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特定免疫球蛋白 E 反应和合并症对真实研究中 MP-AzeFlu 疗效的影响。

Effect of Specific Immunoglobulin E Response and Comorbidities on Effectiveness of MP-AzeFlu in a Real-Life Study.

机构信息

Zentrum für Rhinologie und Allergologie, Wiesbaden, Germany,

Primary Care Respiratory Medicine, University of Aberdeen, Aberdeen, United Kingdom.

出版信息

Int Arch Allergy Immunol. 2020;181(10):754-764. doi: 10.1159/000508749. Epub 2020 Aug 21.

Abstract

INTRODUCTION

Phenotyping allergic rhinitis (AR) by immunoglobulin E (IgE) sensitivity and comorbidities may help characterize AR and provide a framework for treatment decisions.

METHODS

This prospective, noninterventional study evaluated the effectiveness of MP-AzeFlu (azelastine hydrochloride plus fluticasone propionate intranasal spray formulation) across AR phenotypes. Patients with moderate-to--severe seasonal or perennial AR for whom MP-AzeFlu was prescribed were enrolled. AR subpopulations (ARPs) were assigned based on the classification of IgE response and comorbidities. AR symptoms over the previous 24 h were documented using an AR visual analog scale (AR-VAS), with ratings from "not at all bothersome" (0 mm) to "extremely bothersome" (100 mm), at the inclusion visit and on days 1, 3, 7, and the last day of the study (approximately day 14). AR quality-of-life measures were recorded using a VAS.

RESULTS

A total of 1,103 patients with AR were included. Mean baseline AR-VAS scores ranged from 70.3 to 75.1 mm (severe) across ARPs. In the overall population, 86.6% of patients responded to treatment (AR-VAS score <50 mm on ≥1 days). In the ARPs, response rates ranged from 79.3 to 89.6%. Mean reduction in AR-VAS scores ranged from 47.9 to 40.9 mm, a decrease from severe to mild across all ARPs. Quality-of-life VAS scores were similarly reduced in the total population and ARPs.

DISCUSSION/CONCLUSION: MP-AzeFlu treatment reduced VAS severity and quality-of-life scores from baseline in the total population and ARPs, supporting MP-AzeFlu as an effective treatment for all patients with moderate-to-severe AR, regardless of AR phenotype or comorbidities.

摘要

简介

通过免疫球蛋白 E(IgE)敏感性和合并症对变应性鼻炎(AR)进行表型分析可以帮助确定 AR 并为治疗决策提供框架。

方法

这项前瞻性、非干预性研究评估了 MP-AzeFlu(盐酸氮卓斯汀和丙酸氟替卡松鼻喷雾剂)在各种 AR 表型中的疗效。招募了因中度至重度季节性或常年性 AR 而被处方 MP-AzeFlu 的患者。根据 IgE 反应和合并症的分类,将 AR 亚群(ARPs)分配。在纳入访视以及第 1、3、7 天和研究的最后一天(大约第 14 天),使用 AR 视觉模拟量表(AR-VAS)记录过去 24 小时的 AR 症状,评分从“完全不麻烦”(0 毫米)到“非常麻烦”(100 毫米)。使用 VAS 记录 AR 生活质量指标。

结果

共有 1103 例 AR 患者入选。在 ARPs 中,平均基线 AR-VAS 评分从 70.3 至 75.1 毫米(重度)不等。在总体人群中,86.6%的患者对治疗有反应(至少 1 天 AR-VAS 评分<50 毫米)。在 ARPs 中,反应率从 79.3%至 89.6%不等。AR-VAS 评分的平均降低幅度从 47.9 至 40.9 毫米不等,在所有 ARPs 中,从重度到轻度。在总体人群和 ARPs 中,生活质量 VAS 评分也得到了类似的降低。

讨论/结论:MP-AzeFlu 治疗可降低总体人群和 ARPs 中 AR-VAS 严重程度和生活质量评分,支持 MP-AzeFlu 作为治疗中重度 AR 的有效药物,无论 AR 表型或合并症如何。

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