基于CONSORT声明的广西中医药壮瑶医药治疗脑血管疾病临床随机对照试验报告质量评价  

Quality Evaluation of Clinical Randomized Controlled Trial Reports on Guangxi Traditional Chinese Medicine and Zhuang Yao Medicine for the Treatment of Cerebrovascular Diseases Based on the CONSORT Statement

作　　者：谭蜀琼 谢璋庆 梁海月 陈月婷 鲁震 莫小丽 丁一 姜枫[1] TAN Shuqiong;XIE Zhangqing;LIANG Haiyue;CHEN Yueting;LU Zhen;MO Xiaoli;DING Yi;JIANG Feng(Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine,Nanning 530011,China)

机构地区：[1]广西中医药大学附属瑞康医院,广西南宁530011

出　　处：《中国民族民间医药》2025年第3期102-107,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：广西中医药壮瑶医药循证能力建设项目、多学科交叉创新团队建设项目(桂中医药发[2024]8号);广西中医药重点研究室、高水平中医药重点学科建设项目(桂中医药发[2024]11号);广西科技基地和人才专项项目(桂科AD22035165)。

摘　　要：目的:通过CONSORT声明评价广西中医药壮瑶医药治疗脑血管疾病临床随机对照试验(RCT)的文献质量。方法:计算机检索自建库以来至2023年12月中国知网(CNKI)、维普中文科技期刊数据库(VIP)、万方数据(WANFANG DATA)、中国生物医学文献数据库(SinoMed)中有关的广西中医药壮瑶医药治疗脑血管疾病随机对照试验研究。将上述数据库检索到的文献筛选出符合要求的文献,依据CONSORT声明2010版,对纳入的文献进行质量评价。结果:共纳入RCT文献165篇,其中2篇(1.2%)在标题中提及“随机平行对照研究”字样,16篇(9.7%)对试验设计进行了报告,21篇(12.7%)同时报告了诊断标准、纳入标准、排除标准、退出标准,72篇(43.6%)阐述了具体随机方法,1篇(0.6%)提及了分配隐藏,3篇(1.8%)提到了盲法,144篇(87.3%)对统计学方法进行了说明,1篇(0.6%)报告了受试者流程图,15篇(9.1%)对脱落情况进行报告,27篇(16.4%)通过表格列出了组间的基线资料,11篇(6.7%)记录了试验过程中出现的事件不良,75篇(45.5%)详细叙述了试验基金的来源。结论:目前广西地区发表的关于中医药壮瑶医药治疗脑血管疾病的RCT报告整体质量偏低,有较大提升空间,建议今后严格参照CONSORT声明条目进行规范报告,提高报告的撰写质量。Objective To evaluate the literature quality of the randomized controlled trial(RCT)of Guangxi traditional Chinese medicine Zhuang Yao medicine in the treatment of cerebrovascular diseases using the CONSORT statement.Method The computer searched for randomized controlled trials of Guangxi traditional Chinese medicine Zhuang Yao in the treatment of cerebrovascular diseases from CNKI,VIP databases,WANFANG DATA,and SinoMed since the establishment of the database until December 2023.Screen the literature retrieved from the above database to meet the requirements,and evaluate the quality of the included literature according to the 2010 version of the CONSORT statement.Result A total of 165 RCT articles were included,of which 2(1.2%)mentioned the term“randomized parallel controlled study”in the title,16(9.7%)reported on the trial design,21(12.7%)simultaneously reported diagnostic criteria,inclusion criteria,exclusion criteria,and exit criteria,72(43.6%)explained specific randomization methods,1(0.6%)mentioned allocation concealment,and 3(1.8%)mentioned blinding,144 articles(87.3%)provided explanations on statistical methods,1 article(0.6%)reported subject flowcharts,15 articles(9.1%)reported dropouts,27 articles(16.4%)presented baseline data between groups through tables,11 articles(6.7%)recorded adverse events that occurred during the experiment,and 75 articles(45.5%)detailed the sources of experimental funds.Conclusion The overall quality of RCT reports on the treatment of cerebrovascular diseases with traditional Chinese medicine Zhuang Yao medicine published in Guangxi region is relatively low,and there is significant room for improvement.It is recommended to strictly follow the CONSORT declaration entries for standardized reporting in the future to improve the quality of report writing.

关 键 词：中医药 壮瑶医药 随机对照试验 脑血管疾病 CONSORT声明 质量评价 

分 类 号：R743[医药卫生—神经病学与精神病学]