Whether a combination of glucocorticoid and antifungal triazole is superior to glucocorticoid alone in reducing exacerbations in patients with allergic bronchopulmonary aspergillosis (ABPA) remains unknown. We aimed to compare the efficacy and safety of prednisolone–itraconazole combination versus prednisolone monotherapy in ABPA.

We randomised subjects with treatment-naïve acute-stage ABPA complicating asthma to receive either prednisolone alone (4 months) or a combination of prednisolone and itraconazole (4 and 6 months, respectively). The primary outcomes were exacerbation rates at 12 months and glucocorticoid-dependent ABPA within 24 months of initiating treatment. The key secondary outcomes were response rates, percentage decline in serum total IgE at 6 weeks, time to first ABPA exacerbation and treatment-emergent adverse events (TEAEs).

We randomised 191 subjects to receive either prednisolone (n=94) or prednisolone–itraconazole combination (n=97). The 1-year exacerbation rate was 33% and 20.6% in the prednisolone monotherapy and prednisolone–itraconazole combination arms, respectively (p=0.054). None of the participants progressed to glucocorticoid-dependent ABPA. All of the subjects experienced a composite response at 6 weeks, along with a decline in serum total IgE (mean decline 47.6% versus 45.5%). The mean time to first ABPA exacerbation (417 days) was not different between the groups. None of the participants required modification of therapy due to TEAEs.

There was a trend towards a decline in ABPA exacerbations at 1 year with the prednisolone–itraconazole combination versus prednisolone monotherapy. A three-arm trial comparing itraconazole and prednisolone monotherapies with their combination, preferably in a multicentric design, is required to define the best treatment strategy for acute-stage ABPA.

糖皮质激素和抗真菌三唑的组合在减少过敏性支气管肺曲霉病 (ABPA) 患者的恶化方面是否优于单独使用糖皮质激素尚不清楚。我们的目的是比较泼尼松龙-伊曲康唑联合疗法与泼尼松龙单一疗法治疗 ABPA 的疗效和安全性。

我们将患有初治急性期 ABPA 并发哮喘的受试者随机分组，分别接受泼尼松龙单独治疗（4 个月）或泼尼松龙和伊曲康唑联合治疗（分别接受 4 个月和 6 个月）。主要结局是 12 个月时的恶化率和开始治疗后 24 个月内依赖糖皮质激素的 ABPA。关键的次要结果是反应率、6 周时血清总 IgE 的下降百分比、首次 ABPA 恶化的时间和治疗中出现的不良事件（TEAE）。

我们将 191 名受试者随机分配接受泼尼松龙 (n=94) 或泼尼松龙-伊曲康唑组合 (n=97)。泼尼松龙单一疗法和泼尼松龙-伊曲康唑联合疗法的 1 年恶化率分别为 33% 和 20.6% (p=0.054)。没有参与者进展为糖皮质激素依赖性 ABPA。所有受试者在 6 周时都经历了综合反应，同时血清总 IgE 下降（平均下降 47.6%对45.5%）。首次 ABPA 恶化的平均时间（417 天）在各组之间没有差异。由于 TEAE，没有参与者需要修改治疗。

与泼尼松龙单一疗法相比，泼尼松龙-伊曲康唑联合疗法在 1 年时有降低 ABPA 恶化的趋势。需要一项比较伊曲康唑和泼尼松龙单一疗法及其联合疗法的三臂试验，最好采用多中心设计，以确定急性期 ABPA 的最佳治疗策略。