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含利福布汀的三联疗法与铋四联疗法治疗幽门螺杆菌补救治疗的比较:一项多中心、随机对照试验。

Rifabutin-Containing Triple Therapy Versus Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Multicenter, Randomized Controlled Trial.

机构信息

Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, NHC Key Laboratory of Digestive Diseases; Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

Department of Gastroenterology, Shanghai Songjiang District Central Hospital, Shanghai, China.

出版信息

J Infect Dis. 2023 Aug 31;228(5):511-518. doi: 10.1093/infdis/jiad114.

DOI:10.1093/infdis/jiad114
PMID:37079894
Abstract

BACKGROUND

We compared the efficacy and safety of rifabutin-containing triple therapy with bismuth quadruple therapy for rescue treatment of Helicobacter pylori.

METHODS

This was a noninferiority study trial of H. pylori treatment for subjects who had failed at least 2 prior treatments. Subjects were randomly assigned to receive rifabutin triple therapy with 14-day esomeprazole (20 mg), amoxicillin (1.0 g), and rifabutin (150 mg) twice a day; or bismuth quadruple therapy with esomeprazole (20 mg) and bismuth (220 mg) twice a day, plus metronidazole (400 mg) and tetracycline (500 mg) 4 times a day. Antimicrobial susceptibility was assessed by agar dilution and E-test.

RESULTS

From May 2021 to October 2022, a total of 364 subjects were randomized. The eradication rates by intention-to-treat, per-protocol, and modified intention-to-treat were 89.0% (162/182; 95% confidence interval [CI], 83.6%-92.8%), 94.0% (157/167; 95% CI, 89.3%-96.7%), and 93.6% (162/173; 95% CI, 89.0%-96.4%) for rifabutin triple group. For bismuth quadruple group, they were 89.6% (163/182; 95% CI, 84.3%-93.2%), 95.3% (143/150; 95% CI, 90.7%-97.7%), and 93.7% (163/174; 95% CI, 89.0%-96.4%).

CONCLUSIONS

The rifabutin triple therapy is an alternative to classical bismuth quadruple therapy for the rescue treatment of H. pylori with fewer side effects and higher compliance.

CLINICAL TRIALS REGISTRATION

NCT04879992.

摘要

背景

我们比较了含利福布汀的三联疗法与铋四联疗法对幽门螺杆菌补救治疗的疗效和安全性。

方法

这是一项针对至少接受过 2 种先前治疗失败的幽门螺杆菌治疗的受试者的非劣效性研究试验。受试者被随机分配接受利福布汀三联疗法,每日 2 次服用埃索美拉唑(20mg)、阿莫西林(1.0g)和利福布汀(150mg);或铋四联疗法,每日 2 次服用埃索美拉唑(20mg)和枸橼酸铋(220mg),加甲硝唑(400mg)和四环素(500mg),每日 4 次。通过琼脂稀释和 E 试验评估抗菌药物敏感性。

结果

2021 年 5 月至 2022 年 10 月,共纳入 364 例受试者。意向治疗、符合方案和改良意向治疗的根除率分别为 89.0%(162/182;95%置信区间[CI],83.6%-92.8%)、94.0%(157/167;95%CI,89.3%-96.7%)和 93.6%(162/173;95%CI,89.0%-96.4%)。铋四联组分别为 89.6%(163/182;95%CI,84.3%-93.2%)、95.3%(143/150;95%CI,90.7%-97.7%)和 93.7%(163/174;95%CI,89.0%-96.4%)。

结论

利福布汀三联疗法是经典铋四联疗法的替代方案,用于补救治疗幽门螺杆菌,副作用更少,依从性更高。

临床试验注册

NCT04879992。

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