School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515, PR China.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, PR China; State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, Beijing 100875, PR China.
Pharmacol Res. 2020 Jun;156:104773. doi: 10.1016/j.phrs.2020.104773. Epub 2020 Mar 31.
With the increasing incidence of cerebrovascular diseases and dementia, considerable efforts have been made to develop effective treatments on vascular cognitive impairment (VCI), among which accumulating practice-based evidence has shown great potential of the traditional Chinese medicine (TCM). Current randomized double-blind controlled trial has been designed to evaluate the 6-month treatment effects of Dengzhan Shengmai (DZSM) capsules, one TCM herbal preparations on VCI, and to explore the underlying neural mechanisms with graph theory-based analysis and machine learning method based on diffusion tensor imaging (DTI) data. A total of 82 VCI patients were recruited and randomly assigned to drug (45 with DZSM) and placebo (37 with placebo) groups, and neuropsychological and neuroimaging data were acquired at baseline and after 6-month treatment. After treatment, compared to the placebo group, the drug groups showed significantly improved performance in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog) score (p < 0.001) and the other cognitive domains. And with the reconstruction of white matter structural network, there were more streamlines connecting the left thalamus and right hippocampus in the drug groups (p < 0.001 uncorrected), with decreasing nodal efficiency of the right olfactory associated with slower decline in the general cognition (r = -0.364, p = 0.048). Moreover, support vector machine classification analyses revealed significant white matter network alterations after treatment in the drug groups (accuracy of baseline vs. 6-month later, 68.18 %). Taking together, the present study showed significant efficacy of DZSM treatment on VCI, which might result from white matter microstructure alterations and the topological changes in brain structural network.
随着脑血管病和痴呆发病率的增加,人们已经做出了相当大的努力来开发针对血管性认知障碍(VCI)的有效治疗方法,其中积累的实践证据表明中药(TCM)具有很大的潜力。目前已经设计了一项随机、双盲对照临床试验,以评估中药丹珍生脉胶囊对 VCI 的 6 个月治疗效果,并通过基于图论的分析和基于弥散张量成像(DTI)数据的机器学习方法来探索潜在的神经机制。共招募了 82 例 VCI 患者,并随机分为药物组(45 例,给予丹珍生脉胶囊)和安慰剂组(37 例,给予安慰剂),在基线和 6 个月治疗后采集神经心理学和神经影像学数据。治疗后,与安慰剂组相比,药物组在阿尔茨海默病评估量表-认知分量表(ADAS-cog)评分(p<0.001)和其他认知领域的表现均显著改善。并且通过对大脑白质结构网络的重建,药物组左侧丘脑和右侧海马之间有更多的束流连接(p<0.001 未校正),右侧嗅球的节点效率降低与一般认知的下降速度较慢有关(r=-0.364,p=0.048)。此外,支持向量机分类分析显示,治疗后药物组的白质网络发生了显著变化(基线与 6 个月后的准确率,68.18%)。综上所述,本研究表明丹珍生脉胶囊治疗 VCI 具有显著疗效,这可能与白质微观结构的改变以及大脑结构网络的拓扑变化有关。