摘要
目的评价可变剂量帕利哌酮缓释片治疗既往口服抗精神病药缺乏疗效或无法耐受而需换药的非急性期精神分裂症患者的疗效及安全性。方法本研究为非随机、单组、为期12周的多中心的开放性临床研究，共纳入405例患者。主要疗效指标为治疗第12周末阳性和阴性症状量表（PANSS）评分较基线的变化。次要疗效指标包括：临床总体印象-严重度量表（CGI．S）、个人和社会功能量表（PSP）。安全性评价包括不良反应记录、锥体外系症状评定量表（ESRS）、实验室及生命体征监测等。结果PANSS总分由基线的（70．1±19．3）分下降至治疗终点的（48．1±15．7）分（P〈0．01），CGI—S由基线的（4．1±1．2）分下降至治疗终点的（2．5±1．1）分（P〈0．01），PSP总分由基线的（58．6±14．9）分提高至治疗终点的（74。5±13．4）分（P〈0．01）。发生率〉5％的不良反应有：锥体外系反应（39．0％）、失眠（6．5％）和过度镇静（5．5％），ESRS总分由基线的（13．0±2．1）分下降至治疗终点的（12．6±1．6）分（P〈0．01）。平均体质量治疗终点较基线增加（0．2±3．5）kg（P〈0．05）。结论换用可变剂量帕利哌酮缓释片对既往抗精神病药疗效不佳或耐受性不佳的非急性期精神分裂症患者疗效肯定，并具有较好安全性和耐受性。
Objective To explore the tolerability, safety and efficacy in adult non-acute schizophrenic patients after switching to flexibly doses of paliperidone extended-release （ paliperidone ER）, for lack of efficacy, safety or tolerability with their previous oral antipsychotic. Methods In this non- randomized, single arm, multi-center, 12-week and open-label study, the primary efficacy measure was the total score changes of the Positive and Negative Syndrome Scale （PANSS）, and the Clinical Global Impression-Severity Scale （CGI-S）, Personal and Social Performance Scale （PSP） were adopted as secondary efficacy measures. The safety evaluation included monitoring adverse events, Extrapyramidal Symptom Rating Scale （ESRS）, clinical laboratory testing and vital sign measurements. Results For all patients, the mean total PANSS score change was from （70. 1 ± 19.3） at baseline to （48.1 ± 15.7） at endpoint（P 〈0. 01 ）. The mean total CGI-S score decrease was from （4. 1 ± 1.2） at baseline to （2. 5 ± 1.1 ） at endpoint （P 〈0. 01 ）. Mean total PSP score increased from （58.6 ± 14. 9） at baseline to （74. 5 ± 13.4） at endpoint （P 〈 0. 01）. Adverse events （AEs） with the incidence rate of I〉 5% included extrapyramidal disorder （39. 0% ）, insomnia （6. 5% ）, somnolence （5.5%）. The mean total ESRS score decreased from （ 13.0 ± 2. 1 ） at baseline to （ 12. 6 ± 1.6） at endpoint （ P 〈 0. 01 ）. The mean weight change from baseline to endpoint was （0. 2 ± 3.5 ） kg （ P 〈 0.05 ）. Conclusion It indicates that flexibly dosed of oral paliperidone ER is safe, well tolerated and effective in adult non-acute schizophrenic patients after switching to paliperidone ER for lack of efficacy, safety or tolerability with their previous oral antipsychotic.
出处
《中华精神科杂志》
CAS
CSCD
北大核心
2012年第1期20-24,共5页
Chinese Journal of Psychiatry
关键词
抗精神病药
精神分裂症
治疗结果
安全
帕利哌酮
Antipsychotic agents
Schizophrenia
Treatment outcome
Safety
Paliperidone
