本試驗在治療修格連症候群主觀症狀的「黃連阿膠湯」複方療效 進行評估，以及此試驗所選用之中藥與臨床西藥治療對修格連氏症候 群口眼乾燥主觀症狀療效評估及比較，整體結果雖在統計學上不具顯 著差異 3, 6, 8，然以數項單一評估呈現統計差異，尤其是口部症狀的 顯效差異性，這顯示此方仍具有進一步研究的價值。
另外，本研究重點在於評估中藥複方黃連阿膠湯對於修格連症候 群的的影響，因此，設計重點亦以能否客觀評估結果為原則。然若欲 擴展研究角度，探究中醫藥對此疾病的影響與治療中各症狀變化，以 中醫對修格連氏症的論治為出發點，一病可能有不同證型的表現，加 入中醫證型及診法分類並區分用藥類型，應更能觀察疾病與用藥相互 間的關連，及更明白中西醫合治時用藥方向與方法。
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英文摘要
試 驗主題 ： Huang-Lian-Ejiao-Tang on the subjective symptoms of
Sjögren’s syndrome clinical curative effect appraisal
關 鍵詞：Huang-Lian-Ejiao-Tang ；Sjögren’s syndrome； subjectivesymptoms
摘 要：Sjögren's syndrome which would ordinarily be termed "dry syndrome" is a life-long chronic autoimmune disease. The characterize of the disease is continuous violation of exocrine gland body, especially the salivary glands and the lacrimal glands, and the main symptoms are dry mouth and dry eyes.
In traditional Chinese medicine theory, Sjögren's syndrome can be vested to Tzaw-Zhèng in scope.We often read medical literature describe the theory of “The therapy of dry disease is to treat Tzaw”.Those herbs and Prescriptions used to treat Tzaw-Zhèng in accordance with symptom types are also divided into many categories, but there are rarely to be proved the treatment validity by research .
The clinical case demonstrated that the compound prescription
“ Huang-Lian-Ejiao -Tang” can improve the subjective symptom - argument –dry mouth which caused by Sjögren's syndrome.Therefore, we designed a study from an objective and scientific methods to evaluate the uni-compound prescription “ Huang-Lian-Ejiao -Tang” improve the subjective symptom.
The research drafts elects the syndrome to meet the test condition by Sjögren's syndrome, divides into three groups: The traditional Chinese medicine group picks the stochastic double blind way to divide into two groups, the traditional Chinese medicine sole compound prescription
“ Huang-Lian-Ejiao -Tang” for the traditional Chinese medicine experiment
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group, takes the placebo is the traditional Chinese medicine control group, and take six weeks as the sole treatment course, completes the subjective symptom change by the 100mmVAS degree discrimination law subjective symptom appraisal table the appraisal, accepts the clinical western medicine to treat and to continue the people treated with medication is third group, makes the similar appraisal. Finally we analyzed difference by analysis of variance with repeated measures.
The findings showed that is obvious in the xerostomia shape subjective symptom score chart and the tendency chart demonstration with the control group difference; The influence experiment group and the western medicine group tendency chart all presents the rule to the speech to drop, the xerophthalmia shape change tendency chart three groups all present the rule drop and most have the obvious difference by the western medicine group;
Other project tendency chart disorder present. The above condition may serve as contrast to compare afterward mutually in the number of days with each group compares. However, these not regular availability difference, is unable to induce the experimental traditional Chinese medicine compound prescription
“ Huang-Lian-Ejiao -Tang” to have continually to the forward curative effect, and appears not the regular validity in the independent category and the appraisal project. Therefore we think in this research the “ Huang-Lian-Ejiao -Tang” traditional Chinese medicine compound prescription regarding the Sjögren's syndrome oral cavity symptom demonstration for the forward influence; But in statistics has not demonstrated the regular appearance difference.
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附錄一 臨床試驗研究經費預算表
臨床試驗研究經費預算表
2009-12-25 製表
試驗主題：黃連阿膠湯對於修格連氏症候群主觀症狀臨床療效評估
項目 名稱 金額 備註
01 藥品費及代工費 28600 復旦製藥有限公司
02 專任研究助理薪資 71200 以二個月工作天計
03 文具及印刷費 6000
04 調查訪問及 電腦處理費 9000 以 90 份數計
總金額：新台幣 114800.0 元整
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附錄二 藥品許可證
62
附錄三 仿單
63
附錄四 藥商執照
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附錄五 黃連阿膠湯檢驗單 coa
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附錄六 主觀症狀評估表
表一、口乾症狀臨床評估 100mmVAS 程度區分法 第 ___________ 日評估 填表日期： 年 月 日 性名：______________ 性別：_________________
年齡：_______________ 病歷號：_______________
1. 口乾症（病人自覺症狀）：
2.說話影響：
3.飲食吞嚥：
4.睡眠影響：
5 喝水量： 大約 ____________ C.C./日
0 10 20 30 40 50 60 70 80 90 100mm
（沒有口乾） （非常口乾）
0 10 20 30 40 50 60 70 80 90 100mm
（無失眠） （完全失眠）
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表二、眼乾症狀臨床評估（VAS 方法）
第 ___________ 日評估 填表日期： 年 月 日 性名：______________ 性別：_________________
年齡：_______________ 病歷號：_______________
1.眼乾症（病人自覺症狀）
2. 目癢或異物感：
3. 畏光：
4.視力模糊：
5.流淚症(眼睛)：
6.人工淚液使用次數/日：______ (單位: 次/日)
0 10 20 30 40 50 60 70 80 90 100mm
（沒有眼乾） （非常眼乾）
0 10 20 30 40 50 60 70 80 90 100mm
（無感覺） （非常刺癢）
0 10 20 30 40 50 60 70 80 90 100mm
（沒有畏光） （非常畏光）
0 10 20 30 40 50 60 70 80 90 100mm
（視力無異） （非常模糊）
0 10 20 30 40 50 60 70 80 90 100mm
（無流淚） （常流淚）
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附錄七 人體試驗委員會人體試驗計畫同意書
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謝 辭
一路過來甘苦參半，多少個月光接連晨曦相伴，終於完成了此論 文。首先感謝所長陳汶吉教授、指導教授黃春明教授的提攜與教導以 及擔任口試委員的魏正宗副教授的不吝建議；也感謝參與試驗的病友、
一路上愛護關心與幫助的師長、同事、同學們；在此特別感謝沈小姐 一直以來的幫忙。
謹以此論文向所有曾幫助與協助我的師長、同事、同學們及朋友 致謝。