中国临床药学杂志

目的 分析医院抗肿瘤药物可疑且非预期严重不良反应（SUSAR）基本情况，为抗肿瘤药物临床试验的安全性监测与管理提供参考。方法 收集2020年11月至2022年5月上报的SUSAR报告，对报告类型、临床试验项目分期、病例人口学特征、药物分类及靶点、SUSAR累及系统-器官、临床表现、严重程度、不良事件通用术语标准（CTCAE）分级和事件转归等方面进行统计分析。结果 346例次SUSAR报告中，受试者年龄（57.00±11.05）岁，女性（229例次，占66.2%）和乳腺癌患者（89例次，占25.7%）居多。从药物类型来看，绝大多数（326例次，占94.2%）为新型靶向抗肿瘤药物，主要包括小分子靶向药物（166例次，占45.5%）、免疫检查点抑制剂（74例次，占20.3%）、双特异性抗体（35例次，占9.6%）和抗体偶联药物（34例次，占9.3%）等。346例次SUSAR主要累及系统-器官包括消化系统（77例次，占22.3%）、血液系统（42例次，占12.1%）、呼吸系统（40例次，占11.6%）和心血管系统（33例次，占9.5%）等。SUSAR的CTCAE分级主要为3～5级（277例次，占80.1%），严重程度主要为导致住院或延长住院时间（260例次，占75.1%）。结论 该院现开展的临床试验以创新药物为主，发生SUSAR的风险较高；医疗机构应加强临床试验从业人员对SUSAR快速报告标准程序的理解与认识，制定项目安全性监测计划，切实保护临床试验受试者安全。

AIM To analyze the suspected and unexpected serious adverse reaction(SUSAR) of antitumor drugs in a hospital, so as to provide reference for the safety monitoring and management of clinical trials of antitumor drugs.METHODS SUSAR reported from November 2020 to May 2022 were retrospectively collected and analyzed. The analyse focused on report type, clinical trial stage, demographic characteristics, drug classification and target, systemsorgans involved in SUSAR, clinical manifestations, severity, CTCAE grade and event outcome. RESULTS The age of the subjects in 346 SUSAR reports was 57.00 ± 11.05 years old. The incidence of SUSAR in females(229 patients, 66.2%)was higher than in males. SUSAR mainly occurred in breast cancer subjects(89 patients, 25.7%). In terms of drug types,the majority(326 patients, 94.2%) were novel antitumor drugs, mainly including small-molecule targeted drugs(166patients, 45.5%), immune checkpoint inhibitors(74 patients, 20.3%), bi-specific antibodies(35 patients, 9.6%), antibody conjugate drugs(34 patients, 9.3%), etc. The clinical manifestations of SUSAR involved several systems-organs, including digestive system(77 patients, 22.3%), blood system(42 patients, 12.1%), respiratory system(40 patients, 11.6%), and cardiovascular system(33 patients, 9.5%), etc. The CTCAE grade of SUSAR was mainly grade 3 ～ 5(277 patients, 80.1%).The severity of SUSAR mainly involved hospitalization or prolonged hospitalization(260 patients, 75.1%). CONCLUSION The types of clinical trials conducted in the hospital are mainly innovative drugs, and the risk of SUSAR is high. Medical institutions should enhance the understanding of clinical trial practitioners regarding the standard procedures for promptly reporting of SUSAR and develop safety monitoring plans to effectively safeguard the well-being of clinical trial subjects.