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利培酮治疗青少年精神分裂症的有效性、安全性及耐受性:一项开放标签研究。

Effectiveness, safety, and tolerability of risperidone in adolescents with schizophrenia: an open-label study.

作者信息

Zalsman Gil, Carmon Einat, Martin Andrés, Bensason Daniela, Weizman Abraham, Tyano Samuel

机构信息

Adolescent Inpatient Department, Geha Mental Health Center, Rabin Medical Center/Sackler Faculty of Medicine, Tel Aviv University, Petah Tiqva, Israel.

出版信息

J Child Adolesc Psychopharmacol. 2003 Fall;13(3):319-27. doi: 10.1089/104454603322572651.

DOI:10.1089/104454603322572651
PMID:14642020
Abstract

Data on risperidone's efficacy and tolerability in adolescents with schizophrenia are scarce. We found only one prospective, open-label study in this population. The aim of this open-label, prospective study was to estimate the effectiveness, safety, and tolerability of risperidone treatment in adolescents with first-episode schizophrenia. Subjects were adolescent inpatients diagnosed with Diagnostic and Statistical Manual of Mental Disorders (fourth edition) first-episode schizophrenia by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present Episode version. Most of the patients (10/11) were drug naïve. Improvement was assessed during the first 6 weeks of treatment using the Positive and Negative Syndrome Scale (PANSS), the Brief Psychiatric Rating Scale (BPRS), and the Clinical Global Impression (CGI) scale. Side effects were monitored using the Abnormal Involuntary Movement Scale, the Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Udvalg for Kliniske Undersogelser Side Effect Rating Scale. Eleven adolescents between 15.5 and 20 years of age (mean = 17.27, SD = 1.27 years) were included in this study. Risperidone in an average dose of 3.14 mg/day (SD = 1.60 mg/day) produced a significant improvement on the total PANSS score (28%, p < 0.01), BPRS score (30.11%, p < 0.01), and CGI-Severity score (31.36%, p < 0.01). Risperidone was ineffective in the treatment of negative signs as assessed by the PANSS. The major side effects were extrapyramidal side effects, somnolence, depression, and weight gain. In conclusion risperidone appears to be a safe, acceptably tolerated, and effective antipsychotic medication for the treatment of adolescent-onset schizophrenia.

摘要

关于利培酮治疗青少年精神分裂症的疗效和耐受性的数据很少。我们在该人群中仅发现了一项前瞻性、开放标签研究。这项开放标签的前瞻性研究旨在评估利培酮治疗首发精神分裂症青少年的有效性、安全性和耐受性。研究对象为根据儿童情感障碍和精神分裂症量表(适用于学龄儿童——当前发作版)被诊断为《精神疾病诊断与统计手册》(第四版)首发精神分裂症的青少年住院患者。大多数患者(10/11)此前未接受过药物治疗。在治疗的前6周使用阳性与阴性症状量表(PANSS)、简明精神病评定量表(BPRS)和临床总体印象(CGI)量表评估病情改善情况。使用异常不自主运动量表、辛普森-安格斯量表、巴恩斯静坐不能评定量表和临床研究不良反应评定量表监测副作用。本研究纳入了11名年龄在15.5至20岁之间(平均 = 17.27,标准差 = 1.27岁)的青少年。平均剂量为3.14毫克/天(标准差 = 1.60毫克/天)的利培酮使PANSS总分显著改善(28%,p < 0.01)、BPRS评分显著改善(30.11%,p < 0.01)以及CGI-严重程度评分显著改善(31.36%,p < 0.01)。根据PANSS评估,利培酮对阴性症状治疗无效。主要副作用为锥体外系副作用、嗜睡、抑郁和体重增加。总之,利培酮似乎是一种安全、耐受性尚可且有效的抗精神病药物,可用于治疗青少年期精神分裂症。

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