伊布替尼治疗B细胞恶性肿瘤的疗效和安全的单臂Meta分析  

Efficacy and Safety of Ibrutinib in B-cell Malignancies:A Single Arm Meta-Analysis

作　　者：沈昊[1] 李超群 郭玉娇[1] 杨燕玲 张凯[1] 孙鲁宁[1,2] 王永庆 SHEN Hao;LI Chaoqun;GUO Yujiao;YANG Yanling;ZHANG Kai;SUN Luning;WANG Yongqing(The First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China;Nanjing Medical University,Nanjing 211166,China)

机构地区：[1]南京医科大学第一附属医院,南京210029 [2]南京医科大学,南京211166

出　　处：《药学与临床研究》2022年第5期434-440,共7页Pharmaceutical and Clinical Research

基　　金：江苏省卫生健康发展研究中心2021年度开放课题(JSHD2021004)。

摘　　要：目的:系统评价伊布替尼治疗B细胞恶性肿瘤的疗效与安全性,为临床用药提供参考。方法:检索中国知网、维普、万方、PubMed、Cochrane Library、Medline及Clinical trials.gov数据库从建库至2021年10月前发表的研究,采用ROBINS-I对文献进行质量评价,并进行单臂Meta分析,所有分析均采用随机效应模型。结果:共纳入23篇文献、2013例患者。Meta分析显示:伊布替尼治疗的总生存期率为89.7%(95%CI:82.8%~94.0%),无进展生存期率为75.9%(95%CI:66.0%~83.5%),总缓解率为86.3%(95%CI:79.8%~91.0%),主要应答率为77.5%(95%CI:72.6%~81.7%),不良事件发生率为97.6%(95%CI:90.1%~99.5%),血液学不良事件发生率为26.3%(95%CI:14.0%~44.0%),3级及以上不良事件发生率为54.4%(95%CI:31.8%~75.3%)。结论:伊布替尼在治疗B细胞恶性肿瘤患者中疗效较好,且可持续治疗;但不良事件发生率较高。在实际应用中应密切监测不良事件的发生,提高患者用药安全。Objective:To systematically evaluate the efficacy and safety of ibutinib in the treatment of B-cell malignancies for clinical medication reference.Methods:Studies published in CNKI,VIP,Wanfang,PubMed,Cochrane Library,Medline and ClinicalTrials.gov from establishment to October 2021 were searched.The quality of the literatures was evaluated by ROBINS-I,and single-arm Meta analysis was applied on the pooled data based on a random effect model.Results:Twenty-three literatures were enrolled,including 2013patients.Meta analysis showed that the overall survival rate of ibutinib treatment was 89.7%(95%CI:82.8%-94.0%),the progression free survival rate was 75.9%(95%CI:66.0%-83.5%),the overall remission rate was86.3%(95%CI:79.8%-91.0%),the main response rate was 77.5%(95%CI:72.6%-81.7%),and the incidence of adverse events was 97.6%(95%CI:90.1%-99.5%).The incidence of hematological adverse events was 26.3%(95%CI:14.0%-44.0%),and the incidence of grade 3 and above adverse events was 54.4%(95%CI:31.8%-75.3%).Conclusions:Ibrutinib has good efficacy and the treatment is sustainable in patients with B-cell malignancies,but the incidence of adverse events is high.In clinical practice,the occurrence of adverse events should be closely monitored to improve the medication safety of patients.

关 键 词：伊布替尼 B细胞恶性肿瘤 疗效 安全 META分析 

分 类 号：R9694[医药卫生—药理学]