{"title":"MP-AzeFlu (Dymista®)在瑞典持续性变应性鼻炎患者中的实际疗效:通过视觉模拟量表评估","authors":"Pär Stjärne, Duc Tung Nguyen, Hans Christian Kuhl","doi":"10.2147/POR.S375403","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista<sup>®</sup>) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device.</p><p><strong>Objective: </strong>This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity.</p><p><strong>Methods: </strong>A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality.</p><p><strong>Results: </strong>VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both <i>p</i> < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42.</p><p><strong>Conclusion: </strong>MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved sleep quality. MP-AzeFlu significantly improved the QoL of the patients and was well tolerated.</p>","PeriodicalId":20399,"journal":{"name":"Pragmatic and Observational Research","volume":"14 ","pages":"1-11"},"PeriodicalIF":2.3000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cf/0f/por-14-1.PMC9826638.pdf","citationCount":"0","resultStr":"{\"title\":\"Real-Life Effectiveness of MP-AzeFlu (Dymista<sup>®</sup>) in Swedish Patients with Persistent Allergic Rhinitis, Assessed by the Visual Analogue Scale.\",\"authors\":\"Pär Stjärne, Duc Tung Nguyen, Hans Christian Kuhl\",\"doi\":\"10.2147/POR.S375403\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista<sup>®</sup>) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device.</p><p><strong>Objective: </strong>This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity.</p><p><strong>Methods: </strong>A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality.</p><p><strong>Results: </strong>VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both <i>p</i> < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42.</p><p><strong>Conclusion: </strong>MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved sleep quality. MP-AzeFlu significantly improved the QoL of the patients and was well tolerated.</p>\",\"PeriodicalId\":20399,\"journal\":{\"name\":\"Pragmatic and Observational Research\",\"volume\":\"14 \",\"pages\":\"1-11\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cf/0f/por-14-1.PMC9826638.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pragmatic and Observational Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/POR.S375403\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pragmatic and Observational Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/POR.S375403","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Real-Life Effectiveness of MP-AzeFlu (Dymista®) in Swedish Patients with Persistent Allergic Rhinitis, Assessed by the Visual Analogue Scale.
Background: Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista®) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device.
Objective: This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity.
Methods: A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality.
Results: VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both p < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42.
Conclusion: MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved sleep quality. MP-AzeFlu significantly improved the QoL of the patients and was well tolerated.
期刊介绍：
Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.
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