社團法人臺灣臨床藥學會

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【原著】探討Dapagliflozin作為輔助療法用於第2型糖尿病病人之臨床療效與安全性
Clinical Effectiveness and Safety of Dapagliflozin as Add-On Therapy for Patients With Type 2 Diabetes
Dapagliflozin,第2 型糖尿病,SGLT-2 Inhibitor、Dapagliflozin, Type 2 Diabetes, SGLT-2 Inhibitor
楊璦瑜Ai-Yu Yang1,*
1高雄醫學大學附設中和紀念醫院藥學部
目的:Dapagliflozin 是選擇性sodium-glucose cotransporter-2 inhibitor (SGLT-2i),藉由抑制葡萄糖在近端腎小管的再吸收,促使葡萄糖由尿液中排除,因此達到降血糖的作用。目前dapagliflozin 使用於亞洲病人的臨床證據有限,本回顧性研究將探討dapagliflozin 用於第2 型糖尿病病人之療效與安全性。

方法:運用回溯性觀察性研究,於單一醫院門診就醫的第2 型糖尿病病人,於2016 年1 月至12 月使用dapagliflozin 作為輔助療法 (add-on therapy) 用於有使用其他降血糖藥物的效果評估。主要療效評估為治療6 個月後糖化血色素 (hemoglobin A1c, HbA1c) 與基線值的差異。次要指標包括空腹血糖值、體重變化以評估療效;腎功能變化及不良反應的發生評估安全性。

結果:我們的研究收納55 位慢性腎病第1 期 ( 估算腎絲球過濾率 [estimated glomerular filtration rate, eGFR] ≥ 90 mL/min/1.73 m2) 及44 位第2 期 (eGFR = 60 ~ 89 mL/min/1.73 m2) 的病人。兩組病人治療6 個月後,HbA1c、空腹血糖、體重及eGFR 皆顯著降低。疑似藥物不良反應以泌尿道感染、皮膚過敏、多尿為最常見。

結論:我們的研究顯示dapagliflozin 作為輔助療法與其他降血糖藥物併用,在6個月後能顯著降低第2 型糖尿病的HbA1c、空腹血糖及體重,但需注意腎功能變化及不良反應對病人的影響。

Objective: Dapagliflozin is a selective sodium/glucose cotransporter 2 inhibitor that can reduces reabsorption of filtered glucose in the proximal renal tubules to promote urinary excretion of glucose and can reduce blood glucose levels. There are a relatively
low number of clinical evidence in Asia patients. This retrospective study examined effectiveness and safety of dapagliflozin in patients with type 2 diabetes.

Methods: This retrospective observational study included patients with type 2 diabetes and treated with dapagliflozin. It aimed to assess the effectiveness and safety as add-on therapy to dapagliflozin in combination with other hypoglycemic agents. The primary outcome measures were the differences in hemoglobin A1c (HbA1c) from baseline after six months. Therapeutic efficacy (differences in fasting plasma glucose, body weight) and safety (changes in estimated glomerular filtration rate [eGFR] and adverse events) were assessed at six months.
 
Results: Our study included 55 patients in chronic kidney disease stage G1 and 44 patients in stage G2 (eGFR ≥ 90 and 60–89 mL/min/1.73 m2). HbA1c, fasting plasma glucose, body weight, and eGFR were significantly reduced at 6 months in two groups before and after treatment. Among these adverse drug reactions, urinary tract infections, skin allergies and polyuria were the most common.
 
Conclusions: Our study demonstrated that dapagliflozin, as add-on therapy, at the 6th months for patients with type 2 diabetes, significantly decreased HbA1c levels, fasting plasma glucose, and body weight, but renal function and adverse event needed to  be closely monitored.
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