Abstract：
UNASSIGNED: Drug-induced immune hemolytic anemia (DIIHA) is a rare but potentially life-threatening pharmacogenic hematological adverse effect. Updating the risk of DIIHA among the currently available drugs based on spontaneously reported adverse event data is of great significance.
UNASSIGNED: This study aimed to identify the top 50 drugs associated with immune hemolytic anemia in adults as well as common drugs that could cause immune hemolytic anemia in children based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.
UNASSIGNED: We extracted adverse events (AE) in the FAERS database from Q1 2004 to Q3 2022 using Open vigil2.1. We use the high-level term \"anaemias haemolytic immune\" according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary (version 24.0). The reported correlation between drugs and DIIHA risk was identified by reported odds ratio (ROR) and proportional reporting ratio (PRR).
UNASSIGNED: There were 10500309 AEs in FAERS from 2004Q1 to 2022Q3, of which 2326 (0.02%) were DIIHA cases. The incidence of DIIHA is comparable between males and females. The most common drugs associated with DIIHA in adults and children are summarized according to the number of AE reports. The top 3 categories in terms of quantity of drugs are antineoplastic agents, immunosuppressants, and antibiotics for systemic use. The top 5 drugs in terms of ROR and PRR are alemtuzumab, daclizumab, fludarabine, busulfan, and bendamustine in adults, with entecavir, treosulfan, vinorelbine, pegademase, and alemtuzumab for children.
UNASSIGNED: Our study identified the most common drugs that could induce DIIHA in adults and children, as well as the respective ROR and PRR value to discover new drug signals. This study provides references to clinicians for the management of rare DIIHA.
UNASSIGNED: This study aimed to identify the top 50 drugs associated with immune hemolytic anemia in adults as well as common drugs that could cause immune hemolytic anemia in children based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.
UNASSIGNED: We extracted adverse events (AE) in the FAERS database from Q1 2004 to Q3 2022 using Open vigil2.1. We use the high-level term \"anaemias haemolytic immune\" according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary (version 24.0). The reported correlation between drugs and DIIHA risk was identified by reported odds ratio (ROR) and proportional reporting ratio (PRR).
UNASSIGNED: There were 10500309 AEs in FAERS from 2004Q1 to 2022Q3, of which 2326 (0.02%) were DIIHA cases. The incidence of DIIHA is comparable between males and females. The most common drugs associated with DIIHA in adults and children are summarized according to the number of AE reports. The top 3 categories in terms of quantity of drugs are antineoplastic agents, immunosuppressants, and antibiotics for systemic use. The top 5 drugs in terms of ROR and PRR are alemtuzumab, daclizumab, fludarabine, busulfan, and bendamustine in adults, with entecavir, treosulfan, vinorelbine, pegademase, and alemtuzumab for children.
UNASSIGNED: Our study identified the most common drugs that could induce DIIHA in adults and children, as well as the respective ROR and PRR value to discover new drug signals. This study provides references to clinicians for the management of rare DIIHA.
摘要：
药物诱导的免疫性溶血性贫血（DIIHA）是一种罕见但可能危及生命的药物血液学不良反应。根据自发报告的不良事件数据更新当前可用药物中的DIIHA风险具有重要意义。
本研究旨在根据美国食品和药物管理局不良事件报告系统（FAERS）数据库，确定与成人免疫性溶血性贫血相关的前50种药物以及可能导致儿童免疫性溶血性贫血的常见药物。
■我们在FAERS数据库中提取了2004年第一季度至2022年第三季度的不良事件（AE）。根据监管活动医学词典（MedDRA）词典（24.0版），我们使用高级术语“贫血溶血免疫”。通过报告比值比（ROR）和比例报告比（PRR）确定药物与DIIHA风险之间的报告相关性。
■从2004Q1到2022Q3，FAERS共有10500309例AE，其中2326例（0.02％）为DIIHA病例。DIIHA的发病率在男性和女性之间相当。根据AE报告的数量，总结了成人和儿童中与DIIHA相关的最常见药物。药物数量排名前三的是抗肿瘤药,免疫抑制剂,和全身使用的抗生素。ROR和PRR排名前5位的药物是阿仑单抗，daclizumab,氟达拉滨,白消安,和成人苯达莫司汀，恩替卡韦,曲硫丹,长春瑞滨,pegademase,和阿仑单抗用于儿童。
■我们的研究确定了可以在成人和儿童中诱导DIIHA的最常见药物，以及各自的ROR和PRR值，以发现新的药物信号。本研究为临床医师罕见的DIIHA的管理提供参考。
本研究旨在根据美国食品和药物管理局不良事件报告系统（FAERS）数据库，确定与成人免疫性溶血性贫血相关的前50种药物以及可能导致儿童免疫性溶血性贫血的常见药物。
■我们在FAERS数据库中提取了2004年第一季度至2022年第三季度的不良事件（AE）。根据监管活动医学词典（MedDRA）词典（24.0版），我们使用高级术语“贫血溶血免疫”。通过报告比值比（ROR）和比例报告比（PRR）确定药物与DIIHA风险之间的报告相关性。
■从2004Q1到2022Q3，FAERS共有10500309例AE，其中2326例（0.02％）为DIIHA病例。DIIHA的发病率在男性和女性之间相当。根据AE报告的数量，总结了成人和儿童中与DIIHA相关的最常见药物。药物数量排名前三的是抗肿瘤药,免疫抑制剂,和全身使用的抗生素。ROR和PRR排名前5位的药物是阿仑单抗，daclizumab,氟达拉滨,白消安,和成人苯达莫司汀，恩替卡韦,曲硫丹,长春瑞滨,pegademase,和阿仑单抗用于儿童。
■我们的研究确定了可以在成人和儿童中诱导DIIHA的最常见药物，以及各自的ROR和PRR值，以发现新的药物信号。本研究为临床医师罕见的DIIHA的管理提供参考。
