METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
方法:于2021年4月1日至2022年10月1日在我们的三级耳鼻喉科中心对CRSwNP患者进行了一项前瞻性对照研究。我们包括进行dupilumab治疗的活跃组(n=60例)和使用鼻内和口服皮质类固醇治疗的对照组(n=60例)。主要终点是嗅觉视觉模拟量表(VAS)和SS-I(Sniffin\'Sticks-identification)评分的变化,和嗅觉回收率。次要疗效终点是鼻塞,鼻漏,头痛,SNOT-22和鼻塞评分(NCS)。
结果:在6个月时,活动组的SS-I评分结果优于对照组(10.23±4.21vs.3.68±3.08;p<0.001).血嗜酸性粒细胞计数无显著差异,SNOT-22和NPS(全部p>0.05)。治疗臂嗅觉功能改善86.66%(52/60例),正常分数为48.33%(29/60),而对照组报告较低的恢复率(3/60;5%),没有正常嗅觉病例。Kaplan-Meier函数的对数秩比较具有统计学意义(p<0.001),但在基于基线时血液嗜酸性粒细胞计数的亚组分析中没有发现差异,SNOT-22和NPS得分。
结论:接受dupilumab治疗的患者与接受皮质类固醇治疗的患者相比,嗅觉功能恢复更快。无论2型CRSwNP炎症的严重程度如何,这一结果都将得到维持。息肉的体积,或者病人的主观症状。