Otorhinolaryngology Hospital, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Institute of Otorhinolaryngology and Shenzhen Key of Otorhinolaryngology, Longgang Otorhinolaryngology Hospital, Shenzhen, China.
Rhinology. 2023 Aug 1;61(4):328-337. doi: 10.4193/Rhin22.328.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disorder. We aimed to evaluate the value of blood eosinophil count (BEC) for guiding oral corticosteroid therapy for CRSwNP.
Subjects with CRSwNP were entered into a 2:1 randomized biomarker-directed corticosteroid versus standard therapy study base on the principle of potential benefits to patients. Subjects in the standard arm received oral prednisone (30mg/day) alone for 7 days, whereas in the biomarker-directed arm, prednisone (30mg/day), or nasal steroid spray (budesonide 256ug/day) was given according to the BEC which was measured to define eosinophil-high and -low CRSwNP (BEC > and < 0.37x109/L, respectively). The primary outcome was the total nasal symptom scores (TNSS) of the two arms with the non-inferiority margin of 1.8. Secondary outcomes included nasal polyp size scores (NPSS) and SNOT-22. Patients were followed up the day after last dose of treatment.
A total of 105 subjects with CRSwNP were randomized into the biomarker-directed therapy group or the standard care group. The biomarker therapy demonstrated non-inferiority compared to standard care. There were no between-group differences for TNSS, NPSS and SNOT-22 improvements after treatment. Comparisons of TNSS, SNOT-22 and NPSS revealed no significant difference in terms of the effectiveness ratios of the biomarker-directed therapy and the standard care.
A biomarker-directed strategy using the BEC can be used to direct corticosteroid therapy without increasing treatment failure or worsening of symptoms in patients with CRSwNP.
伴有鼻息肉的慢性鼻-鼻窦炎（CRSwNP）是一种异质性疾病。我们旨在评估血嗜酸性粒细胞计数（BEC）指导 CRSwNP 患者口服皮质类固醇治疗的价值。
根据对患者潜在获益的原则，将 CRSwNP 患者纳入 2:1 随机生物标志物指导皮质类固醇与标准治疗研究。标准组接受单独口服泼尼松龙（30mg/天）治疗 7 天，而生物标志物指导组则根据 BEC 给予泼尼松龙（30mg/天）或鼻用皮质类固醇喷雾（布地奈德 256ug/天），以定义嗜酸性粒细胞高和低 CRSwNP（BEC>和<0.37x109/L，分别）。主要结局是两个治疗组的总鼻症状评分（TNSS），非劣效性边界为 1.8。次要结局包括鼻息肉大小评分（NPSS）和 SNOT-22。患者在最后一次治疗剂量后第二天进行随访。
共有 105 例 CRSwNP 患者被随机分配到生物标志物指导治疗组或标准护理组。生物标志物治疗与标准护理相比具有非劣效性。治疗后 TNSS、NPSS 和 SNOT-22 改善方面，两组间无差异。生物标志物指导治疗与标准护理的有效性比较显示，TNSS、SNOT-22 和 NPSS 均无显著差异。
使用 BEC 的生物标志物指导策略可用于指导皮质类固醇治疗，而不会增加 CRSwNP 患者的治疗失败率或症状恶化。
