Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: a prospective randomized trial
Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: a prospective randomized trial
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DOI：
10.3748/wjg.v21.i36.10435
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发表时间：
2015-09-28
影响因子：
4.3
通讯作者：
Wu, Deng-Chyang
中科院分区：
文献类型：
--
作者：
Chen, Kuan-Yang;Lin, Tsung-Jung;Wu, Deng-Chyang
方法：将175例幽门螺杆菌感染患者随机分为序贯疗法(雷贝拉唑20 mg、阿莫西林1 g，每日2次，连用5 d；雷贝拉唑20 mg，克拉霉素500 mg，甲硝唑500 mg，每日2次，连用5 d)和混合疗法(雷贝拉唑20 mg，阿莫西林1 g，雷贝拉唑20 mg，阿莫西林1 g，连用7 d)。快速尿素酶试验和组织学检查阳性或培养阳性确认幽门螺杆菌感染状态。抗-H治疗结束后8wk复查胃镜、快速尿素酶试验和组织学检查，评价根除效果。治疗结束后至少4wk进行幽门螺杆菌治疗或C-13-尿素呼气试验。结果：167例患者(序贯组83例，混合组84例)完成研究。两组服药依从率分别为97.6%和97.7%。经ITT分析，序贯组根治率为78.2%，混合组为92%(P=0.01)。PP分析显示序贯组和混合组的根治率分别为81.9%和96.4%(P=0.01)。对临床和细菌因素的单变量分析没有发现与治疗失败相关的任何危险因素。序贯组和混合组的严重不良反应发生率分别为2.3%和2.4%。结论：由于PP分析显示，混合疗法根除幽门螺杆菌的成功率为A级(95%)，依从性和不良反应相似，因此混合疗法似乎是台湾地区一种合适的根除方案。
AIM: To evaluate the efficacy of sequential vs hybrid therapy in patients with Helicobacter pylori (H. pylori) infection.METHODS: From March 2013 to May 2014, one hundred and seventy-five H. pylori infected patients who had not been treated for H. pylori before were randomized to receive either sequential therapy (rabeprazole 20 mg and amoxicillin 1 g twice daily for 5 d, followed by rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 5 d) or hybrid therapy (rabeprazole 20 mg and amoxicillin 1 g for 7 d, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 d). H. pylori status was confirmed by positive results of both rapid urease test and histology examination or a positive result of culture. Eradication efficacy was assessed by follow-up endoscopy with rapid urease test and histological examination 8 wk after the end of anti-H. pylori therapy, or C-13-urea breath test at least 4 wk after completion of treatment. The primary outcome was H. pylori eradication by intension-to-treat (ITT) and per-protocol (PP) analyses.RESULTS: One hundred and sixty-seven patients (83 patients in the sequential group and 84 patients in the hybrid group) completed the study. The compliance rates were 97.6% and 97.7% for the two groups, respectively. The eradication rate was 78.2% for the sequential group and 92% for the hybrid group by ITT analysis (P = 0.01). The eradication rate was 81.9% for the sequential group and 96.4% for the hybrid group by PP analysis (P = 0.01). Univariate analysis for the clinical and bacterial factors did not identify any risk factors associated with treatment failure. Severe adverse events were observed in 2.3% of patients in the sequential group and 2.4% of those in the hybrid group.CONCLUSION: Due to a grade A (> 95%) success rate for H. pylori eradication by PP analysis, similar compliance and adverse events, hybrid therapy seems to be an appropriate eradication regimen in Taiwan.