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免疫检查点抑制剂相关的肺结核:一项药物警戒研究。

Pulmonary tuberculosis associated with immune checkpoint inhibitors: a pharmacovigilance study.

机构信息

Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.

Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, People's Republic of China.

出版信息

Thorax. 2022 Jul;77(7):721-723. doi: 10.1136/thoraxjnl-2021-217575. Epub 2022 Mar 11.

DOI:10.1136/thoraxjnl-2021-217575
PMID:35277447
Abstract

We examined case reports of immune checkpoint inhibitors (ICIs) associated pulmonary tuberculosis (PT) using data from the Food and Drug Administration Adverse Event Reporting System database. Disproportionality analysis was performed by using the reporting OR (ROR) with relevant 95% CI. A total of 74 cases of PT related to ICIs therapy were identified. ICIs were significantly associated with over-reporting frequencies of PT (ROR=3.16, 95% CI: 2.51 to 3.98), while the signal was differed between anti-programmed death-1/ligand-1 and anti-cytotoxic T lymphocyte antigen-4 agents. Most indications were lung cancer (64.9%), the median onset age was 70 years, the median time to onset of PT was 70 days, ICIs were discontinued in most cases (85.2%).

摘要

我们使用食品和药物管理局不良事件报告系统数据库中的数据,检查了与免疫检查点抑制剂(ICI)相关的肺结核(PT)病例报告。通过使用报告比值比(ROR)和相关的 95%置信区间进行了比例失调分析。共确定了 74 例与 ICI 治疗相关的 PT 病例。ICI 与 PT 的过度报告频率显著相关(ROR=3.16,95%CI:2.51 至 3.98),而抗程序性死亡-1/配体-1 和抗细胞毒性 T 淋巴细胞抗原-4 药物之间的信号有所不同。大多数适应症为肺癌(64.9%),中位发病年龄为 70 岁,PT 的中位发病时间为 70 天,大多数情况下(85.2%)停止了 ICI 治疗。

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