医学
随机对照试验
不利影响
慢性鼻-鼻窦炎
重症监护医学
荟萃分析
内科学
临床试验
梅德林
系统回顾
鼻息肉
样本量测定
科克伦合作
物理疗法
生活质量(医疗保健)
鼻窦炎
药品
安全概况
作者
Ali M. Alsudays,Yasser Alarimah,Khaled A. Almanea,Ahmad Alroqi
标识
DOI:10.1177/19458924251414922
摘要
Background Chronic rhinosinusitis with nasal polyps (CRSwNP) presents significant management challenges, largely due to reliance on systemic corticosteroids (SCS) for symptom control. Advances in biologic therapies targeting type 2 inflammation have shown promise in reducing polyp burden, improving symptoms, and decreasing the need for SCSs and surgery. Objective This systematic review and meta-analysis compare the steroid-sparing efficacy of biologics and safety with other biologics or standard care in CRSwNP. Key outcomes include reducing SCS Use and drug safety. Methods We searched PubMed, Embase, Cochrane Library, Scopus, and the Web of Science. We included randomized controlled trials (RCTs) comparing biologics versus placebo/standard care in adults with CRSwNP. The primary outcomes were SCS reduction and safety. Meta-analyses, which use a statistical method called random effects models, were employed. Results This meta-analysis of seven RCTs (n = 3097) revealed that biologic therapies significantly reduce SCS use in CRSwNP patients (pooled proportion: 20.9%, 95% CI: 8.4%-37.0%), though with substantial heterogeneity (I 2 = 98.3%). Trial-level predictors included control-arm safety profiles (higher serious adverse events (SAEs) reduced treatment effects) [odds ratio (OR) 0.70]. In contrast, placebo-arm SAEs enhanced them [OR 1.81]) and sample size (larger trials showed diluted responses [OR 0.993 per patient]). These results highlight the role of trial design and baseline patient risk in determining the interest of the results. They further highlight the possibility for individualized strategies in terms of treatment and call for more in-depth studies with patient-level data to refine the steroid-sparing therapeutic strategy, providing an impetus for future work in this area. Conclusions The biologics, specifically dupilumab, represent a paradigm shift in treating CRSwNP, significantly decreasing the burden of SCS—their consistent safety and efficacy support integration into treatment algorithms for severe cases.
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