中药治疗糖尿病足溃疡结局评价的问题与对策

Problems and Countermeasures of Outcomes Evaluation on Treatment of Diabetic Foot Ulcer with Traditional Chinese Medicine

药物的疗效和安全性通过结局指标的报告来体现,因此恰当地选择并报告结局指标是临床研究中应该重视的关键环节。目前中药治疗糖尿病足随机对照试验的文献在结局指标的选择和报告方面存在以下问题:滥用综合性指标评价结局;结局评价指标模糊不清;结局评价指标不分主次;结局评价标准不统一;缺少对不良事件的报告。因此,应明确定义主次结局指标,并且说明测量方法;对主要和次要结局指标分别进行报告,避免采用综合性结局指标;采用相对效应指标和绝对效应指标相结合的报告方法;报告药物不良事件。

The efficacy and safety of drugs are reflected by clinical outcomes,so correctly selecting and reporting the clinical outcomes is the key in clinical research.Recently,some problems exist in literatures associated with selecting and reporting clinical outcomes of randomized controlled clinical trials on diabetic foot ulcer by Chinese herbal medicine,that is,misuse of synthetic outcomes,vague outcomes,not distinguishing primary outcomes from secondary ones,a unified evaluating standard of outcomes,lack of reporting adverse events.So some suggestions are given as follows： defining primary and secondary outcomes and illustrating measurement methods;separately reporting primary and secondary outcomes and avoiding using synthetic index of outcomes;combining relative effect index with absolute effect index;reporting adverse events.