2020年版中国药典含何首乌中成药的说明书分析及山东第一医科大学附属省立医院的应用情况研究

Analysis on the Instructions of Chinese Patent Medicines Containing Polygoni Multiflori Radix in Chinese Pharmacopoeia 2020 Edition and Application Situation in Shandong Provincial Hospital Affi liated to Shandong First Medical University

目的:分析《中华人民共和国药典》(以下简称《中国药典》)2020年版收载的含何首乌成分中成药说明书及山东第一医科大学附属省立医院(以下称我院)的应用情况。方法:查阅《中国药典》2020年版含何首乌成分中成药并统计其说明书内容及含何首乌成分日剂量等16项信息。查询我院使用含何首乌成分的中成药病历,分析用药和不良反应情况。结果:《中国药典》2020年版共收集含何首乌成分中成药71种,其说明书存在多项问题,尤其“老年用药”缺项情况严重。生血宝合剂等3种中成药何首乌成分日剂量超过药典最大推荐剂量。我院实际使用生血宝合剂不良反应记录少,无肝损伤等严重病案报道。结论:以何首乌成分为君臣药的中成药说明书缺项问题亟待解决,建议在注意事项中提示用药风险;同时应注重对患者用药教育。

Objective:To analyze the instructions of Chinese patent medicines(CPMs)containing Polygoni Multifl ori Radix(PMR)contained in Chinese Pharmacopoeia 2020 edition and the actual drug use in the Shandong Provincial Hospital Affiliated to Shandong First Medical University.Methods:CPMs containing PMR were consulted in Chinese Pharmacopoeia(2020 edition),and 16 items of information including the instruction content and daily dose of PMR were counted.The medical records of CPMs containing PMR in our hospital were inquired,and the medication and adverse reactions were analyzed.Results:A total of 71 kinds of CPMs containing PMR were collected in Chinese Pharmacopoeia,with numbers of problems in their instructions,especially the lack of"medicine for the elderly".The daily dose of PMR components of 3 kinds of CPMs like Shengxuebao mixture exceeded the maximum recommended dose of pharmacopoeia.There were few adverse reactions records of Shengxuebao mixture in our hospital and no reports of serious cases such as liver injury.Conclusion:It is urgent to solve the problem of missing items in the instructions of CPMs with PMR as the monarch medicine.Additionally,attention should be paid to drug education for patients.