中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 105-109.
DOI: 10.19803/j.1672-8629.2021.02.02

• 新型冠状病毒肺炎治疗药品安全研究专栏 • 上一篇    下一篇

洛匹那韦利托那韦治疗新型冠状病毒肺炎的不良反应主动监测研究

吴菲, 李民, 方玉婷, 陈泳伍, 沈爱宗*   

  1. 中国科学技术大学附属第一医院（安徽省立医院）药剂科,安徽 合肥 230001
  • 收稿日期:2020-06-15 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
  • 通讯作者: *沈爱宗,男,主任药师,药物经济学与医院药学。E-mail：1649441800@qq.com
  • 作者简介:吴菲,女,主管药师,临床药学。
  • 基金资助:
    2018年高等学校省级质量工程项目（2018sxzx57）

Active Monitoring of Adverse Drug Reactions Caused by Lopinavir/ritonavir in Treating Coronavirus Disease 2019

WU Fei, LI Min, FANG Yuting, CHEN Yongwu, SHEN Aizong*   

  1. Department of Pharmacy, the First Affiliated Hospital of USTC, Hefei Anhui 230001,China
  • Received:2020-06-15 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

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摘要： 目的 探讨洛匹那韦利托那韦（LPV/r）治疗新型冠状病毒肺炎（COVID-19）患者的安全性,为临床安全使用LPV/r提供参考。方法 基于中国医院药物警戒系统(CHPS),通过团队讨论的方式建立LPV/r主动监测模型,监测2020年1月21日至2月23日使用LPV/r的COVID-19患者,阳性预警病例经人工再评价后开展药品不良反应（ADR）研究。结果 共监测65例住院患者,经人工再评价后,LPV/r致肝功能异常的发生率为29.23%,3级ADR 1例。用药疗程大于10 d为LPV/r致肝功能异常的独立危险因素（OR =4.511,95%CI: 1.128~18.033）。文本主动监测发现23例次ADR,以恶心最为多见。结论 LPV/r可引起肝功能异常、恶心、呕吐等不良反应,临床用药期间应严密监测患者各项实验室指标,提前预防、积极对症治疗,防止严重ADR发生。

关键词: 新型冠状病毒肺炎, 洛匹那韦利托那韦, 主动监测, 安全性, 药品不良反应

Abstract: Objective To investigate the safety of LPV/r in the treatment of patients with COVID-19, and to provide reference for the safe use of LPV/r. Methods Based on China Hospital Pharmacovigilance System, an LPV/r active monitoring model was established through teamwork to monitor COVID-19 patients who were using LPV/r from January 21 to February 23, 2020.The positive warning cases were reviewed manually for further study on ADRs. Results A total of 65 patients were monitored. After manual re-evaluation, the incidence of LPV/r-related hepatic dysfunction was 29.23% and severe ADRs occurred in one patient. A duration of medication of more than10 d (OR=4.511, 95% CI: 1.128~18.033) was an independent risk factor for hepatic dysfunction caused by LPV/r. Text active monitoring found 23 cases of adverse reactions, the most common one of which was nausea. Conclusion LPV/r can cause hepatic dysfunction, nausea, vomiting and other adverse reactions. During clinical medication, the laboratory indicators of patients should be closely monitored as a precaution, and symptomatic treatment should be actively conducted to prevent the occurrence of severe ADRs.

Key words: COVID-19, lopinavir/ritonavir, active monitoring, security, adverse drug reaction

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