澳大利亚研究人员对采用药物降低血压和血糖控制的2型糖尿病患者进行随访研究,发现降低血压疗法能降低死亡风险,而强化血糖控制对降低死亡率或大血管事件的长期效果并不明显。

 

—2014919日《新英格兰医学杂志》

中文翻译


 

【题目】随访2型糖尿病患者血压降低和血糖控制情况

【译文】

背景:在糖尿病和血管疾病中的作用:百普乐与达美康缓释片对照评估(ADVANCE)析因试验,培哚普利与吲达帕胺联用降低2型糖尿病患者的死亡率,但是强化血糖控制不能使糖化血红蛋白水平低于6.5%。我们现在报告的结果来自于6年的试验后随访。

方法:我们邀请了ADVANCE研究中仍是在世的志愿者,来参与试验后的随访评估。他们曾被分配到培哚普利-吲达帕胺组或者安慰剂组,以及强化血糖控制(血糖控制治疗多延长6个月)或者标准血糖控制组的幸存者。主要的观察结局是任何原因导致的死亡和主要的大血管事件。

结果:参与初始随机试验的11140例患者和参与实验后随访的8494例患者的基线特征相似,中位随访时间是5.9年(血压降低比较)和5.4年(血糖控制比较)。 在第一次试验后随访中,血压和糖化血红蛋白水平的组间差异在试验期间不明显。在积极降压治疗组,任何原因导致的死亡和心血管原因导致的死亡风险降低效果在试验期间较弱,但在试验后随访研究中该风险明显降低;风险比分别为0.91(95%CI,0.84-0.99;P=0.03)和0.88(95%CI,0.77-0.99;P=0.04)。在强化血糖控制组和标准血糖控制组,随访研究中任何原因造成的死亡风险或主要大血管事件风险没有差异;风险比分别为1.00(95%CI,0.92-1.08)和1.00(95%CI,0.92-1.08)。

结论:虽然在一开始就接受降压治疗的患者中,降低死亡率效益是发生衰减的,但在随访结束时仍然明显。没有证据表明,在试验中进行强化血糖控制治疗在降低死亡率或减少大血管事件方面有长期效益。

 

英文原稿


 

[Title] Follow-up of Blood-Pressure Lowering and Glucose Control in Type 2 Diabetes

[Authors] Sophia Zoungas, John Chalmers, Bruce Neal, Laurent Billot, Qiang Li., Yoichiro Hirakawa,
Hisatomi Arima, Helen Monaghan, Rohina Joshi, Stephen Colagiuri, Mark E. Cooper, Paul Glasziou,
Diederick Grobbee, Pavel Hamet, Stephen Harrap, Simon Heller, Liu Lisheng, Giuseppe Mancia,
Michel Marre, David R. Matthews, Carl E. Mogensen, Vlado Perkovic, Neil Poulter, Anthony
Rodgers, Bryan Williams, Stephen MacMahon, Anushka Patel, Mark Woodward

[Abstract]

BACKGROUND: In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified
Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and
indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control,
targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the
6-year post-trial follow-up.

METHODS: We invited surviving participants, who had previously been assigned to perindopril–
indapamide or placebo and to intensive or standard glucose control (with the glucose-control
comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation.
The primary end points were death from any cause and major macrovascular events.

RESULTS: The baseline characteristics were similar among the 11,140 patients who originally underwent
randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years
(blood-pressure–lowering comparison) or 5.4 years (glucose-control comparison). Between-group
differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by
the first post-trial visit. The reductions in the risk of death from any cause and of death from
cardiovascular causes that had been observed in the group receiving active blood-pressure–lowering
treatment during the trial were attenuated but significant at the end of the post-trial follow-up; the
hazard ratios were 0.91 (95% confidence interval [CI], 0.84 to 0.99; P=0.03) and 0.88 (95% CI,
0.77 to 0.99; P=0.04), respectively. No differences were observed during follow-up in the risk of
death from any cause or major macrovascular events between the intensive-glucose-control group
and the standard-glucose-control group; the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and
1.00 (95% CI, 0.92 to 1.08), respectively.

CONCLUSIONS: The benefits with respect to mortality that had been observed among patients originally
assigned to blood-pressure–lowering therapy were attenuated but still evident at the end of follow-up.
There was no evidence that intensive glucose control during the trial led to long-term benefits with
respect to mortality or macrovascular events.

 

原文地址

http://www.nejm.org/doi/full/10.1056/NEJMoa1407963?query=featured_home

 

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