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

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。

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

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 2013 patients. 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 was 86.3%(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.