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| 題 名 | 中藥治療異位性皮膚炎病患之療效評估及免疫學研究=Efficacy and the Immunologic Study of Atopic Dermatitis Patients Treated with Traditional Chinese Medicine |
|---|---|
| 作 者 | 鄭慧滿; | 書刊名 | 中醫藥年報 |
| 卷 期 | 24:2 民95.10 |
| 頁 次 | 頁1-30 |
| 專 輯 | 中醫藥基因體及免疫學研究 |
| 分類號 | 414.51 |
| 關鍵詞 | 異位性皮膚炎; 雙盲安慰劑對照試驗; 中藥; 消風散; Atopic dermatitis; Traditional Chinese herbs; C-F-S; Double-blind placebo-control study; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 異位性皮膚炎是一常見的慢性搔癢性皮膚病,罹患率約2-20%,近年有日益增多的趨勢,部分病人病灶範圍廣泛,呈乾燥脫屑、苔蘚化,搔癢不已,病情頑固,對一般性治療(如:外用類固醇藥膏,口服抗組織胺)反應欠佳,病患深受其擾,不僅影響生活、求學、工作、睡眠、情緒,甚至累及家人,使家庭社會都付出極大的成本。 為評估中藥消風散的臨床療效,本研究採隨機雙盲安慰劑對照試驗,研究對象為慢性、病情嚴重、病灶呈非滲出性且以苔蘚化為主、對一般性治療反應欠佳的異位性皮膚炎病人,病人隨機進入治療組(消風散)或對照組(安慰劑),研究治療期間為八週,以評估中藥消風散的療效,評估指標主要以病灶嚴重度(紅斑及表皮損傷)和病灶面積計分。 共有71名病患加入本研究,有61名病患完成追蹤,完成率為85.9%。結果顯示第8週時治療組病灶分數改善百分比為57.6±16.1,顯著優於對照組病灶分數改善百分比之8.4±30.2,兩者差異達到統計之顯著水準(p<0.001),其中病灶紅斑分數改善百分比為58.3±24.0,顯著優於對照組病灶紅斑分數改善百分比之-0.9±40.9,兩者差異達到統計之顯著水準(p<0.001),而病灶表皮損傷分數之改善百分比治療組為56.4±19.3,對照組為10.9±28.5,兩者也達到統計之顯著水準(p<0.001)。有關病人症狀方面,皮膚搔癢改善情形治療組為1.3±0.1,對照組為0.1±0.2,治療組皮膚搔癢改善情形優於對照組,兩組之比較達統計之顯著水準(p<0.001)。而睡眠狀態之變化,治療組為0.9±0.2,對照組為-0.2±0.2,治療組也比對照組有較佳的睡眠改善情形,但兩組之比較未達統計之顯著水準(p=0.75)。病患於治療前後進行肝腎功能、血液常規檢查,治療前後並無明顯異常變化。在研究起始點,測量兩組病人血中免疫球蛋白-E(IgE),嗜伊紅性白血球(Eosinophil)數目,嗜伊紅性陽離子蛋白(ECP),細胞間白質-5(IL-5),細胞間白質-13(IL-13),結果顯示皆高於正常值,且兩組間沒有達統計之顯著水準;第八週再次測量,比較治療前後的免疫指標變化,結果顯示治療組與對照組兩組並沒有達到統計之顯著水準。本研究結果顯示中藥消風散可作為治療頑固異位性皮膚炎的另一種治療選擇,但作用機轉仍須進一步的研究及探討。 |
| 英文摘要 | Atopic Dermatitis is a common chronic pruritic disease. Recent studies suggest an overall cumulative prevalence ranges 2-20%. It is generally agreed that the reported prevalence of atopic dermatitis has been increasing 2-3 times over the last 30 years. Severe and widespread atopic dermatitis often fails to respond adequately to currently available therapy, e.g., Topical steroid and oral antihistamin. These individuals frequently endure great suffering due to extreme pruritus. Following the observations of substantial benefit among patients receiving oral treatment with traditional Chinese herbs, we undertook a double-blind, placebo- control study to assess the efficacy, and safety of traditional Chinese herbs (C-F-S 消風散) for widespread non-exudative atopic dermatitis. A total of 71 patients with long standing, refractory, widespread, atopic dermatitis were randomized into two groups: active treatment group (C-F-S 消風散) or placebo control group to receive 8-week treatments of either the active formulation of herbs or placebo herbs. The main outcome measures were extent and severity of erythema and surface damage as judged by standardized body score. Theare are 61 patients being follow-up during the entire study period with an overall complete rate of 85.9%. The results reveal that the differences of the improvemental perscent of the lesion score change during 8-week period between active treatment group and placebo group are statistically significant (active treatment group is 57.6±16.1; placebo control group is 8.4±30.2; p<0.001). The differences of the improvemental perscent of the erythema score change during 8-week period between active treatment group and placebo group are statistically significant (active treatment group is 58.3±24.0; placebo control group is -0.9±40.9; p<0.001). The differences of the improvemental perscent of the surface damage score change during 8-week period between active treatment group and placebo group are statistically significant (active treatment group is 56.4±19.3; placebo control group is 10.9±28.5; p<0.001). The differences of change of pruritus score change between active treatment group and placebo control group are statistically significant during the eight-week period (for pruritus score change, active treatment group vs. placebo control group: 1.3±0.1 vs. 0.1±0.2, p<0.001). But the differences of change of sleep condition between active treatment group and placebo control group are not statistically significant during the eight-week period (for change of sleep condition, active treatment group vs. placebo control group: 0.9±0.2 vs. -0.2±0.2, p=0.75). The patients reported no side effect although some commented on the unpalatability of the drug. Immunologic markers (IgE, eosinophil count, ECP, IL-5, IL-13) revealed above normal range at baseline. But the differences of change of Immunologic markers (IgE, eosinophil count, ECP, IL-5, IL-13) between active treatment group and placebo control group are not statistically significant during the eight-week period. Our study results suggest that Traditional Chinese herbs (C-F-S消風散) maybe an alternative choice of therapy for severe refractory, extensive, and non-exudative atopic dermatitis. But the mechanism of Traditional Chinese herb (C-F-S消風散) need to further study. |
本系統中英文摘要資訊取自各篇刊載內容。