Efficacy of combination therapy with oseltamivir phosphate and azithromycin for influenza: a multicenter, open-label, randomized study.

Efficacy of combination therapy with oseltamivir phosphate and azithromycin for influenza: a multicenter, open-label, randomized study.
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DOI:
10.1371/journal.pone.0091293
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发表时间:
2014
期刊:
影响因子:
3.7
通讯作者:
Kohno S
Kohno S
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Kakeya H;Seki M;Izumikawa K;Kosai K;Morinaga Y;Kurihara S;Nakamura S;Imamura Y;Miyazaki T;Tsukamoto M;Yanagihara K;Tashiro T;Kohno S

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大环内酯类具有抗菌和免疫调节活性,可能对感染(包括流感)患者的临床结局产生有利影响。本研究旨在评价抗流感药物奥司他韦和阿奇霉素(AZM)单剂量制剂联合治疗对流感患者的影响,AZM已用于流感相关继发性肺炎。主要终点是炎性细胞因子表达水平的变化。次要终点是流感相关症状消退所需的时间、并发症发生率和不良反应。本多中心、开放标签、随机研究纳入了季节性流感患者。根据高危因素的存在对患者进行分层,并随机接受奥司他韦加AZM缓释制剂的联合治疗(组合组)或奥司他韦单药治疗(单药组)。我们招募了107名患者,并将其随机分为单药组(56名患者)或联合组(51名患者)。所有患者均被诊断为甲型流感感染,无患者合并肺炎。两组间炎性细胞因子和趋化因子的表达水平无统计学显著差异。第3天至第5天,联合组的最高体温低于单药组(p = 0.048),特别是第4天(p = 0.037)。    据我们所知,这是第一个奥司他韦和AZM联合治疗流感的前瞻性、随机、临床试验。虽然炎性细胞因子表达水平的差异没有统计学意义,但联合治疗显示出一些症状的早期解决。大学医院医疗信息网(UMIN)。 UMIN000005371
Macrolides have antibiotic and immunomodulatory activities, which may have a favorable effect on the clinical outcome of patients with infections, including influenza. This study aimed to evaluate the effects of combination therapy with an anti-influenza agent, oseltamivir, and a single-dose formulation of azithromycin (AZM), which has been used for influenza-related secondary pneumonia, on influenza patients. The primary endpoint was a change in the expression levels of inflammatory cytokines. Secondary endpoints were the time required for resolution of influenza-related symptoms, incidence of complications, and adverse reactions. Patients with seasonal influenza were enrolled in this multicenter, open-label, randomized study. Patients were stratified according to the presence of a high risk factor and were randomized to receive combination therapy with oseltamivir plus an extended-release formulation of AZM (combo-group) or oseltamivir monotherapy (mono-group). We enrolled 107 patients and randomized them into the mono-group (56 patients) or the combo-group (51 patients). All patients were diagnosed with influenza A infection, and none of the patients had comorbid pneumonia. Statistically significant differences were not observed in the expression levels of inflammatory cytokines and chemokines between the 2 groups. The maximum temperature in the combo-group was lower than that in the mono-group on day 3 through day 5 (p = 0.048), particularly on day 4 (p = 0.037). To our knowledge, this is the first prospective, randomized, clinical trial of oseltamivir and AZM combination therapy for influenza. Although the difference in inflammatory cytokine expression level was not statistically significant, combination therapy showed an early resolution of some symptoms. University hospital Medical Information Network (UMIN). UMIN000005371
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