2026-11-092026-11-09https://scholars.csmu.edu.tw/handle/123456789/38378The Chinese Medicine Clinical trial Center of Chung Shan Medical University Hospital was funded in 2004, now directed by Dr James Cheng-Chung WEI, who provides full resources in clinical trials regarding TCM and CAM, especially in the treatment of autoimmune diseases, ankylosing spondylitis, rheumatoid arthritis, psoriasis, hyperuricemia and allergic diseases. In Year 2007, we proposed two clinical trials using TCM: Trial 1 named “traditional Chinese formula in the treatment of patients with hyperuricemia—a double blind placebo controlled clinical trial. “. Forty six adult patients with serum uric acid level more than 7 mg/dl were included. Patients were randomized into two arms: Traditional Chinese Medicine formula UA3 or placebo for 4 weeks. Efficacy and safety were evaluated at week 2 and 4. Primary endpoint was serum uric acid at week 4. Secondary endpoints were serum uric acid at week 2 and 8, serum SGPT, creatinine, cholesterol, triglyceride, LDL, fasting sugar, body weight and gouty attack evaluation. Trial 2 named “traditional Chinese formula in the treatment of patients with hyperlipidemia—a double blind placebo controlled clinical trial. “ Sixty patients with serum LDL more than 160 mg/dl or triglyceride more than 200 were included for this 8 weeks’ trial. Patients were randomized into two arms: TCM or placebo for 8 weeks. Primary endpoint was the serum LDL and triglyceride level at week 8. Secondary endpoints included blood pressure, body mass index, quality of life, serum total cholesterol, HDL, uric acid, glucose, creatinine, SGPT, SGOT at week 4 and 8.配合衛生署實施『藥品優良臨床試驗規範』及推行「中草藥產業技術發展五年計畫」，提升國內中醫藥人體試驗水準及進行中草藥新藥開發，本院有幸獲衛生署中醫藥委員會評審通過「93年度教學醫院成立中藥臨床試驗中心」之方案計劃，於93年6月本院大慶院區核子醫學大樓13樓成立「中藥臨床試驗中心」，協助推動建立完善臨床試驗環境，進行中藥製劑臨床應用之評估。目前中心的人員配置包含：主任一名，臨床研究護理師四名，臨床研究藥師一名，行政助理一名，統計人員兩名，其中包含一名統計博士。每週定期召開中心內部會議，並邀請相關諮詢人員，每個月定期舉辦中草藥團隊的小組會議，修訂標準作業流程，尤其在稽核制度部分，以提昇中心臨床試驗之品質。 95年度執行臨床試驗共5件，包括中藥方劑治療高尿酸血症之先導性試驗；MORA生物能共振檢測儀用於過敏病患之臨床試驗；植物萃取物moducare治療過敏性鼻炎之臨床試驗；Etanercept治療僵直性脊椎炎的多中心、開放性研究；隨機雙盲安慰劑對照四組平行多中心多國家之Abetimus Sodium對罹患全身性紅斑狼瘡並具腎臟疾病病史病人的安全性及療效試驗。96年度將繼續執行2件中藥臨床試驗：1.「中藥方劑治療高尿酸血症之先導性試驗」：本研究以金錢草、佛手及山楂組成科學中藥”金錢草複方”治療高尿酸血症。實驗設計為隨機雙盲安慰劑控制先導性試驗（early exploratory study），將收集46例高尿酸血症病人，受試者納入條件為血中尿酸值大於7 mg/dl之18歲以上成人。排除條件為兩週內有痛風發作者、兩週內有改變降尿酸藥物劑量者、肝腎功能中度異常者。受試者隨機分派服用”金錢草複方”或安慰劑四週，另延伸觀察兩週。主要療效指標為第4週之血中尿酸值。次要療效指標包括脂蛋白、血糖、血壓、體重及24小時尿中尿酸排泄量、痛風發作次數、及SF-36生活品質量表。2.「勻采茶對降血脂作用之評估」：本研究為隨機雙盲安慰劑控制先導性試驗，收受60位原發性高血脂病人經隨機分配到勻采茶組或安慰劑組，中藥勻采茶之組成為：紫蘇、山楂、烏梅、白扁豆、赤小豆、洛神花等六味，進行8週治療，全程皆需進行飲食控制及運動衛教。病人於第0、4、8週回診，主要指標是用藥8週後血漿中低密度脂蛋白膽固醇(LDL-C)和基礎值比較的平均改變百分比。次要指標是三酸甘油脂(TG)用藥前後的平均改變百分比及相關安全性評估。中藥臨床試驗尿酸金錢草佛手山楂高脂血症勻采茶Uric AcidGouthyperlipidemiaobesityTraditional Chinese MedicineProject