| 摘要: | 目標
過去文獻已經有許多的研究探討西方人群糖尿病藥物和心血管事件之間的關係，但這些研究在亞洲人群是很少的。此研究是探討加入糖尿病論質計酬的第二型糖尿病病患，他們的糖尿病用藥與急性心肌梗塞、中風、心臟衰竭與死亡之間的關係。
方法
本研究是一個回顧性世代研究，包括了41,105名患者。研究加入期間從2001到2004年，追蹤所有患者直到心血管事件發生或是2010年12月31日。使用存活分析調整人口學特徵、臨床生化指標與共病的干擾效應。
結果
本研究共觀察到31,949個事件的發生，平均追蹤7.3年。胰島素單藥和胰島素加一種口服藥物組合與雙胍單藥治療相比會增加急性心肌梗塞的風險，調整後的危險比分別為1.74 (95%信賴區間: 1.26-2.41)、1.69 (1.16-2.46)。雙胍加磺脲類組合、三種口服藥物組合、四種以上的口服藥物組合、胰島素單藥、胰島素加一種口服藥物組合和胰島素加兩種以上口服藥物組合與雙胍類單藥治療相比，增加中風的風險，調整後的危險比分別為1.20 (1.07- 1.34)、1.16 (1.01-1.32)、1.36 (1.11-1.66)、1.58 (1.34-1.86)、1.40 (1.15-1.71)和1.62 (1.36-1.92)。磺脲類單藥、磺脲類加一種其他口服藥物組合、胰島素單藥、胰島素加一種口服藥物組合、和胰島素加兩種以上口服藥物組合與雙胍單藥治療相比，增加心臟衰竭的風險，調整後的危險比分別為1.10 (1.03-1.18)、1.16 (1.05-1.29)、1.13 (1.03-1.25)、1.12 (1.00-1.25)和1.17 (1.06-1.29)。兩種其他口服藥物合併使用和短暫使用糖尿病藥物與雙胍單藥治療相比，增加死亡風險，調整後的危險比分別為2.31 (1.37-3.91)和1.25 (1.04-1.49)。三種口服藥物合併使用與雙胍單藥治療相比，降低死亡的風險，調整後的危險比為0.77 (0.63-0.93)。
討論
這是第一個在亞洲人的大型觀察性追蹤研究，顯示出在台灣第二型糖尿病患在臨床上的糖尿病用藥與心血管事件有顯著的相關。我們的研究結果可以提供在今後的臨床執業參考，並可指引探討心血管疾病和糖尿病藥物之間相關的未來研究。
Background
There has been a lot of research in exploring the association between diabetes medication and cardiovascular events for western populations, but there is limited data about this relationship for Chinese. The aim of the study was to compare risks of acute myocardial infarction, stroke, heart failure, and death in patients with type 2 diabetes treated with anti-diabetes medications in participants of Taiwan National Diabetes Care Management Program (NDCMP).
Methods
This study planned a retrospective cohort study consisting of 41,105 Chinese patients with type 2 diabetes who were enrolled in the Taiwan NDCMP. The baseline period was at 2001-2004 and all identified patients were followed up until cardiovascular events, death, or December 2010. Extensive adjustments for demographic, biomarkers, and comorbidity were made by using Cox proportional hazards regression analysis.
Results
A total of 31,949 end points were observed during a median follow-up of 7.3 years. The adjusted hazard ratios of acute myocardial infarction for patients having insulin monotherapy, and insulin plus one OAD combination compared with metformin monotherapy were 1.74 (95% confidence interval: 1.26-2.41), and 1.69 (1.16-2.46), respectively. The adjusted hazard ratios of stroke for patients having metformin plus sulfonylurea combination, three OAD combination, more than three OAD combination, insulin monotherapy, insulin plus one OAD combination, and insulin plus more than one OAD combination compared with metformin monotherapy were 1.20 (1.07-1.34), 1.16 (1.01-1.32), 1.36 (1.11-1.66), 1.58 (1.34-1.86), 1.40 (1.15-1.71), and 1.62 (1.36-1.92), respectively. The adjusted hazard ratios of heart failure for patients having sulfonylurea monotherapy, sulfonylurea plus OAD-other combination, insulin monotherapy, insulin plus one OAD combination, and insulin plus more than one OAD combination combination compared with metformin monotherapy were 1.10 ( 1.03-1.18), 1.16 (1.05-1.29), 1.13 (1.03-1.25), 1.12 (1.00-1.25), and 1.17 (1.06-1.29), respectively. The adjusted hazard ratios of death for patients having two OAD-other combination, three OAD combination, and short-time OAD compared with metformin monotherapy were 2.31 (1.37-3.91), 0.77 (0.63-0.93), and 1.25 (1.04-1.49), respectively.
Conclusions
This study demonstrates the effects of anti-diabetes medications on cardiovascular events and death, which is the first evidence of anti-diabetes medication effects for Chinese from a large cohort of patients with type 2 diabetes under clinical practice. Our findings should be useful for clinical practice and for guiding the future research regarding cardiovascular and anti-diabetes medications. |
