丙戊酸镁缓释片与丙戊酸钠缓释片治疗躁狂发作的对照研究

A comparative study of magnesium valprote extended action tablet and sodium vaiproate sustained-release tablets in treatment of patients with mania

目的比较丙戊酸镁缓释片与丙戊酸钠缓释片治疗躁狂发作的疗效及安全性。方法采用人院顺序分层随机法，将60例躁狂发作的患者随机分为研究组（用丙戊酸镁缓释片系统治疗）与对照组（用丙戊酸钠缓释片系统治疗），疗程共3周，分别于治疗前、治疗后第1、第2、第3周末采用躁狂量表（BRMS）及副反应量表（TESS）分别评定疗效及不良反应。结果研究组和对照组的BRMS评分在第1周末[分别为（21±3．6）分、（20±4．3）分]、第2周末[分别为（11±2．3）分、（12±3．5）分]、第3周末[分别为（6±1．7）分、（5±2．4）分]时比较，差异均无显著性（t=3．27～5．34，P：0．053～0．082）。在第1周末，研究组的TESS评分[（3．12±2．37）分]显著低于对照组[（4．57±2．83）分]，差异有显著性（t=3．58，P=0．002），而研究组和对照组的TESS评分在第2周末[分别为（2．95±2．26）分、（3．15±2．01）分]、第3周末[分别为（1．43±2．04）分、（1．72±2．31）分]比较，差异均无显著性（t=2．48～3．06，P=0．552～0．931）。结论丙戊酸镁缓释片具有疗效高，不良反应小等优点；

Objective To compare the efficacy and side effects f magnesium valprote extended action tablet and sodium valproate sustained-release tablets in treatment of patients with mania. Methods A total of 60 patients with mania randomly divided into two groups, study group with magnesium valprote extended action tablet and control group with sodium valproate sustained-release tablets for treatment of three weeks. They were assessed and analysed contrastively using with Bech-Rafaelsen Mania Scale（BRMS） and Treatment Emergent Side Effect Scale （TESS） before treatment and in the lst,2nd and 3rd weekend after treatment. Results There were no significantly differences between study group and control group for scores of BRMS in the 1 st （ as follows ：21±3.6,20 ±4.3） ,2nd （as follows：11±2.3,12±3.5）and 3rd （as follows：6±1.7,5±2.4）weekend after treatment（t = 3.27 5.34, P=0.053-0.082）. In the 1st weekend of treatment, the total scores of TESS （3.12±2.37） in study group were significantly lower than those （4.57±2.83） in control group（t = 3.58, P = 0. 002）. There were no significantly differences between study group and control group for scores of TESS in the 2nd （as follows：2.95±2.26,3.15±2.01 ） and 3rd （ as follows ： 1.43±2.04,1.72±2.31 ） weekend after treatment（t = 2.48 - 3.06, P = 0. 552- 0. 931 ）. Conclusion Magnesium valprote extended action tablet is effective in treating mania without severe side effects.