丙戊酸镁缓释片联合奥氮平治疗伴冲动攻击行为精神分裂症患者的疗效和安全性研究

Efficacy and safety study of Magnesium valproate sustained-release tablets combined with Olanzapine tablets in treatment of schizophrenia patients with impulsive and aggressive behaviors

目的:观察丙戊酸镁缓释片联合奥氮平治疗伴冲动攻击行为的精神分裂症患者的临床疗效和安全性。方法:将120例伴有攻击行为的精神分裂症患者随机分为研究组(61例)和对照组(59例)。研究组患者给予丙戊酸镁缓释片联合奥氮平治疗;对照组患者给予单纯奥氮平治疗。两组患者治疗的疗程均为6周。治疗后,采用外显攻击行为量表(MOAS)、阳性与阴性症状评定量表(PANSS)评定两组患者的临床疗效,并分别于基线及治疗第2、4、6周末各评定1次,采用不良反应症状量表(TESS)评定两组患者的不良反应。结果:治疗第2、4、6周末,两组患者的MOAS和PANSS评分较治疗前显著降低,且研究组患者的各测量点MOAS和PANSS评分显著低于对照组,差异具有统计学意义(P<0.05)。两组患者各种不良反应比较差异无统计学意义(P>0.05)。结论:丙戊酸镁缓释片联合奥氮平治疗伴冲动攻击行为的精神分裂症患者的临床疗效优于单纯奥氮平治疗,且两者安全性相当。

Objective： To investigate clinical effects and safety of Magnesium valproate sustained-release tablets combined with Olanzapine in treatment of schizophrenia patients with impulsive and aggressive behaviors. Methods ： 120 schizophrenia patients complicated with aggressive behaviors were randomized into study group （n = 61, Magnesium valproate sustained-release tablets com-bined with Olanzapine） and control group （n = 59, sing Olanzapine）. Both groups were treated for 6 weeks. The modified overt aggres-sion scale （MOAS） and positive and negative syndrome scale （ PANSS） were used to evaluate the clinical curative effects at the base-line and at the 2nd, 4th, and 6th week of the treatment. The treatment emergent symptom scale （TESS） was used to evaluate adverse reactions. Results： At the 2nd, 4th, and 6th week of the treatment, the MOAS and PANSS scores of the two groups were significantly reduced. The scores of the study group were lower than those of the control group at each time point, and the differences were statisti-cally significant （ P〈0.05）. However, there was no significant difference in the incidence of adverse reactions between the two groups （P〉0. 05）. Conclusions ： Magnesium valproate sustained-release tablets combined with Olanzapine in the treatment of the schizophre-nia patients with impulsive and aggressive behaviors is more effective than single Olanzapine, but they have a similar safety.