可变剂量帕利哌酮缓释片治疗急性期精神分裂症的疗效和安全性

目的:研究可变剂量帕利哌酮缓释片治疗急性期精神分裂症的有效性和安全性。方法:使用可变剂量帕利哌酮缓释片(3～12 mg.d-1)治疗急性期精神分裂症住院患者60例,观察期8周。分别在基线、第1,24,和8周末使用阳性与阴性症状量表(Positive and Negative Syndrome Scale,PANSS)、个人与社会功能量表(Personal and Social Performance Scale,PSP)、临床试验委员会用(Udvalg for Kliniske Undersgelser,UKU)不良反应量表、体格检查、实验室检查等来评价其有效性和安全性。结果:最终纳入意向分析集的病例为53例。各随访点的PANSS总分和分量表评分均显著低于基线水平,差异具有统计学意义(P<0.01);PSP总分均显著高于基线水平,差异具有统计学意义(P<0.01)。各随访点体重和体重指数与基线相比的变化无统计学意义。8周末催乳素和甘油三酯较基线时显著升高(P<0.01),而血糖、低密度脂蛋白、高密度脂蛋白的变化无统计学意义。治疗期间常见的不良反应是疲乏无力(17.0%)、静坐不能(17.0%)和思睡镇静(13.2%),多为轻到中度。结论:可变剂量帕利哌酮缓释片能够全面改善急性期精神分裂症的临床症状和社会功能,对糖脂代谢和体重的影响较小,不良反应轻,耐受性好。

Efficacy and safety of flexible-dose oral paliperidone extended-release tablets in the treatment of acute schizophrenia

Objective: To evaluate the efficacy and safety of flexible-dose oral paliperidone extended-release tablets in the treatment of acute schizophrenia.Methods: Totally 60 inpatients with acute schizophrenia who were treated with flexible doses of paliperidone-ER(3~12 mg·d-1),participated in the open label trial for 8 weeks.The Positive and Negative Syndrome Scale(PANSS),Personal and Social Performance scale(PSP) and UKU side effect rating scale were used to evaluate effectiveness and safety at baseline,and 1,2,4 and 8 weeks.Meanwhile,the results of physical examination and laboratory assessments were used to evaluate endocrine and metabolic effects.Results: Finally,there were 53 inpatients included in ITT.In all the follow-up points,the scores of PANSS and subscales were significantly lower than that at baseline(P<0.01),and the total scores of PSP were significantly higher than baseline(P<0.01).Body weight and body mass index had no significant difference between baseline and any follow-up points.At the end of the 8th week,meanwhile the mean plasma prolactin and triglycerides levels were significantly higher than baseline(P<0.01),the level of blood glucose,low-density lipoprotein(LDL) and high-density lipoprotein(HDL) had no significant differences.During treatment,the common side effects were fatigue(17.0%),akathisia(17.0%) and somnolence(13.2%),most of which were mild or moderate.Conclusion: Effective symptom control and improvement in personal and social functioning can be obtained with flexible-dose paliperidone ER in treating acute schizophrenia.Paliperidone ER is generally safe and well-tolerated with no unexpected AEs emerging over the study period,but is associated with unafavorable prolactin profile.