Carvalhal Giulia, Peralta-Jiménez Gonzalo Alberto, Roca Mora Maria Meritxell, Ayasa Laith, Barrera Vivian, Advani Kavita, Anzueto Antonio, Aljazeeri Jafar
Department of Medicine, Federal University of Campina Grande, Paraíba, Brazil.
Subdirección de Gestión Asistencial, Health Service of Arica and Parinacota, Arica, Chile.
Expert Rev Respir Med. 2025 Jun;19(6):609-618. doi: 10.1080/17476348.2025.2493367. Epub 2025 Apr 23.
To evaluate the efficacy and safety of ensifentrine in chronic obstructive pulmonary disease (COPD).
We searched electronic databases and registries until 25 January 2025, for randomized clinical trials (RCTs) comparing ensifentrine vs placebo in patients with COPD. Primary outcomes include forced expiratory volume in one second (FEV₁) area under the curve (AUC), peak FEV₁, and morning trough FEV₁.
Ten RCTs involving 2,589 patients were included. Compared with placebo, ensifentrine improved FEV₁ AUC by 104.24 ml (95% CI, 74.03 to 133.44; moderate certainty) on day 1 and by 90.37 ml (95% CI, 54.94 to 125.81; moderate certainty) at study end. Ensifentrine increased peak FEV₁ by 140.99 ml on day 1 (95% CI, 107.48 to 174.5; moderate certainty) and by 118.98 ml at the final assessment (95% CI, 86.49 to 151.47; moderate certainty). Ensifentrine improved morning trough FEV₁ by 42.15 ml (95% CI, 19.87 to 64.43; high certainty). Dose-response analysis showed a bell-shaped curve for all outcomes. Ensifentrine did not significantly differ from placebo in adverse events or improvements in COPD symptoms and quality of life.
Compared with placebo, ensifentrine improved lung function in COPD. Larger RCTs are needed to integrate this bronchodilator benefit with patient-centered outcomes.
CRD42024571928.
评估恩昔芬净治疗慢性阻塞性肺疾病（COPD）的疗效和安全性。
我们检索了电子数据库和注册库，直至2025年1月25日，查找比较恩昔芬净与安慰剂治疗COPD患者的随机临床试验（RCT）。主要结局包括一秒用力呼气容积（FEV₁）曲线下面积（AUC）、FEV₁峰值和清晨FEV₁谷值。
纳入了10项涉及2589例患者的RCT。与安慰剂相比，恩昔芬净在第1天使FEV₁ AUC提高了104.24 ml（95%CI，74.03至133.44；中等确定性），在研究结束时提高了90.37 ml（95%CI，54.94至125.81；中等确定性）。恩昔芬净在第1天将FEV₁峰值提高了140.99 ml（95%CI，107.48至174.5；中等确定性），在最终评估时提高了118.98 ml（95%CI，86.49至151.47；中等确定性）。恩昔芬净使清晨FEV₁谷值提高了42.15 ml（95%CI，19.87至64.43；高确定性）。剂量反应分析显示所有结局均呈钟形曲线。恩昔芬净在不良事件或COPD症状及生活质量改善方面与安慰剂无显著差异。
与安慰剂相比，恩昔芬净改善了COPD患者的肺功能。需要开展更大规模的RCT，将这种支气管扩张剂的益处与以患者为中心的结局相结合。
PROSPERO注册编号：CRD42024571928。
