含毒性成分中成药在心病科临床应用中的风险控制  

Risk Control with Chinese Patent Medicines Containing Toxic Components for Clinical Application in Cardiology Department

作　　者：李琦 葛思琪 石晓宇 吕福杰 LI Qi;GE Si-qi;SHI Xiao-yu;LV Fu-jie(Hospital of Traditional Chinese Medicine of Liaocheng City,Liaocheng 252000,China)

机构地区：[1]聊城市中医医院,聊城252000

出　　处：《中国合理用药探索》2024年第10期108-114,共7页Chinese Journal of Rational Drug Use

摘　　要：目的:基于安全合理用药,探讨某院含毒性成分中成药监护要点,保障其在心病科临床实践中药学工作切实可行。方法:以《中国药典》(2020年版)收载的83种毒性中药、《医疗用毒性药品管理办法》收录的28种毒性中药及国家药品监管部门发布的具有安全风险的中药为依据,结合《中华人民共和国药典临床用药须知·中药成方制剂卷》(2020年版)、药品说明书,制定医院心病科使用的含毒性成分中成药目录;以药品说明书的用法用量、适应症、不良反应、禁忌和注意事项为参考,结合药物相关文献、指南确立药物监护要点。结果:确定14种含毒性成分中成药的监护要点,制定风险控制措施。结论:含毒性成分中成药在心病科疾病治疗中应用领域广,不良反应发生率较高。临床给药应侧重药物的监护要点,提升安全合理用药。Objective:Based on safe and rational drug use,to explore the monitoring points with Chinese patent medicines containing toxic components in a hospital,so as to ensure that the points are clinically practicable as pharmacy work in cardiology department.Methods:A list of Chinese patent medicines containing toxic components used in the cardiology department in hospitals were prepared based on 83 kinds of toxic traditional Chinese medicines included in Chinese Pharmacopoeia(2020 edition),28 kinds of toxic traditional Chinese medicines included in Administrative Measures for Toxic Drugs for Medical Use,and traditional Chinese medicines with safety risks issued by the National Medical Products Administration,as well as Guideline for Clinical Use of Traditional Chinese Medicine in the Chinese Pharmacopoeia-Volume of Chinese Herbal Formula Preparations(2020 edition)and package inserts;Monitoring points with drugs were determined by reference to the usage and dosage,indications,adverse reactions,contraindications and precautions indicated in the package inserts,and taking into account the relevant literature and guidelines.Results:The monitoring points for 14 kinds of Chinese patent medicines containing toxic components were determined,and the risk control measures were established.Conclusion:Chinese patent medicines containing toxic components are widely used in the treatment of heart diseases,and the incidence of adverse reactions is high.Monitoring points should be emphasized in clinical treatment with the drugs in order to promote safe and rational drug use.

关 键 词：毒性成分 中成药 心病科 风险控制 监护要点 

分 类 号：R288[医药卫生—中药学]