阿立哌唑联合丙戊酸钠缓释片治疗双相障碍躁狂发作40例

Control Study of Aripiprazole Combined with Sodium Valproate for Treating Bipolar Ⅰ Disorder Manic Episode

目的观察阿立哌唑联合丙戊酸钠缓释片治疗双相障碍躁狂发作的疗效和安全性。方法利用随机对照方法,将79例双向障碍躁狂发作患者分为研究组40例(阿立哌唑合并丙戊酸钠缓释片)和对照组39例(奎硫平合并丙戊酸钠缓释片)。观察疗程均为6周,于治疗前及治疗后2,4,6周末采用Young躁狂评定量表、阳性和阴性症状量表(PANSS)评定临床疗效,安全性指标包括不良反应、实验室检查和心电图检查。结果 Young躁狂评定量表减分值比较显示,研究组的总有效率为72.50%,对照组的总有效率为74.36%,但研究组治疗2周末Young躁狂评定量表减分较对照组下降更快(P<0.05)。两组不良反应发生率比较,无显著差异性(P>0.05)。结论阿立哌唑联合丙戊酸钠缓释片治疗双相情感障碍躁狂发作与奎硫平联合丙戊酸钠缓释片疗效相同,且安全性高、起效快,适用于躁狂急性期的治疗。

Objective To investigate the effects and safety of aripiprazole combined with sodium valproate for the treatment of bipolar I disorder manic episode.Methods By adopting the random control method,79 patients diagnosed bipolar I disorder manic episode were randomly divided into the treatment group（n=40,aripiprazole plus sodium valproate） and the control group（n=39,quetiapine plus sodium valproate）.The observation treatment course was 6 weeks in the two groups.The Young Mania Rating Scale（YMRS） and the Positive and Negative Syndrome Scale（PANSS） were adopted to assess the efficacy before treatment and at the end of 2,4,6 weeks after treatment.The safety indexes included the adverse events,EEG recordings and laboratory tests.Results Comparing the reduced scores of YMRS showed that the effective rate was 72.50%in the aripiprazole plus sodium valproate group and 74.36%in the quetiapine plus sodium valproate group,revealing the similar curative effects without statistical difference between the two groups.But the reduced scores of YMRS at the end of 2 weeks after treatment in the quetiapine plus sodium valproate were decreased more fast with statistical difference（P〈0.05）.The incidence rate of adverse events had no significant difference between the two groups（P〈0.05）.Conclusion Aripiprazole combined with Sodium Valproate Sustained Release Tablets demonstrates the same therapeutic efficacy as quetiapine combined with sodium valproate for treating bipolar I disorder manic episode,which has the high safety,rapid onset of action and is suitable for treating manic episode.