valbenazine治疗迟发性运动障碍的疗效与安全性:Meta分析

Efficacy and safety of valbenazine in treatment of tardive dyskinesia: a metaanalysis

目的系统分析valbenazine治疗迟发性运动障碍(TD)的疗效与安全性。方法计算机检索PubMed、 EBSCO、 Embase、 Cochrane Library、中国知网、万方及维普数据库,查找有关valbenazine治疗TD的随机对照临床试验(RCT),时限为建库至2018年6月。由2名研究者根据纳入与排除标准独立筛选文献,进行质量评价及数据提取。采用RevMan 5.0软件进行Meta分析及文献发表偏倚评估。结果纳入4篇RCT,文献质量评估均属高质量。纳入患者603例,其中valbenazine 40 mg·d^(-1)组192例,valbenazine 80 mg·d^(-1)组210例,安慰剂组201例。Meta分析显示,与安慰剂组相比,疗效评价指标方面,valbenazine 40、 80 mg·d^(-1)组各症状量表评分变化及反应值均有显著改善(P <0.05);安全性指标方面,valbenazine 40、 80 mg·d^(-1)组不良事件发生率与安慰剂组相比均无显著差异(P> 0.05)。结论 valbenazine治疗TD疗效确切,患者耐受性高,但仍需严格设计的、大样本、多中心临床试验予以验证。

AIM To evaluate the efficacy and safety of valbenazine in patient with tardive dyskinesia(TD).METHODS Literatures searches were conducted using PubMed,EBSCO,Embase,Cochrane Library,CNKI,Wanfang and VIP databases with the time limit of establishing the database until June 2018.Randomized controlled trials(RCTs) of valbenazine for treatment of TD were found.Literature,quality evaluation and data extraction were independently screened by two researchers according to inclusion and exclusion criteria.RevMan5.0 software was used for meta-analysis and literature publication bias evaluation.RESULTS Four RCTs were enrolled,and the literature quality assessment was of high quality.Totally 603 patients with TD were included,including 192 patients in the valbenazine 40 mg·d-1 group,210 patients in the valbenazine 80 mg·d-1 group and 201 patients in the placebo group.Meta analysis shows that:compared with the placebo group,the scores and response values of each symptom scale were significantly improved in the valbenazine 40,80 mg·d-1 groups(P <0.05).There were no significant differences in the incidence of adverse events between the valbenazine groups and the placebo group(P > 0.05).CONCLUSION Valbenazine is effective in the treatment of TD,and patients are well tolerated,but still need to be verified by rigorously designed,large sample,multicenter clinical trials.