Treanor J J, Hayden F G, Vrooman P S, Barbarash R, Bettis R, Riff D, Singh S, Kinnersley N, Ward P, Mills R G
Infectious Diseases Unit, University of Rochester, NY 14642, USA.
JAMA. 2000 Feb 23;283(8):1016-24. doi: 10.1001/jama.283.8.1016.
Previous studies have shown oseltamivir, a neuraminidase inhibitor, to be effective in preventing influenza and treating experimental influenza.
To evaluate the efficacy and safety of oseltamivir in the treatment of naturally acquired influenza infection.
Randomized, placebo-controlled, double-blind study conducted January through March 1998.
Sixty primary care and university health centers throughout the United States.
A total of 629 healthy nonimmunized adults aged 18 to 65 years with febrile respiratory illness of no more than 36 hours' duration with temperature of 38 degrees C or more plus at least 1 respiratory symptom and 1 constitutional symptom.
Individuals were randomized to 1 of 3 treatment groups with identical appearing pills: oral oseltamivir phosphate, 75 mg twice daily (n = 211) or 150 mg (n = 209) twice daily, or placebo (n = 209).
Duration and severity of illness in individuals infected with influenza.
Two individuals withdrew before receiving medication and were excluded from further analyses. A total of 374 individuals (59.6%) were infected with influenza. Their duration of illness was reduced by more than 30% with both oseltamivir, 75 mg twice daily (median, 71.5 hours; P < .001), and oseltamivir, 150 mg twice daily (median, 69.9 hours; P = .006), compared with placebo (median, 103.3 hours). Severity of illness was reduced by 38% (median score, 597 score-hours; P < .001) with oseltamivir, 75 mg twice daily, and by 35% (median score, 626 score-hours; P < .001) with oseltamivir, 150 mg twice daily, vs placebo (median score, 963 score-hours). Oseltamivir treatment reduced the duration of fever and oseltamivir recipients returned to usual activities 2 to 3 days earlier than placebo recipients (P < or = .05). Secondary complications such as bronchitis and sinusitis occurred in 15% of placebo recipients compared with 7% of combined oseltamivir recipients (P = .03). Among all 629 subjects, oseltamivir reduced illness duration (76.3 hours and 74.3 hours for 75 mg and 150 mg, respectively, vs 97.0 hours for placebo; P = .004 for both comparisons) and illness severity (686 score-hours and 629 score-hours for 75 mg and 150 mg, respectively, vs 887 score-hours for placebo; P < .001 for both comparisons). Nausea and vomiting occurred more frequently in both oseltamivir groups (combined, 18.0% and 14.1%, respectively; P = .002) than in the placebo group (7.4% and 3.4%; P < .001).
Our data suggest that oral oseltamivir treatment reduces the duration and severity of acute influenza in healthy adults and may decrease the incidence of secondary complications.
先前的研究表明，神经氨酸酶抑制剂奥司他韦在预防流感和治疗实验性流感方面有效。
评估奥司他韦治疗自然获得性流感感染的疗效和安全性。
1998年1月至3月进行的随机、安慰剂对照、双盲研究。
美国各地的60个初级保健和大学健康中心。
共有629名18至65岁健康、未接种疫苗的成年人，患有发热性呼吸道疾病，病程不超过36小时，体温38摄氏度或更高，伴有至少1种呼吸道症状和1种全身症状。
将个体随机分为3个治疗组之一，服用外观相同的药丸：口服磷酸奥司他韦，75毫克，每日2次（n = 211）或150毫克（n = 209），每日2次，或安慰剂（n = 209）。
感染流感个体的疾病持续时间和严重程度。
2名个体在接受药物治疗前退出，被排除在进一步分析之外。共有374名个体（59.6%）感染了流感。与安慰剂组（中位数为103.3小时）相比，每日2次服用75毫克奥司他韦（中位数为71.5小时；P <.001）和每日2次服用150毫克奥司他韦（中位数为69.9小时；P =.006），他们的疾病持续时间缩短了30%以上。每日2次服用75毫克奥司他韦，疾病严重程度降低了38%（中位数得分597分-小时；P <.001），每日2次服用150毫克奥司他韦，疾病严重程度降低了35%（中位数得分626分-小时；P <.001），而安慰剂组（中位数得分963分-小时）。奥司他韦治疗缩短了发热持续时间，服用奥司他韦的患者比服用安慰剂的患者提前2至3天恢复正常活动（P≤.05）。15%的安慰剂接受者出现了如支气管炎和鼻窦炎等继发性并发症，而联合使用奥司他韦的接受者中这一比例为7%（P =.03）。在所有629名受试者中，奥司他韦缩短了疾病持续时间（75毫克组和150毫克组分别为76.3小时和74.3小时，而安慰剂组为97.0小时；两组比较P =.004）和疾病严重程度（75毫克组和150毫克组分别为686分-小时和629分-小时，而安慰剂组为887分-小时；两组比较P <.001）。与安慰剂组（7.4%和3.4%；P <.001）相比，两个奥司他韦组中恶心和呕吐的发生率更高（分别为18.0%和14.1%；P =.002）。
我们的数据表明，口服奥司他韦治疗可缩短健康成年人急性流感的持续时间和严重程度，并可能降低继发性并发症的发生率。
