目的 综述阿兹夫定(azvudine,FNC)药物作用机制、代谢动力学、有效性、安全性、相互作用及注意事项等内容,为临床用药提供依据。方法 系统检索中国临床试验注册中心、美国临床试验注册中心网站(clinicaltrials.gov)、Pubmed、中国期刊全文数据库(CNKI)、万方数据库中FNC相关文献并综述相关信息。结果 FNC是我国自主研发的小分子新冠肺炎治疗药物,作为一种抑制病毒RNA依赖性RNA聚合酶的核苷类似物,能特异性抑制RNA病毒逆转录和复制过程。临床数据显示,对于轻度、普通患者可以显著缩短患者核酸转阴时间,与对照组相比病毒载量大幅下降以及明显缩短肺炎改善时间;对于中、重度患者,核酸转阴时间、治疗时间等也有显著疗效。结论 该药物具有比较好的安全性和耐受性,为未来新冠肺炎治疗提供参考。
Abstract
OBJECTIVE To summarize the basic information, mechanism of action, pharmacokinetics, efficacy, safety, interactions, and precautions of azvudine, to provide references for its clinical use. METHODS Literatures related to azvudine from the official website of Chinese clinical trial regi stry, clinicaltrials.gov, Pubmed, CNKI and Wanfang were systematically searched and summarized. RESULTS Azvudine is an oral small-molecule corona virus disease(COVID-19) treatment drug independently developed by China. As a nucleoside analogue targeting to viral RNA-dependent RNA polymerases (RdRp), it can inhibit RNA virus reverse transcription process and replication process. The results of phase Ⅲ clinical trials showed that azvudine could significantly shorten the time of nucleic acid conversion in patients with mild to moderate corona virus disease (COVID-19). Compared with the control group, the azvudine group can significantly shorten the improvement time of pneumonia. For moderate and severe patients, azvudine treatment also showed significant therapeutic effects in the time of nucleic acid conversion, discharge, and rehabilitation. CONCLUSION The drug possesses good safety and tolerability in patients, which provide a choice for the clinical treatment of COVID-19.
关键词
阿兹夫定 /
新型冠状病毒肺炎 /
RNA聚合酶 /
严重急性呼吸综合征冠状病毒 2 /
逆转录
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Key words
azvudine /
corona virus disease 2019 (COVID-19) /
RNA polymerase /
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) /
reverse transcription
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中图分类号：
R978.7
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参考文献
[1] Novel Coronavirus-infected Pneumonia Diagnosis and Treatment Protocol (Trial Version 8) [EB/OL]. 2020. http://www.nhc.gov.cn/yzygj/s7653p/202008/0a7bdf12bd4b46e5bd28ca7 f9a7f 5e5a/files/a449a3e2e2c94d9a856d5faea2ff0f94.
[2] WHO. WHO coronavirus(COVID-19) dashboard [EB/OL]. (2022-08-31) [2022-08-31]. https://covid19.who.int/.
[3] VANGEEL L, CHIU W, DEJONGHE S, et al. Remdesivir,molnupiravir and nirmatrelvir remain active against SARS-CoV-2 Omicron and other variants of concern[J]. Antivir Res, 2022,198:105252. Doi:10.1016/j.antiviral.2022.105252.
[4] GOWRISANKAR A, PRIYANKA T, BANERJEE S. Omicron: a mysterious variant of concern[J]. Eur Phys J Plus, 2022, 137(100):4-8. Doi:10.1140/epjp/s13360-021-02321-y.
[5] LIU Y D, XIANG X H, HUANG W J, et al. Results and discussion on national vaccine proficiency testing schemes in 2020[J]. Chin Pharm J(中国药学杂志), 2021, 56(13):1099-1103.
[6] LEVIN E G, LUSTIG Y, COHEN C, et al. Waning immune humoral response to BNT162b2 COVID-19 vaccine over 6 months[J]. N Engl J Med, 2021, 385(24):e84. Doi:10.1056/NEJMoa2114583.
[7] BERGWERK M, GONEN T, LUSTIG Y, et al. COVID-19 break through infections in vaccinated health care workers[J]. N Engl J Med, 2021, 385(16):1474-1484.
[8] WANG H, WANG H L, XIE F. First oral non-covalent, non-peptide severe acute respiratory syndrome coronavirus 2 3CL protease inhibitor: Ensitrelvir [J]. Clin Med J (临床药物治疗杂志), 2022, 20(8):17-21.
[9] ZHANG J L, LI Y H, WANG L L, et al. Azvudine is a thymus-homing anti-SARS-CoV-2 drug effective in treating COVID-19 patients[J]. Signal Transduct Tar, 2021, 6(414):1-15. Doi: 10.1038/s41392-021-00835-6.
[10] YU B, CHANG J B. Azvudine (FNC):a promising clinical candidate for COVID-19 treatment[J]. Signal Transduct Tar, 2020, 5 (236):1-2. Doi: 10.1038/s41392-020-00351-z.
[11] REN Z G, LUO H, YU Z J, et al. A randomized, open-label, controlled clinical trial of Azvudine tablets in the treatment of mild and common COVID-19, a pilot study[J]. Adv Sci, 2020, 7(19):e2001435. Doi:10.1002/advs.202001435.
[12] Henan Real Biological Technology Co., Ltd. Instructions for azvudine tablets[EB/OL]. 2022 [2022-08-12]. https://www.cde.org.cn/main/xxgk/postmarketpage?acceptidCODE=93007324365052ca04d998ec99e4cdaf.
[13] Henan Real Biological Technology Co., Ltd. Stock exchange of Hong Kong limited and the securities and futures commission [EB/OL]. 2022[2022-08-12]. https://www1.hkexnews.hk/app/sehk/2022/104646/documents/sehk22080402058_c.pdf.
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基金
国家重点研发计划项目资助(2020YFC2008300)
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