首页|基于SYRCLE工具和ARRIVE 2.0指南的中药复方防治胃癌前病变动物实验文献质量评价

基于SYRCLE工具和ARRIVE 2.0指南的中药复方防治胃癌前病变动物实验文献质量评价

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目的 通过评价中药复方防治胃癌前病变(PLGC)动物实验研究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,为提高中药复方防治PLGC动物实验研究质量提供参考。方法 计算机检索中国知识资源总库(CNKI)、万方数据知识服务平台(Wanfang Data)、中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、Web of Science 和 Embase 数据库2014年1月1日-2024年2月23日发表的关于中药复方防治PLGC动物实验文献,采用SYRCLE工具和ARRIVE 2。0指南对纳入文献进行评分并计算各条目"低风险"符合率。结果 共纳入文献213篇,其中中文文献189篇、英文文献24篇。SYRCLE工具评分为(12。86±1。29)分,"低风险"符合率为32。79%。ARRIVE 2。0指南必备条目评分为(24。15±2。80)分,"低风险"符合率为49。08%;推荐条目评分为(11。28±3。40)分,"低风险"符合率为30。27%。SYRCLE工具评价中,144项(67。61%)研究未详细阐述分配序列产生的方法,所有研究均未描述分配隐藏充分与否及实施偏倚过程中的盲法,7项(3。29%)研究描述对结果评价者施盲。ARRIVE 2。0指南中,所有研究均未报告样本量的确定方法、均未提供用于确定样本量的结局指标及实验方案注册声明,51项(23。94%)研究明确提出PLGC造模成功标准,66项(30。96%)研究提供所使用统计方法的详细信息,29项(13。62%)研究提供完整的伦理声明,22项(10。33%)报告了利益冲突。结论 2014-2024年发表的中药复方防治PLGC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策略的实施、样本量计算细节及纳入排除标准报告等方面存在缺陷,建议今后研究参考SYRCLE工具及ARRIVE 2。0指南清单,以优化研究方案和报告,提高PLGC动物实验研究结果的可信度与规范性。
Evaluation on the Quality of Animal Experimental Literature about the Prevention and Treatment of Precancerous Lesions of Gastric Cancer with TCM Compounds Based on SYRCLE Tool and ARRIVE 2.0 Guideline
Objective To analyze the risk of bias during the experimental process and the shortcomings of the research report by evaluating the methodological and reporting quality of animal experimental studies on the prevention and treatment of precancerous lesions of gastric cancer(PLGC)using TCM compounds.To provide reference for improving the quality of animal experimental research on the prevention and treatment of PLGC with TCM compounds.Methods Experimental literature about the prevention and treatment of PLGC with TCM compounds was retrieved from CNKI,Wanfang Data,VIP,CBM,PubMed,Cochrane Library,Web of science and Embase from January 1,2014 to February 23,2024.SYRCLE assessment tool and ARRIVE 2.0 guideline were used to score the included literature and calculate the"low-risk"compliance rate for each item.Results Totally 213 articles were finally included,including 189 Chinese articles and 24 English articles.The SYRCLE tool score was(12.86±1.29)points,and the"low risk"compliance rate was 32.79%.The score of the necessary items of the ARRIVE 2.0 guideline was(24.15±2.80)points,and the"low risk"compliance rate was 49.08%;the score of the recommended items was(11.28±3.40)points,and the"low risk"compliance rate was 30.27%.In the SYRCLE tool evaluation,144(67.61%)studies did not elaborate on the method of generating the allocation sequence.All studies did not describe the adequacy of allocation concealment and the blinding method in the implementation of bias.Only 51 studies(23.94%)explicitly proposed the success criteria for PLGC modeling,only 66 studies(30.96%)provided detailed information on the statistical methods used,29 studies(13.62%)provided complete ethical statements,and 22 studies(10.33%)reported conflicts of interest.Conclusion There are many problems in the methodological quality and reporting quality of animal experimental literature on the prevention and treatment of PLGC with TCM compounds published from 2014 to 2024,especially the implementation of the random blinding strategy during the experimental process,the calculation details of the sample size,and the reporting of inclusion and exclusion criteria,etc.There are many deficiencies in this aspect.It is recommended to refer to the SYRCLE evaluation tool and the ARRIVE 2.0 guideline list to design and report the research plan,thereby improving the credibility and standardization of the PLGC animal experimental research results.

precancerous lesions of gastric cancerTCM compoundanimal experimentSYRCLE toolARRIVE 2.0 guidelinemethodological qualityreporting quality

左娇娇、唐晓玲、宋瑞平、豆鹏程、陈心怡、舒劲

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甘肃中医药大学,甘肃兰州 730000

江西省中医药研究院,江西南昌 330046

甘肃省中医院,甘肃兰州 730050

甘肃省中医药研究院,甘肃兰州 730050

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胃癌前病变 中药复方 动物实验 SYRCLE工具 ARRIVE 2.0指南 方法学质量 报告质量

2025

中国中医药信息杂志
中国中医科学院中医药信息研究所

中国中医药信息杂志

影响因子:0.889
ISSN:1005-5304
年,卷(期):2025.32(1)