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