Liang Ying, Yu Xin
Peking University Sixth Hospital, Peking University Institute of Mental Health, Key Laboratory of Mental Health, Ministry of Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, People's Republic of China.
Neuropsychiatr Dis Treat. 2017 Apr 21;13:1163-1173. doi: 10.2147/NDT.S132363. eCollection 2017.
Second-generation antipsychotics show significant interpatient variability in treatment response and side-effect profiles, and the majority of patients with schizophrenia require multiple treatment changes. This subgroup analysis of the ESCAPE study evaluated the efficacy and safety of amisulpride in Chinese patients with schizophrenia who switched from risperidone or olanzapine.
ESCAPE was a prospective, open-label, multicenter, single-arm Phase IV study in which Chinese patients with an ICD-10 diagnosis of schizophrenia received amisulpride for 8 weeks. This analysis included 109 patients who switched to amisulpride from risperidone (n=68) or olanzapine (n=41) and 59 treatment-naïve patients for reference. The primary effectiveness outcome was a ≥50% decrease in Positive and Negative Syndrome Scale (PANSS) Total score from Baseline to Week 8. The study was registered at ClinicalTrials.gov (NCT01795183).
Of the patients who switched from risperidone and olanzapine, 77.9% and 56.1% achieved ≥50% reduction in PANSS Total score from Baseline to Week 8 and 57.4% and 46.3% achieved ≥20% reduction in PANSS score from Baseline to Week 2, respectively; these end points were achieved by 66.1% and 61.0% of treatment-naïve patients, respectively. No unexpected adverse events (AEs) were reported. Of the most common AEs, extrapyramidal side effects occurred in 32.4% and 14.6%, blood prolactin increase in 32.4% and 39.0%, and ≥7% increase in body weight in 4.4% and 12% of patients switching from risperidone and olanzapine, respectively.
The results of this subgroup analysis suggest that switching to amisulpride from risperidone and olanzapine is effective and generally well tolerated in Chinese patients with schizophrenia.
第二代抗精神病药物在治疗反应和副作用方面存在显著的个体差异，大多数精神分裂症患者需要多次更换治疗方案。这项对ESCAPE研究的亚组分析评估了氨磺必利对从利培酮或奥氮平转换而来的中国精神分裂症患者的疗效和安全性。
ESCAPE是一项前瞻性、开放标签、多中心、单臂IV期研究，其中符合ICD-10精神分裂症诊断标准的中国患者接受氨磺必利治疗8周。该分析纳入了109例从利培酮（n=68）或奥氮平（n=41）转换为氨磺必利的患者以及59例未接受过治疗的患者作为对照。主要有效性结局是从基线到第8周阳性和阴性症状量表（PANSS）总分降低≥50%。该研究已在ClinicalTrials.gov注册（NCT01795183）。
从利培酮和奥氮平转换而来的患者中，分别有77.9%和56.1%从基线到第8周实现了PANSS总分降低≥50%，57.4%和46.3%从基线到第2周实现了PANSS评分降低≥20%；未接受过治疗的患者分别有66.1%和61.0%达到这些终点。未报告意外不良事件（AE）。在最常见的AE中，锥体外系副作用分别发生在32.4%和14.6%的从利培酮和奥氮平转换而来的患者中，血催乳素升高分别发生在32.4%和39.0%的患者中，体重增加≥7%分别发生在4.4%和12%的从利培酮和奥氮平转换而来的患者中。
该亚组分析结果表明，对于中国精神分裂症患者，从利培酮和奥氮平转换为氨磺必利是有效的，且总体耐受性良好。
