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Efficacy and safety of high-dose esomeprazole–amoxicillin dual therapy for Helicobacter pylori rescue treatment:a multicenter,prospective,randomized,controlled trial

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Chinese Medical Journal 2022年第14期135卷 1707-1715页

作者： Hanxin Bi Xingxing Chen Yuxin Chen Xin Zhao Shasha Wang Jiehong Wang Ting Lyu Shuang Han Tao Lin Mingquan Li Donghong Yuan Junye Liu Yongquan Shi Xi’an Medical University Xi’anShaanxi 710021China State Key Laboratory of Cancer Biology National Clinical Research Center for Digestive Diseases and Xijing HospitalAir Force Medical UniversityXi’anShaanxi 710032China Department of Gastroenterology Xianyang Central HospitalXianyangShaanxi 712000China Department of Gastroenterology Affiliated Hospital of Shaanxi University of Chinese MedicineXianyangShaanxi 712000China Department of Gastroenterology Shaanxi Nuclear Industry 215 HospitalXianyangShaanxi 712000China Department of Gastroenterology Xi’an Red Cross HospitalXi’anShaanxi 710054China Department of Gastroenterology Xi’an Daxing HospitalXi’anShaanxi 710082China Department of Gastroenterology Yan’an People’s HospitalYan’anShaanxi 716000China Department of Gastroenterology Yan’an University Affiliated HospitalYan’anShaanxi 716000China Department of Radiation Protective Medicine Air Force Medical UniversityXi’anShaanxi 710032China

Background:High-dose dual therapy(HDDT)with proton pump inhibitors(PPIs)and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori(***).This study aimed to compare the efficacy and safety of high-dose PPI-amoxicillin dual therapy and bismuth-containing quadruple therapy for *** rescue ***:This was a prospective,randomized,multicenter,non-inferiority *** recruited from eight centers who had failed previous treatment were randomly(1:1)allocated to two eradication groups:HDDT(esomeprazole 40 mg and amoxicillin 1000 mg three times daily;theHDDTgroup)and bismuth-containing quadruple therapy(esomeprazole 40 mg,bismuth potassium citrate 220 mg,and furazolidone 100 mg twice daily,combined with tetracycline 500 mg three times daily;the tetracycline,furazolidone,esomeprazole,and bismuth[TFEB]group)for 14 *** primary endpoint was the *** eradication *** secondary endpoints were adverse effects,symptom improvement rates,and patient ***:A total of 658 patients who met the criteria were enrolled in this *** HDDT group achieved eradication rates of 75.4%(248/329),81.0%(248/306),and 81.3%(248/305)asdetermined by the intention-to-treat(ITT),modified intention-totreat(MITT),and per-protocol(PP)analyses,*** eradication rates were similar to those in the TFEB group:78.1%(257/329),84.2%(257/305),and 85.1%(257/302).The lower 95%confidence interval boundary(9.19%in the ITT analysis,9.21%in the MITT analysis,and9.73%in the PP analysis)was greater than the predefined non-inferiority margin of10%,establishing a non-inferiority of the HDDT group *** TFEB *** incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group(11.1%vs.26.8%,P<0.001).Symptom improvement rates and patients’compliance were similar between the two ***:Fourteen-day HDDT is non-inferior to bismuth-containing quadruple the

关键词： Bismuth-containing quadruple therapy Helicobacter pylori High-dose dual therapy rescue treatment

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