摘要
目的通过循证医学的方法来评价近十年国内发表的使用功能矫治器矫治安氏Ⅱ类错(牙合)畸形的临床试验质量。材料与方法我们搜索了 CNKI(1997～2007年)和万方数据库,以"功能矫治器"作为主题词进行搜索,共获得378篇可能相关的文献,浏览摘要后得到98篇功能矫治器矫治安氏Ⅱ类错(牙合)的临床试验文章。我们应用循证医学的方法对临床试验的设计方法及试验结果的可靠性进行了评价。结果在98篇临床试验中,包括77篇临床总结或者系列病例报告,所有试验均得出功能矫治器能获得较好的临床效果的结论。有21篇临床对照试验,只有一篇比较了双期矫治与单期固定矫治器矫治的疗效,结果在组间没有得出疗效的差异,其余均为阳性结论。结论国内功能矫治器矫治安氏Ⅱ类错(牙合)的临床试验设计并不完善,试验往往夸大了阳性结果。
Objective To appraise the quality of Chinese clinical trials during 10 years about using functional appliance in treating Angle Class Ⅱ malocclusions with evidence-based quality control methods. Material and Methods We searched the CNKI （Chinese National Knowledge Infrastructure） and WanFang electronic database with key words ＂functional appliance＂. It hit 378 maybe results during latest 10 years, and after screened the abstracts, 98 key papers about functional appliance in treating Angle Class Ⅱ were retrieved. We appraised the quality by study designs and results reliability. Results Within the 98 key papers, 77 clinical studies were case reports and case series, the biggest sample size was 62, and all the case reports and case series got the positive results for good clinical treating effects. For the left 21 controlled clinical trials, the sample sizes were not more than 100, 5 clinical trials were clearly stated it was randomized. In all the controlled trials, only one study compared the two-stage and one-stage treatment of the functional appliance, which did not show the statistical significant between groups. All the other trials left still support the positive results which showed satisfied clinical effects. Conclusion For the clinical studies of functional appliance in treating Angle Class Ⅱ malocclusions in China, the study design is not perfect, most results reporting without control groups. The positive results of good clinical effects need to be confirmed by well designed randomized clinical trials.
出处
《口腔正畸学》
2008年第3期97-99,共3页
Chinese Journal of Orthodontics
关键词
功能矫治器
循证医学
质量评价
functional appliance
evidence-based
quality assessment
