Stakhovskaya L V, Shamalov N A, Khasanova D R, Melnikova E V, Agafiina A S, Golikov K V, Bogdanov E I, Yakupova A A, Roshkovskaya L V, Lukinykh L V, Lokshtanova T M, Poverennova I E, Shepankevich L A
Pirogov Russian National Research Medical University, Moscow, Russia.
Research Institute of Cerebrovascular Pathology and Stroke of Pirogov Russian National Research Medical University, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(3. Vyp. 2):55-65. doi: 10.17116/jnevro20171173255-65.
To evaluate the efficacy and safety of prolonged sequential therapy with mexidol in the acute and early recovery stages of hemispheric ischemic stroke (IS).
A randomized double blind multicenter placebo-controlled, in parallel groups trial included 151 patients (62 men and 89 women) with hemispheric IS. Using a method of simple randomization, 150 patients (62 men and 88 women), aged 40-79 years, were randomized into two groups. Patients of Group I were treated with mexidol: 500 mg/day IV infusion for 10 days, followed by 125 mg tid (375 mg/day) PO for 8 weeks. Patients of Group II received the placebo according to the same scheme. The total duration of patients' participation in trial ranged from 67 to 71 days.
By the end of treatment, the mean score on the modified Rankin scale (mRS) was lower in Group I compared to Group II (p=0.04). In Group I, the decrease in mRS mean score (Visit 1-5) was more prominent (p=0.023), percentage of patients with 0-2 scores by mRS scale (Visit 5) was higher (p=0.039), mean NIHSS score lower (p=0.035) in Visit 5 compared to group II. By the end of treatment, the decrease in mean NIHSS score in patients with diabetes mellitus was more prominent in Group I in comparison with Group II (p=0.038). In Group I, the dynamic of improvement of quality of life was more prominent and started from Visit 2 in general population and subpopulation of patients with diabetes mellitus. The share of patients with no problems with movement in space was higher in Group I (p=0.022). There were no statistically significant differences in frequency of side effects in patients of both groups.
It is recommended to include mexidol in therapy of patients with IS in the acute and early rehabilitation stages.
评估美西多宁延长序贯疗法在半球缺血性卒中（IS）急性和早期恢复阶段的疗效及安全性。
一项随机双盲多中心安慰剂对照平行组试验纳入了151例半球缺血性卒中患者（62例男性和89例女性）。采用简单随机化方法，将150例年龄在40 - 79岁之间的患者（62例男性和88例女性）随机分为两组。第一组患者接受美西多宁治疗：静脉输注500 mg/天，持续10天，随后口服125 mg，每日三次（375 mg/天），持续8周。第二组患者按照相同方案接受安慰剂治疗。患者参与试验的总时长为67至71天。
治疗结束时，第一组改良Rankin量表（mRS）的平均得分低于第二组（p = 0.04）。在第一组中，mRS平均得分的降低（访视1 - 5）更为显著（p = 0.023），mRS量表评分为0 - 2分的患者百分比（访视5）更高（p = 0.039），与第二组相比，访视5时的平均美国国立卫生研究院卒中量表（NIHSS）得分更低（p = 0.035）。治疗结束时，与第二组相比，第一组糖尿病患者的平均NIHSS得分降低更为显著（p = 0.038）。在第一组中，总体人群以及糖尿病患者亚组的生活质量改善动态更为显著，且从访视2开始。第一组中空间移动无问题的患者比例更高（p = 0.022）。两组患者副作用发生频率无统计学显著差异。
建议在IS患者的急性和早期康复阶段治疗中纳入美西多宁。
