拉莫三嗪与丙戊酸钠治疗双相抑郁的对照研究

A random controlled study of lamotrigine and sodium valproate for bipolar depression

目的评价拉莫三嗪治疗双相障碍抑郁发作的效果和安全性。方法对107例双相障碍抑郁发作患者采用随机、平行分组、对照的方法分别以拉莫三嗪和丙戊酸钠治疗,疗程8周,以汉密尔顿抑郁量表(HAMD)、临床疗效总评量表(CGI)在治疗前和治疗后第1、2、4、6、8周末评价疗效,同时采用治疗时出现的症状量表(TESS)进行安全性评估,在第1、2、4、6、8周末及需要时用Bech-Rafaelsen躁狂量表(BRMS)评定躁狂症状。结果拉莫三嗪组和丙戊酸钠组比较,两组有效率分别为75.5%和51.9%,治疗第6周和第8周末HAMD总分和减分率差异有统计学意义。治疗组不良反应明显较对照组发生率低。结论拉莫三嗪治疗双相障碍抑郁发作疗效优于丙戊酸钠,且前者不良反应较少,安全性高。

Objective： To compare the effects and adverse events of lamotrigine and sodium valproate in the treatment of depression in bipolar disorder. Methods： One hundred and seven inpatients were entered into the study by a random, controlled way for 8 weeks. The effects and safety were evaluated by the Hamilton Rating Scale for Depression （HAMD） , Clinical Global Impressions scale （CGI） and Treatment Emergent Symptom Scale（TESS） at baseline and at the end of weeks 1,2,4 ,6and 8. The Beth-Rafaelsen Mania Rating Scale （BRMS） was also administered at the end of weeks 1,2,4 ,6and 8 or when necessary. Results：The response rates were 75.5% and 51.9% respectively in lamotrigine and sodium valproate group. Significant difference in the efficacy was found between lamotrigine and sodium valproate. There were more adverse effects in sodium valproate group than in lamotrigine. Conclusion：Lamotrigine has higher efficacy with less side effects to sodium valproate in treatment of depression in bipolar disorder.