Leatherman Sarah M, Liang Matthew H, Krystal John H, Lew Robert A, Valley Danielle, Thwin Soe Soe, Rosenheck Robert A
*Massachusetts Veterans Epidemiology and Research Information Center (MAVERIC) Cooperative Studies Program Coordinating Center (CSPCC), Boston; †Yale School of Medicine, New Haven, CT; and ‡Veterans Affairs (VA) Connecticut Healthcare System, West Haven.
J Nerv Ment Dis. 2014 Jan;202(1):13-7. doi: 10.1097/NMD.0000000000000069.
A long-term randomized trial of unstable patients with schizophrenia found no benefit of long-acting injectable (LAI) risperidone over oral treatment in preventing or delaying time to psychiatric hospitalizations or on clinical outcomes. The initial analyses did not examine whether benefits of LAI emerged in selected subgroups.Patients with schizophrenia or schizoaffective disorder who had been hospitalized within the past 2 years or judged to be at risk for hospitalization because of increasing psychiatric service use were randomly assigned to LAI risperidone 12.5 to 50 mg per injection biweekly or to the psychiatrist's choice of oral antipsychotics and followed for up to 2 years. The primary endpoint was psychiatric rehospitalization. Symptoms, quality of life, and global functioning were assessed through blinded videoconference interviews. Cox's regression and mixed effects models were used to assess difference in treatment effect within 12 subgroups defined by hospitalization at study entry, substance abuse, race, symptom severity, quality of life, body mass index, age, race or sex, or reported medication compliance.Mixed models and Cox's regression using up to 24 months of follow-up data showed no significant differences in treatment effect in 10 of 12 subgroups on psychiatric symptoms, quality of life, or time to hospitalization. With adjustment for multiple comparisons, treatment effect differed by race on substance use outcomes, with white participants showing more benefit from LAI than other groups.LAI risperidone showed no superiority to psychiatrist's choice of oral treatment in most clinically defined subgroups, although the white patients benefited more than the other groups on substance abuse outcomes.
一项针对不稳定型精神分裂症患者的长期随机试验发现，长效注射用利培酮在预防或延迟精神科住院时间或临床结局方面，并不优于口服治疗。最初的分析并未考察长效注射用药物的益处是否在特定亚组中显现。过去2年内曾住院或因精神科服务使用增加而被判定有住院风险的精神分裂症或分裂情感性障碍患者，被随机分配至每两周注射一次12.5至50毫克长效注射用利培酮组，或由精神科医生选择的口服抗精神病药物组，并随访长达2年。主要终点是精神科再次住院。通过盲法视频会议访谈评估症状、生活质量和整体功能。使用Cox回归和混合效应模型评估在由研究入组时的住院情况、药物滥用、种族、症状严重程度、生活质量、体重指数、年龄、种族或性别或报告的药物依从性所定义的12个亚组内的治疗效果差异。使用长达24个月随访数据的混合模型和Cox回归显示，在12个亚组中的10个亚组，在精神症状、生活质量或住院时间方面，治疗效果无显著差异。经多重比较校正后，在药物使用结局方面，治疗效果因种族而异，白人参与者从长效注射用药物中获益比其他组更多。在大多数临床定义的亚组中，长效注射用利培酮并不优于精神科医生选择的口服治疗，尽管白人患者在药物滥用结局方面比其他组获益更多。
