中国临床药学杂志

目的 调查不同等级和类型的医疗机构中中成药超说明书用药现状并分析原因，促进临床中成药的合理使用。方法 利用“问卷星”网站设计中成药超说明书相关情况的调查问卷，向44家不同等级和类型的医疗机构发放，共回收到42份有效问卷。对中成药超说明书用药现状、管理制度、审批流程以及审批备案后的体现形式、制度落实情况、追踪分析和处方点评等方面进行分析。结果 中成药超说明书用药现象在等级较高的综合医疗机构和专科医疗机构中较多。中医医疗机构中中成药超说明书用药现象多于西医和中西医结合医疗机构。等级较高的综合医疗机构在管理制度、审批流程等方面优于等级较低的医疗机构；西医医疗机构在制度落实、处方授权、备案资料审核、追踪分析等方面优于中医医疗机构。结论 完善中成药超说明书用药的管理体系，加强中成药处方的授权管理，追踪评价中成药超说明书用药的临床效果和不良反应，有利于改善中成药超说明书用药的现状，提高中成药临床的合理使用水平。

AIM To investigate the current situation of off-label use of Chinese patent medicines(CPMs) in various medical institutions at all levels and analyze the causes, so as to promote the rational application of CPMs in clinical practice. METHODS A questionnaire on the off-label use of CPMs was designed using Questionnaire Star. A total of 42valid questionnaires were obtained from 44 medical institutions of different levels and types. The off-label use of CPMs was analyzed from the following aspects: the phenomenon of off-label use of CPMs, management system, approval process,manifestation form of reflection after approval and filing, implementation of the system, follow-up analysis and prescription review. RESULTS The off-label use of CPMs was more common in high-grade and specialized medical institutions.The phenomenon of off-label use of CPMs in the medical institutions of traditional Chinese medicine series was more than that in the medical institutions of Western series and integrated Chinese and Western series. The medical institutions with high levels were better than the medical institutions with low levels in terms of management systems and approval processes. The medical institutions of the Western medicine series were superior to the medical institutions of the Chinese medicine series in terms of system implementation, prescription authorization, filing data review and tracking and analysis.CONCLUSION Improving the management system of off-label use of CPMs, strengthening authorization management of Chinese patent medicine prescriptions and tracking the clinical outcomes and adverse reactions of off-label use of CPMs are conducive to improving the current situation of off-label use of CPMs and improving the rational clinical application of CPMs.