中国药物警戒 ›› 2019, Vol. 16 ›› Issue (8): 473-477.

• 法规与管理研究 • 上一篇    下一篇

中药配方颗粒上市后风险监测体系现状调查与分析

刘祯1, 喻锦扬1,*, 周杰2   

  1. 1 广东省药品不良反应监测中心,广东 广州 510080;
    2 广州循证医药科技有限公司,广东 广州 510060
  • 收稿日期:2019-09-09 修回日期:2019-09-09 出版日期:2019-08-20 发布日期:2019-09-09
  • 通讯作者: *喻锦扬,男,临床医学博士,药品安全性监测及评价。E-mail：23676090@qq.com
  • 作者简介:刘祯,女,药理学博士,药品安全性监测及评价。

Investigation and Analysis on the Status quo of Post-marketing Risk Monitoring System of TCM Formula Granules

LIU Zhen1, YU Jinyang1,*, ZHOU Jie2   

  1. 1 Center for ADR Monitoring of Guangdong,Guangdong Guangzhou 510080;
    2 Guangzhou Evidence-based Medicine Technology Co.,ltd.,Guangdong Guangzhou 510060, China
  • Received:2019-09-09 Revised:2019-09-09 Online:2019-08-20 Published:2019-09-09

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摘要： 目的 了解中药配方颗粒上市后风险监测体系现状,引导企业构建完善的安全性监测体系,为企业后续开展安全性有效性评价提供参考,为中药配方颗粒的监管提供依据。方法 采用电子问卷为主、访谈为辅的方法收集数据,中药配方颗粒生产企业调查问卷共设置37个题目,调查了6家企业;医疗机构调查问卷采用线上网络发放,共设置45个题目,问卷回收161份。结果 6家企业均已构建不良反应监测组织架构和基本制度。2家企业认为需要开展临床研究对品种安全性进行评价,2家企业倾向于开展上市后安全性集中监测,3家企业倾向于开展随机对照临床试验。回收医生问卷显示：医生目前获知不良反应渠道主要通过患者主动反馈（73.56%）。对未来开展不良反应监测的方法,83.90%的临床医生认为需要开展临床研究对品种安全性进行评价,56.90%临床医生倾向于开展上市后安全性集中监测,51.72%临床医生倾向于开展随机对照临床试验。结论 企业对中药配方颗粒的安全性监测缺乏足够的重视。建议企业对既往已经开展的临床研究的安全性数据进行总结分析,同时,落实主体责任及药品不良反应直接报告制度,对药品不良反应进行主动监测与分析评价。

关键词: 中药配方颗粒, 上市后, 风险监测体系

Abstract: Objective To understand the status quo of post-marketing risk monitoring system of TCM formula granules and guide enterprises to build a perfect safety monitoring system, so as to provide references for enterprises to carry out follow-up safety and effectiveness evaluations and provide basis for supervision of TCM formula granules. Methods The data were collected mainly by electronic questionnaires and supplemented by interviews, a total of 37 questions were set in the questionnaire for enterprises producing TCM formula granules, and 6 enterprises were investigated; Questionnaires for medical institutions were distributed online with 45 questions in total and 161 ones were collected. Results All six enterprises have established the organizational structure and basic system for adverse reaction monitoring. Two enterprises considered that clinical studies needed to be carried out to evaluate the safety of varieties, two tended to carry out centralized post-marketing safety monitoring, and three tended to carry out randomized controlled clinical trials. The questionnaires collected from doctors showed that doctors are currently informed of adverse reactions mainly through patients' active feedback (73.56%). For the adverse reaction monitoring methods carried out in the future, 83.90% of clinicians considered that clinical studies needed to be carried out to evaluate the safety of varieties, 56.90% of clinicians tended to carry out centralized post-marketing safety monitoring, and 51.72% of clinicians tended to carry out randomized controlled clinical trials. Conclusions Enterprises did not pay enough attention to the safety monitoring of TCM formula granules. It is suggested that enterprises should summarize and analyze the safety data of previous clinical studies, implement the systems of main responsibility and direct reporting of adverse drug reactions at the same time, and actively monitor, analyze and evaluate the adverse drug reactions.

Key words: TCM formula granules, post-marketing, risk monitoring system

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