Whitley R J, Hayden F G, Reisinger K S, Young N, Dutkowski R, Ipe D, Mills R G, Ward P
University of Alabama, Birmingham, USA.
Pediatr Infect Dis J. 2001 Feb;20(2):127-33. doi: 10.1097/00006454-200102000-00002.
Oral oseltamivir administration is effective treatment for influenza in adults. This study was conducted to determine the efficacy, safety and tolerability of oseltamivir in children with influenza.
In this randomized, double blind, placebo-controlled study, children 1 through 12 years with fever [> or =100 degrees F (> or =38 degrees C)] and a history of cough or coryza <48 h duration received oseltamivir 2 mg/kg/dose or placebo twice daily for 5 days. The primary efficacy endpoint was the time to resolution of illness including mild/absent cough and coryza mild/absent, return to normal activity and euthermia.
Of 695 enrolled children 452 (65%) had influenza (placebo, n = 235; oseltamivir, n = 217). Among infected children the median duration of illness was reduced by 36 h (26%) in oseltamivir compared with placebo recipients (101 h; 95% confidence interval, 89 to 118 vs. 137 h; 95% confidence interval, 125 to 150; P < 0.0001). Oseltamivir treatment also reduced cough, coryza and duration of fever. New diagnoses of otitis media were reduced by 44% (12% vs. 21%). The incidence of physician-prescribed antibiotics was significantly lower in influenza-infected oseltamivir (68 of 217, 31%) than placebo (97 of 235, 41%; P = 0.03) recipients. Oseltamivir therapy was generally well-tolerated, although associated with an excess frequency of emesis (5.8%). Discontinuation because of adverse events was low in both groups (1.8% with oseltamivir vs. 1.1% with placebo). Oseltamivir treatment did not affect the influenza-specific antibody response.
Oral oseltamivir administration is an efficacious and well-tolerated therapy for influenza in children when given within 48 h of onset of illness.
口服奥司他韦对成人流感是有效的治疗方法。本研究旨在确定奥司他韦对儿童流感的疗效、安全性和耐受性。
在这项随机、双盲、安慰剂对照研究中，1至12岁发热[≥100华氏度（≥38摄氏度）]且咳嗽或鼻塞病史<48小时的儿童，接受奥司他韦2毫克/千克/剂量或安慰剂，每日两次，共5天。主要疗效终点是疾病缓解时间，包括轻度/无咳嗽和轻度/无鼻塞、恢复正常活动及体温正常。
695名入组儿童中，452名（65%）患有流感（安慰剂组，n = 235；奥司他韦组，n = 217）。在感染儿童中，与接受安慰剂的儿童相比，奥司他韦治疗使疾病的中位持续时间缩短了36小时（26%）（101小时；95%置信区间，89至118小时 vs. 137小时；95%置信区间，125至150小时；P < 0.0001）。奥司他韦治疗还减少了咳嗽、鼻塞和发热持续时间。中耳炎的新诊断病例减少了44%（12% vs. 21%）。在感染流感的儿童中，接受奥司他韦治疗的患者（217名中的68名，31%）医生开具抗生素的发生率显著低于接受安慰剂的患者（235名中的97名，41%；P = 0.03）。奥司他韦治疗一般耐受性良好，尽管呕吐发生率较高（5.8%）。两组因不良事件停药的比例都较低（奥司他韦组为1.8%，安慰剂组为1.1%）。奥司他韦治疗不影响流感特异性抗体反应。
在疾病发作48小时内给予口服奥司他韦，对儿童流感是一种有效且耐受性良好的治疗方法。
