中医临床研究疗效评价的优化

Optimization of assessment of efficacy in clinical research of Traditional Chinese Medicine

疗效评价是中医临床研究的关键部分。疗效评价指标选择的原则是公认、先进、可行,应采纳最新通用的国际标准。疗效指标选取要与研究内容协调,使疗效指标恰好是干预措施的优势作用所在。证候疗效评价、疗效综合评价等尚在探讨中。干预性研究需要根据研究设计类型,选取均数、百分率、相对危险度、比值比等不同的疗效指标表示方式。需要根据干预措施的效果确定适当的观察期,选择研究的终点。疗效评价的统计分析,需遵守意向性分析原则,同时选择全分析集及符合方案集对主要疗效指标进行分析,妥善解释结果。疗效评价要注重结果的亚组分析,籍此可以寻求和确定干预措施的效应点,充分利用研究数据信息,剔除研究因素中的混杂因素。

Assessment of efficacy is a key part of TCM clinical research, the principle of selecting assessment indicator is acknowledged, advanced and feasible; the latest general international standards should be adopted. Indicators of assessment of efficacy should coordinate with the research contents and can just reflect the superior effect of intervening measures. Syndromes assessment and comprehensive assessment of efficacy is still in the discussion. According to design type in intervention researches, selecting different indicators of the efficacy such as the mean, percentage, relative risk, odds ratio etc.; according to effects of interventions, determine the appropriate period of observation, select study endpoint. Statistical analysis of assessment of efficacy subjects to the principle of intentional analysis, besides, analyze the primary assessment indicator by full analysis set and meet the program set, properly explain the results. Pay attention to results subgroup analysis in assessment of efficacy, seek and determine the effect point of intervention measures, make full use of data information and eliminate confounding factors.