| 摘要: | 研究目的：
糖尿病族群發生心律不整，如心房顫動或心室性心律不整的機率比一般族群要高，而當糖尿病患者產生心律不整時，對心血管疾病預後的影響又比一般族群來的差，甚至可能引起猝死的風險。第二型鈉葡萄糖共同運送受體抑制劑(Sodium–glucose cotransporter inhibitors，SGLT2 inhibitors)為近年來新發展的口服降血糖藥物，被證實能改善糖尿病患者的死亡率及減少心衰竭住院的風險。然而目前並沒有明確的文獻報告顯示SGLT2 inhibitors對於心律不整的影響。因此本實驗的目的在於分析糖尿病族群使用SGLT2 inhibitors與心律不整風險之關聯性。
研究方法及資料：
本研究為全國性的族群世代分析研究，使用台灣健保資料庫全國檔，分析2,464,548位糖尿病患者就醫資料。共1,532,381位糖尿病患者符合條件收入研究分析。研究對象分為兩組：(1) SGLT2 inhibitors使用組 (2)非SGLT2 inhibitors使用組。研究終點為死亡、心律不整發生或是達到試驗時間終點（西元2016年12月31號）。
研究結果：
實驗組共22,045位SGLT2 inhibitors使用者符合本研究收案條件。另外經過1:4年齡及性別配對後，對照組共88,180位非SGLT2 inhibitors使用者符合本研究收案條件。兩組間經過傾向分數配對後，SGLT2 inhibitors使用者比起對照組發生死亡率的風險較低(Hazard ratio 0.454; P = 0.0001)。比起對照組，SGLT2 inhibitors使用者發生心律不整的風險也較低，然而並沒有顯著統計學上的意義 (Hazard ratio 0.728; P = 0.0673)。
結論：
糖尿病族群使用SGLT2 inhibitors作為降血糖藥物，比起使用其它降血糖藥物，可以顯著減少死亡率，並且有降低心律不整風險的趨勢。
Objective：Arrhythmias included atrial fibrillation and ventricular arrhythmias are frequent in diabetes mellitus. Prolonged arrhythmic episodes increase an individual likelihood of significant morbidity and mortality, and even sudden cardiac death. Sodium–glucose cotransporter inhibitors (SGLT2 inhibitors) as newly developed hypoglycemic agents have been demonstrated to reduce cardiovascular events, particularly mortality and risk of hospitalization for heart failure. However, there are no studies investigated the impact of SGLT2 inhibitors on arrhythmias currently. The purpose of the this study was to evaluate the risk of arrhythmias associated with use of SGLT2 inhibitors in a nationwide cohort study of diabetic patients in Taiwan. .
Methods and Materials：This nationwide population-based cohort study analyzed 2,464,548 patients with diabetes utilizing Taiwan’s National Health Insurance Research Database and 1,532,381 patients were enrolled. Patients were further divided into two groups: (1) SGLT2 inhibitors users: those taking SGLT2 inhibitors and (2) non- SGLT2i users: those not taking SGLT2 inhibitors. Study end point was defined by diagnosis of all-cause mortality, arrhythmias or the end of the study period (December 31, 2016).
Results：A total of 22,045 SGLT2 inhibitors users and 88,180 non-SGLT2 inhibitors users which undergoing 1: 4 age and sex matched controls were eligible for the study. SGLT2 inhibitors users were associated with a lower risk of mortality compared with non-SGLT2 inhibitors users after propensity-score matching (Hazard ratio 0.454; P = 0.0001). SGLT2 inhibitors users were associated with a lower risk of arrhythmias compared with non-SGLT2 inhibitors users although no statistical significance (Hazard ratio 0.728; P = 0.0673).
Conclusion：Among patients with diabetes prescribed with SGLT2 inhibitors, there were associated with a lower risk of mortality and a trend of lower risk of arrhythmias compared with those not taking SGLT2 inhibitors in real-world practice. |
