典型文献
Efficacy and safety of high-dose esomeprazole–amoxicillin dual therapy for
Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial
文献摘要：
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 (
H. pylori). This study aimed to compare the efficacy and safety of high-dose PPI–amoxicillin dual therapy and bismuth-containing quadruple therapy for
H. pylori rescue treatment.
Methods::This was a prospective, randomized, multicenter, non-inferiority trial. Patients 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; the HDDT group) 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 days. The primary endpoint was the
H. pylori eradication rate. The secondary endpoints were adverse effects, symptom improvement rates, and patient compliance.
Results::A total of 658 patients who met the criteria were enrolled in this study. The 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-to-treat (MITT), and per-protocol (PP) analyses, respectively. The 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, and –9.73% in the PP analysis) was greater than the predefined non-inferiority margin of –10%, establishing a non-inferiority of the HDDT group
vs. the TFEB group. The 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 groups.
Conclusions::Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy, with fewer adverse effects and good treatment compliance, suggesting HDDT as an alternative for
H. pylori rescue treatment in the local region.
Trial registration::Clinicaltrials.gov, NCT04678492.
文献关键词：
Bismuth-containing quadruple therapy;Helicobacter pylori;High-dose dual therapy;Rescue treatment
中图分类号：
作者姓名：
Bi Hanxin;Chen Xingxing;Chen Yuxin;Zhao Xin;Wang Shasha;Wang Jiehong;Lyu Ting;Han Shuang;Lin Tao;Li Mingquan;Yuan Donghong;Liu Junye;Shi Yongquan
作者机构：
Xi’an Medical University, Xi’an, Shaanxi 710021, China;State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital, Air Force Medical University, Xi’an, Shaanxi 710032, China;Department of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi 712000, China;Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi 712000, China;Department of Gastroenterology, Shaanxi Nuclear Industry 215 Hospital, Xianyang, Shaanxi 712000, China;Department of Gastroenterology, Xi’an Red Cross Hospital, Xi’an, Shaanxi 710054, China;Department of Gastroenterology, Xi’an Daxing Hospital, Xi’an, Shaanxi 710082, China;Department of Gastroenterology, Yan’an People’s Hospital, Yan’an, Shaanxi 716000, China;Department of Gastroenterology, Yan’an University Affiliated Hospital, Yan’an, Shaanxi 716000, China;Department of Radiation Protective Medicine, Air Force Medical University, Xi’an, Shaanxi 710032, China
文献出处：
引用格式：
[1]Bi Hanxin;Chen Xingxing;Chen Yuxin;Zhao Xin;Wang Shasha;Wang Jiehong;Lyu Ting;Han Shuang;Lin Tao;Li Mingquan;Yuan Donghong;Liu Junye;Shi Yongquan-.Efficacy and safety of high-dose esomeprazole–amoxicillin dual therapy for
Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial
)[J].中华医学杂志（英文版）,2022(14):1707-1715
A类：
trial
,asdetermined,NCT04678492
B类：
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AB值：
0.42647
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