The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study.

IF 7.5 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

Chinese Medical Journal Pub Date : 2025-04-29 DOI:10.1097/CM9.0000000000003534

Minjuan Lin, Junnan Hu, Jing Liu, Juan Wang, Zhongxue Han, Xiaohong Wang, Zhenzhen Zhai, Yanan Yu, Wenjie Yuan, Wen Zhang, Zhi Wang, Qingzhou Kong, Boshen Lin, Yuming Ding, Meng Wan, Wenlin Zhang, Miao Duan, Shuyan Zeng, Yueyue Li, Xiuli Zuo, Yanqing Li

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引用次数: 0

Abstract

Background: The effect of the interval between previous Helicobacter pylori (H. pylori) eradication and rescue treatment on therapeutic outcomes remains unknown. The aim of this study was to investigate the association between eradication rates and treatment interval durations in H. pylori infections.

Methods: This prospective observational study was conducted from December 2021 to February 2023 at six tertiary hospitals in Shandong, China. We recruited patients who were positive for H. pylori infection and required rescue treatment. Demographic information, previous times of eradication therapy, last eradication therapy date, and history of antibiotic use data were collected. The patients were divided into four groups based on the rescue treatment interval length: Group A, ≥4 weeks and ≤3 months; Group B, >3 and ≤6 months; Group C, >6 and ≤12 months; and Group D, >12 months. The primary outcome was the eradication rate of H. pylori . Drug compliance and adverse events (AEs) were also assessed. Pearson's χ2 test or Fisher's exact test was used to compare eradication rates between groups.

Results: A total of 670 patients were enrolled in this study. The intention-to-treat (ITT) eradication rates were 88.3% in Group A, 89.6% in Group B, 89.1% in Group C, and 87.7% in Group D. The per-protocol (PP) eradication rates were 92.9% in Group A, 94.5% in Group B, 94.5% in Group C, and 93.6% in Group D. There was no statistical difference in the eradication rates between groups in either the ITT ( P = 0.949) or PP analysis ( P = 0.921). No significant differences were observed in the incidence of AEs ( P = 0.934) or drug compliance ( P = 0.849) between groups.

Conclusion: The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs.

Registration: ClinicalTrials.gov , NCT05173493.

查看原文本刊更多论文

抢救治疗间隔不影响幽门螺杆菌根除的有效性和安全性：一项前瞻性多中心观察性研究。

背景：先前幽门螺杆菌（h.p ylori）根除和抢救治疗之间的间隔时间对治疗结果的影响尚不清楚。本研究的目的是调查根除率与幽门螺杆菌感染的治疗间隔时间之间的关系。方法：本前瞻性观察研究于2021年12月至2023年2月在中国山东省的6家三级医院进行。我们招募了幽门螺旋杆菌感染阳性并需要抢救治疗的患者。收集人口统计信息、既往根除治疗次数、最后一次根除治疗日期和抗生素使用史数据。根据抢救治疗间隔时间长短将患者分为4组：A组，≥4周，≤3个月；B组：bb0 3个月，≤6个月；C组：6个月及≤12个月；D组12个月。主要观察指标为幽门螺杆菌的根除率。药物依从性和不良事件（ae）也进行了评估。采用Pearson χ2检验或Fisher精确检验比较各组间的根除率。结果：本研究共纳入670例患者。意向治疗（ITT）根除率A组为88.3%，B组为89.6%，C组为89.1%，d组为87.7%。按方案（PP）根除率A组为92.9%，B组为94.5%，C组为94.5%，d组为93.6%。ITT分析（P = 0.949）和PP分析（P = 0.921）各组间根除率无统计学差异。各组不良反应发生率（P = 0.934）和药物依从性（P = 0.849）差异无统计学意义。结论：抢救治疗间隔时间对幽门螺杆菌根除率和不良反应发生率无显著影响。注册：ClinicalTrials.gov, NCT05173493。

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来源期刊

Chinese Medical Journal 医学-医学：内科

CiteScore

9.80

自引率

4.90%

发文量

19245

审稿时长

6 months

期刊介绍： The Chinese Medical Journal (CMJ) is published semimonthly in English by the Chinese Medical Association, and is a peer reviewed general medical journal for all doctors, researchers, and health workers regardless of their medical specialty or type of employment. Established in 1887, it is the oldest medical periodical in China and is distributed worldwide. The journal functions as a window into China’s medical sciences and reflects the advances and progress in China’s medical sciences and technology. It serves the objective of international academic exchange. The journal includes Original Articles, Editorial, Review Articles, Medical Progress, Brief Reports, Case Reports, Viewpoint, Clinical Exchange, Letter,and News,etc. CMJ is abstracted or indexed in many databases including Biological Abstracts, Chemical Abstracts, Index Medicus/Medline, Science Citation Index (SCI), Current Contents, Cancerlit, Health Plan & Administration, Embase, Social Scisearch, Aidsline, Toxline, Biocommercial Abstracts, Arts and Humanities Search, Nuclear Science Abstracts, Water Resources Abstracts, Cab Abstracts, Occupation Safety & Health, etc. In 2007, the impact factor of the journal by SCI is 0.636, and the total citation is 2315.