中医药治疗黄疸型病毒性肝炎临床研究文献的质量评价

目的:评价自1994年以来我国关于黄疸型病毒性肝炎中医药研究已发表文献的质量.方法:计算机检索MEDLINE,CBMdisk,CMCC,CMAC,CNKI,VIP等数据库,凡文中有"随机"或"随机分组","随机对照"字样,以黄疸型病毒性肝炎为治疗疾病的研究,均予纳入,并对其质量进行评价.结果:检索出文献185篇.符合纳入标准的109篇文献中,有7篇简单描述了随机分组方法,没有一篇提及分配隐藏、样本含量估算依据、盲法,仅有1篇提及失访,但未进行意向治疗分析(ITT).结论:目前中医药治疗的临床试验设计仍存在一些问题,高质量的随机对照试验(RCT)数量较少,研究的总体水平有待提高.

Quality Evaluation on the Trials of TCM for Icteric Viral Hepatitis

Objective:To evaluate the quality of randomized controlled trials ( RC T) on traditional Chinese medicine(TCM) for icteric viral hepatitis(IVH) perform ed from 1994 to March 2005.Methods:We did electronic search in CNKI,VIP,CMCC,CMA C and evaluated the quality of obstained trials.Results:109 trials met the crite ria,of which 7 described methods of RCT in the trials.None of them mentioned all ocation concealment and the calculation basement of sample size.And none of the trials mentioned blind study.Drop outs were described in one trial without ITT.C onclusion:There still exist some problems in the design of RCT of TCM for IVH:(1 )inadequate use of randomization methods or no use of RCT and no concealment in allocation;(2)no calculation basement of sample size,and ITT analysis after dro p out;(3)lower rate of utilization for blind study.Rigorously designed,randomiz ed,double blind,placebo-controlled trials are required.In conclusion,the quanti ty and quality of trials of TCM for IVH were inadequate.Some well-designed scie ntific methods were not adequately applied.