Ciliberto Natalie, Bossie Cynthia A, Urioste Ronald, Lasser Robert A
Medical Services CNS, Medical Affairs Division, Janssen Pharmaceutica, Inc, Titusville, New Jersey 08560, USA.
Int Clin Psychopharmacol. 2005 Jul;20(4):207-12. doi: 10.1097/00004850-200507000-00003.
This analysis aimed to assess the relationship between race and clinical response to long-acting, injectable risperidone treatment in patients with schizophrenia or schizoaffective disorder. In a 12-week, randomized, double-blind study, patients with schizophrenia or schizoaffective disorder received placebo or long-acting risperidone (25, 50 or 75 mg every 2 weeks). Data were stratified by race as identified by demographic information: Caucasian, African-American or Other. Psychotic symptoms were assessed by the Positive and Negative Syndrome Scale (PANSS); movement disorders by the Extrapyramidal Symptom Rating Scale (ESRS); adverse events (AEs) were reported spontaneously. Data were available for 439 patients: 193 Caucasian (44%), 174 (40%) African-American and 72 (16%) Other patients. Baseline characteristics were similar between racial groups, as were study completion rates (overall: 30% placebo; 48% long-acting risperidone). There was a significant effect of treatment (P<0.001), but not of race, on improvement in PANSS total scores from baseline to endpoint. ESRS scores were low throughout the study, and no significant impact of race was observed. Overall rates of AEs were similar among the racial groups. Race did not appear to impact the efficacy and tolerability of long-acting risperidone.
本分析旨在评估精神分裂症或分裂情感性障碍患者的种族与长效注射用利培酮治疗临床反应之间的关系。在一项为期12周的随机双盲研究中，精神分裂症或分裂情感性障碍患者接受安慰剂或长效利培酮（每2周25、50或75毫克）治疗。数据根据人口统计学信息确定的种族进行分层：白种人、非裔美国人或其他种族。通过阳性和阴性症状量表（PANSS）评估精神病症状；通过锥体外系症状评定量表（ESRS）评估运动障碍；不良事件（AE）通过自发报告收集。共有439例患者的数据纳入分析：193例白种人（44%）、174例非裔美国人（40%）和72例其他种族患者（16%）。种族组间的基线特征及研究完成率相似（总体：安慰剂组30%；长效利培酮组48%）。从基线到终点，PANSS总分的改善有显著的治疗效果（P<0.001），但种族无显著影响。在整个研究过程中，ESRS评分较低，未观察到种族的显著影响。种族组间AE的总体发生率相似。种族似乎不影响长效利培酮的疗效和耐受性。
