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2型糖尿病血糖控制及心血管疾病结局的随访研究
Follow-up of Glycemic Control and Cardiovascular Outcomes in Type 2 Diabetes


Rodney A. Hayward ... 糖尿病 • 2015.06.04

摘要


背景

退伍军人糖尿病试验(Veterans Affairs Diabetes Trial)前期结果表明,在1,791名退伍军人中(中位随访时间5.6年),与标准治疗相比,强化降血糖并没有显著降低主要心血管事件的发生率。这里我们报道了该研究参与者的后续随访结果。

 

方法

在临床试验结束之后,我们通过中心数据库继续对参与者(全体队列,取得92.4%参与者的随访数据)的治疗、住院和死亡进行随访。大部分的参与者(研究队列,包括77.7%的参与者)同意通过每年的调查和定期的病历调查来参与进一步的数据收集。主要结局事件是第一次主要心血管事件(包括心脏病发作、卒中、新发或恶化的充血性心力衰竭、缺血型坏疽截肢、心血管相关死亡)发生的时间。次要结局是心血管疾病死亡率和全因死亡率。

 

结果

强化治疗组与标准治疗组的糖化血红蛋白的平均差异为1.5个百分点(中位数:6.9%对8.4%),在试验结束后的3年里此差异缩小到0.2~0.3个百分点。经过中位数为9.8年以上的随访,强化治疗组与标准治疗组相比,主要结局发生的风险显著降低(风险比0.83;95% CI,0.70~0.99;P=0.04),风险绝对值下降8.6件主要心血管事件/1000人年,但是心血管死亡率并没有降低(风险比0.88;95% CI;0.64~1.20;P=0.42)。总死亡率也没有明显降低(强化治疗组风险比1.05,95% CI;0.89~1.25;P=0.54;中位随访时间11.8年)。

 

结论

在近10年的随访中,随机进入强化治疗组的2型糖尿病患者在治疗5.6年后,与进入标准治疗组的患者相比,主要心血管事件减少8.6件/1000人年,但是整体的生存率并未见提高(由VA合作研究项目[VA Cooperative Studies Program]等赞助;VADT ClinicalTrials.gov注册号为NCT00032487)。





作者信息

Rodney A. Hayward, M.D., Peter D. Reaven, M.D., Wyndy L. Wiitala, Ph.D., Gideon D. Bahn, Ph.D., Domenic J. Reda, Ph.D., Ling Ge, M.S., Madeline McCarren, Ph.D., William C. Duckworth, M.D., and Nicholas V. Emanuele, M.D., for the VADT Investigators*
From the Veterans Affairs (VA) Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI (R.A.H., W.L.W.); Phoenix VA Health Care System, Phoenix, AZ (P.D.R., W.C.D.); and the Hines VA Cooperative Studies Program Coordinating Center and Edward Hines, Jr., VA Hospital (G.D.B., D.J.R., L.G., N.V.E.), and VA Pharmacy Benefits Management Services (M.M.) — all in Hines, IL. Address reprint requests to Dr. Hayward at the Robert Wood Johnson Foundation Clinical Scholars Program, 2800 Plymouth Rd., North Campus Research Complex, Bldg. 10, Rm. G016, Ann Arbor, MI 48019-2800, or at rhayward@umich.edu. *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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