2019冠狀病毒病藥物研發

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2019冠狀病毒病藥物研發是指人們开发2019冠狀病毒病處方藥的过程,目的是治療2019冠狀病毒病的患者,減輕患者痛苦。從2020年初到2021年,几百家製藥公司生物技術公司、大學研究小組、和衛生組織在臨床前或臨床研究的各個階段開發COVID-19疾病的候選治療藥物(2021年4月共有506個候選藥物),截至2021年4月 ,有419個候選藥物正在進行臨床試驗[1]

早在2020年3月,世界衛生組織 (WHO)[2]歐洲藥品管理局 (EMA)[3]美國食品藥品監督管理局 (FDA)[4] 、 以及中國政府和藥品製造商[5][6] 正在與學術和行業研究人員協調,以加快疫苗、抗病毒藥物、和感染後療法的開發[7][8][9][10]世界衛生組織國際臨床試驗註冊平台英语International Clinical Trials Registry Platform(ICTRP)已经記錄了536項臨床研究,以開發針對 COVID-19 感染的感染後療法[11][12], 許多已確定的抗病毒化合物用於治療臨床研究中的其他感染,將被重新利用英语COVID-19 drug repurposing research[7][13][14][15]

2019冠状病毒病药物研发的方式主要有两种:一种是药物再利用研究英语COVID-19 drug repurposing research,即考察已被批准用于治疗其他疾病的药物,研究是否可用于治疗2019冠状病毒病。通过这一途径开发的比较有代表性的药物有瑞德西韦地塞米松。另一策略是针对新冠病毒感染机制及感染后症状开发全新的新药。用这种方法已经开发出的新药,包括Paxlovid莫納皮拉韋沙利姆單抗英语SotrovimabBebtelovimab英语BebtelovimabEvusheld抗体组合英语Tixagevimab/cilgavimab

目前经由临床试验证明有较明确疗效的新冠药物,主要分两大类:一类是以沙利姆单抗、Bebtelovimab、Evusheld等为代表,通过生物技术开发出的抗体类生物大分子药物;另一类为小分子药物,如地塞米松、帕克斯洛維德及莫納皮拉韋。

藥物開發是一個多步驟的過程,通常需要五年以上的時間才能確保新化合物的安全性和有效性[16] 。 一些國家監管機構,如歐洲藥品管理局 (EMA)和美國食品藥品監督管理局 (FDA),批准了加快臨床試驗的程序[4][17]。 到2021年6月,數十種潛在的感染後療法已進入人體試驗的最後階段 – III-IV 期臨床試驗[18]。根據最近的杰富瑞集團有限公司估計,一種有效、方便的COVID-19治療方法的年銷售額可能超過$100億美元[19]

參見

参考文献

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