品牌利培酮与类似利培酮治疗老年神经精神障碍患者的疗效及安全性：一项回顾性研究。

Efficacy and safety of brand-risperidone versus similar-risperidone in elderly patients with neuropsychiatric disorders: A retrospective study.

作者信息

Folquitto Jefferson Cunha, de Barros Sérgio Barbosa, Pinto Junior Jony Arrais, Bottino Cássio M C

机构信息

Projeto Terceira Idade (PROTER), Instituto e Departamento de Psiquiatria, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.

Departamento de Estatística, Universidade de São Paulo, São Paulo, Brasil, Projeto Terceira Idade (PROTER), Instituto e Departamento de Psiquiatria, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brasil.

出版信息

Dement Neuropsychol. 2010 Jan-Mar;4(1):69-74. doi: 10.1590/S1980-57642010DN40100012.

DOI:10.1590/S1980-57642010DN40100012

PMID:29213664

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5619534/

Abstract

UNLABELLED

To compare the efficacy and tolerability of brand-risperidone against similar-risperidone in elderly outpatients.

METHOD

The medical files of 16 elderly outpatients from the IPq-HCFMUSP treated with two formulations of risperidone (brand and similar) between July/1999 and February/2000 were reviewed. Two independent raters, using the Clinical Global Impression scale, evaluated the efficacy of the treatment with risperidone and the frequency of adverse effects.

RESULTS

Comparing October/1999 to November/1999, Rater 1 observed a trend (p=0.059) and Rater 2 found a statistically significant difference, in favor of the brand-risperidone group (p=0.014). Comparing October/1999 to February/2000, Rater 1 observed no statistically significant difference (p=0.190), but the Rater 2 found a statistically significant difference in favor of the brand-risperidone group (p=0.029). Comparing November/1999 to February/2000, both raters found no statistically significant differences between both risperidone formulations. Regarding adverse effects, a statistically significant difference (p=0.046) was found in favor of the patients treated with brand-risperidone.

CONCLUSIONS

The risperidone-reference, compared to similar-risperidone, showed a trend toward greater efficacy and tolerability.

摘要

未标注

比较品牌利培酮与类似利培酮在老年门诊患者中的疗效和耐受性。

方法

回顾了1999年7月至2000年2月期间在IPq-HCFMUSP接受两种利培酮制剂（品牌和类似制剂）治疗的16名老年门诊患者的病历。两名独立评估者使用临床总体印象量表评估利培酮治疗的疗效和不良反应的发生频率。

结果

将1999年10月与1999年11月进行比较，评估者1观察到一种趋势（p=0.059），评估者2发现存在统计学显著差异，支持品牌利培酮组（p=0.014）。将1999年10月与2000年2月进行比较，评估者1未观察到统计学显著差异（p=0.190），但评估者2发现存在统计学显著差异，支持品牌利培酮组（p=0.029）。将1999年11月与2000年2月进行比较，两名评估者均未发现两种利培酮制剂之间存在统计学显著差异。关于不良反应，发现存在统计学显著差异（p=0.046），支持接受品牌利培酮治疗的患者。