MLC601/MLC901（NeuroAiD）在原发性脑出血中的安全性及应用：一项来自NeuroAiD安全治疗注册库的队列研究
Safety and Use of MLC601/MLC901 (NeuroAiD) in Primary Intracerebral Hemorrhage: A Cohort Study from the NeuroAiD Safe Treatment Registry.
作者信息
Kumar Ramesh, Abu Bakar Azizi, Thanabalan Jegan, Paramasvaran Sanmugarajah, Toh Charng Jeng, Jaffar Ainul, Fadzil Farizal, Kamalanathan Palaniandy, Soon Bee Hong, Venketasubramanian Narayanaswamy
机构信息
Department of Neurosurgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur 56000, Malaysia.
Raffles Neuroscience Centre, Raffles Hospital, Singapore 188770, Singapore.
出版信息
Brain Sci. 2020 Jul 30;10(8):499. doi: 10.3390/brainsci10080499.
BACKGROUND
MLC601/MLC901 (NeuroAiD™) is a combination of natural products shown to be safe and to aid neurological recovery after brain injuries, especially ischemic stroke. Few studies have investigated NeuroAiD in primary intracerebral hemorrhage (ICH). The NeuroAiD Safe Treatment (NeST) Registry explores NeuroAiD use in the real-world setting. This cohort study aimed to assess its use and safety in ICH.
METHODS
The online NeST Registry of subjects with ICH given NeuroAiD prospectively collected clinical data at baseline and monthly visits (V) 1 to 3. Outcome measures included compliance, side effects, Glasgow Coma Scale (GCS), National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Short Orientation-Memory-Concentration Test (SOMCT).
RESULTS
Sixty-six subjects were included. NeuroAiD was well-tolerated with fair compliance over three months. Two non-serious side effects were reported. Mean scores significantly improved on all outcome scales. The proportion of subjects with favorable outcomes significantly improved from baseline to V3: NIHSS 0-4, from 12% to 59% ( < 0.0001); GCS 13-15, from 64% to 88% ( = 0.007); mRS 0-1, from 9% to 37% ( = 0.004); and SOMCT score 0-8, from 44% to 68% ( = 0.029).
CONCLUSIONS
NeuroAiD in the real-world setting was safe and showed potential for a sustained positive effect on neurological recovery after ICH.
背景
MLC601/MLC901（NeuroAiD™）是一种天然产物的组合，已证明其安全且有助于脑损伤尤其是缺血性中风后的神经功能恢复。很少有研究调查NeuroAiD在原发性脑出血（ICH）中的应用。NeuroAiD安全治疗（NeST）注册研究探索了NeuroAiD在现实环境中的使用情况。这项队列研究旨在评估其在ICH中的使用情况和安全性。
方法
NeST在线注册研究前瞻性收集了接受NeuroAiD治疗的ICH患者在基线以及第1至3个月每月随访时的临床数据。观察指标包括依从性、副作用、格拉斯哥昏迷量表（GCS）、美国国立卫生研究院卒中量表（NIHSS）、改良Rankin量表（mRS）以及简易定向-记忆-注意力测试（SOMCT）。
结果
纳入了66名受试者。NeuroAiD耐受性良好，在三个月内依从性尚可。报告了两例非严重副作用。所有观察指标的平均得分均有显著改善。从基线到第3个月随访时，预后良好的受试者比例显著提高：NIHSS评分为0 - 4分的比例从12%提高到59%（<0.0001）；GCS评分为13 - 15分的比例从64%提高到88%（=0.007）；mRS评分为0 - 1分的比例从9%提高到37%（=0.004）；SOMCT评分为0 - 8分的比例从44%提高到68%（=0.029）。
结论
在现实环境中，NeuroAiD是安全的，并且对ICH后的神经功能恢复显示出持续积极作用的潜力。
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