• 沒有找到結果。

臨床應用上目前認為防止胰島素阻抗性已是治療最重要目標,應該 早期介入胰島素增敏劑的使用,以防止β 細胞功能喪失。經由動物研究 初步證實兩者合併使用,較單獨電針或口服Rosiglitazone 都有較好的降 糖效果;但臨床試驗中,可能因干擾因子太多,而未能達明顯降糖,但 卻可見到,Rosiglitazone 或合併電針都有明顯改善胰島素敏感度的作 用,而且,此胰島素阻抗的改善可能是透過調降游離脂肪酸。因此,電 針用於糖尿病病人可以透過調降游離脂肪酸,改善胰島素阻抗程度,進 而調整血糖。合併用藥是否能有更好的作用,目前僅是短期介入前後的 比較,仍須長期試驗結果才能證實針藥並用可以較快達到理想控制血糖 的目標。針藥並用,調節的多種 Cytokines,這些 Cytokines 是否參與了 胰島素阻抗的改善,仍需進一步的研究。

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附錄一

附錄二

附錄三

附錄四

附錄五 減少Rosiglitazone 產生副作用的機會。

(二)試驗方法:

1. 受試者標準及數目:年齡為 20~65 歲,本國籍病人;五年內新 診斷為Type 2 DM,且於實驗前使用相同類型降血糖藥控制血 糖者,且無心衰竭或裝有心臟節律器。排除合併有肝功能異常

(GOT、GPT 大於正常上限值 2 倍)、肝硬化;腎病徵候群(尿 蛋白>3.5 g/d,水腫)、腎衰竭(Cr>1.3 mg/dl);懷孕婦女者為 對象共四十人。

中 國 醫 藥 大 學 附 設 醫 院 受 試 者 同 意 書

(二)試驗方法:

2. 試驗設計及進行步驟:病人平常皆在門診處方控制血糖,隨機分 為針藥並用組、藥物控制組,每組二十人,在試驗前空腹 8 小 時,針藥併用組和藥物組將於試驗前 30 min 服用 Rosiglitazone 8 mg,30 min 後電針,將於電針試驗前後抽血各 5 ㏄,觀察其短 時間 30 min 電針處置前後 HOMA 值及 FFA、TG、Cholesterol 值的變化,並比較cytokine(細胞激素)血中濃度的變化。試驗 針 機 ( Han’s Healthronic Likon, Taipei, Taiwan),正極接在陰陵泉

5. 評估及統計方法:HOMA 值及 FFA、TG、Cholesterol 值的變化皆於 中西所實驗室進行檢驗分析。組間以One Way ANOVA 檢定,同組 前後均值則採 self-paired t test。相關的 cytokine 由 RayBiotech 公司 antibody array 進行分析。

(三)參與試驗費用說明:除正常門診外,無須再掛號看診。

陰陵泉 足三里

中 國 醫 藥 大 學 附 設 醫 院 受 試 者 同 意 書

(四)參與試驗可能獲得之效益:

針藥併用理論上應有比單獨藥物使用有較佳的降血糖效果,並改善胰島 素敏感度。

(五)可能產生之副作用及危險:

所採用的電針皆為目前臨床常用者,應無顯著傷害。為抽血或電針 過程可能造成的疼痛、瘀青、血管炎或其他可能產生的併發症。雖 Rosiglitazone 長期大量使用易有肝腎的毒副作用,本實驗僅短期介入,

副作用極少;使用的藥物是Rosiglitazone,也是目前臨床糖尿病常用處 方,使用劑量也是臨床常用者,而且研究顯示服用Rosiglitazone 不會增 加低血糖的機會。

(若有抽血請務必填入:抽血過程可能造成的疼痛、淤青、血管炎或其他 可能產生的併發症。若試驗中無抽血項目請將此註記說明刪除)

(六)目前其他可能之療法及其說明:

目前降血糖的方法一方面為補充胰島素或增加胰島素分泌的藥物;

另外一方面為改善胰島素敏感度的藥物,主要為Thiazodinediones 類藥 物,但長期的使用,可能有水腫、肝衰竭的毒副作用;本研究僅試驗時 短期介入,使用針藥併用,目的是為了減少藥物副作用,減少用藥劑量,

另外一方面為改善胰島素敏感度的藥物,主要為Thiazodinediones 類藥 物,但長期的使用,可能有水腫、肝衰竭的毒副作用;本研究僅試驗時 短期介入,使用針藥併用,目的是為了減少藥物副作用,減少用藥劑量,

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