2026-11-092026-11-09https://scholars.csmu.edu.tw/handle/123456789/38369AIM. To test the safety and efficacy of traditional Chinese formula in the treatment of patients with hyperuricemia METHODS. We conducted this exploratory double blind randomized control trial in adult patients with hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were included. Patients were randomized into three arms: Traditional Chinese Medicine formula UA1 or UA2 or placebo for 4 weeks. Efficacy and safety were evaluated at week 2, 4 and 8. 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. RESULTS. By the end of 2006, we will enroll 60 patients with hyperuricemia. This study is still ongoing now. From the preliminary data, there were no significant differences among three arms on serum uric acid level, cholesterol, triglyceride, 24 hours uric acid excretion amount and body weight. The only significant finding is that diastolic blood pressure was reduced in treatment arm B at week 8. There were no significant adverse events. Keywords：Uric Acid , Gout, Traditional Chinese Medicine隨經濟發展及社會結構改變民眾生活型態與飲食習性改變，導致高尿酸血症的盛行率愈來愈高，且有鑑於行政院衛生署中醫藥委員會對於中醫藥在疾病療效評估上的重視，故本研究擬使用中藥方劑來治療高尿酸血症患者，並評估其療效及安全性。 本研究方法採隨機分派雙盲試驗方式進行，符合收案條件患者，取得受試者同意書後，隨機分派成三組：五苓散、茵陳五苓散、安慰劑，受試者需服用試驗藥物4週，另後續追蹤4週。主要療效指標為第4週之血中尿酸值；次要療效指標含血糖、血中總膽固醇值、低密度脂蛋白、高密度脂蛋白、三酸甘油值、丙胺基轉移酶(SGPT)、肌酐酸(creatinine)、24小時尿中尿酸排泄量、血壓、體重、血中尿酸值<6 mg/dl之比例、痛風發作次數及副作用評估。 本研究預計於2006年12月前收案60名患者，並進行期中分析以評估第二年樣本數，依據第一年期中分析後評估決定藥方，再進行第二階段之隨機、雙盲、安慰劑控制研究。初步顯示，三組尿酸< 6.0 mg/dl的比例無顯著性差異，三組血中尿酸值和尿中尿酸值皆無顯著性的減少，病患於服藥後第4週B組舒張壓顯著較A組降低，可進一步探討此方劑控制血壓的效果。 關鍵詞：高尿酸血症、痛風、五苓散、茵陳五苓散高尿酸血症痛風五苓散茵陳五苓散Uric AcidGoutTraditional Chinese MedicineProject