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已发表论文
中国精神分裂症患者从使用利培酮 (risperidone) 或奥氮平 (olanzapine) 转换到氨磺必利 (amisulpride) 的效果和安全性：ESCAPE 研究的亚组分析
Authors Liang Y, Yu X
Received 20 January 2017
Accepted for publication 30 March 2017
Published 21 April 2017 Volume 2017:13 Pages 1163—1173
DOI https://doi.org/10.2147/NDT.S132363
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Prof. Dr. Roumen Kirov
Peer reviewer comments 3
Editor who approved publication: Professor Wai Kwong Tang
Introduction: 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.
Methods: 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).
Results: 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.
Conclusion: 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.
Keywords: schizophrenia, amisulpride, risperidone, olanzapine, China
Methods: 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).
Results: 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.
Conclusion: 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.
Keywords: schizophrenia, amisulpride, risperidone, olanzapine, China