丙戊酸钠缓释片治疗双相障碍Ⅰ型躁狂发作的随机双盲对照多中心临床研究  

Randomized,double-blind,controlled,multicenter clinical trial of sustained-release divalproex versus lithium carbonate in the treatment of manic episodes of bipolar disorder typeⅠ

作　　者：肖卫东[1] 张鸿燕[2] 陈振华[1] 赵靖平[3] 孙学礼[4] 李婷[5] 许秀峰[6] 谢世平[7] 王传跃[8] 杨甫德[9] 高成阁[10] 舒良[2] 

机构地区：[1]武汉大学人民医院,武汉430060 [2]北京大学精神卫生研究所,北京100083 [3]中南大学湘雅二院,长沙410011 [4]四川大学华西医院心理卫生中心,成都610041 [5]广州脑科医院,广州510370 [6]昆明医学院第一附属医院,昆明650032 [7]南京脑科医院,南京210029 [8]北京安定医院,北京100088 [9]北京回龙观医院,北京100096 [10]西安交通大学第一医院,西安710061

出　　处：《中国临床药理学杂志》2007年第4期247-250,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价丙戊酸钠缓释片(心境稳定剂)与碳酸锂治疗双相障碍I型躁狂发作的疗效及安全性。方法用随机双盲多中心对照研究方法,对157例患者分别进行丙戊酸钠缓释片(丙戊酸钠缓释片组)和碳酸锂(碳酸锂组)治疗,其中丙戊酸钠缓释片组78例,碳酸锂组79例;观察疗程均为4周。以Young躁狂评定量表作为主要疗效评价指标。结果丙戊酸钠缓释片组患者的有效率为68.8%,碳酸锂组的有效率为68.4%。Young躁狂评定量表减分值的比较显示,丙戊酸钠缓释片治疗急性躁狂的疗效与碳酸锂相近。药物不良反应发生率2组均为22%,因不良事件导致脱落的发生率丙戊酸钠缓释片组(2.5%)低于碳酸锂组(7.6%)。结论丙戊酸钠缓释片治疗双相障碍I型躁狂发作的疗效与碳酸锂相当,耐受性较好。Objective To evaluate the efficacy and safety of sustained - release divalproex （depakine） and lithium carbonate in the treatment of patients that met DSM - Ⅳ bipolar disorder type Ⅰ , acute manic episodes. Methods A randomized, double - blind, multieentre controlled clinical trial was conducted. All 157 patients received 4 weeks treatment with either depakine （ n = 78 ） or lithium carbonate （ n = 79）. The main efficacy measure was the change in total score of the Young mania rating scale（YMRS）. Results The clinical response rates were 68.8% （ depakine） and 68.4% （lithium）. The adverse reaction of the two groups both were 22%. The reduction of YMRS score is similar between the two groups. The rates of diseontinuations due to adverse events were 2.5% （ depakin depakine kine has e） and 7.6% （lithium）. Conclusion The results shown that and lithium carbonate have similar therapeutic effect, but depabetter tolerability.

关 键 词：双相障碍Ⅰ型躁狂发作 丙戊酸钠缓释片 碳酸锂 

分 类 号：R749.41[医药卫生—神经病学与精神病学] R971.41[医药卫生—临床医学]