伏诺拉生、呋喃唑酮和克拉霉素三联7d方案在青霉素过敏人群幽门螺杆菌感染中的作用:一项单中心、非劣效性随机对照研究OA
The effect of the triple 7-day regimen of Vonoprazan,Furazolidone and Clarithromycin on Helicobacter pylori infection in people with penicillin allergy:a single-center,non-inferior randomized controlled study
目的 探索伏诺拉生、呋喃唑酮和克拉霉素三联7 d方案在青霉素过敏人群幽门螺杆菌(Helicobacter pylori,Hp)感染中的治疗效果和安全性.方法 收集东莞松山湖东华医院2022年6月至2024年6月诊断Hp感染的青霉素过敏患者180例,按1∶1比例随机分为研究组和对照组.研究组接受伏诺拉生、呋喃唑酮和克拉霉素三联7 d方案,对照组接受艾司奥美拉唑、呋喃唑酮、克拉霉素和铋剂四联2周方案,所有患者均在停药至少4周后再次接受13C尿素呼气试验检测.比较两组患者的一般资料、不良反应、用药依从性和Hp根除率.采用意向性治疗(ITT)和符合方案集(PP)分析两组患者的Hp根除率情况.结果 剔除依从性差、自行停药和失访患者,最终得到研究组81例,对照组74例.两组患者的一般资料方面比较差异均无统计学意义(P＞0.05).研究组的总体不良反应发生率为11.1％,对照组为27.0％,差异具有统计学意义(P＜0.05).服药依从性方面,研究组显著高于对照组,差异具有统计学意义(P＜0.05).按ITT分析,研究组和对照组的根除率分别为80.0％(72/90)和74.4％(67/90),风险差为6.2％(95％CI-1.8％～6.8％),差异无统计学意义(x2=0.790,P=0.374).按PP分析,研究组和对照组的根除率分别为88.9％(72/81)和90.5％(67/74),风险差为 1.6％(95％CI-8.0％～11.3％),差异无统计学意义(x2=0.114,P=0.736).所有分析集的95％CI下限均高于预设的非劣效界值(-10％).结论 伏诺拉生、呋喃唑酮和克拉霉素三联7 d方案在治疗Hp感染中效果确切,具有不良反应少、服药依从性高等特点,在未来有望成为青霉素过敏患者治疗Hp感染的一种新的方案和选择.
Objective To explore the therapeutic effect and safety of a 7-day triple regimen of vonoprazan,furazolidone and clarithromycin in the infection of Helicobacter pylori(Hp)in penicillin-allergic population.Methods A total of 180 patients with penicillin allergy and diagnosed with Hp infection in Dongguan Songshan Lake Tungwah Hospital from June 2022 to June 2024 were collected and randomly divided into the study group and the control group at a ratio of 1∶1.The study group received a 7-day triple regimen of vonoprazan,furazolidone and clarithromycin,while the control group received a 2-week quadruple regimen of esomeprazole,furazolidone,clarithromycin and bismuth.All patients underwent the 13C urea breath test again at least 4 weeks after drug withdrawal.The general information,adverse reactions,medication compliance and Hp eradication rate of the two groups of patients were compared.The eradication of Hp in the two groups of patients was analyzed using intention to treat(ITT)and per protocol(PP).Results After excluding patients with poor compliance,self-discontinuation of medication and loss to follow-up,a total of 81 patients were obtained in the study group and 74 patients in the control group.There was no statistically significant difference in the general data of the two groups of patients(P＞0.05),and they were comparable.The overall incidence of adverse reactions in the study group was 11.1％,while that in the control group was 27.0％.The difference was statistically significant(P＜0.05).In terms of medication compliance,the study group was significantly higher than the control group,and the difference was statistically significant(P＜0.05).According to the ITT analysis,the eradication rates of the study group and the control group were 80.0％(72/90)and 74.4％(67/90)respectively,with a risk difference of 6.2％(95％CI-1.8％-6.8％),and the difference was not statistically significant(x2=0.790,P=0.374).According to the PP analysis,the eradication rates of the study group and the control group were 88.9％(72/81)and 90.5％(67/74)respectively,with a risk difference of 1.6％(95％CI-8.0％-1 1.3％),and the differences were not statistically significant(x2=0.114,P=0.736).The lower limit of the 95％CI for all analysis sets was higher than the preset non-inferiority threshold(-10％).Conclusion The 7-day triple regimen of vonoprazan,furazolidone combined with clarithromycin has a definite effect in the treatment of Hp infection,with the characteristics of few adverse reactions and high medication compliance.It is expected to become a new regimen and option for the treatment of Hp infection in patients allergic to penicillin in the future.
金成范;刘海花;李思琼;闭彩莹;张成军;王先令
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医药卫生
伏诺拉生呋喃唑酮青霉素过敏幽门螺杆菌
VonoprazanFurazolidonepenicillin allergyHelicobacter pylori
《中国实用内科杂志》 2026 (7)
571-575,590,6
东莞市社会发展科技面上项目(20231800939222)
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