- 學位論文
加入sitagliptin或pioglitazone治療血糖控制不佳之第二型糖尿病人其療效及安全性評估
Comparison of sitagliptin versus pioglitazone added to Oral Hypoglycemic Therapy in Patients with a Pooly- controlled of Type 2 Diabetes
摘要
【研究目的】 評估使用metformin與glimepiride加入sitagliptin或pioglitazone治療血糖控制不佳之第二型糖尿病病人之療效與安全性。 【研究方法】 本研究採回溯性方式，收錄2010年1月1日至2010年12月31日，門診首次開立sitagliptin或pioglitazone並合併口服降血糖藥物（metformin與glimepiride）治療的第二型糖尿病病人為研究對象。療效評估以病人加入sitagliptin或pioglitazone治療前、後的糖化血色素、空腹血糖值的變化。安全性方面則評估治療前、後的總膽固醇 (TC)，三酸甘油酯 (TG),低密度脂蛋白 (LDL-C)及高密度脂蛋白 (HDL-C)，麩丙酮酸轉胺酶(GPT)及血清肌酐酸(Scr)數值變化。 【結果與討論】 sitagliptin(≥50歲)組共38人納入， pioglitazone組共有82人納入。 sitagliptin(≥50歲)組A1C 平均值由9.74 % 下降至8.45 % (9.74 ± 2.06 vs 8.45 ± 1.61 %, p＜0.05)，FPG 平均值由197.45 mg/dL 下降至166.61 mg/dL (197.45 ± 57.60 vs 166.61 ± 50.35 mg/dL, p＜0.05) 有統計學上的意義。 pioglitazone組 A1C平均值由9.19 %下降至8.19 % (9.19 ± 1.56 vs 8.19 ± 1.44 %, p＜0.05)， FPG平均值由179.05mg/dL 下降至163.33 mg/dL (179.05 ± 42.74 vs 163.33 ± 57.83 mg/dL, p＜0.05) 有統計學上的意義。 sitagliptin(≥50歲)組Scr平均值由1.12 mg/dL 下降至1.05 mg/dL (1.12 ± 0.24 vs 1.05 ± 0.25 mg/dL, p＜0.05)，HDL-C由47.10 mg/dL下降至45.15 mg/dL (47.10 ± 10.17 vs 45.15 ± 12.07 mg/dL, p＜0.05) 有統計學上的意義。 pioglitazone組TC平均值由191.33 mg/dL下降至182.64 mg/dL (191.33 ± 37.71 vs 182.64 ± 27.35 mg/dL, p＜0.05)、TG平均值由149.00 mg/dL下降至134.98 mg/dL (149.00 ± 80.89 vs 134.98 ± 64.49 mg/dL, p＜0.05)、LDL-C平均值由119.51 mg/dL下降至105.95 mg/dL (119.51 ± 367.84 vs 105.95 ± 27.72 mg/dL, p＜0.05) 皆有統計學上的意義。 【結論】 合併metformin與glimepiride治療血糖控制不佳之第二型糖尿病病人，加入sitagliptin或pioglitazone降低糖化血色素及空腹血糖值有治療效果，但在3~6個月仍未達ADA治療規範準則標準。安全性方面，pioglitazone組較sitagliptin組有降低TG、TC、LDL-C的功能。
並列摘要
Objective To assess the efficacy and safety of addition of sitagliptin or pioglitazone, in patients with type 2 diabetes who had been poor glycemic control by metformin and glimepiride. Methods In this retrospective study, pharmacy prescription database from a regional teaching hospital in southern Taiwan were used. Patients who were given sitagliptin or pioglitazone between January 1 and December 31, 2010 to improve their glycemic control with metformin and glimepiride therapy were the subjects of this study. The changes between baseline and end-point values in hemoglobin A1C (A1C) and fasting plasma glucose (FPG) were used for efficacy evaluation of the patient’s hypoglycemic therapy while change in their lipid profiles [total cholesterol (TC), triglycerides (TG), high-density-lipoprotein cholesterol (HDL-C), and low-density-lipoprotein cholesterol (LDL-C)], serum creatinine (Scr) and glutamic pyruvic transaminase (GPT) levels were used for safety evaluation of their hypoglycemic therapy. Results and Discussion Group sitagliptin (age≥ 50 years old), has 38 patients who have poor glycemic control with metformin and glimepiride were given sitagliptin in addition to their current medications. Group pioglitazone contains 82 patients who were added pioglitazone in addition to their current metformin and glimepiride medications. In group sitagliptin, after 3 to 6 months of data collection, the mean of A1C (9.74 ± 2.06 % vs 8.45 ± 1.61 %, p<0.05) and FPG (197.45 ± 57.60 mg/dL vs 166.61 ±50.35 mg/dL, p<0.05) show a significantly decrease when compared to the baseline data. In group pioglitazone, after 3 to 6 months of data collection, the mean of A1C (9.19 ± 1.56 % vs 8.19 ± 1.44 %, p<0.05) and FPG (179.05 ± 42.74 mg/dL vs 163.33 ± 57.83 mg/dL, p<0.05) show a significantly decrease when compared to the baseline data. In Scr (1.12 ± 0.24 mg/dL vs 1.05 ± 0.25 mg/dL, p<0.05) and HDL-C (47.10 ± 10.17 mg/dL vs 45.15 ± 12.07 mg/dL, p<0.05) show significantly decreased in group sitagliptin. In TG (149.00 ± 80.89 mg/dL vs 134.98 ± 64.49 mg/dL, p<0.05), TC (191.33 ±37.71 mg/dL vs 182.64 ± 27.35 mg/dL, p<0.05) and LDL-C (119.51 ± 37.84 mg/dL vs 105.95 ± 27.72 mg/dL, p<0.05) show significantly decreased in group pioglitazone. Conclusions Addition of sitagliptin or pioglitazone is effective for decreasing A1C and FPG in a 3 to 6 months period in type 2 diabetic patients who are inadequately controlled with metformin and glimepiride. But results of A1C and FPG after addition of sitagliptin or pioglitazone did not match ADA guideline. In safety, group pioglitazone is better than group sitagliptin in TG, TC and LDL-C lowing effect.
參考文獻
延伸閱讀
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