基于SYRCLE工具和ARRIVE2.0指南的中医药治疗腹泻型肠易激综合征的动物实验研究质量评价

Quality Evaluation of Animal Experimental Studies on Traditional Chinese Medicine for Diarrhea-Predominant Irritable Bowel Syndrome Based on the SYRCLE Tool and ARRIVE 2.0 Guidelines

摘要: 目的：评价近十年中医药治疗腹泻型肠易激综合征(IBS-D)动物实验的报告质量，为高质量实验设计提供循证依据。方法：检索CNKI、万方、维普、PubMed、Web of Science 2015-01-01至2025-05-01中医药干预IBS-D动物实验文献，采用SYRCLE偏倚风险工具与ARRIVE 2.0指南开展质量评价。结果：初检文献1607篇，最终纳入109篇。中医外治、中药内服类研究报告质量整体偏低；突出问题包括缺少样本量计算、随机化与分配隐藏报告不足、盲法实施记录缺失、伦理与动物护理监测信息不全、缺少实验预注册，由此引发选择偏倚、实施偏倚、测量偏倚。结论：中医药治疗IBS-D动物实验存在方法学缺陷、报告不规范，影响结果真实性与外推性。研究者开展方案设计、实验实施与论文撰写应参考SYRCLE工具及ARRIVE 2.0指南；期刊与实验监管平台需完善管理制度，推动该领域动物实验标准化，助力基础成果临床转化。

Abstract: To evaluate the reporting quality of animal experimental studies on Traditional Chinese Medicine (TCM) for diarrhea-predominant irritable bowel syndrome (IBS-D) in the past decade, so as to provide evidence base for high-quality experimental design. Methods: Literature on TCM animal experiments for IBS-D was retrieved from CNKI, Wanfang, VIP, PubMed and Web of Science from January 1, 2015 to May 1, 2025. SYRCLE risk-of-bias tool and ARRIVE 2.0 guidelines were used for quality assessment. Results: A total of 1607 records were initially searched and 109 articles were finally included. Both TCM external therapy and oral herbal studies showed unsatisfactory reporting quality. Major deficiencies were lack of sample-size calculation, incomplete reporting of randomization and allocation concealment, missing records of blinding implementation, insufficient information on ethics, animal care and monitoring, and absence of study pre-registration, leading to selection bias, performance bias and measurement bias. Conclusion: Methodological defects and non-standard reporting commonly exist in TCM IBS-D animal experiments, which impair validity and generalizability of research findings. Researchers should refer to the SYRCLE tool and ARRIVE 2.0 guidelines when designing protocols, conducting experiments, and writing manuscripts; journals and platforms overseeing experiments should improve their management systems to promote the standardization of animal experiments in this field and support the clinical translation of basic research findings.