Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep.
Edaravone Dexborneol is a novel neuroprotective agent that comprised edaravone and (+)-borneol, a food additive with an anti-inflammatory effect in animal ischaemic stroke models. This study aims to assess the safety and efficacy of Edaravone Dexborneol compared with edaravone in treating patients with acute ischaemic stroke (AIS).
In this multicentre, randomised, double-blind, multiple-dose, active-controlled, phase II clinical trial, patients with AIS within 48 hours after stroke onset were randomly assigned (1:1:1:1) to low-dose (12.5 mg), medium-dose (37.5 mg) or high-dose (62.5 mg) Edaravone Dexborneol groups, and an active control group with edaravone (30 mg) by 30 min intravenous infusion every 12 hours, for 14 consecutive days. The primary efficacy outcome was the proportion of modified Rankin Scale (mRS)score ≤1 at 90 days and National Institutes of Health Stroke Scale (NIHSS) score change from baseline to 14 days after randomisation. The safety outcome included any adverse event during 90 days after treatment.
Of 385 patients included in the efficacy analysis, 94 were randomised to low-dose group, 97 to medium-dose group, 98 to high-dose group and 96 to the control group. No significant difference was observed among the four groups on mRS score (mRS ≤1, p=0.4054) at 90 days or NIHSS score change at 14 days (p=0.6799). However, a numerically higher percentage of patients with mRSscore ≤1 at 90 days in the medium-dose (69.39%) and high-dose (65.63%) groups was observed than in the control group (60.64%). No significant difference in severe adverse events was found among the four groups (p=0.3815).
Compared with edaravone alone, Edaravone Dexborneol was safe and well tolerated at all doses, although no significant improvement in functional outcomes was observed at 90days.
NCT01929096.
依达拉奉右莰醇是一种新型的神经保护剂，由依达拉奉和（+）-冰片组成，在动物缺血性中风模型中具有抗炎作用，是一种食品添加剂。本研究旨在评估依达拉奉右莰醇与依达拉奉治疗急性缺血性中风（AIS）患者的安全性和有效性。
这是一项多中心、随机、双盲、多剂量、阳性对照、二期临床试验，纳入发病 48 小时内的 AIS 患者，按 1:1:1:1 随机分配至低剂量（12.5mg）、中剂量（37.5mg）或高剂量（62.5mg）依达拉奉右莰醇组，以及阳性对照依达拉奉（30mg）组，均采用 30min 静脉输注，每 12 小时 1 次，连续 14 天。主要疗效终点为治疗 90 天时改良 Rankin 量表（mRS）评分≤1 的比例和随机分组后 14 天内美国国立卫生研究院卒中量表（NIHSS）评分变化。安全性终点包括治疗后 90 天内的任何不良事件。
385 例患者纳入疗效分析，94 例随机分入低剂量组，97 例分入中剂量组，98 例分入高剂量组，96 例分入对照组。90 天时 mRS 评分（mRS≤1，p=0.4054）和 14 天时 NIHSS 评分变化（p=0.6799）在四组间无显著差异。然而，中剂量（69.39%）和高剂量（65.63%）组治疗 90 天时 mRS 评分≤1 的患者比例高于对照组（60.64%），但差异无统计学意义。四组严重不良事件发生率无显著差异（p=0.3815）。
与依达拉奉单药治疗相比，依达拉奉右莰醇在所有剂量下均安全且耐受良好，尽管治疗 90 天内功能结局无显著改善。
NCT01929096。
