洛匹那韦/利托那韦单药或联合其他抗病毒药治疗新型冠状病毒肺炎安全性的回顾性分析

目的:对洛匹那韦/利托那韦单药或联合其他抗病毒药治疗新型冠状病毒肺炎的安全性进行调查分析,其安全性包括腹泻、恶心、呕吐、肝功能损伤等。方法:采用回顾性研究方法,收集合肥市某三甲医院于2020年1月至2020年2月期间收治的40例新型冠状病毒肺炎患者病例,对患者应用洛匹那韦/利托那韦期间可能发生的药品不良反应进行监测,药品不良反应报告直接上报国家药品不良反应监测系统,并分析洛匹那韦/利托那韦(单药组)与洛匹那韦/利托那韦联合其他抗病毒药物组(联合用药组)不良反应差异有无统计学意义。结果:共36例住院患者应用洛匹那韦/利托那韦治疗新型冠状病毒肺炎,其中31例患者(86.1%)发生不同程度的不良反应,包括1级(轻度)不良反应12例(33.3%),2级(中度)不良反应15例(41.7%),3级(严重)不良反应4例(11.1%)。洛匹那韦/利托那韦单药组、联合用药组发生2级及以上腹泻分别为4例(26.7%),12例(57.1%),ALT升高分别为0例、4例(19.0%)。洛匹那韦/利托那韦单药组与联合组在腹泻、恶心、呕吐、ALT升高不良反应分级分布上的差异无统计学意义(P>0.05)。由于洛匹那韦/利托那韦导致的不良反应而提前停药共例7例(19.4%)。结论:洛匹那韦/利托那韦单药或联合其他抗病毒药在治疗新型冠状病毒肺炎时,腹泻、恶心、呕吐等胃肠道反应及ALT升高常见,2级(中度)及3级(严重)药品不良反应发生率达52.8%。临床在应用洛匹那韦/利托那韦时应关注其安全性,尤其对于2级(中度)及2级以上不良反应宜给予对症处理,必要时甚至停药。

Retrospective analysis of the safety of lopinavir/ritonavir aloneor in combination with other antivirals in the treatment of COVID-19

OBJECTIVE To investigate and analyze the safety of lopinavir/ritonavir alone or in combination with other antiviral drugs in the treatment of novel coronavirus pneumonia, and its safety includes diarrhea, nausea, vomiting, and liver function impairment.METHODS A retrospective study was performed in 40 patients between January 2020 and February 2020 at a tertitary hospital in hefei. The adverse drug reactions that may occurred during the application of lopinavir/ritonavir were monitored, and the ADR data were reported to the National Drug Adverse Drug Reaction Monitoring System,and the statistically significant differences in adverse reactions between lopinavir/ritonavir (monotherapy group) and lopinavir/ritonavir combined with other antiviral drugs (combined drug group) that were analyzed.RESULTS A total of 36 hospitalized patients were treated with lopinavir/ritonavir for novel coronavirus pneumonia, of which 31 patients (86.1%) had different degrees of adverse reactions, including grade 1 (mild) adverse reactions in 12 patients (33.3%), grade 2 (moderate) adverse reactions in 15 patients (41.7%), and grade 3 (serious) adverse reactions in 4 patients (11.1%).Grade 2 and higher diarrhea occurred in 4 patients (26.7%) and 12 patients (57.1%), respectively, and ALT elevation occurred in 0 and 4 patients (19.0%) in the lopinavir/ritonavir and combination groups, respectively.There was no significant difference in the grade distribution of adverse reactions between lopinavir/ritonavir and combined diarrhea, nausea and vomiting, and elevated ALT (P>0.05).Seven patients (19.4%) discontinued prematurely due to adverse reactions caused by lopinavir/ritonavir.CONCLUSION Lopinavir/ritonavir alone or in combination with other antiviral drugs in the treatment of novel coronavirus pneumonia, gastrointestinal reactions such as diarrhea, nausea, vomiting and elevated ALT are common, and the incidence of grade 2 (moderate) and grade 3 (serious) adverse drug reactions is 52.8%.The safety of lopinavir/ritonavir should be concerned in clinical application, especially for grade 2 (moderate) and above adverse reactions, symptomatic treatment should be given, and even drug withdrawal should be performed when necessary.