喹硫平与丙戊酸镁缓释片治疗双相障碍抑郁发作的对照研究

A comparison study of quetiapine and magnesium valproate sustained release tablets in the treatment of bipolar depression

目的探讨喹硫平单药治疗双相情感障碍抑郁发作患者的临床疗效及安全性。方法选取住院患者双相情感障碍抑郁发作患者61例,按随机数字表法将其分为研究组和对照组两组,研究组(31例)予以喹硫平治疗,对照组(30例)予以丙戊酸镁缓释片治疗,为期8周,在治疗前及治疗后第1、2、4、8周末分别采用汉密尔顿抑郁量表(HAMD-17)、阳性症状与阴性症状量表(PANSS)评定临床疗效,治疗副反应量表(TESS)评定不良反应。结果治疗前两组HAMD-17评分差异无统计学意义(P>0.05),在治疗后第2、4、8周研究组HAMD-17评分低于对照组,差异显著(P<0.05);研究组患者PANSS评分在第2、4、8周PANSS评分低于对照组,差异有统计学意义(P<0.05);研究组治愈率比对照组要高,但差异无统计学意义(χ~2=0.78;P>0.05);研究组的不良反应发生率低。结论与丙戊酸镁缓释片相比,喹硫平单药治疗双相情感障碍抑郁发作临床疗效好,能有效改善患者的临床症状,且不良反应轻,安全性高。

Objective The aim of this study was to investigate the clinical efficacy and safety of quetiapine monotherapy in patients with bipolar disorder. Methods 61 patients with bipolar disorder were divided into two groups： the study group and the control group according to the random number table method. The study group （ 31cases ） was treated with quetiapine and the control group （ 30 cases ） was treated with magnesium valproate sustained release tablets for 8 weeks. The clinical efficacy was evaluated by hamilton depression scale （ HAMD-17 ）, positive and negative syndrome scale （ PANSS ） before and after the first, second, fourth and eighth weekend after treatment. The adverse reactions were accessed. Results There was no significant difference in HAMD-17 score between the two groups before treatment （P 〉 0.05 ） . The scores of HAMD-17 in the study group were significantly lower than those in the control group at the second, fourth and eighth week after treament （P 〈 0.05 ） . The PANSS score of the study group was significantly lower than that of the control group at the second, fourth and eighth week （P 〈 0.05 ） . The cure rate of the study group was higher than that of the control group, but the difference was not statistically significant （ X 2=0-78; P〉0.05 ）, the incidence of adverse reactions in the study group was low. Conclusion Quetiapine monotherapy is more effective than valproate sustained release tablets in the treatment of bipolar disorder depression. Quetiapine monotherapy can effectively improve the clinical symptoms of patients, and mild adverse reactions, with higher safety.