的长期疗效和安全性milnacipran中的氯丙咪嗪相比,抑郁症患者。
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Leinonen E Lepola U, Koponen H, Mehtonen OP, Rimon R
的长期疗效和安全性milnacipran中的氯丙咪嗪相比,抑郁症患者。
Acta Psychiatr Scand。1997年12月,96 (6):497 - 504。
- PubMed ID
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9421348 (在PubMed]
- 文摘
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Milnacipran是一种新的抗抑郁的药物,5 -羟色胺和去甲肾上腺素的结合(NA / 5)再摄取抑制剂,已建议并具有更好的耐受性比三环类抗抑郁药一样有效。由于长期研究缺乏,我们比较了有效性、安全性和耐受性milnacipran和氯丙咪嗪双盲,随机,与这些相应平行的组织研究设置在26周的治疗重度抑郁症患者。共有107名患者治疗与milnacipran (n = 52)或氯丙咪嗪(n = 55)。由于积极治疗的持续时间少于12天在四个病人和协议偏差在一个病人,总共47 milnacipran-treated患者的疗效分析。氯米帕明组9个病人继续积极治疗少于12天。因此46 clomipramine-treated患者最终纳入疗效分析。1周剂量升级后,有一个固定的给药方案milnacipran(每日200毫克)或氯丙咪嗪(150毫克每天)在周2到10,紧随其后的是灵活的剂量milnacipran(100、150或200毫克每天)或氯丙咪嗪(75、100或150毫克每天)在11到26周。共有53名患者(49%)完成了26周的学习时间;21%(11/52)的患者在milnacipran组和38%(21/55)的患者氯丙咪嗪组不服用药物过早由于不良事件,而milnacipran(10/52)的19%和7%(4/55)的氯丙咪嗪治疗了由于缺乏有效性或临床恶化。均值变化(+ / -标准差)汉密尔顿抑郁量表(HAMD)评分之间的基线最后评级范围从23.7 + / - -3.1到12.0 + / - -9.5 milnacipran-treated患者,从23.1 + / - -3.5到8.0 + / - -8.5 clomipramine-treated病人,揭示氯丙咪嗪的显著差异。 In total 58% of the milnacipran-treated patients vs. 72% of the clomipramine-treated patients showed a > or = 50% reduction in their baseline HAMD scores and 45% vs. 63% had an HAMD score of < or = 7 at the last rating, respectively. Moreover, the time to the onset of the antidepressant action (defined as > or = 50% reduction of the baseline HAMD score) showed a significant difference in favour of clomipramine. In addition, clomipramine was significantly more efficacious in patients with a baseline HAMD score of > or = 24 as evidenced by the analysis of the HAMD score at week 6 and at the last rating. The Montgomery Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression (CGI) scale did not show significant differences between the treatment groups. The safety analysis did not reveal any differences of clinical significance in cardiovascular variables between the study drugs. Dry mouth was significantly less frequently reported by the milnacipran-treated patients during the early and later phases (weeks 6 to 26) of the study, while insomnia was more common in the milnacipran group during weeks 1 to 6. In conclusion, milnacipran appeared to be less effective than clomipramine in the long-term treatment of depression. The side-effects of the drugs differed to a certain extent, and milnacipran tended to be somewhat better tolerated than clomipramine.
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