| 摘要: |
| [目的] 通过系统检索与梳理中医药治疗幽门螺杆菌（Hp）感染的随机对照试验（RCT）现状，总结当前该领域取得的证据、进展和存在的问题。[方法] 检索2017年1月—2025年6月中国知网（CNKI）、万方数据知识服务平台（Wanfang Database）、维普中文科技期刊数据库（VIP）、中国生物医学文献数据库（SinoMed）、EMbase、Pubmed、Web of science、Cochrane library8个数据库中关于中医药治疗Hp感染的RCT，对文献质量进行评价，分析RCT中西药用药方案及结局指标设置。[结果] 共纳入280项RCT，证据质量普遍不高，存在抗生素剂量及疗程不规范、结局指标主次不明确、复合结局指标评价混乱等问题。[结论] 中医药治疗Hp感染具有优势，中药代替一种抗生素、分阶段治疗等新兴治疗方案扩大了中医药治疗优势，为改善Hp感染治疗困境提供了可能。未来应进一步规范临床设计，提升临床研究质量，开展大样本、多中心的RCT，为中医药治疗Hp感染提供高质量证据。 |
| 关键词: 幽门螺杆菌 中医药 随机对照试验 质量评价 结局指标 |
| DOI：10.11656/j.issn.1672-1519.2026.09.08 |
| 分类号:R573.6 |
| 基金项目:北京市东城区优秀人才培养项目（2019WJGW-10-04）；北京中医药大学东直门医院临床研究和成果转化能力提升试点项目（DZMG-ZJXY-23010）。 |
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| Analysis of medication strategies and outcome indicators in randomized controlled trials of traditional Chinese medicine for treating Helicobacter pylori infection |
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LIU Yang, JIANG Feng, PANG Chenxu, YU Yanhui, HUANG Yafang
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Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
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| Abstract: |
| [Objective] To systematically retrieve and sort out the current status of randomized controlled trials（RCTs）on the treatment of Helicobacter pylori（Hp）infection with traditional Chinese medicine（TCM），present the results in the form of evidence mapping， and summarize the current evidence，progress，and existing issues in this field. [Methods] RCTs on the treatment of Hp infection with TCM published from January 2017 to June 2025 were retrieved from eight databases：CNKI，Wanfang Database，VIP，SinoMed， EMbase，Pubmed，Web of Science，and Cochrane Library. The quality of the literature was evaluated，and the medication strategies for both Western and Chinese medicines，as well as the setting of outcome measures，were analyzed. [Results] A total of 280 RCTs were included，with generally low quality of evidence，with issues such as non-standard antibiotic dosages and treatment durations，unclear primary and secondary outcome measures，confusion in the evaluation of composite outcome measures. [Conclusion] TCM has advantages in the treatment of Hp infection. Replacing one antibiotic with Chinese medicine and staged treatment expand the advantages of TCM，and provide a solution to the challenges in treating Hp infection. In the future，clinical design should be further standardized to enhance the quality of clinical research. Large-sample，multicenter RCTs should be conducted to provide high-quality evidence for the treatment of Hp infection with TCM. |
| Key words: Helicobacter pylori traditional Chinese medicine randomized controlled trial quality evaluation outcome indicator |
