Blood eosinophil-guided systemic corticosteroid duration in adults hospitalised for asthma exacerbation: a randomised, controlled, open-label, non-inferiority trial.

Biomarker-guided approaches could reduce corticosteroid exposure without compromising outcomes.

基于生物标志物的治疗策略可能在不损害治疗结果的情况下减少皮质类固醇的暴露。

We aimed to evaluate whether the blood eosinophil count can be used to safely reduce systemic corticosteroid exposure in hospitalised asthma exacerbations.

我们旨在评估血液嗜酸性粒细胞计数是否可以安全减少住院哮喘加重期间的全身性皮质类固醇暴露。

Methods

In this open-label, two-centre randomised trial, adults hospitalised for asthma exacerbation were assigned 1:1 to usual care (5 days prednisolone) or eosinophil-guided care using blood eosinophil counts obtained prior to corticosteroid administration (3 days if eosinophils <300 cells/µL; 5 days if ≥300 cells/µL).

在这项开放标签、两中心的随机试验中，因哮喘加重而住院的成人被1:1分配到常规护理组（5天泼尼松）或使用血嗜酸性粒细胞计数指导的护理组（如果嗜酸性粒细胞<300细胞/微升，则为3天；如果≥300细胞/微升，则为5天）。

The primary outcome was non-inferiority of treatment failure rates (composite of extension of steroid duration, mechanical ventilation or death), with a prespecified 20% non-inferiority margin.

主要结果是治疗失败率的非劣效性（包括糖皮质激素治疗时间延长、机械通气或死亡的复合指标），预设的非劣效性边界为20%。

Results

Among 110 randomised patients (55 per group), 60% were eosinophilic, and 40% non-eosinophilic.

在随机分配的110名患者中（每组55人），60%为嗜酸性粒细胞增多型，40%为非嗜酸性粒细胞增多型。

Treatment failure occurred in 6/55 (10.9%) of eosinophil-guided versus 4/55 (7.3%) of usual care patients, with a 3.6% absolute difference (95% CI -8.9% to 16.2%), meeting non-inferiority.

治疗失败发生在嗜酸性粒细胞指导组的55名患者中有6人（10.9%），而在常规护理组的55名患者中有4人（7.3%），绝对差异为3.6%（95%置信区间-8.9%至16.2%），达到了非劣效性标准。

Cumulative corticosteroid dose per patient was similar between groups but significantly lower for non-eosinophilic than eosinophilic exacerbations in the eosinophil-guided group (136 vs 214 mg; p=0.0004), a difference not observed in usual care (186 vs 211 mg; p=0.18).

两组患者每人累积的皮质类固醇剂量相似，但在嗜酸性粒细胞指导组中，非嗜酸性加重的患者与嗜酸性加重的患者相比，皮质类固醇剂量显著较低（136毫克对比214毫克；p=0.0004），而在常规护理组中未观察到这种差异（186毫克对比211毫克；p=0.18）。

Length of stay, Asthma Control Questionnaire-5 change, additional steroid bursts at 14 days or time to next exacerbation up to 1 year showed no significant differences.

住院时间、哮喘控制问卷-5评分变化、14天内额外的类固醇爆发或长达1年的下一次加重时间没有显著差异。

Conclusions

Eosinophil-guided therapy safely reduced systemic corticosteroid exposure in non-eosinophilic exacerbations while maintaining non-inferior outcomes in this proof-of-concept trial.

以嗜酸性粒细胞为指导的治疗在非嗜酸性加重的情况下安全地减少了全身性皮质类固醇的暴露，同时在这一概念验证试验中保持了非劣效的结果。

trial_registration_number

NCT05417906.

NCT05417906。