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Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke

依达拉奉 医学 改良兰金量表 随机化 麻醉 内科学 随机对照试验 临床试验 缺血性中风 缺血
作者
Jie Xu,Anxin Wang,Xia Meng,Gulbahram Yalkun,Chunxue Wang,Zhiqiang Gao,Dawei Chen,Yong Ji,Jun Xu,Deqin Geng,Runxiu Zhu,Bo Liu,Aiqin Dong,Hua Mu,Zhihong Lu,Shuya Li,Huaguang Zheng,Xia Chen,Yilong Wang,Xingquan Zhao
出处
期刊:Stroke [Lippincott Williams & Wilkins]
卷期号:52 (3): 772-780 被引量:153
标识
DOI:10.1161/strokeaha.120.031197
摘要

Background and Purpose: Edaravone dexborneol, comprised of 2 active ingredients, edaravone and (+)-borneol, has been developed as a novel neuroprotective agent with synergistic effects of antioxidant and anti-inflammatory in animal models. The present clinical trial aimed at testing the effects of edaravone dexborneol versus edaravone on 90-day functional outcome in patients with acute ischemic stroke (AIS). Methods: A multicenter, randomized, double-blind, comparative, phase III clinical trial was conducted at 48 hospitals in China between May 2015 and December 2016. Inclusion criteria included patients diagnosed as AIS, 35 to 80 years of age, National Institutes of Health Stroke Scale Score between 4 and 24, and within 48 hours of AIS onset. AIS patients were randomized in 1:1 ratio into 2 treatment arms: 14-day infusion of edaravone dexborneol or edaravone injection. The primary end point was the proportion of patients with modified Rankin Scale score ≤1 on day 90 after randomization. Results: One thousand one hundred sixty-five AIS patients were randomly allocated to the edaravone dexborneol group (n=585) or the edaravone group (n=580). The edaravone dexborneol group showed significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization, compared with the edaravone group (modified Rankin Scale score ≤1, 67.18% versus 58.97%; odds ratio, 1.42 [95% CI, 1.12–1.81]; P =0.004). The prespecified subgroup analyses indicated that a greater benefit was observed in female patients than their male counterparts (2.26, 1.49–3.43 versus 1.14, 0.85–1.52). Conclusions: When edaravone dexborneol versus edaravone was administered within 48 hours after AIS, 90-day good functional outcomes favored the edaravone dexborneol group, especially in female patients. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02430350.
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