名老中医经验方优化研究病例报告表设计思路与方法.docVIP

名老中医经验方优化研究病例报告表设计思路与方法 　　摘要：名老中医经验方优化研究对来源于实际临床的经验方具有优化经验方组成、进一步明确经验方的适应证和疗效特点的作用。通常适应于临床新药研究的病例报告表不能满足经验方优化的观察性研究的需求。本文通过在名老中医经验方优化研究中对病例报告表进行的实践，阐述了设计特点、结构要素和采集时间点等，并对采集的信息提出了要求，期望通过名老中经验方观察性研究帮助实现经验方的优化，并为经验方进一步开展临床研究提供证据。 　　关键词：名老中医经验方；观察性研究；病例报告表 　　DOI：10.3969/j.issn.1005-5304.2016.09.004 　　中图分类号：R2-05 文献标识码：A 文章编号：1005-5304（2016）09-0015-04 　　Design Concept and Method of Case Report Forms in Optimum Research on Famous TCM Doctors’ Experienced Prescriptions XU Li-li1， ZHANG Run-shun1， WANG Ying-hui2， LIU Bao-yan3， XUE Yan-xing1， SONG Guan-li1 （1. Guang’anmen Hospital， China Academy of Chinese Medical Sciences， Beijing 100053， China； 2. Institute of Information on Traditional Chinese Medicine， China Academy of Chinese Medical Sciences， Beijing 100700， China； 3. China Academy of Chinese Medical Sciences， Beijing 100700， China） 　　Abstract： Optimum research on famous TCM doctors’ experienced prescriptions can optimize the composition of prescriptions which originated from experienced prescriptions， clarify the functions of indications and efficacy features of experienced prescriptions. Case report forms which are normally adapted to clinical new medicine study cannot meet the demand of observational study to optimize experienced prescriptions. This article expounded design features， structure elements and collection timing and proposed requirements for information collection through practice of case report forms in the optimum research on famous TCM doctors’ experienced prescriptions， with a purpose to realize the optimization of experienced prescriptions through observational study on famous TCM doctors’ experienced prescriptions and provide evidence for further clinical research on experienced prescriptions. 　　Key words： famous TCM doctors’ experienced prescription； observational research； case report form 　　古代医家基于个体化诊疗，通过长期临床实践，创制了许多名方，这些处方主要是基于长期的临床实践和经验总结。当代名老中医在长期临床实践中，亦创制或总结了一些经验方，但因多为回顾性资料，尚不能作为经验方转化为新药等成果的关键支撑材料，其适应证、疗效、不良反应等尚未完全明确。如直接对这些经验方进行随机对照