地氯雷他定的安全性和有效性对象季节性过敏性鼻炎和慢性荨麻疹:四个上市后监测研究的结果。

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Bachert C,毛雷尔M

地氯雷他定的安全性和有效性对象季节性过敏性鼻炎和慢性荨麻疹:四个上市后监测研究的结果。

中国药物Investig。2010; 30(2): 109 - 22所示。doi: 10.2165 / 11530930-000000000-00000。

PubMed ID
20067329 (在PubMed
]
文摘

背景和目的:过敏性鼻炎(AR)和慢性荨麻疹(铜)是常见疾病症状,影响生活质量。第二代抗组胺药(如西替利嗪、地氯雷他定、盐酸非索非那定,氯雷他定、mizolastine)建议一线治疗条件;然而,研究这些代理商缺乏临床相关的差异。这次调查的目的是评估安全性、耐受性和疗效的地氯雷他定5毫克每天一次在四个上市后监测的研究主题与季节性AR (SAR)或慢性特发性荨麻疹(CIU)在实际临床实践设置。方法:这个项目的前瞻性监测研究是在德国进行的2001年2月至2002年3月在过敏;皮肤病;耳、鼻、喉;或惯例设置。主题(总数77 880)>或= 12岁和满足需求概述的SAR或CIU地氯雷他定治疗在包插入。所有实验对象都接受口服地氯雷他定5毫克每天一次平均持续时间为40.4天。 Adverse events (AEs) were reported throughout the studies; serious AEs were recorded for up to 30 days after treatment. Investigators and subjects both rated tolerability at the end of treatment. Symptom severity and sleep and daily activity impairment were evaluated at baseline and after treatment using 4-point scales (0 = none; 1 = mild; 2 = moderate; 3 = severe). A post hoc subanalysis assessed desloratadine efficacy and onset of symptom relief in subjects who had received monotherapy with another second-generation antihistamine. RESULTS: A total of 386 AEs were reported by 287 subjects (0.37%) in the four studies. The most commonly reported treatment-related AEs were fatigue (0.07%), headache (0.07%), dry mouth (0.04%) and nausea (0.03%). Tolerability was rated as excellent/good by 99.1% of investigators and 98.5% of subjects. Desloratadine therapy significantly reduced nasal and ocular symptom severity, itching and wheals, and sleep and activity disruption (p < 0.0001), as indicated by a reduction in mean total and individual symptom scores, and reported impairment of sleep and daily activities. The efficacy of desloratadine was rated as significantly greater by 59.4-88.0% of subjects who had previously received monotherapy with cetirizine, fexofenadine, loratadine or mizolastine (p < 0.01 for all). The percentage of subjects who rated onset of symptom relief with desloratadine as faster than previous treatment ranged from 51.6% to 82.4%. CONCLUSION: Desloratadine was safe, well tolerated and efficacious in this series of surveillance studies. A post hoc analysis of subjects who had received previous monotherapy with a second-generation antihistamine found that most subjects rated efficacy as higher than their previous treatment, with a faster onset of symptom relief.

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