迄今为止，免疫检查点抑制剂（ICIs）的确切安全性尚不清楚。当前研究的目的是分析 ICI 在癌症患者中的安全性。使用 FAERS 数据库和元数据对上市后数据进行更新的全面不成比例分析-进行了随机临床试验（RCT）分析。不成比例的测量是根据与卡方值相关的 PRR 和具有 95% 置信区间的 ROR 来计算的，而具有 95% CI 的总体估计测量、发表偏倚和异质性是使用 RevMan 5.4 计算的。还进行了 GRADE 分析，以检查每个结果的证据质量。通过 ICI 识别出与不同系统器官类别相关的各种新信号，例如胆管炎、脑炎、无尿、骨髓抑制和恶病质。敏感性分析结果表明了合并药物对已识别信号的影响。荟萃分析结果显示，atezolizumab 在非小细胞肺癌 (NSCLC) 和黑色素瘤中具有良好的安全性，pembrolizumab 在胃食管癌、尿路上皮癌和头颈鳞状细胞癌 (HNSCC) 中具有良好的安全性，nivolumab 在 HNSCC 中具有良好的安全性。与非 ICI 组相比。ICIs 的安全性取决于其类型以及癌症类型。版权所有 © 2024 Elsevier B.V. 保留所有权利。

The exact safety profile of Immune checkpoint inhibitors (ICIs) is unclear so far.The aim of the current study is to analyse the safety profile of ICIs in cancer patients.The updated comprehensive disproportionality analysis of post-marketing data using the FAERS database and meta-analysis of randomized clinical trials (RCTs) was conducted. Disproportionality measures were calculated in terms of PRR associated with chi-square value and ROR with 95% confidence intervals whereas overall estimate measures with 95% CIs, publication bias and heterogeneity were calculated using RevMan 5.4. The GRADE analysis was also done to check the quality of evidence for each outcome.Various novel signals such as cholangitis, encephalitis, anuria, myelosuppression, and cachexia related to different system organ class were identified with ICIs. The sensitivity analysis results have indicated the influence of concomitant drugs on the identified signals. The meta-analysis results have shown a good safety profile of atezolizumab in non-small cell lung cancer (NSCLC) and melanoma, pembrolizumab in gastro-oesophageal cancer, urothelial cancer and head and neck squamous cell carcinoma (HNSCC), nivolumab in HNSCC as compared to the non-ICI group.The safety of ICIs is dependent on their types as well as on the types of cancer.Copyright © 2024 Elsevier B.V. All rights reserved.