評估第二型糖尿病患使用不同 sulfonylurea 類藥物發生嚴重低血糖住院機率之研究

【研究背景】低血糖是管理第二型糖尿病病患的限制因子，sulfonylurea類藥物副作用就包含低血糖。本研究以中央健康保險局全民健保資料庫為研究基礎進行分析統計，觀察台灣民眾罹患第二型糖尿病之病患使用何種sulfonylurea類藥物較容易發生嚴重低血糖而導致住院。【研究目的】本研究主要分析是否 glibenclamide（屬於sulfonylurea 類降血糖藥物）比其他 sulfonylurea 類藥物會導致第二型糖尿病病患產生嚴重低血糖住院的比例較高。【研究方法】本研究採用之資料為中央健康保險局全民健保資料庫2005年承保人為主檔之系統抽樣檔，抽樣人數為100萬人。資料庫篩選方式先以第二型糖尿病【ICD 9 Code: 250.00, 250.40, 250.50, 250.70, 250.80, 250.90】且住院的病患做初步篩選，再從中篩選低血糖病患【ICD 9 Code: 251.0, 251.1, 251.2】來收錄為此研究的目標病患，屬case- control study回推住院的目標病患前三個月門診用藥記錄；最後再用台灣常用之4種sulfonylurea類藥物：glibenclamide、glimepiride、glipizide、gliclazide以健保局藥品代碼做藥品篩選，探討是否有第二型糖尿病患因口服某種sulfonylurea 類藥物而產生嚴重低血糖住院的比例較高。收案標準：年齡 20 歲以上之第二型糖尿病病患、資料庫顯示發生過低血糖。排除標準：慢性腎衰竭、快速進行性腎衰竭、尿毒症、心臟衰竭、肝壞死、在發生低血糖前三個月內有換過或沒有使用sulfonylurea類藥物的病患、使用insulin、quinidine、disopyramide、ciprofloxacin、levofloxacin、sulfonamides的病患。以上述條件篩選出資料並以使用的 sulfonylurea類藥物分為兩組：other sulfonylureas（glimepiride、glipizide、gliclazide）及glibenclamide 兩組，兩組比較嚴重低血糖住院的發生機率。【研究結果】總收錄第二型糖尿病且住院的病患為 10,689 人，其中因低血糖住院且前三個月的門診記錄有服用 sulfonylurea 類的病患為 64人，其中 other sulfonylureas 組人數為 31 人、glibenclamide 組人數為 33 人，odds ratio 1.99（Cl 95：1.21∼3.25）。【結論】此研究統計結果顯示若依此研究條件收錄之第二型糖尿病患使用sulfonylurea類藥物以 glibenclamide 為主的治療發生嚴重低血糖住院的危險性高於以 other sulfonylureas 治療的 1.99倍，達統計上之差異（P＝0.0064）。

關鍵字

低血糖；住院

並列摘要

Background Sulfonylureas (SUs) were widely used to treat type 2 diabetes in Taiwan due to its efficacy and guideline recommendation. However, some published papers pointed out that some sulfonylureas such as glibenclamide (glyburide) might have higher incidence of hypoglycemia compared with other sulfonylureas in type 2 diabetes. Objective To evaluate the incidence of hypoglycemia in hospitalized patients receiving sulfonylurea on type 2 diabetes patients. Material & Methods A retrospective study using data from Taiwan Bureau of National Health Insurance system from year 2000 to 2008. The sampling data included 1,000,000 subjects. Statistical analysis was performed using SAS statistics system and matched by age and gender. The inclusion criteria were ICD-9 Code 250.00, 250.40, 250.50, 250.70, 250.80, 250.90 (Type 2 Diabetes) hospitalized patients, age more than 20 year-old, and selection of hypoglycemia by ICD 9 Code 251.0, 251.1, 251.2. The patients should continue taken the same sulfonylurea more than 3 months before admission. The exclusion criteria were patients who had end stage renal disease, uremia, heart failure, acute and subacute necrosis of liver, using insulin before including period. Subjects were separated into two groups: other SUs group (including glimepiride, glipizide and gliclazide) and glibenclamide group. The glibenclamide group was defined as the reference group to evaluate the incidence of hypoglycemia related to other SUs. Results： There were 10,689 hospitalized patients enrolled, of which 64 patients got hypoglycemia who had been receiving sulfonylurea 3 month prior to admission. Other SUs group consists of 31 patients and glibenclamice group consists of 33 patients. The odds ratio was 1.99(Cl 95:1.21~3.25). Conclusions： Our result reveals that the patients on glibenclamide group have significantly 1.99 times higher incidence of hypoglycemia than those on other SUs group (P=0.0064).