功能性胃肠病临床疗效评价中症状学评价的若干问题

Discussions on Symptomatic Assessment in Clinical Evaluation of FGIDs

在《中药新药临床研究技术指导原则》的编制过程中,常面临着中医症状学的评价问题。功能性胃肠病(Functional gastrointestinal disorders,FGIDs)是消化系统常见的一组疾病,其在临床诊断及治疗方面均以症状学为主,与中医学以症状为靶点进行诊断治疗有一定的类同性。因而此次以FGIDs为代表,组织专家对其临床疗效评价中症状学问题进行讨论,涉及内容包括指导原则的总体思路及设计、症状学研究在FGIDs乃至功能性疾病研究中的意义、FGIDs中的症状学评价中遇到的问题及解决方案等,并达成一系列重要共识,希望借此推进FGIDs指导原则编制过程中相关问题的解决,并为今后其他疾病中涉及症状学问题的处理提供参考。

The symptomatic assessment of traditional Chinese medicine(TCM) had been a common problem in the compilation of Guidelines for the Clinical Research of Chinese Medicine New Drugs. Functional gastrointestinal disorders(FGIDs) are common diseases of the digestive system. The diagnosis and treatment of FGIDs are often based on symptoms, which is similar to TCM regarding symptoms as the target. In the conference, symptom-related clinical evaluation issues had been discussed with FGIDsas an example. There was a final agreement among the experts on several issues, including the general idea of guidelines of new drugs, the significance of symptoms assessment in treating FGIDsand other functional diseases, problems and solutions in the clinical evaluation of FGIDs, etc., hoping to solve the problems in compiling the guidelines for clinical research of new drugs of traditional Chinese medicine for FGIDs and provide references for dealing with other diseases involving symptomatology.