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題 名 | 臺灣地區異位性皮膚炎患者使用tacrolimus油膏之療效與安全性評估=Efficacy and Safety of Tacrolimus Ointment for Patients of Atopic Dermatitis in Taiwan |
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作 者 | 吳育欣; 王璽卿; 宗天一; 李定達; 沈瑞隆; | 書刊名 | 中華皮膚科醫學雜誌 |
卷 期 | 22:1 2004.03[民93.03] |
頁 次 | 頁15-22 |
分類號 | 415.712 |
關鍵詞 | 異位性皮膚炎; tacrolimus油膏; 療效; 安全性; Atopic dermatitis; Tacrolimus; Efficacy; Safety; |
語 文 | 中文(Chinese) |
中文摘要 | Tacrolimus油膏是專為異位性皮膚炎開發之局部使用、非類固醇類之免疫調節劑。我們選擇78名台灣地區兩歲以上之中、重度異位性皮膚炎患者進行一多醫學中心、開放、單一藥物、為期四週之治療試驗,試驗期間給予0.03%或0.1%的tacrolimus油膏,針對其療效與安全性作進一步探討。我們發現醫師臨床整體評估、濕疹面積與嚴重度指標、患部體表面積百分比及患者/家屬對癢的評估,在第一週後都有顯著的改善,並且其療效能持續到試驗結束。在安全性方面,tacrolimus之血中濃度大都在安全下限(1.5 ng/ ml)之下。最常見之副作用包括使用後有短暫之灼熱感、搔癢情形及刺痛感,但大都在三天內便消失(佔52%)。在我們的臨床試驗中可以發現,tacrolimus油膏在治療異位性皮膚炎患者是具療效且安全的。 |
英文摘要 | Tacrolimus ointment is a topical non - steroid immunomodulator formulated for patients of atopic dermatitis. In this multi-center, open -labeled, single - drug, 4 - week clinical trial, 78 patients of moderate to severe atopic dermatitis in Taiwan were enrolled. During this study, we used 0.03 % or 0.1 % tacrolimus ointment to assess its efficacy and safety. Significant improvement in physician's global evaluation of clinical response, eczema area and severity index, percent body surface affected and the patient's / parent's assessment of pruritus was observed in the first week. The effectiveness could be maintained through the study. In evaluation of safety, the concentration of tacrolimus in serum was mostly lower than the limit of quantification (1.5 ng / ml). The most common side effects observed included burning sensation, pruritus and stinging sensation, but the symptoms usually subsided in the first three days (52 %). In conclusion, tacrolimus ointment is effective and safe for patients of atopic dermatitis. |
本系統中英文摘要資訊取自各篇刊載內容。