Oyewumi L K, Lapierre Y D, Hrdina P D
Prog Neuropsychopharmacol Biol Psychiatry. 1983;7(4-6):733-8. doi: 10.1016/0278-5846(83)90055-6.
This was a single-blind, open study undertaken to assess the antidepressant efficacy of mianserin, a new tetracyclic antidepressant in in-patients with major depression (DSM III). The relationship between steady state plasma levels and clinical response, and the predictability of steady-state mianserin plasma levels from a single point determination after an initial dose of the drug were also studied. There was remarkable clinical improvement as measured by the significant (P 0.001) reduction in mean HDRS scores after first week of active treatment which continued till day 28 when mean HDRS scores were reduced to about 50% of initial mean scores. There was a modest correlation (r = 0.623, n.s.) between the steady state levels of mianserin and the plasma concentration 12 hours after initial dose. No significant cardiovascular effect was noted throughout the course of treatment. Mianserin is a safe, efficacious antidepressant with minimal cardiovascular effects. Further clinical investigations of this new useful drug are recommended.
这是一项单盲、开放性研究，旨在评估新型四环类抗抑郁药米安色林对重度抑郁症（DSM III）住院患者的抗抑郁疗效。同时还研究了稳态血浆水平与临床反应之间的关系，以及在首次给药后通过单点测定预测米安色林稳态血浆水平的可能性。积极治疗第一周后，平均汉密尔顿抑郁量表（HDRS）评分显著降低（P<0.001），这表明临床有显著改善，这种改善持续到第28天，此时平均HDRS评分降至初始平均评分的约50%。米安色林的稳态水平与首次给药后12小时的血浆浓度之间存在适度相关性（r = 0.623，无显著性差异）。在整个治疗过程中未观察到明显的心血管效应。米安色林是一种安全、有效的抗抑郁药，对心血管的影响极小。建议对这种新型有用药物进行进一步的临床研究。
