中医药治疗复发性口腔溃疡临床随机对照试验文献质量分析

Analysis of Randomized Controlled Trials of Traditional Chinese Medicine for Recurrent Oral Ulcer

目的系统评价中医药治疗复发性口腔溃疡的临床随机对照试验(RCT)的文献质量。方法全面检索有关中医药治疗复发性口腔溃疡的RCT文献,参照Cochrane手册对其进行评价。结果共有分布于41种杂志上53篇符合要求的文献,出现12种诊断标准和8种疗效标准,39篇有基线比较,3篇采用盲法,2篇提及随访情况,l0篇提及不良反应,0篇报告失访情况。结论中医药治疗复发性口腔溃疡的RCT质量有待提高。

Objective To systemically evaluate the quality of randomized controlled trials （RCTs） of recurrent oral ulcer （ROU） treated by traditional Chinese medicine. Methods The randomized controlled trials of TCM treatment on ROU were retrieved, and the related information from database was retrieved and assessed with Cochrane Handbook. Results Fifty-three articles in 41 journals were found. There were 12 diagnostic criteria and 8 effect criteria. Base-line comparision in 39 articles, blind methods in 3 articles, follow-up survey in 2 articles, adverse reaction in 10 articles, no case loss in all articles were reported. Conclusions The quality of RCTs of TCM for ROU should be improved.