帕利哌酮缓释片治疗急性精神分裂症疗效及安全性的对照研究  

The efficacy and safety of flexible doses of paliperidone extended-release tablets in the treatment of acute schizophrenia： a randomized, double blind olanzapine-controlled study

作　　者：张鸿燕[1] 李华芳[2] 王刚[3] 李婷[4] 谢世平[5] 肖卫东[6] 谭庆荣[7] 舒良[1] 

机构地区：[1]北京大学精神卫生研究所药物临床研究机构办公室,100191 [2]上海市精神卫生中心国家药品临床研究机构 [3]北京安定医院国家药品临床研究机构 [4]广州脑科医院精神科 [5]南京脑科医院精神科 [6]湖北省人民医院精神科 [7]第四军医大学西京医院心理卫生科

出　　处：《中华精神科杂志》2009年第3期153-157,共5页Chinese Journal of Psychiatry

摘　　要：目的评价可变剂量帕利哌酮缓释片治疗急性精神分裂症患者的疗效与安全性，并与奥氮平进行比较。方法采用为期6周的随机、双盲、平行对照、多中心的临床研究方法。按1：1的比例将288例精神分裂症住院患者随机分入帕利哌酮缓释片组（143例；3～12mg／d）或奥氮平组（145例；5～15mg／d），观察疗程均为6周。主要疗效指标为治疗第6周末阳性和阴性症状量表（PANSS）总分较基线的改变。以临床总体印象量表（CGI）、有效率、睡眠视觉模拟评分（VAS）为次要疗效指标。结果治疗第6周末，2组的PANSS总分较基线均有明显降低（配对t检验，P均〈0．001）。帕利哌酮缓释片组减分（32．3±17．1）分，奥氮平组减分（34．1±17．4）分，2组的差异无统计学意义（方差分析检验，P=0．369）。2组的CGI、有效率及VAS的差异均无统计学意义（CMH卡方检验，P均〉0．05）。帕利哌酮缓释片的主要不良反应为锥体外系不良反应（EPS）、失眠、便秘、泌乳素升高等；奥氮平的主要不良反应为嗜睡、EPS、脂代谢及肝功能异常等。结论帕利哌酮缓释片治疗急性精神分裂症的疗效与奥氮平相当。较少引起嗜睡、肝功能异常及脂代谢异常。Objective The study was designed to evaluate the efficacy and safety of flexible doses of paliperidone extended-release tablets （ paliperidone ER） （ 3 - 12 ） mg/d comparing with olanzapine （5 - 15） mg/d in acute hospitalized patients with schizophrenia. Methods All 288 hospitalized patients with DSM-IV schizophrenia were randomized into paliperidone ER （ n = 143 ） or olanzapine （ n = 145 ） treatment in a 6-week, multicenter, double-blind, parallel-group study. The primary efficacy measure was the total score changes of the Positive and Negative Syndrome Scale （PANSS）. Clinical Global Impression （CGI）, response rate and Visual Analogue Scale （VAS） were adopted as secondary efficacy measures. Results Both paliperidone ER and olanzapine groups demonstrated a significant improvement in total PANSS score （ P 〈 0.001 ）. The PANSS total score in paliperidone ER group was reduced （ 32.3 ± 17.1 ） at end point, and olanzapine group （34.1 ± 17.4）. There was no statistically significant difference between the two groups （P = 0. 369） after 6-week treatment. There were no statistical differences between two groups in CGI, response rate and VAS sleep quality assessments by the end of the treatment. The common adverse events were extrapyramidal symptoms, insomnia, constipation and prolactin increasing in paliperidone ER group, and somnolence, EPS, abnormal liver function and abnormal lipid metabolism in olanzapine group. Conclusion Paliperidone ER and olanzapine are similarly effective in significantly improving the symptoms of inpatient with acute schizophrenia. Paliperidone ER demonstrates a favorable safety profile with fewer somnolence, abnormal liver function and abnormal lipid metabolism comparing with olanzapine.

关 键 词：精神分裂症 治疗效果 帕利哌酮缓释片 奥氮平 安全 

分 类 号：R686[医药卫生—骨科学]