摘要目的:评估马来酸桂哌齐特注射液治疗急性缺血性脑卒中的早期有效性和安全性。方法:本研究为多中心、随机、双盲、安慰剂对照Ⅳ期临床研究，由北京协和医院牵头，全国65家国家临床试验机构的神经内科专业组共同完成。于2016年8月至2019年2月连续入组发病时间≤48 h，美国国立卫生研究院卒中量表（NIHSS）评分为7~25分的急性前循环非心源性脑梗死患者，其中937例（治疗组466例，对照组471例）进入最终全分析集进行分析。以用药后14 d改良Rankin量表（mRS）评分≤1分比例和Barthel指数为疗效终点，安全性终点指标包括用药后14 d的生命体征、实验室检查指标和心电图结果。结果:共入组946例患者，其中937例纳入最终分析。多因素Logistic回归分析显示，治疗组用药后14 d mRS≤1分受试者比例高于对照组［分别为102/466（21.89%）和76/471（16.14%）］，两组间差异具有统计学意义（ OR=0.677， 95%CI0.484～0.948， P=0.023）；治疗组病后14 d Barthel指数≥95受试者比例高于对照组［分别为125/466（26.82%）和91/471（19.32%）］，两组间差异具有统计学意义（ OR=0.632， 95%CI0.459～0.869， P=0.005）。两组间不良事件发生率相似。 结论:马来酸桂哌齐特注射液治疗急性缺血性脑卒中，早期即可显著改善患者残障程度和日常生活能力，且安全性良好。

abstractsObjective:To assess the efficacy and safety of cinepazide maleate injection in the treatment of patients with acute ischemic stroke.Methods:A multicenter, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial, led by Peking Union Medical College Hospital, was conducted in 65 Hospitals in China. The efficacy of cinepazide maleate injection in patients with acute anterior circulation cerebral infarction with onset time of ≤48 hours, 7≤National Institute of Health stroke scale (NIHSS) score ≤25 was assessed from August 2016 to February 2019, using the proportion of modified Rankin scale (mRS) score≤1 and Barthel index (BI) score≤95 on day 14 as efficacy endpoint. The patients were divided into treatment group who were treated with cinepazide maleate injection and control group who were treated with placebo.Results:A total 937 patients were involved in the final efficacy analysis (466 in treatment group and 471 in control group). The proportion of subjects with mRS score≤1 on day 14 after treatment were higher in the treatment group than that in the control group (102/466(21.89%) vs76/471(16.14%)). Logistic regression analysis showed that patients treated with cinepazide maleate were significantly more likely to have a favorable outcome (mRS score≤1) than patients treated with placebo on day 14 ( OR=0.677, 95% CI 0.484-0.948 , P=0.023), and patients treated with cinepazide maleate were more likely to reach independence in activities of daily living (Barthel Index ≥95) than those treated with placebo on day 14 (125/466(26.82%) vs 91/471(19.32%); OR=0.632, 95% CI0.459-0.869, P=0.005). The rate of adverse events was similar between the treatment and control groups. Conclusion:The 14-day treatment with cinepazide maleate injection could reduce the degree of disability whereas did not increase the risk of adverse events.