| 引用本文:侯文斌1，张晓雯1，孙屿昕1，廖星2，韩梅1，郑酉友1，刘兆兰1，刘建平1.复方苦参制剂治疗溃疡性结肠炎动物实验的质量评价研究[J].世界中医药,2023,(14):. |
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| 复方苦参制剂治疗溃疡性结肠炎动物实验的质量评价研究 |
| Quality Evaluation of Sophorae Flavescentis Radix-containing Compound Preparations in the Treatment of Ulcerative Colitis in Animals |
| 投稿时间：2021-10-15 |
| DOI：10.3969/j.issn.1673-7202.2023.14.009 |
| 中文关键词: 溃疡性结肠炎 复方苦参 五味苦参 动物实验 动物实验研究报告指南2.0 SYRCLE 质量评价 |
| English Keywords:Ulcerative colitis Sophorae Flavescentis Radix-containing compound Wuwei Kushen Animal experiments ARRIVE 2.0 SYRCLE Quality evaluation |
| 基金项目:国家自然科学基金青年科学基金项目（81904052） |
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| 中文摘要: |
| 目的：评价当前复方苦参制剂治疗溃疡性结肠炎动物实验研究的方法学质量和报告质量。方法：计算机检索相关数据库，检索日期从各数据库建库至2021年9月。纳入复方苦参制剂治疗溃疡性结肠炎的动物实验文献，2位作者独立进行文献筛选、资料提取，参照动物实验研究报告指南（ARRIVE）2.0和SYRCLE工具对纳入研究的偏倚风险和报告质量进行评价。结果：共纳入16项研究，11项为复方苦参汤干预，5项为五味苦参肠溶胶囊干预。根据SYRCLE工具，有1项研究报告随机序列的产生方法、基线情况和结局评价者的盲法，研究均未报告分配隐藏、实验实施者盲法和随机性结果评估。根据ARRIVE指南2.0进行评价，研究均未报告样本量确定方法、纳入排除标准、最小化潜在混杂因素的控制策略、伦理审查信息、实验动物福利、建立的实验动物人道终点、实验方案注册信息、研究数据获得途径、利益冲突和资助方在研究设计分析和报告中所起的作用，2项研究解释了实验中使用的动物种类和模型如何达到研究目标，3项研究报告了发生的不良事件。结论：本研究纳入复方苦参制剂治疗溃疡性结肠炎动物实验的方法学质量和报告质量较低，建议今后的动物实验研究应严谨设计实施，参考SYRCLE工具进行科学合理设计，并遵循ARRIVE指南2.0科学严谨地报告研究结果。 |
| English Summary: |
| To evaluate the methodological and reporting quality of animal experimental studies on the treatment of ulcerative colitis with Sophorae Flavescentis Radix(SFR)-containing compound preparations.Methods:Relevant databases were searched from database inception to September 2021.Animal experimental studies on the treatment of ulcerative colitis with SFR-containing compound preparations were included.Two authors independently screened and extracted data from the literature and assessed the risk of bias and reporting quality of the included studies according to the Animal Research：Reporting of In Vivo Experiments(ARRIVE) 2.0 guidelines and the SYRCLE tool.Results:Sixteen studies were included，with 11 using SFR-containing compound preparations and 5 using Wuwei Kushen Enteric Capsules.According to the SYRCLE tool，one study reported the generation method of random sequence，baseline conditions，and blinding of outcome assessors，but all studies did not report allocation concealment，blinding of experimenters，and assessment of randomization results.According to the ARRIVE 2.0 guidelines，all studies did not report the method of sample size determination，inclusion and exclusion criteria，control strategy to minimize potential confounding factors，ethical review information，animal welfare during the experiment，establishment of humane endpoints for experimental animals，registration information of the experimental plan，data acquisition method，conflicts of interest，and the role of funding sources in study design，analysis，and reporting.Two studies explained how the animal species and models used in the experiment achieved the research objectives，and three studies reported adverse events that occurred during the study.Conclusion:The methodological and reporting quality of animal experimental studies on the treatment of ulcerative colitis with SFR-containing compound preparations included in this study is low.It is recommended that future animal experimental studies be rigorously designed and implemented，following the SYRCLE tool for scientifically reasonable design，and adhering to the ARRIVE 2.0 guidelines for the scientific and rigorous reporting of research results. |
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