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.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2007年第4期247-250,共4页
The Chinese Journal of Clinical Pharmacology
关键词
双相障碍Ⅰ型躁狂发作
丙戊酸钠缓释片
碳酸锂
bipolar disorder type Ⅰ manic episode
deparkine tablets
lithium carbonate
