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題 名 | Tacrolimus Ointment for the Treatment of Atopic Dermatitis: Report of First Clinical Experience in Taiwan=Tacrolimus軟膏治療異位性皮膚炎--臺灣首度臨床報告 |
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作 者 | 藍政哲; 黃潔貞; 陳毓婷; 王莉芳; 林建德; 陳國熏; | 書刊名 | The Kaohsiung Journal of Medical Sciences |
卷 期 | 19:6 2003.06[民92.06] |
頁 次 | 頁296-304 |
分類號 | 415.712 |
關鍵詞 | 異位性皮膚炎; 臺灣病人; Atopic dermatitis; Tacrolimus; Taiwanese; |
語 文 | 英文(English) |
中文摘要 | 異位性皮膚炎是一種搔癢、反覆性發炎的皮膚疾病。近年來,topical tacrolimus 已發展在治療異位性皮膚炎。本文描述台灣第一個 topical tacrolimus 之臨床經驗。研究方法採 opened-labeled 及 single-arm。從 2002 年 2-5 月在三個中心實施。每一個獨立的研究期間為 4 週,將個案分為兒童(26 位)及成人(42 位)兩群體,在治療結束時由 physician's global evaluation 評估 tacrolimus 療效。有效的治療定義為 50% 以上的改善。其他評值包含 Eczema Area and Severity Index(EASI)、受影響的體表面積 body surface area(BSA)百分比、病人搔癢狀況及整體反應評估。在安全考量面之評估,為血液、生化及 tacrolimus 血液中濃度三方面。所有藥物副作用均作完整紀錄。在整體成功率為兒童 80.8% 及成人 82.1%。EASI、受影響的 BSA 及病人搔癢狀況三方面的下降皆具統計意義(p < 0.001)。在兒童及成人群體各有 88% 及 100% 對 tacrolimus 的臨床反應表示滿意。在兒童及成人群體各自有 61.5% 及 76.2% 的人有副作用產生,最常見副作用為皮膚燒灼感,但並不會造成病人終止治療。本文揭示了 tacrolimus 軟膏對治療台灣病人異位性皮膚炎是有效且安全的。 |
英文摘要 | Atopic dermatitis (AD) is a pruritic recurring inflammatory skin disease. Recently, topical tacrolimus has been developed to treat AD. This report presents the first clinical experience with topical tacrolimus in Taiwan. This open-label, single-arm study was conducted at three centers from February to May 2002. The duration of each individual treatment was 4 weeks. Two groups were defined: pediatric and adult. Efficacy was evaluated on the basis of the physician’s global evaluation at the end of treatment. Success was defined as at least 50% improvement. Other evaluations included the Eczema Area and Severity Index (EASI), the percentage of body surface area (BSA) involved, the patient’s assessment of pruritus, and the patient’s assessment of overall response. Safety profile was established by monitoring changes in hematology and biochemistry profiles and tacrolimus concentration in blood. All adverse events were recorded. Twenty-six pediatric patients and 42 adult patients were enrolled. Overall success rates were 80.8% and 82.1% in the pediatric and adult groups, respectively. The declines in EASI, percentage of BSA affected, and patient’s assessment of pruritus were significant (p < 0.001); 88% and 100% of pediatric and adult patients, respectively, reported a favorable response to treatment. Changes in blood samples were unremarkable. Of pediatric and adult patients, 61.5% and 76.2%, respectively, reported adverse events. The most common adverse event reported was skin burning, which did not result in discontinuation of therapy. This report reveals that tacrolimus ointment is effective and safe for the treatment of AD in Taiwanese patients. |
本系統中英文摘要資訊取自各篇刊載內容。