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| 题名: | 教學醫院成立中藥臨床試驗中心
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| 作者: | 陳家玉;魏正宗;林隆堯;李鴻森;張宏州;蘇奕彰
Chen, Jia Yuh;Wei, Cheng-Chung;Lin, Long-Yau;Lee, HS;Chang, HC;Su,Yi Chang |
| 贡献者: | 中山醫學大學醫學系 |
| 关键词: | 高尿酸血症;痛風;金錢草複方 |
| 日期: | 2007 |
| 上传时间: | 2010-11-25T03:11:18Z (UTC)
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| 摘要: | 編號：CCMP96-CT-205 中藥方劑治療高尿酸血症之先導性試驗 計畫主持人：魏正宗執行單位：中山醫學大學附設醫院 摘要 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，符合收案條件患者共46名，取得受試者同意書後，隨機分派成二組各23名：金錢草複方（治療）組、安慰劑（對照）組，受試者需服用試驗藥物4週，另後續追蹤2週。評估項目包括：(1)主要療效指標：第4週之血中尿酸值；(2)次要療效指標：第2、6週之血中尿酸值；第4週之血中總膽固醇值(total cholesterol)、低密度脂蛋白(LDL-C)、高密度脂蛋白(HDL-C)、三酸甘油酯(triglyceride)、麩丙醋酸轉胺(GPT)、血糖值(blood sugar ac)、肌肝酸(creatinine)、24小時尿中尿酸排泄量(UUA)；第4週之血壓、體重；第4週之血中尿酸值<6 mg/dL之比例；受試期間痛風發作次數；SF-36健康生活品質量表；副作用及退出試驗原因評估。結果顯示，二組經過服藥後第4、6週之主要療效指標：血中尿酸值無顯著差異，但可見其降低趨勢：治療組第0週到第6週由8.7mg/dL降至8mg/dL，對照組由8.3mg/dL降至7.9mg/dL，第0週到第6週二組p值分別為0.477、0.770。病患於服藥後第4週之治療組體重平均降低0.6kg，對照組平均增加0.1 kg(p=0.152)，並於第6週達統計顯著(p=0.022)。二組血中尿酸值< 6.0 mg/dL之比例在治療組第4週與第6週皆為14.3％，在對照組第4週與第6週分別為8.7％與13％；血中尿酸值降低2.0 mg/dL之比例在治療組第4週與第6週分別為9.5％與14.9％，在對照組第4週與第6週分別為8.7％與13.0％，二組皆無顯著差異。其他指標：如尿中尿酸值、血中總膽固醇值、高、低密度脂蛋白、三酸甘油酯、麩丙醋酸轉胺、肌肝酸、24小時尿中尿酸排泄量、健康生活品質(SF36)評估表數值等皆無顯著差異。結論：服用金錢草複方劑安全無虞，在降低血中尿酸與體重方面可見其發展淺力，未來需進一步進行更長期、更大規模之隨機雙盲安慰劑控制式試驗，以確認其功效與安全性。關鍵詞：高尿酸血症、痛風、金錢草複方
CCMP96-CT-205 Traditional Chinese Medicine in the Treatment of Patients with Hyperuricemia James Cheng-Chung Wei, M.D. Chinese Medicine Clinical Trial Center, Division of Allergy, Immunology and Rheumatology Chung Shan Medical University Hospital Abstract AIM. To test the safety and efficacy of traditional Chinese medicine (TCM) in the treatment of patients with hyperuricemia. METHODS. We conducted this exploratory double-blind randomized control trial in 46 adult patients with hyperuricemia. Patients was randomized to placebo or TCM for 4 weeks. Primary endpoints was serum uric acid level at the 4th week . Secondary endpoints were serum uric acid at 2nd week and the 6th week and serum total cholesterol, LDL-C, HDL-C, triglyceride, GPT, blood ac sugar,creatinine, 24 hours urine uric acid amount, blood pressure and body weight at 4th week. Responder was defined by serum uric acid<6 mg/dl after treatment. Gouty attack frequency during study period, quality of life by Short Form-36 were also evaluated. RESULTS. At week 6, serum uric acid level decreased from 8.7mg/dl to 8.0 decrease (-0.7 mg/dl) in the TCM group and 8.3 to 7.9 (-0.4 mg/dl) in the placebo group. After 4 weeks’ treatment, body weight of patients under TCM treatment reduced 0.6kg, compared to 0.1 kg increase in the placebo group. (p=0.022). There were no significant differences between two groups on serum uric acid level, percentage of responder, serum total cholesterol, LDL-C, HDL-C, triglyceride, GPT, creatinine, 24hours urin uric acid amount and SF36. No significant adverse events were found between two groups. CONCLUSION. TCM formula is promising in the treatment of patients with hyperuricemia and overweight. However, further extensive large-scale, long-term double-blind randomized control studies is necessary to confirm the efficacy and safety. Keywords：Uric Acid , Gout, traditional Chinese medicine |
| URI: | https://ir.csmu.edu.tw:8080/handle/310902500/2851 |
| 显示于类别: | [醫學系] 研究計劃
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