摘要
目的:评价针灸治疗踝关节扭伤的临床随机对照试验的质量。方法:电子检索CBM、中国知网、维普、万方等数据库,广泛收集相关文献,按照临床流行病学和循证医学的原则和方法,对1979～2008年发表的临床随机对照试验的临床研究类型及方法学、一般情况、疾病诊断及纳入和排除标准、盲法、分配隐藏、样本量估算、疗效判定标准、随访、不良反应等方面进行评价。结果:符合标准的文献共38篇,其中真正随机对照试验仅4篇;半随机对照试验4篇;随机字样29篇;非随机对照试验1篇;运用盲法的6篇;采用诊断标准的有20篇;有疗效判定标准的34篇;有随访记录的1篇。没有分配隐藏的描述和样本量的估算。结论:针灸治疗踝关节扭伤的临床随机对照试验研究的质量有待提高,目前迫切需要正确实施随机、隐藏及盲法、安慰剂对照、有公认诊断及疗效评价标准、进行安全性评价、合理设计随访的随机对照试验研究。
Objective:To evaluate the quality of randomized controlled trials ( RCTs) on acupuncture and moxibustion for sprained ankle and carries on the method to study the quality evaluation to all randomized controlled trials.Methods:The literatures between 1979-2008 were searched by means of electronic retrieval.Type and methodology,gener-al condition,diagnosis of diseases and enrolled and excluded criteria,as-sessment of sample content,treatment condition,criteria for assessment of therapeutic effects,following-up,etc.in clinical studies are evaluat-ed according to principles and methods of clinical epidemiology and evi-dence-based medicine.Results:Of the 38 literatures enrolled,only 4 were authentic randomized controlled trials (RCTs),4 quasi-random-ized controlled trials,1 non-randomized concurrent controlled trials,20 had clear diagnostic criteria,16 mentioned enrolled or excluded criteria,34 had clear criteria for therapeutic effects,1 reported follow-up,1 re-ported adverse reaction.Conclusion:The quality of RCT papers rele-vant to acupuncture and moxibustion for sprained ankle needs improv-ing.At present,correct randomization,concealment,blinding and place-bo-control,and the RCTs with generally accepted criteria for assess-ment of diagnosis and therapeutic effects,safety evaluation and rational design of follow-up are needed.
出处
《针灸临床杂志》
2009年第12期1-3,共3页
Journal of Clinical Acupuncture and Moxibustion
基金
国家"十一五"科技支撑计划项目
项目编号:2006BAI12B01
