Zinderman Craig E, Landow Laurence, Wise Robert P
Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, MD 20852, USA.
J Vasc Surg. 2006 May;43(5):1004-9. doi: 10.1016/j.jvs.2006.01.006. Epub 2006 Apr 5.
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.
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 on volumes of dextrans sold in a sample of retail and nonretail outlets.
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.
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.
临床用葡聚糖，如右旋糖酐40和右旋糖酐70，与由右旋糖酐反应性免疫球蛋白G抗体引起的类过敏反应有关。在临床用葡聚糖之前立即输注时，右旋糖酐1可显著降低严重类过敏反应的发生率。本研究的目的是描述向美国食品药品监督管理局（FDA）提交的关于临床用葡聚糖给药后过敏反应或类过敏事件报告的频率和特征。
我们在FDA的不良事件报告系统中搜索与临床用葡聚糖相关且描述过敏反应/类过敏反应的报告。我们对可能的过敏反应/类过敏事件的病例定义要求至少两个身体系统出现体征或症状，其中至少一个体征或症状为低血压、血管扩张或呼吸困难，且在60分钟内发作。如果报告者明确将反应描述为过敏反应或类过敏反应，则其他报告被视为可能的病例。Premier RxMarket Advisor根据美国医院样本的出院计费数据，提供了2000年至2004年美国临床用葡聚糖或右旋糖酐1给药的住院总数估计值。IMS全国销售视角根据零售和非零售网点样本中葡聚糖的销售量，提供了1999年至2004年美国葡聚糖销售总量的估计值。
1969年至2004年，FDA收到366份临床用葡聚糖不良事件报告，其中90份（24.6%）为过敏反应/类过敏事件。临床用葡聚糖的住院病例数与右旋糖酐1的住院病例数之比为28.4:1。如果所有临床用葡聚糖患者都接受右旋糖酐1预处理，预期比例应为1:1。美国临床用葡聚糖销售量与右旋糖酐1销售量之比为38.6:1。
临床用葡聚糖的不良事件报告中有很大一部分描述了过敏反应或类过敏反应。医院出院和产品销售数据表明，近年来在临床用葡聚糖给药前，右旋糖酐1并未得到一致使用。为降低类过敏反应的风险，医生应考虑在输注临床用葡聚糖前常规使用右旋糖酐1。
