艾司奥美拉唑联合阿莫西林方案与含铋剂四联方案对幽门螺杆菌感染初治患者的疗效比较

Efficacy of asmeprazole combined with amoxicillin versus bismuth-containing quadruple therapy in initially treated patients with Helicobacter pylori infection

目的 比较艾司奥美拉唑联合阿莫西林方案与含铋剂四联方案对幽门螺杆菌(Hp)感染初治患者的治疗效果。方法 选取240例Hp感染初治患者作为研究对象,随机分为二联组(口服艾司奥美拉唑20 mg+阿莫西林750 mg,4次/d,疗程14 d)和四联组(口服艾司奥美拉唑20 mg+胶体果胶铋250 mg+阿莫西林1.0 g+克拉霉素0.5 g,2次/d,疗程14 d)。于治疗第3、7、14天随访2组患者的不良反应发生情况,比较2组患者服药依从性,根除治疗结束后1个月时复查肝功能,停药1~2个月内复查;C尿素呼气试验评估疗效(Hp根除率)。结果 二联组、四联组患者Hp根除率的意向性(ITT)分析结果(66.67%、72.50%)、改良意向性(MITT)分析结果(82.47%、86.14%)、符合方案集(PP)分析结果(81.91%、86.60%)比较,差异均无统计学意义(P>0.05)。2组患者不良反应发生率、肝功能损害发生率、服药依从性比较,差异均无统计学意义(P>0.05);2组患者的不良反应均在停药后消失,未发生严重不良反应。结论 艾司奥美拉唑联合阿莫西林方案与含铋剂四联方案对Hp感染初治患者的疗效相当,具有良好的安全性,且患者服药依从性较高。

Objective To compare the curative efficacy between esomeprazole combined with amoxicillin and bismuth-containing quadruple therapy in patients with Helicobacter pylori infection. Methods A total of 240 newly treated patients with Hp infection were randomly divided into dual therapy group(orally taken 20 mg of esomeprazole and 750 mg of amoxicillin)and quadruple therapy group(orally taken esomeprazole 20 mg,colloidal bismuth 250 mg,amoxicillin 1.0 g and clarithromycin 0.5 g,twice a day,the course of treatment was 14 d). The incidence of adverse reactions in the two groups was followed up on the 3 rd,7 th and 14 th day of treatment,and the medication compliance of the two groups was compared. Liver function was reexamined one month after the end of eradication treatment,and;C urea breath test was reexamined within 1 month to 2 months after with drawal to evaluate efficacy(Hp eradication rate). Results There were no significant differences in the eradication rate of intention-to-treat analysis(ITT) results(66.67%,72.50%),modified intention-to-treat analysis(MITT) results(82.47%,86.14%) and per-protocol analysis(PP) results(81.91%,86.60%) between the two groups( P > 0. 05). There were no significant differences in the incidence of adverse reactions,incidence of liver function damage and compliance of drugs administration( P > 0. 05).The adverse reactions of the two groups disappeared after drug withdrawal,no serious adverse reactions occurred. Conclusion Esomeprazole combined with amoxicillin is as effective as bismuthcontaining quadruple therapy,and has good safety andcompliance of drugs administration.