Nagata Takashi, Lefor Alan K, Hasegawa Manabu, Ishii Masami
1Japan Medical Association Research Institute,Bunkyo-ku,Tokyo,Japan.
2Department of Surgery,Jichi Medical School,Shimotsuke,Japan.
Disaster Med Public Health Prep. 2015 Feb;9(1):79-81. doi: 10.1017/dmp.2014.151. Epub 2014 Dec 29.
The purpose of this report is to advocate speedy approval and less stringent regulations for the use of experimental drugs such as favipiravir in emergencies. Favipiravir is a new antiviral medication that can be used in emerging viral pandemics such as Ebola virus, 2009 pandemic influenza H1N1 virus, Lassa fever, and Argentine hemorrhagic fever. Although favipiravir is one of the choices for the treatment of patients with Ebola virus, several concerns exist. First, a clinical trial of favipiravir in patients infected with the Ebola virus has not yet been conducted, and further studies are required. Second, favipiravir has a risk for teratogenicity and embryotoxicity. Therefore, the Ministry of Health, Welfare and Labor of Japan has approved this medication with strict regulations for its production and clinical use. However, owing to the emerging Ebola virus epidemic in West Africa, on August 15, 2014, the Minister of Health, Welfare and Labor of Japan approved the use of favipiravir, if needed.
本报告的目的是倡导在紧急情况下迅速批准并放宽对法匹拉韦等实验性药物使用的监管。法匹拉韦是一种新型抗病毒药物，可用于应对诸如埃博拉病毒、2009年甲型H1N1大流行性流感病毒、拉沙热和阿根廷出血热等新出现的病毒性大流行。尽管法匹拉韦是治疗埃博拉病毒患者的选择之一，但仍存在一些问题。首先，尚未对感染埃博拉病毒的患者进行法匹拉韦的临床试验，还需要进一步研究。其次，法匹拉韦有致畸性和胚胎毒性风险。因此，日本厚生劳动省已对该药物的生产和临床使用制定严格规定后予以批准。然而，由于西非出现埃博拉病毒疫情，2014年8月15日，日本厚生劳动大臣批准在必要时使用法匹拉韦。
