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[洲际精神分裂症门诊患者健康结局研究(IC-SOHO):拉丁美洲样本的最初6个月研究结果]

[The intercontinental schizophrenia outpatient health outcomes study (IC-SOHO): initial 6 month findings of the sample in Latin America].

作者信息

Brunner E, Gargoloff P, Caro O, González C, Landa E, González C H, Barahona A, Soria D, Tamayo J, Rovner J, Adrianzen C, Silva H, Hodge A, O'Halloran R, Assunção S S M

机构信息

Eli Lilly, Canadá.

出版信息

Actas Esp Psiquiatr. 2006 Jan-Feb;34(1):16-27.

Abstract

The IC-SOHO study was designed to supply information on antipsychotic treatments in the real clinical practice by assessment of a large and diverse sample population with schizophrenia. This document describes the findings of the first 6 months of IC-SOHO in Latin America. To date, this is the largest observational study of its type in this region. In this observational and prospective study, those out-patients with schizophrenia, who require a change or initiation of antipsychotic medication are hospitalized. Effectiveness was evaluated using the Clinical Global Impression-Seriousness (CGI-S) grading scale. Tolerability was assessed by questionnaires on adverse events and weight measurements. Herein, the comparisons between olanzapine (monotherapy), risperidone (monotherapy) and conventional antipsychotics (monotherapy and combined therapy) are presented. As a whole, 7,658 patients participated in the ICSOHO; n=2,671 from 11 countries of Latin America that were included in this report. At 6 months, the proportion of patients who responded to olanzapine was significantly greater than those who responded to risperidone or conventional antipsychotics (p<0.001). Patients from the olanzapine group had greater improvements in all the symptom domains, including general, positive, negative, depressive and cognitive symptoms in comparison with risperidone (p<0.05) or conventional antipsychotics (p < 0.001). Extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) decreased from baseline in the groups treated with olanzapine and risperidone, but increased in the conventional group. The adverse events related with the sexual function were more prominent in the conventional group. Weight gain was observed in each treatment group, although the patients from the olanzapine group had greater weight grain followed by those of risperidone and then by those of conventional antipsychotics. Our findings in this population of the Latin American sample emulate the results of other studies in different samples, where it was found that olanzapine was more effective and better tolerated than risperidone or conventional antipsychotics.

摘要

IC-SOHO研究旨在通过评估大量多样化的精神分裂症样本人群,提供真实临床实践中抗精神病药物治疗的相关信息。本文档描述了IC-SOHO在拉丁美洲前6个月的研究结果。迄今为止,这是该地区此类最大规模的观察性研究。在这项观察性前瞻性研究中,那些需要更换或开始使用抗精神病药物的精神分裂症门诊患者被收治入院。使用临床总体印象-严重程度(CGI-S)分级量表评估疗效。通过不良事件问卷和体重测量评估耐受性。在此,呈现了奥氮平(单药治疗)、利培酮(单药治疗)与传统抗精神病药物(单药治疗和联合治疗)之间的比较。总体而言,7658名患者参与了ICSOHO研究;本报告纳入了来自拉丁美洲11个国家的2671名患者。在6个月时,对奥氮平有反应的患者比例显著高于对利培酮或传统抗精神病药物有反应的患者(p<0.001)。与利培酮(p<0.05)或传统抗精神病药物(p<0.001)相比,奥氮平组患者在所有症状领域,包括一般症状、阳性症状、阴性症状、抑郁症状和认知症状方面都有更大改善。在接受奥氮平和利培酮治疗的组中,锥体外系症状(EPS)和迟发性运动障碍(TD)较基线水平有所下降,但在传统药物组中有所增加。传统药物组中性功能相关不良事件更为突出。每个治疗组均观察到体重增加,不过奥氮平组患者体重增加最多,其次是利培酮组,然后是传统抗精神病药物组。我们在拉丁美洲样本人群中的研究结果与其他不同样本研究的结果相似,即发现奥氮平比利培酮或传统抗精神病药物更有效且耐受性更好。

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