中国实用内科杂志2026，Vol.46Issue(7)：571-575,590,6.DOI:10.19538/j.nk2026070107
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
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
摘要
Abstract
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.关键词
伏诺拉生/呋喃唑酮/青霉素过敏/幽门螺杆菌Key words
Vonoprazan/Furazolidone/penicillin allergy/Helicobacter pylori分类
医药卫生引用本文复制引用
金成范,刘海花,李思琼,闭彩莹,张成军,王先令..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[J].中国实用内科杂志,2026,46(7):571-575,590,6.基金项目
东莞市社会发展科技面上项目(20231800939222) （20231800939222）
