McConville Brian, Carrero Lynn, Sweitzer Dennis, Potter Larry, Chaney Robert, Foster Keith, Sorter Michael, Friedman Loren, Browne Kerri
Department of Psychiatry, University of Cincinnati Medical Center, 231 Albert Sabin Way, Cincinnati, OH 45267-0559, USA.
J Child Adolesc Psychopharmacol. 2003 Spring;13(1):75-82. doi: 10.1089/104454603321666216.
Quetiapine is a novel, atypical antipsychotic agent that has been shown to provide long-term efficacy without serious adverse effects in adults. This is the first study of the extended use of quetiapine in adolescents. Five boys and 5 girls, ages 12.3 to 15.9 years, with diagnoses of schizoaffective disorder (n = 7) or bipolar disorder with psychotic features (n = 3) were eligible for entry into this single-site, 88-week, open-label trial. Subjects had completed a pharmacokinetic study over 23 days, during which the dosage of quetiapine was increased sequentially from 25 mg bid to a maximum of 400 mg bid (800 mg/day) (McConville et al. 2000). In the open-label extension of this trial, which followed directly after this trial, a physician's choice design allowed for flexible dose titration of quetiapine by the study physician to an optimal dose for each patient, with ending doses ranging from 300 mg/day to 800 mg/day. Concomitant medications, especially for anxiety and/or manic symptoms, were allowed as deemed necessary. Tolerability and safety were assessed using clinical laboratory tests, physical examinations, measurements of vital signs, interviews for selective symptomatology, and electrocardiograms. Psychiatric measurements included the 18-item Brief Psychiatric Rating Scale (BPRS), the Clinical Global Impression (CGI) scale, and the modified Scale for the Assessment of Negative Symptoms (SANS). Neurologic symptom ratings included the Simpson-Angus Scale and the Abnormal Involuntary Movement Scale. Mean BPRS, CGI, and SANS scores improved significantly during the trial (p < 0.05). No extrapyramidal symptoms or evidence of tardive dyskinesia was seen. Clinically, there was a nonsignificant increase in mean weight and body mass index at week 64. This long-term study suggests that quetiapine is a well-tolerated antipsychotic agent that is efficacious for the treatment of symptoms of selected psychotic disorders in adolescents.
喹硫平是一种新型非典型抗精神病药物，已证明在成人中能提供长期疗效且无严重不良反应。这是第一项关于喹硫平在青少年中延长使用的研究。5名男孩和5名女孩，年龄在12.3至15.9岁之间，诊断为分裂情感障碍（n = 7）或伴有精神病性特征的双相情感障碍（n = 3），符合进入这项单中心、88周、开放标签试验的条件。受试者完成了一项为期23天的药代动力学研究，在此期间，喹硫平的剂量从每日两次25毫克依次增加至每日两次最大400毫克（800毫克/天）（麦康维尔等人，2000年）。在该试验之后紧接着进行的开放标签扩展试验中，采用医生选择设计，允许研究医生将喹硫平灵活滴定至每位患者的最佳剂量，最终剂量范围为300毫克/天至800毫克/天。必要时允许使用辅助药物，尤其是用于治疗焦虑和/或躁狂症状的药物。使用临床实验室检查、体格检查、生命体征测量、选择性症状访谈和心电图评估耐受性和安全性。精神科测量包括18项简明精神病评定量表（BPRS）、临床总体印象（CGI）量表以及改良的阴性症状评定量表（SANS）。神经症状评定包括辛普森 - 安格斯量表和异常不自主运动量表。试验期间，平均BPRS、CGI和SANS评分显著改善（p < 0.05）。未观察到锥体外系症状或迟发性运动障碍的证据。临床上，在第64周时平均体重和体重指数有不显著的增加。这项长期研究表明，喹硫平是一种耐受性良好的抗精神病药物，对治疗青少年特定精神病性障碍的症状有效。
