Berger W, Bousquet J, Fox A T, Just J, Muraro A, Nieto A, Valovirta E, Wickman M, Wahn U
Division of Basic Clinical Immunology, School of Medicine, University of California, Irvine, CA, USA.
Allergy & Asthma Associates, Mission Viejo, CA, USA.
Allergy. 2016 Aug;71(8):1219-22. doi: 10.1111/all.12903. Epub 2016 Jun 1.
The objective was to evaluate the efficacy of MP-AzeFlu (Dymista(®) ) vs fluticasone propionate (FP), (both 1 spray/nostril bid), in children with allergic rhinitis (AR). MP-AzeFlu combines azelastine hydrochloride, FP and a novel formulation in a single spray. Children were randomized in a 3 : 1 ratio to MP-AzeFlu or FP in this open-label, 3-month study. Efficacy was assessed in children aged ≥ 6 to <12 years (MP-AzeFlu: n = 264; FP: n = 89), using a 4-point symptom severity rating scale from 0 to 3 (0 = no symptoms; 3 = severe symptoms). Over the 3-month period, MP-AzeFlu-treated children experienced significantly greater symptom relief than FP-treated children (Diff: -0.14; 95% CI: -0.28, -0.01; P = 0.04), noted from the first day (particularly the first 7 days) and sustained for 90 days. More MP-AzeFlu children achieved symptom-free or mild symptom severity status, and did so up to 16 days faster than FP. MP-AzeFlu provides significantly greater, more rapid and clinically relevant symptom relief than FP in children with AR.
目的是评估MP - AzeFlu(Dymista(®))与丙酸氟替卡松(FP)(均为每侧鼻孔喷1次,每日2次)治疗变应性鼻炎(AR)儿童的疗效。MP - AzeFlu在单一喷雾剂中联合了盐酸氮卓斯汀、FP和一种新型制剂。在这项开放标签的3个月研究中,儿童按3∶1的比例随机分组接受MP - AzeFlu或FP治疗。对年龄≥6至<12岁的儿童(MP - AzeFlu组:n = 264;FP组:n = 89)进行疗效评估,使用0至3的4级症状严重程度评定量表(0 =无症状;3 =严重症状)。在3个月期间,MP - AzeFlu治疗的儿童比FP治疗的儿童症状缓解明显更显著(差异:-0.14;95%置信区间:-0.28,-0.01;P = 0.04),从第1天(尤其是前7天)开始即有此表现,并持续90天。更多接受MP - AzeFlu治疗的儿童达到无症状或轻度症状严重程度状态,且比接受FP治疗的儿童快达16天。在AR儿童中,MP - AzeFlu比FP能提供更显著、更迅速且具有临床意义的症状缓解。