Neurology and Neurosurgery Department, Medical Faculty, I.M. Sechenov Moscow State University, Moscow, Russian Federation.
Department of Neurological diseases, Military Medical Academy, Kirov Russian Ministry of Defense, Saint-Petersburg, Russian Federation.
Eur Neurol. 2020;83(6):591-601. doi: 10.1159/000508184. Epub 2020 Nov 17.
Chronic cerebral ischemia (CCI) is a form of cerebrovascular disease manifested as a vascular cognitive impairment (VCI). The management of the patients with CCI is determined by a healthy lifestyle and early therapy aimed at correcting and preventing this disease. Divaza is a drug with endothelial protective and nootropic effects. We present the final efficacy and safety analysis of all-Russian, open-label, prospective, observational, multicenter study of Divaza and emphasize the role of demographic and socioeconomic factors in cognitive disorder (CD) progression.
CCI patients (n = 2,583) with or without CD were enrolled. Patients received Divaza (2 tablets 3 times per day for 12 weeks). Montreal Cognitive Assessment (MoCA) testing was required. The change in the mean MoCA score post-treatment was used as the primary endpoint. As the secondary endpoints, the number of patients with a MoCA <26 and ≤17 (dementia); the percentage of patients with a MoCA score improvement in different age groups; the dynamics of mean MoCA score in age groups; and the relationship between CD and sex or regional social/economic factors were assessed.
Divaza therapy led to a significant improvement: the mean MoCA score was up to 20% higher post-treatment (Wilcoxon test, p < 0.0001 vs. baseline). The number of participants with MoCA ≥26 increased by 33.6%. The number of patients with dementia was 4.1 times less after therapy (p < 0.00001 vs. baseline). Divaza improved cognitive functions of patients in each age group. Findings demonstrate that regional socioeconomic factors contribute to CD development and severity. The observed divergence between sexes was a result of a larger number of women enrolled. The study confirmed the safety of Divaza.
In the study, we observed the efficacy of Divaza for the treatment of CD: a therapy contributed to an increase in the mean MoCA score and the positive dynamics in the number of patients with cognitive improvement.
慢性脑缺血（CCI）是一种脑血管疾病，表现为血管性认知障碍（VCI）。CCI 患者的治疗取决于健康的生活方式和早期治疗，旨在纠正和预防这种疾病。Divaza 是一种具有内皮保护和促智作用的药物。我们报告了一项全俄、开放性、前瞻性、观察性、多中心 Divaza 研究的最终疗效和安全性分析，并强调了人口统计学和社会经济因素在认知障碍（CD）进展中的作用。
纳入了伴有或不伴有 CD 的 CCI 患者（n=2583）。患者接受 Divaza（每日 3 次，每次 2 片，持续 12 周）治疗。需要进行蒙特利尔认知评估（MoCA）测试。治疗后平均 MoCA 评分的变化被用作主要终点。次要终点包括 MoCA<26 和≤17 的患者数量（痴呆）；MoCA 评分改善的患者百分比；不同年龄组的平均 MoCA 评分变化；CD 与性别或区域社会/经济因素之间的关系。
Divaza 治疗可显著改善：治疗后平均 MoCA 评分提高了 20%（Wilcoxon 检验，p<0.0001 与基线相比）。MoCA≥26 的患者数量增加了 33.6%。治疗后痴呆患者数量减少了 4.1 倍（p<0.00001 与基线相比）。Divaza 改善了每个年龄组患者的认知功能。研究结果表明，区域社会经济因素会影响 CD 的发展和严重程度。观察到的性别差异是由于女性患者人数较多所致。研究证实了 Divaza 的安全性。
在这项研究中，我们观察到了 Divaza 治疗 CD 的疗效：治疗可提高平均 MoCA 评分，并使认知改善的患者数量呈积极变化。
