【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。更多还原

【Abstract】 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.更多还原