黄连素联合铋剂四联方案根除幽门螺杆菌感染的随机对照研究  

Berberine as an add therapy for Helicobacter pylori infection:a randomized controlled trial

作　　者：司小北 蓝宇 吴改玲 张灵云 高岩 樊宇靖 张月霞 SI Xiaobei;LAN Yu;WU Gailing;ZHANG Lingyun;GAO Yan;FAN Yujing;ZHANG Yuexia(Department of Gastroenterology,Beijing Jishuitan Hospital,Capital Medical University,Beijing,100096,China)

机构地区：[1]首都医科大学附属北京积水潭医院消化内科,北京100096

出　　处：《中国中西医结合消化杂志》2024年第4期304-308,314,共6页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：北京市中医药管理局北京中医药科技发展基金(No:JJ2018-08)。

摘　　要：目的探究黄连素联合铋剂四联方案根除幽门螺杆菌(Helicobacter pylori,HP)感染的疗效和安全性。方法本研究为随机、对照、开放标签临床试验研究,共纳入80例HP感染初治患者。入组患者随机分入黄连素组和对照组。对照组患者予以阿莫西林+克拉霉素+雷贝拉唑+枸橼酸铋钾方案治疗,黄连素组患者在对照组基础上加用黄连素治疗,两组治疗时间均为14 d。主要结局指标包括HP根除率和不良反应发生率。结果黄连素组中5例患者因难以耐受的不良反应而提前终止治疗,对照组中1例患者因可疑药物相关皮疹而提前终止治疗,1例入组患者不明原因失访,最终73例患者完成了治疗和随访。在意向治疗分析(ITT)和方案分析(PP)中,黄连素组的根除率均低于对照组,但差异无统计学意义(PP:85.71%vs 89.47%,P=0.447;ITT:75.00%vs 85.00%,P=0.201)。黄连素组的总不良反应发生率显著高于对照组(74.29%vs 50.00%,P=0.029)。结论黄连素联合BCQT治疗HP感染不能有效提高根除率,可能存在加重不良反应的风险。Objective The present study aimed to assess the efficacy and safety of berberine combination in the bismuth containing quadruple therapy(BCQT)regimen as the first-line therapy for Helicobacter pylori(H.pylori)eradication.Methods This randomized,open-label,controlledtrial enrolled 80 patients with untreated H.pylori infection.Participants in the berberine group received eradication therapy with a rabeprazole-amoxicillin-clarithromycin-bismuth-berberine regimen for 14 days,whereas those in the control group received a rabeprazole-amoxicillin-clarithromycin-bismuth regimen for the same duration.The primary outcomes were eradication rate and side effects rate.Results Five participants in the berberine group dropped out due to intolerant side effects,while two participants in the control group opted out due to rash and loss to follow-up.In the intention-to-treat(ITT)and per-protocol(PP)analyses,the eradication rates in the berberine group were lower than those in the control group,without significant differences(PP:85.71%vs 89.47%,P=0.447;ITT:75.00%vs 85.00%,P=0.201).The total side-effect rate in the berberine group was higher than that in the control group(74.29%vs 50.00%,P=0.029).Conclusion We concluded that the combination of berberine and BCQT results in elevated and severe side effects.The hypothesis that berberine as an add-on therapy would improve eradication rate of BCQT was not confirmed.

关 键 词：黄连素 幽门螺杆菌 根除治疗 

分 类 号：R256.3[医药卫生—中医内科学]