Venketasubramanian Narayanaswamy, Pokharkar Yogesh, Chai Jia Hui, Chen Christopher Li Hsian
Raffles Neuroscience Centre, Raffles Hospital, Singapore 188770, Singapore.
Singapore Clinical Research Institute, Consortium for Clinical Research and Innovation Singapore, 23 Rochester Park, Singapore 139234, Singapore.
J Cardiovasc Dev Dis. 2023 Mar 12;10(3):117. doi: 10.3390/jcdd10030117.
Despite recent progress with revascularisation interventions after acute ischemic stroke, many patients remain disabled after stroke. Using data from a multi-centre, randomised, double-blind, placebo-controlled trial of a neuro-repair treatment (NeuroAiD/MLC601) with a long-term follow-up, we analysed the savings in time to functional recovery, measured by a modified Rankin Scale (mRS) score of 0 or 1, in patients receiving a 3-month oral course of MLC601. Analysis of time to recovery was assessed by a log-rank test and hazard ratios (HRs) adjusted for prognosis factors. A total of 548 patients with baseline NIHSS scores 8-14, mRS scores ≥ 2 at day 10 post-stroke, and at least one mRS assessment on or after month 1 were included in the analysis (placebo = 261; MLC601 = 287). Time to functional recovery was significantly shortened for patients receiving MLC601 versus patients receiving placebo (log-rank test: = 0.039). This result was confirmed by Cox regression adjusting for the main baseline prognostic factors (HR: 1.30 [0.99, 1.70]; = 0.059) and was more pronounced in patients with additional poor prognosis factors. The Kaplan-Meier plot showed that approximately 40% cumulative incidence of functional recovery was achieved within 6 months after stroke onset in the MLC601 group versus 24 months in the placebo group. The main findings are that MLC601 reduced the time to achieve functional recovery, and a 40% functional recovery rate was achieved 18 months earlier compared to placebo.
尽管急性缺血性中风后血管重建干预措施最近取得了进展,但许多患者中风后仍有残疾。我们利用一项神经修复治疗(NeuroAiD/MLC601)的多中心、随机、双盲、安慰剂对照试验的数据,并进行长期随访,分析了接受为期3个月口服MLC601疗程的患者达到功能恢复(改良Rankin量表[mRS]评分为0或1)的时间节省情况。通过对数秩检验和针对预后因素调整的风险比(HR)评估恢复时间。共有548例基线美国国立卫生研究院卒中量表(NIHSS)评分8 - 14、中风后第10天mRS评分≥2且在第1个月及以后至少有一次mRS评估的患者纳入分析(安慰剂组 = 261例;MLC601组 = 287例)。接受MLC601的患者与接受安慰剂的患者相比,功能恢复时间显著缩短(对数秩检验: = 0.039)。通过对主要基线预后因素进行Cox回归分析证实了这一结果(HR:1.30 [0.99, 1.70]; = (此处原文缺失数据)0.059),并且在具有其他不良预后因素的患者中更为明显。Kaplan - Meier曲线显示,MLC601组在中风发作后6个月内实现功能恢复的累积发生率约为40%,而安慰剂组为24个月。主要发现是MLC601缩短了实现功能恢复的时间,与安慰剂相比,功能恢复率提前18个月达到40%。