Department of Medical and Surgical Sciences and Advanced Technologies "GF Ingrassia" ENT Section, University of Catania, 95123, Catania, Italy.
ENT Surgeon, Department of Oto-Rhino-Laryngology Head and Neck Surgery, La Conception University Hospital, Aix-Marseille Univ, 147 Bd Baille, 13005, Marseille, France.
Eur Arch Otorhinolaryngol. 2024 Jan;281(1):219-226. doi: 10.1007/s00405-023-08184-6. Epub 2023 Aug 18.
Recovery of olfactory function plays a prominent role in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). While rates and timing of such recovery vary, monoclonal antibodies might yield better results which we aimed at evaluating with this study.
A prospective controlled study was conducted at our tertiary otolaryngological center from April 1, 2021, to October 1, 2022, in CRSwNP patients. We included an active group (n = 60 patients) performing dupilumab treatment and a control group (n = 60 patients) treated with intranasal and oral corticosteroids. Primary endpoints were changes in smell visual analogical scale (VAS) and SS-I (Sniffin' Sticks-identification) scores, and olfactory recovery rate. The secondary efficacy endpoints were nasal obstruction, rhinorrhea, headache, SNOT-22, and nasal congestion score (NCS).
At 6 months, the active group demonstrated better outcomes than control in SS-I scores (10.23 ± 4.21 vs.3.68 ± 3.08; p < 0.001). No significant differences were found in blood eosinophil count, SNOT-22, and NPS (p > 0.05 for all). Olfactory function in the treatment arm improved in 86.66% (52/60 cases), with normal scores in 48.33% (29/60), while the control group reported a lower recovery rate (3/60; 5%), with no normal olfaction cases. Log-rank comparison for Kaplan-Meier functions was statistically significant (p < 0.001), but no differences were found in subanalysis in the active group based on blood eosinophil count at baseline, SNOT-22, and NPS scores.
Patients who receive dupilumab treatment may experience a faster recovery of olfactory function compared to those receiving corticosteroid therapy. This result would be maintained regardless of the severity of type 2 CRSwNP inflammation, the volume of the polyps, or the patient's subjective symptomatology.
嗅觉功能的恢复在慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)患者中起着重要作用。尽管恢复的速度和时间有所不同,但单克隆抗体可能会产生更好的效果,我们旨在通过这项研究对此进行评估。
本研究为 2021 年 4 月 1 日至 2022 年 10 月 1 日在我们的三级耳鼻喉中心进行的前瞻性对照研究,纳入 CRSwNP 患者,包括实验组(n=60 例,接受度普利尤单抗治疗)和对照组(n=60 例,接受鼻内和口服皮质类固醇治疗)。主要终点为嗅觉视觉模拟量表(VAS)和 SS-I(Sniffin' Sticks-Identification)评分以及嗅觉恢复率的变化。次要疗效终点为鼻阻塞、鼻漏、头痛、SNOT-22 和鼻腔充血评分(NCS)。
在 6 个月时,实验组的 SS-I 评分优于对照组(10.23±4.21 对 3.68±3.08;p<0.001)。两组间血嗜酸性粒细胞计数、SNOT-22 和 NPS 无显著差异(p>0.05)。治疗组 86.66%(52/60 例)嗅觉功能改善,48.33%(29/60)嗅觉正常,对照组恢复率较低(3/60;5%),无嗅觉正常病例。Kaplan-Meier 函数的对数秩检验具有统计学意义(p<0.001),但在实验组中,根据基线时血嗜酸性粒细胞计数、SNOT-22 和 NPS 评分进行亚分析时未发现差异。
与接受皮质类固醇治疗的患者相比,接受度普利尤单抗治疗的患者嗅觉功能恢复更快。无论 2 型 CRSwNP 炎症的严重程度、息肉体积或患者的主观症状如何,这种结果都将保持不变。