- 學位論文
血糖控制不佳的第二型糖尿病人加入基礎胰島素或Pioglitazone治療之療效與安全性評估
Comparison of Basal Insulin versus Pioglitazone Added to Oral Agents Therapy for Poor Controlled of Type 2 Diabetes
摘要
背景：2010年1月美國糖尿病協會（American Diabetes Association, ADA）刊載的第二型糖尿病人臨床治療準則中使用口服降血糖藥物（Sulfonylureas與Metformin）血糖控制不佳的糖尿病病人可以加入基礎胰島素（Basal insulin）或加入Thiazolidinediones（TZD）類藥物治療。其目的在於早期將病人血糖控制於目標值內以減少併發症的發生。本研究嘗試比較血糖控制不佳的第二型糖尿病人，介入Insulin glargine或TZD類藥物治療的臨床療效與安全性，以提供臨床治療選擇之參考。 方法：以回溯性方式，由南部某區域教學醫院電腦資料搜尋2008年1月1日至2008年12月31日期間，門診首次開立Insulin glargine或Pioglitazone並合併口服降血糖藥物（Sulfonylureas與Metformin）治療的第二型糖尿病病人為研究對象。療效方面評估病人介入Insulin glargine或Pioglitazone藥物治療，於治療前、後的糖化血色素、空腹血糖、飯後血糖值的變化。安全性方面則評估病人於治療前、後的體重、血脂肪、肝功能及腎功能指數變化。 結果：療效評估方面，Insulin glargine組共56人，在治療6個月後糖化血色素下降0.69%（p=0.02）。空腹血糖下降 30.62 mg/dL（p=0.001）、飯後血糖下降40.21 mg/dL（p=0.027）皆呈現有意義的降低。Pioglitazone組共67人，治療6個月後糖化血色素略為上升0.08％（p=0.564）、空腹血糖上升0.69 mg/dL（p=0.921）、飯後血糖上升10.96 mg/dL（p=0.116）皆無統計學上的差異。 安全性評估方面，體重變化兩組皆呈現明顯增加0.83 ± 2.68 kg（p=0.029）、0.83 ± 2.4 kg（p=0.008），肌酐酸、氨酸氨基轉胺?”漜晙珛L明顯差異。血脂肪方面，除Pioglitazone組於低密度脂蛋白明顯降低（p<0.0001），其他於總膽固醇、三酸甘油酯、高密度脂蛋白兩組皆無明顯差異。 結論：若要積極治療血糖控制不佳的第二型糖尿病人宜先採用 Insulin glargine治療。
並列摘要
Objective For many patients with type 2 diabetes, oral antidiabetic agents (OADs) do not provide optimal glycemic control, necessitating insulin therapy. Nevertheless, the majority of patients in Taiwan are reluctant to use insulin therapy. American Diabetes Association (ADA) recommended that patients with poor glycemic control while using OADs could also consider adding basal insulin or thiazolidinediones (TZDs) treatment. In the present research, we compared efficacy and safety of the treatment of adding once-daily basal insulin or TZDs in type 2 diabetic patients insufficiently glycemic control by OADs. Methods Pharmacy prescription database from a regional teaching hospital in southen Taiwan were employed in this retrospective study. Type 2 diabetic patients who are insufficiently controlled by OADs (sulfonylurea plus metformin) were designed by adding on either insulin glargine or pioglitazone between January 1 and December 31 of 2008. We compared the changes between baseline and end-point in hemoglobin A1C (HbA1C) and fasting plasma glucose (FPG) for efficacy of the treatment while comparing patients’ body weight changes and their changes in lipid profile (total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), and triglycerides (TG)), serum creatinine (Scr) and glutamic pyruvic transaminase (GPT) levels for safety of the treatment. Results and Discussion Group one have 56 patients with poor glycemic control (FPG >120 mg/dL, HbA1C > 7.5%) by OADs (sulfonylurea plus metformin) and were added with once-daily insulin glargine. With same condition, group two contains 67 patients were added with pioglitazone. After six months of data collection the mean of HbA1C (9.46 ± 1.67 vs 8.77 ± 1.73 ％, p<0.05) and FPG (168.97 ± 50.73 vs 138.35 ± 43.78 mg/dL, p<0.001) show a significantly decrease when compared to the baseline data in group one. Group two, however do not show any statistically significant changes of HbA1C and FPG after received six months of treatment. In weight changes, both two groups are significantly increased. TC, HDLC, TG, Scr and GPT levels in both groups are not change significantly, but LDL-C is significantly decreased in group two. Conclusions Adding once-daily insulin glargine is effective to decrease HbA1C and FPG in a six months period in type 2 diabetic patients who are inadequately controlled with sulfonylurea plus metformin. Except LDL-C, the results of safety profile are not statistically significant changes in both groups. Keyword Insulin glargine, Pioglitazone, Poor controlled of type 2 diabetes