Geha Mental Health Center, Petach Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Postgrad Med. 2013 Jul;125(4):181-90. doi: 10.3810/pgm.2013.07.2689.
To compare the effects of metadoxine extended release (ER) with those of placebo on inattentive (IA) versus hyperactive-impulsive (H-I) symptoms and predominantly inattentive (PI) versus combined type (CT) subtype in adults with attention-deficit/hyperactivity disorder (ADHD).
This was a 1:1 randomized, double-blind, parallel-design study of metadoxine ER 1400 mg/day for 6 weeks in 120 adults with ADHD. Efficacy measures were baseline to end-of-treatment changes in Conners' Adult ADHD Rating Scale-Investigator Rated (CAARS-INV) Total ADHD Symptoms scores with adult ADHD prompts, the Test of Variables of Attention ADHD scores, and response rates (≥ 25% or ≥ 40% improvement in CAARS-INV Total ADHD Symptoms score).
There was a significant decrease in CAARS-INV Total ADHD Symptoms scores in patients with ADHD-PI taking metadoxine ER (40%) compared with those taking placebo (21%) (P < 0.05), while the decrease for patients with ADHD-CT was not significant (27% vs 26%). Similarly, there was a significant decrease in IA scores in patients with ADHD-PI (metadoxine ER, 50% vs placebo, 23%; P < 0.005), while the change in patients with ADHD-CT was not significant. There was no significant difference in percent decreases seen in H-I scores for patients with PI or ADHD-CT. Significantly higher response rates at both cutoffs (ie, 25% and 45% improvement) were seen in the metadoxine ER group compared with the placebo group in CAARS-INV Total ADHD Symptoms scores in patients with ADHD-PI, but not those with ADHD-CT. Test of Variables of Attention ADHD scores were significantly decreased in the metadoxine ER group compared with the placebo group for patients with ADHD-PI, but not those with ADHD-CT.
These data suggest that metadoxine ER is selectively efficacious for treating IA symptoms in adults with ADHD-PI.
www.ClinicalTrials.gov identifier NCT01243242.
比较美他多辛缓释片（ER）与安慰剂对成人注意力缺陷多动障碍（ADHD）患者注意力不集中（IA）与多动冲动（H-I）症状的影响，以及对以注意力不集中为主型（PI）与混合型（CT）亚型的影响。
这是一项为期 6 周、1：1 随机、双盲、平行设计的美他多辛 ER 1400mg/天治疗成人 ADHD 的研究，共纳入 120 例患者。采用成人 ADHD 评定量表-研究者评定版（CAARS-INV）总分及成人 ADHD 提示的注意变量测试（Test of Variables of Attention ADHD）评分评估疗效，疗效评估指标为基线至治疗结束时的 Conners' 成人 ADHD 评定量表-研究者评定版（CAARS-INV）总分的变化，以及应答率（CAARS-INV 总分 ADHD 症状改善≥25%或≥40%）。
ADHD-PI 患者服用美他多辛 ER 后 CAARS-INV 总分 ADHD 症状显著下降（40%），而安慰剂组仅为 21%（P＜0.05）；ADHD-CT 患者的降幅无统计学意义（27%比 26%）。同样，ADHD-PI 患者的 IA 评分也显著下降（美他多辛 ER 组 50%，安慰剂组 23%；P＜0.005），而 ADHD-CT 患者的变化无统计学意义。PI 或 ADHD-CT 患者的 H-I 评分下降率无显著差异。在 CAARS-INV 总分 ADHD 症状方面，美他多辛 ER 组在两个截止值（即改善≥25%或≥40%）的应答率均显著高于安慰剂组，在 ADHD-PI 患者中，但在 ADHD-CT 患者中则不然。对于 ADHD-PI 患者，美他多辛 ER 组的注意变量测试 ADHD 评分显著低于安慰剂组，但对于 ADHD-CT 患者则不然。
这些数据表明，美他多辛 ER 对治疗 ADHD-PI 患者的 IA 症状具有选择性疗效。
www.ClinicalTrials.gov 标识符 NCT01243242。
