Fatima Eeshal, Rehman Obaid Ur, Nadeem Zain Ali, Akram Umar, Karamat Riyan Imtiaz, Larik Muhammad Omar, Fatima Maurish, Chitwood Joshua, Ahmad Arslan, Esposito Sarah, Nashwan Abdulqadir J
Department of Medicine, Services Institute of Medical Sciences, Jail Road, Lahore, Punjab, 54000, Pakistan.
Department of Medicine, Allama Iqbal Medical College, Allama Shabbir Ahmed Usmani Road, Lahore, Punjab, 54700, Pakistan.
Respir Investig. 2025 Jan;63(1):146-155. doi: 10.1016/j.resinv.2024.12.012. Epub 2024 Dec 18.
We evaluated the efficacy and safety of Ensifentrine in COPD via a systematic review and meta-analysis of randomized controlled trials (RCTs).
We performed a detailed literature search on Medline (via PubMed), Scopus, Google Scholar, and Cochrane on the basis of pre-specified eligibility criteria. We used Review Manager to calculate pooled mean differences (MD) and 95% Confidence Interval (CI) using a random effects model. The Cochrane's Risk of Bias 2 (RoB-2) tool was used to assess the risk of bias in the included RCTs.
A total of 4 studies, consisting of 2020 patients, were included in the meta-analysis. The mean age ranged from 62.5 years to 65.5 years in the included studies. All the included studies were at low risk of bias. Ensifentrine 3 mg dose significantly improved the mean peak Forced Expiratory Volume-1 (FEV-1), morning trough FEV-1, TDI score, ERS score, and SGRQ-C score as compared to the placebo, yielding a pooled MD of 149.76 (95% CI, 127.9 to 171.6), 43.93 (95% CI, 23.82 to 64.05), 0.92 (95% CI, 0.64 to 1.21, -1.20 (95% CI, -1.99 to -0.40), and -1.92 (95% CI, -3.24 to -0.59), respectively.
Ensifentrine is associated with improvements in outcomes related to COPD symptoms such as peak FEV-1, morning trough FEV-1 and TDI in the patients suffering from this chronic disease. It is also associated with improved quality of life as seen by E-RS score and SGRQ-C score.
我们通过对随机对照试验（RCT）进行系统评价和荟萃分析，评估了恩昔芬净治疗慢性阻塞性肺疾病（COPD）的疗效和安全性。
我们根据预先设定的纳入标准，在Medline（通过PubMed）、Scopus、谷歌学术和Cochrane上进行了详细的文献检索。我们使用Review Manager，采用随机效应模型计算合并平均差（MD）和95%置信区间（CI）。使用Cochrane偏倚风险2（RoB-2）工具评估纳入的RCT中的偏倚风险。
荟萃分析共纳入4项研究，涉及2020例患者。纳入研究中的平均年龄在62.5岁至65.5岁之间。所有纳入研究的偏倚风险均较低。与安慰剂相比，3 mg剂量的恩昔芬净显著改善了平均第1秒用力呼气容积（FEV-1）峰值、晨起FEV-1谷值、圣乔治呼吸问卷-咳嗽/咳痰/呼吸困难（TDI）评分、欧洲呼吸学会（ERS）评分和圣乔治呼吸问卷-总评分（SGRQ-C），合并MD分别为149.76（95%CI，127.9至171.6）、43.93（95%CI，23.82至64.05）、0.92（95%CI，0.64至1.21）、-1.20（95%CI，-1.99至-0.40）和-1.92（95%CI，-3.24至-0.59）。
恩昔芬净可改善COPD患者与症状相关的结局，如FEV-1峰值、晨起FEV-1谷值和TDI。从ERS评分和SGRQ-C评分来看，它还与生活质量改善相关。
