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一项观察性研究,以确定MP-AzeFlu在奥地利持续性变应性鼻炎患者中的实际疗效。

An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu in Austrian Patients with Persistent Allergic Rhinitis.

作者信息

Marth Katharina, Renner Andreas, Langmayr Georg, Pohl Wolfgang, Nguyen Duc Tung, Kuhl Hans Christian

机构信息

Department of Pulmonology, Karl Landsteiner Institute for Experimental and Clinical Pneumology, Hietzing Hospital, 1130, Vienna, Austria.

Diakonissen-Hospital Linz, Leoding, Austria.

出版信息

Drugs Real World Outcomes. 2024 Jun;11(2):231-240. doi: 10.1007/s40801-023-00412-z. Epub 2024 Feb 13.

Abstract

BACKGROUND

Many patients with allergic rhinitis (AR) have moderate-to-severe persistent AR. Meda Pharma's AzeFlu (MP-AzeFlu) is an intranasal AR treatment comprising a novel formulation of azelastine hydrochloride and fluticasone propionate in a single device.

METHODS

This prospective observational study of 214 adults and adolescents in Austria with moderate-to-severe persistent AR assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; daily doses: azelastine hydrochloride 548 μg; and fluticasone propionate 200 μg) for AR control in clinical practice using the visual analog scale. Symptom severity was reported on days 0, 1, 3, 7, 14, 21, 28, 35, and 42. Patient demographics, AR phenotype, allergen sensitization, symptomatology, AR treatments in the previous year, and the reason for the MP-AzeFlu prescription were recorded.

RESULTS

MP-AzeFlu treatment was associated with a rapid and statistically significant reduction in the visual analog scale score from baseline to each timepoint measured, including day 1 (all p < 0.0001). Mean (standard deviation) visual analog scale score was 53.5 mm (26.3) at baseline, 25.3 mm (21.0) on day 28, and 19.6 mm (17.4) on day 42, a mean overall reduction from baseline of 41.4 (23.9) mm for completers. Results were consistent irrespective of patient age, gender, severity, or traditional AR phenotype. Prior to MP-AzeFlu prescription, congestion was considered the most bothersome symptom. The majority of patients reported using at least two AR therapies in the past year, including oral antihistamines, intranasal corticosteroids, and intranasal antihistamines.

CONCLUSIONS

Many patients in Austria live with uncontrolled persistent AR despite treatment. MP-AzeFlu provides effective and rapid control of persistent AR in a real-world Austrian setting.

摘要

背景

许多过敏性鼻炎(AR)患者患有中重度持续性AR。美达药业的阿泽氟(MP - 阿泽氟)是一种鼻内AR治疗药物,在单一装置中包含盐酸氮卓斯汀和丙酸氟替卡松的新型配方。

方法

这项对奥地利214名患有中重度持续性AR的成人和青少年进行的前瞻性观察研究,使用视觉模拟量表评估了MP - 阿泽氟(每侧鼻孔每日两次喷雾;每日剂量:盐酸氮卓斯汀548μg;丙酸氟替卡松200μg)在临床实践中控制AR的有效性。在第0、1、3、7、14、21、28、35和42天报告症状严重程度。记录患者人口统计学、AR表型、过敏原致敏情况、症状学、前一年的AR治疗情况以及MP - 阿泽氟处方的原因。

结果

MP - 阿泽氟治疗与从基线到每个测量时间点(包括第1天)的视觉模拟量表评分快速且具有统计学意义的降低相关(所有p < 0.0001)。基线时平均(标准差)视觉模拟量表评分为53.5mm(26.3),第28天为25.3mm(21.0),第42天为19.6mm(17.4),完成治疗者从基线的平均总体降低为41.4(23.9)mm。无论患者年龄、性别、严重程度或传统AR表型如何,结果均一致。在开具MP - 阿泽氟处方之前,鼻塞被认为是最困扰的症状。大多数患者报告在过去一年中至少使用过两种AR治疗方法,包括口服抗组胺药、鼻内皮质类固醇和鼻内抗组胺药。

结论

在奥地利,尽管进行了治疗,但许多患者仍患有未得到控制的持续性AR。MP - 阿泽氟在奥地利的实际环境中能有效且快速地控制持续性AR。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc5c/11176283/63b15ede14c4/40801_2023_412_Fig1_HTML.jpg

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