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鼻息肉患者对生物制剂治疗及内镜鼻窦手术的疗效与应答预测因素:一项系统综述

Efficacy and Predictors of Response to Biologic Therapy and Endoscopic Sinus Surgery in Patients With Nasal Polyps: A Systematic Review.

综述 Meta鼻科IF 4.9Q1

文献信息

中文摘要

背景: 生物制剂与内镜鼻窦手术(ESS)用于治疗难治性慢性鼻窦炎伴鼻息肉(CRSwNP),但缺乏直接比较。我们综合了生物制剂与ESS的随机对照试验(RCT)中的疗效及亚组数据。
方法: 检索PubMed截至2025年12月的文献,纳入针对成人CRSwNP的生物制剂或ESS的RCT及亚组分析。纳入10项3期安慰剂对照生物制剂RCT、2项实用性ESS试验和1项头对头生物制剂试验。提取22项鼻窦结局测试(SNOT-22)和鼻息肉评分(NPS)的效应量及亚组交互作用。
结果: 共纳入来自21篇出版物的13项试验(n = 3775)。通过间接比较,tezepelumab和dupilumab产生最大改善(tezepelumab:SNOT-22:-27.4;NPS:-2.1;dupilumab:SNOT-22:-17至-21;NPS:-1.7至-2.1),而mepolizumab和omalizumab显示中等效应(SNOT-22:-10.6至-16.5);benralizumab改善NPS但不改善SNOT-22,depemokimab显示的改善低于临床可辨别差异。ESS效应因试验和随访而异(MACRO中6个月时SNOT-22:-21.9,而PolypESS中12个月时SNOT-22:-4.9)。不同疗法的改善预测因素不同(dupilumab为血嗜酸性粒细胞计数、NSAID加重性呼吸系统疾病和既往ESS;benralizumab为哮喘;ESS为基线严重程度),而tezepelumab和omalizumab显示一致疗效,无效应修饰。
结论: ESS和生物制剂均提供具有临床意义的获益。在生物制剂中,dupilumab和tezepelumab显示出最大的效应量,但跨试验在基线严重程度、随访和对照方面的差异限制了间接比较。需要头对头试验和标准化亚组分析来指导治疗选择。

英文摘要

BACKGROUND: Biologics and endoscopic sinus surgery (ESS) treat refractory chronic rhinosinusitis with nasal polyposis (CRSwNP), but direct comparisons are lacking. We synthesized efficacy and subgroup data across randomized controlled trials (RCTs) of biologics and ESS.
METHODS: PubMed was searched through December 2025 for RCTs and subgroup analyses of biologics or ESS for adult CRSwNP. Included were ten Phase-3 placebo-controlled biologic RCTs, two pragmatic ESS trials, and one head-to-head biologic trial. 22-Item Sino-Nasal Outcome Test (SNOT-22) and nasal polyp score (NPS) effect sizes and subgroup interactions were extracted.
RESULTS: A total of 13 trials (n = 3775) from 21 publications were included. By indirect comparison, tezepelumab and dupilumab produced the largest improvements (tezepelumab: SNOT-22: -27.4; NPS: -2.1; dupilumab: SNOT-22: -17 to -21; NPS: -1.7 to -2.1), while mepolizumab and omalizumab showed intermediate effects (SNOT-22: -10.6 to -16.5); benralizumab improved NPS but not SNOT-22, and depemokimab showed improvement below clinically discernible differences. ESS effects varied by trial and follow-up (SNOT-22: -21.9 at 6 months in MACRO vs. -4.9 at 12 months in PolypESS). Predictors of improvement differed across therapies (blood eosinophil count, NSAID-exacerbated respiratory disease, and prior ESS for dupilumab; asthma for benralizumab; baseline severity for ESS), while tezepelumab and omalizumab showed consistent efficacy without effect modification.
CONCLUSIONS: ESS and biologics provide clinically meaningful benefit. Among biologics, dupilumab and tezepelumab demonstrated the largest effect sizes, though cross-trial differences in baseline severity, follow-up, and comparators limit indirect comparisons. Head-to-head trials and standardized subgroup analyses are needed to guide treatment selection.