中国药物警戒 ›› 2021, Vol. 18 ›› Issue (5): 459-463.
DOI: 10.19803/j.1672-8629.2021.05.12

• 安全与合理用药 • 上一篇    下一篇

药品安全性个案报告的国际规范介绍及初步应用

张晓雯, 刘建平*   

  1. 北京中医药大学循证医学中心,北京 100029
  • 收稿日期:2020-05-09 出版日期:2021-05-15 发布日期:2021-05-12
  • 通讯作者: *刘建平,男,博士·博导,循证中医药临床研究。E-mail:jianping_l@hotmail.com
  • 作者简介:张晓雯,女,在读硕士,中西医结合循证医学。
  • 基金资助:
    国家自然科学基金面上项目（81673828）;国家自然科学基金资助项目（81830115）

Introduction and Application of Standardization of case Reports on Drug Safety

ZHANG Xiaowen, LIU Jianping*   

  1. Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2020-05-09 Online:2021-05-15 Published:2021-05-12

PDF (PC)

411

摘要： 目的 评估药品安全性个案报告(Case Report, CARE)的规范性,以提高个案报告的完整度和透明度,为药品不良反应的确证和因果推断提供足够的信息支持。方法 根据CARE清单要求,分析《中国药物警戒》期刊2010~2019年期间发表个案报告的情况。结果 《中国药物警戒》期刊在2010~2019年期间发表个案报告508篇,主要报告内容为药品安全性。按照CARE清单要求报告的14个条目,平均每篇文章报告了5.85个条目,其中随访和结果部分的报告较为全面,不良反应和意外事件的产生、处理及结果也均有详细描述,但对患者的情况描述仅限于现阶段的检测结果,病例局限性报告不充分。结论 建议根据CARE清单要求,个案报告应详细报告患者的既往史,体现诊断的思维过程,适当辅以患者自身观点或体验,从而使个案报告更准确、透明,利于判断药品不良反应带来的影响,推断药品与事件的因果关系。

关键词: 安全性, 个案报告, 案例报告, CARE, 报告规范

Abstract: Objective To evaluate the standardization of Case Report(CARE) on drug safety, improve the accuracy and transparency of case reports, and provide sufficient information for identification of adverse drug reactions and the causality between drugs and events. Methods Based on CARE Checklist and Chinese Journal of Pharmacovigilance, the quality of case reports published in this journal over the past ten years was assessed. Results Between 2010 and 2019, 508 case reports were published in Chinese Journal of Pharmacovigilance on drug safety. Each report had an average of 5.85 items that met the 14 items requirements of CARE Checklist. Follow-up and results were fully reported, adverse reactions and adverse drug events were described in detail; but the description of the patients' condition was based on results of detection currently available, and the limitations of cases were not fully reported. Conclusion We recommend reporting the past history of a patient in detail, presenting the diagnostic process, and mentioning the perspective and experience of patients, which can improve the accuracy and transparency of case reports and provide more information for identification of adverse drug reactions and the causality between drugs and events.

Key words: safety, case reports, CARE, standardization of case reports

中图分类号: