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静脉滴注帕拉米韦对比口服奥司他韦治疗流感高危急诊科患者:一项先导随机对照研究结果。

Intravenous peramivir vs oral oseltamivir in high-risk emergency department patients with influenza: Results from a pilot randomized controlled study.

机构信息

Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Department of Emergency Medicine, University of Arizona College of Medicine, Phoenix, Arizona, USA.

出版信息

Influenza Other Respir Viruses. 2021 Jan;15(1):121-131. doi: 10.1111/irv.12794. Epub 2020 Oct 2.

Abstract

BACKGROUND

Peramivir offers a single-dose intravenous (IV) treatment option for influenza (vs 5-day oral dosing for oseltamivir). We sought to compare outcomes of emergency department (ED) patients at high risk for influenza complications treated with IV peramivir vs oral oseltamivir.

METHODS

During the 2015-16 and 2016-17 influenza seasons, adult patients in two US EDs were randomized to either oral oseltamivir or IV peramivir treatment group. Eligibility included positive molecular influenza test; met CDC criteria for antiviral treatment; able to provide informed consent and agree to follow-up assessment. Outcomes were measured by clinical end-point indicators, including FLU-PRO Score, Ordinal Scale, Patient Global Impression on Severity Score, and Karnofsky Performance Scale for 14 days. Non-inferior t test was performed to assess comparative outcomes between the two groups.

RESULTS

Five hundred and seventy-five (68%) of 847 influenza-positive patients were approached. Two hundred and eighty-four met enrollment criteria and 179 were enrolled; of these 95 (53%) were randomized to peramivir, and 84 to oseltamivir. Average FLU-PRO score at baseline was similar (peramivir: 2.67 vs oseltamivir: 2.52); the score decreased over time for both groups (day 5: peramivir: 1.71 vs oseltamivir: 1.62; day 10: peramivir: 1.48 vs oseltamivir: 1.37; day 14: peramivir: 1.40 vs oseltamivir: 1.33; all P < .05 for significantly non-inferior). Influenza-related complications were similar between two groups (All: peramivir: 31% vs oseltamivir: 21%, P > .05; pneumonia: peramivir: 11% vs oseltamivir: 14%, P > .05).

CONCLUSIONS

Clinical outcomes of influenza-infected patients treated with single-dose IV peramivir were comparable to those treated with oral oseltamivir, suggesting potential utility of peramivir for influenza-infected patients in the ED.

摘要

背景

帕拉米韦为流感提供了一种单剂量静脉(IV)治疗选择(而奥司他韦为 5 天口服剂量)。我们旨在比较接受 IV 帕拉米韦和口服奥司他韦治疗的流感高危急诊科(ED)患者的结局。

方法

在 2015-16 和 2016-17 流感季节,美国两家 ED 的成年患者被随机分配至口服奥司他韦或 IV 帕拉米韦治疗组。入选标准包括分子流感检测阳性;符合 CDC 抗病毒治疗标准;能够提供知情同意并同意进行随访评估。通过临床终点指标(包括 FLU-PRO 评分、有序量表、患者对严重程度的总体印象评分和卡诺夫斯基表现量表)评估 14 天的结局。采用非劣效 t 检验评估两组的比较结局。

结果

847 例流感阳性患者中,575 例(68%)接受了评估。284 例符合入组标准并纳入研究,其中 179 例入组;95 例(53%)被随机分配至帕拉米韦组,84 例至奥司他韦组。基线时平均 FLU-PRO 评分相似(帕拉米韦:2.67 vs 奥司他韦:2.52);两组的评分随时间下降(第 5 天:帕拉米韦:1.71 vs 奥司他韦:1.62;第 10 天:帕拉米韦:1.48 vs 奥司他韦:1.37;第 14 天:帕拉米韦:1.40 vs 奥司他韦:1.33;所有 P<.05 均为非劣效)。两组流感相关并发症相似(全部:帕拉米韦:31% vs 奥司他韦:21%,P>.05;肺炎:帕拉米韦:11% vs 奥司他韦:14%,P>.05)。

结论

接受单剂量 IV 帕拉米韦治疗的流感感染患者的临床结局与接受口服奥司他韦治疗的患者相当,提示帕拉米韦在 ED 中对流感感染患者具有潜在效用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d18a/7767951/19cee12c58ba/IRV-15-121-g001.jpg

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