帕拉米韦对流感病毒感染合并慢性呼吸道疾病患者呼吸道症状改善的影响：一项随机、开放标签研究的结果。
Effect of peramivir on respiratory symptom improvement in patients with influenza virus infection and pre-existing chronic respiratory disease: Findings of a randomized, open-label study.
机构信息
Chest Disease Clinical and Research Institute, Kishiwada City Hospital, Osaka, Japan.
Shionogi & Co., Ltd., Osaka, Japan.
出版信息
Influenza Other Respir Viruses. 2021 Jan;15(1):132-141. doi: 10.1111/irv.12788. Epub 2020 Jul 17.
BACKGROUND
The efficacy of neuraminidase inhibitors on improvement of respiratory symptoms triggered by influenza in patients with pre-existing chronic respiratory diseases is unknown.
METHODS
This 2-week, randomized, open-label study evaluated intravenous peramivir 600 mg on two consecutive days (peramivir-repeat), peramivir 300 mg single dose (peramivir-single), and oral oseltamivir 75 mg twice daily for 5 days in patients with confirmed influenza and chronic respiratory diseases. Patients recorded symptom scores daily. The primary endpoint of cumulative area of time vs symptoms (CATVS) was expressed as an index value of area under the curve vs time of the total score of cough, sore throat, and nasal congestion from baseline to 2 weeks.
RESULTS
Of 214 randomized patients, 209 (56% female, 77% aged <65 years, 94% outpatients, 91% bronchial asthma, 62% influenza A) received ≥1 dose of study drug. Mean (standard deviation) CATVS was similar for peramivir-repeat (782.78 [487.17]) vs peramivir-single (717.35 [347.55]; P = .4371), and for peramivir-repeat vs oseltamivir (856.34 [404.99]; P = 1.00). However, CATVS was significantly shorter for peramivir-single vs oseltamivir, with an estimated treatment difference (TD) of -145.07 (95% confidence interval: -284.57, -5.56; P = .0416). In subgroup analyses, CATVS was significantly shorter for peramivir-single vs oseltamivir among patients with influenza A (TD: -206.31 [-383.86, -28.76]; P = .0231), bronchial asthma (TD: -156.57 [-300.22, -12.92]; P = .0328), baseline respiratory severity score <5 (TD: -265.32 [-470.42, -60.21]; P = .0120), and age <65 (TD: -184.30 [-345.08, -23.52]; P = .0249).
CONCLUSIONS
In patients with chronic respiratory diseases, peramivir-single was not significantly different from peramivir-repeat and was more effective than oseltamivir at alleviating respiratory symptoms.
背景
神经氨酸酶抑制剂对改善患有慢性呼吸道疾病的流感患者的呼吸道症状的疗效尚不清楚。
方法
这是一项为期 2 周、随机、开放标签的研究，评估了静脉滴注帕拉米韦 600mg 连续 2 天（帕拉米韦重复组）、帕拉米韦 300mg 单次剂量（帕拉米韦单剂量组）和口服奥司他韦 75mg，每日 2 次，连续 5 天，用于确诊流感和慢性呼吸道疾病患者。患者每天记录症状评分。累积时间与症状比值（CATVS）的主要终点表示从基线到 2 周时咳嗽、咽痛和鼻塞总分的曲线下时间与面积的指数值。
结果
在 214 名随机患者中，209 名（56%女性，77%年龄<65 岁，94%为门诊患者，91%为支气管哮喘，62%为流感 A）接受了至少 1 剂研究药物。帕拉米韦重复组（782.78[487.17]）和帕拉米韦单剂量组（717.35[347.55]；P=0.4371）的平均（标准差）CATVS 相似，帕拉米韦重复组与奥司他韦（856.34[404.99]；P=1.00）的 CATVS 也相似。然而，帕拉米韦单剂量组的 CATVS 明显短于奥司他韦组，估计治疗差异（TD）为-145.07（95%置信区间：-284.57，-5.56；P=0.0416）。在亚组分析中，流感 A（TD：-206.31[-383.86，-28.76]；P=0.0231）、支气管哮喘（TD：-156.57[-300.22，-12.92]；P=0.0328）、基线呼吸严重程度评分<5（TD：-265.32[-470.42，-60.21]；P=0.0120）和年龄<65 岁（TD：-184.30[-345.08，-23.52]；P=0.0249）患者中，帕拉米韦单剂量组的 CATVS 明显短于奥司他韦组。
结论
在患有慢性呼吸道疾病的患者中，帕拉米韦单剂量与帕拉米韦重复剂量无显著差异，且在缓解呼吸道症状方面比奥司他韦更有效。
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