Anaphylactoid reactions to Dextran 40 and 70: Reports to the United States Food and Drug Administration, 1969 to 2004
Anaphylactoid reactions to Dextran 40 and 70: Reports to the United States Food and Drug Administration, 1969 to 2004
复制标题
DOI：
10.1016/j.jvs.2006.01.006
复制
发表时间：
2006-05-01
影响因子：
4.3
通讯作者：
Wise, RP
中科院分区：
文献类型：
--
作者：
Zinderman, CE;Landow, L;Wise, RP
工作背景：临床葡聚糖，如葡聚糖40和葡聚糖70，与葡聚糖反应性免疫球蛋白G抗体引起的类速发过敏反应相关。当在临床使用右旋糖酐前立即输注时，右旋糖酐1可显著降低重度过敏样反应的发生率。这项研究的目的是描述的频率和特点的报告提交给美国食品和药物管理局（FDA）的过敏反应或过敏样事件后，临床dextranadministration.Methods：我们搜索了FDA的不良事件报告系统的报告与临床右旋糖酐和描述过敏反应/过敏样反应。我们对可能的速发过敏反应/类速发过敏反应事件的病例定义要求至少有两个身体系统的体征或症状，至少有一个体征或症状是低血压、血管舒张或呼吸困难，并且在60分钟内发作。如果报告者将反应具体描述为速发过敏反应或类速发过敏反应，则认为其他报告为可能病例。Premier RxMarket Advisor根据美国医院样本的出院账单数据，提供了2000年至2004年使用临床右旋糖酐或右旋糖酐1给药的美国住院总人数的估计值。IMS国家销售的角度提供了估计的总剂量的右旋糖酐在美国销售的1999年至2004年，基于石油体积的右旋糖酐销售的样本零售和非零售outlets.Results：FDA收到366临床右旋糖酐不良事件报告，从1969年至2004年，其中90（24.6%）是过敏反应/过敏样事件。给予临床右旋糖酐的住院与给予右旋糖酐1的住院的比率为28.4：1。如果所有临床右旋糖酐患者均接受右旋糖酐1预处理，则预期比例为1：1。在美国销售的右旋糖酐临床剂量与右旋糖酐1剂量之比为38.6：1。高比例的临床右旋糖酐不良事件报告描述了速发过敏反应或类速发过敏反应。出院和产品销售数据表明，近年来，在临床使用右旋糖酐之前，右旋糖酐1并未持续使用。为了降低类速发过敏反应的风险，医生应考虑在输注临床右旋糖酐前常规给予右旋糖酐1。
Background: Clinical dextrans, such as Dextran 40 and Dextran 70, are associated with anaphylactoid reactions caused by dextran-reactive immunoglobulin G antibodies. When infused immediately before clinical dextrans, dextran 1 significantly reduces the incidence of severe anaphylactoid reactions. The objective of the study was to describe the frequency and characteristics of reports submitted to the United States Food and Drug Administration (FDA) for anaphylaxis or anaphylactoid events after clinical dextran administration.Methods: We searched the FDA's Adverse Event Reporting System for reports associated with a clinical dextran and describing anaphylaxis/anaphylactoid reactions. Our case definition for a probable anaphylaxis/anaphylactoid event required signs or symptoms from at least two body systems, with at least one sign or symptom being hypotension, vasodilation, or respiratory difficulty, and onset within 60 minutes. Other reports were considered possible cases if the reporter specifically described the reaction as anaphylaxis or an anaphylactoid reaction. Premier RxMarket Advisor provided estimates of total US hospitalizations with clinical dextran or dextran 1 administration from 2000 to 2004, based on discharge billing data from a sample of US hospitals. The IMS National Sales Perspective provided estimates of total doses of dextrans sold in the United States from 1999 to 2004, based oil volumes of dextrans sold in a sample of retail and nonretail outlets.Results: The FDA received 366 clinical dextran adverse event reports from 1969 to 2004, of which 90 (24.6%) were anaphylaxis/anaphylactoid events. The ratio of hospitalizations where clinical dextran was administered to hospitalizations where dextran 1 was administered was 28.4:1. The expected ratio would be 1:1 if all clinical dextran patients had received dextran 1 pretreatment. The ratio of clinical dextran doses sold to dextran 1 doses sold in the United States was 38.6:1.Conclusions. A high proportion of adverse event reports for clinical dextrans described anaphylaxis or anaphylactoid reactions. Hospital discharge and product sales data suggest that dextran 1 has not been used consistently before clinical dextran administration in recent years. To reduce the risk of anaphylactoid reactions, physicians should consider routine administration of dextran 1 before the infusion of a clinical dextran.