中医药治疗勃起功能障碍随机对照临床试验报告的质量评价及思考  

Quality evaluation and thinking of randomized controlled clinical trial reports on treatment of erectile dysfunction with traditional Chinese medicine

作　　者：任凯 郭军[1] 于文晓 晏斌 杜冠潮 王浩[1] 张继伟[1] REN Kai;GUO Jun;YU Wenxiao;YAN Bin;DU Guanchao;WANG Hao;ZHANG Jiwei(Department of Andrology,Xiyuan Hospital,Chinese Academy of Chinese Medical Sciences,Beijing 100091,China;Postdoctoral Mobile Station of Xiyuan Hospital,Chinese Academy of Chinese Medical Sciences,Beijing 100091,China)

机构地区：[1]中国中医科学院西苑医院男科,北京100091 [2]中国中医科学院西苑医院博士后流动站,北京100091

出　　处：《中国性科学》2023年第4期123-127,共5页Chinese Journal of Human Sexuality

摘　　要：目的采用《CONSORT-中药复方》作为评价依据,对中医药复方治疗勃起功能障碍的文献进行质量报告评价,为未来相关临床研究、论文报告撰写提供建议。方法检索中国知网、PubMed等数据库建库至2021年12月收录的中医药治疗勃起功能障碍的随机对照试验(RCT)文献,进行质量报告评价。结果最终纳入69篇文献,仅2篇文献可通过文题识别为RCT,9篇介绍了随机方法的类型,8篇阐述了样本量估算内容,33篇列出了基线资料,8篇描述了盲法的设置。结论当前中医药治疗勃起功能障碍的RCT文献中部分文献未展现临床试验的重要内容,《CONSORT-中药复方》应受到研究者的重视,以期在未来得到更高质量的评价结果。Objective To evaluate the quality report of literatures on traditional Chinese medicine(TCM)compounding for erectile dysfunction using CONSORT-CHM formulas as an evaluation basis,and to provide suggestions for future related clinical studies and paper report writing.Methods Randomized controlled trial(RCT)literatures on the treatment of erectile dysfunction by TCM were retrieved from CNKI,PubMed and other databases from establishment to December 2021,and the quality reports were evaluated.Results Finally,69 papers were included,only 2 papers could be identified as RCT by the title of the text,9 papers described the type of randomization method,8 papers described the content of sample size estimation,33 papers listed the baseline information,and 8 papers described the setting of blinding method.Conclusions Some of the current RCT literatures on TCM for erectile dysfunction did not show important elements of clinical trial,and CONSORT-CHM formulas should be paid more attention by researchers in order to obtain higher quality evaluation results in the future.

关 键 词：中医药 勃起功能障碍 随机对照试验 质量评价 

分 类 号：R698[医药卫生—泌尿科学]