国产阿立哌唑与利培酮治疗难治性精神分裂症的对照研究

A Control Study of Treating Patients with Treatment- resistant Schizophrenia with Aripiprazole or Risperidone

目的比较国产阿立哌唑与利培酮对难治性精神分裂症的疗效及安全性。方法 63例难治性精神分裂症患者,随机分为阿立哌唑组(A组31例)和利培酮组(L组32例),疗程12周。采用阳性和阴性症状量表(PANSS)、临床总体印象量表(CGI)及副反应症状量表(TESS),在治疗基线时及治疗第2、4、8、12周末分别评定疗效和副反应。结果 1治疗第12周末,A组、L组临床总有效率分别为67.74%、46.67%,差异有显著性(Z=-2.05,P<0.05);2两组PANSS总分、阳性症状分及一般病理分均从治疗第2周末起较基线时下降(t=-2.2547,-2.0219;P<0.05或0.01);阴性症状分A组从治疗第2周末起,L组从第4周末起均较基线时下降(t=-1.9958,-2.0107;P<0.05或0.01);A组从第4周末起各时点PANSS总分、阴性症状分均低于L组(t=-0.3654,-1.9982;P<0.05或0.01);3治疗第2周末起,两组CGI-SI分较基线时下降(t=-0.3853,-0.5554;P<0.05或0.01);两组间各时点CGI-SI分比较无显著性差异(t=0.4648,-4.6663;P>0.05);4 A组、L组不良反应发生率分别为51.61%、56.25%,差异无显著性(χ2=0.24,P>0.05);A组静坐不能、异常泌乳和(或)闭经明显低于L组(χ2=6.23,5.84;P<0.05)。结论国产阿立哌唑治疗难治性精神分裂症疗效好,不良反应轻。

Objective To compare the efficacy and safety of aripiprazole and risperidone in the treatment of treatment- resistant schizophrenia. Methods A total of 66 patients with treatment- resistant schizophrenia were randomly assigned to aripiprazole group and risperidone group,and received aripiprazole or risperidone for 12 weeks respectively. The positive and negative symptoms scale（ PANSS）,Clinical Global Impression（ CGI） and treatment emergent symptom scale（ TESS） were used to assess at baseline and week 2,4,8,12 weekends. Results 1 The rate of efficiency of aripiprazole group（ 67. 74%） was higher than that of risperidone group（ 46. 67%） after treatment（ P 0. 05）. 2 The total scores of PANSS,PANSS- P（ positive symptom） and PANSS- G（ general psychotic symptom） in both groups decreased significantly from the 2nd weekend after treatment（ t =-2. 2547,-2. 0219; P 0. 05）. The scores of PANSS- N（ negative symptom） in aripiprazole group from the 2nd weekend after treatment and in risperidone group from the 4th weekend were significantly decreased（ t =-1. 9958,-2. 0107; P 0. 05）. The scores of PANSS- N in aripiprazole group were significant lower than those of risperidone group at each time point from the 4th weekend after treatment（ t =-0. 3654,-1. 9982; P 0. 05 ~ 0. 01）. 3 The CGI- SI scores in both groups decreased significantly after treatment（ t =-0. 3853,-0. 5554; P 0. 05 ~ 0. 01）. The differences of CGI- SI scores at each time point in both groups were not significant（ t = 0. 4648,4. 6663; P 0. 05）. 4 The rates of side effects caused by aripiprazole and risperidone were similar,51. 61%,56. 25% respectively（ χ2= 0. 24,P 0. 05）. Compared with aripiprazole group,there were more akathisia,abnormal lactation and / or menostasia in risperidone group（ χ2= 6. 23,5. 84; P 0. 05）. Conclusion Aripiprazole is of good efficacy and less side effects in the treatment of treatment- resistant schizophrenia.