基于Cochrane偏倚评估工具及CONSORT-中药复方评价补阳还五汤治疗慢性心力衰竭随机对照试验方法学与报告质量评价  

Based on Cochrane Bias Evaluation Tool and Consort Traditional Chinese Medicine Compound Evaluation Buyang Huanwu Decoction in the Treatment of Chronic Heart Failure Randomized Controlled Trial Methodology and Report Quality Evaluation

作　　者：潘巧晶 曾建斌[2] 万蝉俊[2] 吴炳林 PAN Qiao-jing;ZENG Jian-bin;WAN Chan-jun;WU Bing-lin(Jiangxi University of Chinese Medicine,Nanchang 330004,China;The Affiliated Hospital of Jiangxi University of Chinese Medicine,Nanchang 330006,China)

机构地区：[1]江西中医药大学研究生院,南昌330004 [2]江西中医药大学附属医院,南昌330006

出　　处：《江西中医药大学学报》2022年第5期42-46,49,共6页Journal of Jiangxi University of Chinese Medicine

基　　金：江西省卫生计生委中医药科研项目(2017A015)。

摘　　要：目的:通过对补阳还五汤治疗慢性心力衰竭RCT的方法学和报告质量评价,为未来高质量的中医药临床试验的开展提供一些意见。方法:检索国内中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普(VIP)、万方(WF)四个主要的论文数据库,参照Cochrane偏倚评估工具及CONSORT-中药复方条目对符合条件的文章进行评价。结果:最终纳入合格文献46篇。评价显示:因文献的报告不全,大部分文献的偏倚风险均评定为不清楚;在产生随机分配序列的方法、受试者合格标准、基线情况的描述、结局和估计值及研究的局限性等方面报告率分别为34.8%、56.6%、15.2%、0.0%、6.5%,无文献在分配隐藏、盲法、试验注册等方面进行报告。结论:目前补阳还五汤治疗慢性心力衰竭RCT的总体质量偏低,未来研究者应严谨地对待试验方法学上的实施并完善书面报告。Objective:To evaluate the methodology and report quality of Buyang Huanwu Decoction in the treatment of chronic heart failure RCT,so as to provide some suggestions for the development of high-quality clinical trials of Traditional Chinese medicine in the future.Methods:Chinese biomedical literature database(CBM),Chinese Journal Full-text Database(CNKI),VIP and WF were searched,and the eligible articles were evaluated with reference to the items of consort Chinese herbal compound and Cochrane bias evaluation tool.Results:46 qualified literatures were included.The evaluation showed that the bias risk of most literatures was not clear due to incomplete reports;the reporting rates in the methods of generating random assignment sequence,the eligibility criteria of subjects,the description of baseline conditions,the outcomes and estimates,and the limitations of the study were 34.8%,56.6%,15.2%,0.0%and 6.5%respectively No literature had been reported on distribution concealment,blinding,trial registration,etc.Conclusion:At present,the overall quality of Buyang Huanwu Decoction in the treatment of chronic heart failure RCT is low.In the future,researchers should treat the implementation of experimental methodology seriously and improve the written report of the article.

关 键 词：补阳还五汤 慢性心力衰竭 CONSORT-中药复方 Cochrane偏倚评估工具 报告质量 方法学 

分 类 号：R541.61[医药卫生—心血管疾病]