雷贝拉唑与奥美拉唑三联疗法根除幽门螺杆菌多中心、随机、双盲、平行对照研究

Rabeprazole-based Triple Therapy versus Omeprazole-based Triple Therapy for the Eradication of Helicobacter pylori Infection: A Multicentre, Randomized, Double-blind, Parallel-controlled Study

背景:新一代质子泵抑制剂雷贝拉唑具有较高的解离常数（pKa）,在抑酸方面起效更快,作用更持久稳定。目的:通过与奥美拉唑三联疗法比较,观察雷贝拉唑三联疗法根除幽门螺杆菌（H.pylori）和治疗十二指肠溃疡的疗效。方法:采用多中心、随机、双盲、平行对照研究方法,于2002年1～7月在5家医院进行。109例经胃镜检查确诊为十二指肠溃疡活动期并经快速尿素酶试验和病理学检查确定为H.pylori阳性的患者分为两组:雷贝拉唑（商品名:波利特）试验组（RAC组,53例）和奥美拉唑（商品名:洛赛克）对照组（OAC组,56例）。两组均先给予三联治疗:雷贝拉唑10mg或奥美拉唑20mg+阿莫西林1g+克拉霉素500mg,每日2次,连续7天,然后单独给予雷贝拉唑10mg,每日1次或奥美拉唑20g,每日1次,连续7天,并于用药结束后第28天复查胃镜并检测H.pylori。于用药后第1、2、3、6和42天对患者的上腹痛、反酸以及上腹烧灼感等症状进行评估。结果:101例患者完成全部治疗方案,8例失访。H.pylori根除率:病理学检查结果显示RAC组的H.pylori根除率为86.0％,OAC组为76.5％,两组间差异无显著性（P>0.05）。溃疡愈合率:PAC组的溃疡愈合率为92.0％,OAC组为76.5％,OAC组高于OAC组,两组间差异有显著性（P<0.05）。

Background: Rabeprazole is a new member of proton pump inhibitors with a higher pKa. It has a rapid onset of action on acid inhibition and a long-term stable efficacy. Aims: To compare two differ-ent regimens of rabeprazole-based triple therapy versus omeprazole-based triple therapy for the eradication of Helicobacter pylori (H. pylori) infection and the efficacy on healing of duodenal ulcer. Methods: This multicentre, randomized, double-blind, parallel-controlled study was conducted at 5 hos-pitals since January to July in 2002. One hundred and nine patients with H. pylori infection proven by both histology and rapid urease test and active duodenal ulcer were assigned to receive one of the two regimens: clarithromycin 500 mg bid and amoxicillin 1 g bid together with either rabeprazole (Pariet) 10 mg bid (RAC group) or omeprazole (Losec) 20 mg bid (OAC group) for 7 days, then either rabeprazole 10 mg qd or omeprazole 20 mg qd for another 7 days. The eradication rates of H. pylori and the healing rates of duodenal ulcer were evaluated by the second endoscopy on the 28th day after completion of treatment. The relieves of the symptoms of epigastric pain, sour regurgitation and heart-burn were also evaluated on the 1st, 2nd, 3rd, 6th and 42nd day after the treatment. Results: One hundred and one patients completed the trial. Eight patients dropped out. The eradication rates of H. pylori in RAC group and OAC group were 86.0% and 76.5%, respectively. There was no statistically significant dif-ference between the two groups (P>0.05). The ulcer healing rates in RAC group and OAC group were 92.0% and 76.5%, respectively. The difference between the two groups was statistically significant (P< 0.05). The symptoms of both two groups relieved rapidly at the beginning of the treatment. Although the total score of symptom relief in RAC group was higher than that in OAC group, there was no statistically significant difference between them (P>0.05). Conclusions: Both two regimens can im-prove the symptoms of duodenal ulcer patients effectively, and may eradicate H. pylori, and heal the ul-cers. Only the ulcer healing rate in RAC group is higher than that in group OAC.