帕利哌酮缓释片与氯氮平治疗难治性精神分裂症对照研究

目的：探讨帕利哌酮缓释片与氯氮平治疗难治性精神分裂症的临床疗效和安全性。方法将60例难治性精神分裂症患者随机分为两组，每组30例，研究组口服帕利哌酮缓释片治疗，对照组口服氯氮平治疗，观察12周。治疗前后采用阳性与阴性症状量表、功能大体评定量表评定临床疗效，副反应量表评定不良反应。结果治疗第12周末研究组总有效率为56．7％，对照组为60．0％，两组比较差异无显著性（χ^2＝0．07，P＞0．05）。治疗后两组功能大体评定量表评分均呈持续性升高，研究组治疗第8周、12周末较对照组升高更显著（ P＜0．05或0．01）。研究组不良反应发生率为36．7％，对照组为73．3％，研究组显著低于对照组（χ^2＝8．15，P＜0．01）。结论帕利哌酮缓释片与氯氮平治疗难治性精神分裂症疗效显著且相当，但帕利哌酮缓释片能显著改善患者的社会功能，安全性更高，更有利于提高患者的治疗依从性。

A control study of paliperidone extended-release tablets vs . clozepine in the treatment of treatment-resistant schizophrenia

Objective To explore the efficacy and safety of paliperidone extended-release tablets （paliperidone ER） vs .clozepine in the treatment of treatment-resistant schizophrenia （TRS） .Methods Sixty TRS patients were randomly assigned to two groups of 30 ones each ,research group took orally paliperidone ER and control did clozepine for 12 weeks .Efficacies were assessed with the Positive and Negative Syndrome Scale （PANSS） and Global Assessment of Function （GAF） and adverse reactions with the Treatment Emergent Symptom Scale （TESS） before and after treatment .Results At the end of the 12th week total effective rate was respectively 56 .7% in research and 60 .0% in control group ,which showed no significant difference （χ^2 =0 .07 ,P〉 0 .05） .After treatment GAF scores of both groups heightened continuously , those did more significantly at the end of the 8th and 12th week in research than in control group （P〈0 .05 or 0 .01） .The incidence of adverse reaction was respectively 36 .7% in research and 73 .3% in control group ,the former was significantly lower than the latter （χ^2 =8 .15 ,P〈0 .01） .Conclusion Paliperidone ER has an evident effect equivalent to clozapine in TRS ,but the former could improve patients’ social functions ,has higher safety ,and is more beneficial to improving patients’ compliance .