帕金森病中医药治疗性文献的系统评价

目的对帕金森病的中医药临床治疗性文献进行科研设计质量的分析,以期对中医药治疗帕金森病的疗效作出客观的评价。方法按照循证医学和临床流行病学／DME原则,制订“中医药治疗性文献系统性评价质量及信息采集表”,用其对1979—2000年间的帕金森病中医药“对照试验”文献(15篇)进行评价。结果66．7％(10篇)的文献对随机情况未作任何描述,33．3％(5篇)的文献提及为随机研究,但其随机化分配亦存在问题;没有文献述及退出与失访病例情况,未见文献给出病例筛选记录,样本同质性、结局指标选择、结论推导等重要环节亦存在着一些问题,影响了随机对照试验的质量及其可信度。结论帕金森病的中医药临床研究的方法学设计有待加强。

Systematic Evaluation on Clinical Literature Related with Treatment of Parkinson's Disease with Traditional Chinese Medicine

OBJECTIVE: To analyze the quality of scientific research design of clinical literature related with treatment of Parkinson's disease with traditional Chinese medicine, so as to objectively evaluate the therapeutic effect of TCM. METHODS :According to principles of evidence-based medicine, clinical epidemiology/design measurement evaluation (DME), the "Table of Systematic Evaluation of Quality and Information Collection for TCM Clinical Research Literature" were established and used to evaluate clinical control trial literature related with treatment of Parkinson's disease with TCM published during 1979 to 2000. RESULTS: The method of randomization was not described in 66.7% of the literature. Although randomized design was declared in 33.3 %, problems or mistakes of randomized allocation still existed in them. No record about the state of dropped out or absconded cases in follow-up study and without any record of samples screening presented in all literature. There were some problems of key links concerning samples' homogeneity, outcome indexes selection, conclusion deduction and so on, which could also influence the quality and reliability of randomized controlled trials. CONCLUSION: Methodological design of clinical research of TCM on Parkinson's disease should be strengthened.