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2型糖尿病患者的强化血糖控制——15年随访
Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-up


Peter D. Reaven ... 糖尿病 • 2019.06.06
相关阅读
• 2型糖尿病血糖控制及心血管疾病结局的随访研究

摘要


背景

我们之前报道,经过总共10年的联合干预和观察性随访,在患2型糖尿病的1,791名退伍军人中,与标准降糖治疗相比,中位5.6年的强化降糖治疗使主要心血管事件的风险显著降低(降幅17%)。我们在本文中报道全部15年的随访结果。

 

方法

完成最初的临床试验后,我们使用中央数据库确定心血管事件、住院治疗和死亡,从而对纳入的参与者(完整队列)进行观察性随访。我们还询问参与者是否愿意通过问卷调查和病历审核的方式提供更多数据(调查队列)。预设的主要结局是由主要心血管事件(包括非致死性心肌梗死、非致死性卒中、新发充血性心力衰竭或充血性心力衰竭恶化、因缺血性坏疽截肢和心血管原因死亡)构成的复合结局。全因死亡是预设的次要结局。

 

结果

完整队列包括1,655例参与者,调查队列包括1,391例参与者。在本试验(最初纳入1,791例参与者)期间,强化治疗组(892例参与者)和标准治疗组(899例参与者)的糖化血红蛋白曲线有平均1.5个百分点的分离,而到试验结束后3年时,这一差异减小至0.2~0.3个百分点。在15年随访(活性药治疗+试验后观察)期间,强化治疗组的主要心血管事件或死亡风险并未低于标准治疗组(主要结局的风险比,0.91;95%置信区间[CI],0.78~1.06;P=0.23;死亡的风险比,1.02;95% CI,0.88~1.18)。然而,在糖化血红蛋白曲线长时间分离期间,主要心血管疾病结局的风险降低(风险比,0.83;95% CI,0.70~0.99),但这一获益在糖化血红蛋白水平相等后未能持续(风险比,1.26;95% CI,0.90~1.75)。

 

结论

被随机分配接受5.6年强化血糖控制的2型糖尿病患者与接受标准治疗的患者相比,前者的心血管事件风险仅在糖化血红蛋白曲线长时间分离期间较低。并无证据表明强化血糖控制有遗留效应或生存获益(由美国退伍军人事务部合作研究计划[VA Cooperative Studies Program]资助;VADT在ClinicalTrials.gov注册号为NCT00032487)。





作者信息

Peter D. Reaven, M.D., Nicholas V. Emanuele, M.D., Wyndy L. Wiitala, Ph.D., Gideon D. Bahn, Ph.D., Domenic J. Reda, Ph.D., Madeline McCarren, Ph.D., William C. Duckworth, M.D., and Rodney A. Hayward, M.D. for the VADT Investigators*
From the Phoenix Veterans Affairs (VA) Health Care System, Phoenix (P.D.R., W.C.D.); the Hines VA Cooperative Studies Program Coordinating Center and Hines VA Hospital (N.V.E., G.D.B., D.J.R.) and the VA Pharmacy Benefits Management Services (M.M.), Hines, IL; and the VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI (W.L.W., R.A.H.). Address reprint requests to Dr. Reaven at the Phoenix VA Health Care System, 650 E. Indian School Rd., Phoenix, AZ 85012, or at peter.reaven@va.gov. *A complete list of the investigators in the Veterans Affairs Diabetes Trial (VADT) is provided in the Supplementary Appendix, available at NEJM.org.

 

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