Mansour-Ghanaei Fariborz, Pedarpour Zahra, Shafaghi Afshin, Joukar Farahnaz
Professor, Gastrointestinal & Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran.
Researcher, GI Cancers Screening and Prevention Research Center (GCSPRC), Guilan University of Medical Sciences, Rasht, Iran.
Middle East J Dig Dis. 2017 Apr;9(2):100-106. doi: 10.15171/mejdd.2017.58.
BACKGROUND infection is a major casual factor in any peptic diseases. Clarithromycin as one of the drugs recommended for the infection eradication regimen has shown different levels of resistance. The present study is comparing the effectiveness of clarithromycin- and gemifloxacin - based quadruple regimens in eradication. METHODS This was a prospective double blind randomized clinical trial on patients with clear indication of eradication. The patients were randomly divided into two groups: "BPAC group" treated with bismuth subcitrate (240 mg), pantoprazole (20 mg), amoxicillin (1 gr), and clarithromycin (500 mg), all twice daily, and the "BPAG group" treated with bismuth subcitrate, pantoprazole, and amoxicillin with same doses as "BPAC group" and gemifloxacin (320 mg daily) all for 10 days. Three months after the end of therapy, 14C-Urea breath test was performed to confirm the eradication. All the patients were assessed for compliance and drug side effects. Based on per-protocol (PP) and intention-to-treat (ITT) methods, data were analyzed and a P value<0.05 was considered as statistically significant. This project has been registered in the Iranian registry of clinical trials (IRCT). RESULTS Three patients were excluded from the survey and finally, 179 patients (89 patients in BPAC group and 90 patients in BPAG group) including 71(39.66%) men with the mean age of 46.4±12.3 years completed the treatment period. The incidence of side effects between the two study groups did not differ significantly. The success rate of BPAC regimen eradication was remarkably greater than BPAG regimen (ITT analysis; 89% vs 77%, respectively; CI 95%: 1.072-5.507, <0.015 and PP analysis; 91% vs 77.8% respectively; CI 95%: <0.015). There was no significant relationship between the demographic features and the eradication results. CONCLUSION The results showed that gemifloxacin is not a good alternative for clarithromycin in eradication regimens in our region.
背景 感染是任何消化性疾病的主要致病因素。克拉霉素作为根除感染方案中推荐使用的药物之一，已显示出不同程度的耐药性。本研究比较了以克拉霉素和吉米沙星为基础的四联方案在根除幽门螺杆菌方面的有效性。方法 这是一项针对有明确根除指征患者的前瞻性双盲随机临床试验。患者被随机分为两组：“BPAC组”，接受枸橼酸铋钾（240毫克）、泮托拉唑（20毫克）、阿莫西林（1克）和克拉霉素（500毫克）治疗，均每日两次；“BPAG组”，接受与“BPAC组”相同剂量的枸橼酸铋钾、泮托拉唑和阿莫西林，以及吉米沙星（每日320毫克），疗程均为10天。治疗结束三个月后，进行14C-尿素呼气试验以确认根除情况。对所有患者进行依从性和药物副作用评估。基于符合方案（PP）和意向性分析（ITT）方法进行数据分析，P值<0.05被认为具有统计学意义。本项目已在伊朗临床试验注册中心（IRCT）注册。结果 3名患者被排除在研究之外，最终，179名患者（BPAC组89名，BPAG组90名）完成了治疗期，其中包括71名（39.66%）男性，平均年龄为46.4±12.3岁。两个研究组之间的副作用发生率无显著差异。BPAC方案的根除成功率显著高于BPAG方案（ITT分析；分别为89%和77%；95%置信区间：1.072 - 5.507，<0.015；PP分析；分别为91%和77.8%；95%置信区间：<0.015）。人口统计学特征与根除结果之间无显著关系。结论 结果表明，在我们地区的根除方案中，吉米沙星不是克拉霉素的良好替代药物。
