恒前牙外伤固定疗效国内临床试验的循证医学质量评价

Evidence-based quality assessment of Chinese clinical trials on the effects of stabilization of permanent anterior dental trauma

目的:通过循证医学方法,评价近10年国内发表的关于使用各种固定方法治疗恒前牙外伤的临床试验质量。方法:搜索CNKI与万方数据库(2001—2011年),以"恒前牙外伤"作为主题词进行搜索,共获得245篇可能相关的文献,浏览摘要后,得到46篇关于恒前牙固定疗效的文献,对临床试验的设计进行分类评价,分别采用临床试验统一报告标准(CONSORT)和加强观察性流行病学研究报告声明(STROBE)所建立的临床试验评价标准进行质量评估。结果:46篇临床试验中,随机对照试验8篇,其余38篇均为观察性研究。绝大部分试验设计不够科学严谨,即使是随机对照试验,其随机方法、分配方式的隐藏、盲法的采用等方面并不完善,无法进行全面的方法学质量评价。结论:国内关于恒前牙外伤固定疗效临床试验的质量有待提高,需在试验设计和论文写作上加以完善。

PURPOSE： To appraise the quality of Chinese clinical trims during recent 10 years about the treatment of permanent anterior dental trauma with evidence-based quality control methods. METHODS： The CNKI （Chinese National Knowledge Infrastructure） and Wanfang electronic database with key words ＂permanent anterior dental trauma ＂ were searched. Two hundred and forty-five papers were obtained during recent 10 years, 46 key papers about the treatment of permanent anterior dental trauma were retrieved. The quality of the Chinese clinical trials according to the consolidated standards of reporting trials （CONSORT） and strengthening the reporting of observational studies in epidemiology （STROBE） statement were assessed. RESULTS： Within the 46 key papers, there were 8 randomized controlled clinical trials, while the other 38 papers were observational studies. It was hard to evaluate precisely due to the lack of scientific information. The randomized controlled trials lacked details for randomization, allocation concealment and blinding compromised the quality. CONCLUSIONS： For the clinical studies about the effects of stabilization of permanent anterior dental trauma, the study quality needs to be improved, and progress should be made both in the clinical study design and the paper writing. Supported by Grants for Selecting and Training Outstanding Faculty in Shanghai Universities（jdy 10048）.