联合使用米氮平治疗抑郁症的临床研究

A study of antidepressant augmentation with mirtazapine in outpatients with major depression

目的评价抗抑郁剂联合使用米氮平对治疗反应不佳的抑郁症的临床疗效和安全性。方法对81例单一抗抑郁剂治疗无效或部分反应的抑郁症添加米氮平或在原剂量不变的基础上治疗,共观察6周,使用汉密尔顿抑郁量表(HAMD17)评价疗效,并观察不良反应,记录不良事件。结果合并米氮平组和常规组分别脱落6例及4例,可供分析病例71例。结果显示观察终点时合并米氮平组(n=35)和常规组(n=36)HAMD17减分分别为(-11.5±5.2)分和(-6.1±4.8)分(t=4.53,P<0.01),有效率分别为66%及22%(χ2=13.65,P<0.01),合并米氮平组疗效明显增加,增效作用在治疗早期(1或2周)就有表现;合并米氮平组体重增加较多,常规组失眠多见。结论米氮平联合抗抑郁剂治疗抑郁症增加疗效,不良反应并未增多,增效作用较快,适合于治疗对单一抗抑郁剂治疗部分有效或未能缓解的抑郁症患者。

Objective： To evaluate the efficacy and safety of mirtazapine augmentation for the patients with major depression who were not responsive to usual treatment. Methods： 81 depressive patients were enrolled who were not or partially responsive to the treatment of usual antidepressants. A group of patients were randomly added with mirtazapine for six weeks and the others remained on previous medication at the same dose. The Hamilton Depression Scale （HAMD17） was used to evaluate the efficacy and the side effect was observed. Results ： At the endpoint the deduction of HAMD total scores in mirtazapine group（11.5 ± 5, n=35 ） was significantly greater than that in the usual group （6.1±4, 8, n=36 ）（t=4.53, P〈0.01）. The response respectively（X^2=13.65 ,P〈0.01）. The response in the augmentation rates in two groups were 66% and 22% ,respectively （X^2=13.65,P〈0.01）.The response in the augmentation group began at the early stage （first or second week）. More weight gains were found in the mirtazapine group, but more insomnia in the usual group. Conclusion： Mirtazapine augmentation could enhance the efficacy of antidepressants with good safety.