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目的探讨中药治疗勃起功能障碍随机对照试验中存在的方法学问题。方法通过清华同方全文数据库、万方数据库和中国生物文献数据库,检索近10年国内中药治疗勃起功能障碍的随机对照试验,按照“CONSORT声明”方法部分条目结合中医特征,对文献的方法特征报告情况进行调查。结果共计63篇文献纳入调查。各条目内容的报告率分别为诊断标准71%,中医证型标准40%,纳入与排除标准29%,资料收集来源76%,试验组100%,对照组100%,疗效标准98%,中医证候疗效标准10%,样本含量计算0%,序列产生方法11%,分配方案隐藏0%,实施0%,双盲6%,单盲5%,提及统计学处理100%,统计方法描述54%,统计量的描述25%,P值描述2%。结论中药治疗勃起功能障碍随机对照试验在方法学存在诸多问题,需要规范设计、实施和报告。
Objective To explore the methodological problems existing in randomized controlled trials of traditional Chinese medicine in the treatment of erectile dysfunction. Methods A randomized controlled trial of domestic traditional Chinese medicine in the treatment of erectile dysfunction in recent 10 years was conducted by using Tsinghua Tongfang full text database, Wanfang database and Chinese biological literature database. According to the “CONSORT statement” part of the article combined with the characteristics of traditional Chinese medicine, Report the situation to investigate. A total of 63 articles were included in the survey. The report rates of each item were 71% of diagnostic criteria, 40% of TCM syndrome standards, 29% of inclusion and exclusion criteria, 76% of data collection sources, 100% of experimental group, 100% of control group, 98% of standard of efficacy, Efficacy criteria 10%, sample content calculation 0%, sequence generation method 11%, distribution scheme hidden 0%, 0% implementation, double blind 6%, single blind 5%, referred to statistical processing 100%, statistical methods described 54 %, Description of statistics 25%, P value description 2%. Conclusion Traditional Chinese medicine for erectile dysfunction randomized controlled trials in the methodology there are many problems that need to standardize the design, implementation and reporting.