拉莫三嗪治疗精神分裂症和双相抑郁及重性抑郁症耐受性与敏感性的文献分析  

Comparisons of the tolerability and sensitivity of lamotrigine in the treatment of schizophrenia,bipolar depression and major depressive disorder： a systematic review

作　　者：汪作为[1] 方贻儒[1] GAO Ke-ming 张少平[2] Joseph R.Calabrese 

机构地区：[1]上海交通大学医学院附属精神卫生中心,200030 [2]上海市虹口区精神卫生中心 [3]凯斯西储大学附属医院凯斯医疗中心

出　　处：《中华精神科杂志》2011年第3期155-158,共4页Chinese Journal of Psychiatry

摘　　要：目的 分析拉莫三嗪在精神分裂症、双相抑郁和重性抑郁症急性期治疗中耐受性与敏感性.方法 选择符合急性期、随机双盲、安慰剂对照的关于拉莫三嗪治疗急性期精神分裂症、双相抑郁和重性抑郁症的临床试验进行分析;以不良事件引起治疗终止发生率为拉莫三嗪的耐受性指标,以皮疹和头痛为敏感性指标.分别计算拉莫三嗪（200 mg/d）事件发生率相对于安慰剂事件发生率增加（ARI）,以及拉莫三嗪（200 mg/d）治疗相对于安慰剂治疗所致1例不良事件发生前需要治疗的患者数（NNH）;显著性检验以95%可信区间（95%CI）表示.结果 （1）难治性精神分裂症4项、双相抑郁4项、难治性双相抑郁1项和重性抑郁症3项临床试验被分析;（2）在难治性精神分裂症、双相抑郁及难治性双相抑郁、重性抑郁症的急性治疗期,与安慰剂比较,拉莫三嗪（200 mg/d）相关不良事件引起治疗终止NNH（95%CI）依次为323（-23～20）、-47（-17～60）、-34（-10～22）和-32（-14～158）例,皮疹依次为133（-51～29）、-46（-18～83）、51（-16～10）和-31（-15～1208）例,头痛依次为-26（-11～61）、-168（-16～19）、-28（-6～9）和53（-24～13）例,差异无统计学意义（95%CI包括0）.结论 拉莫三嗪单药或增效治疗精神分裂症、双相抑郁和重性抑郁症具有良好的耐受性与安全性.Objective To compare the tolerability and sensitivity of lamotrigine in the treatment of schizophrenia, bipolar depression and major depressive disorder （MDD）. Methods Data from randomized,double-blind, placebo-controlled trials of lamotrigine adjunctive or monotherapy in the acute treatment of treatment-resistant schizophrenia, bipolar depression, and MDD were used. The discontinuation due to adverse events （DAEs） was used as an index of tolerability. The reported headache and occurrence of rash were used as indexes of sensitivity. Absolute risk increase （ARI） and number needed to harm （NNH） of lamotrigine at dose of 200 mg/d relative to placebo for DAEs, headache, and rash were estimated with 95% confidence interval （CI） to reflect the magnitude of variance. Results Four trials in treatment-resistant schizophrenia, 4 in bipolar depression, 1 in treatment-resistant bipolar depression and 3 in major depressive disorder were analyzed. In the acute treatment of treatment-resistant schizophrenia, bipolar depression or treatment-resistant bipolar depression and major depressive disorder, lamotrigine 200 mg/d did not significantly increase the risk for DAEs [NNH 95% CI respectively as 323（-23 to 20） ,-47（-17 to 60）, -34（-10 to 22） and-32（-14 to 158）], rash [NNH 95% CI respectively as 133 （-51 to 29）,-46（-18 to 83）, 51 （-16 to 10） and -31 （-15 to 1208）] and headache [NNH 95% CI respectively as -26（-11 to 61）,-168 （-16 to 19）,-28 （-6 to 9） and 53 （-24 to 13）] relative to placebo. Conclusion The available data indicate patients with schizophrenia, bipolar depression and major depressive disorder tolerate lamotrigine 200 mg/d as well as placebo and have a similar sensitivity to lamotrigine as to placebo.

关 键 词：精神分裂症 双相情感障碍 抑郁症 安全 药物耐受性 拉莫三嗪 

分 类 号：R749.4[医药卫生—神经病学与精神病学]