Institute for Lung Health, Department of Infection, Immunity and Inflammation, University of Leicester, and the Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.
Institute for Lung Health, Department of Infection, Immunity and Inflammation, University of Leicester, and the Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.
J Allergy Clin Immunol. 2014 Jul;134(1):33-9. doi: 10.1016/j.jaci.2013.09.050. Epub 2013 Nov 28.
IgE sensitization to Aspergillus fumigatus and a positive sputum fungal culture result are common in patients with refractory asthma. It is not clear whether these patients would benefit from antifungal treatment.
We sought to determine whether a 3-month course of voriconazole improved asthma-related outcomes in patients with asthma who are IgE sensitized to A fumigatus.
Asthmatic patients who were IgE sensitized to A fumigatus with a history of at least 2 severe exacerbations in the previous 12 months were treated for 3 months with 200 mg of voriconazole twice daily, followed by observation for 9 months, in a double-blind, placebo-controlled, randomized design. Primary outcomes were improvement in quality of life at the end of the treatment period and a reduction in the number of severe exacerbations over the 12 months of the study.
Sixty-five patients were randomized. Fifty-nine patients started treatment (32 receiving voriconazole and 27 receiving placebo) and were included in an intention-to-treat analysis. Fifty-six patients took the full 3 months of medication. Between the voriconazole and placebo groups, there were no significant differences in the number of severe exacerbations (1.16 vs 1.41 per patient per year, respectively; mean difference, 0.25; 95% CI, 0.19-0.31), quality of life (change in Asthma Quality of Life Questionnaire score, 0.68 vs 0.88; mean difference between groups, 0.2; 95% CI, -0.05 to -0.11), or any of our secondary outcome measures.
We were unable to show a beneficial effect of 3 months of treatment with voriconazole in patients with moderate-to-severe asthma who were IgE sensitized to A fumigatus on either the rate of severe exacerbations, quality of life, or other markers of asthma control.
烟曲霉致敏和真菌痰培养阳性在难治性哮喘患者中很常见。目前尚不清楚这些患者是否会从抗真菌治疗中获益。
我们旨在确定伏立康唑治疗是否可以改善烟曲霉致敏哮喘患者的哮喘相关结局。
采用双盲、安慰剂对照、随机设计，对至少在过去 12 个月中有 2 次严重加重史的烟曲霉致敏哮喘患者进行为期 3 个月的 200mg 伏立康唑每日 2 次治疗，然后进行 9 个月的观察。主要结局是治疗期末生活质量的改善和研究期间严重加重次数的减少。
共有 65 例患者被随机分组。59 例患者开始接受治疗（32 例接受伏立康唑治疗，27 例接受安慰剂治疗），并纳入意向治疗分析。56 例患者完成了全部 3 个月的治疗。伏立康唑组和安慰剂组之间，严重加重的次数（每年患者 1.16 次 vs 1.41 次，平均差异 0.25；95%CI 0.19-0.31）、生活质量（哮喘生活质量问卷评分的变化，0.68 分 vs 0.88 分；两组之间的平均差异 0.2；95%CI -0.05 至-0.11）或我们的其他次要结局均无显著差异。
我们未能证明烟曲霉致敏、中重度哮喘患者接受 3 个月伏立康唑治疗对严重加重率、生活质量或其他哮喘控制标志物有有益效果。
