Data Sheet 1_Safety and efficacy of anti-IL-5 monoclonal antibodies as second-line therapy for chronic rhinosinusitis with nasal polyps: a meta-analysis.pdf

IntroductionThis meta-analysis aimed to evaluate the safety and efficacy of anti-IL-5 monoclonal antibody (anti-IL-5 mAb) as a second-line therapy for chronic rhinosinusitis with nasal polyps (CRSwNP).
Materials and methodsFour databases (PubMed, Web of Science, Embase and Cochrane Library) were searched from the establishment of the databases to September 15, 2025, for randomized controlled trials (RCTs) comparing anti-IL-5 mAb versus placebo in the treatment of CRSwNP. The primary outcome measure of this meta-analysis were nasal polyp score (NPS) and Sino-Nasal Outcome Test-22 (SNOT-22) score. Secondary outcome measures included nasal blockage score (NBS), loss of smell score (LSS), Lund-Mackay score (LMS), University of Pennsylvania Smell Identification Test (UPSIT) score, nasal overall visual analog scale(VAS) score, nasal composite visual analog scale(VAS) score, number of first-time NP surgery patients and number of systemic corticosteroids (≥1 course) patients.
ResultsTotally 10 RCTs were included for meta-analysis. Compared with placebo, anti-IL-5 mAb provided a significantly lower NPS (WMD = -0.58, 95%CI: -0.70 ~ -0.46, P < 0.00001, I2 = 83%), SNOT-22 score (WMD: -9.57, 95% CI: -11.03 ~ -8.11, P < 0.00001, I2 = 80%), NBS (SMD: -1.75; 95% CI: -3.13 ~ -0.36, P = 0.01, I2 = 99%), LSS (SMD: -1.68; 95% CI: -3.13 ~ -0.24, P = 0.02, I2 = 99%), LMS (WMD: -2.00; 95% CI: -2.65 ~ -1.34, P < 0.00001, I2 = 97%), nasal overall VAS score (WMD: -1.54, 95% CI: -1.64 ~ -1.43, P < 0.00001, I2 = 0%), nasal composite VAS score (WMD: -1.28, 95% CI: -1.66 ~ -0.19, P < 0.00001, I2 = 0%), number of first-time NP surgery patients (RR: 0.64, 95% CI: 0.41 ~ 1.00, P = 0.05, I2 = 69%) and number of systemic corticosteroids (≥1 course) patients (RR: 0.73, 95% CI: 0.62 ~ 0.86, P = 0.0002, I2 = 0%), while significantly improved UPSIT (WMD: 2.09, 95% CI: 0.42 ~ 3.77, P = 0.01, I2 = 0%).
ConclusionsThis results confirmed that anti-IL-5 mAb therapy was safe and effective for CRSwNP and can serve as a second-line therapy.
Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD420251170717.

引言 本项Meta分析（meta-analysis）旨在评估抗IL-5单克隆抗体（anti-IL-5 mAb）作为慢性鼻鼻窦炎伴鼻息肉（chronic rhinosinusitis with nasal polyps, CRSwNP）二线治疗方案的安全性与有效性。

材料与方法 检索PubMed、Web of Science、Embase及Cochrane Library四个数据库，检索时限为建库至2025年9月15日，纳入比较抗IL-5单克隆抗体与安慰剂治疗CRSwNP的随机对照试验（randomized controlled trials, RCTs）。本项Meta分析的主要结局指标为鼻息肉评分（nasal polyp score, NPS）与22项鼻腔鼻窦结局测试（Sino-Nasal Outcome Test-22, SNOT-22）评分；次要结局指标包括鼻塞评分（nasal blockage score, NBS）、嗅觉减退评分（loss of smell score, LSS）、Lund-Mackay评分（Lund-Mackay score, LMS）、宾夕法尼亚大学嗅觉识别测试（University of Pennsylvania Smell Identification Test, UPSIT）评分、鼻腔总体视觉模拟量表（visual analog scale, VAS）评分、鼻腔复合视觉模拟量表评分、首次鼻息肉手术患者例数以及全身糖皮质激素（≥1个疗程）使用患者例数。

结果 最终纳入10项随机对照试验进行Meta分析。与安慰剂组相比，抗IL-5单克隆抗体治疗可显著降低鼻息肉评分（加权均数差WMD=-0.58，95%置信区间CI：-0.70~-0.46，P<0.00001，I²=83%）、SNOT-22评分（WMD=-9.57，95%CI：-11.03~-8.11，P<0.00001，I²=80%）、鼻塞评分（标准化均数差SMD=-1.75；95%CI：-3.13~-0.36，P=0.01，I²=99%）、嗅觉减退评分（SMD=-1.68；95%CI：-3.13~-0.24，P=0.02，I²=99%）、Lund-Mackay评分（WMD=-2.00；95%CI：-2.65~-1.34，P<0.00001，I²=97%）、鼻腔总体VAS评分（WMD=-1.54，95%CI：-1.64~-1.43，P<0.00001，I²=0%）、鼻腔复合VAS评分（WMD=-1.28，95%CI：-1.66~-0.19，P<0.00001，I²=0%）、首次鼻息肉手术患者例数（相对危险度RR=0.64，95%CI：0.41~1.00，P=0.05，I²=69%）以及全身糖皮质激素（≥1个疗程）使用患者例数（RR=0.73，95%CI：0.62~0.86，P=0.0002，I²=0%），同时显著改善宾夕法尼亚大学嗅觉识别测试评分（WMD=2.09，95%CI：0.42~3.77，P=0.01，I²=0%）。

结论 本研究结果证实，抗IL-5单克隆抗体治疗慢性鼻鼻窦炎伴鼻息肉安全有效，可作为二线治疗方案。

系统评价注册信息 系统评价注册平台：https://www.crd.york.ac.uk/prospero/，标识符为CRD420251170717。