拉莫三嗪与碳酸锂治疗双相障碍急性抑郁发作对照研究

A controlled study of lamotrigine versus lithium carbonate in the treatment of acute depressive episode of bipolar disorder

目的评价拉莫三嗪治疗双相障碍急性抑郁发作的疗效及安全性。方法采用随机、平行对照的方法将117例双相障碍抑郁发作患者分别以拉莫三嗪（n=59）和碳酸锂治疗（n=58），疗程8周，分别于治疗前和治疗后第1周、2周、4周、6周、8周末以汉密尔顿抑郁量表、Young躁狂评定量表及临床疗效总评量表评价疗效，副反应量表评定不良反应。结果拉莫三嗪治疗组有效率为67．8％（40／59），碳酸锂组为72．4％（42／58），两组疗效差异无显著性（P〉0．05）。拉莫三嗪组的药物不良反应发生率（23．7％）显著低于碳酸锂组（41．3％）（P〈0．05）。结论拉莫三嗪与碳酸锂治疗双相障碍急性抑郁发作均有效，但前者不良反应较少，安全性好。

Objectives To evaluate the efficacy and safety of lamotrigine in the treatment of acute depressive episode of bipolar disorder. Methods Using a randomized-parallel-controlled method, 117 patients with acute depressive episode of bipolar disorder were respectively treated with lamotrigine （n = 59） and lithium carbonate （n=58） for 8 weeks. Clinical efficacies were assessed with the the Hamilton Depression Scale （HAMD）, the Young Mania Rating Scale （YMRS） and the Clinical Global Impression（CGI） and adverse reactions with the Treatment Emergent Symptom Scale（TESS） at baseline and the end of week 1, 2, 4 , 6 and 8. Results Effective rates were respectively 67.8%（40/59） of lamotrigine and 72.4%（42/58） of lithium carbonate（P〉0.05）. Incidences of adverse reactions were significantly lower in the lamotrigine（23. 7%） than in the lithium carbonate group（41.3%,P〈0.05）. Conclusion Both lamotrigine and lithium carbonate are effective on acute depressive episode of bipolar disorder, but the former has few adverse reactions and higher safety.