既往卒中患者强化与指南指导的血压和血脂降低：“卒中后认知功能下降预防试验”（PODCAST）随机对照试验的主要结果
Intensive versus Guideline Blood Pressure and Lipid Lowering in Patients with Previous Stroke: Main Results from the Pilot 'Prevention of Decline in Cognition after Stroke Trial' (PODCAST) Randomised Controlled Trial.
作者信息
Bath Philip M, Scutt Polly, Blackburn Daniel J, Ankolekar Sandeep, Krishnan Kailash, Ballard Clive, Burns Alistair, Mant Jonathan, Passmore Peter, Pocock Stuart, Reckless John, Sprigg Nikola, Stewart Rob, Wardlaw Joanna M, Ford Gary A
机构信息
Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom.
Sheffield Institute for Translational Neuroscience, University of Sheffield, Sheffield, United Kingdom.
出版信息
PLoS One. 2017 Jan 17;12(1):e0164608. doi: 10.1371/journal.pone.0164608. eCollection 2017.
BACKGROUND
Stroke is associated with the development of cognitive impairment and dementia. We assessed the effect of intensive blood pressure (BP) and/or lipid lowering on cognitive outcomes in patients with recent stroke in a pilot trial.
METHODS
In a multicentre, partial-factorial trial, patients with recent stroke, absence of dementia, and systolic BP (SBP) 125-170 mmHg were assigned randomly to at least 6 months of intensive (target SBP <125 mmHg) or guideline (target SBP <140 mmHg) BP lowering. The subset of patients with ischaemic stroke and total cholesterol 3.0-8.0 mmol/l were also assigned randomly to intensive (target LDL-cholesterol <1.3 mmol/l) or guideline (target LDL-c <3.0 mmol/l) lipid lowering. The primary outcome was the Addenbrooke's Cognitive Examination-Revised (ACE-R).
RESULTS
We enrolled 83 patients, mean age 74.0 (6.8) years, and median 4.5 months after stroke. The median follow-up was 24 months (range 1-48). Mean BP was significantly reduced with intensive compared to guideline treatment (difference -10·6/-5·5 mmHg; p<0·01), as was total/LDL-cholesterol with intensive lipid lowering compared to guideline (difference -0·54/-0·44 mmol/l; p<0·01). The ACE-R score during treatment did not differ for either treatment comparison; mean difference for BP lowering -3.6 (95% CI -9.7 to 2.4), and lipid lowering 4.4 (95% CI -2.1 to 10.9). However, intensive lipid lowering therapy was significantly associated with improved scores for ACE-R at 6 months, trail making A, modified Rankin Scale and Euro-Qol Visual Analogue Scale. There was no difference in rates of dementia or serious adverse events for either comparison.
CONCLUSION
In patients with recent stroke and normal cognition, intensive BP and lipid lowering were feasible and safe, but did not alter cognition over two years. The association between intensive lipid lowering and improved scores for some secondary outcomes suggests further trials are warranted.
TRIAL REGISTRATION
ISRCTN ISRCTN85562386.
背景
中风与认知障碍和痴呆的发生有关。在一项试点试验中，我们评估了强化血压和/或降脂对近期中风患者认知结局的影响。
方法
在一项多中心、部分析因试验中，将近期中风、无痴呆且收缩压（SBP）为125 - 170 mmHg的患者随机分配至至少6个月的强化（目标SBP <125 mmHg）或指南（目标SBP <140 mmHg）降压治疗组。缺血性中风且总胆固醇为3.0 - 8.0 mmol/l的患者亚组也被随机分配至强化（目标低密度脂蛋白胆固醇<1.3 mmol/l）或指南（目标低密度脂蛋白胆固醇<3.0 mmol/l）降脂治疗组。主要结局是修订版的Addenbrooke认知检查（ACE-R）。
结果
我们纳入了83例患者，平均年龄74.0（6.8）岁，中风后中位时间为4.5个月。中位随访时间为24个月（范围1 - 48个月）。与指南治疗相比，强化治疗使平均血压显著降低（差值 -10·6/-5·5 mmHg；p<0·01），与指南降脂治疗相比，强化降脂治疗使总胆固醇/低密度脂蛋白胆固醇也显著降低（差值 -0·54/-0·44 mmol/l；p<0·01）。两种治疗比较中，治疗期间的ACE-R评分均无差异；降压治疗的平均差值为 -3.6（95%CI -9.7至2.4），降脂治疗的平均差值为4.4（95%CI -2.1至10.9）。然而，强化降脂治疗与6个月时ACE-R评分、连线测验A、改良Rankin量表和欧洲五维度健康量表视觉模拟评分的改善显著相关。两种比较的痴呆发生率或严重不良事件发生率均无差异。
结论
在近期中风且认知正常的患者中，强化血压和降脂治疗是可行且安全的，但在两年内并未改变认知。强化降脂与一些次要结局评分改善之间的关联表明有必要进行进一步试验。
试验注册号
ISRCTN ISRCTN85562386。
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