臺灣博碩士論文加值系統

乾癬是一種臨床上反覆發作的慢性皮膚病，我們先前的臨床初步觀察，發現以青黛為主的外用油膏局部治療尋常型乾癬有令人滿意的成效。因此本研究的目的在評估青黛外用治療尋常型乾癬的療效，並藉由分析治療後的病灶組織學變化進一步暸解其藥理機轉。
本研究採用單盲、隨機、基質對照、病人自身左右比較的方法進行實驗。治療病灶採用中藥青黛油膏局部外用，1次/天，對照病灶用基質當安慰劑，療程為8週。依病患受試病灶紅斑、浸潤厚度、鱗屑的輕重程度和病灶清除比率來對療效進行評估。實驗結束後對受試病灶進行皮膚切片，做組織H&E染色與免疫組織化學染色，受試前後每位受試者均做全血常規和肝腎功能檢查分析。病灶治療前後和青黛與安慰劑之間的差異，其統計學分析採用Wilcoxon sign rank檢驗。
治療8週後，使用青黛油膏的治療病灶，無論是紅斑、病灶厚度、脫屑程度和病灶面積的改善程度，都比基質治療的對照病灶顯著。H & E染色：青黛治療病灶的角質層增厚、角化不全現象、真皮乳頭層增長和毛細血管擴張等現象，都比對照病灶明顯改善。免疫組織化學染色：青黛油膏治療病灶的Ki-67和keratin 6表現明顯比對照病灶減少，而involucrin、filaggrin和keratin 10的表現則比對照病灶顯著，接近正常的皮膚。實驗過程中並無不良反應出現，治療前後各項血液檢驗都正常。
總結我們的研究發現局部使用青黛治療尋常型乾癬是一種安全的、且具有療效的治療方式，而其作用機理可能與調節表皮角質細胞的增殖和分化有關。

Psoriasis is a chronic dermatosis with repeated remission and relapse throughout the patient’s life. To begin with the clinical observations that Indigo naturalis ointment might be effective in treating recalcitrant plaque-type psoriasis, the present study’s objective was to evaluate the efficacy and safety of topically applied Indigo naturalis in treating plaque-type psoriasis. By analyzing the immunohistological changes in lesion tissue after therapy, we can further understand the mechanisms underlying the efficacy of Indigo naturalis.
A single-blinded, randomized, vehicle-controlled, intra-individual and right to left trial has been conducted. Two matching lesions on the contralateral body sides of each patient were topically applied with either Indigo naturalis ointment or ointment base for eight weeks. Efficacy was evaluated based on clinical scores including induration, erythema, and clearing percentage. Skin biopsies were taken for immunohistochemical analysis. Routine blood tests for liver and renal functions were done before and after the trial. Wilcoxon sign rank was used for the statistical analysis.
Eight weeks after the treatment, all clinical scores were significantly reduced. HE stain showed apparent histological improvement of the lesion skin and markedly decreased expressions of Ki-67 and keratin 6, and increased expressions of involucrin, filaggrin, and keratin 10. No biochemical changes in liver or renal function or other adverse effects were noted during the trial.
In conclusion, topical Indigo naturalis ointment may be a safe and effective therapy for psoriasis vulgaris that is mediated, at least in part, by modulating the proliferation and differentiation of epidermal keratinocytes.

目 錄
指導教授推薦書………………………………………………………
口試委員會審定書………………………………………………………
授權書………………………………………………………………… iii
簽署人須知……………………………………………………………. iv
誌謝……………………………………………………………………v
中文摘要………………………………………………………………vi
英文摘要………………………………………………………………viii
第一章 緒論……………………………………………………………1
1.1 研究背景…………………………………………………… 1
1.2 相關文獻資料回顧…………………………………………… 2
1.3 研究目的…………………………………………………… 5
第二章 實驗方法………………………………………………….. 7
2.1 實驗設計………………………………………………………7
2.2 藥物製備………………………………………………………7
2.3 病患選擇………………………………………………………7
2.4 治療方法………………………………………………………10
2.5 臨床療效評估………………………………………………10
2.6 皮膚切片與免疫組織化學染色……………………………12
2.7 安全性評估……………………………………………………13
2.8 統計分析……………………………………………………13
第三章 結果與討論…………………………………………………15
3.1 一般資料………………………………………………… 15
3.2 臨床發現與療效分析………………………………………15
3.3組織病理發現………………………………………………16
3.4免疫組織化學染色 ………………………………………….16
3.5不良反應…………………………………………………….17
3.6討論………………………………………………………18
第四章 結論………………………………………………………23
參考文獻……………………………………………………….………26
表(一～三)…………………………………………………….………33
圖(一～十一)………………………………………………….………36
附錄：本論文己發表文獻…………………………………….………47


Table of Contents
CHAPTER I Introduction……………………………………. 1
1.1 Background……………………………………………… 1
1.2 Review of Related Studies……………………………………2
1.3 Objective of the Study………………………………………5
CHAPTER II Methods…………………………………………………7
2. 1 Study Design …………………….……………………………7
2.2 Drug Preparation……………………………..…………………7
2.3 Patient Selection…………………………..…………………7
2.4 Treatment………………………….. ………………………….10
2.5 Clinical Efficacy Assessment…………………………………10
2.6 Skin Biopsy and Immunohistochemistry……………………12
2.7 Safety assessment……………………………………………13
2.8 Statistics……………………………………………………13
CHAPTER III Results and Diccusions.………………………………15
3.1 Baseline Data….…….……. ………….………………………15
3.2 Clinical Findings and Efficacy………………………………15
3.3 Histopathologic Findings…………………………………… 16
3.4 Immunohistopatologic Findings……………………………16
3.5 Adverse events…………………………………………………17
3.6 Discussion…………………………………………………… 18
CHAPTER IV Conclusions…………………………….…………… 23
REFERENCES…………………………………………………………26
Tables (1～3) ……………………………………………………33
Figures(1～11)……………………………………………………36
Appendix ………………………………………………………………47

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