Yang Fu De, Li Juan, Tan Yun Long, Liang Wei Ye, Zhang Rongzhen, Wang Ning, Feng Wei, Cai Shangli, Zhuo Jian Min, Zhang Li Li
Beijing Hui-Long-Guan Hospital.
Department of Medical Affairs, Xian Janssen Pharmaceutical Ltd, Beijing, People's Republic of China.
Neuropsychiatr Dis Treat. 2017 Apr 13;13:1089-1097. doi: 10.2147/NDT.S130483. eCollection 2017.
The aim of this study was to evaluate the changes in treatment satisfaction after switching to paliperidone extended-release (ER) in Chinese schizophrenia patients dissatisfied with their previous antipsychotic treatment.
In this 8-week, open-label, single-arm, multicenter, prospective study, 1,693 patients dissatisfied with previous antipsychotic medication were enrolled and switched to paliperidone ER tablets (3-12 mg/d) based on clinical judgment. The primary efficacy end point was change in Medication Satisfaction Questionnaire (MSQ) score from baseline to week 8. The secondary end points included percentage of patients with MSQ score ≥4, as well as changes in Clinical Global Improvement-Severity (CGI-S) and Personal and Social Performance (PSP) scores.
MSQ scores increased significantly from baseline (mean [standard deviation {SD}]: 2.48 [0.55]) to week 8 (5.47 [0.89], <0.0001; primary end point, full analysis set). The percentage of patients with MSQ score ≥4 was 95.9% at week 8, indicating that most of the patients were satisfied with their treatment. Significant (<0.0001) improvements from baseline to week 8 were noted in CGI-S score (2.37 [1.20]) and PSP score (25.5 [15.0]). A total of 174 (10.28%) patients experienced adverse events (AEs). The most common (>10 patients) events were extrapyramidal disorder (n=84, 4.96%), poor quality sleep (n=18, 1.06%) and akathisia (n=13, 0.77%). The majority of AEs were mild to moderate in severity. No deaths occurred.
Treatment satisfaction improved after switching to paliperidone ER from the previous antipsychotic in Chinese patients with schizophrenia.
本研究旨在评估中国精神分裂症患者在从先前不满意的抗精神病药物换用帕利哌酮缓释片(ER)后治疗满意度的变化。
在这项为期8周的开放标签、单臂、多中心前瞻性研究中,招募了1693名对先前抗精神病药物不满意的患者,并根据临床判断换用帕利哌酮ER片(3 - 12毫克/天)。主要疗效终点是从基线到第8周药物满意度问卷(MSQ)评分的变化。次要终点包括MSQ评分≥4的患者百分比,以及临床总体改善-严重程度(CGI-S)和个人及社会功能(PSP)评分的变化。
MSQ评分从基线(均值[标准差{SD}]:2.48[0.55])显著增加至第8周(5.47[0.89],<0.0001;主要终点,全分析集)。第8周时MSQ评分≥4的患者百分比为95.9%,表明大多数患者对治疗满意。从基线到第8周,CGI-S评分(2.37[1.20])和PSP评分(25.5[15.0])有显著(<0.0001)改善。共有174名(10.28%)患者发生不良事件(AE)。最常见(>10名患者)的事件是锥体外系疾病(n = 84,4.96%)、睡眠质量差(n = 18,1.06%)和静坐不能(n = 13,0.77%)。大多数AE的严重程度为轻度至中度。无死亡病例。
中国精神分裂症患者从先前的抗精神病药物换用帕利哌酮ER后治疗满意度提高。