洛匹那韦/利托那韦及阿比多尔治疗新型冠状病毒肺炎的疗效和安全性观察

The efficacy and safety of lopinavir/ritonavir and arbidol in patients with coronavirus disease 2019

目的评价真实世界中洛匹那韦/利托那韦(LPV/r)及阿比多尔治疗新型冠状病毒肺炎(COVID-19)的疗效和安全性。方法回顾性分析2020年1月20日至2月10日广州市第八人民医院收治的确诊为COVID-19的178例患者临床资料,根据患者的抗病毒治疗方案,分为LPV/r组59例、阿比多尔组36例、LPV/r与阿比多尔合用组25例及未使用任何抗病毒药物的常规治疗组58例。主要观察终点为咽拭子新型冠状病毒核酸转阴时间。结果LPV/r组、阿比多尔组、合用组及常规治疗组患者治疗前基线情况差异无统计学意义;咽拭子新型冠状病毒核酸转阴时间分别为(10.20±3.49)、(10.11±4.68)、(10.86±4.74)、(8.44±3.51)d,各组间差异无统计学意义(F=2.556,P=0.058),且咽拭子新型冠状病毒核酸转阴率、临床症状改善率及肺部感染影像学改善率也无明显差别(P>0.05)。但4组治疗7d由普通/轻型转为重型/危重型的比例存在统计学意义的差异(χ2=9.311,P=0.017):合用组(24.0%,6/25),阿比多尔组(16.7%,6/36),LPV/r组(5.4%,3/56),常规治疗组(5.2%,3/58)。使用抗病毒药物的3组患者发生不良反应的频率显著高于常规治疗组(χ2=14.875,P=0.002)。结论未发现LPV/r和阿比多尔能促进COVID-19患者咽拭子病毒核酸转阴或改善症状,联用LPV/r和阿比多尔可能不利于病情改善,尤其需注意抗病毒药物的不良反应。

Objective To evaluate the efficacy and safety of lopinavir/ritonavir(LPV/r)and arbidol in treating patients with coronavirus disease 2019(COVID-19)in the real world.Methods The clinical data of 178 patients diagnosed with COVID-19 admitted to Guangzhou Eighth People′s Hospital from January 20 to February 10,2020 were retrospectively analyzed.According to patient′s antiviral treatment regimens,178 patients were divided into 4 groups including LPV/r group(59 patients),arbidol group(36 patients),LPV/r plus arbidol combination group(25 patients)and the supportive care group without any antiviral treatment(58 patients).The primary end point was the negative conversion time of nucleic acid of 2019 novel coronavirus(2019-nCoV)by pharyngeal swab.Results The baseline parameters of 4 groups before treatment was comparable.The negative conversion time of viral nucleic acid was(10.20±3.49),(10.11±4.68),(10.86±4.74),(8.44±3.51)days in LPV/r group,arbidol group,combination group,and supportive care group respectively(F=2.556,P=0.058).There was also no significant difference in negative conversion rate of 2019-nCoV nucleic acid,the improvement of clinical symptoms,and the improvement of pulmonary infections by CT scan(P>0.05).However,a statistically significant difference was found in the changing rates from mild/moderate to severe/critical type at day 7(χ2=9.311,P=0.017),which were 24%(6/25)in combination group,16.7%(6/36)in arbidol group,5.4%(3/56)in LPV/r group and 5.2%(3/58)in supportive care group.Moreover,the incidence of adverse reactions in three antiviral groups was significantly higher than that in supportive care group(χ2=14.875,P=0.002).Conclusions Antiviral treatment including LPV/r or arbidol or combination does not shorten the negative conversion time of 2019-nCoV nucleic acid nor improve clinical symptoms.Moreover,these antiviral drugs cause more adverse reactions which should be paid careful attention during the treatment.