Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville New Jersey, USA.
Early Interv Psychiatry. 2010 Feb;4(1):64-78. doi: 10.1111/j.1751-7893.2010.00165.x.
Effective early and persistent antipsychotic treatment in recently diagnosed schizophrenia may positively impact long-term outcomes. Paliperidone extended-release (ER) was assessed in this population.
Post hoc analysis of pooled data from three 6-week, double-blind (DB), placebo-controlled, and three 1-year open-label (OL) studies of paliperidone ER in schizophrenia patients. Data stratified by time since diagnosis (< or =3 vs. >3 years).
At DB (n = 1193) and OL baselines (n = 744), 259 (21.9%) and 188 (25.3%) patients were diagnosed < or =3 years. At DB end point, both populations improved with paliperidone ER versus placebo on Positive and Negative Syndrome Scale (PANSS) total, Clinical Global Impressions-Severity and Personal and Social Performance (PSP) scale scores (all P < 0.05). At OL end point, there were significant improvements from DB baseline in both populations on these scales (P < 0.0001), with greater improvement in the < or =3-year population on PANSS total (P < 0.001) and PSP (P < 0.001) scores. During DB treatment, only the < or =3-year population reported adverse events (AEs) in > or =5% (placebo-adjusted rate) of subjects receiving paliperidone ER: akathisia, extrapyramidal disorder not otherwise specified and somnolence. During OL treatment, akathisia and somnolence occurred more frequently (> or =5%) in the < or =3- versus >3-year population. OL study completion rates were 51.1% in < or =3-year, and 48.2% in >3-year subjects.
Paliperidone ER significantly improved symptoms and functioning in schizophrenia patients, regardless of time since diagnosis. Recently diagnosed patients who continued treatment exhibited greater symptom reduction and functional benefit over the long term. Results also suggest that these patients may be more susceptible to certain AEs.
在新近诊断的精神分裂症患者中，早期和持续有效的抗精神病治疗可能会对长期结局产生积极影响。本研究评估了帕利哌酮缓释剂（ER）在这一人群中的应用。
对帕利哌酮 ER 治疗精神分裂症患者的 3 项 6 周双盲（DB）、安慰剂对照和 3 项 1 年开放标签（OL）研究的汇总数据进行事后分析。按诊断后时间（≤3 年与>3 年）进行分层。
在 DB（n=1193）和 OL 基线（n=744）时，259（21.9%）和 188（25.3%）例患者的诊断时间≤3 年。在 DB 终点时，与安慰剂相比，帕利哌酮 ER 治疗使两组患者的阳性与阴性综合征量表（PANSS）总分、临床总体印象严重度量表和个人与社会功能量表（PSP）评分均得到改善（均 P<0.05）。在 OL 终点时，两组患者的这些量表评分均较 DB 基线时显著改善（均 P<0.0001），其中诊断时间≤3 年的患者在 PANSS 总分（P<0.001）和 PSP（P<0.001）评分上的改善更显著。在 DB 治疗期间，仅诊断时间≤3 年的患者报告了帕利哌酮 ER 治疗组发生率>5%（安慰剂校正率）的不良事件（AE）：静坐不能、锥体外系障碍未特指和嗜睡。在 OL 治疗期间，诊断时间≤3 年的患者较诊断时间>3 年的患者更常报告 AE（发生率>5%）：静坐不能和嗜睡。诊断时间≤3 年的患者 OL 研究完成率为 51.1%，而诊断时间>3 年的患者为 48.2%。
帕利哌酮 ER 显著改善了精神分裂症患者的症状和功能，与诊断时间无关。继续治疗的新近诊断患者在长期治疗中表现出更大的症状缓解和功能获益。结果还表明，这些患者可能更容易出现某些 AE。
