Mosolov S N, Malyutin A V, Pikalov A A
Moscow Research Institute of Psychiatry, the Branch of National Medical Research Center for Psychiatry and Addictology named after V.P. Serbsky of the Ministry of Health of Russia, Moscow, Russia.
Angelini Pharma Rus, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2019;119(12):29-37. doi: 10.17116/jnevro201911912129.
Evaluation of a new five-factor dimensional model of schizophrenia in recent revisions of classifications of mental disorders (DSM-5 and ICD-11) dictates the need to use this approach in conducting a comprehensive assessment of the effectiveness of new antipsychotic agents, including ethnically homogeneous populations of patients.
Post-hoc analysis of pooled data from two randomized, double-blind, placebo-controlled, 6-week clinical studies (RCTs) of lurasidone (fixed doses, 40, 80, 120 or 160 mg/d) in patients experiencing an acute exacerbation of schizophrenia. Changes in PANSS total score, CGI-S score and five established PANSS factors were assessed using mixed-model repeated measures analysis.
Lurasidone (n=162, dose groups pooled) compared with placebo (n=68), significantly improved the PANSS total score at Week 6 (-23.0 vs. -10.5; p<0.001; effect size 0.82) as well as all PANSS factor scores: positive symptoms (-8.5 vs. -4.2; p<0.001; effect size 0.88), negative symptoms (-4.4 vs. -2.8; p=0.011, effect size 0.44), disorganized thoughts (-4.4 vs. -2.1; p<0.001; effect size 0.70), hostility/excitement (-2.7 vs. -0.7; p<0.001; effect size 0.66), and depression/anxiety (-3.5 vs. -2.2; p=0.002; effect size 0.53).
Lurasidone demonstrated significant improvement for both PANSS total score and each of the five PANSS factor scores, indicating effectiveness across the broad spectrum of schizophrenia symptoms. Effect size for both PANSS total score and each of the five PANSS factor scores for the local population was higher than for the wider population, which included patients from various countries.
对精神障碍分类（《精神疾病诊断与统计手册》第5版和《国际疾病分类》第11版）的最新修订中一种新的精神分裂症五因素维度模型进行评估，这表明在对新型抗精神病药物的有效性进行全面评估时需要采用这种方法，包括对种族同质的患者群体。
对两项随机、双盲、安慰剂对照、为期6周的鲁拉西酮（固定剂量，40、80、120或160mg/天）治疗精神分裂症急性加重患者的临床研究（随机对照试验）的汇总数据进行事后分析。使用混合模型重复测量分析评估阳性和阴性症状量表（PANSS）总分、临床总体印象量表严重程度（CGI-S）评分以及五个既定的PANSS因子的变化。
与安慰剂组（n = 68）相比，鲁拉西酮组（n = 162，各剂量组合并）在第6周时显著改善了PANSS总分（-23.0对-10.5；p < 0.001；效应大小0.82）以及所有PANSS因子评分：阳性症状（-8.5对-4.2；p < 0.001；效应大小0.88）、阴性症状（-4.4对-2.8；p = 0.011，效应大小0.44）、思维紊乱（-4.4对-2.1；p < 0.001；效应大小0.70）、敌对/兴奋（-2.7对-0.7；p < 0.001；效应大小0.66）以及抑郁/焦虑（-3.5对-2.2；p = 0.002；效应大小0.53）。
鲁拉西酮在PANSS总分和五个PANSS因子评分方面均显示出显著改善，表明其对精神分裂症的广泛症状有效。当地人群的PANSS总分和五个PANSS因子评分的效应大小均高于包括来自不同国家患者的更广泛人群。
