以雷贝拉唑为基础的序贯疗法根除幽门螺杆菌的疗效评估_孟亚平

以雷贝拉唑为基础的序贯疗法根除幽门螺杆菌的疗效评估孟亚平① 【摘要】　目的：比较以雷贝拉唑、阿莫西林、克拉霉素、呋喃唑酮组成的10 d序贯疗法与奥美拉唑+阿莫西林+呋喃唑酮组成的10 d标准三联疗法根除幽门螺杆菌（Hp）的疗效和安全性。

方法：160例Hp感染活动性消化性溃疡患者随机分为治疗组和对照组，每组80例。

治疗组为序贯疗法组：给予雷贝拉唑10 mg/次、阿莫西林1000 mg/次，2次/d，服用5 d，5 d后口服雷贝拉唑10 mg/次、克拉霉素500 mg/次、呋喃唑酮100 mg/次，2次/d，再服用5 d，10 d后使用雷贝拉唑10 mg/次，1次/d，续服3周。

对照组为标准三联疗法组：第1~10天给予奥美拉唑20 mg/次、阿莫西林1000 mg/次、呋喃唑酮100 mg/次，2次/d，第11~31天服用奥美拉唑20 mg/次，1次/d。

治疗结束后4周复查胃镜，行快速尿素酶试验和14C尿素呼气试验测定Hp，评估疗效及安全性。

结果：156例患者按方案完成治疗。

治疗组按ITT分析Hp根除率为92.50%（74/80），明显高于对照组的78.75%（63/80），差异有统计学意义（χ2=19.262，P<0.01）。

治疗组按PP分析Hp根除率为94.87%（74/78），明显高于对照组的80.77%（63/78），差异有统计学意义（χ2=15.566，P<0.01）。

治疗组和对照组的不良反应发生率分别为18.75%（15/80）和22.50%（18/80），比较差异无统计学意义（P>0.05）。

结论：雷贝拉唑、阿莫西林、呋喃唑酮、克拉霉素组成的10 d序贯治疗方案较奥美拉唑、阿莫西林、呋喃唑酮组成的标准三联10 d治疗方案更加能有效根除Hp，取得了很高的Hp根除率，治疗效果佳，个体差异小，不良反应发生率低，患者依从性好，值得临床上推广应用。

【关键词】　幽门螺杆菌；　序贯疗法；　标准三联疗法；　雷贝拉唑；　奥美拉唑 Efficacy Evaluation of Rabeprazole-based Sequential Therapy in Helicobacter Pylori Eradication/MENG Ya-ping.//Medical Innovation of China，2015，12（29）：069-073 【Abstract】　Objective：To compare the efficacy and safety of Rabeprazole-based 10-days sequential therapy including Rabeprazole，Amoxicillin，Clarithromycin，Furazolidone，with 10-days standard triple therapy including Omeprazole，Amoxicillin，Furazolidone in Helicobacter pylori.eradication.Method：A total of 160 Helicobacter pylori patients with infection in active peptic ulcer were recruited and randomly assigned into the treatment group and the control group，80 cases in each group.The treatment group（sequential therapy） was implemented with RA program which included orally taking Rabeprazole 10 mg per time，Amoxicillin 1000 mg per time，twice per day in the first five days，after the five days，the treatment group was implemented with RCF program which included orally taking Rabeprazole 10 mg per time，Clarithromycin 500 mg per time，Furazolidone 100 mg per time，twice per day for five days，then the treatment group was given Rabeprazole 10 mg once per day for three weeks.The control group（standard triple therapy） was implemented with OAF program which included orally taking Omeprazole 20 mg twice per day，Amoxicillin 1000 mg twice per day，Furazolidone 100 mg twice per day for 10 days，then the control group was given Omeprazole 20 mg，once per day for three weeks.Four weeks after the completion of treatment，the efficacy and safety were evaluated by gastroscopy，rapid urease test and 14C urea breath test were determined for Helicobacter pylori.Result：A total of 156 patients completed the treatment.With intention-to-treat（ITT） analysis，the Helicobacter pylori eradication rate in the treatment group was 92.50%（74/80），which was significantly higher than 78.75%（63/80） of the control group，the difference was statistically significant（χ2=19.262，P<0.01）.With per protocol（PP） analysis，the Helicobacter pylori eradication rate in the treatment group was 94.87%（74/78），which was significantly higher than 80.77%（63/78） of the control group，the difference was statistically significant（χ2=15.566，P<0.01）.The incidence of adverse reaction rates of the treatment group and the control group were 18.75% （15/80） and 22.50%（18/80） respectively，there was no statistically significant difference（P>0.05）.Conclusion：The 10-days sequential therapy including Rabeprazole，Amoxicillin，Clarithromycin，Furazolidone is more effective than 10-days standard triple therapy including Omeprazole，Amoxicillin，①江苏省东台市三仓人民医院　江苏　东台　224231通信作者：孟亚平Furazolidone in eradicating Helicobacter pylori，can achieve a very high rate of Helicobacter pylori eradication and good curative effect.The individual difference is small，the incidence of adverse reaction is low，the patients’ compliance is good，it is worthy to be popularized in clinic. 【Key words】　Helicobacter pylori；　Sequential therapy；　Standard triple therapy；　Rabeprazole；　Omeprazole First-author’s address： Dongtai Sancang People’s Hospital，Dongtai 224231，China doi：10.3969/j.issn.1674-4985.2015.29.021 幽门螺杆菌（Helicobacter pyloyi，H.pylori）是全球最常见的感染源之一，幽门螺杆菌感染是慢性活动性胃炎、消化性溃疡、胃黏膜相关淋巴组织（MALT）淋巴瘤和胃癌的主要致病因素，世界卫生组织已经将幽门螺杆菌列为第一类致癌因子，将幽门螺杆菌明确为胃癌的危险因素[1-2]。

对证实存在Hp感染的消化性溃疡患者进行根除Hp可有效治愈溃疡，缩短溃疡愈合时间，显著降低溃疡的复发率并减少并发症的发生已成共识[3]。

理想的Hp根除疗法Hp根除率在90%以上，且患者依从性好、不良反应少、药物价廉，即使根治失败也不增加Hp对抗菌药物的耐药性。

三联疗法是最常用的根除Hp的方法，可选择质子泵抑制剂（PPI）、雷尼替丁枸橼酸铋（RBC）、枸橼酸铋钾三者中的任一种加两种抗生素构成。

目前耐药是Hp根除治疗失败的主要原因之一。

随着Hp根除率的不断下降，寻找更可靠、有效的Hp根除方案是临床上十分热点的问题。

本试验旨在评估新一代质子泵抑制剂（雷贝拉唑）为基础的序贯疗法能否比以第一代质子泵抑制剂（奥美拉唑）为基础的10 d三联疗法更具优势，能否提高对Hp的根除率，避免或克服日趋严重的Hp的耐药性而有机会成为一线治疗方案。