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題 名 | Clinical Evaluation of Azelastine Nasal Spray Versus Terfenadine in the Treatment of Allergic Rhinitis=Azelastine鼻噴劑與Terfenadine治療鼻過敏症的臨床評估 |
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作 者 | 劉嘉銘; 許明哲; | 書刊名 | 中華民國耳鼻喉科醫學雜誌 |
卷 期 | 34:6 民88.11-12 |
頁 次 | 頁471-478 |
分類號 | 416.853 |
關鍵詞 | 鼻噴劑; 過敏性鼻炎; Azelasine; Terfenadine; Nasal spray; Allergic rhinitis; |
語 文 | 英文(English) |
中文摘要 | 背景:抗組織胺是治療鼻過敏症必須使用的葯物。Azelastine是一種具選擇性的抗組織胺其口服劑相當有效且病人忍受度高。Azelastine (Az)鼻噴劑局部。給葯劑量較小,較不會產生嗜睡等副作用。本試驗的目的即為比較Az與Terfenadine(Te) 對於治療過敏性鼻炎之療效及耐受性。方法:本試驗為雙盲試驗,受試者被隨機分成2組,每組分別接受: 1) Az鼻噴劑,每天用2次,每次噴各個鼻腔一下。安慰錠劑,每天2次,每次1顆。2) Te 60mg 錠劑,每天2次,每次1顆。鼻噴安慰劑,每天2次次噴各個鼻腔一下。試驗過程為期3週,4次門診,包含1週之run-in-phase 及2週之治療期。症狀評估包括:1)鼻症動:打噴嚏,鼻子癢,流鼻水,鼻塞 ; 2) 眼症狀:眼睛癢,流眼淚。以上6種症狀,以分為4級之量表評估症狀嚴重程度。另蛉並記錄:想睡覺、口乾、口苦、頭暈、腸胃不適、鼻子有炙熱感,或是其他副作用。49名過敏性鼻炎者加入此試驗,其中19名接受Az鼻噴劑,23名接受口服Te的受試者完成此試驗。總計42名的臨床數據納入統計分析評估療效及安全性。結果:79%的Az鼻噴劑者及59%的Te 者的症狀有明顯改善。2組之差異不具統計學意義(p值>0.200)。2組受試者在第3次及第4次回診(治療期第8天及第15天)症狀總分均獲得改善。Az 組比Te 組有較好的改善。接受Az鼻噴劑者其症狀總分平均值由6.0(治療前1天)降到4.0(治療期第8天)及3.8(治療期第15天)。接受Te 者其症狀總分平均值由5.9 (治療前1天)降到5.2(治療期第8天)及4.1 (治療期第15天)。42名受試者的數據也同時作安全性的評估。評估標準以受試者報告之副作用為依據,評估之重點是思睡、口乾、口苦、頭暈、腸胃不適,鼻子有炙熱感。結果顯示,除了口苦之副作用有明顯差界(Az組高於Te組),其他副作用2組受試者之發生機率相當。結論:每天2次,每次使用Az 鼻噴劑0.14mg/每鼻腔(0.56mg/天)對過敏性鼻炎的治療有效及具安全性。Az 鼻噴劑至少與口服Te 每天2次,每次60mg的效果相似,且僅少數有輕微的副作用。 |
英文摘要 | BACKGROUND: Anitihistamines are primarile used for the therapy of allergic rhinitis. Azelastine tablet is very effective and well tolerated. The newly developed Azelastine nasal spray has the advantage of acting more rapidly and in lower doses because of the local administration in the affected area. METHODS: This study was designed as double-blind, randomized, active controlled with parallel group to compare the therapeutic efficacy and tolerance of intranasal Azelastine with that of Terfenadine tablet in relieving both the nasal and eye symptoms in allergic rhinitis patients. RESULTS: The results showed that after 2 weeks of treatment, 79% of patients in Azelastine group (n=19) and 59% of patients in Terfenadine group (n=23) had improvement in the symptom assessment. The percentage was not statistically different between treatments (p>0.20). Except for the event of bitter taste when significant difference was found in Azelastine group, other adverse experiences were compatible between treatments. CONCLUSIONS: This clinical study demonstrates the efficacy and safety of a twice daily dosage of Azelastine nasal spray, 0.14 mg per nostril (0.56mg Azelastine/day), in the treatment of allergic rhinitis. The efficacy of Azelastine nasal spray is at least as good as that of Terfenadine, 60 mg tablets b.i.d. The safety outcomes show that Azelastine nasal spray is safe in the treatment of allergic rhinitis. |
本系統中英文摘要資訊取自各篇刊載內容。