International University of Health and Welfare, Tochigi.
Neuropsychiatr Dis Treat. 2013;9:555-65. doi: 10.2147/NDT.S42915. Epub 2013 Apr 26.
A double-blind, parallel-group, controlled study was performed to investigate if milnacipran was noninferior to paroxetine in terms of improvement in symptoms of depression in Japanese patients with major depressive disorders in a fixed-dose design. The efficacy and safety of milnacipran 200 mg/day were also assessed in comparison with those at the standard dose of 100 mg/day.
Changes in 17-item Hamilton depression rating scale (HAM-D) total score (mean ± standard deviation) for group M1 (milnacipran 100 mg/day), group M2 (milnacipran 200 mg/day), and group PX (paroxetine 30 or 40 mg/day) were -12.9 ± 5.8, -12.8 ± 6.1, and -13.1 ± 6.2, respectively, and the estimated differences in total score for group PX (Dunnett's 95% simultaneous confidence interval) were 0.1 (-1.1 to 1.3) for group M1 and 0.3 (-0.9 to 1.5) for group M2. The noninferiority of groups M1 and M2 to group PX was thus confirmed, because the upper confidence limit of differences between groups M1 and PX and between groups M2 and PX was less than 2.0. The estimated mean difference of change in HAM-D total score (95% confidence interval) between groups M2 and M1 was 0.2 (-0.9 to 1.2), indicating a comparable change in total score for both groups. The incidence of treatment-related adverse events was 71.7% for group M1, 68.8% for group M2, and 69.3% for group PX, indicating no significant difference between the three groups.
These results demonstrate that milnacipran 100 mg/day and 200 mg/day is not inferior to paroxetine in terms of efficacy and safety.
一项双盲、平行组、对照研究旨在以固定剂量设计，调查米那普仑是否在改善日本重性抑郁障碍患者的抑郁症状方面不劣于帕罗西汀。还评估了米那普仑 200mg/天的疗效和安全性与 100mg/天的标准剂量相比。
组 M1（米那普仑 100mg/天）、组 M2（米那普仑 200mg/天）和组 PX（帕罗西汀 30 或 40mg/天）的 17 项汉密尔顿抑郁评定量表（HAM-D）总分变化（平均值±标准差）分别为-12.9±5.8、-12.8±6.1 和-13.1±6.2，组 PX 的总分估计差值（Dunnett 的 95%同时置信区间）分别为 0.1（-1.1 至 1.3）和 0.3（-0.9 至 1.5）。因此，证实了组 M1 和 M2 对组 PX 的非劣效性，因为组 M1 和 PX 之间以及组 M2 和 PX 之间差异的置信上限小于 2.0。组 M2 和 M1 之间 HAM-D 总分变化的估计平均差值（95%置信区间）为 0.2（-0.9 至 1.2），表明两组总分的变化相当。组 M1 的治疗相关不良事件发生率为 71.7%，组 M2 为 68.8%，组 PX 为 69.3%，三组间无显著差异。
这些结果表明，米那普仑 100mg/天和 200mg/天在疗效和安全性方面不劣于帕罗西汀。
