Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing 100730, China (Email:
Chin Med J (Engl). 2013;126(18):3405-10.
Dl-3-n-butylphthalide (NBP), first isolated from the seeds of celery, showed efficacy in animal models of stroke. This study was a clinical trial to assess the efficacy and safety of NBP with a continuous dose regimen among patients with acute ischemic stroke.
A randomized, double-blind, double-dummy trial enrolled 573 patients within 48 hours of onset of ischemic stroke in China. Patients were randomly assigned to receive a 14-day infusion of NBP followed by an NBP capsule, a 14-day infusion of NBP followed by aspirin, or a 14-day infusion of ozagrel followed by aspirin. The efficacy measures were Barthel index score and the modified Rankin scale (mRS) at day 90. Differences among the three groups on mRS were compared using χ(2) test of proportions (with two-sided α = 0.05) and Logistic regression analysis was conducted to take the baseline National Institutes of Health Stroke Scale (NIHSS) score into consideration.
Among the 535 subjects included in the efficacy analysis, 90-day treatment with NBP was associated with a significantly favorable outcome than 14-day treatment with ozagrel as measured by mRS (P < 0.001). No significant difference was found among the three groups on Barthel index at day 90. The rate of adverse events was similar among the three groups.
The 90-day treatment with NBP could improve outcomes at the third month after stroke. The NBP treatment (both intravenous and oral) is safe (ChiCTR-TRC-09000483).
二氢-1-正丁基苯酞（NBP）最初从芹菜籽中分离出来，在中风动物模型中显示出疗效。本研究是一项临床试验，旨在评估 NBP 在连续剂量方案下对急性缺血性中风患者的疗效和安全性。
一项在中国进行的随机、双盲、双模拟试验纳入了发病后 48 小时内的 573 例缺血性中风患者。患者被随机分配接受为期 14 天的 NBP 输注，随后是 NBP 胶囊，或接受为期 14 天的 NBP 输注，随后是阿司匹林，或接受为期 14 天的奥扎格雷输注，随后是阿司匹林。90 天时的疗效评估指标为巴氏指数评分和改良 Rankin 量表（mRS）。采用比例 χ²检验（双侧 α = 0.05）比较三组间 mRS 的差异，并采用 Logistic 回归分析考虑基线美国国立卫生研究院卒中量表（NIHSS）评分的影响。
在纳入疗效分析的 535 例患者中，与奥扎格雷相比，90 天的 NBP 治疗与 mRS 评分的良好预后显著相关（P < 0.001）。90 天时三组间巴氏指数无显著差异。三组间不良事件发生率相似。
NBP 治疗 90 天可改善中风后第三个月的结局。NBP 治疗（静脉和口服）是安全的（ChiCTR-TRC-09000483）。
