阿比多尔和洛匹那韦/利托那韦治疗新冠肺炎的疗效和安全性比较

Comparison of Efficacy and Safety of Arbidol and Lopinavir/Ritonavir in the Treatment of COVID-19

目的:比较真实世界中阿比多尔及洛匹那韦/利托那韦治疗新型冠状病毒肺炎(COVID-19,以下简称“新冠肺炎”)的疗效和安全性。方法:回顾性分析2020年1月26日至2020年3月9日湖北省宜昌市第三人民医院由国家援鄂福建医疗队收治的确诊为新冠肺炎的246例患者的临床资料。246例患者均接受重组人干扰素α2b喷雾治疗以及常规对症支持治疗,根据患者的抗病毒药物治疗方案,分为阿比多尔组115例和洛匹那韦/利托那韦组131例。主要观察终点为咽拭子新型冠状病毒(SARS-CoV-2,以下简称“新冠病毒”)核酸转阴时间,次要终点为药物的不良反应。两组患者间比较采用卡方检验或t检验。结果:246例患者中,男132例(53.66%),女114例(46.34%),年龄为20~82岁,平均年龄为(53.58±15.19)岁。阿比多尔组和洛匹那韦/利托那韦组咽拭子新冠病毒核酸7 d转阴率分别为46.1%和50.4%,14 d转阴率分别为96.5%和90.1%,差异均无统计学意义(P>0.05)。阿比多尔组和洛匹那韦/利托那韦组患者咽拭子新冠病毒核酸转阴中位时间均为治疗后7 d,差异无统计学意义(P=0.960)。阿比多尔组11例(9.6%)、洛匹那韦/利托那韦组13例(9.9%)患者出现药物相关的不良反应,两组间差异无统计学意义(χ^(2)=0.009,P=1.000)。结论:在治疗新冠肺炎方面,阿比多尔和洛匹那韦/利托那韦在7 d和14 d核酸转阴率及不良反应方面差异无统计学意义。

Objective:To evaluate the efficacy and safety of arbidol and lopinavir/ritonavir in the treatment of corona virus disease 2019(COVID-19)in the real world.Methods:The clinical data of 246 patients with COVID-19 were retrospectively collected at Yichang Third People′s Hospital in Hubei China,where was medical supported by Fujian medical support team during January 26 to March 9,2020.All 246 patients received interferon-α2b spray and symptomatic and supportive treatment.According to the patient′s antiviral treatment regimen,the patients were divided into two groups:the arbidol group(n=115 patients)and the lopinavir/ritonavir group(n=131 patients).The primary end point was the negative conversion time of nucleic acid of SARS-CoV-2 in pharyngeal swab.The second end point was the adverse drug reactions.Results:The 246 patients included 132 males(53.66%)and 114 females(46.34%),and the average age was(53.58±15.19)years(20-82).The SARS-CoV-2 nucleic acid negative rates after the treatment of the arbidol group and the lopinavir/ritonavir group were 46.1%and 50.4%at 7d,and 96.5%and 90.1%at 14d,respectively.There were no statistical difference(P>0.05).The median negative conversion times of nucleic acid of the SARS-CoV-2 were 7d in both groups(P=0.960).The incidence rate of adverse drug reactions of the two groups had no statistical difference(9.6%vs.9.9%,χ^(2)=0.009,P=1.000).Conclusion:This study showed that in the treatment of COVID-19,there were no statistical differences in the nucleic acid negative conversion rate and adverse reactions between arbidol and lopinavir/ritonavir at 7 d and at 14 d.