中医临床疗效评价的思路与方法

随着疾病谱的改变、医疗模式的转化、健康观念的更新,中医的诊疗思路受到全世界越来越多的关注和重视.在疗效判断由"以病为本"渐向"以人为本"迁移的背景下,如何科学、客观地回答"中医有效性"成为中医发展和走向世界的前提.本文通过对中医临床疗效评价现状的分析,指出了当前存在的问题与不足,阐明了开展中医临床疗效评价的基本方法.强调要在中医理论指导下,进行证候标准规范化研究,重视生命质量,合理选择结局指标,引入循证医学与临床流行病学等现代临床研究方法,采用随机对照试验设计,加强多学科密切合作,严格质量监控,组建专业机构和培养专业人员等.

General methods for clinical effect assessment of traditional Chinese medicine

Along with the changes of disease spectrum, medical models and health concept, people pay more and more attention to the diagnostic and therapeutic approaches of traditional Chinese medicine (TCM). With the effect assessment being changed from disease-based model to patient-based model, how to scientifically and objectively explain the validity of TCM has become the premise for further development of TCM and dissemination of it throughout the world. In this article, the authors analyzed the status quo and problems of the effect assessment of TCM, and proposed some general methods for clinical effect assessment of TCM, including formulating criteria for syndrome differentiation under the guidance of TCM theories, paying attention to quality of life, proper selection of indexes for outcome assessment, application of modern clinical study methods, such as the methods of evidence-based medicine and clinical epidemiology, designing randomized controlled trials, multi-subject co-operation, strict supervision of the quality of researches, and establishment of organizations for professional training.