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含铋剂/阿莫西林/四环素四联方案对比序贯疗法根除幽门螺杆菌有效性和安全性比较
Efficacy and safety of amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori
【摘要】 目的比较含铋剂/阿莫西林/四环素四联方案的有效性和安全性。方法选取2015年1月至2016年12月就诊于本院的幽门螺旋杆菌(Hp)感染患者128例,随机分为PBAT组(泮托拉唑、枸橼酸铋钾、四环素、阿莫西林)和SQT组(泮托拉唑40mg,阿莫西林、泮托拉唑、克拉霉素、甲硝唑)各64例,比较两组患者Hp根除率和不良反应发生率的差异。结果 ITT分析PBAT方案Hp根治率为90.63%(58/64),SQT方案根治率为79.69%(51/64),差异无统计学意义(χ~2=14.56,P>0.05);PP分析PBAT方案Hp根治率为95.08%(58/61),SQT方案根治率为85.00%(51/60),差异无统计学意义(χ~2=11.28,P>0.05)。两组患者不良反应发生率差异均无统计学意义(P>0.05)。结论PBAT方案可作为Hp根除治疗首选,其安全性和有效性可通过开展多中心、大样本的随机对照试验作进一步验证。
【Abstract】 Objective To evaluate the efficacy and safety of a 14-day modified bismuth quadruple protocol for first-line treatment of Helicobacter pylori infection. Methods In total,128 patients infected with H.pylori participated in a clinical trial.Patients received either a 14-day modified bismuth quadruple therapy(pantoprazole,bismuth subcitrate,tetracycline,and amoxicillin;denoted here as 14-day PBAT)or a 10-day sequential therapy(pantoprazole,amoxicillin,pantoprazole,clarithromycin,and metronidazole;denoted here as 10-day SQT).A 14C-urea breath test,rapid urease testing,or histology was performed to verify eradication Results The intention-to-treat(ITT)eradication rate was 90.63%(58/64) for the 14-day PBAT and 79.69%(51/64) for the 10-day SQT,and the per-protocol(PP)rate was 95.08%(58/61) for the 14-day PBAT and 85.00%(51/60) for the 10-day SQT.The eradication rate was higher in the PBAT group,but neither the ITT eradication rate nor the PP rate differed significantly.There was no significant difference in the incidence of adverse events in the two groups(P>0.05). Conclusion The 14-day PBAT was not inferior to the 10-day SQT,so the 14-day PBAT could be another treatment option.Additional trials are necessary to identify a more satisfactory first-line therapy for eradication of H.pylori.
【Key words】 Helicobacter pylori; eradication; amoxicillin; tetracycline; bismuth; quadruple;
- 【文献出处】 中国病原生物学杂志 ,Journal of Pathogen Biology , 编辑部邮箱 ,2017年08期
- 【分类号】R57
- 【被引频次】17
- 【下载频次】153