Fairchild Carol J, Meltzer Eli O, Roland Peter S, Wells David, Drake Margaret, Wall G Michael
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, Texas 76134, USA.
Allergy Asthma Proc. 2007 Nov-Dec;28(6):716-23. doi: 10.2500/aap.2007.28.3062.
Seasonal allergic rhinitis (SAR) treatment should reduce symptoms and help patients resume normal function. This study was performed to determine the effect of olopatadine (Olo) nasal spray on symptoms, quality of life (QoL), work, and activities of SAR patients. A pooled analysis was conducted of two Institutional Review Board-approved, randomized, double-blind clinical trials that compared 2-week treatment with Olo 0.6% and Olo 0.4% to placebo. Symptoms were assessed with the Total Nasal Symptom Score (TNSS) from daily diaries. Health outcomes were measured by the Work Productivity and Activity Impairment Questionnaire-Allergy Specific (WPAI-AS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The studies included 1240 SAR patients with a mean age of 37 years; 64% were women. TNSS and RQLQ improvements were significantly different from placebo: TNSS, Olo 0.6% (p < 0.0001) and Olo 0.4% (p < 0.0037); RQLQ, Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). WPAI-AS improvements also were significant for overall work impact and activity impairment in the Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). Correlations between Olo 0.6% TNSS scores and work impact were r = 0.45 (p < 0.0001); activities, r = 0.55 (p < 0.0001); and RQLQ score, r = 0.61 (p < 0.0001), indicating that symptom reduction with Olo therapy was associated with improvements in function and QoL. Adverse events were nonserious and infrequent in all treatment groups. The most frequent adverse events were unpleasant taste and headache. This analysis indicates that Olo is a safe and effective intranasal treatment and is associated with significant improvement in QoL and ability to perform work and conduct usual activities of SAR patients.
季节性变应性鼻炎(SAR)的治疗应减轻症状,并帮助患者恢复正常功能。本研究旨在确定奥洛他定(Olo)鼻喷雾剂对SAR患者的症状、生活质量(QoL)、工作及日常活动的影响。对两项经机构审查委员会批准的随机双盲临床试验进行了汇总分析,这两项试验比较了使用0.6% Olo和0.4% Olo进行2周治疗与使用安慰剂治疗的效果。通过每日日记中的总鼻症状评分(TNSS)评估症状。通过工作效率和活动障碍问卷-变应性鼻炎特异性(WPAI-AS)和鼻结膜炎生活质量问卷(RQLQ)衡量健康结果。研究纳入了1240例平均年龄为37岁的SAR患者;64%为女性。TNSS和RQLQ的改善与安慰剂相比有显著差异:TNSS方面,0.6% Olo组(p < 0.0001)和0.4% Olo组(p < 0.0037);RQLQ方面,0.6% Olo组(p < 0.001)和0.4% Olo组(p < 0.05)。在总体工作影响和活动障碍方面,0.6% Olo组(p < 0.001)和0.4% Olo组(p < 0.05)的WPAI-AS改善也具有显著性。0.6% Olo组的TNSS评分与工作影响之间的相关性为r = 0.45(p < 0.0001);与活动之间的相关性为r = 0.55(p < 0.0001);与RQLQ评分之间的相关性为r = 0.61(p < 0.0001),这表明Olo治疗减轻症状与功能和QoL的改善相关。所有治疗组的不良事件均不严重且发生率低。最常见的不良事件是味觉不适和头痛。该分析表明,Olo是一种安全有效的鼻内治疗药物,与SAR患者的QoL显著改善以及工作和进行日常活动的能力提高相关。