目的 观察富马酸伏诺拉生联合阿莫西林在武警某部官兵幽门螺杆菌(Hp)首治失败后补救治疗的效果和安全性。方法 选取2021-12至2022-12武警江西总队医院Hp感染首治失败的患者为研究对象,共纳入85例。随机分为观察组(42例)和对照组(43例)。观察组采用富马酸伏诺拉生联合阿莫西林二联治疗,对照组采用经典四联疗法,均连续服用14 d。评估患者的治疗依从性,记录两组患者意向性分析(ITT)和符合治疗方案分析(PP)的Hp根除率。结果 观察组42例(100%)完成治疗方案,对照组38例(88.4%)完成治疗方案,观察组完成治疗方案率高于对照组,差异具有统计学意义(P<0.05)。观察组不良反应率(4.8%)明显低于对照组的16.7%,差异具有统计学意义(P<0.05)。复查Hp根除情况,观察组Hp阴性32例,Hp阳性10例,ITT根除率为83.3%,PP根除率为83.3%。对照组Hp阴性31例,Hp阳性12例,ITT根除率72.1%,PP根除率为81.6%。观察组与对照组的ITT根除率、PP根除率差异均无统计学意义。结论 与经典四联补救治疗方案比较,富马酸伏诺拉生联合阿莫西林二联治疗具有同样的Hp根除率,且患者有更好的治疗依从性,不良反应发生率低,临床使用安全。

Objective To explore the effect and the safety of voronolasen combined with amoxicillin salvage treatment after the failure of initial treatment of Helicobacter pylori(Hp).Methods From December 2021 to December 2022, 85 patients with Hp infection diagnosed in Jiangxi Provincial Crops Hospital of Chinese People'S Armed Police Force who failed in the first treatment and needed salvage theropy were selected. All patients were randomly divided into an observation group (n=42) and a control group (n=43). The observation group received voronolasen combined with amoxicillin salvage theropy, the control group received classical quadruple therapy, and all the patients took the treatment for consecutive 14 days. Comparison of the eradication rate of Hp about the Intention-To-Treat analysis(ITT analysis) and the Per-Protocol analysis (PP analysis) were made after the end of medication.Results All the 42 patients (100%) finished the treatment plan in the observation group, while the number for the control group was 38 patients(88.4%). The completion rate in the observation group were higher than the control group, and there were statistically significant differences had (P<0.05). The adverse reaction rate of the observation group was lower than that of the control group, and there were also statistically significant differences (P<0.05). The eradication rates of HP of the ITT analysis and the PP analysis in the observation group were both 83.3%, while the rates in the control group were 72.1% and 81.6% respectively. The differences of ITT analysis and the PP analysis between the two groups were not obvious, and had no statistical significance(P>0.05).Conclusions Compared with classical quadruple therapy, the voronolasen combined with amoxicillin salvage theropy has the same Hp eradication rate and lower cost, and the patients has better treatment compliance and lower incidence of adverse reactions.