肾功能不全对溶栓治疗急性缺血性脑卒中结局的影响：ENCHANTED（强化高血压控制和溶栓治疗卒中研究）事后分析。
Influence of Renal Impairment on Outcome for Thrombolysis-Treated Acute Ischemic Stroke: ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study) Post Hoc Analysis.
机构信息
From the John Walls Renal Unit, University Hospitals of Leicester NHS Trust, United Kingdom (S.J.C.); The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (X.W., M.W., J.C., C.S.A.); The George Institute for Global Health, University of Sydney, New South Wales, Australia (R.I.L.); Clinica Alemana de Santiago, Facultad de Medicina, Clinica Alemana, Universidad del Desarrollo, Santiago, Chile (V.V.O., P.M.L., J.A.R.); Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile, Santiago (P.M.L.); Facultad de Medicina, Universidad Andrés Bello, Santiago, Chile (J.A.R.); Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, Korea (J.S.K.); Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan (T.-H.L.); Westmead Clinical School (R.I.L.) and School of Public Health (M.W.), University of Sydney, New South Wales, Australia; Department of Neurosciences and Behavioral Sciences, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil (O.M.P.-N.); Uo Neurologia, USL Umbria 1, Sedi di Citta di Castello e Branca, Italy (S.R.); Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan (S.S.); Yong Loo Lin School of Medicine, National University of Singapore and National University Hospital (V.K.S.); Department of Epidemiology, Johns Hopkins University, Baltimore, MD (M.W.); The George Institute for Global Health, University of Oxford, United Kingdom (M.W.); Neurology Department, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (C.S.A.); The George Institute China at Peking University Health Sciences Center, Beijing (C.S.A.); and Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, United Kingdom (T.G.R.).
出版信息
Stroke. 2017 Sep;48(9):2605-2609. doi: 10.1161/STROKEAHA.117.017808. Epub 2017 Jul 24.
BACKGROUND AND PURPOSE
Renal dysfunction (RD) is associated with poor prognosis after stroke. We assessed the effects of RD on outcomes and interaction with low- versus standard-dose alteplase in a post hoc subgroup analysis of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study).
METHODS
A total of 3220 thrombolysis-eligible patients with acute ischemic stroke (mean age, 66.5 years; 37.8% women) were randomly assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) intravenous alteplase within 4.5 hours of symptom onset. Six hundred and fifty-nine (19.8%) patients had moderate-to-severe RD (estimated glomerular filtration rate, <60 mL/min per 1.73 m) at baseline. The impact of RD on death or disability (modified Rankin Scale scores, 2-6) at 90 days, and symptomatic intracerebral hemorrhage, was assessed in logistic regression models.
RESULTS
Compared with patients with normal renal function (>90 mL/min per 1.73 m), those with severe RD (<30 mL/min per 1.73 m) had increased mortality (adjusted odds ratio, 2.07; 95% confidence interval, 0.89-4.82; =0.04 for trend); every 10 mL/min per 1.73 m lower estimated glomerular filtration rate was associated with an adjusted 9% increased odds of death from thrombolysis-treated acute ischemic stroke. There was no significant association with modified Rankin Scale scores 2 to 6 (adjusted odds ratio, 1.03; 95% confidence interval, 0.62-1.70; =0.81 for trend), modified Rankin Scale 3 to 6 (adjusted odds ratio, 1.20; 95% confidence interval, 0.72-2.01; =0.44 for trend), or symptomatic intracerebral hemorrhage, or any heterogeneity in comparative treatment effects between low-dose and standard-dose alteplase by RD grades.
CONCLUSIONS
RD is associated with increased mortality but not disability or symptomatic intracerebral hemorrhage in thrombolysis-eligible and treated acute ischemic stroke patients. Uncertainty persists as to whether low-dose alteplase confers benefits over standard-dose alteplase in acute ischemic stroke patients with RD.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616.
背景与目的
肾功能障碍（RD）与中风后预后不良有关。我们在 ENCHANTED（强化高血压控制和溶栓治疗研究）的事后亚组分析中评估了 RD 对结局的影响，并与低剂量与标准剂量阿替普酶之间的相互作用。
方法
共有 3220 名符合溶栓条件的急性缺血性中风患者（平均年龄 66.5 岁；37.8%为女性）在症状发作后 4.5 小时内随机分配接受低剂量（0.6 mg/kg）或标准剂量（0.9 mg/kg）的静脉内阿替普酶治疗。基线时有 659 名（19.8%）患者有中度至重度 RD（估计肾小球滤过率 <60 mL/min/1.73 m）。使用逻辑回归模型评估 RD 对 90 天死亡或残疾（改良 Rankin 量表评分 2-6）和症状性颅内出血的影响。
结果
与肾功能正常（>90 mL/min/1.73 m）的患者相比，严重 RD（<30 mL/min/1.73 m）的患者死亡率增加（校正优势比，2.07；95%置信区间，0.89-4.82；趋势检验=0.04）；每 10 mL/min/1.73 m 估算肾小球滤过率降低与溶栓治疗的急性缺血性中风患者死亡的校正优势比增加 9%相关。与改良 Rankin 量表评分 2-6（校正优势比，1.03；95%置信区间，0.62-1.70；趋势检验=0.81）、改良 Rankin 量表评分 3-6（校正优势比，1.20；95%置信区间，0.72-2.01；趋势检验=0.44）、症状性颅内出血或 RD 分级比较治疗效果的任何异质性均无显著相关性。
结论
RD 与溶栓治疗的急性缺血性中风患者的死亡率增加有关，但与残疾或症状性颅内出血无关。在 RD 患者中，低剂量阿替普酶是否优于标准剂量阿替普酶仍存在不确定性。
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