从瑞德西韦看中国同情用药的前景。
Prospect of compassionate use in China from remdesivir.
机构信息
Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008.
Institute of Hospital Pharmacy, Central South University, Changsha 410008.
出版信息
Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2021 Aug 28;46(8):909-914. doi: 10.11817/j.issn.1672-7347.2021.200255.
Compassionate use may play an important role in responding to major public health emergencies. The Jinyintan Hospital in Wuhan launched the III phase of clinical trials of antiviral drug-remdesivir on February 6, 2020. As an unapproved drug, remdesivir raised great concerns about compassionate use in China. Compassionate use is therapeutic use of unauthorized drugs outside of clinical trials. It is used for critically ill patients with life-threatening diseases and no effective treatment means in China. Patients voluntarily apply to their medical institutions. The Center for Drug Evaluation, National Medical Products Administration shall conduct scientific and reasonable review, approval, and supervision on patients' application for compassionate medication. By analyzing and comparing the current situation of compassionate use at home and abroad, it is expected to provide thinking for the development of compassionate use system in China.
同情用药在应对重大突发公共卫生事件中可能发挥重要作用。2020 年 2 月 6 日，武汉金银潭医院启动了瑞德西韦的 III 期临床试验。作为一种未获批药物，瑞德西韦在中国的同情用药引发了极大关注。同情用药是指在临床试验之外使用未获批准的药物进行治疗。在中国，同情用药适用于患有危及生命的疾病且无有效治疗手段的重症患者。患者自愿向医疗机构提出申请。国家药品监督管理局药品审评中心对患者的同情用药申请进行科学、合理的审评、审批和监管。通过分析和比较国内外同情用药的现状，以期为我国同情用药制度的发展提供思路。
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