Abstract：
BACKGROUND: 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.
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.
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.
摘要：
背景：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。虽然这种恢复的速度和时间各不相同，单克隆抗体可能会产生更好的结果，我们旨在通过这项研究进行评估。
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。
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。
