消風散治療異位性皮膚炎的臨床與實驗研究

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题名:	消風散治療異位性皮膚炎的臨床與實驗研究 Study on the Clinical Trial and Mechanism of Xiao-Feng-San in Atopic Dermatitis
作者:	鄭慧滿
贡献者:	中醫學系博士班
关键词:	異位性皮膚炎;中醫藥;隨機雙盲安慰劑對照臨床試驗;消風散;NF-κB活性 Atopic Dermatitis;randomized double-blind placebo - controlled trial;Traditional Chinese Medicine;Xiao-Feng-San;NF-κB activation
日期:	2011-01-13
上传时间:	2011-10-17 16:05:02 (UTC+8)
出版者:	中國醫藥大學
摘要:	中文摘要異位性皮膚炎是一常見的搔癢性慢性發炎性皮膚病，病情頑固嚴重的異位性皮膚炎病患，對外用類固醇及口服抗組織胺反應欠佳，而需要服用免疫抑制劑治療，有些雖然有效但對人體常有副作用。近年來吾人從治療異位性皮膚炎病患的經驗中，發現以消風散治療這類頑固異位性皮膚炎病患有良好的療效。本研究欲探討消風散治療異位性皮膚炎的臨床療效及安全性，並探討消風散抑制皮膚炎症反應的作用機轉。本臨床試驗採隨機雙盲安慰劑對照方式，有71名病情頑固的嚴重異位性皮膚炎病患接受8週治療，其中消風散組47名，安慰劑組24名，每4週評估一次，觀察病灶分數、紅斑分數、表皮損傷分數、搔癢及睡眠狀況，評估消風散的療效。有關探討消風散抑制皮膚炎症反應的作用機轉部分，選用人體皮膚角質細胞株(HaCat cell line)，利用酵素連結免疫吸附法(enzyme-linked immunosorbent assay, ELISA)、西方墨點法分析(Western Blot Analysis)和電泳遷移率方法(Electrophoretic Mobility Shift Assay )，建立研究皮膚炎症的體外細胞模式，藉此模式探討消風散對NF-κB活性的抑制作用，並進一步探討消風散的活性成分抑制NF-κB活性之機轉。研究結果顯示臨床試驗消風散組病灶分數改善百分比顯著優於安慰劑組(79.10 ± 5.70% vs. 13.50 ± 7.56%；p < 0.001)，在紅斑分數、表皮損傷分數、皮膚搔癢及睡眠狀況，消風散組改善的情形也是優於安慰劑組，兩組間達到統計之顯著水準，此外消風散並無明顯副作用，所以消風散可以作為治療頑固異位性皮膚炎的有效方法。有關消風散抑制皮膚炎症反應的作用機轉，透過脂多醣體（lipopolysaccharide；LPS）誘發HaCat Cells 產生細胞激素(IL-1β 及 TNF-α)，成功建立皮膚炎症的體外細胞模式，藉此模式證實消風散可抑制NF-κB的活性，其組成中以荊芥的抑制作用最佳，而荊芥的主要成分是薄荷酮(Menthone)，它也可抑制NF-κB的活性，其機轉可能與I-κB磷酸化及β-TrCP路徑有關。本研究建立從臨床到基礎的研究模式，以嚴謹的科學方法證實消風散的臨床療效，並首創皮膚炎症的體外細胞模式，透過此模式證實消風散及其活性成分可抑制NF-κB活性，達到抑制皮膚炎症反應的作用。 Abstract Background: Severe and widespread atopic dermatitis often fails to respond adequately to topical steroids and oral antihistamines, and requires immunomodulatory drugs which, although effective, have undesirable toxic effects. Methods: (1).In this prospective, randomized, double-blind, placebo - controlled trial, 71 patients with severe intractable atopic dermatitis were given an 8-week treatment with oral Xiao-Feng-San (47 patients) or placebo (24 patients). Total lesion score, erythema score, surface damage score, pruritus score, and sleep score were measured at 4 week intervals. (2).During the HaCat cell line experiment, we observed cell growth with MTT assay and lipopolysaccharide (LPS) induced IL-1β and TNF-α production in HaCat cells with ELISA. We also observed the influence and mechanism of Xiao-Feng-San and menthone in NF-κB activity with Western blot and EMSA. Results: (1). Fifty-six patients completed both the treatment and follow-up periods. The decrease in the total lesion score in the treatment group at 8 weeks was significantly greater than that of the placebo group (79.7±5.8% vs 13.5±7.64%; p<0.001). There was also a statistically significant difference between treatment and placebo groups in erythema, surface damage, pruritus, and sleep scores. The difference between the two groups was still significant in all outcome measures except the erythema score, at 12 weeks follow-up, after the 8 week-treatment had ended. Patients reported no side effects from treatment. (2). Xiao-Feng-San and menthone can suppress the LPS-induced proinflammatory cytokines, IL-1β and TNF-α, as well as NF-κB activity induced by LPS. The translocation of NF-κB activated by LPS into the nucleus was suppressed by menthone. I-κB and β-transducin repeat containing protein (β-TrCP) were both involved in this suppression. Conclusion: Our study results suggest that the traditional Chinese herbal medicine, Xiao-Feng-San, may be an alternative choice of therapy for severe intractable atopic dermatitis.And it has provided molecular evidence for Xiao-Feng-San and menthone effect on NF-κB activation. Our study builds up a model from clinical to basic study in tranditional Chinese medicine.
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