2020年 第6卷 第10期
《工程（英文）》 >> 2020年 第6卷 第10期 doi: 10.1016/j.eng.2020.03.007
法匹拉韦治疗新冠病毒肺炎的开放性对照临床研究
a National Clinical Research Center for Infectious Diseases, The Third People's Hospital of Shenzhen, The Second Affiliated Hospital of Southern University of Science and Technology, Shenzhen 518100, China
b National Engineering Research Center for the Emergence Drugs, Beijing Institute of Pharmacology and Toxicology, Beijing 100850, China
# These authors contributed equally to this work.
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摘要
2019年12月以来，中国暴发了一场由严重急性呼吸系统综合征冠状病毒2（SARS-CoV-2）感染所引发的新冠病毒肺炎（COVID-19）疫情。超过16%的患者出现急性呼吸窘迫综合征，病死率为1%~2%。目前尚无有关特效治疗方法的报道。在此，我们比较了法匹拉韦（Favipiravir, FPV）和洛匹那韦（Lopinavir, LPV）/利托那韦（Ritonavir, RTV）治疗COVID-19的效果。FPV治疗组给药方案为实验室确诊COVID-19感染患者口服FPV（第1天：给药2次，单次1600 mg；第2~14天：每日2次，单次600 mg），同时干扰素α（IFN-α）雾化吸入（每日2次，单次500万国际单位）。而对照组给药方案为对患者进行洛匹那韦/利托那韦治疗（第1~14天：每日2次，单次400 mg/100 mg），同时IFN-α雾化吸入（每日2次，单次500万国际单位）。FPV治疗组的35例患者和对照组的45例患者在入组时，两组之间患者的所有基线特征均具有可比性。经过比较两组患者在胸部CT、病毒清除和药物安全性方面的变化发现，在病毒清除时间[中位时间（四分位间距，IQR）]方面，FPV治疗组的病毒清除时间[4天（IQR, 2.5~9）]比对照组[11天（IQR, 8~13）]的更短（P < 0.001）。在胸部CT方面，FPV治疗组的胸部CT改善率（91.43%）相比对照组（62.22%）有显著改善（P = 0.004）。在调整了潜在的混杂因素后，FPV治疗组在胸部CT方面仍显示出明显更高的改善率。多变量Cox回归分析显示，FPV的使用与病毒清除速度的提高具有独立的相关性。此外，FPV治疗组出现的不良事件比对照组少。在本项开放的给药前后对照研究中，FPV在疾病进展控制和病毒清除方面对COVID-19表现出更好的治疗效果。这些初步的临床结果为感染SARS-CoV-2患者的治疗提供了有价值的信息。
关键词
法匹拉韦 ; 新冠病毒肺炎 ; SARS-CoV-2 ; 抗病毒治疗 ; 开放性非随机对照研究
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