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目的观察以枸橼酸铋雷尼替丁(Ranitidine Bismuth Citrate,RBC瑞倍)为基础的三联疗法对幽门螺杆菌(Hp)根除疗效及安全性。方法将确诊为Hp阳性147例患者随机分为3组,即瑞倍组、奥美拉唑组和雷尼替丁组,疗程1周,应用14C-尿素呼气试验及荧光定量PCR法检测Hp-DNA判断Hp根除效果。结果根据意图分析治疗(ITT)分析Hp根除率分别为瑞倍组83.7%、奥美拉唑组87.5%、雷尼替丁组70%。根据试验方案分析(PP)Hp根除率分别为87.2%、93.3%及72.9%。瑞倍组Hp根除率与奥美拉唑组相近,但2组均较雷尼替丁组明显升高。瑞倍组和奥美拉唑组较雷尼替丁组消化道症状明显改善,但瑞倍组与奥美拉唑2组间无明显差异。瑞倍组与奥美拉唑组不良反应均较雷尼替丁组轻微。结论瑞倍三联疗法根除Hp的临床疗效优于雷尼替丁三联疗法,但与奥美拉唑三联疗法相当,副反应发生情况也与奥美拉唑三联疗法无显著性差异,且因瑞倍相对价格低廉,值得作为一线药物推广应用。
Objective To observe the efficacy and safety of triple therapy based on Ranitidine Bismuth Citrate (RBC) in the eradication of Helicobacter pylori (Hp). Methods One hundred and fourteen patients diagnosed as positive for Hp were randomly divided into three groups: Ruibi group, omeprazole group and ranitidine group. The course of treatment was 1 week. 14C-urea breath test and fluorescent quantitative PCR method were used to detect Hp DNA to determine the effect of Hp eradication. Results Hp eradication rates were 83.7% for Intertube, 87.5% for Omeprazole, and 70% for ranitidine, respectively, based on Intent-to-Treat (ITT) analysis. According to the experimental protocol analysis (PP) Hp eradication rates were 87.2%, 93.3% and 72.9%. Rehxipin Hp eradication rate and omeprazole group was similar, but two groups were significantly higher than ranitidine group. Rebam group and omeprazole group than in the ranitidine group gastrointestinal symptoms improved significantly, but the Rebam group and omeprazole two groups no significant difference. Rebam group and omeprazole group adverse reactions than ranitidine group was mild. Conclusion Treponema triple therapy is superior to ranitidine triple therapy in the clinical efficacy of eradication of Hp, but comparable with omeprazole triple therapy, side effects and omeprazole triple therapy no significant difference, Relatively low prices, it is worth promoting as a front-line application.