奥氮平联合丙戊酸镁缓释片治疗难治性精神分裂症的随机对照试验

Olanzapine combined with magnesium valproate sustained-release tablets for patients with refractory schizophrenia: a randomized controlled trial

目的探讨奥氮平片联用丙戊酸镁缓释片对难治性精神分裂症的临床疗效和认知功能的影响.方法选择2014年6月-2015年12月湖北科技学院附属第二医院精神科收治的符合《国际疾病分类第10版》（ICD-10）诊断标准的住院难治性精神分裂症患者为研究对象,共100例,按照随机数字表法分为研究组和对照组各50例,研究组给予奥氮平联合丙戊酸镁缓释片治疗,对照组给予奥氮平联合安慰剂治疗,两组疗程均为3个月.在治疗前、治疗后半月、1月、2月、3月采用改良版威斯康星卡片分类测试（M-WCST）、阳性和阴性症状量表（PANSS）和副反应量表（TESS）分别评定患者的认知功能改善、临床疗效和不良反应.结果治疗3月后,研究组PANSS总评分、阴性症状评分较治疗前低（t=2.364、1.268,P均〈0.01）,M-WCST错误数、持续错误数、非持续错误数各因子评分和总评分均较治疗前低（t=0.365～4.116,P均〈0.01）;对照组PANSS总评分、各条目评分、M-WSCT各项目评分与治疗前比较差异无统计学意义（P均〉0.05）.治疗3月后,研究组M-WCST正确数、正确分类数高于对照组（t=2.369、5.118,P均〈0.01）,M-WCST错误数、持续错误数、非持续错误数低于对照组（t=1.368～5.118,P均〈0.01）.两组不良反应发生率差异无统计学意义（t=-1.261,P〉0.05）.结论奥氮平联合丙戊酸镁缓释片对长期住院难治性精神分裂症患者的疗效优于奥氮平联合安慰剂,前者能改善认知功能.

Objective To explore clinical efficacy and cognitive function of olanzapine combined with magnesium valproate sustained release tablets for patients with treatment-resistant schizophrenia. Methods A total of 100 cases with hospitalized refractory spirit schizophrenia who met ICD-10 criteria in the Second Affiliated Hospital of Hubei Science and Technology College from June2014 to December 2015 were included in the study. All patients were divided into study group( n = 50) and the control group( n = 50)according to the random number table method. The study group was given olanzapine combined with magnesium valproate sustained release tablets and the control group was given olanzapine combination with placebo. The course of treatment was 3 months in the two groups. Modified version of Wisconsin Card Sorting Test( M-WCST),Positive and Negative Symptoms Scale( PANSS) and Treatment Emergent Symptom Scale( TESS) were used to evaluate the cognitive function,clinical efficacy and adverse reactions of patients before treatment,after treatment of half month,1 month,2 months and 3 months. Results After 3 months of treatment,the total scores of PANSS and negative symptom were lower than before treatment( t = 2. 364、1. 268,P < 0. 01) in study group,and the scores of error number,number of perseverative errors,non persistent error number and total score of M-WCST were lower than before treatment( t = 0. 365 ~ 4. 116,P < 0. 01). There were no statistically significant difference compared with before treatment in the total and each factor score of PANSS,each factor score of M-WCST( P > 0. 05). After treatment,the correct number,correct classification number of the study group were higher than the control group( t = 2. 369、5. 118,P < 0. 01). The error number,number of perseverative errors,non persistent error number were lower than the control group( t = 1. 368 ~ 5. 118,P < 0. 01). There was no significant difference in the incidence of adverse reactions between the two groups( t =-1. 261,P > 0. 05). Conclusion Olanzapine combined with magnesium valproate sustained release tablets is more effective than olanzapine combined with placebo for long-term hospitalization refractory schizophrenia patients,and the former can improve the cognitive function.