免疫系统靶向/抗癌药物的全球发展已经彻底改变了免疫肿瘤学，但其与微血管血栓性微血管病（TMA）的关联越来越受到怀疑。本研究旨在利用现实世界数据，确定与TMA报告相关的药物，并描述这些药物在TMA报告中的演变趋势。本研究使用来自世界卫生组织（WHO）药物监测数据库（VigiBase）的个体病例安全报告（ICSRs）进行全球不均衡性研究，时间范围从1968年开始到2022年4月30日。在31,251,040个ICSRs中，包括55个国家的6946例疑似药物引起的TMA病例。其中18.2%的病例结果是致命的。共有72种免疫系统靶向/抗癌药物与显著的过度报道相关，包括17种可能对TMA具有新的安全关切的药物。虽然每百万ICSRs的TMA报道率保持相对稳定，但过去十年间报告的疑似药物引起的TMA病例数量有绝对增加的趋势。TMA报告中涉及的药物模式随时间演变，从1992-2001年占47.3%（205/433）增加到2012-2021年占80.7%（3819/4730）。多种最近上市的免疫系统靶向/抗癌药物被确定为与TMA相关的潜在新药物，需要确认性研究。与TMA报告相关的药物数量在过去的10年内显著增加，主要是由于创新的抗癌药物。© 2023《国际医学杂志》出版协会。

The worldwide development of immune system targeting/anticancer drugs has revolutionized immuno-oncology, but their implication in thrombotic microangiopathy syndromes (TMA) is increasingly suspected. Using real-world data, the aim of this study was to identify drugs associated with TMA reporting and to describe the evolution of TMA reporting over time with a focus on these drugs.A global disproportionality study was performed using the individual case safety reports (ICSRs) extracted from the World Health Organization (WHO) pharmacovigilance database (VigiBase) from its inception (1968) to April 30, 2022.Of the 31,251,040 ICSRs, 6946 cases of suspected drug-induced TMA were included from 55 countries. The outcome was fatal in 18.2% of cases. A total of 72 immune system targeting/anticancer drugs were associated with significant overreporting, including 17 drugs with a potential new safety concern for TMA. Although the rate of TMA reporting per million of ICSRs has remained fairly stable, an absolute increase in reported cases of suspected drug-induced TMA has been observed over the last decade. The pattern of drugs reported in TMA has evolved with a substantial increase in the proportion of cases involving immune system-targeting drugs/anticancer drugs from 47.3% (205/433) in the period 1992-2001 to 80.7% (3819/4730) in the period 2012-2021.Several recently marketed immune system targeting/anticancer drugs have been identified as potential new drugs associated with TMA, which will require confirmatory studies. The number of drugs associated with TMA reporting markedly increased within the past 10 years, primarily due to innovative anticancer drugs.© 2023 The Association for the Publication of the Journal of Internal Medicine.