Xu Zhaofeng, Luo Xin, Xu Lei, Deng Jie, Gao Wenxiang, Jiang Lijie, Huang Zhaoqi, Shi Jianbo, Lai Yinyan
Department of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.
Guangzhou Key Laboratory of Otorhinolaryngology, The First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University. Guangzhou, 510080, PR China.
World Allergy Organ J. 2020 Jun 11;13(6):100131. doi: 10.1016/j.waojou.2020.100131. eCollection 2020 Jun.
Local and systemic glucocorticoids are mainstay therapies for chronic rhinosinusitis. With respect to local glucocorticoids, nasal spray is used extensively, but some patients do not benefit from short-course treatment. Recently, some clinicians have focused on the effects of high-dose local glucocorticoids in chronic rhinosinusitis with nasal polyps (CRSwNP), such as treatment using nasal irrigation, transnasal nebulization, and nose-dripping therapy (nasal drop) with high-dose budesonide. However, there are little data comparing the effect of short-course high-dose local glucocorticoids with regular nasal spray and oral steroids in the treatment of preoperative CRSwNP patients. Furthermore, the appropriate use of different types of glucocorticoids in different endotypes of CRSwNP remains unclear.
This randomized controlled clinical research study was performed at a single academic center. Patients who satisfied the criteria of chronic rhinosinusitis with bilateral nasal polyps were randomly assigned in a 1:1:1 ratio to receive oral methylprednisolone, 24 mg/d and budesonide nasal spray, 256 μg/d, or intranasal budesonide suspension, 1 mg/d and budesonide nasal spray, 256 μg/d, or budesonide nasal spray, 256 μg/d for one week. Symptoms, endoscopic scores, and tissue and blood inflammatory cells were recorded before and after the study. Adverse events were recorded by clinicians.
A total of 127 patients with CRSwNP underwent randomization. The total nasal symptoms scores (TNSS) decreased significantly in all groups compared to those at baseline. The assessment of the reduction in TNSS demonstrated that the change was significantly greater in the nasal drop group than in the nasal spray group (-7.47 vs -4.10, = 0.032), and it was also greater in the oral steroid group than in the nasal spray group (-7.30 vs -4.10, = 0.039). A similar trend also appeared in the reduction in Sinonasal-Outcome Test 22 (SNOT-22). After treatment, a significantly reduction in NP score was observed in the nasal drop group (-0.82) and oral steroid group (-0.85) compared with that in the nasal spray group (-0.10), and there was no significant difference between the nasal drop and oral steroid groups ( = 0.98). While calculating the percentage of patients who were sensitive to glucocorticoid treatment, there was 10.26% in the nasal spray group, 47.37% in the nasal drop group, and 52.50% in the oral steroid group that were sensitive to glucocorticoid treatment. The reduction in NP score was more significant in patients with eosinophilic CRSwNP in the nasal drop group and oral steroid group than in the nasal spray group. However, in patients with non-eosinophilic CRSwNP, the change in NP size was similar in the different treatment groups.
Budesonide suspension nasal drop can significantly improve the quality of life and reduce the endoscopic score following short-course treatment, and the treatment effect of nasal drop was better than that of regular nasal spray. Budesonide nasal suspension can be used as a regular treatment for eosinophilic CRSwNP and can be an alternative choice for patients with a high percentage of tissue eosinophil infiltration who cannot use oral glucocorticoids.
局部和全身糖皮质激素是慢性鼻窦炎的主要治疗方法。关于局部糖皮质激素,鼻喷雾剂被广泛使用,但一些患者未从短期治疗中获益。最近,一些临床医生关注高剂量局部糖皮质激素在伴有鼻息肉的慢性鼻窦炎(CRSwNP)中的作用,例如使用高剂量布地奈德进行鼻腔冲洗、经鼻雾化和滴鼻疗法(滴鼻)。然而,比较短期高剂量局部糖皮质激素与常规鼻喷雾剂和口服类固醇在术前CRSwNP患者治疗中的效果的数据很少。此外,在CRSwNP的不同内型中不同类型糖皮质激素的适当使用仍不清楚。
这项随机对照临床研究在一个单一学术中心进行。符合双侧鼻息肉慢性鼻窦炎标准的患者按1:1:1比例随机分配,分别接受口服甲泼尼龙,24mg/d和布地奈德鼻喷雾剂,256μg/d,或鼻内布地奈德混悬液,1mg/d和布地奈德鼻喷雾剂,256μg/d,或布地奈德鼻喷雾剂,256μg/d,治疗一周。在研究前后记录症状、内镜评分以及组织和血液中的炎性细胞。临床医生记录不良事件。
共有127例CRSwNP患者进行了随机分组。与基线时相比,所有组的总鼻症状评分(TNSS)均显著降低。TNSS降低情况的评估表明,滴鼻组的变化显著大于鼻喷雾剂组(-7.47对-4.10,P = 0.032),口服类固醇组的变化也大于鼻喷雾剂组(-7.30对-4.10,P = 0.039)。鼻窦结局测试22(SNOT-22)降低方面也出现了类似趋势。治疗后,滴鼻组(-0.82)和口服类固醇组(-0.85)的鼻息肉(NP)评分较鼻喷雾剂组(-0.10)显著降低,滴鼻组和口服类固醇组之间无显著差异(P = 0.98)。在计算对糖皮质激素治疗敏感的患者百分比时,鼻喷雾剂组为10.26%,滴鼻组为47.37%,口服类固醇组为52.50%对糖皮质激素治疗敏感。滴鼻组和口服类固醇组中嗜酸性粒细胞性CRSwNP患者的NP评分降低比鼻喷雾剂组更显著。然而,在非嗜酸性粒细胞性CRSwNP患者中,不同治疗组的NP大小变化相似。
布地奈德混悬液滴鼻在短期治疗后可显著改善生活质量并降低内镜评分,且滴鼻的治疗效果优于常规鼻喷雾剂。布地奈德鼻混悬液可作为嗜酸性粒细胞性CRSwNP的常规治疗方法,对于不能使用口服糖皮质激素且组织嗜酸性粒细胞浸润百分比高的患者可作为替代选择。