不同剂量帕利哌酮缓释片治疗精神分裂症的疗效与安全性研究

目的:比较不同剂量帕利哌酮缓释片治疗精神分裂症的疗效和安全性。方法:将93例精神分裂症患者随机分成3mg、6mg、9mg、12mg四组,给予帕利哌酮缓释片口服治疗8周,在治疗前及治疗第2、4、8周末采用阳性与阴性症状量表(Positive and Negative SyndromeScale,PANSS)和不良反应症状量表(Treatment Emergent Symptoms Scale,TESS)评定疗效和不良反应。结果:在治疗的第2、4、8周末,四组的PANSS量表总分及各因子分及减分率较治疗前差异均有统计学意义(P<0.05);第4周末,12mg组的PANSS评分明显低于3mg组(P<0.05);治疗第8周末,6mg、9mg、12mg组的PANSS评分明显低于3mg组(P<0.05),差异均具有统计学意义。帕利哌酮的主要不良反应为锥体外系反应、睡眠障碍、头痛。12mg组的不良反应明显高于其它剂量组(P<0.05)。结论:帕利哌酮缓释片能有效控制精神分裂症的阳性症状、阴性症状和一般精神病理学症状,且存在一定的量效关系。

Clinical efficacy and safety of different dose of Paliperidone extended-release tablets in the treatment of schizophrenia

Objective:To compare the clinical effect and safety of different dose of Paliperidone extended-release tablets in the treatment of schizophrenia.Methods: 93 patients with schizophrenia were randomly divided into 3mg group,6mg group,9mg group and 12mg group,treatment for 8 weeks.PANSS and TESS were used to assess the efficacy and side effect before treatment and after 2,4,8 weeks.Results: At the 2nd,4th,8th weekend,there were significant differences in 4 groups of PANSS total scores,each factor score and reduced rate(P<0.05).At the 4th weekend,the score of PANSS in 12mg group was significantly lower than that in 3mg group(P<0.05);At the 8th weekend,the score of PANSS in 3mg group was significantly higher than that in 6mg,9mg and 12mg group(P<0.05);there were statistical differences.The common side effects of Paliperidone extended-release tablets were extrapyramidal symptoms(EPS),insomnia and headache.The side effects in 12mg group was higher than other groups(P<0.05).Conclusion:Paliperidone extended-release tablets can effectively control the positive symptoms,negative symptoms and general psychopathological symptoms of schizophrenia,there is positive relationship between the dose of Paliperidone extended-release tablets and therapeutic effect.