吸入装置在新发轻度哮喘中的疗效：一项随机双盲多中心试验
Efficacy of Inhaler Devices in New-Onset Mild Asthma: A Randomized Blinded Multicenter Trial.
作者信息
Zhou Yan, Li Na, Zheng Qi, Han Wei, Zhou Luqian, Zhao Hui, Liu Xunchao, Bao Wuping, Pan Yilin, Zhang Yingying, Lv Chengjian, Cao Huifang, Li Dang, Ge Changsheng, Zhu Hui, Zhu Shilong, Shen Huahao, Zhang Min
机构信息
Department of Respiratory and Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No. 100 Haining Rd, Shanghai, 200080, China.
Department of Respiratory and Critical Care Medicine, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, 310000, Zhejiang Province, China.
出版信息
Adv Ther. 2025 Jun 11. doi: 10.1007/s12325-025-03263-y.
INTRODUCTION
Low-dose inhaled corticosteroids (ICS) manage mild bronchial asthma effectively. Although pressurized metered-dose inhalers (pMDI) and dry powder inhalers (DPI) demonstrate similar efficacy in moderate-to-severe asthma, their effectiveness against mild asthma remains less established. This multicenter study evaluates the efficacy of ICS-pMDI versus ICS-DPI in newly diagnosed mild asthma.
METHODS
Patients (156) with newly diagnosed mild asthma were randomized to receive pMDI or DPI treatment for 4 weeks. Evaluations included lung function, asthma control test (ACT) scores, and blood eosinophil (EOS) counts. Data were analyzed using the full analysis set (FAS) and per-protocol set (PPS).
RESULTS
FAS analysis indicated that the pMDI group had significantly improved large airway parameters such as forced expiratory volume in 1 s (FEV) and forced vital capacity (FVC). PPS analysis revealed enhanced small airway function (SAF) indicators such as forced expiratory flow at 50% of forced vital capacity (FEF) and forced expiratory flow at 25-75% of forced vital capacity (FEF) in the pMDI group, with no significant changes in the DPI group. The pMDI group also showed greater absolute improvement in FEV, especially in patients with baseline small airway dysfunction (SAD) or EOS ≥ 150 cells/µL. Both groups had significantly improved ACT scores and reduced EOS counts, without significant intergroup differences. Correlation analysis revealed a positive relationship between baseline FEV reversibility and improvements in FEV and FEF in the pMDI group. Exacerbation rates and adverse events were similar between groups.
CONCLUSION
A 4-week ICS-pMDI treatment may improve both large and small airway function in patients with newly diagnosed mild asthma, with comparable symptom control, inflammation reduction, and adverse event profile to ICS-DPI. Baseline SAD, elevated EOS levels, and FEV reversibility may predict pMDI effectiveness in improving airway function.
CLINICAL TRIAL REGISTRATION
ChiCTR2400094311, www.chictr.org.cn .
引言
低剂量吸入性糖皮质激素（ICS）可有效治疗轻度支气管哮喘。尽管压力定量吸入器（pMDI）和干粉吸入器（DPI）在中重度哮喘中显示出相似的疗效，但其对轻度哮喘的有效性仍不太明确。这项多中心研究评估了ICS-pMDI与ICS-DPI治疗新诊断轻度哮喘的疗效。
方法
156例新诊断的轻度哮喘患者被随机分为接受pMDI或DPI治疗4周。评估包括肺功能、哮喘控制测试（ACT）评分和血液嗜酸性粒细胞（EOS）计数。使用全分析集（FAS）和符合方案集（PPS）进行数据分析。
结果
FAS分析表明，pMDI组的大气道参数如第1秒用力呼气容积（FEV）和用力肺活量（FVC）有显著改善。PPS分析显示，pMDI组的小气道功能（SAF）指标如用力肺活量50%时的用力呼气流量（FEF）和用力肺活量25%-75%时的用力呼气流量（FEF）有所增强，而DPI组无显著变化。pMDI组的FEV绝对改善也更大，尤其是在基线小气道功能障碍（SAD）或EOS≥150个细胞/微升的患者中。两组的ACT评分均显著改善，EOS计数减少，组间无显著差异。相关性分析显示，pMDI组基线FEV可逆性与FEV和FEF改善之间存在正相关。两组间的加重率和不良事件相似。
结论
4周的ICS-pMDI治疗可能改善新诊断轻度哮喘患者的大气道和小气道功能，在症状控制、炎症减轻和不良事件方面与ICS-DPI相当。基线SAD、EOS水平升高和FEV可逆性可能预测pMDI改善气道功能的有效性。
临床试验注册
ChiCTR2400094311，www.chictr.org.cn 。
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