Simpson George M, Mahmoud Ramy A, Lasser Robert A, Kujawa Mary, Bossie Cynthia A, Turkoz Ibrahim, Rodriguez Steven, Gharabawi Georges M
Department of Psychiatry, Keck School of Medicine of the University of Southern California, Los Angeles, USA.
J Clin Psychiatry. 2006 Aug;67(8):1194-203. doi: 10.4088/jcp.v67n0804.
This study examined the effects of 2 doses of long-acting risperidone injection in patients with schizophrenia or schizoaffective disorder.
This 52-week, prospective, randomized, double-blind, multicenter, international study included clinically stable outpatients with schizophrenia or schizoaffective disorder (DSM-IV criteria). Settings included physicians' offices and clinics. Patients received a fixed dose of long-acting risperidone (25 or 50 mg) every 2 weeks. Primary outcome was time to relapse, defined as either re-hospitalization or other exacerbation criteria. Other assessments included the Positive and Negative Syndrome Scale, Clinical Global Impressions-Severity of Illness scale, and functional and quality-of-life measures. Safety was assessed via treatment-emergent adverse events, laboratory tests, and movement disorder rating scales. Data were collected from December 2002 to September 2004.
A total of 324 patients were randomized to 25 mg (N = 163) or 50 mg (N = 161) of long-acting risperidone. Time to relapse was comparable (p = .131) for both groups. Projected median time to relapse was 161.8 weeks (95% CI = 103.0 to 254.2) with 25 mg and 259.0 weeks (95% CI = 153.6 to 436.8) with 50 mg. One-year incidences of relapse were 21.6% (N = 35) and 14.9% (N = 24), respectively (p = .059). Psychiatric hospitalization was the reason for relapse for 16 (10%) in the 25-mg group and 10 (6%) in the 50-mg group. Patients experienced statistically significant but modest improvements at endpoint in most measures (i.e., psychotic symptoms, functioning, movement disorder severity) with both doses, with no significant between-group differences.
In this 1-year study, long-acting risperidone was associated with low relapse and rehospitalization rates, indicating that doses of 25 to 50 mg are appropriate for long-term treatment in schizophrenia.
本研究探讨了两种剂量的长效利培酮注射液对精神分裂症或分裂情感性障碍患者的影响。
这项为期52周的前瞻性、随机、双盲、多中心国际研究纳入了符合精神分裂症或分裂情感性障碍（DSM-IV标准）且病情临床稳定的门诊患者。研究地点包括医生办公室和诊所。患者每两周接受一次固定剂量的长效利培酮（25毫克或50毫克）。主要结局指标为复发时间，定义为再次住院或符合其他病情加重标准。其他评估包括阳性和阴性症状量表、临床总体印象-疾病严重程度量表以及功能和生活质量指标。通过治疗中出现的不良事件、实验室检查和运动障碍评定量表评估安全性。数据收集时间为2002年12月至2004年9月。
共有324例患者被随机分为接受25毫克（N = 163）或50毫克（N = 161）长效利培酮治疗组。两组的复发时间相当（p = 0.131）。预计25毫克组的中位复发时间为161.8周（95%可信区间 = 103.0至254.2），50毫克组为259.0周（95%可信区间 = 153.6至436.8）。一年复发率分别为21.6%（N = 35）和14.9%（N = 24）（p = 0.059）。25毫克组有16例（10%）因精神科住院而复发，50毫克组有10例（6%）。在大多数指标（即精神病性症状、功能、运动障碍严重程度）上，两组患者在研究终点时均有统计学意义但程度适中的改善，组间差异无统计学意义。
在这项为期一年的研究中，长效利培酮与低复发率和再住院率相关，表明25至50毫克的剂量适用于精神分裂症的长期治疗。
