Ison Michael G, Gnann John W, Nagy-Agren Stephanie, Treannor John, Paya Carlos, Steigbigel Roy, Elliott Michael, Weiss Heidi L, Hayden Frederick G
University of Virginia, Charlottesville, Va., USA.
Antivir Ther. 2003 Jun;8(3):183-90.
Influenza is an important cause of hospitalization due to lower respiratory tract involvement for which there is no specific antiviral treatment with proven efficacy. We conducted a double-blind, randomized, placebo-controlled trial to assess the tolerability and efficacy of nebulized zanamivir (16 mg four times a day) in combination with rimantadine compared to rimantadine with nebulized saline for treating influenza in adults hospitalized with influenza. Twenty patients tolerated the inhaled zanamivir (ZNV) plus rimantadine without decline in peak expiratory flow rates compared to the 21 who received inhaled saline. The study was terminated early because the approval of ZNV made further enrollment untenable. No significant differences were observed in the proportion of patients shedding virus by treatment day 3 (57% ZNV plus rimantadine, 67% placebo plus rimantadine), or in the durations of hospitalization and supplemental oxygen use. More ZNV plus rimantadine recipients exhibited no or mild cough on day 3 of treatment (94 vs 55%, P=0.01). Two rimantadine-resistant viruses emerged during rimantadine monotherapy; no ZNV resistance was observed. Nebulized ZNV appears to be well tolerated in this hospitalized population but further studies are needed to assess its efficacy.
流感是因下呼吸道受累导致住院的一个重要原因，对此尚无经证实有效的特异性抗病毒治疗方法。我们开展了一项双盲、随机、安慰剂对照试验，以评估雾化扎那米韦（每日4次，每次16毫克）联合金刚乙胺与雾化生理盐水联合金刚乙胺相比，在治疗因流感住院的成人流感时的耐受性和疗效。与21名接受雾化生理盐水的患者相比，20名患者耐受吸入扎那米韦（ZNV）加金刚乙胺，呼气峰值流速未下降。该研究提前终止，因为ZNV获批使得进一步入组变得不可行。在治疗第3天时，病毒脱落患者的比例（ZNV加金刚乙胺组为57%，安慰剂加金刚乙胺组为67%）、住院时间和使用补充氧气的时间方面均未观察到显著差异。更多接受ZNV加金刚乙胺治疗的患者在治疗第3天时无咳嗽或仅有轻度咳嗽（分别为94%和55%，P = 0.01）。在金刚乙胺单药治疗期间出现了两株金刚乙胺耐药病毒；未观察到ZNV耐药情况。雾化ZNV在该住院人群中似乎耐受性良好，但需要进一步研究来评估其疗效。
