Use of the selective oral neuraminidase inhibitor oseltamivir to prevent influenza
Use of the selective oral neuraminidase inhibitor oseltamivir to prevent influenza
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DOI：
10.1056/nejm199910283411802
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发表时间：
1999-10-28
影响因子：
158.5
通讯作者：
Mills, RG
中科院分区：
文献类型：
--
作者：
Hayden, FG;Atmar, RL;Mills, RG
背景 需要安全有效的抗病毒药物来预防甲型和乙型流感病毒感染。奥司他韦 (GS4104) 可口服给药，是 GS4071 的前药，GS4071 是流感病毒神经氨酸酶的有效选择性抑制剂。我们于 1997 年至 1998 年冬季在美国不同地点进行了两项安慰剂对照、双盲试验，研究了奥司他韦用于长期预防流感的情况。方法我们随机分配 1559 名 18 至 65 岁健康、未免疫成年人接受口服奥司他韦（75 毫克，每日一次或两次，每日总剂量为 75 或 150 毫克）或安慰剂治疗在当地流感病毒活动高峰期持续六周。与疗效相关的主要终点是实验室确认的流感样疾病（定义为至少 37.2 摄氏度的体温，并伴有至少一种呼吸道症状和至少一种全身症状）。 结果 在两项综合研究中，每日一次或每日两次奥司他韦组受试者的流感风险（分别为 1.2% 和 1.3%）低于安慰剂组受试者（4.8%；P）
Background Safe and effective antiviral agents are needed to prevent infection with influenza A and B viruses. Oseltamivir (GS4104), which can be administered orally, is the prodrug of GS4071, a potent and selective inhibitor of influenzavirus neuraminidases. We studied the use of oseltamivir for longterm prophylaxis against influenza in two placebo-controlled, double-blind trials at different U.S. sites during the winter of 1997-1998.Methods We randomly assigned 1559 healthy, nonimmunized adults 18 to 65 years old to receive either oral oseltamivir (75 mg given once or twice daily, for a total daily dose of 75 or 150 mg) or placebo for six weeks during a peak period of local influenzavirus activity. The primary end point with respect to efficacy was laboratory-confirmed influenza-like illness (defined as a temperature of at least 37.2 degrees C accompanied by at least one respiratory and at least one systemic symptom).Results In the two studies combined, the risk of influenza among subjects assigned to either once-daily or twice-daily oseltamivir (1.2 percent and 1.3 percent, respectively) was lower than that among subjects assigned to placebo (4.8 percent; P