泽布替尼单药治疗B细胞淋巴瘤疗效和安全性的Meta分析-现代医学

泽布替尼单药治疗B细胞淋巴瘤疗效和安全性的Meta分析

单位：川北医学院附属医院血液内科, 四川南充 637000

分类号：R559

出版年·卷·期（页码）：2024·52·第十期（1557-1564）

摘要：

目的： 系统评价泽布替尼单药治疗B细胞淋巴瘤(BCM)的疗效及安全性。方法： 检索PubMed、Embase、Cochrane library、Web of science、中国知网、万方、维普、中国生物医学文献数据库自建库至2023年8月发表的文献，采用Cochrane风险偏倚评估工具以及MINORS条目进行文献质量评价，并进行随机对照试验(RCT)及单臂临床试验Meta分析，数据分析采用随机和固定效应模型。结果： 共纳入11篇文献，包括RCT 3篇，单臂临床试验8篇，共1 869例患者。Meta分析显示：(1) RCT：与对照组相比，客观缓解率(ORR)及无进展生存期(PFS)差异均有统计学意义(均P <0.05)，而完全缓解率(CR)、总生存期(OS)、不良反应(AE)发生率等差异均无统计学意义(均P＞0.05)。(2) 单臂临床试验：泽布替尼治疗的ORR为0.73(95%CI 0.59～0.86)，CR为0.24(95%CI 0.03～0.45)，1、2、3年PFS分别为0.57(95%CI 0.08～1.06)、0.66(95%CI 0.49～0.82)、0.60(95%CI 0.40～0.79),1、2、3年OS分别为0.81(95%CI 0.57～1.05)、0.85(95%CI 0.77～0.92)、0.84(95%CI 0.77～0.90)，总AE发生率为0.99(95%CI 0.91～1.08)。结论： 泽布替尼可明显延长BCM患者的PFS，提高ORR。总AE发生率高，但≥3级高血压、出血、感染发生率并不高。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 zanubrutinib monotherapy in the treatment of B-cell lymphoma(BCM). Methods: A comprehensive literature search was conducted from database inception to August 2023 in PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, VIP, and CBM databases. Study quality was assessed using the Cochrane risk of bias tool for randomized controlled trials(RCTs) and the MINORS checklist for observational studies. A Meta-analysis was performed on RCTs and single-arm clinical trials. Data were analyzed using both random and fixed-effects models. Results: A total of 11 studies were included, comprising 3 RCTs and 8 single-arm clinical trials, involving a total of 1, 869 patients. The Meta-analysis showed:(1) RCTs: Compared with the control group, the differences in overall response rate(ORR) and progression-free survival(PFS) were statistically significant(all P <0.05), while there were no statistically significant differences in complete response(CR), overall survival(OS), or the incidence of overall adverse events(AEs)(all P>0.05). (2) Single-arm clinical trials: The ORR for zanubrutinib treatment was 0.73(95%CI 0.59-0.86), the CR was 0.24(95%CI 0.03-0.45), and the 1-, 2-, and 3-year PFS were 0.57(95%CI 0.08-1.06), 0.66(95%CI 0.49-0.82), and 0.60(95%CI 0.40-0.79), respectively. The 1-, 2-, and 3-year OS were 0.81(95%CI 0.57-1.05), 0.85(95%CI 0.77-0.92), and 0.84(95%CI 0.77-0.90), respectively. The overall incidence of AEs was 0.99(95%CI 0.91-1.08). Conclusion: Zanubrutinib significantly prolongs PFS and improves ORR in patients with BCM. Although the overall incidence of AEs is high, the rates of severe(≥grade 3) hypertension, bleeding, and infection are not elevated. Close monitoring of adverse events is necessary in clinical practice to enhance patient safety.

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