帕利哌酮与利培酮治疗首发精神分裂症的临床疗效与安全性Δ

Efficacy and Safety of Paliperidone vs.Risperidone for First-episode Schizophrenia

目的:比较帕利哌酮与利培酮治疗首发精神分裂症的临床疗效及安全性。方法:92例首发精神分裂症患者分为帕利哌酮(3～12 mg.d-1)组和利培酮(4～6 mg.d-1)组各46例,疗程为8周。于基线及服药2、4、6、8周末,采用阳性和阴性症状量表(PANSS)评定疗效、副反应量表(TESS)评定不良反应。结果:最终入组的患者为89例,其中帕利哌酮组45例,利培酮组44例,治疗4、6、8周末2组的PANSS总分、阳性症状评分、阴性症状评分和精神病理评分均显著降低(P<0.01)。治疗2周末,2组间PANSS总分、阳性症状评分和一般病理症状评分比较,有显著差异(P<0.01),阴性症状评分比较无显著差异(P>0.05)。治疗8周末帕利哌酮组PANSS总分减分率为(68.3±11.7)%,利培酮组为(67.8±12.1)%;帕利哌酮组有效率为71.1%,利培酮组为68.2%,2组疗效比较无显著差异(P>0.05)。帕利哌酮组锥体外系反应发生少于利培酮组(P<0.05)。结论:帕利哌酮治疗首发精神分裂症疗效与利培酮相当,且起效快、锥体外系反应少、安全性较好。

OBJECTIVE：To evaluate the clinical efficacy and safety of paliperidone vs. risperidone for first-episode schizophrenia. METHODS： A total of 92 patients with first-episode schizophrenia were randomly assigned to receive either paliperidone （3-12 mg.d-1 ） （n =46） or risperidone （4-6 mg.d-1 ） （n =46） for 8 weeks. The efficacy and safety at baseline, end of 2, 4, 6 and 8 weeks were assessed using Positive and Negative Syndrome Scale （PANSS） and Treatment Emergent Symptom Scale （TESS）, respectively. RESULTS： 89 patients with schizophrenia were eventually enrolled in the study, with 45 in paliperidone group and 44 in risperidone group. Compared with baseline, the total scores of PANSS, positive symptom scores and negative symptom scores in both groups decreased significantly at the end of 4, 6 and 8 weeks （P 〈0. 01 ）. At the end of 2 weeks, there were significant differences between the two groups in the total scores of PANSS, positive symptom scores and psychopathological scores （P 〈 0. 01 ） whereas no significant differences were noted between the two groups in negative symptoms scores （P 〉 O. 05）. At the end of 8 weeks, the was a reduction of （68. 3 ± 11.7 ） % in total PANSS score for paliperidone group vs. a reduction of （67. 8 ± 12. 1 ） % for rispefidone group. The effective rate was 71.1% for paliperidone group vs. 68. 2% for risperidone group （P 〉0. 05）. The incidence rate of extrapyrarnidal symptoms in paliperidone group was lower than in risperidone group （P 〈 0. 05 ）. CONCLUSION： Paliperidone is as effective as risperidone for first-episode schizophrenia but with faster onset of action, fewer extrapyramidal symptoms and better safety as compared with risperidone.