Clark Richard F, McKinney Patrick E, Chase Peter B, Walter Frank G
Division of Medical Toxicology, Department of Emergency Medicine, University of California San Diego Medical Center, and the California Poison Control System, San Diego Division, San Diego, CA, USA.
Ann Emerg Med. 2002 Jun;39(6):671-6. doi: 10.1067/mem.2002.123134.
Allergic reactions are the most commonly reported adverse events after administration of antivenoms. Conventional horse serum-based crotalid antivenom used in the United States (Antivenin [Crotalidae] polyvalent) can lead to both immediate and delayed hypersensitivity reactions. Crotalidae polyvalent immune Fab (ovine) (CroFab; FabAV) has recently been approved for use in the United States. Experience from premarketing trials of this product and in the administration of other types of Fab, such as in digoxin poisoning, has demonstrated these fragments to be safe and effective, with a low incidence of sequella; however, allergic reactions can occur when any animal-protein derivatives are administered to human subjects. We report in detail the nature and course of allergic reactions that occurred in 4 patients treated with FabAV. Cases of anaphylaxis, acute urticaria, angioedema, and delayed serum sickness are described. All reactions were easily treated with some combination of antihistamines, epinephrine, and steroids, with prompt resolution of signs and symptoms enabling further dosing of antivenom as required. Several of these cases may have resulted from batches of antivenom contaminated with Fc fragments. The overall incidence of immediate and delayed allergic reactions to this product appears so far to be lower than that reported with conventional whole-immunoglobulin G (IgG) antivenom, but postmarketing surveillance is warranted.
过敏反应是抗蛇毒血清给药后最常报告的不良事件。在美国使用的传统马血清来源的响尾蛇科抗蛇毒血清（抗蛇毒血清[响尾蛇科]多价）可导致即刻和延迟性超敏反应。响尾蛇科多价免疫Fab（羊）（CroFab；FabAV）最近已在美国获批使用。该产品上市前试验以及其他类型Fab（如用于地高辛中毒治疗）的给药经验表明，这些片段安全有效，后遗症发生率低；然而，当向人类受试者施用任何动物蛋白衍生物时，都可能发生过敏反应。我们详细报告了4例接受FabAV治疗的患者发生的过敏反应的性质和过程。描述了过敏反应、急性荨麻疹、血管性水肿和迟发性血清病的病例。所有反应均通过联合使用组胺拮抗剂、肾上腺素和类固醇轻松治疗，症状和体征迅速缓解，从而能够根据需要进一步给予抗蛇毒血清。这些病例中有几例可能是由于抗蛇毒血清批次被Fc片段污染所致。到目前为止，该产品即刻和延迟过敏反应的总体发生率似乎低于传统全免疫球蛋白G（IgG）抗蛇毒血清报告的发生率，但仍需进行上市后监测。
