Objective; To investigate the efficacy and safety of paliperidone extended-release tablets (paliperidone ER) in treating schizophrenia outpatients. Methods; Schizophrenia patients were randomly divided into paliperidone ER group '( n = 76) and risperidone group (n - 79 ) and treated with paliperidone ER or risperidone respectively for 4 weeks. The efficacy, side effects and social function were assessed with PANSS, TESS and PSP at the baseline and week 4 respectively. Results; At the end of 4 week, the scores of PANSS in paliperidone ER group was lower than baseline,and the total scores of PANSS and negative symptoms score of PANSS in were lower than that in risperidone group (P < 0. 05 ) . At the end of 4 weeks, paliperidone ER group showed more significant improvement of PSP than risperidone group (P <0. 05) . There had no severe side-effects in both groups. Conclusion ; Paliperidone ER shows significant improvement in positive and negative symptoms and social function in schizophrenia patients. It also has good safety.%目的:探讨帕利哌酮缓释片对精神分裂症的疗效及安全性.方法:门诊确认的精神分裂症患者分为帕利哌酮缓释片治疗组(n=76)和利培酮对照组(n=79),共治疗4周,治疗前及治疗4周后分别应用阳性与阴性症状量表(PANSS)、个人和社会功能量表(PSP)和副反应量表(TESS)评定疗效及安全性.结果:帕利哌酮组治疗4周后PANSS总分及各因子评分低于基线,差异均具有统计学意义(P<0.05);帕利哌酮组PANSS总分及阴性症状评分均低于对照组,差异具有统计学意义(P<0.05).治疗4周后,帕利哌酮组PSP评分较利培酮组有不同程度提高,差异具有统计学意义(P<0.05).帕利哌酮组不良反应与利培酮组相当,均未见严重不良反应.结论:帕利哌酮缓释片可有效改善精神分裂症患者的阳性症状、阴性症状以及社会功能,安全性较高.
展开▼