队列研究在中医肿瘤临床研究中的应用

Application of the Cohort Study in the Clinical Research of TCM Oncology

个体化辨证论治的综合治疗是中医诊治肿瘤的特色,也是一个复杂干预的过程,使用什么样的临床研究方法并评价其疗效是当前亟待解决的重要问题。随机对照试验是临床试验的金方案,但其实施条件严格,临床依从性低。分层多中心前瞻性队列研究临床可操作性高,可以避免随机对照试验的实施困难并控制偏倚,更符合中医辨证论治的思想,有可能为中医肿瘤临床研究提供可行、科学严谨的研究模式。

Tumor treatment based on syndrome differentiation, which is a complicated process, is a characteristic of Chinese medical diagnosis. What clinical study methods should be used and how to evaluate the treatment efficacy are the important problems that need urgent solutions. The randomized control trial is called the golden design of the clinical trial, but it requires a strict condition and thus has a low compliance. Stratified, polycentric and prospective cohort study is highly feasible. It may overcome the shortcomings of the randomized control trial and the cohort study and thus decrease the control bias. Therefore, it may serve as a prospective and excellent mode in individual tumor treatment of Chinese medicine.