Antipenko E A, Shulyndin A V, Belyakov K M
Privolzhsky Research Medical University, N. Novgorod, Russia.
Vectorpharm, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(3):42-51. doi: 10.17116/jnevro202412403142.
To evaluate the effect of a sequential therapy regimen with Mexidol (500 mg injections intravenously for 14 days) and Mexidol FORTE 250 (250 mg tablets 3 times a day for 60 days) on higher cortical functions in patients with moderate cognitive disorders in chronic cerebral ischemia.
A comparative, prospective study included 63 patients with chronic cerebral ischemia with moderate cognitive impairment. All patients received basic therapy aimed at reducing risk factors (antihypertensive, antithrombotic drugs as indicated). Patients of the main group (30 people: 12 men, 18 women) received Mexidol intravenously 500 mg in 100 ml of 0.9% NaCl solution once a day for 14 days, then Mexidol FORTE 250 (film-coated tablets) 250 mg 3 times a day for the next 60 days. The comparison group consisted of 33 patients (14 men, 19 women) who received only basic therapy. The groups were comparable in terms of age, sex characteristics and severity of cognitive deficit. We examined cognitive status (MoCA scale, Frontal Dysfunction Battery, 10 Word Memorization tests), severity of asthenia (MFI-20 scale), anxiety and depression (HADS scale), patient's subjective assessment of the dynamics of the condition (CGI-improvement scale) in 1st, 14th and 74th±5 days of observation. On days 1 and 74±5 of observation, patients were examined using transcranial magnetic stimulation to study the neuronal activity of the cerebral cortex.
In the main group, at the time of completion of taking Mexidol and Mexidol FORTE 250, a pronounced cognitive regression was noted (MoCA scale +3 points, difference with the comparison group 1 point (<0.0001); Frontal Dysfunction Battery test +4 points, difference with comparison group 2 points (<0.001); memory test «10 words» +2 points, difference with the comparison group 1 point (<0.05), emotional (HADS anxiety scale -8 points, difference with the comparison group 3 points (<0.001), depression -3.5 points, difference with the comparison group 1.5 points (<0.01), asthenic disorders (MFI-20 scale -30 points, difference with the comparison group 15.5 points (<0.01), improvement in the well-being of patients (CGI-improvement scale -2 points, difference with the comparison group 1 point (<0.0001). According to the transcranial magnetic stimulation performed, a statistically significant decrease in the central motor conduction time at the level of 1 and 2 motor neurons of the pyramidal tract bilaterally from the start to the end of therapy with Mexidol and Mexidol FORTE 250 was determined (<0.01). An inverse correlation was found between the time of central motor conduction and the results of the Frontal Dysfunction Battery test at the same time points with left-sided localization of 1 motor neuron (<0.01). The results of a study of the use of sequential therapy with Mexidol 500 mg IV drip 1 time per day for 14 days followed by oral administration of Mexidol FORTE 250 1 tablet 3 times a day for 60 days indicate its clinical effectiveness and safety in patients with chronic cerebral ischemia with mild cognitive impairment, and also confirm its importance for preventing the progression of cognitive disorders.
评估美西多（静脉注射500mg，持续14天）和美西多福250（250mg片剂，每日3次，持续60天）序贯治疗方案对慢性脑缺血中度认知障碍患者高级皮质功能的影响。
一项比较性前瞻性研究纳入了63例慢性脑缺血伴中度认知障碍的患者。所有患者均接受旨在降低危险因素的基础治疗（根据情况使用抗高血压、抗血栓药物）。主要组（30人：12名男性，18名女性）患者先静脉注射美西多500mg，加入100ml 0.9%氯化钠溶液中，每日1次，共14天，然后服用美西多福250（薄膜包衣片）250mg，接下来60天每日3次。对照组由33例患者（14名男性，19名女性）组成，他们仅接受基础治疗。两组在年龄、性别特征和认知缺陷严重程度方面具有可比性。在观察的第1天、第14天和第74±5天，我们检查了认知状态（蒙特利尔认知评估量表、额叶功能障碍评定量表、10词记忆测试）、乏力严重程度（MFI - 20量表）、焦虑和抑郁（医院焦虑抑郁量表）、患者对病情变化的主观评估（临床总体印象改善量表）。在观察的第1天和第74±5天，使用经颅磁刺激检查患者，以研究大脑皮质的神经元活动。
在主要组中，在完成美西多和美西多福250服用时，观察到明显的认知改善（蒙特利尔认知评估量表增加3分，与对照组差异1分（<0.0001）；额叶功能障碍评定量表测试增加4分，与对照组差异2分（<0.001）；“10词”记忆测试增加2分，与对照组差异1分（<0.05），情绪方面（医院焦虑量表降低8分，与对照组差异3分（<0.001），抑郁降低3.5分，与对照组差异1.5分（<0.01），乏力障碍（MFI - 20量表降低30分，与对照组差异15.5分（<0.01），患者幸福感改善（临床总体印象改善量表降低2分，与对照组差异1分（<0.0001）。根据经颅磁刺激结果，从开始使用美西多和美西多福250治疗到结束，双侧锥体束1级和2级运动神经元水平的中枢运动传导时间有统计学意义的降低（<0.01）。在同一时间点，左侧1级运动神经元处，中枢运动传导时间与额叶功能障碍评定量表测试结果之间发现负相关（<0.01）。对先静脉滴注美西多500mg每日1次共14天，随后口服美西多福250 1片每日3次共60天的序贯治疗的研究结果表明，该方案对慢性脑缺血伴轻度认知障碍患者具有临床有效性和安全性，并证实了其对预防认知障碍进展的重要性。
