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'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'

'NIH研究發現, Tecovirimat是安全的,但並沒有改善Mpox的恢復或疼痛。'
Benzinga ·  2024/12/11 03:38

Study Examined Tecovirimat in Countries Affected by Global Clade II Mpox Outbreak

研究考察了全球貨幣克萊德 II 型猴痘疫情影響的國家中的 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.

根據名爲猴痘的 Tecovirimat 研究(STOMP)的國際臨床試驗的中期數據分析,抗病毒藥物 Tecovirimat 並未縮短病變癒合時間,也未在輕至中度克萊德 II 型猴痘且發展嚴重疾病風險低的成年人中對疼痛產生影響。Tecovirimat 不存在安全隱患。

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.

考慮到這些明確的發現,研究的數據安全監測委員會(DSMB)建議停止進一步招募隨機分配到 Tecovirimat 或安慰劑的參與者。作爲研究的贊助方,美國國立衛生院(NIH)的國立過敏和傳染病研究院(NIAID)接受了 DSMB 的建議。鑑於缺乏療效信號,NIAID 還關閉了對未設計估計藥物療效的、針對有或處於嚴重疾病高風險參與者的開放標籤研究組的招募。

譯文內容由第三人軟體翻譯。


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