帕利哌酮对精神分裂症患者社会功能影响的随机开放对照研究

目的探讨帕利哌酮治疗精神分裂症患者的疗效及对社会功能的影响。方法 92例精神分裂症患者随机分为研究组(帕利哌酮组,47例,剂量3～12 mg.d-1)和对照组(利培酮组,45例,剂量1～6 mg.d-1),观察12 wk。于基线、治疗wk 8、wk 12末分别采用阳性与阴性症状量表(PANSS)、个人和社会功能量表(PSP)、药物治疗满意度调查问卷(MSQ)以及治疗时出现的症状量表(TESS)进行临床评定,并检测相关的实验室指标等。结果至研究终点,研究组总有效率与对照组相似(64%vs.60%,P>0.05)。2组在治疗wk 8、wk 12末的PANSS总分及各因子分、PSP总分较基线有明显改善(P<0.05)。研究组在治疗wk 12末的PANSS总分及各因子分较治疗wk 8末有下降(P<0.05)、PSP总分有升高(P<0.05),而对照组无显著变化。2组均未出现严重不良反应,而研究组不良反应发生率相对较低(P<0.05)。研究组药物治疗满意度更好(72%vs.51%,P<0.05)。结论帕利哌酮能有效改善精神分裂症患者的精神症状和社会功能。

Effects of paliperidone on social functioning in schizophrenia patients:a randomized,opened,controlled trial

AIM To study the effects of paliperidone on social functioning in schizophrenia patients.METHODS In a 12-week open-label study,a total of 92 patients with schizophrenia were randomly assigned to trial group(n = 47)and control group(n = 45),and were respectively administered with paliperidone(3-12 mg·d-1)or risperidone(1-6 mg·d-1)for 12 weeks.The clinical effects were assessed and analyzed by the Positive and Negative Symptoms Scales(PANSS),Personal and Social Performance scale(PSP),Medication Satisfaction Questionnaire(MSQ)and Treatment Emergent Symptom Scale(TESS)at baseline,at the end of the 8 weeks and 12 weeks.And the related laboratory parameters were analyzed.RESULTS At the end of the study,the response rate was 64% in the trial group and 60% in the control group,there was no significant difference between two groups(P > 0.05).In both groups,the factors and total scores of PANSS at the end of the 8 weeks and 12 weeks after administration were significantly lower than those at the baseline(P < 0.05),and the total scores of PSP at the end of the 8 weeks and 12 weeks were significantly higher than those at the baseline(P < 0.05).In the trial group,the factors and total scores of PANSS at the end of the 12 weeks were significantly lower than those at the end of the 8 weeks(P < 0.05),and the total scores of PSP at the end of the 12 weeks were significantly higher than those at the end of the 8 weeks(P < 0.05).There was no significant difference in the factors and total scores of PANSS and PSP at the end of the 8 weeks and 12 weeks in the control group(P > 0.05).No severe adverse reactions were observed in both groups,while the incidence of treatment-emergent adverse reactions were lower in the trial group than that in the control group(P < 0.05).At the end of study,patient satisfaction rate in the trial group was better than that in the control group(72% vs.51%,P < 0.05).CONCLUSION Paliperidone is effective in improving psychiatric symptoms and social functioning of patients with schizophrenia.