Lindenmayer Jean-Pierre, Khan Akbar, Eerdekens Mariëlle, Van Hove Ilse, Kushner Stuart
Manhattan Psychiatric Center, New York University of Medicine, New York, NY, USA.
Eur Neuropsychopharmacol. 2007 Jan 15;17(2):138-44. doi: 10.1016/j.euroneuro.2006.08.004. Epub 2006 Oct 17.
Subjects were patients with schizophrenia or schizoaffective disorder enrolled in extension studies (Study A and Study B) after participating in 12-week studies of long-acting injectable risperidone [Kane, J.M., Eerdekens, M., Lindenmayer, J.-P., Keith, S.J., Lesem, M., Karcher, K., 2003. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am. J. Psychiatry 160, 1125-1132; Lindenmayer, J.-P., Eerdekens, L., Berry, S., Eerdekens, M., 2004. Safety and efficacy of long-acting risperidone in schizophrenia: a 12-week, multicenter, open-label study in stable patients switched from typical and atypical oral antipsychotics. J. Clin. Psychiatry 65, 1084-1089]. Twelve months of treatment were completed by 55% of Study A patients and 52% of Study B patients. The median modal dose of long-acting injectable risperidone was 50 mg/14 days in both studies. Most frequent adverse events were psychosis, headache, insomnia, agitation, and rhinitis. EPS-related adverse events were reported in 33% of patients in Study A and 22% in Study B. Patients with Clinical Global Impressions ratings of "not ill" and "mild" increased from 14% at baseline to 54% at endpoint in Study A and from 42% to 65% in Study B. It is concluded that treatment with long-acting injectable risperidone for 1 year or longer appeared to be safe and well tolerated in patients with schizophrenia or schizoaffective disorder.
受试者为参与长效注射用利培酮12周研究（研究A和研究B）后进入扩展研究的精神分裂症或分裂情感性障碍患者[凯恩，J.M.，埃尔德肯斯，M.，林登迈尔，J.-P.，基思，S.J.，莱斯姆，M.，卡彻，K.，2003年。长效注射用利培酮：首个长效非典型抗精神病药物的疗效和安全性。《美国精神病学杂志》160，1125 - 1132；林登迈尔，J.-P.，埃尔德肯斯，L.，贝里，S.，埃尔德肯斯，M.，2004年。长效利培酮治疗精神分裂症的安全性和疗效：一项针对从典型和非典型口服抗精神病药物转换而来的稳定患者的12周多中心开放标签研究。《临床精神病学杂志》65，1084 - 1089]。研究A中55%的患者和研究B中52%的患者完成了12个月的治疗。两项研究中长效注射用利培酮的中位模式剂量均为50 mg/14天。最常见的不良事件为精神病、头痛、失眠、激越和鼻炎。研究A中33%的患者和研究B中22%的患者报告了与锥体外系反应（EPS）相关的不良事件。临床总体印象评分为“无病”和“轻度”的患者在研究A中从基线时的14%增至终点时的54%，在研究B中从42%增至65%。得出的结论是，长效注射用利培酮治疗1年或更长时间对精神分裂症或分裂情感性障碍患者似乎是安全且耐受性良好的。
