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.
作者
沈昊
李超群
郭玉娇
杨燕玲
张凯
孙鲁宁
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)
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)。
