法匹拉韦单药治疗COVID-19的有效性：来自泰国的真实世界数据分析。
Effectiveness of Favipiravir monotherapy in the treatment of COVID-19: real world data analysis from Thailand.
作者信息
Srisubat Attasit, Thanasitthichai Somchai, Kongsaengdao Subsai, Maneeton Narong, Maneeton Benchalak, Akksilp Somsak
机构信息
Department of Medical Services, Ministry of Public Health of Thailand, Nonthaburi, 11000, Thailand.
Division of Neurology, Department of Medicine, Rajavithi Hospital, Department of Medical Services, Ministry of Public Health of Thailand, Bangkok, Thailand.
出版信息
Lancet Reg Health Southeast Asia. 2023 Apr;11:100166. doi: 10.1016/j.lansea.2023.100166. Epub 2023 Feb 7.
BACKGROUND
Previous studies showed that Favipiravir, a selective viral ribonucleic acid dependent-ribonucleic acid polymerase inhibitor, exhibited a trend of clinical improvement within 14 days and promoted viral clearance by day 7, without reduction of mortality rate in COVID-19.
METHODS
During the COVID-19 pandemic, Department of Medical Services (Thailand) formulated National Clinical Treatment Guidelines for COVID-19 and approved Favipiravir to eight medical centres. After treatment with Favipiravir monotherapy, we compared real-world data analysis to supportive treatment without antiviral agents.
FINDINGS
We analysed 12,888 COVID-19 patients between June 1, 2021, and July 31, 2021. This group study excluded 66 asymptomatic and 4634 COVID-19 patients treated with other antiviral agents. The 4896 mild, 2357 moderate, and 935 severe COVID-19 patients were analysed. All patients neither had previous SARS-CoV-2 infection nor received an mRNA vaccine during study period. Favipiravir monotherapy reduced the 28-day mortality risk in severe COVID-19 by relative risk (RR) = 0.72 (95% CI 0.58-0.91 P = 0.006) after adjustment for aging and hypertension. However, in mild and moderate COVID-19, Favipiravir monotherapy did not significantly reduce 28-day mortality risk by RR = 0.59 (95% CI 0.06-5.43 P = 0.65) after adjustment for aging, and RR = 0.60 (95% CI 0.32-1.13 P = 0.11) after adjustment for aging and obesity, respectively. In the patient with recovery, Favipiravir monotherapy exhibited a shortening time to recovery when compared to supportive treatment without antiviral agents (mean ± SD by 9.6 ± 7.1 vs. 12.9 ± 7.6 days: P < 0.0001, 10.0 ± 5.9 vs. 12.4 ± 5.3 days: P < 0.0001, and 11.2 ± 7.8 vs. 13.1 ± 8.0 days: P < 0.0001 in mild, moderate, and severe COVID-19 respectively).
INTERPRETATION
Real-world data analysis showed that favipiravir monotherapy was superior to supportive treatment without antiviral agents in shortening the recovery time in surviving patients and significantly reducing 28-day mortality risk in severe COVID-19.
FUNDING
Department of Medical Services, Ministry of Public Health, Thailand.
背景
先前的研究表明，法匹拉韦是一种选择性的病毒核糖核酸依赖性核糖核酸聚合酶抑制剂，在14天内呈现出临床改善的趋势，并在第7天促进了病毒清除，但在COVID-19中并未降低死亡率。
方法
在COVID-19大流行期间，泰国医疗服务部制定了COVID-19国家临床治疗指南，并批准法匹拉韦用于八个医疗中心。在接受法匹拉韦单药治疗后，我们将真实世界数据分析与无抗病毒药物的支持性治疗进行了比较。
研究结果
我们分析了2021年6月1日至2021年7月31日期间的12888例COVID-19患者。该组研究排除了66例无症状患者和4634例接受其他抗病毒药物治疗的COVID-19患者。对4896例轻症、2357例中症和935例重症COVID-19患者进行了分析。所有患者在研究期间既没有既往SARS-CoV-2感染史，也没有接种过mRNA疫苗。在调整年龄和高血压因素后，法匹拉韦单药治疗将重症COVID-19患者28天的死亡风险降低了相对风险（RR）=0.72（95%CI 0.58-0.91，P=0.006）。然而，在轻症和中症COVID-19中，分别调整年龄后，法匹拉韦单药治疗并未显著降低28天死亡风险，RR=0.59（95%CI 0.06-5.43，P=0.65）；调整年龄和肥胖因素后，RR=0.60（95%CI 0.32-1.13，P=0.11）。在康复患者中，与无抗病毒药物的支持性治疗相比，法匹拉韦单药治疗的恢复时间缩短（轻症、中症和重症COVID-19患者的平均±标准差分别为9.6±7.1天对12.9±7.6天：P<0.0001；10.0±5.9天对12.4±5.3天：P<0.0001；11.2±7.8天对13.1±8.0天：P<0.0001）。
解读
真实世界数据分析表明，法匹拉韦单药治疗在缩短存活患者的恢复时间以及显著降低重症COVID-19患者28天死亡风险方面优于无抗病毒药物的支持性治疗。
资金来源
泰国公共卫生部医疗服务部。
Zotero 插件