心血管中成药超说明书用药循证评价方法和程序的建立

摘要

As the use of cardiovascular Chinese patent medicine increases,the phenomenon of off-label drug use is being more and more common.Off-label drug use is one of the important sources of new discoveries that is of certain clinical rationality and necessity.For its scientific and standardized application,however,the premise is to ensure the patient's medication safety and standardize the off-label drug use.This study draws on the concept and method of evidence-based medicine,with cardiovascular Chinese patent medicine as a breakthrough point,providing the off-label use of cardiovascular Chinese patent medicine with methodological support through exploring the method and procedure of establishing the evidence-based evaluation of the off-label drug use of cardiovascular Chinese patent medicine.%随着心血管中成药使用日益增多,超说明书用药现象也越来越多.超说明书用药具有一定的临床合理性与需要性,是新的发现的重要来源之一.但前提是保障患者用药安全,规范超说明书用药行为,使其逐步走向科学化、规范化的轨道.本研究借鉴循证医学理念和方法,以心血管中成药为切入点,通过探索建立心血管中成药超说明书用药循证评价方法和程序,为客观评价心血管中成药超说明书用药提供方法学支撑.