国产米氮平与阿米替林治疗抑郁障碍对照研究

A control study of domestic mirtazapine vs.amitriptyline in the treatment of depressive disorder

目的 探讨国产米氮平与阿米替林治疗抑郁障碍的临床疗效和安全性.方法 将64例抑郁障碍患者随机分为两组,每组32例,研究组口服国产米氮平治疗,对照组口服阿米替林治疗,观察6周.于治疗前及治疗1周、2周、4周、6周末采用汉密顿抑郁量表评定临床疗效,副反应量表评定不良反应.依据汉密顿抑郁量表评分统计两组治疗前后抑郁症状检出率,同时评估两组患者服药依从性.结果 治疗后两组汉密顿抑郁量表评分均较治疗前呈持续性显著下降（P＜0.01）,减分率呈持续性升高.研究组治疗1周末、2周末汉密顿抑郁量表评分较对照组下降更显著,减分率较对照组升高更显著（P＜0.05）.治疗6周末除对照组自责、自杀念头症状检出率与治疗前差异无显著性外（P＞0.05）,两组各种抑郁症状检出率均显著低于治疗前（P＜0.01）;研究组兴趣丧失、自责、自杀念头症状检出率均显著低于对照组（P＜0.01）,其他症状检出率差异均无显著性（P＞0.05）.研究组不良反应发生率为21.9%,对照组为46.9%,研究组显著低于对照组（χ2=4.43,P＜0.05）;服药依从性显著高于对照组（P＜0.01）.结论 国产米氮平治疗抑郁障碍疗效显著,与阿米替林相当,但起效更快,安全性更高,依从性更好,优于阿米替林治疗.

Objective To explore the clinical efficacy and safety of domestic mirtazapine and arnitriptyline in the treatment of depressive disorder. Methods Sixty-four depressive disorder patients were randomly divided into two groups of 32 ones each, research group took orally domestic mirtazapine and control group did amitriptyline for 6 weeks, Clinical efficacies were assessed with the Hamilton Depression Scale （HAMD） before treatment and at the end of the 1st, 2nd, 4th and 6th week and adverse raections with the Treatment Emergent Symptom Scale （TESS）. Detection rates of pre- and post-treatment depressive symptoms were added up according to the HAMD score and drug compliance was assessed at the same time. Results After treatment, the HAMD scores of both groups continuatively lowered more significantly compared with pretreatment （P〈0.01）, the score-reducing rate heightened continuatively. At the end of the 1st and 2nd week, the HAMD scores lowered more significantly and score reducing rates heightened more significantly in the research than in the control group （P〈0.05） . At the end of the 6th week, except that detection rates of self-reproach and suicidal intention had no significant differences from pretreatment in the control group （P〉0.05）, those of depressive symptoms of both groups were significantly lower compared with pretreatment （P〈0.01）. Detection rates of loss of interest, self-accusation and suicidal intention were significantly lower in the research than in the control group （P〈0.01）, there were no significant differences in those of the other symptoms （P〉0. 05）. The incidences of adverse reactions were 21.9o/00 in th eresearch and 46.9 % in the control group, the former was significantly lower than the latter （x2 =4.43, P〈0.05） ; drug compliance was significantly higher in the research than in the control group （P〈0.05）. Conclussion Domestic mirtazapine is as effective as arnitriptyline for the treatment of depressive disorder, but takes effect more rapidly, has higher safety and better compliance compared with amitriptyline treatment.