拉莫三嗪与碳酸锂治疗双相抑郁的对照研究  

An open-labeled,randomized comparative study of lamotrigine and lithium in treatment of bipolar depression

作　　者：马燕桃[1] 陈玉芳[1] 钟宝亮[1] 于欣[1] 

机构地区：[1]北京大学精神卫生研究所,北京100083

出　　处：《中国新药杂志》2008年第23期2054-2058,共5页Chinese Journal of New Drugs

摘　　要：目的：评价拉莫三嗪治疗双相抑郁的疗效和安全性。方法：采用开放，随机，活性药物平行对照设计。入选双相抑郁患者34例，随机分为拉莫三嗪组18例，碳酸锂组16例。分别口服拉莫三嗪50—200mg·d^-1，碳酸锂750～1500mg·d^-1，疗程8周，疗效观察指标包括基线以及治疗终点的17项汉密尔顿抑郁量表（HAMD17）、蒙哥马利抑郁量表（MADRS）、临床总体印象量表（CGI）评分。结果：治疗结束时，两组HAMD17总分与基线相比均明显降低，两组HAMD减分率差异有显著性，分别为24．8％和47．4％；以HAMD17减分率判断的有效率，两组间差异无显著性，分别为33．3％和50％。拉莫三嗪组治疗结束时体重无变化，有2例皮疹报告，其他不良事件两组发生频率相当。结论：拉莫三嗪治疗轻中度的双相抑郁部分有效，安全性较好。Objective ： To investigate the efficacy and safety of lamotrigine （LMG） in treatment of Chinese patients with bipolar depression. Methods： Totally 34 patients with bipolar depression were randomly divided into 2 groups, and were treated with either lamortrigine （5 -200 mg·d^-1, n = 18） or lithium （75 - 1 500 mg·d^-1, n = 16） in an 8-weeks＇ open-labeled and randomized study. The evaluation scales included Hamilton Depression Rating Scale（HAMD-17） , Montgomery-Asberg Depression Scale（MADRS） , and Clinical Global Impressions （CGI）. Resuits： At the end of the treatment, the scores of HAMD-17 decreased significantly in both lamotrigine and lithium groups; the baseline HAMD scores were significantly decreased by 24.8% and 47.4% , respectively. Based on the decreasing rate of HAMD, the response rates to lamotrigine（33.3% ） and lithium（50% ） were not significantly different（P = 0. 324）. In lamotrigine group, the body weight did not change, but two cases of rash were found. Other adverse effects were similar in both groups. Conclusions： In this pilot study lamotrigine has shown to be partially effective for improving mild or moderate bipolar depression with good safety.

关 键 词：拉莫三嗪 双相抑郁 碳酸锂 疗效 安全性 

分 类 号：R971.4[医药卫生—药品] R969.4[医药卫生—药学]