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达格列净对2型糖尿病合并急性心肌梗死患者炎症水平及预后的影响

Effects of dapagliflozin on inflammatory level and prognosis in patients with type 2 diabetes mellitus and acute myocardial infarction

  • 摘要:
    目的 探讨达格列净对2型糖尿病(T2DM)合并急性心肌梗死(AMI)患者炎症因子水平及预后的影响。
    方法 采用随机双盲试验,纳入146例T2DM合并AMI患者(AMI发病7 d内),随机分为达格列净组(达格列净10 mg/d联合AMI标准治疗)和非达格列净组(AMI标准治疗)。随访12个月,比较两组患者治疗开始后1、3、6、12个月血清白介素1β(IL-1β)、IL-6、高敏C反应蛋白(hs-CRP)水平,12个月左心室射血分数(LVEF)、脑钠肽(BNP)水平及主要心血管不良事件(MACE)发生率。应用Kaplan-Meier曲线分析随访12个月内两组MACE累积发生率。
    结果 退出或失访3例,治疗12个月时,达格列净组(n=71)IL-1β、IL-6、hs-CRP显著低于非达格列净组(n=72,P<0.01),接近正常值;达格列净组LVEF高于非达格列净组(P<0.01)、BNP低于非达格列净组(P<0.01)。广义线性混合模型显示,IL-1β、IL-6、hs-CRP存在显著的组别-时间交互效应(P<0.001),在达格列净组下降更快。达格列净组MACE发生率低于非达格列净组(P=0.047)。Kaplan-Meier分析显示达格列净组12个月内MACE和心衰累积发生率低于非达格列净组(P<0.05)。
    结论 在T2DM合并AMI患者中,达格列净有良好的抗炎和心血管保护作用。

     

    Abstract:
    Objective To investigate the effects of dapagliflozin on inflammatory factors and prognosis in patients with type 2 diabetes mellitus (T2DM) and acute myocardial infarction (AMI).
    Methods In a randomized, double-blind trial, 146 patients with T2DM and AMI (within 7 days of onset) were divided into dapagliflozin (dapagliflozin 10 mg/d combining AMI standard therapy) and control (AMI standard therapy) groups, and were followed up for 12 months. Serum levels of interleukin-1β (IL-1β), IL-6, high-sensitivity C reactive protein (hs-CRP) at baseline, 1, 3, 6, and 12 months, and left ventricular ejection fraction (LVEF), brain natriuretic peptide (BNP), and major adverse cardiovascular events (MACE) rate at 12 months were compared between the two groups. Kaplan-Meier curves were used to analyze the cumulative incidences of MACE in the two groups.
    Results Three patients were withdrawn or dropped out. At 12 months, IL-1β, IL-6, and hs-CRP levels were significantly lower in dapagliflozin group (n=71) than those in control group (n=72, P<0.01), approaching normal levels. Compared with the control group, LVEF was higher (P<0.01), BNP was lower (P<0.01), MACE incidence was lower (P=0.047) in dapagliflozin group at 12 months. Generalized linear mixed models showed significant group-time interactions in IL-1β, IL-6, and hs-CRP (P<0.001), and these factors declined faster in the dapagliflozin group. Kaplan-Meier curve showed the cumulative incidences of MACE and heart failure were lower in dapagliflozin group than those in non-dapagliflozin group (P<0.05).
    Conclusions For patients with T2DM patients and AMI, dapagliflozin has good anti-inflammatory and cardioprotective effects.

     

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