Zavadenko N N, Suvorinova N Y, Batysheva T T, Bykova O V, Platonova A N, Gaynetdinova D D, Levitina E V, Mashin V V, Vakula I N, Maximova N E
Pirogov Russian National Research Medical University, Moscow, Russia.
Scientific Research and Practical Center of Pediatric Psychoneurology, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2022;122(4):75-86. doi: 10.17116/jnevro202212204175.
To evaluate the efficacy and safety of two dosing regimens of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT» LLC Russia), compared with placebo in children with attention deficit hyperactivity disorder (ADHD) aged 6 to 12 years.
A multicenter randomized, double-blind, placebo-controlled study in 3 parallel groups was conducted in 14 clinical centres of the Russian Federation to assess efficacy and safety of Mexidol film-coated tablets, 125 mg («RPC «PHARMASOFT» LLC Russia) in the treatment of attention deficit hyperactivity disorder (ADHD) in children 6-12 years old with different dosing regimens. The study involved 333 boys and girls aged 6 to 12 years with a confirmed diagnosis of ADHD established in accordance with ICD-10 and DSM-5 criteria. After screening (up to 14 days) the patients were randomised into 3 treatment groups in a 1:1:1: Mexidol 125 mg 2 times daily, Mexidol 125 mg daily+placebo and the placebo group. The duration of treatment in all groups was 42 days. 332 children completed the study. ADHD and comorbid disorders assessment scales were used.
There were statistically significant changes in the sum of the total scores on the SNAP-IV inattention and hyperactivity/impulsivity subscales after 6 weeks of therapy in all three study groups (<0.05). There were statistically significant differences between the Mexidol 125 mg and placebo groups and between the Mexidol 125 mg 2 times daily and placebo groups (for the PP population: =0.000308 and =0.000024, respectively; for the FAS population: =0.000198 and =0.000024, respectively), indicating that Mexidol therapy is superior to placebo. Statistically significant differences (0.05) were also obtained for most of the secondary efficacy criteria (average change in SNAP-IV inattention subscale score, average change in SNAP-IV hyperactivity/impulsivity subscale score, average change in SNAP-IV subscale score - Conners index, average change in ADHD-RS-IV score, change in CGI-ADHD-S scores, change in CGI-I score - the Clinical Global Impressions Scale - Improvement) when comparing Mexidol therapy with placebo. The results of statistical analysis of the incidence of adverse events, laboratory values, physical examination show no significant differences between the compared groups in the main safety parameters.
The regimen of Mexidol, 125 mg film-coated tablets twice daily has been shown to be superior to the regimen of Mexidol, 125 mg film-coated tablets once daily and placebo. The safety profiles of the studied dosing regimens of Mexidol and placebo were comparable.
评估俄罗斯“RPC «PHARMASOFT» LLC”生产的125毫克美西多薄膜包衣片两种给药方案相较于安慰剂，对6至12岁注意力缺陷多动障碍（ADHD）儿童的疗效和安全性。
在俄罗斯联邦的14个临床中心进行了一项多中心随机、双盲、安慰剂对照研究，该研究分为3个平行组，以评估125毫克美西多薄膜包衣片（俄罗斯“RPC «PHARMASOFT» LLC”）采用不同给药方案治疗6至12岁儿童注意力缺陷多动障碍（ADHD）的疗效和安全性。该研究纳入了333名6至12岁经国际疾病分类第10版（ICD - 10）和精神疾病诊断与统计手册第5版（DSM - 5）标准确诊为ADHD的男孩和女孩。筛选期（长达14天）后，患者按1:1:1随机分为3个治疗组：美西多125毫克每日2次组、美西多125毫克每日 + 安慰剂组和安慰剂组。所有组的治疗持续时间均为42天。332名儿童完成了研究。使用了ADHD及共病障碍评估量表。
在所有三个研究组中，治疗6周后，SNAP - IV注意力不集中和多动/冲动分量表总分的变化具有统计学意义（<0.05）。美西多125毫克组与安慰剂组之间以及美西多125毫克每日2次组与安慰剂组之间存在统计学显著差异（对于符合方案人群：分别为=0.000308和=0.000024；对于意向性分析人群：分别为=0.000198和=0.000024），表明美西多治疗优于安慰剂。在比较美西多治疗与安慰剂时，大多数次要疗效标准（SNAP - IV注意力不集中分量表得分的平均变化、SNAP - IV多动/冲动分量表得分的平均变化、SNAP - IV分量表得分 - 康纳斯指数的平均变化、ADHD - RS - IV得分的平均变化、CGI - ADHD - S得分的变化、CGI - I得分的变化 - 临床总体印象量表 - 改善）也获得了统计学显著差异（0.05）。不良事件发生率、实验室检查值、体格检查的统计分析结果显示，在主要安全参数方面，比较组之间无显著差异。
已证明美西多125毫克薄膜包衣片每日2次的给药方案优于美西多125毫克薄膜包衣片每日1次的给药方案和安慰剂。所研究的美西多给药方案与安慰剂的安全性相当。
