Yappalparvi Ambanna, Balaraman Ashok Kumar, Padmapriya G, Gaidhane Shilpa, Kaur Irwanjot, Lal Madan, Iqbal Suhaib, Prasad G V Siva, Pramanik Atreyi, Vishwakarma Teena, Malik Praveen, Sharma Promila, Punia Ankit, Jagga Megha, Lingamaiah Doddolla, Mehta Rachana, Sah Sanjit, Zahiruddin Quazi Syed, Abu Serhan Hashem, Shabil Muhammed, Bushi Ganesh
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, India.
Research and Enterprise, University of Cyberjaya, Persiaran Bestari, Cyber 11, 63000, Cyberjaya, Selangor, Malaysia.
Respir Med. 2025 Jan;236:107863. doi: 10.1016/j.rmed.2024.107863. Epub 2024 Nov 16.
Chronic obstructive pulmonary disease (COPD) significantly impacts global health due to persistent airflow limitation and inflammation. Despite standard therapies, symptoms persist. Ensifentrine, targeting both bronchoconstriction and inflammation as a dual phosphodiesterase 3 and 4 inhibitor, offers a promising therapeutic advancement for COPD management. This meta-analysis evaluates the safety and efficacy of ensifentrine in improving lung function, dyspnea, and quality of life in COPD patients.
We searched PubMed, Embase, and Web of Science through August 2024 for randomized controlled trials evaluating ensifentrine in COPD patients over a minimum of four weeks. Data extraction and screening utilized Knowledge software, and meta-analyses were performed using R v4.4 with a random-effects model.
From 206 studies identified, four met our inclusion criteria. Ensifentrine improved FEV1 significantly at a dose of 3 mg (LS mean difference: 40.90 mL; 95 % CI: 19.65-62.15). It also improved dyspnea as measured by the Transition Dyspnea Index (TDI) (LS mean difference: 0.91; 95 % CI: 0.61-1.21) and quality of life according to the St. George's Respiratory Questionnaire-C (SGRQ-C) scores (LS mean difference: -1.92; 95 % CI: -3.28 to -0.55). Safety profiles were comparable between the ensifentrine and placebo groups, with no significant increase in treatment-emergent adverse events (TEAEs) (RR: 1.02; 95 % CI: 0.94-1.10).
Ensifentrine significantly enhances lung function, reduces dyspnea, and improves quality of life in COPD patients, especially at a 3 mg dose. These benefits, coupled with a stable safety profile, support its use as an adjunctive therapy in COPD management.
慢性阻塞性肺疾病（COPD）因持续的气流受限和炎症而对全球健康产生重大影响。尽管有标准治疗方法，但症状仍会持续。恩昔芬净作为一种双重磷酸二酯酶3和4抑制剂，同时针对支气管收缩和炎症，为COPD的管理提供了一种有前景的治疗进展。这项荟萃分析评估了恩昔芬净在改善COPD患者肺功能、呼吸困难和生活质量方面的安全性和有效性。
我们检索了截至2024年8月的PubMed、Embase和Web of Science数据库，以查找评估恩昔芬净治疗COPD患者至少四周的随机对照试验。数据提取和筛选使用Knowledge软件，并使用R v4.4软件采用随机效应模型进行荟萃分析。
在识别出的206项研究中，有4项符合我们的纳入标准。恩昔芬净在3毫克剂量时显著改善了第一秒用力呼气容积（FEV1）（最小二乘均值差异：40.90毫升；95%置信区间：19.65 - 62.15）。它还改善了通过过渡性呼吸困难指数（TDI）测量的呼吸困难（最小二乘均值差异：0.91；95%置信区间：0.61 - 1.21）以及根据圣乔治呼吸问卷 - C（SGRQ - C）评分的生活质量（最小二乘均值差异：-1.92；95%置信区间：-3.28至-0.55）。恩昔芬净组和安慰剂组的安全性概况相当，治疗中出现的不良事件（TEAE）没有显著增加（风险比：1.02；95%置信区间：0.94 - 1.10）。
恩昔芬净显著增强了COPD患者的肺功能，减轻了呼吸困难，并改善了生活质量，尤其是在3毫克剂量时。这些益处，再加上稳定的安全性概况，支持其作为COPD管理中的辅助治疗药物使用。
