丙戊酸钠缓释片与碳酸锂治疗双相Ⅰ型障碍躁狂发作的对照研究

目的了解丙戊酸钠缓释片治疗双相Ⅰ型障碍躁狂发作的疗效与安全性。方法对80例患者分别给予丙戊酸钠缓释片及碳酸锂治疗，观察4周，用BRMS躁狂量表及CGI评定疗效，药物副反应量表评定副反应。结果丙戊酸钠缓释片组有效率75％，碳酸锂组有效率为72．5％。治疗4周后BRMS减分率两者相当，药物不良反应发生率丙戊酸钠组明显低于碳酸锂组。结论丙戊酸钠缓释片治疗双相Ⅰ型障碍疗效与碳酸锂相当，不良反应少，耐受性好，可作为临床一线用药。

Comtrol Study on Sodium Valproate Sustained Release Tablets and Lithium Carbonate in Treatment of the Patients with Manic Episode of Bipolar Disorder Type 1

Objective To investigate the clinical efficacy and safety of Sodium Valproate Sustained Release Tablets（depakine） in treatment of the patients with manic episode of Bipolar disorder type 1. Methods In the 4--week randomly controlled trial, 40 patients were treated with depakine and 40 patients with Lithium Carbonate. The efficacy was assessed with Beeh--Rafaelsen Mania Rating Scale （BRMS） and Clinical Global Impression （CGI） and side effects with Treatment Emergent Symptom Scale （TESS） at baseline and after 1,2,4--week treatment. Results A total of 75 % patients treated with depakine and 72.5 % treated with Lithium Carbonate showed positive response. There was no significant difference between the two groups in the mean reduc- tion score of BRMS. But depakine group showed less side effects. Conclusion Depakine is effective and safe in treatment of the patients with manic episode of Bipolar disorder type 1.