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題 名 | Fexofenadine HCl (Allegra)對於治療過敏性鼻炎效益與安全性評量的臨床試驗=Safety and Efficacy of Fexofenadine HCl (Allegra) in the Treatment of Allergic Rhinitis--Chinical Experience |
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作 者 | 嚴敏心; 王拔群; 張燕良; | 書刊名 | 慈濟醫學 |
卷 期 | 14:5 2002.10[民91.10] |
頁 次 | 頁295-300 |
分類號 | 418.2324 |
關鍵詞 | 啡索啡那定; 過敏性鼻炎; 安全性; 效益; Fexofenadine; Allergic rhinitis; Safety; Efficacy; |
語 文 | 中文(Chinese) |
中文摘要 | 目的:Fexofenadine HC1 (Allegra)是目前市場上最新型的H1接受體拮抗劑,它是terfenadine衍生而來的活性代謝物。根據國外臨床試驗佐證,它具有抗過敏、無嗜睡、作用迅速的優點,不但不會有心臟方面的副作用,更不會因不同的藥劑量影響中樞神經系統而導致行為能力或精神運動的傷害;因此,本篇文章主要是根據本科臨床試驗來探討fexofenadine HC1 (Allegra)於過敏性鼻炎的臨床治療效益。病人與方法:本試驗有33名過敏性鼻炎患者合乎納入標準參與其中,有16名男性,17名女性,年齡均大於12歲,因有1名患者未回診而未納入評估,總計有32名患者資料可供分析。我們給予受試者fexofenadine 60 mg bid治療達14天之久,記錄並分析服用藥物前後症狀嚴重度改善情況並評估其安全性。結果:由試驗結果得知,服藥後32名受試者,有30名受試者明顯的症狀改善(94%),實效上(efficacy)有統計學上顯著的差異(p<0.005):安全性上,32名受試者中,有1位在服藥後有輕微頭痛,1位有輕微思睡,1位有噁心,1位有全身無力,但總體而言,未有明顯的副作用。耐受性上,相當良好者有25位,良好者有5位,不滿意者有2位,共計耐受性高達94%。結論:由本試驗得到的結論是fexofenadine不失為一個有相當良好耐受性及治療效果兼具安全性的過敏性鼻炎治療藥劑,60mg bid是目前建議合理使用劑量。 |
英文摘要 | Objective: Fexofenadine HC1 (Allegra) is a new safe congener of the nonsedating H1 antagonists. It is an active metabolite of terfenadine. It has an established and valued place in the rapid symptomatic treatment of allergy without cardiogenic side effects. It is highly selective for H1 receptors and is devoid of significant anticholinergic actions. Poor penetration by the drug into the CNS appears to account for its low incidence of side effects. Patients and Methods: We studied 33 patients with allergic rhinitis (older than 12 years old) in this open label, randomized clinical trial. Patients with a symptom score (TSS) over 6 for sneezing, rhinorrhea, itchy nose and itchy eyes were selected for study. Fexofenadine 60 mg bid was given for 14 days. The efficacy, tolerance, and safety of the drug were evaluated. Result: One patient was lost to follow-up, for a total of 32 patients in the trial. In the efficacy trial, 30 out of 32 patients had good results. The tolerance for the drug was 94%. Only 4 patients had mild side effects as follows: one with headache, one with sedation, one with nausea, and one with fatigue. Conclusions: Fexofenadine is a safe H1 antagonist. Fexofenadine 60 mg bid is a new H1 antagonist with high efficacy and low risk. It is a good alternative for treatment of allergic rhinitis. |
本系統中英文摘要資訊取自各篇刊載內容。