Divaza 治疗脑动脉硬化患者氧化应激紊乱的疗效和安全性：一项随机对照试验。

Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial.

机构信息

Pirogov Russian National Research Medical University, Moscow, Russian Federation.

Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency, Moscow, Russian Federation.

出版信息

Cerebrovasc Dis. 2021;50(4):472-482. doi: 10.1159/000515233. Epub 2021 May 27.

DOI:10.1159/000515233

PMID:34044407

Abstract

OBJECTIVE

The objective of this study was to determine if Divaza, a drug with nootropic and antioxidant effects, was safe and effective for the correction of oxidative disturbances and to stabilize cognitive impairment in patients with cerebral atherosclerosis.

STUDY DESIGN

The study design consisted of a 12-week multicenter, randomized, double-blind, placebo-controlled, prospective trial in parallel groups.

SETTING

The setting in which the study was conducted comprised 10 clinical centers across the Russian Federation.

INTERVENTIONS

Patients were randomized into 2 groups and instructed to take either 2 tablets of the study drug or a placebo 3 times per day in conjunction with basic therapy.

OUTCOMES

The primary outcome was a change in the average endogenous antioxidant potential after the completion of the study. The blood indicators of the oxidative stress (OS) were analyzed at the baseline and then after 12 weeks of therapy using iron-induced chemiluminescence analysis. The Montreal cognitive assessment test was used as a secondary outcome measure to evaluate cognitive impairment at the end of the study.

RESULTS

124 outpatients with a mean age of 60.7 ± 7.6 years were enrolled and randomly assigned to receive Divaza (n = 65) or a placebo (n = 59). An improvement of cognitive function was observed in all patients of the Divaza group at the end of the treatment; this was significantly better than the placebo group (100 [100] vs. 89.5 [89.1]%, respectively, p = 0.0272 [p = 0.0128]). The administration of Divaza restored the activity of the endogenous antioxidant system. The change in the average level of lipoprotein resistance to oxidation after 12 weeks of therapy, compared to the baseline, was significantly higher in the Divaza group (14.8 ± 14.7 [14.8 ± 14.7] seconds latent period vs. 6.4 ± 16.9 [6.9 ± 16.7] seconds in the placebo group (p = 0.007 [p = 0.0107]).

CONCLUSIONS

Divaza is a safe and effective therapeutic option for attenuating OS and recovery of cognitive impairment in patients with cerebral atherosclerosis.

摘要

目的

本研究旨在确定 Divaza（一种具有益智和抗氧化作用的药物）在纠正氧化紊乱和稳定脑动脉粥样硬化患者认知障碍方面的安全性和有效性。

研究设计

该研究设计为 12 周多中心、随机、双盲、安慰剂对照、平行组前瞻性试验。

设置

该研究在俄罗斯联邦的 10 个临床中心进行。

干预

患者被随机分为 2 组，每天服用 2 片研究药物或安慰剂 3 次，同时进行基础治疗。

结局

主要结局为研究完成后平均内源性抗氧化潜能的变化。在基线时和治疗 12 周后，使用铁诱导化学发光分析分析氧化应激（OS）的血液指标。蒙特利尔认知评估测试作为次要结局测量，用于评估研究结束时的认知障碍。

结果

共纳入 124 名平均年龄 60.7 ± 7.6 岁的门诊患者，并随机分为 Divaza 组（n = 65）或安慰剂组（n = 59）。治疗结束时，Divaza 组所有患者的认知功能均有所改善，明显优于安慰剂组（分别为 100 [100]%和 89.5 [89.1]%，p = 0.0272 [p = 0.0128]）。Divaza 的给药恢复了内源性抗氧化系统的活性。与基线相比，治疗 12 周后脂蛋白对氧化的抵抗力的平均水平变化在 Divaza 组明显更高（14.8 ± 14.7 [14.8 ± 14.7] 秒潜伏期 vs. 安慰剂组的 6.4 ± 16.9 [6.9 ± 16.7] 秒（p = 0.007 [p = 0.0107]）。