中医药治疗糖尿病肾病临床随机对照试验文献评价

Chinese Medicine Treatment of Diabetic Nephropathy Clinical Randomized Controlled Trials Evaluating

目的探讨中医药治疗糖尿病肾病临床随机对照试验文献评价结果。方法选取2004年6月—2014年6月在中文期刊全文数据库和维普数据库发布的有关中医药治疗糖尿病肾病治疗的随机对照实验文献160篇,对每篇文献治疗的方法、结果以及讨论等部分分别涉及的内容作了研究分析。结果对120篇中医药治疗糖尿病肾病临床随机对照试验文献进行评价分析后没有观察安全性指标98篇,占91.68%,报告了安全性指标22例,占18.33%,没有不良反应45篇,占37.50%,报告了安全性指标并有不良反应17篇,占14.17%,中医辩证分型67篇,占55.83%,不良反应原因分析114篇,占95.00%,随访记录98篇,占81.67%,失访病例分析108篇,占90.00%,干预措施运用118篇,占98.33%,所有篇目各项指标评价比较差异有统计学意义(P<0.05)。结论在糖尿病肾病的临床治疗上,利用的实验文献中,对相关指标和观察存在一定不足,流行病学因果判断与关联性原则认识有限,安全结论亦未经过统计学分析。

Objective To explore the Chinese medicine treatment of diabetic nephropathy clinical randomized controlled trials evaluating results.Methods from 2004 June to 2014 June in Chinese Journal Full-text Database and VIP database published about traditional Chinese medicine treatment of diabetic nephropathy treated with random control experiment 160 references on method,each document treatment results and discussion part relates to the content of the analyzed.Results the evaluation and analysis of 120 pieces of Chinese medicine treatment of diabetic kidney of randomized controlled trials of no safety observation index 98,accounted for 91.68%of reported security index in 22 cases,accounting for 18.33%,no adverse reaction 45,accounted for 37.50%of reported security index and adverse reaction of 17,accounting for 14.17%and the Chinese medicine dialectical typing 67,accounted for55.83%,the causes of the adverse reactions analysis of 114 articles,accounting for 95%,were recorded in 98,accounting for 81.67%,lost cases analysis of 108 articles,accounting for 90%,the intervention measures using 118,accounting for 98.33%of all contents,indexes of evaluation has significant difference,P〈 0.05.Conclusion in clinical practice in the treatment of diabetic nephropathy,will inevitably make use of large random controlled experimental literature,safety reporting randomized controlled experimental literature associated with diabetic nephropathy of related index of observation and the inadequate attention,obtains the conclusions of safety without statistical analysis,such as epidemiology causality judgment and relevance principle of insufficient understanding of the importance.