Xian Janssen Pharmaceuticals, Beijing, People's Republic of China.
Department of Clinical Psychopharmacology, Peking University Institute of Mental Health, Beijing, People's Republic of China ; Key Laboratory of Mental Health, Ministry of Health (Peking University), Beijing, People's Republic of China.
Neuropsychiatr Dis Treat. 2015 Mar 11;11:657-68. doi: 10.2147/NDT.S77778. eCollection 2015.
To evaluate the efficacy, safety, and impact on hospitalizations of long-acting injectable paliperidone palmitate (PP) treatment, in patients with recent-onset schizophrenia who had not responded satisfactorily to oral antipsychotics.
In this 18-month, open-label, Phase-IIIb study from Asia-Pacific region, patients (18-50 years) with recent-onset (≤5 years) schizophrenia unsatisfactorily treated with previous oral antipsychotics were initiated on PP 150 mg eq on day 1, 100 mg eq on day 8, followed by flexible once monthly maintenance doses of 50-150 mg eq. The number and duration of hospitalizations were compared using a mirror analysis method between two periods: retrospective (12 months before PP initiation) and prospective (12 and 18 months after PP treatment) periods.
A total of 303 out of 521 (58%) patients (mean age, 28.7 years; 65.5% men, 92.5% Asian) completed the study. Positive and Negative Syndrome Scale (PANSS) total score improved significantly from baseline to month 18 (mean [standard deviation, SD] change: -11.3 [21.38], P<0.0001, primary endpoint). Subgroup analysis revealed greater improvements among patients with worse disease severity at baseline: PANSS ≥70 versus <70 (mean [SD] change: -23.1 [24.62] vs -4.7 [15.98], P<0.0001 each). Secondary efficacy endpoints such as Clinical Global Impression of Schizophrenia (CGI-SCH), Medication Satisfaction Questionnaire (MSQ) scores showed significant improvements (P<0.0001) from baseline; 33.3% patients achieved symptom remission. In mirror analyses set (N=474), PP significantly (P<0.0001) reduced mean number of hospitalization days/person/year (12-month: 74.3 vs 19.7; 18-month: 74.3 vs 18.9) as well as percentage of patients requiring hospitalization in past 12 months (12-month: 39.7% vs 24.6%; 18-month: 39.7% vs 25%), and PP treatment increased the proportion of patients not requiring hospitalization (12-month: 60.3% vs 75.4%; 18-month: 60.3% vs 75%) from retrospective to prospective period. Adverse events (≥15%) were extrapyramidal symptoms-related (31.3%), injection-site pain (18.6%), and insomnia (15.2%).
PP was efficacious and generally tolerable with significant reductions observed in both number of hospitalizations and days spent in hospital.
评估长效注射用棕榈酸帕利哌酮（PP）治疗近期发病且对口服抗精神病药物反应不佳的精神分裂症患者的疗效、安全性和对住院的影响。
在这项来自亚太地区的 18 个月、开放标签、三期研究中，既往口服抗精神病药物治疗反应不佳的近期（≤5 年）发病的精神分裂症患者（18-50 岁）于第 1 天接受 150 mg eq PP，第 8 天接受 100 mg eq PP，随后每月一次接受灵活的维持剂量 50-150 mg eq。使用镜像分析方法比较了两个时期的住院人数和持续时间：回顾期（PP 治疗前 12 个月）和前瞻性期（PP 治疗后 12 和 18 个月）。
共有 521 名患者中的 303 名（58%）（平均年龄 28.7 岁；65.5%为男性，92.5%为亚洲人）完成了研究。阳性和阴性综合征量表（PANSS）总分从基线到第 18 个月显著改善（平均[标准差，SD]变化：-11.3[21.38]，P<0.0001，主要终点）。亚组分析显示，基线疾病严重程度较差的患者改善更大：PANSS≥70 与<70（平均[SD]变化：-23.1[24.62]与-4.7[15.98]，P<0.0001 各）。次要疗效终点，如精神分裂症临床总体印象量表（CGI-SCH）、药物满意度问卷（MSQ）评分也显示出显著改善（P<0.0001），从基线开始；33.3%的患者达到症状缓解。在镜像分析组（N=474）中，PP 显著（P<0.0001）减少了平均住院天数/人/年（12 个月：74.3 比 19.7；18 个月：74.3 比 18.9）以及过去 12 个月需要住院的患者比例（12 个月：39.7%比 24.6%；18 个月：39.7%比 25%），PP 治疗增加了不需要住院的患者比例（12 个月：60.3%比 75.4%；18 个月：60.3%比 75%）从回顾期到前瞻性期。不良反应（≥15%）与锥体外系症状相关（31.3%）、注射部位疼痛（18.6%）和失眠（15.2%）。
PP 是有效的，通常耐受性良好，观察到住院人数和住院天数均显著减少。
