2017—2022年发表的中药复方防治动脉粥样硬化动物实验文献的质量评价  

Quality Evaluation of Animal Experimental Studies on Prevention and Treatment of Atherosclerosis by Traditional Chinese Medicine Compound Formula:Literatures during 2017—2022

作　　者：李若琪 郑丹平 李盈盈 唐丹丽[1] 隋宇[1] LI Ruoqi;ZHENG Danping;LI Yingying;TANG Danli;SUI Yu(Experimental Research Center,China Academy of Chinese Medical Sciences,Beijing,100700;Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences)

机构地区：[1]中国中医科学院医学实验中心,北京市东城区100700 [2]中国中医科学院中医药信息研究所

出　　处：《中医杂志》2023年第9期901-908,共8页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81973722,81873199);中国中医科学院创新工程重大攻关项目(CI2021A00604)。

摘　　要：目的通过评价中药复方防治动脉粥样硬化(AS)动物实验文献的方法学质量及报告质量,分析实验过程中的偏倚风险及研究报告的不足,寻求提高中药复方防治AS动物实验研究质量的方法。方法计算机检索中国知网(CNKI)、万方数据知识服务平台(WF)、维普中文期刊服务平台(VIP)、中国生物医学文献数据库(SinoMed)、PubMed、Web of science、Cochrane library和Embase数据库,收集2017年1月1日至2022年9月20日发表的中药复方防治AS动物实验文献,基于SYRCLE偏倚风险评估工具和ARRIVE指南对纳入的文献进行评分并计算各条目“低风险”符合率。结果初步筛选出7921篇文献,最终纳入符合要求的文献343篇,其中中文文献301篇,英文文献42篇。SYRCLE工具评分为(13.26±1.26)分,“低风险”符合率为35.74%。ARRIVE指南必备条目评分为(24.39±1.65)分,“低风险”符合率为42.22%;推荐条目评分为(9.41±2.34)分,“低风险”符合率为20.10%。在SYRCLE工具评价中,245项(71.43%)研究未提供详细序列分配方法,所有研究均未在实施偏倚以及测量偏倚中报告有效的干预措施,仅有5项(1.46%)研究对基线特征进行了描述,2项(0.58%)研究在结果评估中报告了盲法的实施。在ARRIVE指南中,所有研究均未报告样本量确定方法、指定主要结局指标及注册计划书,仅有49项(14.29%)研究说明了实验分析中未包括的动物,54项(15.74%)研究提供了统计方法的详细信息,33项(9.62%)研究提供了实验动物的进一步信息。结论2017—2022年发表的中药复方防治AS动物实验文献方法学质量及报告质量存在较多问题,尤其是在实验过程中随机盲法的实施、实验数据报告的完整性方面存在较多缺陷,建议参照评价工具对研究进行设计和报告,从而提高实验研究的可信性与再现性。Objective To explore the methods that can improve the quality of animal experiments on the prevention and treatment of atherosclerosis by traditional Chinese medicine(TCM)compound formula,by evaluating the methodological quality and reporting quality,and by analyzing the risk of bias in the experimental process and the inadequacy reporting of the researches.Methods CNKI,WanFang,VIP,SinoMed,PubMed,Web of science,Cochrane library and Embase databases were searched to collect animal experimental literature on the prevention and treatment of atherosclerosis by TCM compounds published between January 1st,2017 and September 20th,2022.The included literature was scored based on the SYRCLE bias risk assessment tool and ARRIVE 2019 guidelines,and the coincidence rate of“low risk”for each item was calculated.Results A total of 343 studies out of the initially screened 7921 studies were included,involving 301 in Chinese and 42 in English.The score of SYRCLE tool was 13.26±1.26,and the“low-risk”coincidence rate was 35.74%.The score of the ARRIVE guideline wass 24.39±1.65,and the“low-risk”coincidence rate was 42.22% of the essential items,while those were 9.41±2.34 and 20.10% of the recommended items.According to the SYRCLE's tool,245 studies(71.43%)did not provide details for sequence allocation reported no effective interventions in terms of selection bias,implementation bias,and measurement bias.Only five studies(1.46%)described baseline characteristics,and two studies(0.58%)reported the implementation of blinding in the outcome evaluation.None of the studies reported method of sample size determination,designation of primary outcome measure,and registration protocol in the ARRIVE guidelines.Only 49 studies(14.29%)identified animals not included in the analysis,and 54 studies(15.74%)provided details of the statistical method.Additional information on experimental animals was provided in 33 studies(9.62%).Conclusion There are many problems in the methodological quality and reporting quality of animal experime

关 键 词：动脉粥样硬化 中药复方 动物实验 SRYCLE工具 ARRIVE指南 方法学质量 报告质量 质量评价 

分 类 号：R259[医药卫生—中西医结合] G353.1[医药卫生—中医内科学]