Department of Psychiatry, Chiang Mai University, Chiang Mai, Thailand.
Neuropsychiatr Dis Treat. 2013;9:1223-30. doi: 10.2147/NDT.S47276. Epub 2013 Aug 20.
Previous studies with extended-release (ER) paliperidone have reported an effective outcome in terms of personal and social functioning improvement and also reported schizophrenia symptom improvement. The main objectives of this study were to further investigate improvements in symptom control and social functioning of paliperidone ER and acknowledge the safety profile of paliperidone ER in Thai patients with schizophrenia.
Patients with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders criteria were allowed flexible 3-12 mg/day dosing during the 10-week study duration. Patients were interviewed and assessed in social functioning using the Personal and Social Performance (PSP) scale. Patients were also rated on overall severity of illness using the Clinical and Global Impressions - Severity (CGI-S) scale.
In total, 40 patients were enrolled, 80% of enrolled patients (n = 32) completed the 10-week study period. Thirty-eight eligible patients were included in the intention-to-treat analysis set (male 39.5%, female 60.5%). One patient was lost to follow-up without postbaseline-efficacy measurements. Another patient was terminated early due to a change in diagnosis during the trial. Statistically significant improvements from baseline in PSP total score were observed at all time points. Clinically relevant improvement in PSP (increase of at least one 10-point category) was observed in 47.40% of patients at end point. Improvement in CGI-S was observed at end point (P < 0.001). The mean reduction ± standard deviation at end point in CGI-S was 0.8 ± 1.04 (95% confidence interval 0.48-1.16). The most commonly reported adverse events (≥5% of patients) were daytime drowsiness (15%) and headache (15%). Three subjects (7.5%) discontinued due to adverse events.
This study suggests that paliperidone ER is well tolerated in Thai patients with schizophrenia. Paliperidone ER showed improvement in schizophrenic symptom control and social functioning.
先前关于延长释放（ER）帕利哌酮的研究报告称，在改善个人和社会功能方面取得了有效结果，同时也改善了精神分裂症症状。本研究的主要目的是进一步探讨帕利哌酮 ER 对症状控制和社会功能的改善，并确认帕利哌酮 ER 在泰国精神分裂症患者中的安全性概况。
根据《精神障碍诊断与统计手册》标准，允许患有精神分裂症的患者在 10 周的研究期间灵活使用 3-12 毫克/天的剂量。通过个人和社会表现（PSP）量表对患者进行访谈和社会功能评估。还使用临床和总体印象-严重程度（CGI-S）量表对整体疾病严重程度进行评分。
共有 40 名患者入组，其中 80%（n = 32）的入组患者完成了 10 周的研究期。38 名符合条件的患者被纳入意向治疗分析集（男性 39.5%，女性 60.5%）。1 名患者失访，没有基线后疗效测量。另 1 名患者因试验期间诊断改变而提前终止。在所有时间点均观察到 PSP 总分从基线开始的统计学显著改善。在终点时，47.40%的患者出现 PSP 的临床相关改善（增加至少一个 10 分类别）。在终点时观察到 CGI-S 的改善（P < 0.001）。终点时 CGI-S 的平均减少±标准差为 0.8 ± 1.04（95%置信区间 0.48-1.16）。报告的最常见不良事件（≥5%的患者）是白天嗜睡（15%）和头痛（15%）。有 3 名受试者（7.5%）因不良事件而停药。
本研究表明，帕利哌酮 ER 在泰国精神分裂症患者中耐受良好。帕利哌酮 ER 显示出对精神分裂症症状控制和社会功能的改善。
