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The Efficacy and Safety of Desloratadine versus Loratadine in the Treatment of Allergic Rhinitis

Desloratadine與Loratadine治療過敏性鼻炎之有效性與安全性比較

摘要


背景:Desloratadine是新一代的抗組織胺藥物,屬於loratadine的一個活性代謝物。根據動物試驗結果顯示,desloratadine與loratadine有相同的藥理特徵與機轉,本研究之目的在探討desloratadine治療過敏性鼻炎之有效性與安全性。 方法:本研究是一個雙盲,隨機分布,14天治療期間與活性對照組控制之設計試驗,比較desloratadine與loratadine在治療過敏性鼻炎之有效性與安全性。 結果:經過14天治療,兩組試驗組之所有受試者在第一週後鼻炎與非鼻炎症狀均有明顯的改善,而且改善的程度維持至第二週後。在療效評估中,兩組的結果在統計學上並沒有顯著差異。在安全性評估方面,最常見的藥物不良反應為頭痛。在14天治療後,所有受試者的生命徵象、理學檢查、肝腎功能檢查及心電圖均沒有顯著的改變。 結論:本研究顯示,desloratadine治療過敏性鼻炎和loratadine有相同的療效,同時也有很好的耐受性,而且並未曾發生心臟毒性副作用。

並列摘要


BACKGROUND: Desloratadine, an active metabolite of loratadine, is a new antihistamine agent. According to animal studies, desloratadine and loratadine have the same pharmacological properties and mechanisms. The aim of the current study was to compare the efficacy and safety between desloratadine and loratadine in the treatment of allergic rhinitis. METHODS: This study was designed as a double-blind, randomized, 14-day treatment, which was actively controlled to compare the efficacy and safety of desloratadine with loratadine in subjects with allergic rhinitis. RESULTS: After a 14-day treatment period, all subjects in the two groups showed improvement in the total nasal and non-nasal symptom scores after the first week of treatment and the efficacy was maintained until the end of second week of treatment. However, no statistically significant differences were observed between the two groups. Regarding safety, the most common adverse event was headache. After 14-day treatment period, the vital signs, physical examinations, laboratory tests for renal and hepatic functions and ECG did not show significant changes from baseline in all subjects. CONCLUSIONS: The study showed that desloratadine had comparable efficacy with loratadine, and was well tolerated without cardiotoxic effects in treating patients with allergic rhinitis.

並列關鍵字

allergic rhinitis desloratadine loratadine

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