{"title":"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。","authors":"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","doi":"10.1097/CM9.0000000000003534","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs.</p><p><strong>Registration: </strong>ClinicalTrials.gov , NCT05173493.</p>","PeriodicalId":10183,"journal":{"name":"Chinese Medical Journal","volume":" ","pages":""},"PeriodicalIF":7.5000,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study.\",\"authors\":\"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\",\"doi\":\"10.1097/CM9.0000000000003534\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The interval duration of rescue treatment had no significant effect on H. pylori eradication rates or the incidence of AEs.</p><p><strong>Registration: </strong>ClinicalTrials.gov , NCT05173493.</p>\",\"PeriodicalId\":10183,\"journal\":{\"name\":\"Chinese Medical Journal\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":7.5000,\"publicationDate\":\"2025-04-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chinese Medical Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/CM9.0000000000003534\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chinese Medical Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/CM9.0000000000003534","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study.
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.
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.
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