中药复方干预肝癌动物实验的报告质量与方法学质量评价研究

Evaluation of reporting and methodological quality in animal studies on Chinese herbal compound interventions for hepatocellular carcinoma

关键词:  肝细胞癌  中药复方  动物实验  ARRIVE指南2.0  SYRCLE工具  质量评价

Key words:  hepatocellular carcinoma  Chinese herbal compounds  animal studies  ARRIVE 2.0  SYRCLE tool  quality assessment

摘要:

[目的] 评价2018—2024年发表的中药复方干预肝癌动物实验文献的报告质量和方法学质量，分析文献存在的问题和偏倚风险，为提高本领域研究质量提供借鉴。[方法] 检索中国知网、万方数据、维普中文期刊、中国生物医学文献数据库、PubMed、Web of science、The Cochrane library等数据库，整理汇总2018年1月1日—2024年3月18日发表的中药复方干预肝癌动物实验文献，按照动物实验ARRIVE报告指南2.0和SYRCLE风险评估工具所列条目内容，分别评价纳入文献的报告质量和方法学质量，使用Excel 2019软件对评价结果进行统计分析。[结果] 1）共纳入258篇符合要求文献，中文文献232篇，英文文献26篇。2）ARRIVE指南2.0评价结果显示，38个亚条目中，仅有13个条目较多数文献报告良好。258篇文献中，仅55篇文献的报告质量良好，其余报告不清晰、不充分。3）SYRCLE工具评价结果显示，10个条目中，有4个条目多数文献评估良好，61篇文献的偏倚风险较低，其余文献均存在一定的偏倚风险。[结论] 近五年中药复方干预肝癌的动物实验报告多数在内容上不完整、不详细、不规范，并存在不同程度偏倚风险。建议参照指南和评估工具内容，规范地设计、实施实验和撰写报告。同时有必要制定符合中医药自身特点的动物实验报告标准，推动产生高质量实验研究成果，向临床转化提供有效证据支持。

Abstract:

[Objective] To evaluate the reporting and methodological quality of animal studies on Chinese herbal compound interventions for hepatocellular carcinoma（HCC） published from 2018 to 2024，analyze the existing problems and risk of bias in the literature，and provide references for improving the quality of research in this field. [Methods] The authors searched databases including CNKI，Wanfang Data，VIP Chinese Journal，China Biomedical Literature Database，PubMed，Web of Science，and The Cochrane Library to collect and summarize animal studies on Chinese herbal compound interventions for HCC published from January 1，2018，to March 18，2024. The reporting and methodological quality of the included studies were evaluated according to the ARRIVE Guidelines 2.0（Animal Research：Reporting of In Vivo Experiments） and the SYRCLE risk of bias tool for animal studies. The evaluation results were statistically analyzed using Excel 2019. [Results] 1） A total of 258 studies were included，with 232 in Chinese and 26 in English. 2） The evaluation based on ARRIVE 2.0 showed that only 13 out of 38 sub-items were well-reported in the majority of the studies. Among the 258 studies，only 55 studies demonstrated good reporting quality，while the rest were unclear or insufficient. 3） The SYRCLE tool evaluation revealed that 4 out of 10 items were well-assessed in the majority of the studies. Only 61 studies had a low risk of bias，while the rest exhibited some degree of bias. [Conclusion] Most animal studies on Chinese herbal compound interventions for HCC in the past five years were incomplete，insufficiently detailed，and non-standardized in content，with varying degrees of bias risk. It is recommended to design，conduct，and report animal studies in accordance with the ARRIVE 2.0 and SYRCLE tools. Additionally，it is necessary to establish reporting standards for animal studies that align with the characteristics of Chinese medicine，thereby promoting high-quality research outcomes and providing effective evidence for clinical translation.