Safety and efficacy of peramivir for influenza treatment.
Safety and efficacy of peramivir for influenza treatment.
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DOI：
10.2147/dddt.s46654
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发表时间：
2014
期刊：
影响因子：
--
通讯作者：
Matsumura T
中科院分区：
文献类型：
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作者：
Hata A;Akashi-Ueda R;Takamatsu K;Matsumura T
本报告对帕拉米韦的疗效和安全性进行了综述，帕拉米韦是一种神经氨酸酶抑制剂，在2009年H1N1流感大流行期间于2009年10月23日至2010年6月23日获得美国食品药品监督管理局（FDA）的紧急使用授权。通过PubMed（2000年1月至2014年4月）使用以下检索词访问文献：帕拉米韦; BCX-1812; RWJ 270201; H1N1，流感;抗病毒药;和神经氨酸酶抑制剂。与帕拉米韦生产商Shionogi and Co Ltd和BioCryst Pharmaceuticals进行了联系，以获得在最近的科学会议上提交的未发表数据和信息。信息来自疾病控制和预防中心（CDC）和美国FDA网站。对文献中的英语和日语报告进行了审查，并根据相关性以及来自CDC、US FDA和药品生产商的信息进行了沿着选择。我们获得了11份静脉注射帕拉米韦的临床试验报告，其中两份描述了与奥司他韦的比较。最近发表的其他9项研究中有7项是剂量反应研究。感染H1N1流感大流行的重症患者和儿科患者的临床报告显示，早期治疗可显著降低死亡率。与安慰剂相比，成人流感患者每日一次给予帕拉米韦300 mg显著缩短了症状或发热缓解的时间。它可能与其他神经氨酸酶抑制剂一样有效。尽管帕拉米韦显示出治疗季节性和pH 1 N1流感的疗效，但尚未获得美国FDA的批准。帕拉米韦可安全有效地用于疑似或实验室确诊流感的住院成人和儿童患者。帕拉米韦可能是一种有益的替代抗病毒治疗许多患者，包括那些无法接受吸入或口服神经氨酸酶抑制剂，或那些需要非静脉给药。
This report presents a review of the efficacy and safety of peramivir, a neuraminidase inhibitor that was granted Emergency Use Authorization by the US Food and Drug Administration (FDA) from October 23, 2009 to June 23, 2010 during the 2009 H1N1 pandemic. Literature was accessed via PubMed (January 2000–April 2014) using several search terms: peramivir; BCX-1812; RWJ 270201; H1N1, influenza; antivirals; and neuraminidase inhibitors. The peramivir manufacturers, Shionogi and Co Ltd and BioCryst Pharmaceuticals, were contacted to obtain unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and from US FDA websites. English-language and Japanese-language reports in the literature were reviewed and selected based on relevance, along with information from the CDC, US FDA, and the drug manufacturers. We obtained eleven clinical trial reports of intravenous peramivir, two of which described comparisons with oseltamivir. Seven of nine other recently reported published studies was a dose–response study. Clinical reports of critically ill patients and pediatric patients infected with pandemic H1N1 described that early treatment significantly decreased mortality. Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo. It is likely to be as effective as other neuraminidase inhibitors. Although peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, it has not received US FDA approval. Peramivir is used safely and efficiently in hospitalized adult and pediatric patients with suspected or laboratory-confirmed influenza. Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery.