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.2020.08.011
特力阿扎维林治疗新冠病毒肺炎的疗效和安全性——一项随机对照试验
a College of Pharmacology, Harbin Medical University, Harbin 150001, China
b Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China
c First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China
d First Affiliated Hospital, Harbin Medical University, Harbin 150001, China
e Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China
f Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China
g College of Basic Medical Sciences, Zhejiang Chinese Medical University, Hangzhou 310053, China
h Monash Medical Centre, Monash University, Melbourne, VIC 3800, Australia
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摘要
目前，尚无有效疗法可治愈由新型冠状病毒（severe acute respiratory syndrome coronavirus 2, SARS-CoV-2）引起的新型冠状病毒肺炎（coronavirus disease 2019, COVID-19）。为了评估抗病毒药物特力阿扎维林治疗COVID-19的有效性和安全性，本研究针对感染COVID-19的成年住院患者开展了一项随机双盲对照试验。本研究从10个分中心招募COVID-19患者，并将患者按1:1的比例随机分为两组。试验组的患者每天服用250 mg的特力阿扎维林药物3~4次，对照组患者则服用安慰剂，为期共7 d。主要结局指标为临床改善时间，临床改善时间的定义为随机分组28 d内患者的体温、呼吸频率、血氧饱和度、咳嗽频率和肺CT（计算机断层扫描，computed tomography）所显示的肺部感染吸收情况全部恢复正常的时间。次要结局指标包括主要结局指标的各个组成成分，如肺部感染吸收的平均时间和吸收比例，以及用咽拭子采样法连续2次SARS-CoV-2核酸检测阴性的转阴率。与此同时，记录合并的治疗药物、不良事件和严重不良事件。由于需要进行住院治疗的新增感染病例的减少，本研究在招募52名患者后便停止招募。将52名患者随机分为服用特力阿扎维林药物的试验组（n = 26）和服用安慰剂的对照组（n = 26）。结果显示，两组临床改善时间并无明显差异[中位数，7 d vs. 12 d；风险比（RR）为2.0；95％置信区间（CI）为0.7~5.6；p = 0.2]。服用特力阿扎维林的试验组中有10例患者发生临床改善，服用安慰剂的对照组中有6例患者出现临床改善（38.5％ vs. 23.1％，RR为2.1；95％CI为0.6~7.0；p = 0.2）。除了肺部感染的吸收情况外（试验组50.0％，对照组26.1％），其余主要结局指标的所有指标均在28 d内恢复正常。此外，试验组的患者对呼吸系统、心脏、肾、肝或凝血功能等方面的的合并治疗较对照组少。尽管特力阿扎维林药物对COVID-19患者的疗效尚未达到统计学上的显著性水平，但本研究结果表明，由于特力阿扎维林药物具有抗病毒作用，将其用于COVID-19的治疗也可能具有一定的疗效。对此，需要进一步的研究来予以证明和确认。
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参考文献
[ 1 ] Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020;395 (10223):497–506. 链接1
[ 2 ] Wang T, Du Z, Zhu F, Cao Z, An Y, Gao Y, et al. Comorbidities and multi-organ injuries in the treatment of COVID-19. Lancet 2020;395(10228): e52. 链接1
[ 3 ] Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention. JAMA 2020;323(13):1239–42. 链接1
[ 4 ] National Health Commission of the People’s Republic of China, National Administration of Traditional Chinese Medicine. Diagnosis and treatment protocol for novel coronavirus pneumonia (trial version 7). Chin Med J 2020;133:1087–95.
[ 5 ] Kalil AC. Treating COVID-19-off-label drug use, compassionate use, and randomized clinical trials during pandemics. JAMA 2020;323(19):1897–8. 链接1
[ 6 ] Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, et al. A trial of Lopinavir– Ritonavir in adults hospitalized with severe COVID-19. N Engl J Med 2020;382 (19):1787–99. 链接1
[ 7 ] Karpenko I, Deev S, Kiselev O, Charushin V, Rusinov V, Ulomsky E, et al. Antiviral properties, metabolism, and pharmacokinetics of a novel azolo-1,2,4- triazine-derived inhibitor of influenza A and B virus replication. Antimicrob Agents Chemother 2010;54(5):2017–22. 链接1
[ 8 ] Loginova SI, Borisevich SV, Rusinov VL, Ulomskiĭ UN, Charushin VN, Chupakhin ON. Investigation of Triazavirin antiviral activity against tick-borne encephalitis pathogen in cell culture. Antibiot Khimioter 2014;59(1–2):3–5. Russian. 链接1
[ 9 ] Loginova SY, Borisevich SV, Rusinov VL, Ulomsky UN, Charushin VN, Chupakhin N, et al. Investigation of prophylactic efficacy of Triazavirin against experimental forest-spring encephalitis on albino mice. Antibiot Khimioter 2015;60(5–6):8–11. Russian. 链接1
[10] Kiselev OI, Deeva EG, Mel’nikova TI, Kozeletskaia KN, Kiselev AS, Rusinov VL, et al. A new antiviral drug Triazavirin: results of phase II clinical trial. Vopr Virusol 2012;57(6):9–12. Russian. 链接1
[11] Wu X, Yu K, Wang Y, Xu W, Ma H, Hou Y, et al. The efficacy and safety of Triazavirin for COVID-19: a trial protocol. Engineering 2020;6(10):1199–204. 链接1
[12] National Health Commission of the People’s Republic of China, State Administration of Traditional Chinese Medicine. Diagnosis and treatment protocol for novel coronavirus pneumonia (trial version 7) [Internet]. Beijing: National Health Commission of the People’s Republic of China; [updated 2020 Mar 3; cited 2020 April 20]. Available from: http://www.nhc.gov.cn/xcs/ zhengcwj/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml. Chinese.
[13] Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, et al. Cardiac involvement in a patient with coronavirus disease 2019 (COVID-19). JAMA Cardiol 2020;5(7):819. 链接1
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