中医药临床研究设计中若干问题及其对策

对中医药临床研究设计中有关辨证标准制定、观察对象分组、对照组(药)设定等问题进行探讨,认为必须在认真分析所研究疾病中医病冈病机及其表现特点,结合病的特殊本质而制定具有该病特点的目标适应证候和所需鉴别证候的辨证标准.以证候或病种为主体临床研究所纳入病例要分别注意在病或证方面的均衡性,采用以目标适应证候常见病种或目标适应病种常见证候的随机分组方法.设计对照时应考虑与所研究证候类似容易混淆和性质完全相反的证候为对照证候,并考虑对照证候脏腑功能失调基本相同.在无同类药物可供选择时,可从"相近"或选择两种药物联合使用为对照.

Several Problems and Corresponding Strategies on Clinical Research of Traditional Chinese Medicine

We put forward that ①Etiological factors,pathogenesis and manifestations of a disease must be carefully studied before a syndrome differentiation standard is set up;②The ratio equilibrium of disease and syndrome should be considered when grouping in the process of a study;③In the process of designing a experiment,cases with similar symptoms or contradictory symptoms to the study cases are chosen to the control group;④Similar drug or two drugs used in combination should be adopted for the control drug in case of no same kind drug avalable.