Si Tian Mei, Cai Shang Li, Zhuo Jian Min, Zhang Li Li
National Clinical Research Center for Mental Disorders & The Key Laboratory of Mental Health, Ministry of Health (Peking University).
Peking University Institute of Mental Health/The Sixth Hospital.
Medicine (Baltimore). 2019 Jan;98(3):e13688. doi: 10.1097/MD.0000000000013688.
This post hoc analysis of an open-label, single-arm, multicenter study was designed to assess the efficacy, safety, and tolerability of paliperidone extended release (ER) in Chinese patients with non-acute schizophrenia, after switching from olanzapine.
Patients with schizophrenia who were dissatisfied with prior olanzapine treatment switched to flexible paliperidone ER (3-12 mg/day) based on clinical judgment. Change from baseline to week 12 in Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint), PANSS subscale scores, response rate, Clinical Global Impression-Severity (CGI-S) score, personal and social performance (PSP) scores, patient satisfaction with treatment score, change in sleep quality, level of daytime sleepiness and safety were evaluated.
Out of 118 enrolled patients, 95 (81%) completed the study. Mean duration of study was 76.9 (23.85) days. The primary endpoint, mean (SD) PANSS total score changed significantly from baseline to endpoint (-19.6 [18.71], P <.0001). Secondary endpoints including PANSS subscale score, PSP, patient satisfaction and daytime drowsiness also significantly improved (P <.001). Most commonly reported (≥1%) treatment-emergent adverse events were akathisia (n = 14 [12%]) and insomnia (n = 9 [8%]).
Switching to flexible-dosed paliperidone ER in patients dissatisfied with prior olanzapine treatment achieved good efficacy and tolerability consistently over 12 weeks.
本项对一项开放标签、单臂、多中心研究的事后分析旨在评估从奥氮平换用的帕利哌酮缓释片(ER)在中国非急性精神分裂症患者中的疗效、安全性及耐受性。
对先前奥氮平治疗效果不满意的精神分裂症患者根据临床判断换用灵活剂量的帕利哌酮ER(3 - 12毫克/天)。评估从基线到第12周阳性与阴性症状量表(PANSS)总分(主要终点)、PANSS分量表得分、缓解率、临床总体印象-严重程度(CGI-S)得分、个人及社会功能(PSP)得分、患者对治疗的满意度得分、睡眠质量变化、日间嗜睡程度及安全性的变化。
118名入组患者中,95名(81%)完成了研究。研究平均时长为76.9(23.85)天。主要终点,即PANSS总分平均值(标准差)从基线到终点有显著变化(-19.6 [18.71],P <.0001)。包括PANSS分量表得分、PSP、患者满意度及日间嗜睡等次要终点也有显著改善(P <.001)。最常报告的(≥1%)治疗中出现的不良事件为静坐不能(n = 14 [12%])和失眠(n = 9 [8%])。
对先前奥氮平治疗不满意的患者换用灵活剂量的帕利哌酮ER在12周内持续取得了良好的疗效和耐受性。