{"title":"dupilumab治疗慢性鼻窦炎伴鼻息肉的疗效和安全性：一项系统综述和荟萃分析。","authors":"Linger Sim, Norasnieda Md Shukri, Najib Majdi Yaacob, Chenthilnathan Periasamy, Musat Gabriela Cornelia, Baharudin Abdullah","doi":"10.1080/17512433.2025.2468970","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Chronic rhinosinusitis with nasal polyps (CRSwNP) primarily displays type 2 inflammation, characterized by the activation of interleukin (IL)-4, IL-5, and IL-13 in the pathway. The purpose of this study is to determine the efficacy and safety of dupilumab (an IL-4 antagonist) in treating CRSwNP.</p><p><strong>Methods: </strong>A detailed search was performed in PubMed, Embase and the Cochrane Library databases. All published English-language randomized controlled trials (RCTs) that employed dupilumab to treat CRSwNP in adult patients (≥18 years old) were considered.</p><p><strong>Results: </strong>Three RCTs and 25 studies with 784 individuals were included. The use of dupilumab revealed improvement in polyp size (MD -1.80; 95% CI -2.25 to -1.36), Lund-Mackay score (MD -7.01, 95% CI -9.64 to -4.38), congestion (MD -0.86, 95% CI -0.99 to -0.73), smell (MD 10.83, 95% CI 9.59 to 12.08) and health-related quality of life (MD -19.61, 95% CI -22.53 to -16.69). Systemic corticosteroid use (RR 0.28, 95% CI 0.20-0.39) and revision surgery (RR 0.17, 95% CI 0.05-0.52) were reduced. Serious adverse events were reduced in dupilumab group (RR 0.47; 95% CI 0.29 to 0.76) with no change in risk of adverse events (RR 0.98, 95% CI 0.87 to 1.11).</p><p><strong>Conclusions: </strong>Dupilumab is effective with minimal adverse events.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/prospero identifier is CRD42023413004.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"211-224"},"PeriodicalIF":3.6000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of dupilumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis.\",\"authors\":\"Linger Sim, Norasnieda Md Shukri, Najib Majdi Yaacob, Chenthilnathan Periasamy, Musat Gabriela Cornelia, Baharudin Abdullah\",\"doi\":\"10.1080/17512433.2025.2468970\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Chronic rhinosinusitis with nasal polyps (CRSwNP) primarily displays type 2 inflammation, characterized by the activation of interleukin (IL)-4, IL-5, and IL-13 in the pathway. The purpose of this study is to determine the efficacy and safety of dupilumab (an IL-4 antagonist) in treating CRSwNP.</p><p><strong>Methods: </strong>A detailed search was performed in PubMed, Embase and the Cochrane Library databases. All published English-language randomized controlled trials (RCTs) that employed dupilumab to treat CRSwNP in adult patients (≥18 years old) were considered.</p><p><strong>Results: </strong>Three RCTs and 25 studies with 784 individuals were included. The use of dupilumab revealed improvement in polyp size (MD -1.80; 95% CI -2.25 to -1.36), Lund-Mackay score (MD -7.01, 95% CI -9.64 to -4.38), congestion (MD -0.86, 95% CI -0.99 to -0.73), smell (MD 10.83, 95% CI 9.59 to 12.08) and health-related quality of life (MD -19.61, 95% CI -22.53 to -16.69). Systemic corticosteroid use (RR 0.28, 95% CI 0.20-0.39) and revision surgery (RR 0.17, 95% CI 0.05-0.52) were reduced. Serious adverse events were reduced in dupilumab group (RR 0.47; 95% CI 0.29 to 0.76) with no change in risk of adverse events (RR 0.98, 95% CI 0.87 to 1.11).</p><p><strong>Conclusions: </strong>Dupilumab is effective with minimal adverse events.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/prospero identifier is CRD42023413004.</p>\",\"PeriodicalId\":12207,\"journal\":{\"name\":\"Expert Review of Clinical Pharmacology\",\"volume\":\" \",\"pages\":\"211-224\"},\"PeriodicalIF\":3.6000,\"publicationDate\":\"2025-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Review of Clinical Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17512433.2025.2468970\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/22 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Clinical Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17512433.2025.2468970","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/22 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
慢性鼻窦炎伴鼻息肉（CRSwNP）主要表现为2型炎症，其特征是该通路中白细胞介素(IL)-4、IL-5和IL-13的激活。本研究的目的是确定dupilumab（一种IL-4拮抗剂）治疗CRSwNP的有效性和安全性。方法：在PubMed、Embase和Cochrane Library数据库中进行详细检索。所有已发表的使用dupilumab治疗成人患者（≥18岁）CRSwNP的英语随机对照试验（RCTs）均被纳入考虑。结果：纳入3项随机对照试验和25项研究，共784人。dupilumab的使用显示息肉大小的改善(MD -1.80；95% CI -2.25 ~ -1.36)、lnd - mackay评分（MD -7.01, 95% CI -9.64 ~ -4.38）、充血（MD -0.86, 95% CI -0.99 ~ -0.73）、嗅觉（MD 10.83, 95% CI 9.59 ~ 12.08）和健康相关生活质量（MD -19.61, 95% CI -22.53 ~ -16.69）。全身皮质类固醇使用（RR 0.28, 95% CI 0.20-0.39）和翻修手术（RR 0.17, 95% CI 0.05-0.52）减少。dupilumab组严重不良事件减少(RR 0.47；95% CI 0.29 ~ 0.76)，不良事件风险无变化（RR 0.98, 95% CI 0.87 ~ 1.11）。结论：Dupilumab是有效的，不良事件最小。协议注册：www.crd.york.ac.uk/prospero标识为CRD42023413004。
Efficacy and safety of dupilumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis.
Introduction: Chronic rhinosinusitis with nasal polyps (CRSwNP) primarily displays type 2 inflammation, characterized by the activation of interleukin (IL)-4, IL-5, and IL-13 in the pathway. The purpose of this study is to determine the efficacy and safety of dupilumab (an IL-4 antagonist) in treating CRSwNP.
Methods: A detailed search was performed in PubMed, Embase and the Cochrane Library databases. All published English-language randomized controlled trials (RCTs) that employed dupilumab to treat CRSwNP in adult patients (≥18 years old) were considered.
Results: Three RCTs and 25 studies with 784 individuals were included. The use of dupilumab revealed improvement in polyp size (MD -1.80; 95% CI -2.25 to -1.36), Lund-Mackay score (MD -7.01, 95% CI -9.64 to -4.38), congestion (MD -0.86, 95% CI -0.99 to -0.73), smell (MD 10.83, 95% CI 9.59 to 12.08) and health-related quality of life (MD -19.61, 95% CI -22.53 to -16.69). Systemic corticosteroid use (RR 0.28, 95% CI 0.20-0.39) and revision surgery (RR 0.17, 95% CI 0.05-0.52) were reduced. Serious adverse events were reduced in dupilumab group (RR 0.47; 95% CI 0.29 to 0.76) with no change in risk of adverse events (RR 0.98, 95% CI 0.87 to 1.11).
Conclusions: Dupilumab is effective with minimal adverse events.
Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42023413004.
期刊介绍：
Advances in drug development technologies are yielding innovative new therapies, from potentially lifesaving medicines to lifestyle products. In recent years, however, the cost of developing new drugs has soared, and concerns over drug resistance and pharmacoeconomics have come to the fore. Adverse reactions experienced at the clinical trial level serve as a constant reminder of the importance of rigorous safety and toxicity testing. Furthermore the advent of pharmacogenomics and ‘individualized’ approaches to therapy will demand a fresh approach to drug evaluation and healthcare delivery.
Clinical Pharmacology provides an essential role in integrating the expertise of all of the specialists and players who are active in meeting such challenges in modern biomedical practice.
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