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

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

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。

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.