油性及水性中藥藥膠布之安全性及致敏性評估

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標題:	油性及水性中藥藥膠布之安全性及致敏性評估 Evaluation on the Safty and Allergenic Activity of Oil- and Water-Based Chinese Medicine Patches
作者:	楊竹茂林靖南
貢獻者:	藥學系
關鍵字:	安全性致敏性中藥藥膠布 Safty Allergenic Activites Chinese Medicine Patches
日期:	2000
上傳時間:	2008-11-21 10:35:49 (UTC+8)
出版者:	行政院衛生署
摘要:	本計畫旨在評估市售中藥藥膠布(包括經衛生署查驗登記有案及未經查驗登記)之安全性及致敏性。由於此類藥膠布依所使用煉合基劑之特性又分為所謂「油性」與「水性」兩種，本計畫將同時列入評估。本計畫受試者將徵求本校日間部男、女性同學(年齡:18-26歲)及進修部男、女性同學(年齡:>40歲)，自願者分別為「青少年組」及「中老年組」以期瞭解年齡及性別差異。試驗時，受試樣品(預計20種)將購自本地藥局及中醫診所或民俗療法業者，水性藥膠布將商請製造廠提供。每一品牌藥膠布將同時貼於「青少年組」及「中老年組」各五十名，男、女各半。測試前將每一品牌藥膠布剪成1.5 cm2，登各相距1cm貼於受試者兩上臂內側，上面以3M安全膠布緊密覆蓋。試驗進行時，每位受試者將被要求貼足24小時後接受問卷及檢診判定。試驗結果必須在20分鐘內判讀，並且接續觀察3天。判定標準：以貼藥處之表面症狀及受試者自覺症狀為計分(Scoring)標準 0分：貼處無任何異樣或症狀。 1分：貼處呈現融合性紅斑(confluent erythema)，無其它症狀。 2分：貼處呈現融合性紅斑，且自覺發癢。 3分：貼處呈現融合性紅斑，並且明顯發疹。 4分：除以上症狀外，另有其他症狀：如腫、痛、潰瘍等。以上明顯症狀將同時照相存證問卷內容：包括(1)個人及家庭病史調查(濕疹、特異性體質等) (2)用藥歷史 (3)自覺症狀(癢、刺激性、痛等)。試驗所得數據將使用X2 test及Fisher's exact test作為統計學數據處理，p值＜0.05被認為具有統計學意義。 The aim of this protocol is to evaluate the safeties and allergenic activities of Chinese medicine patches including officially registered and not registered products. Patches classified as "oily" and "moistened" based on the natures of adhesive bases are involved in the experiments. The volunteers will be recruited from the students (both male and female) of this college and divided into two groups, i.e. the "younger" aged from 18~26 and the "elders" aged not less than 40, at least of 100 volunteers are included in each group. At least of 20 preparations will be purchased from drug stores or Chinese medicine clinics. Some of "moistened" preparations will be provided by the manufacturers. Each preparation will be cut as 1.5 cm2 and patched on the tender surface of upper arms of volunteers of both groups, with 1-cm interval between each other, and then occluded with non-allergenic 3M adhesive types. During the experiment, every volunteer will be asked not to tear down the patches for 24 hrs unless suffered unendurable severe syndrome (pruritus, swell, pain,..). After 24 hrs occlusion, the volunteers will be asked to answer the questionnaire and the patched area have to be examined for the possible skin allergy. The examination should be accomplished with 20 minutes and consecutively observed for further 3 days. Examination criteria: scoring based on the manifestation of skin surface and personal complaints. 0: Normal 1: Confluent erythema appeared merely 2: Confluent erythema appeared and pruritus complained 3: Confluent erythema and rash appeared 4: Other than confluent erythema, severe syndromes including swelling, pain, and ulceration suffered Severe syndromes will be photographe d for re-checking. The contents of the questionnaire including: (1) Personal and family history about eczema and atopy (2) Medical history (3) Individual complaints. The data analysis will be performed with X2 test and Fisher's exact test, and p <0.05 will be statistically significant.
關聯:	計畫編號：CCMP89-CP-003
顯示於類別:	[藥學系(所)] 其他研究計畫

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