Department of Pharmacy, Peking University Third Hospital, N. Huayuan Rd, Beijing, China.
Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
BMC Psychiatry. 2018 Sep 5;18(1):286. doi: 10.1186/s12888-018-1867-8.
Amisulpride was introduced into China in 2010 as a second-generation atypical antipsychotic, while olanzapine has been on the market since 1999 as one of the leading treatments for schizophrenia in China. Since more Chinese patients are gaining access to amisulpride, the study aims to compare the efficacy, safety, and costs between amisulpride and olanzapine for schizophrenia treatment in China.
PubMed, Embase, the Cochrane library, China National Knowledge Infrastructure (CNKI) and WanFang database were systematically searched for randomized controlled trials (RCTs) up to July 2018. The Cochrane Risk of Bias tool was utilized to assess the quality of included studies. A meta-analysis was performed to compare the efficacy and safety of amisulpride and olanzapine, followed by a cost-minimization analysis using local drug and medical costs reported in China.
Twenty RCTs with 2000 patients were included in the systematic review. There were no significant differences between amisulpride and olanzapine on efficacy measures based on scores from the Positive and Negative Syndrome Scale, the Scale for the Assessment of Negative Symptoms, the Brief Psychiatric Rating Scale and the Clinical Global Impressions-Severity or Improvement. For safety outcomes, amisulpride was associated with lower fasting blood glucose and less abnormal liver functions as well as significantly lower risks of weight gain, constipation, and somnolence; olanzapine was associated with significantly lower risks of insomnia and lactation/amenorrhea/sexual hormone disorder. No significant differences were found in risks of extrapyramidal symptoms (EPS), tremor, akathisia, abnormal corrected QT interval. Cost-minimization analysis showed that amisulpride was likely to be a cost-saving alternative in China, with potential savings of 1358 Chinese Yuan (CNY) per patient for a three-month schizophrenia treatment compared with olanzapine.
As the first meta-analysis and cost-minimization analysis comparing the efficacy, safety and cost of amisulpride and olanzapine within a Chinese setting, the study suggests that amisulpride may be an effective, well-tolerated, and cost-saving antipsychotic drug alternative in China.
氨磺必利于 2010 年作为第二代非典型抗精神病药引入中国，而奥氮平自 1999 年以来一直是中国治疗精神分裂症的主要药物之一。随着越来越多的中国患者能够获得氨磺必利，本研究旨在比较氨磺必利与奥氮平治疗中国精神分裂症的疗效、安全性和成本。
系统检索了 2018 年 7 月之前的 PubMed、Embase、Cochrane 图书馆、中国知网（CNKI）和万方数据库中的随机对照试验（RCT）。采用 Cochrane 偏倚风险工具评估纳入研究的质量。采用荟萃分析比较氨磺必利和奥氮平的疗效和安全性，然后使用中国报告的当地药物和医疗成本进行成本最小化分析。
系统评价纳入了 20 项 RCT 和 2000 名患者。根据阳性和阴性综合征量表、阴性症状量表、简明精神病评定量表和临床总体印象-严重度或改善评分，氨磺必利和奥氮平在疗效指标上无显著差异。安全性结果显示，氨磺必利与空腹血糖降低、肝功能异常发生率降低有关，且体重增加、便秘和嗜睡的风险显著降低；奥氮平与失眠和哺乳/闭经/性激素障碍的风险显著降低有关。在锥体外系症状（EPS）、震颤、静坐不能、校正 QT 间期异常的风险方面无显著差异。成本最小化分析显示，与奥氮平相比，氨磺必利在中国可能是一种具有成本效益的替代药物，每个患者的三个月精神分裂症治疗费用可能节省 1358 元人民币。
作为第一项在中国人群中比较氨磺必利和奥氮平疗效、安全性和成本的荟萃分析和成本最小化分析，该研究表明，氨磺必利可能是一种有效、耐受良好且具有成本效益的抗精神病药物替代药物。
