elapsed between a previous application of antiplatelet or325anticoagulant acting agent beforehand and the administration of study drug (e.g. the pharmacokinetic 326[PK] and even more importantly, the pharmacodynamic [PD] half-life of these previously administered 327drugs).328For reasons of generalisability of the study results to the future target population it is strongly advised 329not to define the exclusion criteria too narrow, i.e. polymorbid patients (e.g. renal and/or hepatic330impairment, heart failure), should not automatically be excluded from the main therapeutic clinical 331trials.332When fibrinolysis is considered, exclusion criteria for fibrinolysis should be strictly respected [3].6.4. Risk Stratification333334In clinical trials, the ability of the therapy to demonstrate a treatment effect may depend on the335underlying risk and expected event rates. Enrichment strategies are sometimes used in trials to obtain 336the required number of events with a reasonable time in specific subgroups who are likely to exhibit a 337higher event rate than the overall target population and potentially larger treatment effect. In thatcase, it has to be shown that the results of this enriched study population can be extrapolated to the 338339general population.。
中译勿删
Article QQ.E.15:{管理审查的例外}在不妨碍QQ.E.4的范围和对其遵守的情况下，各成员方应该适用或维持对医药品管理审查的例外。
Article QQ.E.16:{药品数据保护/未披露的测试或其它数据的保护}(a)如果一个成员方要求，有关产品安全和效用的未披露的测试或其它数据的提交为获得新医药品上市审批的一个条件，该成员方不应该允许第三方，在没有之前提交这些信息的人同意的情况下，以如下依据营销相同或类似产品：(i)这些信息；或者(ii)授予提交这些信息的人的上市核准从新医药品在成员方地域内上市审批之日起至少5年内。
(b) 如果一个成员方允许提交产品之前在其它地域内上市审批所用的证据作为授予新医药品上市核准的一个条件，则该成员方不应该允许第三方，在没有之前提交的关于产品安全与效用信息的人同意的情况下，从新医药品于该成员方地域内上市审批之日起至少5年内，以有关此前在其它地域内上市审批所用的证据为基础营销相同或类似的产品。
2．各成员方应该：(a) 对于被要求提交的支持先前被核准的医药品的上市审批的关于新指标、新配方或者新管理方法的新临床资料，规定至少三年的比照适用Article QQ.E.16.1的期限；或者，(b)对于包含一种该成员方先前未被批准的化学物质新医药品，规定至少五年的比照适用Article QQ.E.16.1的期限。
3．尽管上述段一、段二和Article QQ.E.20的规定，一个成员方可以依据如下采取措施保护公共健康：(a) 《关于TRIPS协议和公共健康的宣言》（WT/MIN(01)/DEC/2）（简称《宣言》）;(b) 经WTO成员依据WTO协议同意的，放弃任何执行《宣言》的TRIPS协议条款并在成员双方间有效的声明；和(c)任何在成员方间生效的对TRIPS协议的执行《宣言》修正。
Article QQ.E.17如果一成员方允许除最初安全与有效性信息提交者之外的人，以此前被审批的有关某产品安全与有效性的证据或信息，例如此前由某成员方或在其它地域批准上市时的证据，为批准医药品上市的条件，该成员方应该提供：（a）一个向专利持有者发出通知或允许一位专利持有者在这一医药品上市前得到通知的机制，通知他其他这类人正在为被批准的产品或其被批准的使用方法提供保护的专利适用期内寻求该产品的上市。
OSHA现场作业手册说明书
DIRECTIVE NUMBER: CPL 02-00-150 EFFECTIVE DATE: April 22, 2011 SUBJECT: Field Operations Manual (FOM)ABSTRACTPurpose: This instruction cancels and replaces OSHA Instruction CPL 02-00-148,Field Operations Manual (FOM), issued November 9, 2009, whichreplaced the September 26, 1994 Instruction that implemented the FieldInspection Reference Manual (FIRM). The FOM is a revision of OSHA’senforcement policies and procedures manual that provides the field officesa reference document for identifying the responsibilities associated withthe majority of their inspection duties. This Instruction also cancels OSHAInstruction FAP 01-00-003 Federal Agency Safety and Health Programs,May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045,Revised Field Operations Manual, June 15, 1989.Scope: OSHA-wide.References: Title 29 Code of Federal Regulations §1903.6, Advance Notice ofInspections; 29 Code of Federal Regulations §1903.14, Policy RegardingEmployee Rescue Activities; 29 Code of Federal Regulations §1903.19,Abatement Verification; 29 Code of Federal Regulations §1904.39,Reporting Fatalities and Multiple Hospitalizations to OSHA; and Housingfor Agricultural Workers: Final Rule, Federal Register, March 4, 1980 (45FR 14180).Cancellations: OSHA Instruction CPL 02-00-148, Field Operations Manual, November9, 2009.OSHA Instruction FAP 01-00-003, Federal Agency Safety and HealthPrograms, May 17, 1996.Chapter 13 of OSHA Instruction CPL 02-00-045, Revised FieldOperations Manual, June 15, 1989.State Impact: Notice of Intent and Adoption required. See paragraph VI.Action Offices: National, Regional, and Area OfficesOriginating Office: Directorate of Enforcement Programs Contact: Directorate of Enforcement ProgramsOffice of General Industry Enforcement200 Constitution Avenue, NW, N3 119Washington, DC 20210202-693-1850By and Under the Authority ofDavid Michaels, PhD, MPHAssistant SecretaryExecutive SummaryThis instruction cancels and replaces OSHA Instruction CPL 02-00-148, Field Operations Manual (FOM), issued November 9, 2009. The one remaining part of the prior Field Operations Manual, the chapter on Disclosure, will be added at a later date. This Instruction also cancels OSHA Instruction FAP 01-00-003 Federal Agency Safety and Health Programs, May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045, Revised Field Operations Manual, June 15, 1989. This Instruction constitutes OSHA’s general enforcement policies and procedures manual for use by the field offices in conducting inspections, issuing citations and proposing penalties.Significant Changes∙A new Table of Contents for the entire FOM is added.∙ A new References section for the entire FOM is added∙ A new Cancellations section for the entire FOM is added.∙Adds a Maritime Industry Sector to Section III of Chapter 10, Industry Sectors.∙Revises sections referring to the Enhanced Enforcement Program (EEP) replacing the information with the Severe Violator Enforcement Program (SVEP).∙Adds Chapter 13, Federal Agency Field Activities.∙Cancels OSHA Instruction FAP 01-00-003, Federal Agency Safety and Health Programs, May 17, 1996.DisclaimerThis manual is intended to provide instruction regarding some of the internal operations of the Occupational Safety and Health Administration (OSHA), and is solely for the benefit of the Government. No duties, rights, or benefits, substantive or procedural, are created or implied by this manual. The contents of this manual are not enforceable by any person or entity against the Department of Labor or the United States. Statements which reflect current Occupational Safety and Health Review Commission or court precedents do not necessarily indicate acquiescence with those precedents.Table of ContentsCHAPTER 1INTRODUCTIONI.PURPOSE. ........................................................................................................... 1-1 II.SCOPE. ................................................................................................................ 1-1 III.REFERENCES .................................................................................................... 1-1 IV.CANCELLATIONS............................................................................................. 1-8 V. ACTION INFORMATION ................................................................................. 1-8A.R ESPONSIBLE O FFICE.......................................................................................................................................... 1-8B.A CTION O FFICES. .................................................................................................................... 1-8C. I NFORMATION O FFICES............................................................................................................ 1-8 VI. STATE IMPACT. ................................................................................................ 1-8 VII.SIGNIFICANT CHANGES. ............................................................................... 1-9 VIII.BACKGROUND. ................................................................................................. 1-9 IX. DEFINITIONS AND TERMINOLOGY. ........................................................ 1-10A.T HE A CT................................................................................................................................................................. 1-10B. C OMPLIANCE S AFETY AND H EALTH O FFICER (CSHO). ...........................................................1-10B.H E/S HE AND H IS/H ERS ..................................................................................................................................... 1-10C.P ROFESSIONAL J UDGMENT............................................................................................................................... 1-10E. W ORKPLACE AND W ORKSITE ......................................................................................................................... 1-10CHAPTER 2PROGRAM PLANNINGI.INTRODUCTION ............................................................................................... 2-1 II.AREA OFFICE RESPONSIBILITIES. .............................................................. 2-1A.P ROVIDING A SSISTANCE TO S MALL E MPLOYERS. ...................................................................................... 2-1B.A REA O FFICE O UTREACH P ROGRAM. ............................................................................................................. 2-1C. R ESPONDING TO R EQUESTS FOR A SSISTANCE. ............................................................................................ 2-2 III. OSHA COOPERATIVE PROGRAMS OVERVIEW. ...................................... 2-2A.V OLUNTARY P ROTECTION P ROGRAM (VPP). ........................................................................... 2-2B.O NSITE C ONSULTATION P ROGRAM. ................................................................................................................ 2-2C.S TRATEGIC P ARTNERSHIPS................................................................................................................................. 2-3D.A LLIANCE P ROGRAM ........................................................................................................................................... 2-3 IV. ENFORCEMENT PROGRAM SCHEDULING. ................................................ 2-4A.G ENERAL ................................................................................................................................................................. 2-4B.I NSPECTION P RIORITY C RITERIA. ..................................................................................................................... 2-4C.E FFECT OF C ONTEST ............................................................................................................................................ 2-5D.E NFORCEMENT E XEMPTIONS AND L IMITATIONS. ....................................................................................... 2-6E.P REEMPTION BY A NOTHER F EDERAL A GENCY ........................................................................................... 2-6F.U NITED S TATES P OSTAL S ERVICE. .................................................................................................................. 2-7G.H OME-B ASED W ORKSITES. ................................................................................................................................ 2-8H.I NSPECTION/I NVESTIGATION T YPES. ............................................................................................................... 2-8 V.UNPROGRAMMED ACTIVITY – HAZARD EVALUATION AND INSPECTION SCHEDULING ............................................................................ 2-9 VI.PROGRAMMED INSPECTIONS. ................................................................... 2-10A.S ITE-S PECIFIC T ARGETING (SST) P ROGRAM. ............................................................................................. 2-10B.S CHEDULING FOR C ONSTRUCTION I NSPECTIONS. ..................................................................................... 2-10C.S CHEDULING FOR M ARITIME I NSPECTIONS. ............................................................................. 2-11D.S PECIAL E MPHASIS P ROGRAMS (SEP S). ................................................................................... 2-12E.N ATIONAL E MPHASIS P ROGRAMS (NEP S) ............................................................................... 2-13F.L OCAL E MPHASIS P ROGRAMS (LEP S) AND R EGIONAL E MPHASIS P ROGRAMS (REP S) ............ 2-13G.O THER S PECIAL P ROGRAMS. ............................................................................................................................ 2-13H.I NSPECTION S CHEDULING AND I NTERFACE WITH C OOPERATIVE P ROGRAM P ARTICIPANTS ....... 2-13CHAPTER 3INSPECTION PROCEDURESI.INSPECTION PREPARATION. .......................................................................... 3-1 II.INSPECTION PLANNING. .................................................................................. 3-1A.R EVIEW OF I NSPECTION H ISTORY .................................................................................................................... 3-1B.R EVIEW OF C OOPERATIVE P ROGRAM P ARTICIPATION .............................................................................. 3-1C.OSHA D ATA I NITIATIVE (ODI) D ATA R EVIEW .......................................................................................... 3-2D.S AFETY AND H EALTH I SSUES R ELATING TO CSHO S.................................................................. 3-2E.A DVANCE N OTICE. ................................................................................................................................................ 3-3F.P RE-I NSPECTION C OMPULSORY P ROCESS ...................................................................................................... 3-5G.P ERSONAL S ECURITY C LEARANCE. ................................................................................................................. 3-5H.E XPERT A SSISTANCE. ........................................................................................................................................... 3-5 III. INSPECTION SCOPE. ......................................................................................... 3-6A.C OMPREHENSIVE ................................................................................................................................................... 3-6B.P ARTIAL. ................................................................................................................................................................... 3-6 IV. CONDUCT OF INSPECTION .............................................................................. 3-6A.T IME OF I NSPECTION............................................................................................................................................. 3-6B.P RESENTING C REDENTIALS. ............................................................................................................................... 3-6C.R EFUSAL TO P ERMIT I NSPECTION AND I NTERFERENCE ............................................................................. 3-7D.E MPLOYEE P ARTICIPATION. ............................................................................................................................... 3-9E.R ELEASE FOR E NTRY ............................................................................................................................................ 3-9F.B ANKRUPT OR O UT OF B USINESS. .................................................................................................................... 3-9G.E MPLOYEE R ESPONSIBILITIES. ................................................................................................. 3-10H.S TRIKE OR L ABOR D ISPUTE ............................................................................................................................. 3-10I. V ARIANCES. .......................................................................................................................................................... 3-11 V. OPENING CONFERENCE. ................................................................................ 3-11A.G ENERAL ................................................................................................................................................................ 3-11B.R EVIEW OF A PPROPRIATION A CT E XEMPTIONS AND L IMITATION. ..................................................... 3-13C.R EVIEW S CREENING FOR P ROCESS S AFETY M ANAGEMENT (PSM) C OVERAGE............................. 3-13D.R EVIEW OF V OLUNTARY C OMPLIANCE P ROGRAMS. ................................................................................ 3-14E.D ISRUPTIVE C ONDUCT. ...................................................................................................................................... 3-15F.C LASSIFIED A REAS ............................................................................................................................................. 3-16VI. REVIEW OF RECORDS. ................................................................................... 3-16A.I NJURY AND I LLNESS R ECORDS...................................................................................................................... 3-16B.R ECORDING C RITERIA. ...................................................................................................................................... 3-18C. R ECORDKEEPING D EFICIENCIES. .................................................................................................................. 3-18 VII. WALKAROUND INSPECTION. ....................................................................... 3-19A.W ALKAROUND R EPRESENTATIVES ............................................................................................................... 3-19B.E VALUATION OF S AFETY AND H EALTH M ANAGEMENT S YSTEM. ....................................................... 3-20C.R ECORD A LL F ACTS P ERTINENT TO A V IOLATION. ................................................................................. 3-20D.T ESTIFYING IN H EARINGS ................................................................................................................................ 3-21E.T RADE S ECRETS. ................................................................................................................................................. 3-21F.C OLLECTING S AMPLES. ..................................................................................................................................... 3-22G.P HOTOGRAPHS AND V IDEOTAPES.................................................................................................................. 3-22H.V IOLATIONS OF O THER L AWS. ....................................................................................................................... 3-23I.I NTERVIEWS OF N ON-M ANAGERIAL E MPLOYEES .................................................................................... 3-23J.M ULTI-E MPLOYER W ORKSITES ..................................................................................................................... 3-27 K.A DMINISTRATIVE S UBPOENA.......................................................................................................................... 3-27 L.E MPLOYER A BATEMENT A SSISTANCE. ........................................................................................................ 3-27 VIII. CLOSING CONFERENCE. .............................................................................. 3-28A.P ARTICIPANTS. ..................................................................................................................................................... 3-28B.D ISCUSSION I TEMS. ............................................................................................................................................ 3-28C.A DVICE TO A TTENDEES .................................................................................................................................... 3-29D.P ENALTIES............................................................................................................................................................. 3-30E.F EASIBLE A DMINISTRATIVE, W ORK P RACTICE AND E NGINEERING C ONTROLS. ............................ 3-30F.R EDUCING E MPLOYEE E XPOSURE. ................................................................................................................ 3-32G.A BATEMENT V ERIFICATION. ........................................................................................................................... 3-32H.E MPLOYEE D ISCRIMINATION .......................................................................................................................... 3-33 IX. SPECIAL INSPECTION PROCEDURES. ...................................................... 3-33A.F OLLOW-UP AND M ONITORING I NSPECTIONS............................................................................................ 3-33B.C ONSTRUCTION I NSPECTIONS ......................................................................................................................... 3-34C. F EDERAL A GENCY I NSPECTIONS. ................................................................................................................. 3-35CHAPTER 4VIOLATIONSI. BASIS OF VIOLATIONS ..................................................................................... 4-1A.S TANDARDS AND R EGULATIONS. .................................................................................................................... 4-1B.E MPLOYEE E XPOSURE. ........................................................................................................................................ 4-3C.R EGULATORY R EQUIREMENTS. ........................................................................................................................ 4-6D.H AZARD C OMMUNICATION. .............................................................................................................................. 4-6E. E MPLOYER/E MPLOYEE R ESPONSIBILITIES ................................................................................................... 4-6 II. SERIOUS VIOLATIONS. .................................................................................... 4-8A.S ECTION 17(K). ......................................................................................................................... 4-8B.E STABLISHING S ERIOUS V IOLATIONS ............................................................................................................ 4-8C. F OUR S TEPS TO BE D OCUMENTED. ................................................................................................................... 4-8 III. GENERAL DUTY REQUIREMENTS ............................................................. 4-14A.E VALUATION OF G ENERAL D UTY R EQUIREMENTS ................................................................................. 4-14B.E LEMENTS OF A G ENERAL D UTY R EQUIREMENT V IOLATION.............................................................. 4-14C. U SE OF THE G ENERAL D UTY C LAUSE ........................................................................................................ 4-23D.L IMITATIONS OF U SE OF THE G ENERAL D UTY C LAUSE. ..............................................................E.C LASSIFICATION OF V IOLATIONS C ITED U NDER THE G ENERAL D UTY C LAUSE. ..................F. P ROCEDURES FOR I MPLEMENTATION OF S ECTION 5(A)(1) E NFORCEMENT ............................ 4-25 4-27 4-27IV.OTHER-THAN-SERIOUS VIOLATIONS ............................................... 4-28 V.WILLFUL VIOLATIONS. ......................................................................... 4-28A.I NTENTIONAL D ISREGARD V IOLATIONS. ..........................................................................................4-28B.P LAIN I NDIFFERENCE V IOLATIONS. ...................................................................................................4-29 VI. CRIMINAL/WILLFUL VIOLATIONS. ................................................... 4-30A.A REA D IRECTOR C OORDINATION ....................................................................................................... 4-31B.C RITERIA FOR I NVESTIGATING P OSSIBLE C RIMINAL/W ILLFUL V IOLATIONS ........................ 4-31C. W ILLFUL V IOLATIONS R ELATED TO A F ATALITY .......................................................................... 4-32 VII. REPEATED VIOLATIONS. ...................................................................... 4-32A.F EDERAL AND S TATE P LAN V IOLATIONS. ........................................................................................4-32B.I DENTICAL S TANDARDS. .......................................................................................................................4-32C.D IFFERENT S TANDARDS. .......................................................................................................................4-33D.O BTAINING I NSPECTION H ISTORY. .....................................................................................................4-33E.T IME L IMITATIONS..................................................................................................................................4-34F.R EPEATED V. F AILURE TO A BATE....................................................................................................... 4-34G. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-35 VIII. DE MINIMIS CONDITIONS. ................................................................... 4-36A.C RITERIA ................................................................................................................................................... 4-36B.P ROFESSIONAL J UDGMENT. ..................................................................................................................4-37C. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-37 IX. CITING IN THE ALTERNATIVE ............................................................ 4-37 X. COMBINING AND GROUPING VIOLATIONS. ................................... 4-37A.C OMBINING. ..............................................................................................................................................4-37B.G ROUPING. ................................................................................................................................................4-38C. W HEN N OT TO G ROUP OR C OMBINE. ................................................................................................4-38 XI. HEALTH STANDARD VIOLATIONS ....................................................... 4-39A.C ITATION OF V ENTILATION S TANDARDS ......................................................................................... 4-39B.V IOLATIONS OF THE N OISE S TANDARD. ...........................................................................................4-40 XII. VIOLATIONS OF THE RESPIRATORY PROTECTION STANDARD(§1910.134). ....................................................................................................... XIII. VIOLATIONS OF AIR CONTAMINANT STANDARDS (§1910.1000) ... 4-43 4-43A.R EQUIREMENTS UNDER THE STANDARD: .................................................................................................. 4-43B.C LASSIFICATION OF V IOLATIONS OF A IR C ONTAMINANT S TANDARDS. ......................................... 4-43 XIV. CITING IMPROPER PERSONAL HYGIENE PRACTICES. ................... 4-45A.I NGESTION H AZARDS. .................................................................................................................................... 4-45B.A BSORPTION H AZARDS. ................................................................................................................................ 4-46C.W IPE S AMPLING. ............................................................................................................................................. 4-46D.C ITATION P OLICY ............................................................................................................................................ 4-46 XV. BIOLOGICAL MONITORING. ...................................................................... 4-47CHAPTER 5CASE FILE PREPARATION AND DOCUMENTATIONI.INTRODUCTION ............................................................................................... 5-1 II.INSPECTION CONDUCTED, CITATIONS BEING ISSUED. .................... 5-1A.OSHA-1 ................................................................................................................................... 5-1B.OSHA-1A. ............................................................................................................................... 5-1C. OSHA-1B. ................................................................................................................................ 5-2 III.INSPECTION CONDUCTED BUT NO CITATIONS ISSUED .................... 5-5 IV.NO INSPECTION ............................................................................................... 5-5 V. HEALTH INSPECTIONS. ................................................................................. 5-6A.D OCUMENT P OTENTIAL E XPOSURE. ............................................................................................................... 5-6B.E MPLOYER’S O CCUPATIONAL S AFETY AND H EALTH S YSTEM. ............................................................. 5-6 VI. AFFIRMATIVE DEFENSES............................................................................. 5-8A.B URDEN OF P ROOF. .............................................................................................................................................. 5-8B.E XPLANATIONS. ..................................................................................................................................................... 5-8 VII. INTERVIEW STATEMENTS. ........................................................................ 5-10A.G ENERALLY. ......................................................................................................................................................... 5-10B.CSHO S SHALL OBTAIN WRITTEN STATEMENTS WHEN: .......................................................................... 5-10C.L ANGUAGE AND W ORDING OF S TATEMENT. ............................................................................................. 5-11D.R EFUSAL TO S IGN S TATEMENT ...................................................................................................................... 5-11E.V IDEO AND A UDIOTAPED S TATEMENTS. ..................................................................................................... 5-11F.A DMINISTRATIVE D EPOSITIONS. .............................................................................................5-11 VIII. PAPERWORK AND WRITTEN PROGRAM REQUIREMENTS. .......... 5-12 IX.GUIDELINES FOR CASE FILE DOCUMENTATION FOR USE WITH VIDEOTAPES AND AUDIOTAPES .............................................................. 5-12 X.CASE FILE ACTIVITY DIARY SHEET. ..................................................... 5-12 XI. CITATIONS. ..................................................................................................... 5-12A.S TATUTE OF L IMITATIONS. .............................................................................................................................. 5-13B.I SSUING C ITATIONS. ........................................................................................................................................... 5-13C.A MENDING/W ITHDRAWING C ITATIONS AND N OTIFICATION OF P ENALTIES. .................................. 5-13D.P ROCEDURES FOR A MENDING OR W ITHDRAWING C ITATIONS ............................................................ 5-14 XII. INSPECTION RECORDS. ............................................................................... 5-15A.G ENERALLY. ......................................................................................................................................................... 5-15B.R ELEASE OF I NSPECTION I NFORMATION ..................................................................................................... 5-15C. C LASSIFIED AND T RADE S ECRET I NFORMATION ...................................................................................... 5-16。
当代研究生英语 第七单元 B课文翻译
价格的利润生物公司正在吞噬可改变动物DNA序列的所有专利。
这是对阻碍医学研究发展的一种冲击。
木匠认为他们的贸易工具是理所当然的。
他们买木材和锤子后，他们可以使用木材和锤子去制作任何他们所选择的东西。
多年之后来自木材厂和工具储藏室的人并没有任何进展，也没有索要利润份额。
对于那些打造明日药物的科学家们来说，这种独立性是一种罕见的奢侈品。
发展或是发现这些生物技术贸易中的工具和稀有材料的公司，对那些其他也用这些工具和材料的人进行了严格的监控。
这些工具包括关键基因的DNA序列，人类、动物植物和一些病毒的基因的部分片段，例如，HIV,克隆细胞，酶，删除基因和用于快速扫描DNA样品的DNA 芯片。
为了将他们这些关键的资源得到手，医学研究人员进场不得不签署协议，这些协议可以制约他们如何使用这些资源或是保证发现这些的公司可以得到最终结果中的部分利益。
许多学者称这抑制了了解和治愈疾病的进程。
这些建议使Harold得到了警示，Harold是华盛顿附近的美国国家卫生研究院的院长，在同年早期，他建立了一个工作小组去调查此事。
由于他的提早的调查，下个月出就能发布初步的报告。
来自安阿伯密歇根大学的法律教授，该工作组的主席Rebecea Eisenberg说，她们的工作组已经听到了好多研究者的抱怨，在它们中有一份由美国联合大学技术管理组提交的重量级的卷宗。
为了帮助收集证据，NIH建立了一个网站，在这个网站上研究者们可以匿名举报一些案件，这些案件他们相信他们的工作已经被这些限制性许可证严重阻碍了。
迫使研究人员在出版之前需要将他们的手稿展示给公司的这一保密条款和协议是投诉中最常见的原因之一。
另一个问题是一些公司坚持保有自动许可证的权利，该许可证是有关利用他们物质所生产的任何未来将被发现的产品，并且这些赋予他们对任何利用他们的工具所赚取的利润的支配权利的条款也有保有的权利。
Eisenberg说：“如果你不得不签署了许多这样的条款的话，那真的是一个大麻烦”。
药物替代疗法英语作文高中
药物替代疗法英语作文高中Title: Alternative Medicine: A Controversial Approach。
Introduction:Alternative medicine, also known as complementary or integrative medicine, has gained significant attention in recent years as a substitute for conventional medical treatments. While some advocate for its effectiveness and holistic approach, others remain skeptical due to the lack of scientific evidence and potential risks associated with certain practices. This essay delves into the controversial topic of alternative medicine, examining its principles, benefits, drawbacks, and the need for a balanced perspective.Body:I. Understanding Alternative Medicine。
A. Definition and Scope。
1. Definition of alternative medicine。
2. Various forms and practices: acupuncture, herbal medicine, chiropractic care, etc.B. Principles and Philosophy。
病历文书中常用基本用语的英文翻译
病历文书中常用基本用语的英文翻译导语：来源：梅斯医学1、抗生素医嘱[Antibiotic order]·Prophylaxis [预防性用药]Duration of order[用药时间] 24hrProcedure[操作，手术]·Empiric therapy [经验性治疗]Suspected site and organism[怀疑感染的部位和致病菌] 72hr Cultures ordered[是否做培养]·Documented infection[明确感染]Site and organism[部位和致病菌] 5days·Other[其它]Explanation required [解释理由] 24hr·Antibiotic allergies[何种抗生素过敏]No known allergy [无已知的过敏]·Drug dose Route frequency[药名剂量途径次数]2、医嘱首页[Admission / transfer]·Admit / transfer to [收入或转入]·Resident [住院医师] Attending[主治医师]·Condition [病情]·Diagnosis[诊断]·Diet [饮食]·Activity [活动]·Vital signs[测生命体征]·I / O [记进出量]·Allergies[过敏]3、住院病历[case history]·Identification [病人一般情况]Name[性名]Sex[性别]Age [年龄]Marriage[婚姻]Person to notify and phone No.[联系人及电话] Race[民族]I.D. No.[身份证]Admission date[入院日期]Source of history[病史提供者]Reliability of history[可靠程度]Medical record No[病历号]Business phone No.[工作单位电话]Home address and phone No.[家庭住地及电话] ·Chief complaint[主诉]·History of present illness[现病史]·Past History[过去史]Surgical[外科]Medical[内科]Medications[用药]Allergies[过敏史]Social History[社会史]Habits[个人习惯]Smoking[吸烟]Family History[家族史]Ob/Gyn History[ 婚姻/生育史]Alcohol use[喝酒]·Review of Aystems[系统回顾]General[概况]Eyes, Ears, Nose and throat[五官] Pulmonary[呼吸]Cardiovascular[心血管]GI[消化]GU[生殖、泌尿系统]Musculoskeletal[肌肉骨骼]Neurology[神经系统]Endocrinology[内分泌系统]Lymphatic/Hematologic[淋巴系统/血液系统] ·Phys ical Exam[体检]Vital Signs[生命体征]λP[脉博]Bp[血压]R[呼吸]T[温度]Height[身高]Weight[体重]General[概况]λHEENT[五官]Neck[颈部]Back/Chest[背部/胸部]Breast[乳房]Heart[心脏]λHeart rate[心率]Heart rhythm[心律]Heart Border[心界]Murmur[杂音]Abdomen[腹部]λLiver[肝]Spleen[脾]Rectal[直肠]Genitalia[生殖系统]λExtremities[四肢]λNeurology[神经系统]cranial nerves[颅神经]sensation[感觉]Motor[运动]*Special P.E. on diseased organ system[专科情况]*Radiographic Findings[放射]*Laboratory Findings[化验]*Assessment[初步诊断与诊断依据]*Summary[病史小结]*Treatment Plan[治疗计划]4、输血申请单[Blood bank requisition form](1)reason for infusion[输血原因]▲红细胞[packed red cells, wshed RBCs]:*Hb<8.5 [血色素<8.5]*>20% blood volume lost [>20%血容量丢失]*cardio-pulmonary bypass with anticipated Hb <8[心肺分流术伴预计血色素<8]*chemotherapy or surgery with Hb <10[血色素<10的化疗或手术者]▲全血[whole blood]:massive on-going blood loss[大量出血]▲血小板[platelets]:*massive blood transfusion >10 units[输血10单位以上者]*platelet count <50×103/μl with active bleeding or surgery[血小板<5万伴活动性出血或手术者]*Cardio-pulmonary bypass uith pl<100×103/μl with octivebleeding[心肺分流术伴血小板<10万，活动性出血者]*Platelet count <20×103/μl[血板<2万]▲新鲜冰冻血浆[fresh frozen plasma]:*documented abnormal PT or PTT with bleeding orSurgery[PT、PTT异常的出血或手术病人]*specific clotting factor deficiencies with bleeding/surgerg[特殊凝血因子缺乏的出血/手术者]*blood transfusion >15units[输血>15个单位]*warfarin or antifibrinolytic therapy with bleeding[华法令或溶栓治疗后出血]*DIC[血管内弥漫性凝血]*Antithrombin III dficiency[凝血酶III 缺乏](2)输血要求[request for blood components]*patient blood group[血型]*Has the patient had transfusion or pregnancy in the past 3 months? [近3个月，病人是否输过血或怀孕过？]*Type and crossmatch [血型和血交叉]*Units or ml[单位或毫升]5、出院小结[discharge summary]Patient Name[病人姓名]λMedical Record No.[病历号]λAttending Physician[主治医生]λDate of Admission[入院日期]λDate of Discharge[出院日期]λPrincipal Diagnosis[主要诊断]λSecondary Diagnosis[次要诊断]λComplications[并发症]λOperation[手术名称]λReason for Admission[入院理由]λPhysical Findings[阳性体征]λLab/X-ray Findings[化验及放射报告]λHospital Course[住院诊治经过]λCondition[出院状况]λDisposition[出院去向]λMedications[出院用药]λPrognosis[预后]λSpecial Instruction to the Patient(diet, physicalλ activity)[出院指导（饮食，活动量）]λFollow-up Care[随随访]λ6、住院/出院病历首页[Admission/discharge record] ·Patient name[病人姓名]·race[种族]·address[地址]·religion[宗教]·medical service[科别]·admit (discharge) date[入院（出院）日期]·Length of stay [住院天数]·guarantor name [担保人姓名]·next of kin or person to notify[需通知的亲属姓名] ·relation to patient[与病人关系]·previous admit date[上次住院日期]·admitting physician [入院医生]·attending physician [主治医生]·admitting diagnosis[入院诊断]·final (principal) diagnosis[最终（主要）诊断]·secondary diagnosis[次要诊断]·adverse reactions (complications)[副作用（合并症）]·incision type[切口类型]·healing course[愈合等级]·operative (non-operative) procedures[手术（非手术）操作] ·nosocomial infection[院内感染]·consultants [会诊]·Critical-No. of times[抢救次数]·recovered-No. of times[成功次数]·Diagnosis qualitative analysis[诊断质量]OP.adm.and discharge Dx concur [门诊入院与出院诊断符合率] Clinical and pathological Dx concur[临床与病理诊断符合率] Pre- and post-operative Dx concur [术前术后诊断符合率]·Dx determined with in 24 hours (3 days) after admission[入院后24小时（3 天）内确诊]·Discharge status[出院状况]recovered[治愈]improved[好转]not improved[未愈]died [死亡]·Dispositon[去向]home[家]against medical ad[自动出院]autosy[尸检]transferred to[转院到]。
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ORIGINAL PAPEROperative versus non-operative treatment for clavicle fracture:a meta-analysisGuo-dong Liu &Song-lin Tong &Shan Ou &Le-shun Zhou &Jun Fei &Guo-xin Nan &Jian-wen GuReceived:2February 2013/Accepted:11March 2013/Published online:5May 2013#Springer-Verlag Berlin Heidelberg 2013AbstractPurpose The purpose of this study was to assess the effects of operative and non-operative treatment on clavicle fractures.Method Relevant clinical trials on the operative and non-operative treatment for clavicle fractures were retrieved through searching the databases MEDLINE,Embase,OVID and the Cochrane Central Register of Controlled Trials up to December 2011.The quality of the included studies was assessed by two authors.A meta-analysis was carried out onhomogeneous studies.Five studies involving 633clavicle fractures were included.Results The differences in nonunion [risk ratio (RR)0.12,95%confidence interval (CI)0.05–0.29],malunion (RR 0.11,95%CI 0.04–0.29)and neurological complications (RR 0.45,95%CI 0.25–0.81)were statistically significant between operative and non-operative treatment.There was no statistically significant difference in delayed union (RR 0.78,95%CI 0.31–1.95).Conclusion Operative treatment is better than non-operative treatment,but decisions should be made in accordance with specific conditions for clinical application.IntroductionClavicle fractures are frequent injuries,representing 2.6–10%of fractures in adults [1,2],of which midshaft fractures are the most common,accounting for approximately 81%of all clavicle fractures [2].Traditionally,clavicular fracture is treat-ed non-operatively with a figure-of-eight bandage or broad arm sling [3].Non-operative treatment is easily accepted by undemanding patients and patients who do not tolerate sur-gery well as it offers the advantages of minimal trauma,easy procedure and low cost.However,outcomes of non-operative treatment are not always excellent [4,5].Some specific sub-sets of patients are reported to be at a high risk for nonunion,shoulder dysfunction or residual pain after non-surgical man-agement [6].Therefore,operative treatment is playing an increasingly important role in the clinical setting,mainly using compression plating or intramedullary nail fixation [7–10].A number of studies have assessed the effectiveness of operative versus non-operative treatment for clavicle fractures in different populations;however,the results are inconsistent and inconclusive because of the small sample size in most of the studies [11–13].Meta-Guo-dong Liu and Song-lin Tong contributed equally to the study.G.-d.LiuDepartment 8,Research Institute of Surgery,Daping Hospital,Third Military Medical University,Chongqing 400042,People ’s Republic of ChinaS.-l.TongDepartment of Orthopedics,Cixi People ’s Hospital of Zhejiang Province,Cixi 315300,People ’s Republic of ChinaS.Ou (*):L.-s.ZhouDepartment of Anesthesiology,General Hospital of Chengdu Military Command,Chengdu,Sichuan 610083,People ’s Republic of Chinae-mail:euromountainou@J.FeiTraumatic Center,Research Institute of Surgery,Daping Hospital,Third Military Medical University,Chongqing 400042,People ’s Republic of ChinaG.-x.NanDepartment II of Orthopedics,Children ’s Hospital of Chongqing Medical University,Chongqing 400014,People ’s Republic of China J.-w.Gu (*)Department of Neurosurgery,General Hospital of Chengdu Military Command,Chengdu,Sichuan 610083,People ’s Republic of China e-mail:769419161@International Orthopaedics (SICOT)(2013)37:1495–1500DOI 10.1007/s00264-013-1871-zanalysis was first proposed by Beecher in1955and named by Glass in1976.It is defined as a statistical method for systematically combining the results of mul-tiple independent studies(controversial or even conflicting studies)and analysing a large data set to allow definite conclusions,offering great help for scien-tific research and practice decisions[14].Therefore,this report retrieved randomised controlled trials or clinical controlled trials of operative and non-operative treatment for clavicle fracture over nearly20years and meta-analysis was performed to provide a basis for the pre-ferred therapies for clavicle fracture in clinical practice.Materials and methodsLiterature searchThe databases PubMed,MEDLINE,EMBASE and the Cochrane Central Register of Controlled Trials(CCTR) were searched for all articles on operative and non-operative treatment for clavicle fracture with the following search terms:(clavicle)AND(fractures)AND(‘randomised controlled trial’OR‘controlled clinical trial’)where the search date was December2011.We also retrieved the relevant articles with Google Scholar.Inclusion and exclusion criteriaAbstracts of all citations and retrieved studies were reviewed.Studies meeting the following criteria were in-cluded:(1)original literature published at home and abroad;(2)randomised clinical trial(RCT)or controlled clinical trial(CCT)design;(3)having definite study time;(4)hav-ing definite sample size;(5)providing definite pathological diagnostic criteria;(6)the therapeutic methods are operative treatment(plating or intramedullary nailing)and non-operative treatment(arm sling or bandage);(7)the method of data collection is scientific and correct;and(8)compar-ison of Constant score(CS)scores,disabilities of the arm, shoulder and hand(DASH)scores,nonunion,delayed union or neurological complications.Studies were excluded if one of the following existed:(1) providing undefined sample and control source,non-therapeutic clinical studies,animal experiments,non-original studies and undefined grouping;(2)providing undefined path-ological diagnostic criteria;(3)patients without clavicle frac-ture due to trauma;(4)no control design;(5)the method ofTable1Basic situation and quality assessment of the studiesLiterature Journal Type Patients(n)Follow-up(n)Follow-uptimeOperative group Non-operativegroupBöhme(2011)[15]Z Orthop Unfall CCT120968months Plating/elasticintramedullary nailBandage fixation COTS(2007)[16]J Bone JointSurgRCT1321111year Plating Arm sling Jubel(2005)[17]Unfallchirurg CCT53536months Elastic intramedullary nail Bandage fixation Judd(2009)[18]Am J Orthop RCT57501year Elastic intramedullary nail Arm slingKulshrestha(2011) [19]J OrthopTraumaCCT736818months Plating Arm slingSmekal(2009)[20]J OrthopTraumaRCT68602years Elastic intramedullary nail Arm slingSmith(2001)[21]68th AM ofAAOSRCT1006518.5months Plating Arm slingVirtanen(2010) [22]75th AM ofAAOSRCT60511year Plating Arm slingCOTS Canadian Orthopaedic Trauma Society,AM of AAOS Annual Meeting of the American Academy of Orthopaedic SurgeonsTable2CS and DASH scoresLiterature CS scores DASH scoresOperative group Non-operativegroupOperativegroupNon-operativegroupBöhme(2011)[15]9490NA NACOTS(2007)[16]96.190.8 5.213Jubel(2005)[17]9890210 Judd(2009)[18]NA NA NA NAKulshrestha(2011)[19]NA NA NA NA Smekal(2009)[20]97.993.70.53 Smith(2001)[21]NA NA NA NA Virtanen(2010)[22]86.586.1 4.37.1 COTS Canadian Orthopaedic Trauma Societydata collection is not scientific and the method of data analysis is incorrect or not provided;(6)no therapeutic outcome;and (7)review literature,repeated reports and retrospective studies.Data extractionAll data were extracted independently by two authors according to the inclusion criteria listed above.Disagreements were resolved by discussion between the two reviewers.The following characteristics were collected from each study:the first author,year of publication,source,experiment design, sample size,sample characteristics,treatment outcome and others.Statistical analysisThe statistical analysis was conducted using Review Man-ager5.0software.Continuous data were expressed as standardised mean differences(SMD)and95%confidence intervals(CI).Dichotomous data were presented as risk ratios(RR)with95%CI.P≤0.05was considered statisti-cally significant.Heterogeneity was assessed with theχ2-based Q testing.If there was significant heterogeneity(P< 0.1),we selected a random effects model to pool the data.If not,a fixed effects model was used.ResultsLiterature characteristicsA total of37studies related to the effects of operative and non-operative treatment of clavicle fracture and the compli-cations were retrieved after the preliminary screening;eight of the37studies were incorporated into the study[15–22]. The basic characteristics of these studies such as the authors, publication year,journal,study type,the number of patients, therapeutic method and follow-up time are summarised in Table1.There were five RCT[16,18,20–22]and three CCT[15,17,19].The number of patients ranged from53to 132(Table1).Comparison of the CS and DASH scores between operative and non-operative treatment for clavicle fractureFive studies[15–17,20,22]reported the CS scores after the treatment of clavicle fracture and the results showed that the CS scores of the operative group were higher than those of the non-operative group.Four studies[16,17,20,22] reported the DASH scores and the DASH scores of the operative group were shown to be lower than those of the non-operative group.We did not compare thestatistical Fig.1Comparison of the nonunion rate after operative and non-operative treatment for claviclefractureFig.2Comparison of the malunion rate after operative and non-operative treatment for clavicle fracturedifference due to a lack of information on standard devia-tion..The definite scores are shown in Table2. Comparison of the nonunion rate between operativeand non-operative treatment for clavicle fractureEight RCT or CCT[15–22]reported the nonunion rate after operative and non-operative treatment of clavicle fracture in which306patients were included in the operative treatment group and260patients were included in the non-operative treatment group.No heterogeneity was observed between the studies(P=0.74,I2=0%);therefore,a fixed effect model was used.The result of meta-analysis showed that there was a statistical difference in the nonunion rate be-tween operative and non-operative treatment for clavicle fracture(RR0.12,95%CI0.05–0.29).Operative treatment could significantly reduce the nonunion rate(Fig.1). Comparison of the malunion rate between operativeand non-operative treatment for clavicle fractureSix RCT or CCT[15,16,19–22]reported the malunion rate after operative and non-operative treatment for clavicle frac-ture in which251patients were included in the operative treatment group and202patients were included in the non-operative treatment group.Heterogeneity was also not ob-served between the studies(P=0.97,I2=0%).The result of meta-analysis showed there was a significant difference in malunion rate between operative and non-operative treatment for clavicle fracture(RR0.11,95%CI0.04–0.29),indicating operative treatment reduces the malunion rate(Fig.2).Comparison of the delayed union rate between operative and non-operative treatment for clavicle fractureThere were five RCT or CCT[15,18–20,22]which had been performed to study the delayed union rate after operative and non-operative treatment of clavicle fracture.A total of337 patients were studied,including188patients receiving opera-tive treatment and149patients receiving non-operative treat-ment.No heterogeneity was present between the studies(P= 0.23,I2=29%).The result of meta-analysis showed that there was no statistical difference in the delayed union rate between operative and non-operative treatment for clavicle fracture (RR0.78,95%CI0.31–1.95),indicating operative treatment did not reduce the delayed union rate(Fig.3). Comparison of the neurological complication rateThere were seven RCT or CCT[15–18,20–22]which had been performed to study the neurological complication rate after operative and non-operative treatment for clavicle frac-ture.A total of468patients were studied,including261 patients receiving operative treatment and207patients re-ceiving non-operative treatment.No heterogeneity was pres-ent between the studies(P=0.23,I2=28%).The result of meta-analysis showed there was also no statistical difference in the neurological complication rate between operativeand Fig.3Comparison of the delayed union rate after operative and non-operative treatment for claviclefractureFig.4Comparison of the neurological complication rate after operative and non-operative treatment for clavicle fracturenon-operative treatment of clavicle fracture(RR0.45,95% CI0.25–0.80)(Fig.4).DiscussionSome systematic reviews on clavicle fracture treatment have been reported in previous studies.For example, Zlowodzki et al.[23]showed that the nonunion rate can reach4%by operative treatment and6%by non-operative treatment.However,this study only in-cluded three RCT containing a cohort study due to the limitation of methodology.Only one of the three RCT studied the effect of different operations on clavicle fracture.Lenza et al.[24]investigated three reports of non-operative treatment of middle third clavicle frac-tures,but the three reports could not analyse the effect of different operations on clavicle fracture.This meta-analysis included five RCT and three CCT published between2000and2011.This meta-analysis analysed the nonunion,malunion,delayed union and neurological complication rate after operative and non-operative treat-ment for clavicle fracture.The results showed that there were statistical differences in the nonunion,malunion and neurological complication rates between operative and non-operative treatment,suggesting operative treat-ment could decrease the incidence rate of these adverse events.Operative treatment did not reduce the delayed union rate in our study.These meta-analysis results should be cautiously interpreted because there are still some limitations to this study.(1)Although this meta-analysis was performed based on unbiased data,the bias must exist because of the differences in the concerned populations and regions in the studies.By collecting all papers about clavicle fracture using multiple languages,we believe that the results of the study are suitable for almost all populations.(2)Since the deficiency of the original data such as CS scores and the standard devi-ation of DASH scores,the CS scores and DASH scores only could be described.A statistical analysis could not be performed.(3)We did not analyse the effect of treatments on clavicle fracture according to different ages and sexes on account of the limitation of the studies included,which may affect the result of this meta-analysis.(4)Our study may also be influenced by the lack of final effect of the treatments on patients because of the delayed follow-up,the loss to follow-up and the increasing number of patients who dropped out of the studies.(5)Meta-analysis is a retrospective research tool that is subject to methodological deficiencies.Therefore, larger and well-designed studies are needed to confirm our results.ConclusionsOperative treatment reduces the nonunion,malunion and neurological complication rates of clavicle fractures,but does not affect the delayed union rate.For clinical applica-tion,we should make decisions in accordance with specific conditions.In order to avoid the risk of adverse events, operative treatment is a better therapeutic method if it is matched to the individual patient.Acknowledgments This study was supported by National Natural Science Foundation of China(No.81200964and No.31171069); Military Twelfth Five Key Projects(No.BWS11J038);Foundation of State Key Laboratory of Trauma,Burns and Combined Injuries (No.SKLKF201113)Conflict of interest The authors declare that they have no conflict of interest.References1.Robinson C(1998)Fractures of the clavicle in the adult.Epidemi-ology and classification.J Bone Joint Surg Br80(3):476–484 2.Postacchini F,Gumina S,De Santis P,Albo F(2002)Epidemiol-ogy of clavicle fractures.J Shoulder Elbow Surg11(5):452–456 3.Postacchini R,Gumina S,Farsetti P,Postacchini F(2010)Long-term results of conservative management of midshaft clavicle fracture.Int Orthop34(5):731–7364.Nowak J,Holgersson M,Larsson S(2004)Can we predict long-term sequelae after fractures of the clavicle based on initial find-ings?A prospective study with nine to ten years of follow-up.J Shoulder Elbow Surg13(5):479–4865.Robinson CM,Court-Brown CM,McQueen MM,Wakefield AE(2004)Estimating the risk of nonunion following nonoperative treatment of a clavicular fracture.J Bone Joint Surg Am 86(7):1359–13656.van der Meijden OA,Gaskill TR,Millett PJ(2011)Treatment ofclavicle fractures:current concepts review.J Shoulder Elbow Surg 21(3):423–4297.McKee M,Seiler J,Jupiter J(1995)The application of the limitedcontact dynamic compression plate in the upper extremity:an analysis of114consecutive cases.Injury26(10):661–6668.Poigenfürst J,Rappold G,Fischer W(1992)Plating of fresh clavic-ular fractures:results of122operations.Injury23(4):237–2419.Mueller M,Burger C,Florczyk A,Striepens N,Rangger C(2007)Elastic stable intramedullary nailing of midclavicular fractures in adults:32patients followed for1–5years.Acta Orthop78(3):421–42310.Eden L,Doht S,Frey SP,Ziegler D,Stoyhe J,Fehske K,Blunk T,Meffert RH(2012)Biomechanical comparison of the Locking Compression superior anterior clavicle plate with seven and ten hole reconstruction plates in midshaft clavicle fracture stabilisation.Int Orthop36(12):2537–254311.Rokito AS,Zuckerman JD,Shaari JM,Eisenberg DP,Cuomo F,Gallagher MA(2002)A comparison of nonoperative and operative treatment of type II distal clavicle fractures.Bull Hosp Jt Dis61(1–2):32–3912.Vander Have KL,Perdue AM,Caird MS,Farley FA(2010)Oper-ative versus nonoperative treatment of midshaft clavicle fractures in adolescents.J Pediatr Orthop30(4):307–31213.Virtanen KJ,Malmivaara AO,Remes VM,Paavola MP(2012)Operative and nonoperative treatment of clavicle fractures in adults.Acta Orthop83(1):65–7314.Deeks JJ,Altman DG,Bradburn MJ(2008)Statistical methods forexamining heterogeneity and combining results from several stud-ies in meta-analysis.Systematic reviews in health care:meta-analysis in context,2nd edn.BMJ Publishing Group,London, pp285–31215.Böhme J,Bonk A,Bacher G,Wilharm A,Hoffmann R,Josten C(2011)Current treatment concepts for mid-shaft fractures of the clavicle-results of a prospective multicentre study.Z Orthop Unfall 149(1):68–7616.Canadian Orthopaedic Trauma Society(2007)Nonoperative treat-ment compared with plate fixation of displaced midshaft clavicular fractures.A multicenter,randomized clinical trial.J Bone Joint Surg Am89:1–1017.Jubel A,Andermahr J,Prokop A,Lee J,Schiffer G,Rehm K(2005)Treatment of mid-clavicular fractures in adults.Early re-sults after rucksack bandage or elastic stable intramedullary nailing.Unfallchirurg108(9):707–71418.Judd DB,Pallis MP,Smith E,Bottoni CR(2009)Acuteoperative stabilization versus nonoperative management of clavicle fractures.Am J Orthop(Belle Mead NJ)38(7):341–34519.Kulshrestha V,Roy T,Audige L(2011)Operative versusnonoperative management of displaced midshaft clavicle frac-tures:a prospective cohort study.J Orthop Trauma25(1):31–38 20.Smekal V,Irenberger A,Struve P,Wambacher M,Krappinger D,Kralinger FS(2009)Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures-a randomized,controlled,clinical trial.J Orthop Trauma23(2):106–112 21.Smith C,Rudd J,Crosby L(2001)Results of operative versus non-operative treatment for100%displaced mid-shaft clavicle fractures:a prospective randomized trial.In:Proceedings from the68th AnnualMeeting of the American Academy of Orthopaedic Surgeons22.Virtanen KJ,Paavola MP,Remes VM,Pajarinen J,Savolainen V,Bjorkenheim,JM(2010)Nonoperative versus operative treatment of midshaft clavicle fractures:a randomized controlled trial.The 75th Annual Meeting of the American Academy of Orthopaedic Surgeons,9–12:65–7323.Zlowodzki M,Zelle BA,Cole PA,Jeray K,McKee MD(2005)Treatment of acute midshaft clavicle fractures:systematic review of2144fractures:on behalf of the Evidence-Based Orthopaedic Trauma Working Group.J Orthop Trauma19(7):504–50724.Lenza M,Belloti JC,Andriolo RB,Gomes Dos Santos JB,Faloppa F(2009)Conservative interventions for treating middle third clavicle fractures in adolescents and adults.Cochrane Data-base Syst Rev2:CD007121。