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奥司他韦(达菲)及其在流感大流行时的使用潜力。

Oseltamivir (Tamiflu) and its potential for use in the event of an influenza pandemic.

作者信息

Ward Penelope, Small Ian, Smith James, Suter Pia, Dutkowski Regina

机构信息

Roche Products Ltd., Welwyn Garden City, Herts, UK.

出版信息

J Antimicrob Chemother. 2005 Feb;55 Suppl 1:i5-i21. doi: 10.1093/jac/dki018.

Abstract

Recent cross species transmission of avian influenza has highlighted the threat of pandemic influenza. Oseltamivir (Tamiflu) has been shown to be effective in the treatment and prevention of epidemic influenza infection in adults, adolescents and children (> or = 1 year). Although oseltamivir has not been approved for prophylactic use in children, it has been shown to be effective. Oseltamivir is also active against avian influenza virus strains. Evidence suggests that lower doses or shorter durations of treatment/chemoprophylaxis other than those approved may not be effective and may contribute to emergence of viral resistance. Safety data from dose ranging studies show that 5 day courses of 150 mg twice daily for treatment and 6 week courses of 75 mg twice daily for prophylaxis were as well tolerated as the approved dose regimens. The use of oseltamivir in a pandemic is influenced by the goals of the pandemic plan developed by the responsible Government and Health Authority. To optimize use of antiviral medications, processes will be needed to collect, collate and report outcome data from treated patients and/or from use for chemoprophylaxis of pandemic influenza during the first-wave outbreaks. If oseltamivir is included in a national or regional pandemic plan, stockpiling of the material, either in the form of capsules or the bulk active pharmaceutical ingredient will be necessary. In the absence of a stockpile, there is no guarantee that an adequate supply of oseltamivir will be available.

摘要

近期禽流感的跨物种传播凸显了流感大流行的威胁。已证明奥司他韦(达菲)在治疗和预防成人、青少年及儿童(≥1岁)的流行性感冒感染方面有效。尽管奥司他韦尚未获批用于儿童预防,但已证明其有效。奥司他韦对禽流感病毒株也有活性。有证据表明,低于获批剂量或缩短治疗/化学预防疗程可能无效,且可能导致病毒耐药性的出现。剂量范围研究的安全性数据显示,治疗用150毫克每日两次、疗程5天,预防用75毫克每日两次、疗程6周,与获批剂量方案的耐受性相当。在大流行期间使用奥司他韦受负责的政府和卫生当局制定的大流行计划目标影响。为优化抗病毒药物的使用,需要收集、整理和报告首批疫情期间治疗患者和/或用于流感大流行化学预防的结果数据。如果奥司他韦被纳入国家或地区大流行计划,以胶囊或原料药形式储备该药物将是必要的。若无储备,无法保证有足够的奥司他韦供应。

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