Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, China (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).
China National Clinical Research Center for Neurological Diseases, Beijing (Jie Xu, A.W., X.M., G.Y., S.L., H.Z., X.C., Yilong Wang, X.Z., Yongjun Wang).
Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.
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).
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.
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]; =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).
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.
依达拉奉右莰醇由两种活性成分依达拉奉和(+) 莰醇组成，作为一种新型神经保护剂，在动物模型中具有抗氧化和抗炎的协同作用。本临床试验旨在比较依达拉奉右莰醇与依达拉奉对急性缺血性脑卒中（AIS）患者 90 天功能结局的影响。
本多中心、随机、双盲、对照、III 期临床试验于 2015 年 5 月至 2016 年 12 月在 48 家中国医院进行。纳入标准包括诊断为 AIS、年龄 35 至 80 岁、美国国立卫生研究院卒中量表评分 4 至 24 分、发病后 48 小时内的患者。AIS 患者以 1:1 的比例随机分为 2 个治疗组：14 天输注依达拉奉右莰醇或依达拉奉注射液。主要终点为随机分组后 90 天改良 Rankin 量表评分≤1 的患者比例。
1165 名 AIS 患者被随机分配至依达拉奉右莰醇组（n=585）或依达拉奉组（n=580）。与依达拉奉组相比，依达拉奉右莰醇组随机分组后 90 天的功能结局良好的患者比例显著更高（改良 Rankin 量表评分≤1，67.18%比 58.97%；比值比，1.42[95%CI，1.12-1.81]；=0.004）。预设的亚组分析表明，女性患者的获益大于男性患者（2.26，1.49-3.43 比 1.14，0.85-1.52）。
在 AIS 发病后 48 小时内使用依达拉奉右莰醇与依达拉奉相比，90 天的良好功能结局有利于依达拉奉右莰醇组，尤其是女性患者。登记：网址：https://www.clinicaltrials.gov。唯一标识符：NCT02430350。
