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估算肾小球滤过率降低和 B 族维生素治疗对缺血性脑卒中患者预后的影响及相互作用:维生素干预预防脑卒中(VISP)试验。

Impact and interaction of low estimated GFR and B vitamin therapy on prognosis among ischemic stroke patients: the Vitamin Intervention for Stroke Prevention (VISP) trial.

机构信息

Chang Gung University College of Medicine, Department of Neurology, Chang Gung Memorial Hospital, Chiayi, Taiwan.

出版信息

Am J Kidney Dis. 2013 Jul;62(1):52-7. doi: 10.1053/j.ajkd.2013.02.355. Epub 2013 Apr 6.

DOI:10.1053/j.ajkd.2013.02.355
PMID:23566636
Abstract

BACKGROUND

Low estimated glomerular filtration rate (eGFR) has been linked to higher risk of primary stroke, but little is known about the relation of low eGFR to recurrent vascular risk after stroke. B Vitamin therapy has been used to lower homocysteine levels, but its interaction with kidney function on future major vascular events has not been assessed. The objective of this study was to conduct a secondary analysis based on the Vitamin Intervention for Stroke Prevention (VISP) trial to clarify these issues.

STUDY DESIGN

In the VISP trial, patients with a prior ischemic stroke were randomly assigned to receive the high- or low-dose B vitamin therapy. The trial did not find a difference between randomly assigned groups. The present study is a secondary analysis of the VISP trial.

SETTING & PARTICIPANTS: We analyzed the database of a multicenter trial comprising 3,673 patients with recent ischemic stroke who were followed up for 2 years.

PREDICTOR

We subdivided the cohort based on eGFR into 6 groups (≥105, 90-104, 75-89, 60-74, 45-59, and <45 mL/min/1.73 m²) for the analyses and used eGFR of 60-74 mL/min/1.73 m² as the reference category. Low eGFR was defined as <45 mL/min/1.73 m².

OUTCOMES

The primary end point for this analysis was major vascular events, defined as the composite of nonfatal ischemic stroke, nonfatal myocardial infarction, and vascular death (whichever event came first). The secondary end point was recurrent ischemic stroke. Also, the effects of high-dose B vitamin treatment on future major vascular events according to baseline eGFR categories were analyzed and reported separately.

RESULTS

Mean baseline eGFR was 73.9 ± 21.8 (SD) mL/min/1.73 m². 471 major vascular events during an average of 20 months of follow-up, including 300 recurrent strokes, were recorded. Baseline low eGFR was associated with increased risk of major vascular events (HR, 1.83; 95% CI, 1.32-2.52; P < 0.001) and recurrent stroke (HR, 1.53; 95% CI, 1.01-2.32; P = 0.04) after adjustment for traditional vascular risk factors and homocysteine level. At baseline eGFR <45 mL/min/1.73 m², high-dose B vitamin therapy compared to low dose showed a trend of higher risk of future major vascular events (HR, 1.49; 95% CI, 0.95-2.34; P = 0.08). The overall P value for interaction between B vitamin dose and eGFR was not significant (P = 0.6).

LIMITATIONS

No data for albuminuria.

CONCLUSIONS

Low eGFR is associated with higher risk of future major vascular events and recurrent stroke after a recent ischemic stroke.

摘要

背景

估算肾小球滤过率(eGFR)降低与原发性中风风险增加有关,但对于中风后复发性血管风险与 eGFR 降低的关系知之甚少。B 族维生素治疗可降低同型半胱氨酸水平,但尚未评估其与肾功能对未来主要血管事件的相互作用。本研究旨在基于维生素干预预防中风(VISP)试验进行二次分析,以阐明这些问题。

研究设计

在 VISP 试验中,将既往有缺血性中风的患者随机分配接受高剂量或低剂量 B 族维生素治疗。试验未发现随机分组之间的差异。本研究是 VISP 试验的二次分析。

设置和参与者

我们分析了一项多中心试验的数据库,该试验纳入了 3673 例近期发生缺血性中风的患者,对其进行了 2 年的随访。

预测因素

我们根据 eGFR 将队列分为 6 组(≥105、90-104、75-89、60-74、45-59 和<45 mL/min/1.73 m²)进行分析,并将 eGFR 为 60-74 mL/min/1.73 m²作为参考类别。低 eGFR 定义为<45 mL/min/1.73 m²。

结局

本分析的主要终点是主要血管事件,定义为非致命性缺血性中风、非致命性心肌梗死和血管性死亡(以先发生的任何事件为准)的复合终点。次要终点是复发性缺血性中风。此外,还分别分析并报告了高剂量 B 族维生素治疗对根据基线 eGFR 类别预测的未来主要血管事件的影响。

结果

平均基线 eGFR 为 73.9±21.8(SD)mL/min/1.73 m²。在平均 20 个月的随访期间,记录了 471 例主要血管事件,包括 300 例复发性中风。基线时 eGFR 较低与主要血管事件(风险比[HR],1.83;95%置信区间[CI],1.32-2.52;P<0.001)和复发性中风(HR,1.53;95% CI,1.01-2.32;P=0.04)风险增加相关,调整了传统血管危险因素和同型半胱氨酸水平后。在基线 eGFR<45 mL/min/1.73 m²时,与低剂量相比,高剂量 B 族维生素治疗未来主要血管事件的风险呈增高趋势(HR,1.49;95% CI,0.95-2.34;P=0.08)。B 族维生素剂量和 eGFR 之间交互作用的总 P 值不显著(P=0.6)。

局限性

无蛋白尿数据。

结论

近期发生缺血性中风后,较低的 eGFR 与未来主要血管事件和复发性中风风险增加相关。

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