Department of Neurology, Tianjin Medical University General Hospital, Tianjin, 300052, China.
Tianjin Neurological Institute, Key Laboratory of Post-neurotrauma Neuro-repair and Regeneration in Central Nervous System, Ministry of Education and Tianjin City, Tianjin, 300052, China.
BMC Neurol. 2019 Aug 23;19(1):206. doi: 10.1186/s12883-019-1435-y.
Subcortical ischemic vascular dementia (SIVD) is very common among the older people, but has no approved treatment. Preclinical trials show that remote ischemic conditioning (RIC) reduces recurrence of ischemic stroke. We hypothesize that RIC may also be an effective therapy for patients with SIVD.
Thirty-seven consecutive SIVD cases were enrolled in this randomized control study. Eighteen RIC patients underwent five brief cycles of conditioning (bilateral upper limb compression at 200 mmHg) followed by reperfusion twice daily over 6 consecutive months. Nineteen control patients underwent the same process, but at a pressure of 60 mmHg which caused no restriction on the blood flow of the upper limb. The primary outcome measures were changes in neuropsychological assessments. The secondary outcomes included the changes in high-sensitive C-reactive protein (hs-CRP) concentration, white matter lesion volume (WMLV), diffusion tension imaging (DTI) metrics of white matter. All data were collected at baseline and follow-up.
A significant treatment difference favoring RIC at 6 months was observed on performance of Hopkins Verbal Learning Test-Revised (HVLT-R), Controlled Oral Word Association Test (COWAT), Trail Making Test A and B (TMT-A & TMT-B), and Judgment of Line Orientation (JLO) (p < 0.05). The control group did not show much improvement after the treatment, and only with a slight change in HVLT-R and TMT-R (p < 0.05). Covariance analysis of efficacy between the two groups suggested that RIC patients performed better on JLO than control patients at the 6-month follow-up (RIC 23.10 vs. control 18.56; p = 0.013). Although DTI metrics were comparable, Hs-CRP levels and WMLV in RIC patients showed a declining trend.
Over the 6-month treatment period, we found that RIC was safe and effective for improving cognitive function in SIVD patients.
Clinical Trial Registration ( http://www.clinicaltrials.gov ), Unique identifier: NCT03022149; Retrospectively registered; Date of registration: January 16, 2017.
皮质下缺血性血管性痴呆（SIVD）在老年人中非常常见，但尚无批准的治疗方法。临床前试验表明，远程缺血预处理（RIC）可降低缺血性中风的复发率。我们假设 RIC 也可能是 SIVD 患者的有效治疗方法。
本研究纳入了 37 例连续 SIVD 患者，采用随机对照研究。18 例 RIC 患者接受 5 个短暂的预处理周期（双侧上肢加压至 200mmHg），随后每日 2 次再灌注，持续 6 个月。19 例对照患者接受相同的过程，但压力为 60mmHg，不会限制上肢的血流。主要终点是神经心理学评估的变化。次要结果包括高敏 C 反应蛋白（hs-CRP）浓度、白质病变体积（WMLV）、弥散张量成像（DTI）的白质指标的变化。所有数据均在基线和随访时收集。
RIC 组在 6 个月时的霍普金斯言语学习测验修订版（HVLT-R）、控制口头联想测验（COWAT）、连线测试 A 和 B（TMT-A 和 TMT-B）和直线定向判断（JLO）的表现明显优于对照组（p<0.05）。对照组在治疗后改善不大，仅 HVLT-R 和 TMT-R 略有变化（p<0.05）。两组疗效的协方差分析表明，RIC 组在 6 个月随访时的 JLO 评分优于对照组（RIC 23.10 比对照 18.56；p=0.013）。尽管 DTI 指标相似，但 RIC 组的 hs-CRP 水平和 WMLV 呈下降趋势。
在 6 个月的治疗期间，我们发现 RIC 对改善 SIVD 患者的认知功能是安全有效的。
临床试验注册（http://www.clinicaltrials.gov），唯一标识符：NCT03022149；回顾性注册；注册日期：2017 年 1 月 16 日。
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