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降脂药物与血肿增长无关:急性脑出血强化降压试验研究的汇总分析。

No relationship of lipid-lowering agents to hematoma growth: pooled analysis of the intensive blood pressure reduction in acute cerebral hemorrhage trials studies.

机构信息

From the Department of Neurology, Stroke Network, Royal North Shore Hospital, Sydney, Australia (M.P., M.K.); Department of Neurology, George Institute for Global Health, Royal Prince Alfred Hospital, Sydney, Australia (H.A., C.A.); and Sydney Medical School,University of Sydney, Sydney, Australia (M.K., H.A., C.A.).

出版信息

Stroke. 2015 Mar;46(3):857-9. doi: 10.1161/STROKEAHA.114.007664. Epub 2015 Feb 5.

Abstract

BACKGROUND AND PURPOSE

Controversy persists over statins and risk of intracerebral hemorrhage. We determined associations of premorbid lipid-lowering therapy and outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT).

METHODS

The pooled data of INTERACT 1 and 2 (international, multicenter, prospective, open, blinded end point, randomized controlled trials of patients with intracerebral hemorrhage [<6 hours] and elevated systolic blood pressure) were analyzed with regard to associations of baseline lipid-lowering treatment and clinical outcomes of 3184 participants in a multivariate model. Associations of lipid-lowering therapy and hematoma growth (baseline to 24 hours) in computed tomographic substudies participants (n=1310) were estimated in ANCOVA.

RESULTS

Among 204 patients (6.5%) with baseline lipid-lowering treatment, 90-day clinical outcomes were not significantly different after adjustment for confounding variables including region and age. In the computed tomographic substudy, 24-hour hematoma growth was greater in 124 patients (9%) with, compared with those without, prior lipid-lowering therapy. However, this association was not significant between groups (9.2 versus 6.8 mL; P<0.13), after adjustment for prior antithrombotic therapy.

CONCLUSIONS

No independent associations were found between lipid-lowering medication and adverse outcomes in patients with intracerebral hemorrhage.

CLINICAL TRIAL REGISTRATION URL

http://www.clinicaltrials.gov. Unique identifier: NCT00226096 and NCT00716079.

摘要

背景与目的

关于他汀类药物与脑出血风险之间的争议仍然存在。我们旨在确定强化降压脑出血试验(INTERACT)参与者中,发病前降脂治疗与结局之间的相关性。

方法

通过对 INTERACT1 和 2 的汇总数据(一项国际性、多中心、前瞻性、开放性、盲终点、随机对照试验,纳入发病 6 小时内伴颅内出血和收缩压升高的患者)进行分析,评估了基线降脂治疗与 3184 名参与者的临床结局之间的相关性。在计算机断层扫描子研究(n=1310)参与者中,采用协方差分析(ANCOVA)评估降脂治疗与血肿增长(基线至 24 小时)之间的相关性。

结果

在 204 名(6.5%)基线降脂治疗的患者中,在校正混杂因素(包括地域和年龄)后,90 天临床结局无显著差异。在计算机断层扫描子研究中,与未接受降脂治疗的患者相比,124 名(9%)接受过降脂治疗的患者在 24 小时血肿增长更大。然而,在调整既往抗血栓治疗后,两组间无显著差异(9.2 与 6.8mL;P<0.13)。

结论

在脑出血患者中,降脂药物与不良结局之间无独立相关性。

临床试验注册网址

http://www.clinicaltrials.gov。唯一标识符:NCT00226096 和 NCT00716079。

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