新冠病毒治疗药物奈玛特韦片/利托那韦片的作用机制和临床研究情况

Mechanism and Clinical Research Progress of Nirmatrelvir Tablets/Ritonavir Tablets:A New Therapeutic Agent for COVID⁃19

目的分析奈玛特韦片/利托那韦片(Paxlovid^(TM),帕克洛维)的作用机制和临床研究情况,为其合理用药提供参考。方法系统检索美国食品药品监督管理局(FDA)官方网站、Pubmed、Embase、中国期刊全文数据库(CNKI)、中国生物医学文献数据(CBM)、万方数据库(Wanfang)中奈玛特韦片/利托那韦片相关文献,汇总相关的基本信息、作用机制、药动学、药效学、临床疗效评价、安全性、药物相互作用、特殊人群用药等。结果与结论奈玛特韦片/利托那韦片通过作用于SARS⁃CoV⁃2主要蛋白酶,抑制该酶介导的蛋白质前体加工,从而阻止病毒复制。基于目前的试验结果,奈玛特韦片/利托那韦片干预可大大降低轻、中症COVID⁃19成年患者的住院率及病死率。对于该药是否适用于所有COVID⁃19患者的临床治疗,还需要更多研究论证。

OBJECTIVE To review the mechanism and the clinical research progress of nirmatrelvir tablets/ritonavir tablets(Paxlovid^(TM)),so as to provide references for its rational usage.METHODS Literatures related to nirmatrelvir tablets/ritonavir tablets in the official website of US Food and Drug Administration,Pubmed,Embase,CNKI,CBM and Wanfang were systematically searched.The basic information,mechanism of action,pharmacokinetics,pharmacodynamics,clinical efficacy evaluation,safety,drug interaction,drug use in special populations were reviewed.RESULTS AND CONCLUSIONS Nirmatrelvir tablets/ritonavir tablets inhibit the replication of SARS⁃COV⁃2 virus by inhibiting the processing of SARS⁃CoV⁃2 protein precursor mediated by the main protease.Based on current trial results,nirmatrelvir tablets/ritonavir tablets can significantly reduce hospitalization and mortality rates in adult patients with mild and moderate COVID⁃19.More research is required to determine whether the drug is appropriate for the clinical treatment of all COVID⁃19 patients.