'NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution Or Pain'
'NIH Study Finds Tecovirimat Was Safe but Did Not Improve Mpox Resolution Or Pain'
Study Examined Tecovirimat in Countries Affected by Global Clade II Mpox Outbreak
研究考察了全球货币克莱德 II 型猴痘疫情影响的国家中的 Tecovirimat。
The antiviral drug tecovirimat did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). There were no safety concerns associated with tecovirimat.
根据名为猴痘的 Tecovirimat 研究（STOMP）的国际临床试验的中期数据分析，抗病毒药物 Tecovirimat 并未缩短病变愈合时间，也未在轻至中度克莱德 II 型猴痘且发展严重疾病风险低的成年人中对疼痛产生影响。Tecovirimat 不存在安全隐患。
Considering these definitive findings, the study's Data Safety and Monitoring Board (DSMB) recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. As the study sponsor, the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) accepted the DSMB's recommendation. Given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug's efficacy.
考虑到这些明确的发现，研究的数据安全监测委员会（DSMB）建议停止进一步招募随机分配到 Tecovirimat 或安慰剂的参与者。作为研究的赞助方，美国国立卫生院（NIH）的国立过敏和传染病研究院（NIAID）接受了 DSMB 的建议。鉴于缺乏疗效信号，NIAID 还关闭了对未设计估计药物疗效的、针对有或处于严重疾病高风险参与者的开放标签研究组的招募。
