碳酸锂合并米氮平或氟西汀治疗双相抑郁的对照研究

A control study of lithium combined with mirtazapine or fluoxetine for the treatment of bipolar depression

目的评价米氮平合并碳酸锂治疗双相抑郁的疗效和安全性。方法将126例双相抑郁患者分为两组,研究组61例,应用米氮平合并碳酸锂,对照组65例,应用氟西汀合并碳酸锂,治疗8周。分别于治疗后第2、4、6、8周末用汉密尔顿抑郁量表(HAMD)和不良反应量表(TESS)比较两组的疗效和安全性。结果治疗后第2、4、6、8周末两组HAMD总分比较,差异均有显著性(P<0.05),研究组疗效优于对照组(P<0.05),两组脱落率比较差异有显著性(P<0.05),两组治疗后各时期TESS总分比较差异均无显著性(P>0.05),但研究组在治疗早期的嗜睡、困倦发生率较高、失眠发生率较低、胃肠道反应较少、治疗末体重增加较多(P均<0.05)。结论米氮平合并碳酸锂治疗双相抑郁疗效肯定,不良反应较少,依从性好。

Objective： To evaluate the efficacy and safety of mirtazapine in combination with lithium for bipolar depression. Methods： A total of 126 patients with bipolar depression were randomly assigned to 8 weeks treatment with mirtazapine in combination with lithium （ n = 61 ） or with fluoxetine in combination with lithium （ n = 65 ）, and changes from baseline in the Hamilton Rating Scale for Depression （HAMD） total scores of two groups and Treatment Emergent Symptom Scale （TESS） were compared. Results： Mirtazapine group showed statistically significant improvement in depressive symptoms vs the fluoxetine group in HAMD total scores by study visit at 2,4,6,8 weeks （P 〈 0.05 ）;The discontinuation rate in the mirtazapine group also statistically lower than in the fluoxetine group（P 〈 0.05 ）. At every follow - up visit, TESS total scores were no statistically significant between the two groups （ P 〉 0.05 ）, but there was more somnolence, lower gastrointestinal reactions and sleep disorder at early phase, and gaining higher weight at late phase in the mirtazapine group than in the fluoxetine group （ P 〈 0.05 ）. Conclusion ： Mirtazapine in combination with lithium was effective, safe and well tolerated for patients with bipolar depression.