评估与免疫检查点抑制剂 (ICIs) 相关的面神经麻痹 (FP) 风险，并描述其临床特征。纳入了随机对照试验 (RCT) 和 FDA 不良事件报告系统 (FAERS) 数据库的数据。主要结局是与 ICI 相关的 FP 事件的风险。对于来自 RCT 的数据，使用 95% CI 的风险比 (RR) 进行汇总分析。在一项单独的 FAERS 回顾性药物警戒研究中，使用报告比值比 (ROR) 和信息成分 (IC) 的比例报告分析了不成比例性。总共纳入了 21 项随机对照试验（193,05 名患者），ICIs 与增加的风险相关FP（OR=3.07，95%CI：1.43-6.58）。亚组分析结果表明，ICI 相关 FP 的 OR 不会因肿瘤类型、ICIs 治疗方案、事件病例、研究设计、中位 PFS 和发表状态而发生显着变化。 FAERS 药物警戒数据确定了 274 例与 ICI 治疗相关的 FP 病例。 ICI 与 FP 的高报频率显着相关（ROR = 3.03，95% CI：2.69-3.42；IC = 1.56，95% CI：1.38-1.76）。 FP 的中位发病时间为 5.5 周，78.0% 的病例出现药物中断，82.8% 的病例出现积极的去挑战，71.7% 的病例已痊愈或正在恢复中。这些数据表明，ICIs 与药物增加显着相关。试验环境和临床实践中 FP 的风险。版权所有 © 2023 Elsevier B.V. 保留所有权利。

To estimate the risk of facial nerve palsy (FP) associated with immune checkpoint inhibitors (ICIs), and to describe its clinical features.Data from randomized controlled trials (RCTs) and FDA Adverse Event Reporting System (FAERS) database were included. The primary outcome was the risk of FP events associated with ICIs. For data from RCTs, pooled analysis was performed by using risk ratios (RRs) with 95%CIs. In a separate retrospective pharmacovigilance study of FAERS, disproportionality was analyzed using the proportional reports reporting odds ratio (ROR) and information components (IC).A total of 21 RCTs (193,05 patients) were included, ICIs were associated with increased risk of FP (OR = 3.07, 95%CI:1.43-6.58). Results of subgroup analysis indicated that OR of ICI-related FP did not vary significantly by tumor type, ICIs treatment schedule, case of events, study design, median PFS and publication status. FAERS pharmacovigilance data identified 274 cases of FP related to ICIs therapy. ICIs were significantly associated with over-reporting frequencies of FP (ROR = 3.03, 95%CI:2.69-3.42; IC = 1.56, 95%CI:1.38-1.76). The median onset time of FP was 5.5 weeks, drug interruption was recorded in 78.0% of cases, with a positive dechallenge in 82.8 % of cases, and 71.7% of cases were recovered or recovering.These data suggest that ICIs were significantly associated with increased risk of FP in both trial settings and in clinical practice.Copyright © 2023 Elsevier B.V. All rights reserved.