洛匹那韦/利托那韦治疗2019冠状病毒病不良反应发生情况分析

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目的:探讨洛匹那韦/利托那韦(LPV/r)治疗2019冠状病毒病(COVID-19)的不良反应发生情况。方法:收集2020年1月24日至2月6日在南宁市第四人民医院接受过LPV/r治疗的COVID-19患者病历资料,就治疗期间不良事件发生情况进行回顾性分析。依据我国《药品不良反应报告和监测工作手册》中提出的药物不良反应关联性评价5条原则,将与LPV/r的关联性判定为肯定有关、很可能有关、可能有关的不良事件定义为LPV/r相关不良反应。计算不良反应发生率,分析不良反应的主要临床表现和严重程度(1级轻度,2级中度,3级严重,4级危及生命,5级死亡;3~5级定义为严重不良反应)。结果:纳入分析的患者共28例,男性13例,女性15例;年龄18~70岁,平均44岁;LPV/r的疗程为2~12 d,中位疗程6 d;发生LPV/r相关不良反应者18例,发生率为64.3%。18例患者中,LPV/r相关不良反应表现为胃肠道反应者14例(1级13例,2级1例),心动过缓2例(均为2级),急性溶血和肝损伤各1例(均为3级),无4或5级不良反应发生;严重不良反应发生率为7.1%(2/28)。13例发生1级不良反应者未影响治疗,继续用药2~7 d后自行缓解;5例发生2或3级不良反应者均停用LPV/r,其中4例接受了对症治疗,2~10 d后症状消失。结论:我院接受LPV/r治疗的COVID-19患者不良反应发生率为64.3%。LPV/r主要导致轻度胃肠道反应,也可导致心动过缓、急性溶血和肝损伤,治疗期间需要监测血常规、肝功能和心电图。“,”Objective:To explore the occurrence of adverse reactions of lopinavir/ritonavir (LPV/r) in the treatment of coronavirus disease 2019 (COVID-19).Methods:The medical records of patients with COVID-19 who received LPV/r treatment in the Fourth People′s Hospital of Nanning from January 24th to February 6th, 2020 were collected and the occurrence of adverse events during the treatment was retrospectively analyzed. According to the 5 principles of adverse drug reaction correlation evaluation proposed in the n Handbook of Adverse Drug Reaction Reporting and Monitoring in China, adverse events that were certainly related, probably related, and possibly related to LPV/r were defined as LPV/r-related adverse reactions. The incidence of adverse reactions was calculated and the main clinical manifestations and severity of adverse reactions [grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death); grade 3-5 was defined as severe adverse reaction] were analyzed.n Results:A total of 28 patients were enrolled in the analysis, including 13 males and 15 females, aged from 18 to 70 years with an average age of 44 years. The courses of treatment with LPV/r of patients ranged from 2 to 12 days, with a median course of 6 days. Of the 28 patients, 18 developed LPV/r related adverse reactions, with an incidence of 64.3%. The LPV/r-related adverse reactions in 18 patients included gastrointestinal reactions in 14 patients (grade 1 in 13 patients and grade 2 in 1 patient), bradycardia in 2 patients (grade 2 in both patients), and acute hemolysis in 1 patient (grade 3), and liver injury in 1 patient (grade 3), and no grade 4 or 5 adverse reactions occurred. The incidence of severe adverse reactions was 7.1%. Thirteen patients with grade 1 adverse reactions did not affect the treatment, and the symptoms were relieved after 2-7 days of continuous medication. LPV/r was discontinued in 5 patients with grade 2 or 3 adverse reactions, 4 of whom received symptomatic treatment, and the symptoms disappeared 2-10 days later.Conclusions:The incidence of adverse reactions in COVID-19 patients treated with LPV/r in our hospital was 64.3%. LPV/r mainly leads to mild gastrointestinal reactions and can also lead to bradycardia, acute hemolysis, and liver injury. Blood routine, liver function, and electrocardiogram need to be monitored during the treatment.
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