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FDA批准仿制安理申治疗阿尔茨海默病相关的痴呆症状

FDA批准仿制安理申治疗阿尔茨海默病相关的痴呆症状
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医学英语超级无敌终结版(2)

医学英语超级无敌终结版(2)

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omasti a巨乳症glassy透明globispori n球孢菌素globuli nuri a球蛋白尿globuli n球蛋白glycagon胰高血糖素glycan聚糖glyceride甘油酯glycyrrhizi a甘草gol den金黄goniosc opy前房角镜检查goniot omy前房角切开术good优granul ocytop oiesis粒细胞生成gray灰色green绿grisei n灰霉素grise oc occin灰球霉素,灰球菌素grise ofulvi n灰黄霉素grise oviridi n灰绿霉素,灰绿菌素grise um灰色的groove沟gru b幼虫gyrase旋转酶gyraul us旋螺属gyrosc op e回旋器gyrus(复gyri)(脑)回haemat ocrit血细胞比容haemat ology血液病学haemat oma血肿haematuri a血尿haemod ialysis血液透析haemogl obin血色素,血红蛋白haemolytic溶血的haemorrh age出血hairthri x毛发half半har d硬hectogram百克hectoliter百升hectometer百米hectonew ton百牛顿helical螺旋状的helicase解螺旋酶helicobacteri um螺杆菌属helicopepsin螺蛋白酶helicotre ma蜗孔hemangioma血管瘤hemat ocrit血细胞比容hemat ospermi a血精hemat uri a血尿(症)hemifac ial半面的hemiple gi a偏瘫,半身不遂hemipter a半翅目hemisphere半球hemobili a胆道出血hemodi alysi s血液透析hemolytic-resistance溶血抵抗力hemolytic溶血的hemopurific ation血液净化hemostasi s止血hepat ocyte肝细胞heptan e庚烷heptape ptide七肽heptol庚醇heptose庚糖heterau xesi s异速生长heteroantige n异种抗原heterocyst异形细胞;异形囊胞heterogamy异配生殖heterophye s异形吸虫heterophyi dae异形科heterophyi d异形的hetero异形hexagon al六角形的hexane己烷hexok inase己糖(磷酸)激酸hidde n隐hidradeniti s汗腺炎hidroc arci noma汗腺癌hidrocy stoma汗腺囊瘤hidror rhe多汗症,大汗high高histidin e[生化]组氨酸;histoc hemi stry组织化学histoc ompati bility组织相容性histoc ompati ble组织相容的histol ogy组织学holl ow form中空状hol oantige n全抗原hol ocrin e全浆分泌hol oenzyme全酶hol ogr ap hy全息摄影术home od omai n同源结构域home other mi a恒温homoami noaci d高氨基酸homoatropine高阿托品homobet ain e高甜菜碱homob ioti n高生物素homocysteine高半胱氨酸,同型半胱氨酸homogamete同型配子homol actic同乳酸的homol og同源的homosexu ality同性恋homot omu s同体的honeyc omb蜂窝状hot热hyaliniz ati on透明化作用;透明样变化hyaloge n透明蛋白原hyalomere透明质hyalopl asm透明质hydrati on缺水hydrocep hal us脑积水hydrol ase水解酶hydrone phr osi s肾积水hydrop hilic亲水的hydrop hob ic疏水的,狂犬病的hydrotropism向水性hyperacid ity胃酸过多症hyperactive活动过度的;机能亢进的hyperactivity机能亢进hyperamyl ase mi a高淀粉酶血症hyperbiliru bine mi a高胆红素血症hypercalce mi a高钙血症hypercalci uri a多钙尿,尿钙过多,高钙尿hypercellul ar细胞过多的hyperph ori a上隐斜视hyperplasi a超常增生hypoaffectivity情感低下hypobl ast下胚层hypobu li a意志消沉hypoc alcemi a低血钙,低钙血症hypoc alciuri a尿钙过少,低钙尿hypochl orhydr i a胃酸过少hypoch olester ole mi a低胆固醇血hypoder mic皮下的hypopl asi a发育不全hypsarr hythmi a高度节律失调hypsoblenn iu s高鳚icosahe dron二十面体idioblapsi s自发性食物过敏idiogamy自体受精idiogl ossi a自语症idiopatheti c自发的immu nity免疫immu noflu ore scence免疫荧光法immu noge n免疫原immu nogl obul in免疫球蛋白immu nohist ochemistry免疫组织化学immu nother apy免疫疗法immu nother apy免疫疗法immu not oxin免疫毒素incline d倾斜inferiority自卑,卑劣,低劣inferior次的,低等的inferoanteri or下前方的inferol ateral下外侧的infraauricu lar耳下的infraorbit al眶下的infratemp or al颞下的inhibit ory抑制的insecticid e杀虫剂insectifu ge驱虫剂insid e内insuli noma胰岛素瘤insuli n胰岛素insul ogenic胰岛源的insul op athic胰岛病的intercal ate嵌入interferon干扰素interleuk in白(细胞)介素intermedi um中间体,媒介物intermembranou s膜间的internal izati on内化internal内部的internode(拉inter nodi um)节间,结间体interoceptive内感受的interocept or内感受器intimat e亲intoxicati on中毒intra-arteri al动脉内的intra-artic ular关节内的intrac an alicul ar小管内的intrac apsular囊内的intraepith elial上皮内的intrame mbr an ou s膜内的introcepti on内感受作用introitu s口,入口intromissi 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osis真菌毒素中毒症,真菌中毒症myomal aci a肌软化(症)myxede ma黏液(性)水肿myxoc occ us黏球菌属myxoma黏液瘤myxovir us黏液病毒nai l甲nan oc apsule毫微囊剂nan oc apsule微型胶囊,nan ocuri e毫微居里,纳居里nan omete r毫微米,纳米nan omol e纳摩尔,毫微摩nan osec on d毫微秒,纳秒nan osomi a侏儒症nan osurgery超微外科narc ohypn osi s麻醉药催眠narc osi s麻醉narc osynthe sis麻醉综合法narc otic麻醉的,麻醉剂narr ow窄near近necrob acil losis坏死菌病necrob iosis渐进性坏死necrociti n坏死菌素necrocytosi s细胞坏死needle针状nemaline线形状的nemat od a线虫纲nemat od e线虫nemat odi asis线虫病nemat ol ogy线虫学neoanti gen新抗原,肿瘤抗原neoaplect an a新线虫属neocerebe llu m新小脑neoc orte x新(大脑)皮质neomyci n新霉素neuroe nd ocrine神经内分泌neurofi bril神经原纤维neurofi bril神经原纤维neurotr opi c亲神经的neurotr opi n亲神经素;神经妥乐平neutrop hil中性细胞new新nigr al黑质的nigr anil ine苯胺黑nigrif actin黑化菌素nigr ostri atal黑质纹状体的nodek n ot结nod e节nod ose结节状的nod osity结节状nod ular结节性的nod ule小结nod uli(单nodul us)小结nod ulus(复noduli)小结nod us结,结节non ame r九聚物non an e壬烷non an ol壬醇non aone壬酮nonezer o无、未non-specific非特异的normal正常normob ari c正常气压的normocell ul ar正常细胞的normocyte正常红细胞normovolemi a血量正常novaspiri n新阿斯匹林novobioc in新生霉素novomycin新新霉素nucleic核的nucleophili c亲核的nucleopl asm核质nucleosome核小体(ν-小体)nucleosome核小体(ν-小体)nucleoti de核苷酸nucleu s核nullify使无效nullip arity未经产nullip ar ou s未经产的nullisomic缺对染色体的nutobli que斜的obli quimete(骨盆)斜度计obli quity倾斜;斜度obli quu s(拉)斜肌ochr atoxi n赭曲毒素ochre赭石,赭色ochr on osi s褐黄症,褐黄病ochr on otic褐黄病的octamer八聚体octamethyl八甲基octan ol辛醇octape ptide八肽old旧ole oph obi c疏油的oli godactyly少指[畸形],少趾[畸形]oli gohidr osi s少汗oli gohydramni os羊水过少oli guri a少尿onc oge ne癌基因onc otrop ic亲瘤的on e单,一one单,一onu pon over上,外onychi a甲床炎onych odystrophy指(趾)甲营养不良onych omal aci a甲软化onych osi s甲病oocyte卵母细胞;卵泡细胞op acificati on造影术op acity不透明性;浑浊度op aqu e不透明的op aq u不透明的opp osit e逆,对organ ogenesis器官发生organ opl asty器官成形术organ osc opy内脏镜检查organ other apy器官疗法organ器官ori gin al原orosomuc oi d血清类粘蛋白oroti dine乳清酸orrh omen in gitis浆膜炎orrh other apy血清疗法orthoc hromic正色的orthodeoxi a直立低氧血症orthodi agr am正影描记图orthopedi c矫形的oste obl ast成骨细胞oste omalaci a骨软化症oste openi a骨质减少outsi de外ovary卵巢ovicell卵泡ovoi d卵形的ovum卵,卵子ozen a臭鼻症ozoc hroti a皮臭症ozone O;臭氧ozonizer臭氧发生器pachyder ma厚皮pachymet e厚度测量器pachyne ma(核分裂)粗线期pachy onychi a甲肥厚pale obi oche mistry古生物化学pale ocerebel lu m旧小脑pale oc ortex旧皮质pale omicr ob iol ogy古微生物学pan arteritis全身动脉炎,全动脉炎panc hromati c全色的pancre asislet s岛、胰岛pani mmunit全免疫par aaortic主动脉周围的par acentr al旁中央的par acervical宫颈旁的par acervi x子宫颈旁组织par acortic al副皮质区的par asite寄生虫par asitif orme s寄螨目par asiti sm寄生(现象),par asit ology寄生虫学par asit osi s寄生虫病par athyrotr ophi n促甲状旁腺(激)素pariet al壁的,顶骨的parietitis(器官)壁层炎pariet ofront al顶额的pariet ospl anc hnic壁与内脏的part部分penicilli n青霉素pentagonal五角形的pentamidin e戊脘脒pentape ptide五肽pentetate五乙酸盐pentob arbit al戊巴比妥[镇静催眠药]pepper胡椒periad eniti s腺周围炎periap pend iceal阑尾周围的pericar diectomypericyte周细胞period ontiti s牙周炎peripher al-resi stance.末梢抵抗力perisin uous窦周的peritrichat周毛菌phac oan aphyl axi s晶体过敏症phac ocystec om晶状体囊切除术phac oerysi s晶状体针吸术phac ofragmentati on晶状体粉碎术phar mac odyn amics药效动力学phar mac ok inetics药物(代谢)动力学phar mac ol ogy药理学phlegm黏液,phlegm痰phosph orib osyltr ansfer ase磷酸核糖转移酶phylac agogic促成防御素的phylactic防御的physiot herapy物理疗法pia-arac hn oid软-蛛网膜piamater软脑膜picroac onitin e苦乌头碱picroci ne苦糖胺picromycin苦霉素picroti n印防己苦内酯;苦宁piperacilli n哔哌青霉素piperazine哌嗪,胡椒嗪piperidi on e二乙哌啶二酮piperin e胡椒碱plan e平面plan oc onve x平凸型plan ogram X线体层照片plan ograph X射线体层照像术plan omycin平霉素plasmalemma质膜plasmame mbr ane质膜plasma血浆plasmdic id al杀疟原虫的plasmi d质体,质粒plasmin ogen纤维蛋白溶酶原plasmi n血浆反应素plasmodi al疟原虫的,合胞体的plasmodi a疟原虫;合胞体plasmodiu m疟原虫plasmodiu m疟原虫plasm浆,血浆,原生质plasm浆,原生质;胞质pleiotr opi sm(基因)多效性plenocyte脾细胞pleoch roi sm多色现象pleocytosis脑脊液(淋巴)细胞增多pleomor phism多型现象pluril ocul a多腔的plurip ol ar多极的plurip otenti al多能造血干细胞plurispor e多室孢子pneumoc occu s肺炎球菌poik ilocyte异形红细胞poik ilocyt osi s异形红细胞病poik iloderma皮肤异色病poik ilothe rmi a(拉)变温poi son毒poi son毒poli oence ph alopathypoli omyeliti s脊髓灰质炎,小儿麻痹症poli omyel omal aci apoli omyel omal aci a脊髓灰质软化poli osi s白发(症),灰发(症)polyac etylene聚乙烯polyarteriti s多动脉炎polyart hral gi a多关节痛polyaxon多轴突[神经]细胞polyd actylism多指(趾)(畸形)polymorph 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s发红,潮红ruber(拉)红的,红核rubid omyci n柔红霉素salicyl ami de水杨酰胺salicyl anil ide水杨酰苯胺salicyl ate水杨酸盐salicyli c水杨酰的salicy l水杨酸基saliv ation流涎,多涎saliv atory催涎的saliv ator催涎剂salivin涎淀粉酶;唾液淀粉酶sal monell a(复salmonellae)沙门(氏)菌sal monell a(复salmonellae)沙门(氏)菌sal monell al沙门(氏)菌引起的sal monell ose s沙门氏菌病sal monell osi s沙门菌感染sameequ al同same同sap ogeni n皂甙元,皂甙配基sap onific ati on皂化(作用)sap oni n皂甙,皂素sap otoxi n皂角毒苷sap o皂sarc ocysti s肉孢子虫属sarc oma(复sarcomas,sarcomata)肉瘤sarc omer e肌(原纤维)节sarc omer e肌节sarc opl asmic肌质的,肌浆的scal e鳞状scap h a耳舟scap hoce ph aly舟状头,舟状头畸形scap hoiditi s舟骨炎scap hoid舟状的,舟骨schist omete声门裂schist osomacid e杀血吸虫剂schist osomal血吸虫的schist osoma裂体吸虫属schist osoma裂体吸虫属,血吸虫属schist osome裂体吸虫schist osomi asis血吸虫病schiz oge nesi s裂殖schiz ogony裂殖生殖,裂体增殖schiz oid精神分裂样的,类精神分裂症的scleredema硬化病sclerok erat osi s巩膜角膜炎,硬化性角膜炎arterioscler osi s动脉硬化scoli ometer脊柱侧凸测量计scoli osis脊柱侧凸scoli otic脊柱侧凸的scoli ot one脊柱侧凸矫正器scot ob acteri a暗细菌scot oma(复scot omata)暗点scot opi a暗视,暗适应secon d乙sector gate扇形阀门sectori al扇形的sectorsc an indic ator扇形扫描显示器sectorsc an in g扇形扫描sector扇形self自体semen sper m精液semimembr an osus半膜肌semiper me able半(渗)透性的semispin ali s半棘肌semitend in osu s拉)半腱肌seped on腐败sepsi s脓毒症,脓毒病septicemi a败血症septicopyemi a脓毒败血病,脓毒败血症septic败serod iagn osi s血清诊断,血清学诊断serogr oup-specific群特异性的serol ogical血清学的serop ositive血清阳性的serotype血清分型,血清型serum(复sera)血清serumgl obul in血清球蛋白shape形状sheath case鞘shi gell ae(单shi gella)志贺(氏)杆菌shi gell a志贺氏菌属shi gell a志贺氏菌属shi gellemi a志贺菌血症shi gell osi s志贺氏菌病shor t短side旁sinistr al左旋的sinistr oc ardi a左位心sinistr ogyrati on左旋sin oatri al窦房的sin obr onchiti s鼻窦支气管的sin ocar otid颈动脉窦的si x六sk otogra X射线照片,暗示显影片slow慢small小smooth musc le平滑肌soft软sol ute溶质sol ution溶液solvent溶剂space ph obi a空间恐怖症spanopne a呼吸减少spansul e缓释胶囊specificity特异性specific特异spermatic精液的,精子的spermatin精液蛋白spermatol ogy精液学spermatopathy精液病spermic ide杀精子剂spheric al球形的spher obl ast oma球状[神经]胶质母细胞瘤spher ocylinde r球柱透镜spher ocyte球形红细胞spher oph ak ia球形晶状体spir acyn螺旋霉素spir aden oma螺旋腺瘤,汗腺腺瘤spir al螺旋形的spirill a螺[旋]菌spitspittl e唾液splee n脾脏,脾splenect omy脾切除(术),脾切除术spleni c脾的splen ome galy脾大split裂sponge海绵状spongif or m海绵状的spongi n g海绵擦法spongi ob lastoma成胶质细胞瘤spongi ob last成胶质细;胶质母细胞spontane ou s本能的,自发的spor e孢子spor ocyst孢子囊spor ogony孢子生殖,孢子增殖spor ogony孢子生殖,孢子增殖spor oz oa(单spor ozoon)孢子虫spor oz oite子孢子spotfil mdevice X线点片摄影装置spotli ghti ngi llumin ator焦点照明器spotp ape r点滴反应用滤纸spottin g[月经]点滴出血spot斑点sputa(sputum的复数)痰sputal痰的sputamentu m(拉)痰squ ame鳞屑squ amocolumnar鳞部茎突的squ amomast oid(颞)鳞乳突的squ amou s鳞状的squ are方形staphyli ne葡萄状staphyl oc occal葡萄球菌的staphyl oc occosi s葡萄球菌病staphyl ok inase链激酶,葡萄球菌激酶staphyl olysi n葡萄球菌溶(血)素star星stenosed狭窄的stenosis狭窄stenother mophiles嗜狭高温生物stenotic狭窄的stercobi lin oge n粪胆原stercobi lin尿胆素,粪胆素stercobi lin尿胆素,粪胆素stercor al粪的,含粪的stercoremi a粪性毒血症stereogram立体X线照片stereography立体X射线照像术stereomicroscope立体显微镜stereop si s立体影象stick棒状stigmat a皮肤上的红斑stigmatism有红斑的状态stigmatiz ation斑痕形成stink ing恶臭stoolfecesmec on iu m粪,strai ght直streptoc occus(复stre ptococci)链球菌,链球菌属streptoc occusviri dans草绿色链球菌streptod 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FDA批准那他珠单抗用于治疗中至重度节段性肠病

FDA批准那他珠单抗用于治疗中至重度节段性肠病

FDA批准那他珠单抗用于治疗中至重度节段性肠病
佚名
【期刊名称】《世界临床药物》
【年(卷),期】2008(29)2
【摘要】2008年1月FDA批准Elan公司那他珠单抗(natalizumab,TYSABRI)的补充生物产品许可申请(Biologics License Application),可用于节段性肠病(CD)治疗。

此前,本品获准用于引导和维持成年患者中至重度CD的临床应答
及病情缓解,但仅限于那些对传统CD疗法和对TNF-α抑制剂应答不充分或不耐
受者。

【总页数】1页(P66-66)
【关键词】那他珠单抗;FDA批准;节段性;肠病;治疗;TNF-α抑制剂;Elan公司;生物
产品
【正文语种】中文
【中图分类】R744.51;R97
【相关文献】
1.美FDA批准雷尼珠单抗治疗糖尿病性黄斑水肿所致视力损害 [J], 马培奇
2.美FDA批准西珠单抗治疗成人不应性的中至重度活动性类风湿性关节炎 [J], 马培奇
3.美国FDA紧急批准Actemra(tocilizumab/托珠单抗)用于治疗重症新冠肺炎 [J],
4.美国FDA紧急批准Actemra(tocilizumab/托珠单抗)用于治疗重症新冠肺炎 [J],
夏训明(编译)
5.FDA批准那他珠单抗用于治疗中至重度Crohn病 [J],
因版权原因,仅展示原文概要,查看原文内容请购买。

安体舒通联合厄贝沙坦治疗早期糖尿病肾病的疗效分析

安体舒通联合厄贝沙坦治疗早期糖尿病肾病的疗效分析

安体舒通联合厄贝沙坦治疗早期糖尿病肾病的疗效分析荣佐民南阳市第八人民医院内分泌科,河南南阳473000[摘要]目的对安体舒通联合厄贝沙坦治疗糖尿病肾病的疗效进行分析。

方法选择2型糖尿病肾病病人64例,常规用药的基础上,治疗组联合应用厄贝沙坦和安体舒通,疗程6个月,观察治疗效果。

结果治疗组经治疗后24h尿微量白蛋白定量(UAE)有明显下降,与对照组相比有显著性差异。

结论厄贝沙坦和安体舒通联合应用对早期糖尿病肾病有显著疗效.能消除或明显减少尿微量白蛋白。

可以延缓糖尿病肾病的发展,保护肾功能.安全有效,值得临床推广。

[关键词]糖尿病肾病;UAE厄贝沙坦;安体舒通[中图分类号]R587.1[文献标识码]A[文章编号]1672-5654(2013)12(a)-0008-02Clinical observation On Irbesartan in Combination with Spironolactone for Treating elderly Patients in early diabetes nephrosisRONG ZuominNanyang Eighth People’s Hospital,Henan473000,China[Abstract]Objective To explore the therapeutic effect of Irbesartan and Spironolactone in early diabetes nephrosis Methods Sixty-four patients were divideded randomly into two groups:treatment group and comparison group.On the basis of common treatment,sixty-four patients were treated in Irbesartan and Spironolactone for six months.Results UAE were obviously decreased in treatment groups compaired with comparision groups.Conclusion Irbesartan and Spironolactonecan obviously eliminated or reduced microalbuminuria.And may also continue diabetes nephrosis,It is safe and should be used extensively in clinic.[Key words]Diabetes nephrosis;UAE;Irbesartan;Spironolactone糖尿病肾病(DN)是糖尿病(DM)的临床并发症之一,也是导致慢性肾功能衰竭的重要原因之一。

美国FDA批准IcatibantAcetate用于治疗遗传性血管神经性水肿

美国FDA批准IcatibantAcetate用于治疗遗传性血管神经性水肿

美国FDA批准IcatibantAcetate用于治疗遗传性血管神经
性水肿
佚名
【期刊名称】《中国执业药师》
【年(卷),期】2011(8)11
【摘要】2011年8月25日,美国食品药品监督管理局(FDA)批准英国沙尔(Shire)制药公司的新药醋酸艾替班特(通用名:IcatibantAcetate,商品名:FIRAZYR)注射剂上市,用于治疗18岁及以上成人遗传性血管神经性水肿(HAE)的急性发作。

【总页数】1页(P54-54)
【关键词】美国食品药品监督管理局;血管神经性水肿;遗传性;FDA批准;治疗;艾替
班特;制药公司;急性发作
【正文语种】中文
【中图分类】R978.1
【相关文献】
1.美国FDA批准C1酯酶抑制剂Haegarda用于预防遗传性血管性水肿 [J], 夏训明;
2.美国FDA批准C1酯酶抑制剂Haegarda用于预防遗传性血管性水肿 [J], 夏训明
3.首个治疗6岁及以上遗传性血管水肿(HAE)儿科患者药物获FDA批准 [J],
4.Berinert和Peramivir分获FDA上市批准和紧急使用许可 Berinert获准用于治
疗遗传性血管水肿急性发作并发症 [J],
5.FDA批准Ecallantide用于遗传性血管水肿的发作 [J],
因版权原因,仅展示原文概要,查看原文内容请购买。

艾塞那肽FDA说明书

艾塞那肽FDA说明书

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use BYETTA safely and effectively. See full prescribing information for BYETTA.BYETTA® (exenatide) InjectionInitial U.S. Approval: 2005--------------------------RECENT MAJOR CHANGES------------------------Indications and Usage 10/2009Monotherapy and Combination Therapy (1.1)Important Limitations of Use 10/2009History of Pancreatitis (1.2)Warnings and Precautions 10/2009Pancreatitis (5.1)Renal Impairment (5.3)Macrovascular Outcomes (5.7)---------------------------INDICATIONS AND USAGE--------------------------- BYETTA is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Important Limitations of Use• BYETTA is not a substitute for insulin. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis(1.2).• The concurrent use of BYETTA with insulin has not been studied and cannot be recommended (1.2).• BYETTA has not been studied in patients with a history of pancreatitis.Consider other antidiabetic therapies in patients with a history ofpancreatitis (1.2).-------------------------DOSAGE AND ADMINISTRATION------------------- • Inject subcutaneously within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart) (2.1).• Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily after 1 month based on clinical response (2.1).------------------------DOSAGE FORMS AND STRENGTHS------------------- BYETTA is supplied as 250 mcg/mL exenatide in:• 5 mcg per dose, 60 doses, 1.2 mL prefilled pen• 10 mcg per dose, 60 doses, 2.4 mL prefilled pen-----------------------------CONTRAINDICATIONS------------------------------ • History of severe hypersensitivity to exenatide or any product components(4.1).-----------------------WARNINGS AND PRECAUTIONS----------------------- • Pancreatitis: Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue BYETTA promptly.FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Type 2 Diabetes Mellitus1.2 Important Limitations of Use2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosing3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Hypersensitivity5 WARNINGS AND PRECAUTIONS5.1 Acute Pancreatitis5.2 Hypoglycemia5.3 Renal Impairment5.4 Gastrointestinal Disease5.5 Immunogenicity5.6 Hypersensitivity5.7 Macrovascular Outcomes6 ADVERSE REACTIONS6.1 Clinical Trial Experience6.2 Post-Marketing Experience7 DRUG INTERACTIONS7.1 Orally Administered Drugs7.2 Warfarin8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing MothersBYETTA should not be restarted. Consider other antidiabetic therapies in patients with a history of pancreatitis (5.1).• Hypoglycemia: Increased risk when BYETTA is used in combination witha sulfonylurea. Consider reducing the sulfonylurea dose (5.2).• Renal Impairment: Postmarketing reports, sometimes requiring hemodialysis and kidney transplantation. BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. Caution should be applied when initiating BYETTA or escalating the dose of BYETTA in patients with moderate renal failure (5.3).• Severe Gastrointestinal Disease: Use of BYETTA is not recommended in patients with severe gastrointestinal disease (e.g., gastroparesis) (5.4). • Hypersensitivity: Postmarketing reports of hypersensitivity reactions (e.g.anaphylaxis and angioedema). The patient should discontinue BYETTA and other suspect medications and promptly seek medical advice (5.6). • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug(5.7).-----------------------------ADVERSE REACTIONS------------------------------- • Most common (≥5%) and occurring more frequently than placebo in clinical trials: nausea, hypoglycemia, vomiting, diarrhea, feeling jittery, dizziness, headache, dyspepsia. Nausea usually decreases over time (5.2;6).• Postmarketing reports of increased international normalized ratio (INR) with concomitant use of warfarin, sometimes with bleeding (6.2).To report SUSPECTED ADVERSE REACTIONS contact Amylin Pharmaceuticals, Inc. and Eli Lilly and Company at 1-800-868-1190 and or FDA at 1-800-FDA-1088 or /medwatch ------------------------------DRUG INTERACTIONS------------------------------ • Warfarin: Postmarketing reports of increased INR sometimes associated with bleeding. Monitor INR frequently until stable upon initiation oralteration of BYETTA therapy (7.2).-------------------------USE IN SPECIFIC POPULATIONS--------------------- • Pregnancy: Based on animal data, BYETTA may cause fetal harm.BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To report drug exposure duringpregnancy call 1-800-633-9081 (8.1).• Nursing Mothers: Caution should be exercised when BYETTA is administered to a nursing woman (8.3).See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 10/20098.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment ofFertility13.3 Reproductive and Developmental Toxicology14 CLINICAL STUDIES14.1 Monotherapy14.2 Combination Therapy16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage and Handling17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing information are not listed.FULL PRESCRIBING INFORMATION1 INDICATIONS AND USAGE1.1 Type 2 Diabetes MellitusBYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.1.2 Important Limitations of UseBYETTA is not a substitute for insulin. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.The concurrent use of BYETTA with insulin has not been studied and cannot be recommended.Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYETTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.2 DOSAGE AND ADMINISTRATION2.1 Recommended DosingBYETTA should be initiated at 5 mcg administered twice daily at any time within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart). BYETTA should not be administered after a meal. Based on clinical response, the dose of BYETTA can be increased to 10 mcg twice daily after 1 month of therapy. Initiation with 5 mcg reduces the incidence and severity of gastrointestinal side effects. Each dose should be administered as a subcutaneous (SC) injection in the thigh, abdomen, or upper arm. No data are available on the safety or efficacy of intravenous or intramuscular injection of BYETTA.Use BYETTA only if it is clear, colorless and contains no particles.3 DOSAGE FORMS AND STRENGTHSBYETTA is supplied as a sterile solution for subcutaneous injection containing 250 mcg/mL exenatide in the following packages:• 5 mcg per dose, 60 doses, 1.2 mL prefilled pen• 10 mcg per dose, 60 doses, 2.4 mL prefilled peni p i a 4 CONTRAINDICATIONS4.1 HypersensitivityBYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components.5 WARNINGS AND PRECAUTIONS5.1 Acute PancreatitisBased on postmarketing data BYETTA has been associated with acute pancreatitis,ncluding fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation ofBYETTA, and after dose increases, observe patients carefully for signs and symptoms ofancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting). If pancreatitis is suspected,BYETTA should promptly be discontinued and appropriate management should benitiated. If pancreatitis is confirmed, BYETTA should not be restarted. Considerntidiabetic therapies other than BYETTA in patients with a history of pancreatitis.5.2 HypoglycemiaThe risk of hypoglycemia is increased when BYETTA is used in combination with asulfonylurea (hypoglycemia can also occur when other antidiabetic agents are used incombination with a sulfonylurea). Therefore, patients receiving BYETTA and a sulfonylureamay require a lower dose of the sulfonylurea to reduce the risk of hypoglycemia. It is alsopossible that the use of BYETTA with other glucose-independent insulin secretagogues (e.g.meglitinides) could increase the risk of hypoglycemia.For additional information on glucose dependent effects see Mechanism of Action (12.1).5.3 Renal ImpairmentBYETTA should not be used in patients with severe renal impairment (creatinine clearance< 30 mL/min) or end-stage renal disease and should be used with caution in patients with renaltransplantation [see Use in Specific Populations (8.6)]. In patients with end-stage renal disease receiving dialysis, single doses of BYETTA 5 mcg were not well-tolerated due to gastrointestinal side effects. Because BYETTA may induce nausea and vomiting with transient hypovolemia,treatment may worsen renal function. Caution should be applied when initiating or escalatingdoses of BYETTA from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min).There have been postmarketing reports of altered renal function, including increased serumcreatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimesrequiring hemodialysis or kidney transplantation. Some of these events occurred in patientsreceiving one or more pharmacologic agents known to affect renal function or hydration status, such as angiotensin converting enzyme inhibitors, nonsteroidal anti-inflammatory drugs, or diuretics. Some events occurred in patients who had been experiencing nausea, vomiting, or diarrhea, with or without dehydration. Reversibility of altered renal function has been observed in many cases with supportive treatment and discontinuation of potentially causative agents, including BYETTA. Exenatide has not been found to be directly nephrotoxic in preclinical or clinical studies.5.4 Gastrointestinal DiseaseBYETTA has not been studied in patients with severe gastrointestinal disease, including gastroparesis. Because BYETTA is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea, the use of BYETTA is not recommended in patients with severe gastrointestinal disease.5.5 ImmunogenicityPatients may develop antibodies to exenatide following treatment with BYETTA, consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals. In a small proportion of patients, the formation of antibodies to exenatide at high titers could result in failure to achieve adequate improvement in glycemic control. If there is worsening glycemic control or failure to achieve targeted glycemic control, alternative antidiabetic therapy should be considered [see Adverse Reactions (6.1)].5.6 HypersensitivityThere have been postmarketing reports of serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) in patients treated with BYETTA. If a hypersensitivity reaction occurs, the patient should discontinue BYETTA and other suspect medications and promptly seek medical advice [see Adverse Reactions (6.2)].5.7 Macrovascular OutcomesThere have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYETTA or any other antidiabetic drug.6 ADVERSE REACTIONS6.1 Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.HypoglycemiaTable 1 summarizes the incidence and rate of hypoglycemia with BYETTA in five placebo-controlled clinical trials.Table 1: Incidence (%) and Rate of Hypoglycemia When BYETTA was Used as Monotherapy or WithConcomitant Antidiabetic Therapy in Five Placebo-Controlled Clinical Trials*BYETTAPlacebo twice daily 5 mcg twice daily 10 mcg twice dailyMonotherapy (24 Weeks)77 77 78N%1.3% 5.2% 3.8%OverallRate0.03 0.21 0.52 (episodes/patient­year)% Severe 0.0% 0.0% 0.0%With Metformin (30 Weeks)N 113 110 1135.3% 4.5% 5.3%Overall%Rate0.12 0.13 0.12 (episodes/patient­year)% Severe 0.0% 0.0% 0.0%With a Sulfonylurea (30 Weeks)N 123 125 129 % Overall 3.3% 14.4% 35.7%Rate0.07 0.64 1.61 (episodes/patient­year)% Severe 0.0% 0.0% 0.0%With Metformin and a Sulfonylurea (30 Weeks)N 247 245 241 % Overall 12.6% 19.2% 27.8%Rate0.58 0.78 1.71 (episodes/patient­year)% Severe 0.0% 0.4% 0.0%With a Thiazolidinedione (16 Weeks)N 112 Dose not studied 121% Overall 7.1% Dose not studied 10.7%Rate0.56 Dose not studied 0.98(episodes/patient­years)% Severe 0.0% Dose not studied 0.0%* For the 30-week trials, a hypoglycemia episode was recorded if the patient reported symptoms consistent with hypoglycemia and was recorded as severe if the subject required the assistance of another person to treat theevent. For the other trials, a hypoglycemic episode was recorded if a patient reported signs or symptoms ofhypoglycemia or had a blood glucose value consistent with hypoglycemia regardless of associated symptoms ortreatment and was recorded as severe if the subject required the assistance of another person to treat the event.The requirement for assistance had to be accompanied by a blood glucose measurement of <50 mg/dL orprompt recovery after administration of oral carbohydrate.N = The number of Intent-to-Treat subjects in each treatment group.Immunogenicitypatients had low titer antibodies to exenatide at 30 weeks. For this group, the level of glycemic control (hemoglobin A1c [HbA1c]) was generally comparable to that observed in those without antibody titers. An additional 6% of patients had higher titer antibodies at 30 weeks. In about half of this 6% (3% of the total patients given BYETTA in the 30-week controlled studies), the glycemic response to BYETTA was attenuated; the remainder had a glycemic response comparable to that of patients without antibodies.In the 16-week trial of BYETTA add-on to thiazolidinediones, with or without metformin, 9% of patients had higher titer antibodies at 16 weeks. In the 24-week trial of BYETTA used as monotherapy, 3% of patients had higher titer antibodies at 24 weeks. Compared with patients who did not develop antibodies to BYETTA, on average the glycemic response in patients with higher titer antibodies was attenuated [see Warnings and Precautions (5.5)].Other Adverse ReactionsMonotherapyFor the 24-week placebo-controlled study of BYETTA used as a monotherapy, Table 2 summarizes adverse reactions (excluding hypoglycemia) occurring with an incidence ≥2% and occurring more frequently in BYETTA-treated patients compared with placebo-treated patients. Table 2: Treatment-Emergent Adverse Reactions ≥2% Incidence With BYETTA Used as Monotherapy (Excluding Hypoglycemia)*Monotherapy Placebo BIDN = 77%All BYETTA BIDN = 155%Nausea 0 8Vomiting 0 4Dyspepsia 0 3 * In a 24-week placebo-controlled trial.BID = twice daily.Adverse reactions reported in ≥1.0 to <2.0% of patients receiving BYETTA and reported more frequently than with placebo included decreased appetite, diarrhea, and dizziness. The most frequently reported adverse reaction associated with BYETTA, nausea, occurred in a dose-dependent fashion.Two of the 155 patients treated with BYETTA withdrew due to adverse reactions of headache and nausea. No placebo-treated patients withdrew due to adverse reactions.Combination TherapyAdd-on to metformin and/or sulfonylureaadverse reactions (excluding hypoglycemia) with an incidence ≥2% and occurring more frequently in BYETTA-treated patients compared with placebo-treated patients [see Warnings and Precautions (5.2)] are summarized in Table 3.Table 3: Treatment-Emergent Adverse Reactions ≥2% Incidence and Greater Incidence With BYETTA Treatment Used With Metformin and/or a Sulfonylurea (Excluding Hypoglycemia)*Placebo BID N = 483% All BYETTA BIDN = 963%Nausea 18 44Vomiting 4 13Diarrhea 6 13 Feeling Jittery 4 9Dizziness 6 9Headache 6 9Dyspepsia 3 6Asthenia 2 4 Gastroesophageal RefluxDisease1 3Hyperhidrosis 1 3 * In three 30-week placebo-controlled clinical trials.BID = twice daily.Adverse reactions reported in ≥1.0 to <2.0% of patients receiving BYETTA and reported morefrequently than with placebo included decreased appetite. Nausea was the most frequentlyreported adverse reaction and occurred in a dose-dependent fashion. With continued therapy, the frequency and severity decreased over time in most of the patients who initially experiencednausea. Patients in the long-term uncontrolled open-label extension studies at 52 weeks reportedno new types of adverse reactions than those observed in the 30-week controlled trials.The most common adverse reactions leading to withdrawal for BYETTA-treated patients werenausea (3% of patients) and vomiting (1%). For placebo-treated patients, <1% withdrew due tonausea and none due to vomiting.Add-on to thiazolidinedione with or without metforminFor the 16-week placebo-controlled study of BYETTA add-on to a thiazolidinedione, with orwithout metformin, Table 4 summarizes the adverse reactions (excluding hypoglycemia) with an incidence of ≥2% and occurring more frequently in BYETTA-treated patients compared withplacebo-treated patients.Table 4: Treatment-Emergent Adverse Reactions ≥2% Incidence With BYETTA Used With a Thiazolidinedione, With or Without Metformin (Excluding Hypoglycemia)*With a TZD or TZD/MET PlaceboN = 112%All BYETTA BIDN = 121%Nausea 15 40Vomiting 1 13Dyspepsia 1 7Diarrhea 3 6 GastroesophagealReflux Disease0 3* In a 16-week placebo-controlled clinical trial.BID = twice daily.Adverse reactions reported in ≥1.0 to <2.0% of patients receiving BYETTA and reported more frequently than with placebo included decreased appetite. Chills (n = 4) and injection-sitereactions (n = 2) occurred only in BYETTA-treated patients. The two patients who reported an injection-site reaction had high titers of antibodies to exenatide. Two serious adverse events(chest pain and chronic hypersensitivity pneumonitis) were reported in the BYETTA arm. Noserious adverse events were reported in the placebo arm.The most common adverse reactions leading to withdrawal for BYETTA-treated patients werenausea (9%) and vomiting (5%). For placebo-treated patients, <1% withdrew due to nausea.6.2 Post-Marketing ExperienceThe following additional adverse reactions have been reported during post-approval use of BYETTA. Because these events are reported voluntarily from a population of uncertain size, itis generally not possible to reliably estimate their frequency or establish a causal relationship todrug exposure.Allergy/Hypersensitivity: injection-site reactions, generalized pruritus and/or urticaria, macularor papular rash, angioedema, anaphylactic reaction [see Warnings and Precautions (5.6)].Drug Interactions: International normalized ratio (INR) increased with concomitant warfarin use sometimes associated with bleeding [see Drug Interactions (7.2)].Gastrointestinal: nausea, vomiting, and/or diarrhea resulting in dehydration; abdominaldistension, abdominal pain, eructation, constipation, flatulence, acute pancreatitis, hemorrhagicand necrotizing pancreatitis sometimes resulting in death [see Limitations of Use (1.2) andWarnings and Precautions (5.1)].Neurologic: dysgeusia; somnolenceRenal and Urinary Disorders: altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure or acute renal failure (sometimes requiringhemodialysis), kidney transplant and kidney transplant dysfunction [see Warnings and Precautions (5.3)].7 DRUG INTERACTIONS7.1 Orally Administered DrugsThe effect of BYETTA to slow gastric emptying can reduce the extent and rate of absorption of orally administered drugs. BYETTA should be used with caution in patients receiving oral medications that have narrow therapeutic index or require rapid gastrointestinal absorption [see Adverse Reactions (6.2)]. For oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before BYETTA injection. If such drugs are to be administered with food, patients should be advised to take them with a meal or snack when BYETTA is not administered [see Clinical Pharmacology (12.3)].7.2 WarfarinThere are postmarketing reports of increased INR sometimes associated with bleeding, with concomitant use of warfarin and BYETTA [see Adverse Reactions (6.2)]. In a drug interaction study, BYETTA did not have a significant effect on INR [see Clinical Pharmacology (12.3)]. In patients taking warfarin, prothrombin time should be monitored more frequently after initiation or alteration of BYETTA therapy. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on warfarin.8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category CThere are no adequate and well-controlled studies of BYETTA use in pregnant women. In animal studies, exenatide caused cleft palate, irregular skeletal ossification and an increased number of neonatal deaths. BYETTA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Female mice given SC doses of 6, 68, or 760 mcg/kg/day beginning 2 weeks prior to and throughout mating until gestation day 7 had no adverse fetal effects. At the maximal dose,760 mcg/kg/day, systemic exposures were up to 390 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC [see Nonclinical Toxicology (13.3)].In developmental toxicity studies, pregnant animals received exenatide subcutaneously during organogenesis. Specifically, fetuses from pregnant rabbits given SC doses of 0.2, 2, 22, 156, or260 mcg/kg/day from gestation day 6 through 18 experienced irregular skeletal ossifications from exposures 12 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC. Moreover, fetuses from pregnant mice given SC doses of 6, 68, 460, or 760 mcg/kg/day from gestation day 6 through 15 demonstrated reduced fetal and neonatal growth, cleft palate and skeletal effects at systemic exposure 3 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC [see Nonclinical Toxicology (13.3)].Lactating mice given SC doses of 6, 68, or 760 mcg/kg/day from gestation day 6 through lactation day 20 (weaning), experienced an increased number of neonatal deaths. Deaths were observed on postpartum days 2-4 in dams given 6 mcg/kg/day, a systemic exposure 3 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC [see Nonclinical Toxicology (13.3)].Pregnancy RegistryAmylin Pharmaceuticals, Inc. maintains a Pregnancy Registry to monitor pregnancy outcomes of women exposed to exenatide during pregnancy. Physicians are encouraged to register patients by calling 1-800-633-9081.8.3 Nursing MothersIt is not known whether exenatide is excreted in human milk. However, exenatide is present at low concentrations (less than or equal to 2.5% of the concentration in maternal plasma following subcutaneous dosing) in the milk of lactating mice. Many drugs are excreted in human milk and because of the potential for clinically significant adverse reactions in nursing infants from exenatide, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account these potential risks against the glycemic benefits to the lactating woman. Caution should be exercised when BYETTA is administered to a nursing woman.8.4 Pediatric UseSafety and effectiveness of BYETTA have not been established in pediatric patients.8.5 Geriatric UsePopulation pharmacokinetic analysis of patients ranging from 22 to 73 years of age suggests that age does not influence the pharmacokinetic properties of exenatide [see Clinical Pharmacology (12.3)]. BYETTA was studied in 282 patients 65 years of age or older and in 16 patients75 years of age or older. No differences in safety or effectiveness were observed between these patients and younger patients. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function.8.6 Renal ImpairmentBYETTA is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 mL/min) and should be used with caution in patients with renal transplantation. No dosage adjustment of BYETTA is required in patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). Caution should be applied when initiating or escalating doses of BYETTA from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min) [see Clinical Pharmacology (12.3)].8.7 Hepatic ImpairmentNo pharmacokinetic study has been performed in patients with a diagnosis of acute or chronic hepatic impairment. Because exenatide is cleared primarily by the kidney, hepatic dysfunction is not expected to affect blood concentrations of exenatide [see Clinical Pharmacology (12.3)].10 OVERDOSAGEIn a clinical study of BYETTA, three patients with type 2 diabetes each experienced a single overdose of 100 mcg SC (10 times the maximum recommended dose). Effects of the overdoses included severe nausea, severe vomiting, and rapidly declining blood glucose concentrations. One of the three patients experienced severe hypoglycemia requiring parenteral glucose administration. The three patients recovered without complication. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.11 DESCRIPTIONBYETTA (exenatide) is a synthetic peptide that was originally identified in the lizard Heloderma suspectum. Exenatide differs in chemical structure and pharmacological action from insulin, sulfonylureas (including D-phenylalanine derivatives and meglitinides), biguanides, thiazolidinediones, alpha-glucosidase inhibitors, amylinomimetics and dipeptidyl peptidase-4 inhibitors.Exenatide is a 39-amino acid peptide amide. Exenatide has the empirical formulaC184H282N50O60S and molecular weight of 4186.6 Daltons. The amino acid sequence for exenatide is shown below.H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu -Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2BYETTA is supplied for SC injection as a sterile, preserved isotonic solution in a glass cartridge that has been assembled in a pen-injector (pen). Each milliliter (mL) contains 250 micrograms (mcg) synthetic exenatide, 2.2 mg metacresol as an antimicrobial preservative, mannitol as a tonicity-adjusting agent, and glacial acetic acid and sodium acetate trihydrate in water for。

阿加曲班注射液与阿司匹林联合治疗短暂性脑卒中的疗效评价

6中西医结合心血管病杂志Cardiovascular Disease Journal of integrated traditionalChinese and Western Medicine2017 年 2月 A 第 5 卷第 4 期Feb. A 2017 V ol. 5 No. 4阿加曲班注射液与阿司匹林联合治疗短暂性脑卒中的疗效评价李 霞1,李小媛2,潘瑞春1(内蒙古包头市中心医院,1.神经内科;2.手术室,内蒙古包头 014010)【摘要】目的 对阿加曲班注射液与阿司匹林联合治疗短暂性脑卒中的疗效进行研究。

方法 2015年1月至2016年9月期间,将本院收治的122例短暂性脑卒中患者作为研究对象,随机分配患者,分为观察组和对照组,每组均为61例,观察组患者应用阿加曲班注射液联合阿司匹林进行治疗,对照组患者应用阿司匹林进行治疗,观察两组治疗有效率,并进行比较、分析。

结果 观察组、对照组患者完全控制率存在较大差异,有统计学意义(P<0.05);两组患者不良反应发生率无较大差别,无统计学意义(P>0.05)。

结论 阿加曲班注射液与阿司匹林联合治疗短暂性脑卒中的疗效较理想,应推广采纳。

【关键词】阿加曲班注射液;阿司匹林;短暂性脑卒中;疗效【中图分类号】R743.3 【文献标识码】A 【文章编号】ISSN.2095-6681.2017.04.6.02Effect evaluation of Argatroban Injection and aspirin in the treatmentof transient cerebral strokeLI Xia1,LI Xiao-yuan2,PAN Rui-chun1(Inner Mongolia Baotou Central Hospital,1.neurology;2.operating room,Inner Mongolia Baotou 014010,China)【Abstract】Objective To study the efficacy of Argatroban Injection combined with aspirin in the treatmentof transient.Methods From January 2015 to December 2016 The 122 patients with transient stroke treated in our hospital were enrolled in this study, The patients were randomly divided into the observation group and the control group, with 61 cases.The patients in the observation group were treated with Argatroban Injection and aspirin, The patients in the control group were treated with aspirin, and the effective rate of the two gro And compare and analyze. Results The complete control rate of the observation group and the contro There was statistical significance (P<0.05); there was no significant difference in the incidence No statistical significance (P>0.05).Conclusion The combination of Argatroban Injection and aspirin in the treatment of transient stroke is ideal.【Key words】Argatroban Injection;Aspirin;Transient stroke;Curative effect短暂性脑缺血是患者脑部血管病变导致的暂时性、局灶性脑功能异常,对该病患者进行CT、MRI检查时,一般无责任病灶[1]。

不可切除胰腺癌的分子靶向药物治疗进展

不可切除胰腺癌的分子靶向药物治疗进展胡润,李俊蒽,姚沛,桂仁捷,段华新湖南师范大学附属第一医院,湖南省人民医院肿瘤科,长沙 410005通信作者:段华新,****************(ORCID: 0000-0001-9596-5013)摘要:胰腺癌作为消化系统最常见的恶性肿瘤之一,其发病率及死亡率正逐年上升,大多数胰腺癌患者因分期较晚而失去了手术机会。

尽管以吉西他滨、氟尿嘧啶为主的化疗方案在一定程度上延长了患者的生存期,但仍有部分患者因无法耐受化疗而失去治疗机会。

随着精准医疗时代的来临,分子靶向药物治疗展现出的优异疗效使其成为对抗肿瘤的重要治疗手段之一,但由于胰腺癌高度的异质性及复杂的免疫微环境,针对胰腺癌的分子靶向治疗并未取得显著效果,因此亟需探寻新的治疗靶点及药物攻克这一难题。

本综述基于胰腺癌常见分子靶点及肿瘤免疫相关靶点探究在不可切除胰腺癌中分子靶向药物治疗研究的最新进展,为胰腺癌患者提供新的治疗策略。

关键词:胰腺肿瘤;分子靶向治疗;免疫疗法基金项目:湖南省自然科学基金(2020JJ8084)Advances in molecular-targeted therapy for unresectable pancreatic cancerHU Run,LI Junen,YAO Pei,GUI Renjie,DUAN Huaxin.(Department of Oncology,The First Affiliated Hospital of Hunan Normal University, Hunan Provincial People’s Hospital, Changsha 410005, China)Corresponding author: DUAN Huaxin,****************(ORCID: 0000-0001-9596-5013)Abstract:Pancreatic cancer is one of the most prevalent malignant tumors of the digestive system, and its incidence and mortality rates are increasing year by year. Most patients with pancreatic cancer are unable to receive surgery due to the advanced stage. Although chemotherapy regimens based on gemcitabine and fluorouracil have prolonged the survival time of patients to some extent,some patients cannot tolerate chemotherapy and hence lose the opportunity for treatment. With the advent of the era of precision medicine, molecular-targeted therapy has exhibited an excellent therapeutic efficacy and has thus become one of the most important treatment techniques for tumors; however, due to the high heterogeneity of pancreatic cancer and its complicated tumor microenvironment, molecular-targeted therapy for pancreatic cancer has not achieved notable results. Therefore, it is imperative to seek new therapeutic targets and medications to overcome this issue. This article reviews the latest advances in the research on molecular-targeted therapy for unresectable pancreatic cancer based on common molecular targets and tumor immunity-related therapeutic targets, in order to provide new treatment strategies for patients with pancreatic cancer.Key words:Pancreatic Neoplasms; Molecular Targeted Therapy; ImmunotherapyResearch funding:Natural Science Foundation of Hunan Province of China (2020JJ8084)胰腺癌是一种起病隐匿、进展迅速、疗效及预后极差的恶性肿瘤,大多数患者确诊时已经属于晚期。

阿托伐他汀联合阿司匹林治疗脑血栓的效果观察

世界最新医学信息文摘2019年第19卷第38期 13 阿托伐他汀联合阿司匹林治疗脑血栓的效果观察查大伟(吉林省吉林市永吉县岔路河镇中心卫生院内科,吉林 永吉)摘要:目的观察阿托伐他汀联合阿司匹林治疗脑血栓效果。

方法从医院2017年6月至2018年6月收治的脑血栓患者中随机性地抽取70例作为临床观察对象,按照等量性原则对患者实行临床分组,主要分为参照组和联合组两组,每组中35例患者。

对参照组的患者应用阿司匹林治疗,对联合组的患者则是在阿司匹林治疗基础上进一步联合应用阿托伐他汀治疗,分别观察两组患者在不同治疗方法下的实际临床表现,比较其具体的治疗效果。

结果联合组应用阿托伐他汀联合阿司匹林治疗脑血栓的临床治疗总有效率(94.29%)要显著高于参照组(74.29%);参照组、联合组患者治疗前的颈动脉斑块面积分别为(1.87±0.34)cm2、(1.88±0.35)cm2,比较无差异,治疗后两组颈动脉斑块面积均缩小,联合组的颈动脉斑块面积(1.33±0.30)cm2明显少于参照组的(1.61±0.32)cm2;同时联合组不良反应总发生率(8.57%)显著低于参照组(17.14%)。

联合组治疗效果更好,临床结果的比较具备统计学意义(P<0.05)。

结论阿托伐他汀联合阿司匹林治疗脑血栓能够达到更好的临床疗效,患者的疾病症状均有明显的改善,动脉斑块面积缩小,不良反应少,临床药用的总体价值高,值得加强推广。

关键词:阿托伐他汀;阿司匹林;药物治疗;脑血栓;动脉斑块中图分类号:R743.3 文献标识码:A DOI: 10.19613/ki.1671-3141.2019.38.007本文引用格式:查大伟.阿托伐他汀联合阿司匹林治疗脑血栓的效果观察[J].世界最新医学信息文摘,2019,19(38):13-14.Effect of Atorvastatin Combined with Aspirin in the Treatment of Cerebral ThrombosisZHA Da-wei(Department of Internal Medicine, Chaluhe Town Central Health Hospital, Yongji, Jilin, China)ABSTRACT:Objective To observe the effect of atorvastatin combined with aspirin in the treatment of cerebral thrombosis. Methods a total of 70 randomly selected patients with cerebral thrombosis admitted to the hospital from June 2017 to June 2018 were selected as clinical observation objects. According to the principle of equivalence, the patients were divided into two groups: the reference group and the combined group, with an average of 35 patients in each group. Patients in the control group were treated with aspirin, while those in the combination group were further treated with atorvastatin on the basis of aspirin treatment. The actual clinical manifestations of patients in the two groups under different treatment methods were observed, and the specific therapeutic effects were compared. Results The total effective rate (94.29%) of the combined treatment with atorvastatin and aspirin was significantly higher than that of the control group (74.29%). The area of carotid artery plaque in the reference group and the combined group before treatment was (1.87±0.34) cm2 and (1.88±0.35) cm2, respectively. There was no difference between the two groups. After treatment, the area of carotid artery plaque in the combined group was reduced, and the area of carotid artery plaque in the combined group (1.33±0.30) cm2 was significantly less than that in the control group (1.61±0.32) cm2. Meanwhile, the overall incidence of adverse reactions in the combined group (8.57%) was significantly lower than that in the control group (17.14%). The treatment effect was better in the combined group, and the comparison of clinical results was statistically significant (P<0.05). Conclusion Atorvastatin combined with aspirin in the treatment of cerebral thrombosis can achieve better clinical efficacy, patients' disease symptoms have been significantly improved, plaque area reduced, less adverse reactions, the overall clinical value of high, it is worth to strengthen the promotion.KEY WORDS: Atorvastatin; Aspirin; Treatment of cerebral thrombosis; Arterial plaque0 引言脑血栓疾病的发病率较高,并且在临床上具有发病急、发病快的特点,如果病情控制不及时,容易导致患者的死亡[1]。

安罗替尼联合多西他赛二线治疗晚期非小细胞肺癌疗效观察

中华实用诊断与治疗杂志2021年1月第35卷第1期J Chin Pract Diagn Ther,Jan.2021,Vol.35,No.1・83・•论著•安罗替尼联合多西他赛二线治疗晚期非小细胞肺癌疗效观察丁娇娇.高天慧,赵孟阳,张安然,郭莹河南大学人民医院河南省人民医院肿瘤科,河南郑州450003摘要:目的观察晚期非小细胞肺癌患者应用安罗替尼联合多西他赛二线治疗后血清癌胚抗原(carcino-embryonic antigen.CEA)、血管内皮细胞生长因子(vascular endothelial growth factor.VEGF)水平变化.探讨其治疗效果及安全性。

方法60例晚期非小细胞肺癌患者依据治疗方法分为观察组和对照组各30例。

对照组给予多西他赛75mg/m z.静脉滴注.第1天,21d为1个周期;观察组在对照组化疗基础上口服安罗替尼胶囊12mg/次,1次/d,第1〜14天,21d 为1个周期。

每2个周期评估1次疗效,至出现严重不良反应或疾病进展停药。

比较2组化疗前及化疗4个周期后血清CEA、VEGF水平;化疗4个周期后评定2组疾病控制率、客观有效率;随访观察无进展生存时间;比较2组治疗期间不良反应发生情况。

结果观察组、对照组化疗4个周期后血清CEA[(7.25士4.93),(12.28±5,63)隅/L]和VEGF [(56.12士33.69),(102.17±44.94)ng/L]水平均低于治疗前[CEA:(50.47±13.49),(54.15±12.93)“g/L;VEGF:(407.41+147.32),(411.44±143.56)ng/L](P<0.05),观察组低于对照组(P<0.05).化疗4个周期,观察组疾病控制率(86.67%)高于对照组(60.00%)(P<0.05),客观有效率(26.67%)与对照组(20.00%)比较差异无统计学意义(P>0.05)。

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CLINICAL RESEARCHAcetabular Anteversion with CT in Supine,Simulated Standing,and Sitting Positions in a THA Patient PopulationJean-Yves Lazennec MD,PhD,Patrick Boyer MD,PhD,Michel Gorin MD,Yves Catonne´MD,Marc Antoine Rousseau MD,PhDReceived:8February 2010/Accepted:24November 2010/Published online:16December 2010ÓThe Association of Bone and Joint Surgeons 12010AbstractBackground Appraisal of the orientation of implants in THA dislocations currently is based on imaging done with the patient in the supine position.However,dislocation occurs in standing or sitting positions.Whether measured anteversion differs in images projected in the position of dislocation is unclear.Questions/purposes We compared measured acetabular cup orientations on axial CT scans taken with the patient in a supine position with those from CT sections at angles to the sacral slope reflecting standing and sitting positions.Methods We retrospectively reviewed the radiographs of 328asymptomatic patients who had THAs.Anatomicacetabular anteversion (AAA)was measured from the plain CT scan (supine position,axial CT sections).The AAA also was measured on reformatted CT scans in which the orientation was adjusted individually to the sacral slope on lateral radiographs with patients in the standing and sitting positions.Results The mean/(SD)AAA changed from 24.2°(6.9°)in the supine position to 31.7°(5.6°)and 38.8°(5.4°)in simulated standing and sitting positions,respectively.The supine AAA correlated with the standing AAA (r =0.857)but not with the sitting AAA (r =0.484).Conclusions These data suggest measurement of the AAA on a plain CT scan used in current practice is biased.In patients with recurrent posterior dislocation from a sitting position,accounting for the functional variations in mea-surement of the position of the acetabular cup provides more relevant information regarding component positioning.IntroductionHip dislocation is a frequent mode of failure of THA with 0.5%to 10%dislocation rates reported for primary THA [3]and 10%to 25%after revision surgery [1].The dislo-cation risk is multifactorial.In addition to infection,wear,issues with the quality of the surrounding soft tissue,and the type of prosthesis,the position of the implants plays a major role in the mechanical stability of a THA [5,7,10,16,19,23,25,29,30,33].The CT scan is the current gold standard for assessing the position of the implants in case of dislocation.Reference values with the common protocol have been reported for native hips [2,15,35,37]and those with THAs [9,20,32,36,39].However,the CT scan is done with the patient in the supine position,whereas the sitting position is where mostEach author certifies that he or she has no commercial associations (eg,consultancies,stock ownership,equity interest,patent/licensing arrangements,etc)that might pose a conflict of interest in connection with the submitted article.Each author certifies that his or her institution has waived approval for the human protocol for this investigation and that allinvestigations were conducted in conformity with ethical principles of research.This work was performed at the Department of OrthopaedicSurgery,La Pitie´–Salpe ´trie `re Hospital,Assistance Publique–Hopitaux de Paris,Paris,France.zennec,Y.Catonne´,M.A.Rousseau (&)Department of Orthopaedic Surgery,La Pitie´–Salpe ´trie `re Hospital,Assistance Publique–Hopitaux de Paris,47bd de l’Hoˆpital,75013Paris,France e-mail:marc-antoine.rousseau@psl.aphp.fr;m_a_rousseau@P.BoyerDepartment of Orthopaedic Surgery,Bichat Hospital,Assistance Publique–Hopitaux de Paris,Paris,FranceM.GorinDepartment of Radiology,Foch Hospital,Suresnes,FranceClin Orthop Relat Res (2011)469:1103–1109DOI 10.1007/s11999-010-1732-7posterior dislocations occur [12,34].Therefore,knowing the acetabular version in that position might be important,and measuring cup version of the patient in the supine position on a CT scan for hip dislocation,as most clinicians do,could result in misleading information as apparent acetabular anteversion increases 1°for every 2°-increase of pelvic tilt [18,23,25,38].Using an earlier protocol to adjust the plane of the CT scan to the subject’s sacral slope in standing and sitting positions,the AAA was obtained in simulated standing and sitting positions [22].The measured value substantially changed from one position to the other with changes in lumbar spine lordosis and pelvic tilt.We therefore compared measured acetabular cup ori-entations on axial CT scans taken with the patient in a supine position with those on CT sections at angles to the sacral slope reflecting standing and sitting positions.Materials and MethodsWe retrospectively reviewed the images of 328selected asymptomatic patients who had undergone THAs.Allpatients had noncemented THAs with metal-backed ace-tabular implants and followups of 1to 11years (average,4.3years).Forty-eight percent were men and 52%were women.Their ages ranged from 60to 79years (average,70.4years).All patients had AP and lateral radiographs of the pelvis in the standing and sitting positions and a con-ventional low-dose CT scan of the pelvis in a supine position.Patients were checked for the absence of lower limb length differences and lumbosacral junction abnor-malities (fusion,malformation,severe disc degeneration with substantial osteophytes,and disc space narrowing).All measurements were made by two independent observers (JYL,MG).The abduction angle (AA)was measured on the AP view.On the lateral view,the sacral slope (SS)and acetabular sagittal inclination (ASI)were measured.The SS angle is formed by the tangent line to the upper end plate of S1and the horizontal plane [24].As a result of basic trigonometric relationships in three dimen-sions,the ASI has the same value as the operative anteversion,described by Murray [26],while being a dif-ferent angle.The SS,AA,and ASI were measured with patients in the standing,sitting,and supine positions (Fig.1).The standard radiographs were used forstandingFig.1A–D (A )AP and (B )lateral radiographs of a patient in a standing position,and (C )AP and (D )lateral radiographs of the same patient in the sitting position are shown.Measure-ment of the abduction angle (AA)on the AP radiograph and the acetabular sagittal inclination (ASI)and sacral slope (SS)is shown.Variations in orientation of the acetabular cup in the standing versus the sitting position can be seen.1104Lazennec et al.Clinical Orthopaedics and Related Research 1and sitting positions and CT topograms were used for the supine position.In addition,the pelvic incidence (inclination)was measured on the lateral radiographs.The pelvic incidence is the angle between the line perpendicular to the S1end plate and the line connecting the middle of the sacral plateau to the center of the femoral head.This parameter is related to the size of the pelvis in the sagittal plane and the offset between the lumbosacral junction and the hips [6].As a morphometric parameter of bony structure,the pelvic incidence does not vary with the position of the pelvis (Fig.2).The average radiation dose for the AP and lateral radiographs was 3mGy and 4.6mGy,respectively.From the CT scan sections,the AAA was measured according to the usual routine protocol,with the patient in a supine position on the axial section,similar to the protocol described by Stem et al.[35](Fig.3A).Measurement of the AAA corresponding to standing and sitting positions required an adjustment of the sectional plane following the value of the SS on lateral radiographs with the patients in standing (Fig.3C)and sitting positions [23](Fig.3C).Because the SS is a major parameter for assessing the position of the pelvis in the sagittal plane [31],the SS was used as a reference for the functional position of the pelvis.The radiation dose for the CT scan of the pelvis was 500mGy Ácm,which corresponds to 9.5mSv using the conversion ratio from Hidajat et al.[13].The standing AAA measured two times by the two observers showed a paired intraobserver difference of 2.53°.The intraobserver intraclass correlation coefficient (ICC)was 0.951.Thepaired interobserver difference was 3.25°.The interob-server ICC was 0.916.The statistical analysis began with a study of the reproducibility and repeatability of measurement of the AAA of the cup of a THA on a CT scan because repeat-ability data of such measurement were not reported before.We then performed a descriptive analysis of the measured variables (mean ±SD).Normality of the variables was checked using the Shapiro-Wilk test.Paired t-tests were used to investigate differences among standing,sitting,and supine positions for each normally distributed ing the Spearman correlation test,the relationships among the supine,sitting,and standing positions regarding the AAA,AA,and ASI were investigated.Finally,a linear regression analysis aimed at identifying the relevant parameters that influence the gain in AAA from the standing to the sitting position were identified among the pelvic incidence,the standing AAA,AA,ASI,and SS,and the variation.The SPSS 11.5software package (SPSS Inc,Chicago,IL,USA)was used for the calculations with the significance level of p \0.05of the SS between the standing and sitting positions.ResultsThe average (SD)pelvic incidence was 53.7°(13.6°);this anatomic parameter does not vary with the position of the pelvis.The SS decreased from the supine to the standing and the sitting positions.The frontal and sagittalinclinationsFig.2A–B Lateral schematics of the pelvis in (A )standing and (B )sitting positions show variations of the sacral slope (SS)and the acetabular orienta-tion.The SS increases in the standing position,whereas the acetabular sagittal inclination (ASI)angle decreases.The SS decreases in the sitting position and the ASI angle increases.The pelvic incidence (PI)represents the offset between the lumbosacral junction and the hips.The PI is a constant anatomic parameter.It does not vary whatever the pelvic tilt is.Volume 469,Number 4,April 2011Measurement of the Functional Acetabular Anteversion 1105and the anatomic anteversion increased from the supine to the standing and the sitting positions (Table 1).Measurement of anatomic anteversion with the CT scan correlated in the standing and supine positions but not between the sitting position and any other positions (Table 2).Similarly,the AA (Table 3)and the ASI (Table 4)correlated in the standing position and the supine position,but not in the sitting and or any other positions.The regression analysis showed a correlation coefficient of r =0.943and a coefficient of determination r 2=0.889.The regression equation was:ðsitting AAA Àstanding AAA Þ¼À0:385ðsitting SS Àstanding SS ÞÀ0:254standing AAA À0:196standing AA þ0:029standing ASI þ0:05standing SS þ0:001PI þ17:9þe :Table 1.Measured parameters*ParameterSupine Standing Sitting MeanSD Mean SD Mean SD SS 45.69.835.010.720.511.5AA 46.3 3.649.4 4.056.77.1ASI 25.58.436.08.250.611.2AAA24.26.931.75.638.85.4*Variations between positions are statistically significant;SS =sacral slope;AA =acetabular frontal inclination;ASI =acetabular sagittal inclination;AAA =anatomic acetabular anteversion.Table 2.Spearman’s correlation matrix between CT images for AAA*AAASupine Standing Sitting rp r p r p Supine 1–0.857\0.0010.484\0.001Standing 1–0.551\0.001Sitting1–*There is a strong correlation between images in the supine and standing positions;AAA =anatomic acetabularanteversion.Fig.3A–C (A )The standard CT scan protocol is performed with the patient in a supine position.It provides routine measurement of acetabular anteversion (AAA).(B )The proposed CT scan protocol includes an adjustment to the sacral slope,which replicates the standing position.First,the sacral slope (SS)is measured on the lateral radiograph in a standing position.Second,the sacral slope is transferred to the CT scan scout view (1=sacral end plate;2=horizontal plane in a standing position).(C )Adjustment to the SS when measured on a lateral radiograph in a sitting position is shown.Changes of the measured AAA according to the plane of section can be seen.1106Lazennec et al.Clinical Orthopaedics and Related Research 1Only thefirst three factors of the equation had significant p values.Their standardized coefficients were À0.786,À0.273,andÀ0.151,respectively,showing that the gain in AAA from the standing to the sitting position was mostly the result of mobility in the lumbosacral junction.DiscussionBecause posterior dislocations of the hip mostly occur in the sitting position,and some anterior dislocations in the standing position,the rationale of our study was to inves-tigate a novel protocol for measuring AAA on the CT scan with simulating the sitting and standing positions.We therefore compared measured acetabular cup orientations on axial CT scans taken with the patient in a supine posi-tion from those on CT sections at angles to the sacral slope reflecting standing and sitting positions.We acknowledge limitations to our study.First,we studied no patients with dislocations and therefore did not directly assess the importance of the proposed SS-adjusted CT protocol on the diagnosis and understanding of the mechanical dysfunction of unstable THAs.The normal ranges of the AAA,the AA,and the ASI,and the repro-ducibility of measurement of anatomic anteversion on the CT scan are presented in a large asymptomatic population, but it would be necessary to compare numerous dislocation cases with our data to define a predictive safety zone using the sacral slope-adjusted CT protocol.The safety limits for AAA would be the maximal value of the AAA above which there is a substantial risk of anterior dislocations and the minimum value of the AAA below which there is an increased risk of posterior dislocation.For now,the practical implication of the SS-adjusted CT scan protocol is limited to improving the examination of dislocations.Second,CT scans have substantial cost and radiation dose.However,the proposed protocol is based on only two additional lateral radiographs,which represent a little extra cost and radiation source,that substantially improve the results of the CT scans that already are widely performed in current practice for examining dislocations[17,28].It is likely that,in the future,the EOS1imaging system(EOS Imaging SA,Paris, France)could directly and accurately provide the three-dimensional orientation of the acetabulum in various pos-tures with more efficiency and less radiation dose[8].We confirmed that the AAA,frontal inclination,and sagittal inclination were functional parameters that varied substantially among the standing,sitting,and supine posi-tions.We observed that the acetabular parameters in a supine position highly correlated with those in a standing position but poorly correlated with those in a sitting posi-tion.The amount of mobility in the lumbosacral junction accounted most for the variation in the AAA between the standing and sitting positions.The notion of a relationship between AAA and the position of the pelvis was suggested by Anda et al.[2]and Zilber et al.[40]in native hips (Table5).Variations in the acetabular cup position after THA implantation as a function of the patient’s position were reported previously[22,23].The current study con-firmed and numerically showed the functional relationship between the SS and the AAA:the SS increases while the AAA decreases from the sitting to standing positions and reciprocally the SS decreases and the AAA increases from the standing to sitting positions.We found a poor correlation between the supine and sitting AAA.This suggests that the usual CT scan protocol is biased and not fully appropriate for examination of a posterior THA dislocation,which occurs in hipflexion.On the contrary,the strong correlation observed between the supine and standing measurements,which were observed in all the acetabular parameters(AAA,AA,and ASI), suggests that the classic CT assessment of the AAA is still a relevant source of information in cases of anterior THA dislocation and subluxation.Few articles address this issue in the literature.One notices only that the correlation between the supine and standing positions is in agreement with the results presented by Nishihara et al.,who reported less than10°variation in orientation of the pelvis from a standing to a supine position in90%of cases[27].Lumbosacral junction mobility was the main parameter influencing the variations of AAA between the standing and sitting positions.The fact that the risk of dislocationTable3.Spearman’s correlation matrix between AP radiographsfor AA*AA Supine Standing Sittingr p r p r pSupine1–0.864\0.0010.378\0.001Standing1–0.403\0.001Sitting1–*There is a strong correlation between images of the supine andstanding positions;AA=abduction angle.Table4.Spearman’s correlation matrix between lateral radiographsfor ASI*ASI Supine Standing Sittingr p r p r pSupine1–0.828\0.0010.374\0.001Standing1–0.369\0.001Sitting1–*There is a strong correlation between images in the supine andstanding positions;ASI=acetabular sagittal inclination.Volume469,Number4,April2011Measurement of the Functional Acetabular Anteversion1107increases cumulatively with time[4]and the fact that degenerative phenomena in the aging spine that induce progressive changes in sagittal balance with loss of lumbar lordosis and pelvic extension[11,14,31]support the idea of the major role of the function of the lumbosacral junc-tion on function of the hip.In everyday practice,stiffness in the lumbar spine(eg,L5-S1arthrodesis)is a risk factor for THA subluxation and dislocation resulting from the lack of variation in the AAA from a standing to a sitting position.To the best of our knowledge,this question has not been evaluated in the literature.This is not yet well defined,but our study suggests that taking spinalflexibility into account is important when planning a THA implan-tation or at least identifying outlier patients who have an abnormal pelvic(ie,acetabular)posture.Dual mobility cups could be specifically indicated for those patients[21].The classic measurement of AAA on CT scans uniquely taken with patients in the supine position seems insufficient to determine the actual position of the acetabular cup from a functional standpoint.In our opinion,the plain mea-surement is biased specifically in the case of posterior dislocation,because the supine AAA is poorly correlated with the adjusted AAA of the sitting position of disloca-tion.Therefore,when a CT scan is indicated for patients undergoing THA with problems of recurrent THA dislo-cation who need revision arthroplasty,we recommend adjusting the CT sectional plane to the SS that corresponds to the position of interest.This protocol would be more standardized and more efficient for measuring orientation of the acetabular cup than the plain CT scan with the patient in a supine position with a random position of the pelvis on the machine.Based on our observations,we suspect mobility of the lumbosacral junction plays a crucial role in the mechanical function and stability of a THA. Therefore,we also recommend doing dynamic lateral radiographs of the lumbosacral junction in the standing and sitting positions for primary THA in patients who have some abnormal features in their lumbosacral spine,for example,in the elderly population[31].References1.Alberton GM,High WA,Morrey BF.Dislocation after revisiontotal hip arthroplasty:an analysis of risk factors and treatment options.J Bone Joint Surg Am.2002;84:1788–1792.2.Anda S,Terjesen T,Kvistad puted tomography mea-surements of the acetabulum in adult dysplastic hips:which level is appropriate?Skeletal Radiol.1991;20:267–271.3.Berry DJ,von Knoch M,Schleck CD,Harmsen WS.Thecumulative long-term risk of dislocation after primary Charnley total hip arthroplasty.J Bone Joint Surg Am.2004;86:9–14. 4.Berry DJ,von Knoch M,Schleck CD,Harmsen WS.Effect offemoral head diameter and operative approach on risk of dislo-cation after primary total hip arthroplasty.J Bone Joint Surg Am.2005;87:2456–2463.5.Biedermann R,Tonin A,Krismer 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