Kumra S, Briguglio C, Lenane M, Goldhar L, Bedwell J, Venuchekov J, Jacobsen L K, Rapoport J L
Child Psychiatry Branch, NIMH, Bethesda, MD 20892-1600, USA.
Am J Psychiatry. 1999 Jul;156(7):1065-8. doi: 10.1176/ajp.156.7.1065.
There has been an increasing focus on the ethical issues raised by studies requiring the withdrawal of effective medication in schizophrenic adults. This article examines the risks and benefits of a medication-free period for pediatric patients with treatment-refractory schizophrenia who are participating in an ongoing study.
Between April 1993 and March 1998, 31 children and adolescents were admitted with a diagnosis of treatment-resistant, childhood-onset schizophrenia. Parental consent was obtained so that patients could participate in a medication-free research period. Patients were evaluated at screening, at the end of a 4-week washout, at the completion of a 6- to 8-week atypical neuroleptic trial, and at a 2- to 4-year follow-up.
At the completion of a 4-week drug-free period, seven patients (23%) were diagnosed with another disorder on the basis of data gained from the drug-free period and their lack of schizophrenic symptoms. Their revised diagnoses were posttraumatic stress disorder (N = 1), an atypical psychosis labeled "multidimensionally impaired" (N = 4), and personality disorder (N = 2). At follow-up, three of these patients remained free of neuroleptic therapy. For eight patients (26%), the washout was curtailed because of rapid and severe deterioration of their schizophrenic symptoms.
For children and adolescents with treatment-refractory schizophrenia, a medication-free period can be conducted safely for at least 4 weeks for inpatients. Such trials are useful on clinical grounds and for providing homogeneous patient groups for research. This study also highlights the necessity of having access to hospitalization to observe children and adolescents with psychotic symptoms while medication free.
对于需要在成年精神分裂症患者中停用有效药物的研究引发的伦理问题，人们的关注日益增加。本文探讨了参与一项正在进行的研究的难治性精神分裂症儿科患者无药期的风险和益处。
在1993年4月至1998年3月期间，31名儿童和青少年因难治性儿童期起病的精神分裂症诊断入院。获得了家长同意，以便患者能够参与无药研究期。在筛查时、4周洗脱期结束时、6至8周非典型抗精神病药物试验完成时以及2至4年随访时对患者进行评估。
在4周无药期结束时，根据无药期获得的数据及其缺乏精神分裂症症状，7名患者（23%）被诊断为另一种疾病。他们修订后的诊断为创伤后应激障碍（N = 1）、一种标记为“多维度受损”的非典型精神病（N = 4）和人格障碍（N = 2）。在随访时，这些患者中有3名仍未接受抗精神病药物治疗。对于8名患者（26%），由于其精神分裂症症状迅速严重恶化，洗脱期缩短。
对于难治性精神分裂症的儿童和青少年，住院患者至少可以安全地进行4周的无药期。此类试验在临床方面有用，并且可为研究提供同质的患者群体。本研究还强调了在无药状态下观察有精神病症状的儿童和青少年时获得住院治疗的必要性。
