利培酮与奥氮平治疗首发精神分裂症的1年随访研究  

One year follow-up study of olanzapine and risperidone in the treatment of patients with first-episode schizophrenia

作　　者：周卉 江开达[1] 张红霞[1] 杨晓敏 

机构地区：[1]上海交通大学医学院附属精神卫生中心,200030

出　　处：《上海精神医学》2008年第1期29-32,35,共5页Shanghai Archives of Psychiatry

基　　金：上海市精神疾病临床医学中心科研基金(编号K-001-01)

摘　　要：目的评价利培酮与奥氮平治疗首发精神分裂症的疗效与不良反应。方法本研究为开放性,平行对照,药物剂量可调整的临床试验。采用自然观察研究方法,结合全病程管理模式对研究对象进行1年随访研究。分别有131例和136例首发精神分裂症患者被分入利培酮组和奥氮平组。利培酮组剂量为3～6mg,平均(3.8±1.3)mg,奥氮平组剂量为10～20mg,平均(12.9±5.6)mg。疗效主要统计指标为阳性和阴性症状评定量表(PANSS)的总分值及有效率,持续治疗时间。PANSS减分率≥50%定义为有效。次要统计指标为复发率、复发时间及药物不良反应。用副反应量表(TESS)评估药物不良反应。结果12月末时,利培酮组有85例患者(64.9%)完成随访,奥氮平组为93例(68.4%),两组差异无统计学意义(P>0.05)。治疗终点利醅酮和奥氮平组有效率分别为62.6%和69.8%,差异无统计学意义(P>0.05),随访中其他时点(2、3、6、8个月)两组有效率差异亦无统计学意义。12个月末利培酮组和奥氮平组的复发率(14.5%、12.5%)、持续治疗时间(9.5±3.8月、9.7±3.8月)、复发时间(4.0±2.9月、5.1±2.8月)等差异均无统计学意义(均P>0.05)。不良反应方面,利培酮组锥体外系反应比例高于奥氮平组,奥氮平组体重增加比例高于利培酮组。结论利培酮与奥氮平治疗首发精神分裂症1年疗效均好,利培酮组锥体外系反应发生较多,奥氮平组体重增加较多。Objective： To evaluate the efficacy and adverse reaction of olanzapine compared with risperidone in the treatment of patients with first-episode schizophrenia. Methods： This was an open-label, parallel, dose-flexible, 12-months follow up study with integrated case management and naturalistic observation. Patients with first-episode schizophrenia were assigned to treatment with an initial dose of olanzapine 10mg/d （n = 136） or risperidone lmg/d （n = 131 ）. The primary efficacy measure was PANSS （Positive and Negative Syndrome Scale） tolal score, secondary efficacy measure included the relapse rate, the time from response to relapse and the time to treatment discontinuation of treatment for any reason. TESS （Treatment Emergent Symptom Scale） was used to evaluate the adverse reaction. Results：Eighty-five patients （64.9%） in risperidone group and 93 patients （68.4%） in olanzapine group completed the full follow-up study, with no statistical difference in proportion of dropouts. The response rates at the end of 12 months of risperidone group and olanzapine group were 62.6% and 69.8% respectively （ P 〉 0.05 ）. There were no difference for the response rates between two groups at any other follow-up times. There were no difference between risperidone and olanzapine groups for the relapse rate（ 14.5%, 12.5%, respectively）, the time from response to relapse （9. 5 ± 3. 8 months, 9. 7 ± 3. 8 months, respectively ） and the time to treatment discontinuation for any reason （4.0 ± 2.9 months, 5.1 ± 2.8 months, respectively）at the end of 12 month. Olanzapine was associated with more weight gain and risperidone with more EPS （extrapyramidal syndrome）. Conclusion：Both olanzapine and risperidone were effective for patients with first-episode schizophrenia for 1 year. Olanzapine was associated with more weight gain and risperidone with more EPS.

关 键 词：精神分裂症 利培酮 奥氮平 全病程管理 

分 类 号：R749.3[医药卫生—神经病学与精神病学]