中医药规范化治疗方案研究的思路与方法
中医药治疗学,,],中医药治疗学;,规范;,临床方案,1中医药规范化治疗方案研究应遵循的基本原则,2[参考文献]
[摘要] 中医药的突出特点和生命力就在于其疗效，即根据中医基本理论应用方药的治疗效果。中医药规范化治疗方案的研究必须体现中医基本理论，遵循现代医学临床试验设计方法以及利用现代医学关于疾病诊断和疗效判断的标准，应将中医证候相关信息(包括症状、舌象和脉象)纳入临床试验的检查项目之中，开展两次或多次的临床试验，利用多元统计分析方法，对比分析有效和无效人群的特点，寻求与中医药治疗方案有效结局相关的主观症状、舌象和脉象，从而找到该治疗方案的最佳适应症，形成规范的治疗方案。[关键词] 中医药治疗学; 规范; 临床方案
Methodological thoughts about research of standardized clinical protocols of traditional Chinese medicine
AiPing L, QingLin ZHA, ZhiBin ZHANG
(Institute of Basic Theory, China Academy of Traditional Chinese Medicine, Beijing 100700, China; National Center of Pharmaceutical Engineering Research, Jiangxi College of Traditional Chinese Medicine, Nanchang, Jiangxi Province 330006, China; History and Philology Institute of Traditional Chinese Medicine, China Academy of Traditional Chinese Medicine, Beijing 100700, China)
ABSTRACT The treatment of traditional Chinese medicine (TCM) has been proved effective in clinical practice for thousands of years. To standardize the clinical protocols of TCM is absolutely necessary for enhancing the research quality of TCM and expanding the international influence of TCM. The standardization research on clinical protocols of TCM should be based on the basic theory of TCM and in the light of good clinical practice (GCP) principles. The clinical criteria for both diagnosis and efficacy evaluation of disease are also needed. To include all symptoms, tongue manifestations and pulse presentations into case report form, and to compare the differences in these clinical parameters between effective and noneffective cases by multivariate analysis may be helpful to find more specific indications for therapeutic protocol of TCM. Furthermore, It is suggested that two or more clinical trials on one therapeutic protocol are needed to identify its accurate indications. ......
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