摘要
目的系统评价《国家基本医疗保险、工伤保险和生育保险药品目录》(全文简称《医保目录》,2009年版)403种含毒性药材中药制剂品种近30年来的ADR/ADE的文献报道,分析探讨该类制剂存在的安全问题及其ADR/ADE的发生原因。方法采用回顾性研究方法及文献计量学方法,收集并整理ADR/ADE文献及CFDA药品不良反应信息通报资料,应用统计学方法进行数据分析。结果共检索到《医保目录》含毒性药材中药制剂的ADR/ADE 1 976例,其中含ADR 1 478例,ADE 498例,涉及112种药物。由于该类制剂本身含有毒性药材,易出现不良反应,其危害累及人体多个器官/系统。此外,患者机体状态、药物使用不当、问题说明书等问题,也加大了ADR/ADE的风险。结论含毒性药材中药制剂在临床应用中发挥着重要作用,针对该类制剂较为特殊、易出现ADR/ADE的特点,开展相关的药品监管工作,结合临床用药警戒,以确保临床使用过程中的安全有效。
Objective To evaluate the ADR/ADE reports in recent 30 years about 403 species of toxic herbs of TCM varieties in the latest edition of medical insurance directory,and analyze the security problem of the preparation and the causes of ADR/ADE.Methods Based on the related literature retrieval of domestic periodicals and the adverse drug reactions information bulletin of CFDA,which were analyzed by retrospective study method,literature metrology method and statistic method.Results Totally 1 976 ADR/ADE cases about toxic herbs of TCM preparations in medical insurance directory were retrieved,including 1 478 ADR cases and 498 ADE cases which were induced by 112 kinds of toxic herbs of TCM preparations.The toxic herbs in the drugs could induce the adverse reactions which could harm multiple organs and systems.In addition,the status of patient,improper use of drug,imperfect instruction information increased the risk of adverse reactions.Conclusion Toxic herbs of TCM preparations play an important role in clinical applications.In order to ensure the safety and efficacy in the process of clinical use we should take account of the characteristics of ADR/ADE,promote related supervision measures and clinical medical alert.
出处
《实用药物与临床》
CAS
2016年第2期251-256,共6页
Practical Pharmacy and Clinical Remedies
基金
教育部高等学校博士学科点专项科研基金(2013-0013120001
20120013130002)
北京中医药大学青年教师专项自主课题(2013-QNJSZX008)
北京中医药大学科研创新团队(2011-CXTD-014)
北京中医药大学"重点学科"开放课题(2013-ZDXKKF-19)
关键词
含毒性药材中药制剂
安全问题
合理用药
药物警戒
Toxic herbs of traditional Chinese medicine preparations
Security issues
Rational use of drug
Pharmacovigilance
