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盐酸奥洛他定鼻喷雾剂 0.6%与盐酸氮䓬斯汀鼻喷雾剂 0.1%治疗血管运动性鼻炎的两周对比研究。

Two-week comparison study of olopatadine hydrochloride nasal spray 0.6% versus azelastine hydrochloride nasal spray 0.1% in patients with vasomotor rhinitis.

机构信息

Allergy and Asthma Care, Germantown, Tennessee 38138, USA.

出版信息

Allergy Asthma Proc. 2011 Mar-Apr;32(2):151-8. doi: 10.2500/aap.2011.32.3439. Epub 2011 Feb 23.

Abstract

Olopatadine hydrochloride nasal spray 0.6% (OLO) and azelastine nasal spray 137 micrograms (AZE) are effective in treating allergic rhinitis and AZE is indicated for nonallergic vasomotor rhinitis (VMR). This study evaluates the relative safety and efficacy of OLO and AZE in patients with VMR. This randomized, double-blind, parallel-group, multicenter study compared OLO (an investigational use) with AZE over 14 days in patients (n = 129) ≥12 years of age with chronic VMR. Efficacy included the severity of nasal symptom scores. Safety included adverse events (AEs) and nasal examinations. Patient perceptions of treatment satisfaction and changes in allergy condition were determined using the Treatment Satisfaction Questionnaire for Medication and Patient Global Assessment scores. In the OLO and AZE groups, reflective scores for individual nasal symptoms (nasal congestion, rhinorrhea, postnasal drip, and sneezing) and total nasal VMR symptom scores decreased significantly from baseline to day 14 (p < 0.05). No significant between-group differences were observed (p > 0.05). No serious AEs were reported in either group. Overall, 22 and 20 AEs were reported in the OLO and AZE groups, respectively. The most common AE was taste disturbance, reported by three (5.3%) and six (10.3%) patients in the OLO and AZE groups, respectively. Patients in both groups reported similar treatment satisfaction scores and a majority of patients in both groups perceived an overall improvement in their rhinitis condition. OLO has a similar efficacy and safety profile to AZE for the management of VMR in patients ≥12 years of age.

摘要

盐酸奥洛他定鼻腔喷雾剂 0.6%(OLO)和氮卓斯汀鼻腔喷雾剂 137 微克(AZE)可有效治疗过敏性鼻炎,且 AZE 适用于非过敏性血管运动性鼻炎(VMR)。本研究评估了 OLO 和 AZE 在 VMR 患者中的相对安全性和疗效。这是一项随机、双盲、平行分组、多中心研究,比较了 129 例年龄≥12 岁慢性 VMR 患者使用 OLO(研究用)和 AZE 治疗 14 天的效果。疗效包括鼻腔症状评分的严重程度。安全性包括不良事件(AE)和鼻腔检查。采用药物治疗满意度问卷和患者总体评估评分来确定患者对治疗的满意度和过敏状况的变化。在 OLO 和 AZE 组中,从基线到第 14 天,单个鼻腔症状(鼻塞、流涕、鼻后滴注和打喷嚏)和总 VMR 症状评分的反射评分均显著降低(p<0.05)。两组间无显著差异(p>0.05)。两组均未报告严重 AE。总体而言,OLO 和 AZE 组分别报告了 22 例和 20 例 AE。最常见的 AE 是味觉障碍,OLO 和 AZE 组分别有 3 例(5.3%)和 6 例(10.3%)患者报告。两组患者的治疗满意度评分相似,且两组大多数患者均认为其鼻炎状况总体有所改善。OLO 对于治疗年龄≥12 岁的 VMR 患者具有与 AZE 相似的疗效和安全性。

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