对新版《中药新药临床研究指导原则》的若干意见

新版《中药新药临床研究指导原则》,对提高中药新药临床研究水平产生了积极的影响。但其中也存在一些亟待解决的问题:普遍混淆了证与证候两者之间的从属关系;有的证与所属症状不具有合理的对应关系;病证所属复合症状中,多半由两个关联不大或毫无关联的症状拼凑而来;证属症状的分级一概分为主要症状和次要症状二级;对病证所属的一组症状,未能将历时症状和共时症状加以区分;对症状中起注释作用者未能区别对待;将极端症状与其他症状混同。这些问题对中医病证的诊断和疗效判定产生了明显的负面影响,应当解决。

Some Opinions and Proposals for New Edition of "Guiding Principles for Clinical Study of New Chinese Medicines"

The new edition of "Guiding Principles for Clinical Study of New Chinese Medicines has exerted positive influence on the improvement of clinical study of new Chinese medicines. There exist, however, some problems which need to be settled urgently, such as, the relationship of subordination between disease and its syndromes is generally confounded, some diseases do not have rational corresponding relationship with their symptoms, in the symptom compounds of diseases most of them are pieced together by two symptoms which have little even no bearings each other, all the symptoms of diseases are devided into two classes-primary symptoms and secondary ones, in a group of symptoms of a disease duration symptoms and simultaneous symptoms are not marked off, the symptoms which have an explanatory role in all the symptoms are not delt with in a defferent way, and the extreme symptoms and other ones are confounded. These problems have apparently produced negative influence on the diagnosis and the judgment of curative effectiveness of diseases in the field of traditional Chinese medicine and should be resolved.