阿卡波糖与2型糖尿病患者冠心病发病风险的回顾性队列研究

Acarbose Treatment and the Risk of Coronary Heart Disease in Patients with Type 2 Diabetes:A Cohort Study

目的:探究使用阿卡波糖对新发2型糖尿病(T2DM)人群冠心病发病风险的影响。方法:使用2012～2015年北京市城镇职工基本医疗保险数据库进行回顾性队列研究,共1 627例新发T2DM患者纳入分析。以患者首次诊断为糖尿病的时间为随访起点,直到出现研究结局、或最后一次就诊日期为观察终点。按照随访期间有无使用阿卡波糖将研究对象分为暴露组与对照组,使用时间依赖的Cox比例风险回归模型分析阿卡波糖用药对冠心病发病的影响;并根据累积暴露水平(累积用药时间/剂量)进行亚组分析。结果:对研究对象随访4年,发生冠心病共计918例(56. 42%),其中暴露组379例(47. 55%),对照组539例(64. 94%),差异有统计学意义(P <0. 05)。与对照组相比,累积用药天数<60 d、60～180 d和> 180 d组发生冠心病的调整后HR(95%CI)分别为2. 08(1. 77,2. 45)、0. 79(0. 65,0. 97)和0. 29(0. 22,0. 39);累积用药剂量<14 000 mg、14 000～48 000 mg和> 48 000 mg组发生冠心病的调整后HR(95%CI)分别为2. 02(1. 73,2. 37)、0. 72(0. 58,0. 89)和0. 23(0. 17,0. 32)。结论:长期使用阿卡波糖(累积用药达一定的天数或者剂量)可以降低新发T2DM患者冠心病的发病风险。

Objective： To investigate whether acarbose treatment was associated with the potential benefits of coro- nary heart disease （CHD） in newly diagnosed patients with type 2 diabetes mellitus （T2DM） by using nationwide insur- ance claim dataset. Methods： A retrospective cohort study was conducted by using the Beijing Urban Employee Basic Medi- cal Insurance database during 2012-2015. A total of 1 627 newly onset T2DM patients without CHD were identified in 2012 and followed until the earliest of outcome occurrence, the latest medical record or study termination. Time-varying Cox pro- portional hazards regression was applied to calculate the hazard ratio （HR） and 95% confidence interval （C1） for the asso- ciation between acarbose treatment and incident of CHD, adjusted for patients＇demographics, eomorbidity, and co-medica- tions. Subgroup analysis were performed based on the cumulative duration and dosage of acarbose. Results： During 4 years of follow-up, the primary outcome occurred in 379 patients （47.55%） who had received acarbose treatment, as compared with 539 patients （64.94%） who never took acarbose therapy, which suggested that acarbose users group had lower risks of developing CHD （ P 〈 0.05 ）. By using those without exposure to acarbose as reference group, acarbose users revealed neutral adjusted HR 1.07 （95% C1： O. 93, 1.22 ） for developing CHD. However, further analysis indicated that the adjus- ted HR （95%CI） was 2.08 （1.77, 2.45）, 0.79 （0.65, 0.97） and 0.29 （0.22, 0.39） when the duration of taking acarbose was 〈60 days, 60-180 days and 〉 180 days, respectively. Moreover, the adjusted HR was 2.02 （ 1.73, 2.37）, 0.72 （0.58, 0.89） and 0.23 （0.17, 0.32） with acarbose cumulative doses 〈 14 000 rag, 14 000-48 000 mg and 〉 48 000 mg, respectively. Conclusion：Newly diagnosed T2DM patients who used acarbose for a prolonged period or who reached certain amount of doses showed benefits on the development of coronary heart disease.