运用循证医学对血瘀证诊断标准研究文献的评价

Evaluation of Diagnostic Criteria in Literatures of Blood-stasis Syndrome Based on Evidence-based Medicine

[目的]运用循证医学对血瘀证诊断标准研究文献的评价。[方法]参照循证医学及临床流行病学中有关诊断性试验的评价标准,拟定文献评价观察表。评价内容:包括研究文献的设计方案、样本的筛检、样本含量的估算、对照组的设立、随机化方法、盲法、诊断性试验的评价指标等。[结果]所有研究文献均没有设立标准诊断方法作为对照,对结果的判断均没有采用盲法,所提供的诊断性指标(敏感度、特异度、似然比等)不全面,对偏倚的控制没有描述等,采用同一血瘀证诊断标准的研究文献,其所得结论不完全相同,各研究文献所得结论与其所采用的诊断标准不完全吻合,也没有阐述血瘀证诊断标准指标数增减的理由。[结论]提示目前所使用的血瘀证诊断标准可能存在某些不足,有待进一步研究和完善;同时,各研究文献所得结论的差异,也有待进一步研究证实。

[Objective] To assess the diagnostic criteria in literatures of blood-stasis syndrome based on evidence-based medicine. [Methods] The reports on blood-stasis syndrome published in the years of 1978 ~ 2002 were collected and evaluated according to the evidence-based medicine principles. Main outcomes include design method, sample screening, sample size, establishment of control group, randomization, blind method, criteria of diagnostic trials. [Results] In the reports collected, no gold standard and independent blind method were adopted, criteria of diagnostic trials such as sensitivity, specificity and likelihood ratio were incomplete and there was no descriptions of potential bias controlling. As for the literatures sharing the same diagnostic criteria of blood-stasis syndrome, their conclusion did not totally accord with each other. [Conclusion] Diagnostic criteria of blood - stasis syndrome are incomplete and need to be improved. The conclusion in published reports on diagnostic criteria of blood-stasis syndrome will be further verified.