{"title":"抗ige治疗变应性鼻炎在重症特应性支气管哮喘合并变应性鼻炎患者中的临床应用效果","authors":"D. Kiseleva, Evgeny K. Beltyukov, V. Naumova","doi":"10.36691/rja1533","DOIUrl":null,"url":null,"abstract":"BACKGROUND: Omalizumab, by binding IgE in atopic patients, can improve clinical and functional parameters and patients' quality of life. \nAIMS: to evaluate efficacy of anti-IgE-therapy in patients with allergic rhinitis treated with omalizumab for concomitant severe atopic asthma in real clinical practice. \nMATERIALS AND METHODS: An open, non-interventional, prospective and non-randomized study in a real clinical practice. \nThe study was conducted in the Sverdlovsk region in October 2021 based on a regional registry of adult patients with severe asthma with chronic nasal inflammatory diseases and receiving targeted therapy. Dynamics of nasal symptoms was assessed using SNOT-22 questionnaire and visual analogue scale initially, after 4 and 12 months of omalizumab therapy. Peripheral blood eosinophils level was also assessed before and after 4 months of omalizumab therapy. \nRESULTS: The study included 26 patients. Assessment of nasal symptoms dynamics using the SNOT22 questionnaire at baseline and after 4 months on omalizumab therapy revealed decrease in the severity of symptoms (p 0.001): baseline - 46.8522.04 points (95% CI 37.94-55.75), after 4 months - 30.6514.81 points (95% CI 24.67-36.64). Also improvement in SNOT22 questionnaire score was revealed in 18 patients treated with omalizumab during 12 month: before therapy - 47.5 points (Q₁ -Q₃: 35.7-59.3), after 4 months - 30.4 points (Q₁- Q₃: 22.1-38.1), after 12 months - 24.9 points (Q₁ -Q₃: 16.9-32.9) (p = 0.001). Improvement in rhinitis symptoms control was observed according to the VAS scale: VAS before therapy - 8.0 points (Q₁-Q₃: 6.2-9.0), after 4 months - 5.0 points (Q₁- Q₃: 3.2-5, 8), after 12 months of treatment - 5.0 points (Q₁-Q₃: 4.0-6.8). The level of eosinophils (n=16) decreased from 510.9317.9 (95% CI 341.5680.3) cells /l to 327.4217.7 (95% CI 211.4443.5) cells /l after 4 months of anti-IgE-therapy (p0.041). \nCONCLUSIONS: Omalizumab in real clinical practice has demonstrated improvement of rhinitis symptoms control and quality of life in patients with allergic rhinitis with concomitant severe atopic asthma. It was accompanied by a statistically significant decrease in peripheral blood eosinophils level, that largely determines airway inflammation severity and clinical manifestations of allergic rhinitis and bronchial asthma.","PeriodicalId":270411,"journal":{"name":"Russian Journal of Allergy","volume":"30 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2022-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The effectiveness of anti-IgE therapy for allergic rhinitis in patients with severe atopic bronchial asthma and concomitant allergic rhinitis in real clinical practice\",\"authors\":\"D. Kiseleva, Evgeny K. Beltyukov, V. Naumova\",\"doi\":\"10.36691/rja1533\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"BACKGROUND: Omalizumab, by binding IgE in atopic patients, can improve clinical and functional parameters and patients' quality of life. \\nAIMS: to evaluate efficacy of anti-IgE-therapy in patients with allergic rhinitis treated with omalizumab for concomitant severe atopic asthma in real clinical practice. \\nMATERIALS AND METHODS: An open, non-interventional, prospective and non-randomized study in a real clinical practice. \\nThe study was conducted in the Sverdlovsk region in October 2021 based on a regional registry of adult patients with severe asthma with chronic nasal inflammatory diseases and receiving targeted therapy. Dynamics of nasal symptoms was assessed using SNOT-22 questionnaire and visual analogue scale initially, after 4 and 12 months of omalizumab therapy. Peripheral blood eosinophils level was also assessed before and after 4 months of omalizumab therapy. \\nRESULTS: The study included 26 patients. Assessment of nasal symptoms dynamics using the SNOT22 questionnaire at baseline and after 4 months on omalizumab therapy revealed decrease in the severity of symptoms (p 0.001): baseline - 46.8522.04 points (95% CI 37.94-55.75), after 4 months - 30.6514.81 points (95% CI 24.67-36.64). Also improvement in SNOT22 questionnaire score was revealed in 18 patients treated with omalizumab during 12 month: before therapy - 47.5 points (Q₁ -Q₃: 35.7-59.3), after 4 months - 30.4 points (Q₁- Q₃: 22.1-38.1), after 12 months - 24.9 points (Q₁ -Q₃: 16.9-32.9) (p = 0.001). Improvement in rhinitis symptoms control was observed according to the VAS scale: VAS before therapy - 8.0 points (Q₁-Q₃: 6.2-9.0), after 4 months - 5.0 points (Q₁- Q₃: 3.2-5, 8), after 12 months of treatment - 5.0 points (Q₁-Q₃: 4.0-6.8). The level of eosinophils (n=16) decreased from 510.9317.9 (95% CI 341.5680.3) cells /l to 327.4217.7 (95% CI 211.4443.5) cells /l after 4 months of anti-IgE-therapy (p0.041). \\nCONCLUSIONS: Omalizumab in real clinical practice has demonstrated improvement of rhinitis symptoms control and quality of life in patients with allergic rhinitis with concomitant severe atopic asthma. It was accompanied by a statistically significant decrease in peripheral blood eosinophils level, that largely determines airway inflammation severity and clinical manifestations of allergic rhinitis and bronchial asthma.\",\"PeriodicalId\":270411,\"journal\":{\"name\":\"Russian Journal of Allergy\",\"volume\":\"30 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-07-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Russian Journal of Allergy\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.36691/rja1533\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Russian Journal of Allergy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.36691/rja1533","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景:Omalizumab通过结合IgE治疗特应性患者,可以改善患者的临床和功能参数,提高患者的生活质量。目的:评价抗ige治疗奥玛珠单抗治疗变应性鼻炎合并严重特应性哮喘的临床疗效。材料和方法:一项开放、非介入性、前瞻性和非随机的临床实践研究。该研究于2021年10月在斯维尔德洛夫斯克地区进行,基于接受靶向治疗的严重哮喘合并慢性鼻炎性疾病成年患者的区域登记。在奥玛单抗治疗4个月和12个月后,最初使用SNOT-22问卷和视觉模拟量表评估鼻腔症状的动态。在奥玛珠单抗治疗前后4个月也评估外周血嗜酸性粒细胞水平。结果:纳入26例患者。在基线和奥玛单抗治疗4个月后使用SNOT22问卷评估鼻部症状动态显示症状严重程度降低(p 0.001):基线- 46.8522.04点(95% CI 37.94-55.75), 4个月后- 30.6514.81点(95% CI 24.67-36.64)。在12个月内,18名接受omalizumab治疗的患者的SNOT22问卷评分也有所改善:治疗前- 47.5分(Q₁- Q₃:35.7-59.3),4个月后- 30.4分(Q₁- Q₃:22.1-38.1),12个月后- 24.9分(Q₁- Q₃:16.9-32.9)(p = 0.001)。根据VAS量表观察鼻炎症状控制的改善:治疗前VAS - 8.0分(Q₁-Q₃:6.2-9.0),4个月后VAS - 5.0分(Q₁-Q₃:3.2- 5,8),治疗12个月后- 5.0分(Q₁-Q₃:4.0-6.8)。抗ige治疗4个月后,嗜酸性粒细胞(n=16)水平从510.9317.9 (95% CI 341.5680.3)个细胞/l下降到327.4217.7 (95% CI 211.4443.5)个细胞/l (p0.041)。结论:在实际临床实践中,Omalizumab可改善变应性鼻炎合并严重特应性哮喘患者的鼻炎症状控制和生活质量。伴有外周血嗜酸性粒细胞水平的显著下降,这在很大程度上决定了气道炎症的严重程度和变应性鼻炎、支气管哮喘的临床表现。
The effectiveness of anti-IgE therapy for allergic rhinitis in patients with severe atopic bronchial asthma and concomitant allergic rhinitis in real clinical practice
BACKGROUND: Omalizumab, by binding IgE in atopic patients, can improve clinical and functional parameters and patients' quality of life.
AIMS: to evaluate efficacy of anti-IgE-therapy in patients with allergic rhinitis treated with omalizumab for concomitant severe atopic asthma in real clinical practice.
MATERIALS AND METHODS: An open, non-interventional, prospective and non-randomized study in a real clinical practice.
The study was conducted in the Sverdlovsk region in October 2021 based on a regional registry of adult patients with severe asthma with chronic nasal inflammatory diseases and receiving targeted therapy. Dynamics of nasal symptoms was assessed using SNOT-22 questionnaire and visual analogue scale initially, after 4 and 12 months of omalizumab therapy. Peripheral blood eosinophils level was also assessed before and after 4 months of omalizumab therapy.
RESULTS: The study included 26 patients. Assessment of nasal symptoms dynamics using the SNOT22 questionnaire at baseline and after 4 months on omalizumab therapy revealed decrease in the severity of symptoms (p 0.001): baseline - 46.8522.04 points (95% CI 37.94-55.75), after 4 months - 30.6514.81 points (95% CI 24.67-36.64). Also improvement in SNOT22 questionnaire score was revealed in 18 patients treated with omalizumab during 12 month: before therapy - 47.5 points (Q₁ -Q₃: 35.7-59.3), after 4 months - 30.4 points (Q₁- Q₃: 22.1-38.1), after 12 months - 24.9 points (Q₁ -Q₃: 16.9-32.9) (p = 0.001). Improvement in rhinitis symptoms control was observed according to the VAS scale: VAS before therapy - 8.0 points (Q₁-Q₃: 6.2-9.0), after 4 months - 5.0 points (Q₁- Q₃: 3.2-5, 8), after 12 months of treatment - 5.0 points (Q₁-Q₃: 4.0-6.8). The level of eosinophils (n=16) decreased from 510.9317.9 (95% CI 341.5680.3) cells /l to 327.4217.7 (95% CI 211.4443.5) cells /l after 4 months of anti-IgE-therapy (p0.041).
CONCLUSIONS: Omalizumab in real clinical practice has demonstrated improvement of rhinitis symptoms control and quality of life in patients with allergic rhinitis with concomitant severe atopic asthma. It was accompanied by a statistically significant decrease in peripheral blood eosinophils level, that largely determines airway inflammation severity and clinical manifestations of allergic rhinitis and bronchial asthma.