目的:评价奎硫平单药治疗及联合碳酸锂治疗双相情感障碍躁狂发作的疗效和安全性。方法:78例双相情感障碍躁狂发作患者随机分成奎硫平单药治疗组(研究组)和奎硫平联合碳酸锂治疗组(对照组)各39例。观察4周。于治疗前以及治疗1、2和4周分别采用杨氏躁狂量表(YMRS)、阳性与阴性症状量表(PANSS)评价疗效;采用不良事件量表、SimpsonAngus量表、Barnes静坐不能评定量表及不自主运动量表评价药物安全性。结果:治疗4周,研究组痊愈率63.89%,有效率94.44%;对照组分别为66.67%和94.44%,两组比较,差异无统计学意义(P〉0.05)。两组YMRS评分治疗前差异无统计学意义(P〉0.05),治疗后各周均有显著下降(P均〈0.01);两组比较,差异无统计学意义(P〉0.05)。研究组不良反应总发生率显著低于对照组(χ2=4.06,P〈0.05)。结论:奎硫平单药治疗双相情感障碍躁狂发作与奎硫平联合碳酸锂治疗疗效相同,且单药治疗不良反应发生率更低。
Objective:To evaluate the curative effect and safety of quetiapine fumarate with quetiapine fumarate plus lithium carbonate in the treatment of bipolar affective disorder. Method:78 patients meeting bipolar affective disorder standards were randomly divided into research group (n=39) treated with quetiapine fumarate and control group (n=39) with quetiapine fumarate plus lithium carbonate for 4 weeks.Curative effects were assessed with the changing total scores of Young mania rating scale (YMRS),positive and negative symptom scales (PANSS) in the treatment of bipolar affective disorder and safety with the adverse events scale (AES),Simpson-Angus scale (SAS),Barnes akathisia rating scale (BARS) and abnormal involuntary movement scale (AIMS) at the ends of 1st,2nd and 4th week. Results:After 4 weeks treatment,cure and effectiveness rates were 63.89% and 94.44% in the research group while 66.67% and 94.44% in the control group respectively,which showed no significant differences(P0.05).The YMRS scores of both groups decreased significantly after treatment and continuously long with the time of therapy (all P0.01) with no significant difference between groups(P0.05);Incidence of adverse reactions was significantly lower in the research group than in the control group (χ2=4.06,P0.05). Conclusion:Quetiapine fumarate and quetiapine fumarate combined with lithium carbonate have same curative effects in bipolar affective disorder,but there are little negative effects in research group.