Li Huafang, Li Yan, Feng Yu, Zhuo Jianmin, Turkoz Ibrahim, Mathews Maju, Tan Wilson
Shanghai Mental Health Centre, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.
Neuropsychiatr Dis Treat. 2018 Apr 26;14:1107-1117. doi: 10.2147/NDT.S157399. eCollection 2018.
To evaluate the differences in efficacy and safety outcomes in acute exacerbating schizophrenia patients between 2 subgroups (≤1 week and >1 week), differing in time interval from hospitalization to time of initiation of once-monthly paliperidone palmitate.
PREVAIL was a multicenter, single-arm, open-label, prospective Phase IV study in hospitalized Asian patients (either sex, aged 18-65 years) diagnosed with schizophrenia (, Fourth Edition). Change from baseline to week 13 in primary (Positive and Negative Syndrome Scale [PANSS] total score), secondary endpoints (PANSS responder rate, PANSS subscale, PANSS Marder factor, Clinical Global Impression-Severity, and Personal and Social Performance scale scores, readiness for hospital discharge questionnaire) and safety were assessed in this post hoc analysis.
Significant mean reduction from baseline to week 13 in the PANSS total score, 30% PANSS responder rates (≤0.01), PANSS subscales (positive and general psychopathology; all ≤0.01), PANSS Marder factor (positive symptoms, uncontrolled hostility, and excitement and anxiety/depression; all ≤0.01), Personal and Social Performance scale scores (≤0.05) and Clinical Global Impression-Severity categorical summary (≤0.05) were significantly greater in the ≤1 week subgroup versus >1 week subgroup (≤0.05). The readiness for hospital discharge questionnaire improved over time for the overall study population, but remained similar between subgroups at all-time points. Treatment-emergent adverse events were similar between the subgroups.
Early initiation of once-monthly paliperidone palmitate in hospitalized patients with acute exacerbation of schizophrenia led to greater improvements in psychotic symptoms with comparable safety than treatment initiation following 1 week of hospitalization.
评估急性加重期精神分裂症患者中两个亚组（≤1周和>1周）在从住院到开始每月一次棕榈酸帕利哌酮治疗的时间间隔上，疗效和安全性结果的差异。
PREVAIL是一项针对住院的亚洲精神分裂症患者（年龄18 - 65岁，男女不限）的多中心、单臂、开放标签的前瞻性IV期研究（《精神疾病诊断与统计手册》第四版）。在这项事后分析中，评估了从基线到第13周主要终点（阳性与阴性症状量表[PANSS]总分）、次要终点（PANSS应答率、PANSS子量表、PANSS马德因子、临床总体印象 - 严重程度以及个人和社会功能量表评分、出院准备情况问卷）以及安全性的变化。
从基线到第13周，≤1周亚组的PANSS总分、30%的PANSS应答率（≤0.01）、PANSS子量表（阳性症状和一般精神病理学；均≤0.01）、PANSS马德因子（阳性症状、未控制的敌意以及兴奋和焦虑/抑郁；均≤0.01）、个人和社会功能量表评分（≤0.05）以及临床总体印象 - 严重程度分类总结（≤0.05）的平均显著降低幅度均显著大于>1周亚组（≤0.05）。总体研究人群的出院准备情况问卷随时间有所改善，但各亚组在所有时间点均保持相似。亚组间治疗中出现的不良事件相似。
对于急性加重期住院的精神分裂症患者，早期开始每月一次的棕榈酸帕利哌酮治疗比住院1周后开始治疗能在安全性相当的情况下，使精神症状得到更大改善。
