基于CONSORT-CHM声明对中药配方颗粒RCT的质量评价  

Quality evaluation of randomized controlled trials of Chinese medicine formulated granules based on CONSORT-CHM formulas

作　　者：马慧琳 何镇帆 张燊 单泽君 叶芷毓 梁皓嘉 帅雨杏 徐谦[1] 陈丽霞[1] 陈新林[1] MA Huilin;HE Zhenfan;ZHANG Shen;SHAN Zejun;YE Zhiyu;LIANG Haojia;SHUAI Yuxing;XU Qian;CHEN Lixia;CHEN Xinlin(School of Basic Medical Sciences,Guangzhou University of Chinese Medicine,Guangzhou 510405,P.R.China;Guangzhou University of Chinese Medicine,Guangzhou 510405,P.R.China)

机构地区：[1]广州中医药大学基础医学院,广州510405 [2]广州中医药大学中药学院,广州510405

出　　处：《中国循证医学杂志》2025年第3期334-338,共5页Chinese Journal of Evidence-based Medicine

基　　金：国家重点研发计划项目(编号:2023YFC3503000);国家自然科学基金面上项目(编号:81774451);广东省基础与应用研究基金项目(编号:2022A1515220162);广东省基础与应用基础研究基金项目(编号:2022A1515220148)。

摘　　要：目的对我国核心期刊发表的中药配方颗粒随机对照试验(RCT)的质量进行评价。方法计算机检索CNKI、VIP、WanFang Data和CBM数据库的所有中药配方颗粒RCT(限定期刊来源类别为北大核心、CSSCI、EI),提取标题、第一作者、发表期刊、疾病类型、发表年份、基金来源地区、药品来源等相关内容,使用CONSORT–CHM formula和改良后的Jadad量表对纳入文献进行评价,包括文题、摘要和关键词、引言、研究方法、采取步骤、结果、讨论、其他信息共25个条目的报告质量和RCT方法学质量。结果共纳入125篇文献,主要包括消化系统(n=25)、呼吸系统(n=17)、循环系统(n=17)等领域疾病。方法学质量评价结果显示中药配方颗粒RCT质量较差,其中低质量文献97篇,占77.6%。在CONSORT–CHM formula发表后,中药配方颗粒RCT的报告质量没有显著变化,但仍有42.2%的RCT没有充分报告分配序列的产生,93.3%的RCT没有充分报告分配隐藏,62.2%的RCT没有充分报告对失访/脱落的处理。结论中文期刊发表的中药配方颗粒RCT报告质量仍需改进,建议研究者、期刊及审稿人重视CONSORT–CHM formula在论文写作发表全流程中的应用,未来应针对中药配方颗粒临床试验的特点对试验设计和报告规范提出更科学、细致的要求。and keywords,introduction,research methods,steps,results,discussion,and other information.Results A total of 125 papers were included,which mainly included digestive system diseases(n=25),respiratory system diseases(n=17),and circulatory system diseases(n=17).The results showed that the overall reporting quality of RCTs of TCM formulated granules was poor.After the publication of the CONSORT-CHM formulas 2017,the reporting quality of RCTs of TCM formulated granules had no significant changes,while some items were still reported with poor quality.For example,42.2%of RCTs did not adequately report how to generate allocation sequence,93.3%of RCTs did not adequately report allocation concealment,and 62.2%of RCTs did not adequately report how to solve the missing data.Conclusion The quality of RCTs reports on TCM formula granules published in Chinese journals still needs to be improved.It is recommended that researchers,journals and reviewers attach importance to the application of CONSORT-CHM formula throughout the whole process of paper writing.In the future,more scientific and detailed requirements should be put forward for trial design and reporting standards in line with the characteristics of clinical trials of TCM formula granules.

关 键 词：中药配方颗粒 方法学研究 系统评价 随机对照试验 

分 类 号：G23[文化科学]