高剂量埃索美拉唑和阿莫西林双重疗法对比含铋四联疗法治疗幽门螺杆菌感染的疗效和安全性：一项多中心随机对照临床试验。
Efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy bismuth-containing quadruple therapy for infection: a multicenter, randomized controlled clinical trial.
作者信息
Mei Hao, Guo Yan, Zhao Jing-Tao, Yang Jun, Sun Wen-Jing, Zhang De-Kui, He Ping, Shi Gang, Su Na-Yun, Han Ran, Lan Chun-Hui
机构信息
Department of Gastroenterology, Chongqing Key Laboratory of Digestive Malignancies, Daping Hospital, Army Medical University (Third Military Medical University), Chongqing 400042, P. R, China.
Department of Gastroenterology, People's Hospital of Chongqing Banan District, Chongqing, China.
出版信息
Therap Adv Gastroenterol. 2022 Dec 26;15:17562848221142925. doi: 10.1177/17562848221142925. eCollection 2022.
BACKGROUND
A high-dose proton pump inhibitor (PPI)-amoxicillin dual therapy has been investigated for treatment of patients with () infection. Currently, the efficacy of this dual therapy remains inconclusive, with controversial findings from various single-center clinical trials.
OBJECTIVES
To assess the efficacy and safety of high-dose dual therapy (HDDT) compared with the bismuth-containing quadruple therapy (BQT) in treatment-naive patients with infection.
DESIGN
A multicenter, open-label, randomized controlled clinical trial.
METHODS
Three hundred and forty treatment-naïve patients with infection were prospectively recruited from seven participating hospitals. The enrolled patients were randomized into one of two treatment groups: the HDDT group (esomeprazole, 20 mg four times daily; amoxicillin, 750 mg four times daily) and the BQT group (esomeprazole, 20 mg, twice daily; bismuth potassium citrate, 600 mg, twice daily; amoxicillin, 1 g, twice daily; metronidazole, 400 mg, four times daily). The primary outcome was eradication rate, and secondary outcomes were safety and patient compliance.
RESULTS
The eradication rates in the HDDT group the BQT group were 86.47% 87.06% on intention-to-treat (ITT) analysis, 91.88% 92.50% on modified ITT (MITT) analysis, and 91.77% 93.04% on per-protocol (PP) analysis, with no significant differences between the two groups. The patient compliance rates in the HDDT group the BQT group were 97.02% 95.86%, and no significant difference was found between the two groups. Notably, the HDDT group exhibited significantly lower incidence in the drug-induced adverse events (AEs) compared to the BQT group (16.67% 47.94%).
CONCLUSION
HDDT is equally efficacious in eradicating infection and resulted in good patient compliance and safety compared with BQT. These findings provide evidence in support of HDDT as a first-line treatment for infection.
REGISTRATION
This clinical trial was registered at The Chinese Clinical Trial Registry (trial registration number: ChiCTR2000039096).
背景
高剂量质子泵抑制剂（PPI）-阿莫西林双联疗法已被用于研究治疗（）感染患者。目前，这种双联疗法的疗效仍无定论，各单中心临床试验结果存在争议。
目的
评估高剂量双联疗法（HDDT）与含铋四联疗法（BQT）在初治（）感染患者中的疗效和安全性。
设计
一项多中心、开放标签、随机对照临床试验。
方法
从7家参与研究的医院前瞻性招募340例初治（）感染患者。将入选患者随机分为两个治疗组之一：HDDT组（埃索美拉唑，每日4次，每次20mg；阿莫西林，每日4次，每次750mg）和BQT组（埃索美拉唑，每日2次，每次20mg；枸橼酸铋钾，每日2次，每次600mg；阿莫西林，每日2次，每次1g；甲硝唑，每日4次，每次400mg）。主要结局为根除率，次要结局为安全性和患者依从性。
结果
在意向性分析（ITT）中，HDDT组和BQT组的根除率分别为86.47%和87.06%；在改良意向性分析（MITT）中分别为91.88%和92.50%；在符合方案分析（PP）中分别为91.77%和93.04%，两组之间无显著差异。HDDT组和BQT组的患者依从率分别为97.02%和95.86%，两组之间无显著差异。值得注意的是，与BQT组相比，HDDT组药物诱导的不良事件（AE）发生率显著更低（16.67%对47.94%）。
结论
HDDT在根除（）感染方面同样有效，与BQT相比，患者依从性和安全性良好。这些发现为支持HDDT作为（）感染的一线治疗提供了证据。
注册
本临床试验在中国临床试验注册中心注册（试验注册号：ChiCTR2000039096）。
Zotero 插件