针刺治疗小儿脑性瘫痪的临床随机对照试验文献质量评价

Quality Evaluation of Clinical Randomized Controlled Trials of Acupuncture for the Treatment of Cerebral Palsy in Children

目的:评价针刺治疗小儿脑瘫的临床随机对照试验研究的文献质量。方法:以"针刺"or"针灸"and"脑瘫"or"脑性瘫痪"为检索词,通过中国期刊全文数据库(CNKI)、万方数据库和维普数据库获取国内中文期刊文献全文,采用CONSORT声明条款、STRICTA标准和JADAD文献评分量表,对1995年1月至2014年12月期间发表符合纳入标准的文献进行系统评价。结果:共纳入116篇随机对照试验文献,2010—2014年合计发文75篇(占64.66%);大部分文献对诊断、干预措施、组间均衡性、统计学方法等内容进行描述;虽然纳入的文献中均提到随机,但只有42篇(占36.21%)文献注明使用随机数字表法。所有的文献均没有样本估算、分配隐藏、意向分析的描述;记录不良事件发生的文献4篇(3.45%),有随访记录的文献3篇(2.59%)。102篇为低质量文献,14篇文献评分属高质量文献。结论:近几年针刺治疗小儿脑瘫的随机对照试验的文献量增加迅速,但研究质量和文献水平整体偏低,应着力提高研究者的临床研究设计水平。

Objective： To evaluate the quality of the clinical randomized controlled trials of acupuncture for the treatment of children with cerebral palsy. Methods： The ＂acupuncture＂or ＂acupuncture and moxibustion ＂and ＂cerebral palsy＂or ＂of cerebral palsy＂were as the search terms. Through the Chinese journal full text database（ CNKI）,Wanfang database and VIP database access to domestic Chinese Journals Full- text document,by terms of the CONSORT statement,STRICTA standard and score of JADAD literature quantity,from the period of January 1995 to December 2014,which met the inclusion criteria of literature evaluation system. Results：A total of 116 randomized controlled trials were included in this study,which were published in 75 papers（ 64. 66%） between 2010 and 2014; most of the literatures on the diagnosis,intervention measures,the balance between groups,statistical methods and other content description. Although the inclusion of the literature was referred to the random,only 42（ 36. 21%） of the literatures indicated the use of a random number table method. All of the literatures had no description of the samples,the distribution of the hidden,the intention of the analysis. The records of adverse events were recorded in 4（ 3. 45%）,and there were 3（ 2. 59%） of the follow- up records. There were 102 low quality literatures,and 14 papers were high quality literatures. Conclusion： In the recent years,the number of literatures on acupuncture in the treatment of cerebral palsy in children with cerebral palsy has increased rapidly,but the quality of research and the level of literatures are low,we should focus on improving the clinical research design level.