帕利哌酮和奥氮平在急性期精神分裂症的随机对照研究

A Randomized Controlled Trial of Paliperidone and Olanzapine in Acute Schizophrenia

目的:研究帕利哌酮治疗急性期精神分裂症的疗效和安全性。方法:94例符合国际疾病分类第10版(ICD-10)诊断标准的精神分裂症急性期患者随机分为帕利哌酮组(N=45)和奥氮平组(N=49),采用简明精神病量表(the Brief Psychiatric Rating Scale,BPRS)、阳性和阴性症状量表(the Positive and Negative Syndrome Scale,PANSS)及个人和社会功能量表(Personal and Social Per-formance Scale,PSP)评定疗效,采用治疗中需处理的不良反应症状量表(Treatment Emergent Symptoms Scale,TESS)评定安全性。结果:两组治疗后BPRS和PANSS评分均低于治疗前,帕利哌酮组BPRS评分(23.15±4.12)vs(.47.45±3.87),PANSS评分(51.06±6.87)vs(.87.96±4.16),P<0.05;奥氮平组BPRS评分(26.96±4.30)vs(.45.11±3.18),PANSS评分(58.42±5.72)vs.(84.71±10.31),P<0.05;治疗后,帕利哌酮组BPRS、PANSS评分低于奥氮平组,但差异无统计学意义(P>0.05)。两组治疗后PSP评分均优于治疗前,且帕利哌酮组效果较奥氮平组效果更好(P<0.05)。两组TESS评分在治疗后差异无统计学意义(P>0.05)。结论:帕利哌酮治疗急性期精神分裂症疗效,安全性较高,是一种值得借鉴的策略。

Objective： To investigate the efficacy and safety of paliperidone on acute schizophrenia.Methods： Ninty-four acute schizophrenics who met the criteria for schizophrenia in International Classification of Diseases（ICD-10） were randomly assigned into two groups.One group was treated with paliperidone（N=45） while the other with olanzapine（N=49）.The efficacy was measured with the brief psychiatric rating scale（BPRS）,the positive and negative syndrome scale（PANSS） and personal and social performance scale（PSP）.The side effects were assessed with the treatment emergent symptoms scale（TESS）.Results： In all patients,the BPRS score and PANSS score were decreased after treatment（P0.05）.There were no significant differences between the two groups.The PSP score was increased after treatment and the score in paliperidone was higher compared with olanzapine（P0.05）.There were no significant differ-ences between the two groups in the TESS score.Conclusions： The therapy of paliperidone has been found to be effective and well-toler-ated approach in patients with acute schizophrenia.