帕利哌酮缓释片治疗首发精神分裂症的疗效与安全性研究

The efficacy and safety of paliperidone extended-release tablets for first-episode schizophrenia

目的:探讨帕利哌酮缓释片治疗首发精神分裂症的临床疗效、安全性。方法:90例患者随机分为帕利哌酮缓释片治疗组和利培酮对照组,两者各45例,以8周作为研究终点,以阴性和阳性症状量表(PANSS)、不良反应量表(TESS)分别于治疗前、治疗后2、4、8周评定疗效及安全性。结果:研究组与对照组各治疗时点PANSS总分及分量表与治疗前均明显下降(P<0.01),与对照组相比,研究组第2周末PANSS总分差异具有统计学意义(P<0.05),研究组锥体外系反应和肝功能异常发生率较对照组差异具有统计学意义(P<0.01)。结论:帕利哌酮缓释片治疗首发精神分裂症临床疗效可靠、安全性好。

Objective To investigate the efficacy and safety of paliperidone extended-release tablets for first-episode schizophrenia.Methods 90 patients with first-episode were randomly assigned to receive paliperidone extended-release tablets （study group,45 patients）,or risperidone （control group,45 patients） for 8 weeks.The efficacy and safety of the therapies were assessed by Positive and Negative Syndrome scale （PANSS） and Treatment Emergent Symptom Scale （TESS） at weeks 0,2,4,and 8.Results 82 patients completed 8 weeks of treatment.Compared to the data before treatment,PANSS at weeks,2,4,6 and 8 had obvious difference （P 0.01）.Compared with control group,Incident of extrapyramidal side effects and abnormal liver function was lower.Conclusions Paliperidone extended-release tablets is effective and safe in the treatment of schizophrenia.