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布鲁顿酪氨酸激酶抑制剂单药治疗 B 细胞淋巴瘤和感染风险:一项随机对照试验的系统评价和荟萃分析。

Bruton tyrosine kinase inhibitor monotherapy in B-cell lymphoma and risk of infection: A systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Athens, Georgia, USA.

出版信息

Hematol Oncol. 2024 Sep;42(5):e3308. doi: 10.1002/hon.3308.

DOI:10.1002/hon.3308
PMID:39267353
Abstract

Bruton's tyrosine kinase (BTK) inhibitors are important therapeutic advances with promising efficacy outcomes in the treatment of patients with chronic lymphocytic leukemia and other B-cell lymphoma subtypes. However, the utility of BTK inhibitors can be limited by adverse events such as infections. In this systematic review and meta-analysis, we aim to determine the risk of various infections associated with BTK inhibitor monotherapy in B-cell lymphoma patients. A comprehensive search was conducted in MEDLINE/PubMed, Embase, and Web of Science databases from their inception until October 2023. ClinicalTrials.gov, bibliographies, and relevant conference abstracts were also searched for additional records. Randomized controlled trials that included any B-cell lymphoma patients treated with BTK inhibitor monotherapy and reported infection were included. Meta-analysis was performed to calculate risk ratio (RR) using a random-effects model in R Statistical Software, version 4.3.2. Of 3292 studies retrieved, we included 12 studies in this systematic review and meta-analysis. The median age of patients across the study arms ranged between 64 and 73 years. The overall pooled RR for any grade upper respiratory tract infections (URTI) associated with BTK inhibitor treatment was 1.55 (95% Confidence Interval (CI) 1.22-1.97). The RR of grade ≥3 URTI was reported in 14 out of 1046 patients, yielding an RR of 1.46 (95% CI 0.61-3.54), which was not statistically significant. The pooled RR of any grade pneumonia was 1.20 (95% CI 0.68-2.10) and grade ≥3 pneumonia was 1.12 (95% CI 0.67-1.85), both of which were not statistically significant. Patients with B-cell lymphoma who are undergoing BTK inhibitor monotherapy face an elevated risk of developing URTI. Clinicians prescribing BTK inhibitors should be aware of the potential infectious events that may occur. Close monitoring and the implementation of effective prophylactic measures are essential for managing these patients.

摘要

布鲁顿酪氨酸激酶 (BTK) 抑制剂是治疗慢性淋巴细胞白血病和其他 B 细胞淋巴瘤亚型患者的重要治疗进展,具有良好的疗效。然而,BTK 抑制剂的应用可能会受到感染等不良反应的限制。在本系统评价和荟萃分析中,我们旨在确定 BTK 抑制剂单药治疗 B 细胞淋巴瘤患者相关各种感染的风险。我们在 MEDLINE/PubMed、Embase 和 Web of Science 数据库中进行了全面检索,检索时间从建库至 2023 年 10 月。还检索了 ClinicalTrials.gov、参考文献和相关会议摘要,以获取更多记录。纳入了包含任何接受 BTK 抑制剂单药治疗且报告感染的 B 细胞淋巴瘤患者的随机对照试验。使用 R 统计软件,版本 4.3.2 中的随机效应模型进行荟萃分析,计算风险比 (RR)。在检索到的 3292 项研究中,我们纳入了本系统评价和荟萃分析中的 12 项研究。研究臂中患者的中位年龄在 64 至 73 岁之间。与 BTK 抑制剂治疗相关的任何级别上呼吸道感染 (URTI) 的总体汇总 RR 为 1.55(95%置信区间 [CI] 1.22-1.97)。1046 例患者中有 14 例报告了≥3 级 URTI,RR 为 1.46(95% CI 0.61-3.54),无统计学意义。任何级别肺炎的汇总 RR 为 1.20(95% CI 0.68-2.10),≥3 级肺炎的 RR 为 1.12(95% CI 0.67-1.85),均无统计学意义。接受 BTK 抑制剂单药治疗的 B 细胞淋巴瘤患者发生 URTI 的风险增加。开具 BTK 抑制剂的临床医生应意识到可能发生的感染性事件。密切监测和实施有效的预防措施对于管理这些患者至关重要。

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