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.
出处
《中华精神科杂志》
CAS
CSCD
北大核心
2009年第3期153-157,共5页
Chinese Journal of Psychiatry
关键词
精神分裂症
治疗效果
帕利哌酮缓释片
奥氮平
安全
Schizophrenia
Treatment outcom
Paliperidone extended-release tablets
Olanzapine
Safety
