一项观察性研究,旨在确定 MP-AzeFlu® 对奥地利持续性过敏性鼻炎患者的实际疗效。

IF 1.9 Q3 PHARMACOLOGY & PHARMACY Drugs - Real World Outcomes Pub Date : 2024-06-01 Epub Date: 2024-02-13 DOI:10.1007/s40801-023-00412-z
Katharina Marth, Andreas Renner, Georg Langmayr, Wolfgang Pohl, Duc Tung Nguyen, Hans Christian Kuhl
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引用次数: 0

摘要

背景:许多过敏性鼻炎(AR)患者都患有中度至重度持续性 AR。Meda Pharma公司的AzeFlu(MP-AzeFlu®)是一种鼻内AR治疗药物,由盐酸阿折司汀和丙酸氟替卡松的新型配方组成:这项前瞻性观察研究针对奥地利214名患有中度至重度持续性AR的成人和青少年,采用视觉模拟量表评估了MP-AzeFlu(每日两次,每次一喷;每日剂量:盐酸阿折拉斯汀548微克;丙酸氟替卡松200微克)在临床实践中控制AR的效果。第 0、1、3、7、14、21、28、35 和 42 天报告症状严重程度。记录了患者的人口统计学特征、AR 表型、过敏原致敏、症状、前一年的 AR 治疗情况以及开 MP-AzeFlu 处方的原因:结果:MP-AzeFlu治疗后,患者的视觉模拟评分从基线到每个测量时间点(包括第1天)都出现了快速且统计学意义上的显著下降(所有P 均为0):在奥地利,尽管接受了治疗,但仍有许多患者患有无法控制的持续性 AR。在奥地利的实际环境中,MP-AzeFlu 能有效、快速地控制持续性 AR。
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An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu® in Austrian Patients with Persistent Allergic Rhinitis.

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.

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来源期刊
Drugs - Real World Outcomes
Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
5.00%
发文量
49
审稿时长
8 weeks
期刊介绍: Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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