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

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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)。症状改善情况:两组从用药第1天起均能有效改善 Background: A new generation of proton pump inhibitor, rabeprazole, has a high dissociation constant (pKa) and has a faster onset of action and a more sustained and stable effect on acid suppression. OBJECTIVE: To observe the efficacy of rabeprazole triple therapy in the eradication of H. pylori and in the treatment of duodenal ulcer by comparing with omeprazole triple therapy. METHODS: A multicenter, randomized, double-blind, parallel-controlled study was performed in five hospitals from January to July 2002. One hundred and nine patients with H.pylori positive diagnosed with gastroduodenal ulcer during active phase and confirmed by rapid urease test and pathological examination were divided into two groups: rabeprazole (trade name: Polite) (RAC group, 53 cases) and omeprazole (Losec) control group (OAC group, 56 cases). Both groups were given triple therapy: rabeprazole 10mg or omeprazole 20mg + amoxicillin 1g + clarithromycin 500mg, 2 times a day for 7 days, and then given rabeprazole alone 10mg, 1 times a day Or omeprazole 20g, 1 day, for 7 days, and in the 28th day after the end of the gastroscope and H.pylori detection. On the 1st, 2nd, 3rd, 6th and 42th days after treatment, the patients were evaluated on the symptoms such as upper abdominal pain, anti-acid and upper abdominal burning sensation. Results: All the 101 patients completed the treatment and 8 patients were lost. H.pylori eradication rate: pathological examination showed that H.pylori eradication rate was 86.0% in RAC group and 76.5% in OAC group, there was no significant difference between the two groups (P> 0.05). The rate of ulcer healing was 92.0% in PAC group and 76.5% in OAC group, but higher in OAC group than in OAC group (P <0.05). Symptoms improvement: two groups from the first day of medication can effectively improve
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