生物制剂对伴息肉的慢性鼻-鼻窦炎及变应性真菌性鼻窦炎手术的影响
Impact of Biologics on Surgery in Chronic Rhinosinusitis with Polyps and Allergic Fungal Sinusitis.
作者信息
Bentan Mihai A, Pingree Graham, Lee Lawrance, Fitzpatrick Thomas, Schuman Theodore
机构信息
Department of Otolaryngology - Head and Neck Surgery, Virginia Commonwealth University Health Systems, Richmond, Virginia, U.S.A.
Virginia Commonwealth University School of Medicine, Richmond, Virginia, U.S.A.
出版信息
Laryngoscope. 2025 Feb;135(2):593-601. doi: 10.1002/lary.31774. Epub 2024 Sep 17.
OBJECTIVE
To compare the efficacy of th2-targeted biologic medications (dupilumab, omalizumab, and mepolizumab) on absolute risk reduction (ARR) of functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and allergic fungal rhinosinusitis (AFRS).
METHODS
The TriNetX Research Network database was queried for each mAb's market lifespan through March 2024. Adults with CRSwNP were propensity score matched against non-mAb controls based on age, sex, race, and asthma diagnosis. The primary outcome was rate of FESS, with secondary outcomes including inpatient admission, emergency department (ED) visit, and incidence of acute sinusitis. Subgroup analysis was performed for patients with AFRS.
RESULTS
All mAbs decreased FESS risk (dupilumab, ARR 11.48%, 95% CI 9.82%-13.15%, p < 0.001; omalizumab, ARR 12.02%, 95% CI 4.36%-19.68%, p = 0.002; mepolizumab, ARR 10.32%, 95% CI 5.24%-15.40%, p < 0.001) in CRSwNP patients. Only dupilumab also reduced risk of inpatient admission (ARR 8.59%, 95% CI 7.04%-10.15%, p < 0.001), ED visit (ARR 5.94%, 95% CI 4.28%-7.61%, p < 0.001), and acute sinusitis (ARR 2.60%, 95% CI 1.09%-4.12%, p = 0.001). In AFRS patients, only dupilumab reduced the risk of all outcomes: FESS (ARR 6.97%, 95 CI 2.86%-11.09%, p = 0.001), inpatient admission (ARR 16.93%, 95% CI 11.30%-22.57%, p < 0.001), ED visit (ARR 13.15%, 95% CI 7.15%-19.14%, p < 0.001), and acute sinusitis (ARR 7.17%, 95% CI 2.18%-12.17%, p = 0.005).
CONCLUSION
Although all mAbs reduced FESS risk in CRSwNP, only dupilumab reduced secondary outcomes as well. Similarly, only dupilumab improved all outcomes in AFRS patients. These data demonstrate the potential of mAbs in reducing disease burden and enhancing patient outcomes in CRSwNP and AFRS.
LEVEL OF EVIDENCE
NA Laryngoscope, 135:593-601, 2025.
目的
比较靶向Th2的生物药物（度普利尤单抗、奥马珠单抗和美泊利单抗）对慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）和变应性真菌性鼻窦炎（AFRS）患者功能性鼻内镜鼻窦手术（FESS）绝对风险降低（ARR）的疗效。
方法
通过查询TriNetX研究网络数据库，获取每种单克隆抗体截至2024年3月的上市使用期限。将患有CRSwNP的成年人根据年龄、性别、种族和哮喘诊断结果，采用倾向评分法与非单克隆抗体对照组进行匹配。主要结局指标为FESS发生率，次要结局指标包括住院、急诊就诊以及急性鼻窦炎的发生率。对AFRS患者进行亚组分析。
结果
在CRSwNP患者中，所有单克隆抗体均降低了FESS风险（度普利尤单抗，ARR 11.48%，95%CI 9.82%-13.15%，p＜0.001；奥马珠单抗，ARR 12.02%，95%CI 4.36%-19.68%，p = 0.002；美泊利单抗，ARR 10.32%，95%CI 5.24%-15.40%，p＜0.001）。只有度普利尤单抗还降低了住院风险（ARR 8.59%，95%CI 7.04%-10.15%，p＜0.001）、急诊就诊风险（ARR 5.94%，95%CI 4.28%-7.61%，p＜0.001）以及急性鼻窦炎风险（ARR 2.60%，95%CI 1.09%-4.12%，p = 0.001）。在AFRS患者中，只有度普利尤单抗降低了所有结局指标的风险：FESS（ARR 6.97%，95%CI 2.86%-11.09%，p = 0.001）、住院（ARR 16.93%，95%CI 11.30%-22.57%，p＜0.001）、急诊就诊（ARR 13.15%，95%CI 7.15%-19.14%，p＜0.001）以及急性鼻窦炎（ARR 7.17%，95%CI 2.18%-12.17%，p = 0.005）。
结论
虽然所有单克隆抗体均降低了CRSwNP患者的FESS风险，但只有度普利尤单抗还降低了次要结局指标的风险。同样，只有度普利尤单抗改善了AFRS患者的所有结局指标。这些数据证明了单克隆抗体在降低CRSwNP和AFRS患者疾病负担及改善患者结局方面的潜力。
证据级别
NA 《喉镜》，135:593 - 601，2025年
Zotero 插件