皮下特异性免疫治疗辅助内舒拿治疗变应性鼻炎疗效与安全性的多中心临床研究  

Efficacy and safety of specific subcutaneous immunotherapy combined with nasonex for patients with allergic rhinitis in multi-center clinical study

作　　者：王建洪[1] 黄榆岚 王仁君[1] 刘世喜[2] 孙永东[3] 梁国庆[4] 陆中友[4] 王杰[5] 董钏[5] 

机构地区：[1]宜宾市第一人民医院耳鼻咽喉头颈外科,四川宜宾644000 [2]四川大学华西医院耳鼻咽喉头颈外科 [3]泸州医学院附属中医院耳鼻咽喉头颈外科 [4]自贡市第四人民医院耳鼻咽喉头颈外科 [5]绵阳市中心医院耳鼻咽喉头颈外科

出　　处：《临床耳鼻咽喉头颈外科杂志》2015年第20期1777-1781,共5页Journal of Clinical Otorhinolaryngology Head And Neck Surgery

基　　金：四川省卫生厅科研项目(No:120013)

摘　　要：目的：探讨多中心协作临床研究皮下特异性免疫治疗辅助内舒拿治疗变应性鼻炎的疗效与安全性。方法：将4个中心的438例尘螨变应原导致的常年性变应性鼻炎患者随机分为单纯皮下特异性免疫治疗组（对照组）及皮下特异性免疫治疗辅助内舒拿治疗组（实验组）,治疗期间通过鼻部症状评分、鼻炎相关生活质量评分及屋尘螨血清特异性IgE检测指标评价2组患者临床疗效,并对治疗后患者出现的不良反应进行记录分析和评估。结果：全部患者中,42例在治疗过程中因效果不佳脱落,其余396例患者均完成2年治疗疗程。其中192例患者（对照组）和204例患者（实验组）分别完成单纯的皮下特异性免疫治疗和皮下特异性免疫治疗联合使用内舒拿治疗;318例在治疗开始后15周进入维持剂量阶段,72例在16~20周进入维持剂量阶段,6例长期低剂量（60 000~80 000U）维持治疗。治疗2年时,对照组鼻部症状总评分（3.20±1.38）、屋尘螨血清特异性IgE水平（27.69±9.37）及生活质量评分较治疗前显著减少（P〈0.01）;实验组鼻部症状总评分（2.85±1.12）、屋尘螨血清特异性IgE水平（25.31±7.21）及生活质量评分较前均显著减少（均P〈0.01）,且发生全身不良反应的例数与次数均低于对照组。结论：皮下特异性免疫治疗辅助内舒拿治疗变应性鼻炎疗效与安全性优于单纯的皮下特异性免疫治疗。Objective：To explore the efficacy and safety of specific subcutaneous immunotherapy（SCIT） com- bined with nasonex for patients with allergic rhinitis in multi-center. Method： Four hundred and thirty-eight pa tients with perennial allergic rhinitis caused by dust mite allergen in four centers were divided into simple subcuta- neous specific immunotherapy group （control group） and subcutaneous specific immunotherapy treatment with Na- sonex group （active group）. Nasal symptom scores, the Rhinoconjunctivitis Quality of Life Questionnaire （RQLQ）, the specific immunoglobulin E（SIgE） and adverse reactions were recorded to evaluate the clinical effica- cy and satety. Result：In all patients,there were 42 patients quited because the effect was not obvious. The remai- ning 396 patients completed 2 years of treatment, of which 192 patients （control group） and 204 patients （active group） completed simple SCIT and SCIT treatment combined with nasonex; 318 cases entered the maintenance phase after 15 weeks, 72 cases entered the maintenance phase in 16 -- 20 weeks, 6 eases long-term low dose （60 000--80 000 U）maintenance therapy. During the two-years of treatment, in control group, the nasal symptoms total score 3.20± 1.38, the serum house-dust mite specific IgE levels 27.69 ± 9.37 and the quality of life score significantly reduced （P〈0.01）. In active group ,the nasal symptoms total score 2.85±1.12, the serum house- dust mite specific IgE levels 25.31±7.21 and the quality of life score decreased significantly （P〈0.01）, systemic adverse reactions was significantly lower than the control group. Conclusion：The efficacy and safety of SCIT combined with nasonex is better than simple subcutaneous specific immunotherapy.

关 键 词：鼻炎 变应性 常年性 皮下特异性免疫治疗 抗原 尘螨属 内舒拿 

分 类 号：R765.21[医药卫生—耳鼻咽喉科]