小剂量地西他滨治疗成人免疫性血小板减少症的有效性与安全性系统评价  

A systematic review of efficacy and safety of low-dose decitabine in the treatment of adults with immune thrombocytopenia

作　　者：曹新甜 孙妍 王德好 宋英 邹吉轩 赵霈 胡晓梅[2] CAO Xintian;SUN Yan;WANG Dehao;SONG Ying;ZOU Jixuan;ZHAO Pei;HU Xiaomei(Xiyuan Clinical Medical College,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学附属西苑临床学院,北京100029 [2]中国中医科学院西苑医院

出　　处：《山东医药》2022年第27期24-29,共6页Shandong Medical Journal

基　　金：国家重点基础研究发展计划(973计划)(2015CB554403)。

摘　　要：目的 系统评价小剂量地西他滨治疗成人免疫性血小板减少症(ITP)的有效性与安全性。方法 计算机检索外文数据库(PubMed、Cochrane Library、Embase、OVID、Wed of Science)与中文数据库(中国知网、万方数据库、维普数据库、中国生物医学文献数据库),纳入小剂量地西他滨为干预措施治疗成人ITP的临床研究,检索时间从建库至2021年12月。根据纳排标准纳入文献并提取文献特征、有效性结局指标[完全缓解例数(CR)、部分缓解例数、总有效例数,起效时间、疗效持续时间]、安全性结局指标(不良事件数、不良事件类型、不良事件评价标准)等数据后,采用MINORS量表评分系统对文献质量进行评估,采用R软件的meta程序包对ITP患者的有效性与安全性进行meta分析。结果 有效性分析共纳入6篇文献,包括5个前瞻性单臂临床研究和1个非随机对照试验,共194例患者。Meta分析结果显示,小剂量地西他滨治疗成人ITP的总有效率为47.4%[(95%CI(0.40~0.54)]。安全性分析共纳入5篇文献,包括4个前瞻性单臂临床研究和1个非随机对照试验,共165例患者。Meta分析结果显示,小剂量地西他滨治疗成人ITP的总不良事件发生率为17.8%[95%CI(0.12~0.24)]。结论 小剂量地西他滨治疗成人ITP有一定的疗效、不良反应率较低。Objective To systematically evaluate the efficacy and safety of low-dose decitabine in the treatment of adults with immune thrombocytopenia(ITP).Methods Foreign databases(Pubmed,Cochrane Library,Embase,OVID,Wed of Science) and Chinese databases(CNKI,Wanfang database,Wipe database,Chinese Biomedical Literature Database) were searched until December 2021 about studies of low-dose decitabine in the treatment of adult ITP disease.According to inclusion and exclusion criteria,we collected the characteristics of studies,outcome of efficacy [complete remission(CR),partial remission,overall remisson,time to remission,relapse free survival],and outcome of safety(case number of adverse events,adverse events,evaluation criterion of adverse events) et,al.We used the MINORS scoring system to evaluate the quality of the literature,and the meta-package of R software was used to perform a meta-analysis on the efficacy and safety of ITP patients.Results For efficacy,6 articles were selected,including 5 single arm clinical trials and 1 non-randomized controlled trial,with a total of 194 adult ITP patients.The overall effective rate of low-dose decitabine treatment was 47.4% [95%CI(0.40-0.54)].For safety,5 articles were selected,including 4 single arm clinical trials and 1 non-randomized controlled trial,with a total of 165 adult ITP patients.Meta-analysis showed that the overall adverse event rate of low-dose decitabine in treatment of adult ITP was 17.8% [95% CI(0.12-0.24)].Conclusion Lowdose decitabine has certain effect in the treatment of adult ITP with low rate of adverse events.

关 键 词：地西他滨 免疫性血小板减少症 自身免疫性出血性疾病 

分 类 号：R556.2[医药卫生—血液循环系统疾病]