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背景:屋尘螨(HDM)过敏与持续性变应性鼻炎(AR)和变应性性哮喘有关。目的:探讨标准化(SQ)HDM舌下含服免疫治疗片剂(ALK,H?rsholm,丹麦)治疗成人和青少年呼吸道HDM变应性疾病的疗效和安全性并报告AR治疗结果。方法:将604例至少14岁的患HDM过敏的AR及轻至中度HDM变应性哮喘的患者随机双盲1:1:1:1分为4组,每天分别给予1,3,6 SQ-HDM或安慰剂治疗。治疗结束时的鼻结膜炎症状和药物评分是预先确定的肺外终点。随后对总联合鼻炎评分(total combined rhinitis score,TCRS)大于0的患者(如在4周的基线期内的AR症状和/或AR药物的使用)进行亚组分析。该亚组包括498例(82%)患者。结果:在亚组中,6SQ-HDM组和安慰剂组间的治疗结束后的TCRS绝对差异为-0.78在(95%置信区间为-1.47~-0.07,相对差异为28.8%,P=0.0357)。此外,标准活动时的鼻炎生活质量问卷总分(RQLQ)及其各维度评分(活动,睡眠,非鼻、非眼部症状,鼻部症状)存在显着差异。TCRS和鼻炎生活质量问卷评分与计量有关,1和3 SQ-HDM组间评分数值差异较低,无显著性差异。整个试验人群分析显示安慰剂组和治疗组之间的差异无统计学意义。没有观察到所涉及的安全问题。结论:轻到重度AR的6 SQHDM治疗组的疗效与安慰剂组相比表现在,TCRS和鼻炎生活质量问卷评分较鼻炎基线水平明显改善,具有统计学意义。治疗的耐受性良好。
BACKGROUND: House dust mite (HDM) allergy is associated with persistent allergic rhinitis (AR) and allergic asthma. Objective: To investigate the efficacy and safety of standard (SQ) sublingual HDM sublingual immunotherapy tablets (ALK, H? Rsholm, Denmark) in the treatment of allergic diseases of the respiratory tract in adults and adolescents and to report the results of AR treatment. Methods: A total of 604 patients with HDM-allergic AR and mild-to-moderate HDM allergic asthma who were at least 14 years old were randomly assigned to 4 groups with 1, 2 and 6 SQ -HDM or placebo treatment. Nasal conjunctivitis symptoms and drug scores at the end of treatment are pre-determined extra-pulmonary end points. Subsequent analyzes were then performed on patients with a total combined rhinitis score (TCRS) greater than 0, such as AR symptoms and / or use of AR drugs over a 4 week baseline period. This subgroup consisted of 498 patients (82%). RESULTS: In the subgroup, the absolute difference in TCRS after treatment between the 6SQ-HDM and placebo groups was -0.78 (95% confidence interval -1.47 to -0.07, relative difference 28.8%, P = 0.0357) . In addition, there were significant differences in RQLQ and scores of various dimensions (activities, sleep, non-nasal, non-ocular symptoms, nasal symptoms) during standard activities. TCRS and rhinitis quality of life questionnaire scores and measurement, 1 and 3 SQ-HDM scores between the scores were lower, no significant difference. Analysis of the entire trial population showed no significant difference between the placebo group and the treatment group. No security issues were observed. CONCLUSIONS: The efficacy of 6 SQHDM in patients with mild-to-severe AR was significantly better than that of placebo in assessing the quality of life of the TCRS and rhinitis questionnaires, which was statistically significant compared with baseline levels of rhinitis. The treatment is well tolerated.