近期腔隙性卒中患者的血压目标：SPS3 随机试验。
Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomised trial.
出版信息
Lancet. 2013 Aug 10;382(9891):507-15. doi: 10.1016/S0140-6736(13)60852-1. Epub 2013 May 29.
BACKGROUND
Lowering of blood pressure prevents stroke but optimum target levels to prevent recurrent stroke are unknown. We investigated the effects of different blood-pressure targets on the rate of recurrent stroke in patients with recent lacunar stroke.
METHODS
In this randomised open-label trial, eligible patients lived in North America, Latin America, and Spain and had recent, MRI-defined symptomatic lacunar infarctions. Patients were recruited between March, 2003, and April, 2011, and randomly assigned, according to a two-by-two multifactorial design, to a systolic-blood-pressure target of 130-149 mm Hg or less than 130 mm Hg. The primary endpoint was reduction in all stroke (including ischaemic strokes and intracranial haemorrhages). Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT 00059306.
FINDINGS
3020 enrolled patients, 1519 in the higher-target group and 1501 in the lower-target group, were followed up for a mean of 3·7 (SD 2·0) years. Mean age was 63 (SD 11) years. After 1 year, mean systolic blood pressure was 138 mm Hg (95% CI 137-139) in the higher-target group and 127 mm Hg (95% CI 126-128) in the lower-target group. Non-significant rate reductions were seen for all stroke (hazard ratio 0·81, 95% CI 0·64-1·03, p=0·08), disabling or fatal stroke (0·81, 0·53-1·23, p=0·32), and the composite outcome of myocardial infarction or vascular death (0·84, 0·68-1·04, p=0·32) with the lower target. The rate of intracerebral haemorrhage was reduced significantly (0·37, 0·15-0·95, p=0·03). Treatment-related serious adverse events were infrequent.
INTERPRETATION
Although the reduction in stroke was not significant, our results support that in patients with recent lacunar stroke, the use of a systolic-blood-pressure target of less than 130 mm Hg is likely to be beneficial.
FUNDING
National Institutes of Health-National Institute of Neurological Disorders and Stroke (NIH-NINDS).
背景
降低血压可预防中风，但预防中风再发的最佳目标水平尚不清楚。我们研究了不同的血压目标对近期腔隙性中风患者中风再发率的影响。
方法
在这项随机开放标签试验中，符合条件的患者居住在北美、拉丁美洲和西班牙，且有近期 MRI 定义的症状性腔隙性梗死。患者于 2003 年 3 月至 2011 年 4 月间入组，并根据两因素两水平的设计随机分配至收缩压目标值<130mmHg 或<130mmHg 以下。主要终点是减少所有中风（包括缺血性中风和颅内出血）。分析采用意向治疗。本研究在 ClinicalTrials.gov 注册，编号为 NCT 00059306。
结果
3020 名入组患者中，1519 名患者被分至较高目标组，1501 名患者被分至较低目标组，平均随访 3.7（2.0）年。平均年龄为 63（11）岁。在 1 年时，较高目标组的平均收缩压为 138mmHg（95%CI 137-139），较低目标组为 127mmHg（95%CI 126-128）。所有中风（危险比 0.81，95%CI 0.64-1.03，p=0.08）、致残或致死性中风（0.81，0.53-1.23，p=0.32）和心肌梗死或血管性死亡的复合结局（0.84，0.68-1.04，p=0.32）的发生率未见显著降低，而颅内出血的发生率显著降低（0.37，0.15-0.95，p=0.03）。与治疗相关的严重不良事件并不常见。
结论
尽管中风发生率的降低不显著，但我们的结果支持在近期腔隙性中风患者中，使用收缩压目标值<130mmHg 可能有益。
资金来源
美国国立卫生研究院-国家神经疾病和中风研究所（NIH-NINDS）。
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