Gopal Srihari, Pandina Gahan, Lane Rosanne, Nuamah Isaac, Remmerie Bart, Coppola Danielle, Hough David
Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey, USA.
Innov Clin Neurosci. 2011 Aug;8(8):26-33.
First-month data of a 13-week acute schizophrenia study were used to compare paliperidone palmitate to oral risperidone during initiation of long-acting injectable risperidone.
Double-blind, randomized study.
Outpatient or inpatient.
Adults with established (≥1 year) schizophrenia. Those assigned to risperidone long-acting injectable (n=460) received 25mg on Days 8 and 22 with oral risperidone (l-6mg) supplementation for the first 28 days. The paliperidone palmitate group (n=453) received 150mg eq. on Day 1, l00mg eq. on Day 8, and oral placebo supplementation for the first 28 days.
Positive and Negative Syndrome Scale, Personal and Social Performance Scale, Clinical Global Impression-Severity score, and responder rate (percentage of patients with ≥30% reduction in PANSS total score). An analysis of covariance model estimated least-square mean differences between treatment groups. A post-hoc analysis of efficacy data for the period of interest, i.e., at the time points before and after the first 28 days, was conducted.
Positive and Negative Syndrome Scale, Personal and Social Performance Scale, Clinical global Impression-Severity scores showed similar efficacy between the treatment groups during the first weeks of treatment, corresponding to the risperidone long-acting injection initiation period. Mean Positive and Negative Syndrome Scale total score at baseline was 84.7 for paliperidone palmitate and 84.4 for oral risperidone, on Day 22 was 73.6 and 74.1, respectively, and on Day 36 was 71.8 and 72.8, respectively. Overall incidence of adverse events in the first 28 days was generally similar (45% for paliperidone palmitate vs. 35% for oral risperidone), except for injection site pain (4.6% vs. 0.7%). Similar active moiety plasma concentrations were obtained during this period.
During the first month, paliperidone palmitate without oral supplementation has similar efficacy and safety to oral risperidone (during initiation of risperidone long-acting injectable) in acutely exacerbated schizophrenia.
利用一项为期13周的急性精神分裂症研究的首月数据，在长效注射用利培酮起始治疗期间，将棕榈酸帕利哌酮与口服利培酮进行比较。
双盲、随机研究。
门诊或住院部。
患有确诊（≥1年）精神分裂症的成年人。分配至长效注射用利培酮组（n = 460）的患者在第8天和第22天接受25mg药物治疗，并在头28天补充口服利培酮（1 - 6mg）。棕榈酸帕利哌酮组（n = 453）在第1天接受150mg当量药物治疗，第8天接受100mg当量药物治疗，并在头28天补充口服安慰剂。
阳性与阴性症状量表、个人和社会功能量表、临床总体印象 - 严重程度评分以及缓解率（阳性与阴性症状量表总分降低≥30%的患者百分比）。协方差分析模型估计治疗组之间的最小二乘均值差异。对感兴趣时间段（即头28天前后的时间点）的疗效数据进行事后分析。
在治疗的头几周，即对应于长效注射用利培酮起始治疗期，阳性与阴性症状量表、个人和社会功能量表、临床总体印象 - 严重程度评分显示治疗组之间疗效相似。棕榈酸帕利哌酮组基线时阳性与阴性症状量表总分均值为84.7，口服利培酮组为84.4；第22天时分别为73.6和74.1；第36天时分别为71.8和72.8。头28天不良事件的总体发生率通常相似（棕榈酸帕利哌酮组为45%，口服利培酮组为35%），但注射部位疼痛除外（4.6%对0.7%）。在此期间获得了相似的活性成分血浆浓度。
在首月期间，对于急性加重的精神分裂症，不补充口服药物的棕榈酸帕利哌酮与口服利培酮（在长效注射用利培酮起始治疗期间）具有相似的疗效和安全性。
