Loebel A, Cucchiaro J, Silva R, Mao Y, Xu J, Pikalov A, Marder S R
Sunovion Pharmaceuticals Inc., One Bridge Plaza North, Suite 510, Fort Lee, NJ 07024, USA.
Semel Institute for Neuroscience at the University of California, Los Angeles, and the David Geffen School of Medicine, and the West Los Angeles VA Healthcare System, Building 210, Room 130, 11301 Wilshire Boulevard, Los Angeles, CA 90073, USA.
Eur Psychiatry. 2015 Jan;30(1):26-31. doi: 10.1016/j.eurpsy.2014.08.001. Epub 2014 Oct 3.
To evaluate the efficacy of lurasidone for schizophrenia using an established five-factor model of the Positive and Negative Syndrome Scale (PANSS).
Patient-level data were pooled from five randomized, double-blind, placebo-controlled, 6-week studies of lurasidone (fixed doses, 40-160mg/d) for patients with an acute exacerbation of schizophrenia. Changes in five established PANSS factors were assessed using mixed-model repeated measures analysis.
Compared with placebo (n=496), lurasidone (n=1029, dose groups pooled) significantly improved the PANSS total score at Week 6 (-22.6 vs. -12.8; P<0.001; effect size, 0.45), as well as all factor scores (P<0.001 for each): positive symptoms (-8.4 vs. -6.0; effect size, 0.43), negative symptoms (-5.2 vs. -3.3; effect size, 0.33), disorganized thought (-4.9 vs. -2.8; effect size, 0.42), hostility/excitement (-2.7 vs. -1.6; effect size, 0.31), and depression/anxiety (-3.2 vs. -2.3; effect size, 0.31). Separation from placebo occurred at Week 1 for the positive symptoms, disorganized thought, and hostility/excitement factors and at Week 2 for the other factors.
In this pooled analysis of short-term studies in patients with acute schizophrenia, lurasidone demonstrated significant improvement for each of the five PANSS factor scores, indicating effectiveness across the spectrum of schizophrenia symptoms.
使用已确立的阳性和阴性症状量表（PANSS）五因素模型评估鲁拉西酮治疗精神分裂症的疗效。
汇总了五项随机、双盲、安慰剂对照、为期6周的鲁拉西酮（固定剂量，40 - 160mg/天）治疗精神分裂症急性加重患者的研究中的患者水平数据。使用混合模型重复测量分析评估五个已确立的PANSS因素的变化。
与安慰剂组（n = 496）相比，鲁拉西酮组（n = 1029，各剂量组合并）在第6周时显著改善了PANSS总分（-22.6对-12.8；P < 0.001；效应大小，0.45），以及所有因素得分（各因素P < 0.001）：阳性症状（-8.4对-6.0；效应大小，0.43）、阴性症状（-5.2对-3.3；效应大小，0.33）、思维紊乱（-4.9对-2.8；效应大小，0.42）、敌对/兴奋（-2.7对-1.6；效应大小，0.31）和抑郁/焦虑（-3.2对-2.3；效应大小，0.31）。阳性症状、思维紊乱和敌对/兴奋因素在第1周时与安慰剂出现分离，其他因素在第2周时出现分离。
在这项对急性精神分裂症患者短期研究的汇总分析中，鲁拉西酮在PANSS五个因素得分中的每一项上均显示出显著改善，表明其对精神分裂症症状谱具有有效性。
