Lin San-ren
Department of Gastroenterology, The Third Hospital, Beijing University, Beijing 100083, China.
Zhonghua Nei Ke Za Zhi. 2005 Apr;44(4):265-7.
To study the efficacy and safety of rabeprazole in peptic ulcer patients alone or combined with anti-Helicobacter pylori (Hp) agents.
An open labeled multi-center clinical trial was designed. Different types peptic ulcer patients identified by endoscopy were recruited from 24 provinces and cities in China. They were given rabeprazole alone 10 mg/d for 7 days continuously (rabeprazole alone group), or combined anti-Hp protocol (including rabeprazole 10 mg, b.i.d., 5 or 7 days) (combination group) respectively by doctors according to their disease situations. Their symptoms and side effects during the therapy were recorded.
This study included 25 609 patients in total with 11 386 in rabeprazol alone group and 14 223 in combination and following diseases as gastric ulcer, duodenal ulcer, complex ulcer, esophageal ulcer, stress ulcer and anastomotic ulcer. The effective rates relieving epigastric pain was 63.0%, 91.2%, 99.2% and 99.7%, respectively, with elimination rates of 16.0%, 47.8%, 80.3%, 94.8%, respectively on the 1st, 2nd, 5th and 7th day. The effective rate to relieve all symptoms on the 1st, 2nd, 5th and 7th day was 42.0%, 78.0%, 93.1% and 98.3%. No statistical differences between rabeprazole alone group and combined group. 476 patients (1.9%) developed mild side effects during the therapy, labeprazole alone group of 147 (1.3%), and combined group of 329 (2.3%), P < 0.01. No severe side effects occurred.
Whether labeprazole was used alone or combined with anti-Hp agents, it is an effective and safe therapy for the treatment of peptic ulcer.
研究雷贝拉唑单独使用或联合抗幽门螺杆菌（Hp）药物治疗消化性溃疡患者的疗效和安全性。
设计一项开放标签的多中心临床试验。从中国24个省市招募经内镜检查确诊的不同类型消化性溃疡患者。医生根据患者病情分别给予单独连续7天每日10mg雷贝拉唑治疗（单药组），或联合抗Hp方案（包括雷贝拉唑10mg，每日2次，5或7天）（联合组）。记录治疗期间患者的症状和不良反应。
本研究共纳入25609例患者，单药组11386例，联合组14223例，所患疾病包括胃溃疡、十二指肠溃疡、复合溃疡、食管溃疡、应激性溃疡和吻合口溃疡。缓解上腹部疼痛的有效率分别为63.0%、91.2%、99.2%和99.7%，第1、2、5和7天的根除率分别为16.0%、47.8%、80.3%、94.8%。第1、2、5和7天缓解所有症状的有效率分别为42.0%、78.0%、93.1%和98.3%。单药组和联合组之间无统计学差异。476例患者（1.9%）在治疗期间出现轻度不良反应，单药组147例（1.3%），联合组329例（2.3%），P<0.01。未出现严重不良反应。
雷贝拉唑单独使用或联合抗Hp药物，均是治疗消化性溃疡的有效且安全的疗法。
