Lindenmayer Jean-Pierre, Eerdekens Els, Berry Sally A, Eerdekens Mariëlle
Manhattan Psychiatric Center, New York University School of Medicine, New York, NY 10035, USA.
J Clin Psychiatry. 2004 Aug;65(8):1084-9.
The safety and efficacy of the first long-acting injectable atypical antipsychotic, risperidone, were assessed in stable patients with schizophrenia switched from oral antipsychotic medications.
Data were collected between July 1, 2001, and October 25, 2002. The study population included patients from clinics, hospitals, and physicians' offices. After a 4-week run-in period, symptomatically stable patients with schizophrenia (DSM-IV) who had been taking haloperidol (N = 46), quetiapine (N = 45), or olanzapine (N = 50) received 25 mg of long-acting risperidone. The oral antipsychotics were continued for 3 weeks after the first injection of long-acting risperidone. Injections were administered every 2 weeks at 25 mg up to a maximum dose of 50 mg for 12 weeks in this multicenter, open-label study.
Long-acting risperidone was well tolerated. Of the 141 patients who participated in the study, the most frequently reported adverse events were insomnia (16%), headache (15%), psychosis (11%), and agitation (11%). The mean increase in body weight was 0.4 kg. No other clinically relevant laboratory abnormalities or significant electrocardiogram changes were observed during the 12-week treatment. Extrapyramidal Symptom Rating Scale total scores were reduced during treatment with long-acting risperidone. Improvements in symptoms of schizophrenia were observed with long-acting risperidone at week 4 and continued through the 12-week treatment with significant reductions in total Positive and Negative Syndrome Scale (PANSS) scores at week 8 (-2.5, p <.01) and week 12 (-3.9, p <.001). At endpoint, 37% (50/135) of these stable patients were rated as clinically improved (> or = 20% decrease in PANSS total scores).
Switching treatment from oral antipsychotics to long-acting risperidone without an intervening period of oral risperidone was safe and well tolerated. Long-acting risperidone also significantly reduced the severity of symptoms in these stable patients with schizophrenia.
在从口服抗精神病药物转换过来的病情稳定的精神分裂症患者中，评估了首个长效注射用非典型抗精神病药物利培酮的安全性和有效性。
数据收集于2001年7月1日至2002年10月25日期间。研究人群包括来自诊所、医院和医生办公室的患者。在为期4周的导入期后，症状稳定的精神分裂症（DSM-IV）患者，这些患者之前一直在服用氟哌啶醇（N = 46）、喹硫平（N = 45）或奥氮平（N = 50），接受了25mg的长效利培酮治疗。在首次注射长效利培酮后，口服抗精神病药物继续服用3周。在这项多中心、开放标签研究中，每2周注射一次25mg的药物，最大剂量为50mg，持续12周。
长效利培酮耐受性良好。在参与研究的141名患者中，最常报告的不良事件为失眠（16%）、头痛（15%）、精神病（11%）和激越（11%）。体重平均增加0.4kg。在12周的治疗期间，未观察到其他临床相关的实验室异常或显著的心电图变化。在使用长效利培酮治疗期间，锥体外系症状评定量表总分降低。在第4周时，使用长效利培酮观察到精神分裂症症状有所改善，并在12周的治疗过程中持续改善，在第8周（-2.5，p <.01）和第12周（-3.9，p <.001）时，阳性和阴性症状量表（PANSS）总分显著降低。在研究终点，这些病情稳定的患者中有37%（50/135）被评定为临床改善（PANSS总分降低≥20%）。
在没有口服利培酮的干预期的情况下，从口服抗精神病药物转换为长效利培酮治疗是安全且耐受性良好的。长效利培酮还显著降低了这些病情稳定的精神分裂症患者的症状严重程度。
