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雾化吸入利巴韦林治疗流感住院幼儿的疗效与安全性:一项双盲、多中心、安慰剂对照试验

Efficacy and safety of aerosolized ribavirin in young children hospitalized with influenza: a double-blind, multicenter, placebo-controlled trial.

作者信息

Rodriguez W J, Hall C B, Welliver R, Simoes E A, Ryan M E, Stutman H, Johnson G, Van Dyke R, Groothuis J R, Arrobio J

机构信息

George Washington University School of Medicine Department of Pediatrics, Children's National Medical Center, Washington, D.C. 20010-2970.

出版信息

J Pediatr. 1994 Jul;125(1):129-35. doi: 10.1016/s0022-3476(94)70139-3.

DOI:10.1016/s0022-3476(94)70139-3
PMID:8021762
Abstract

We randomly assigned children hospitalized with influenza who had been ill < or = 48 hours and who had a temperature > or = 37.8 degrees C to receive either ribavirin or placebo. All patients had evaluations performed for fever reduction, use of acetaminophen for temperature > or = 38.3 degrees C, duration and severity of influenza symptoms, and feeding behavior. Sixty-two patients (35 in the placebo group, 27 in the ribavirin group) had a diagnosis of influenza confirmed by laboratory study. The groups did not differ significantly in age, initial signs and symptoms, or in distribution of influenza A or B infections. The time to reduction of temperature < or = 38.3 degrees C for the ribavirin group was 8.9 hours compared with 22.6 hours for the placebo group (p = 0.04). The mean duration of acetaminophen use was 7.4 hours in the ribavirin group and 16.3 hours in the placebo group (p = 0.14). There were no significant differences between the groups in outcome of respiratory rate, pulse rate, cough, or level of consciousness. Convalescent influenza antibody geometric mean titer for the placebo group was 9.8 compared with 3.6 for the ribavirin group (p = 0.04). Ribavirin was more effective than placebo in accelerating normalization of temperature but there were no other significant differences.

摘要

我们将发病时间小于或等于48小时且体温大于或等于37.8摄氏度的流感住院儿童随机分配,分别给予利巴韦林或安慰剂。所有患者均接受了退热评估、体温大于或等于38.3摄氏度时对乙酰氨基酚的使用情况、流感症状的持续时间和严重程度以及进食行为的评估。62名患者(安慰剂组35名,利巴韦林组27名)经实验室检查确诊为流感。两组在年龄、初始体征和症状,或甲型或乙型流感感染分布方面无显著差异。利巴韦林组体温降至小于或等于38.3摄氏度的时间为8.9小时,而安慰剂组为22.6小时(p = 0.04)。利巴韦林组对乙酰氨基酚的平均使用时长为7.4小时,安慰剂组为16.3小时(p = 0.14)。两组在呼吸频率、脉搏率、咳嗽或意识水平的结果方面无显著差异。安慰剂组恢复期流感抗体几何平均滴度为9.8,而利巴韦林组为3.6(p = 0.04)。在加速体温恢复正常方面,利巴韦林比安慰剂更有效,但无其他显著差异。

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