Marder Stephen R, Kramer Michelle, Ford Lisa, Eerdekens Els, Lim Pilar, Eerdekens Mariëlle, Lowy Adam
Veteran's Affairs Veteran's Integrated Service Networks 22 Mental Illness Research, Education, and Clinical Center, Los Angeles, California 90073, USA.
Biol Psychiatry. 2007 Dec 15;62(12):1363-70. doi: 10.1016/j.biopsych.2007.01.017. Epub 2007 Jun 28.
Paliperidone extended-release tablet (paliperidone ER; Invega, Janssen L.P., Titusville, New Jersey) is an oral psychotropic for schizophrenia treatment.
Efficacy and safety of once-daily paliperidone ER (6 and 12 mg) were assessed versus placebo in 444 patients with acute schizophrenia in a 6-week, multicenter, double-blind, randomized, parallel-group study. An olanzapine (10 mg) treatment arm was included to confirm trial validity.
Both doses of paliperidone ER demonstrated significant improvement in Positive and Negative Syndrome Scale (PANSS) total score (p < or = .006) and certain PANSS Marder factor scores compared with placebo (p < or = .025); PANSS total score also improved in the olanzapine treatment arm. Paliperidone ER 6 mg (p < or = .008), but not 12 mg, was associated with significant improvements in personal and social performance. The incidence of treatment-emergent adverse events (AEs) for paliperidone ER 6 mg was comparable with placebo and slightly greater with paliperidone ER 12 mg. Changes in blood glucose and lipid levels with paliperidone ER were comparable with placebo. Two patients treated with paliperidone ER experienced glucose-related AEs. Body-weight increases of 1-2 kg were observed with paliperidone ER. Although there were increases in plasma prolactin levels with paliperidone ER treatment, the incidence of prolactin-related AEs was < or =1%.
In this study, paliperidone ER, particularly the 6-mg dose, was effective and well tolerated, and provides a valuable new treatment option for schizophrenia.
帕利哌酮缓释片（帕利哌酮ER；因维加，杨森制药有限公司，新泽西州蒂特斯维尔）是一种用于治疗精神分裂症的口服精神药物。
在一项为期6周的多中心、双盲、随机、平行组研究中，对444例急性精神分裂症患者评估了每日一次的帕利哌酮ER（6毫克和12毫克）与安慰剂相比的疗效和安全性。纳入了一个奥氮平（10毫克）治疗组以确认试验有效性。
与安慰剂相比，两种剂量的帕利哌酮ER在阳性和阴性症状量表（PANSS）总分（p≤0.006）及某些PANSS马德因子评分方面均显示出显著改善（p≤0.025）；奥氮平治疗组的PANSS总分也有所改善。帕利哌酮ER 6毫克（p≤0.008）而非12毫克与个人和社会功能的显著改善相关。帕利哌酮ER 6毫克治疗中出现的治疗中出现的不良事件（AE）发生率与安慰剂相当，帕利哌酮ER 12毫克时略高。帕利哌酮ER引起的血糖和血脂水平变化与安慰剂相当。两名接受帕利哌酮ER治疗的患者出现了与葡萄糖相关的AE。帕利哌酮ER治疗时观察到体重增加1 - 2千克。虽然帕利哌酮ER治疗使血浆催乳素水平升高，但催乳素相关AE的发生率≤1%。
在本研究中，帕利哌酮ER，尤其是6毫克剂量，有效且耐受性良好，为精神分裂症提供了一种有价值的新治疗选择。
