Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Chest. 2018 Mar;153(3):656-664. doi: 10.1016/j.chest.2018.01.005. Epub 2018 Jan 11.
Whether itraconazole monotherapy is effective in the acute stage of allergic bronchopulmonary aspergillosis (ABPA) remains unknown. The goal of this study was to compare the efficacy and safety of itraconazole and prednisolone monotherapy in ABPA.
Treatment-naive subjects with ABPA complicating asthma (January 2012 to December 2013) were randomized to receive either oral itraconazole or prednisolone for 4 months. The study was not blinded. The primary outcomes were proportion of subjects exhibiting a composite response after 6 weeks, percent decline in IgE after treatment, and numbers of subjects experiencing exacerbation. The secondary outcomes included the time to first exacerbation, change in lung function, and treatment-related adverse effects.
A total of 131 subjects (prednisolone group, n = 63; itraconazole group, n = 68) were included in the study. The number of subjects exhibiting a composite response was significantly higher in the prednisolone group compared with the itraconazole group (100% vs 88%; P = .007). The percent decline in IgE after 6 weeks and 3 months and the number of subjects with exacerbations after 1 and 2 years of treatment were similar in the two groups. The time to first exacerbation (mean: 437 vs 442 days) and the improvement in lung function after 6 weeks was also similar in the two groups. The occurrence of side effects was significantly higher in the glucocorticoid arm (P < .001).
Prednisolone was more effective in inducing response than itraconazole in acute-stage ABPA. However, itraconazole was also effective in a considerable number and, with fewer side effects compared with prednisolone, remains an attractive alternative in the initial treatment of ABPA.
ClinicalTrials.gov; No.: NCT01321827; URL: www.clinicaltrials.gov).
伊曲康唑单药治疗变应性支气管肺曲霉病（ABPA）急性期的疗效尚不清楚。本研究旨在比较伊曲康唑和泼尼松单药治疗 ABPA 的疗效和安全性。
2012 年 1 月至 2013 年 12 月，患有哮喘合并 ABPA 的初治患者被随机分为伊曲康唑或泼尼松组，分别接受 4 个月的治疗。该研究未设盲。主要终点为治疗 6 周后复合反应的患者比例、治疗后 IgE 下降百分比以及出现加重的患者数量。次要终点包括首次加重时间、肺功能变化和治疗相关不良反应。
共纳入 131 例患者（泼尼松组 n=63，伊曲康唑组 n=68）。泼尼松组复合反应的患者比例显著高于伊曲康唑组（100% vs 88%；P=.007）。两组治疗后 6 周和 3 个月 IgE 下降百分比以及治疗后 1 年和 2 年出现加重的患者数量相似。两组首次加重时间（平均：437 天 vs 442 天）和治疗后 6 周肺功能改善情况也相似。糖皮质激素组不良反应发生率显著较高（P<.001）。
泼尼松在诱导急性 ABPA 患者应答方面比伊曲康唑更有效。然而，伊曲康唑在相当数量的患者中也有效，且不良反应较泼尼松少，因此在 ABPA 的初始治疗中仍是一种有吸引力的替代药物。
ClinicalTrials.gov；编号：NCT01321827；网址：www.clinicaltrials.gov）。
