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一种新的奥司他韦(Enfluvir®)生物等效配方对 2010-2011 季节性流感病毒的有效性:一项开放的 IV 期研究。

Effectiveness of a new bioequivalent formulation of oseltamivir (Enfluvir®) on 2010-2011 seasonal influenza viruses: an open phase IV study.

机构信息

Department of Pediatrics, Pediatric Infectious Disease Unit, Faculty of Medicine, Hacettepe University, Ankara, Turkey.

出版信息

Int J Infect Dis. 2012 Apr;16(4):e273-8. doi: 10.1016/j.ijid.2011.12.008. Epub 2012 Feb 5.

DOI:10.1016/j.ijid.2011.12.008
PMID:22310296
Abstract

OBJECTIVE

The aim of this multicenter prospective study was to evaluate the efficacy of a new bioequivalent formulation of oseltamivir for the treatment of influenza A, influenza B, and H1N1 during the 2010-2011 influenza season.

METHODS

We compared the symptoms and signs of 300 pediatric patients presenting to three university hospitals with an influenza-like illness between January and March 2011. Nasal swab specimens were collected from all children and tested by reverse-transcription polymerase chain reaction (RT-PCR) for influenza viruses. After randomization, half of the participants were prescribed oseltamivir, while the other half were observed conservatively. Forty patients who were followed-up for influenza prior to the study were also included in the evaluation.

RESULTS

Influenza was confirmed by RT-PCR in 129 children, 71 of whom were prescribed oseltamivir. The durations of the symptoms fever, cough, nasal congestion, and rhinorrhea were significantly shorter for patients who were treated with oseltamivir compared with untreated patients (p<0.002 for all symptoms). Early initiation of oseltamivir therapy (within 48 h of the onset of symptoms) was associated with more favorable outcomes and an earlier recovery than in patients for whom treatment was delayed (beyond 48 h). Thirty-seven patients (28.7%) had H1N1, 44 (34.1%) had influenza A, 46 (35.7%) had influenza B, one (0.8%) had H1N1 plus influenza A, and one (0.8%) had influenza A plus influenza B viruses. In the comparison of the duration of symptoms according to the different virus types, a statistically significant difference was only observed in patients with influenza B who had a longer duration of cough (p<0.001), nasal congestion (p<0.001), and rhinorrhea (p<0.001).

CONCLUSIONS

Oseltamivir is an effective treatment for the management of seasonal influenza and H1N1, and should be initiated immediately without waiting for laboratory confirmation of diagnosis.

摘要

目的

本多中心前瞻性研究旨在评估新奥司他韦生物等效制剂治疗 2010-2011 年流感季节甲型流感、乙型流感和 H1N1 流感的疗效。

方法

我们比较了 2011 年 1 月至 3 月期间三家大学医院 300 名流感样疾病患儿的症状和体征。所有儿童均采集鼻拭子标本,采用逆转录聚合酶链反应(RT-PCR)检测流感病毒。随机分组后,一半患儿给予奥司他韦治疗,另一半患儿给予保守治疗。在研究前对 40 例流感患儿进行了随访评估。

结果

129 例患儿经 RT-PCR 证实为流感,其中 71 例患儿给予奥司他韦治疗。与未治疗组相比,奥司他韦治疗组患儿发热、咳嗽、鼻塞和流涕的症状持续时间明显缩短(所有症状 p<0.002)。奥司他韦治疗开始时间(症状出现后 48 小时内)较晚(超过 48 小时)与治疗效果更差及恢复时间更长相关。37 例(28.7%)患儿为 H1N1,44 例(34.1%)为甲型流感,46 例(35.7%)为乙型流感,1 例(0.8%)为 H1N1 合并甲型流感,1 例(0.8%)为甲型流感合并乙型流感。根据不同病毒类型比较症状持续时间,仅在乙型流感患儿中观察到咳嗽(p<0.001)、鼻塞(p<0.001)和流涕(p<0.001)的持续时间存在统计学差异。

结论

奥司他韦是治疗季节性流感和 H1N1 的有效药物,应在等待实验室确诊前立即开始使用。

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