鲁拉西酮治疗精神分裂症的疗效及不良代谢反应的Meta分析

发布时间：2018-03-13 22:29

本文选题：鲁拉西酮　切入点：精神分裂症　出处：《南昌大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的:鲁拉西酮是由美国食品药品监督管理局(FDA)2010年批准上市的非典型抗精神病药物,在精神科临床广泛使用。虽然该药效果肯定,但鲁拉西酮的临床疗效及不良代谢反应的循证医学证据较少。基于国内外关于鲁拉西酮治疗精神分裂症的临床随机对照试验结果,采用Meta分析的方法,客观地评价鲁拉西酮治疗精神分裂症的疗效及不良代谢反应,为精神分裂症的药物治疗提供选择依据。方法:计算机检索PUBMED、EMBASE、Cochrane Library、Elsevier、中国知网(CNKI)、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)、万方数据库等,检索时间从建库截至2016年12月,收集鲁拉西酮治疗精神分裂症的随机对照试验(randomized controlled trial,RCT)。根据制定的纳入标准、排除标准对收集的文献进行严格筛查;采用Cochrane协作网的研究偏倚风险评价工具对纳入的研究进行质量评价,收集相关数据资料,使用RevMan5.2软件进行Meta分析,切换效应模型进行敏感性分析,漏斗图法分析发表偏倚。结果:本研究共纳入7项符合纳入标准的随机对照研究,合计样本量2615人。在所纳入鲁拉西酮与安慰剂的随机对照研究中,有5项提供了PANSS、CGI-S量表终点较基线评分变化、体重变化情况,3项提供了BMI终点较基线的变化值,1项提供了血糖、血脂变化情况。Meta分析结果显示:与安慰剂比较,治疗后PANSS量表评分变化[MD=-5.60,95%CI(-8.69,-2.52),p=0.0004],CGI-S量表评分变化[MD=-0.31,95%CI(-0.50,-0.12),p=0.001]差异具有统计学意义,体重变化[MD=0.47,95%CI(0.23,0.72),p=0.0002],BMI变化[MD=0.23,95%CI(0.10,0.35),p=0.0003]差异具有统计学意义。提示鲁拉西酮治疗精神分裂症的疗效优于安慰剂,但较安慰剂更易引起体重、BMI升高。仅有1篇文献比较了鲁拉西酮与安慰剂对血糖、血脂方面的影响,不宜进行定量Meta分析,故进行描述性研究。鲁拉西酮与其他抗精神病药的随机对照试验数量有限,故在疗效及不良代谢反应方面,均进行描述性研究。结论:鲁拉西酮治疗精神分裂症疗效确切,与其他抗精神病药相比效果相当,对体重及代谢参数的影响较其他非典型抗精神病药更小。
[Abstract]:Objective: Lurassetron is an atypical antipsychotic drug approved by the Food and Drug Administration (FDA) in 2010 and is widely used in psychiatric clinics. However, the evidence of clinical efficacy and adverse metabolic reaction of Lurassetron was few. Based on the results of randomized controlled trials at home and abroad on the treatment of schizophrenia with Lurassetron, the method of Meta analysis was used. Objective to evaluate the efficacy and adverse metabolic reaction of roxidone in the treatment of schizophrenia. Methods: to search PUBMED EMBASE Cochrane Library Elsevier, CNKIN, CBMN, VIPA, Wanfang database, and so on, to provide the basis for the choice of drug therapy for schizophrenic patients, including PUBMED, EMBASE, Cochrane Library Elsevier, Chinese Biomedical Literature Database, Chinese Biomedical Literature Database, Chinese Journal of Science and Technology Full-text Database, etc. The retrieval time was from the establishment of the library to December 2016, and the randomized controlled trial of Lurassetron for the treatment of schizophrenia was collected. The collected literature was screened strictly according to the inclusion criteria and the exclusion criteria. The research bias risk assessment tool of Cochrane cooperation network was used to evaluate the quality of the included research, to collect relevant data, to use RevMan5.2 software for Meta analysis, and to analyze the sensitivity of the switching effect model. Results: a total of 7 randomized controlled trials with a total sample size of 2,615 subjects were included in the study. Five items provided changes in the end points of the PANSS CGI-S scale compared with the baseline scores, and three items of weight changes provided the change value of the end point of BMI compared with the baseline value. One item provided the change of blood glucose, and the results of Meta-analysis showed that compared with placebo, the change of blood lipid was higher than that of placebo. There were significant differences in PANSS score after treatment [MD-5.6095 CI-8.69C -2.52C + 0.0004] CGI-S scale score [MD-0.31J 95CI-0.50 + -0.12C], and the weight change [MD0.4795CI0.237CI0.232P0.0002] had statistical significance. It suggested that the therapeutic effect of Lurassetron on schizophrenia was better than that of placebo (MD0.2395CIX 0.100.35p0.0003). However, placebo was more likely to lead to higher BMI. Only one article compared the effects of roxidone and placebo on blood glucose and blood lipid, so it was not suitable for quantitative Meta analysis. Therefore, descriptive studies were carried out. A limited number of randomized controlled trials of roxidone and other antipsychotics were carried out. Conclusion: Lurassetron is effective in the treatment of schizophrenia because of its efficacy and adverse metabolic reactions. Compared with other antipsychotics, the effect on body weight and metabolic parameters is smaller than that on other atypical antipsychotics.
【学位授予单位】：南昌大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R749.3

【参考文献】