利培酮和氯氮平治疗难治性精神分裂症的随机对照研究  

A randomized, open label and parallel-control study for the treatment of refractory schizophrenia with risperidone and clozapine

作　　者：杨甫德[1] 李尚明[1] 张兴理[1] 李娟[1] 田玉英[1] 姚付新[1] 陈大春[1] 

机构地区：[1]北京回龙观医院,北京100096

出　　处：《中国新药杂志》2005年第5期610-613,共4页Chinese Journal of New Drugs

基　　金：北京市回龙观医院重点科研项目

摘　　要：目的:比较氯氮平和利培酮治疗难治性精神分裂症的疗效及不良反应。方法:共入组60例符合Kane难治性精神分裂症定义的患者,随机服用氯氮平200～400mg·d^(-1)和利培酮4～8mg·d^(-1)治疗,每组各30例,观察16周,分别于治疗前及治疗1,2,4,8,12,16周末评定阳性症状和阴性症状量表(PANSS)、治疗中不良反应评定量表(TESS)、功能总体评定量表(GAF)指标各1次。治疗前后还需评定韦氏记忆量表(WMS)和威斯康星卡片分类测验(WCST)各1次。结果:两组基线时各项指标包括用药剂量(折合成氯丙嗪)无差异(P均>0.05)。两组治疗第4周末GAF量表评分明显增加,治疗第8周末PANSS总分、阴性症状因子分明显降低,治疗第12周末PANSS总分及各因子分均明显降低,差异均有非常显著性。两组比较治疗第16周末利培酮组TESS量表评分明显低于氯氮平组(P=0.000),而GAF量表得分明显高于氯氮平组(P=0.000),差异均有非常显著性。结论:氯氮平和利培酮治疗难治性精神分裂症患者均有效,且利培酮的不良反应更轻,更利于患者社会功能的改善。Objective: To compare the efficacy and safety of risperidone and clozapine in the treatment of refractory schizophrenia. Methods: 60 inpatients with refractory schizophrenia were randomly assigned to receive either risperidone (200～400mg·d^(-1), n=30) or clozapine (4～8mg·d^(-1), n=30) for 16 weeks. The positive and negative syndrome scale (PANSS), global assessment of function (GAF),and treatment emergent symptoms scale (TESS) were comparable for the two treatment groups prior to the therapy and in weeks 1,2,4,8, 12, 16 post therapy. Weshcler memory scales (WMS) and Wisconsin card sorting test(WCST) were used to evaluate cognitive functions prior to and post the treatment. Results: The GAF in both groups was significantly improved at the end of week 4. The PANSS became a significant decrease at the end of week 8. The GAF score in the patients treated with clozapine was significantly lower compared with the one in the resperidone-treated patients (P=0.000) at the end of week 16. The clozapine-treated patients experienced higher TESS scores than the risperidone-treated patients at the end of week 16. Conclusion: The efficacy of both risperidone and clozapine in the treatment of refractory schizophrenia was apparent. Risperidone showed a better safety profile and more advantage in the improvement of cognition functions.

关 键 词：氯氮平 利培酮 难治性精神分裂症 

分 类 号：R969.4[医药卫生—药理学] R971.41[医药卫生—药学]