Yoshimura Shinichi, Uchida Kazutaka, Daimon Takashi, Takashima Ryuzo, Kimura Kazuhiro, Morimoto Takeshi
From the Department of Neurosurgery (S.Y., K.U.), Department of Clinical Epidemiology (K.U., T.M.), Center for Clinical Research and Education (T.D., T.M.), and Department of Biostatistics (T.D.), Hyogo College of Medicine, Nishinomiya, Hyogo, Japan; and Medical Affairs Department, Shionogi & Co, Ltd, Osaka, Japan (R.T., K.K.).
Stroke. 2017 Nov;48(11):3057-3063. doi: 10.1161/STROKEAHA.117.017623. Epub 2017 Oct 13.
Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available.
We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days.
A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups (=0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53-1.3; =0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups.
Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02549846.
多项研究表明，住院期间使用他汀类药物与急性缺血性脑卒中患者更好的功能预后相关，但仅有一项小型随机试验。
我们在日本11家医院对急性缺血性脑卒中患者进行了一项多中心、开放标签、随机对照试验。急性缺血性脑卒中和血脂异常患者按1:1比例随机分为早期组（入院后24小时内）和延迟组（第7天），在入院后24小时内接受他汀类药物治疗，治疗12周。主要结局是90天时用改良Rankin量表评估的患者功能障碍情况。
共257例患者被随机分组并进行分析（早期组131例，延迟组126例）。90天时，两组间改良Rankin量表评分分布无差异（P=0.68），早期他汀类药物组与延迟他汀类药物组相比，调整后的共同比值比为0.84（95%置信区间，0.53 - 1.3；P=0.46）。90天时因恶性肿瘤死亡3例（早期组2例，延迟组1例）。早期组9例（6.9%）发生缺血性脑卒中复发，延迟组5例（4.0%）复发。两组安全性相似。
我们针对急性缺血性脑卒中和血脂异常患者的随机试验未显示入院后24小时内早期他汀类药物治疗相比入院7天后延迟他汀类药物治疗在减轻发病90天时功能障碍程度方面有任何优势。
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