【摘要】 目的 通过对三氧化二砷的药品不良反应(adverse drug reaction,ADR)信号进行挖掘分析，探讨该药潜在的不良反应，为临床安全合理用药提供参考。方法 检索美国食品药品监督管理局不良事件报告系统(FDA Adverse Event ReportingSystem,FAERS)数据库中1998年第1季度——2023年第2季度有关三氧化二砷的相关数据，利用比值失衡测量法中的报告比值比法以及英国药品和医疗保健产品管理局的综合标准法进行数据挖掘，根据国际人用药品注册技术协调会发布的《国际医学用语词典》的系统器官分类(system organ class,SOC)和首选术语(preferred terms,PT)对数据进行描述和分类。结果 共获取三氧化二砷相关的ADR报告2 084例，其中男性患者924例，女性841例，≥35岁患者1 276例，上报数据主要源于美国(429例，20.59%)；严重ADR共1 914例，占比91.84%，以导致住院或住院时间延长(711例，34.12%)和死亡为主(296例，14.20%)。共挖掘到358个ADR信号，涉及24种SOC，主要为各类检查(1 169例，21.17%)和各类神经系统疾病(361例，6.54%)；发生频次较高的ADR以心电图QT间期延长、分化综合征、发热、呼吸困难等PT为主，其中感染性肺炎、白细胞计数降低、疾病进展等PT未被药品说明书收录。信号强度排名靠前的为分化综合征、造血系统肿瘤、白细胞过多等PT，而心肌心包炎、脓毒性栓子、中枢神经系统出血等PT未被说明书收录。结论 三氧化二砷会导致极高比例的严重ADR，应对发生频次较高以及未收录在说明书中的ADR予以重视。在使用药物治疗前、治疗中及随访阶段，均应做好相关监测及上报工作，以有效保障患者用药安全。更多还原

【Abstract】 OBJECTIVE To mine and analyze the adverse drug reaction(ADR) of arsenic trioxide and explore its potentialadverse reactions, so as to provide reference for the safe and rational use of drugs in clinical practice. METHODS Relative ADRreports of arsenic trioxide from the first quarter of 1998 to the second quarter of 2023 in the FDA Adverse Event ReportingSystem(FAERS) database were collected; conduct data mining by utilizing the reporting odds ratio method within the proportionalimbalance method and the comprehensive criteria method of the UK Medicines and Healthcare Products Regulatory Agency. ADRreports were described and classified according to the system organ class(SOC) and preferred term(PT) in the Medical Dictionaryfor Regulatory Activities. RESULTS A total of 2084 cases of ADR reports related to arsenic trioxide were retrieved; involving924 male patients and 841 female patients. There were more patients aged ≥35(1276 cases), the main reporting country being theUnited States(429 cases, 20.59%), and a total of 1914 cases of severe ADR, accounting for 91.84%, mainly leading tohospitalized(711 cases, 34.12%) and died(296 cases, 14.20%). A total of 358 ADR signals were excavated, involving 24 types ofSOC, mainly including investigations(1 169 cases, 21.17%) and nervous system disorders(361 cases, 6.54%); the main ADR with ahigh frequency of occurrence were electrocardiogram QT prolonged, differentiation syndrome, pyrexia, dyspnoea, and other PTs,the drug instructions didn’t include pneumonia, white blood cell count decreased, and disease progression. The signal intensityranking high was mainly characterized by differentiation syndrome, haematopoietic neoplasm, hyperleukocytosis and other PT, andmyopericarditis, septic embolus, and central nervous system haemorrhage were not included in the druginstructions.CONCLUSION Arsenic trioxide can cause a high proportion of serious ADR, and attention should be paid to ADRthat occur frequently and are not included in the instructions. Before, during, and during the follow-up phase of medicationtreatment, relevant monitoring and reporting work should be carried out, to effectively ensure the safety of medication for patients.更多还原