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抗蛇毒血清在儿童响尾蛇咬伤中的安全性和有效性。

Safety and efficacy of Crotalidae Polyvalent Immune Fab in pediatric crotaline envenomations.

作者信息

Pizon Anthony F, Riley Bradley D, LoVecchio Frank, Gill Ruqayya

机构信息

Division of Medical Toxicology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

出版信息

Acad Emerg Med. 2007 Apr;14(4):373-6. doi: 10.1197/j.aem.2006.10.095. Epub 2007 Feb 12.

DOI:10.1197/j.aem.2006.10.095
PMID:17296804
Abstract

BACKGROUND

Since it was approved by the Food and Drug Administration in October 2000, Crotalidae Polyvalent Immune Fab (CroFab) has largely replaced previously used crotaline antivenom. CroFab is more specifically tailored for crotalids of North America and is less allergenic than whole immunoglobulin antivenoms. However, premarketing and postmarketing studies have excluded children.

OBJECTIVES

To describe the safety and efficacy of CroFab in pediatric crotaline envenomations.

METHODS

Using admission and billing records, the authors identified all children 13 years of age and younger treated with CroFab at a pediatric hospital between October 2000 and September 2005. Charts were reviewed by two trained, blinded extractors. Data regarding age, signs of envenomation, laboratory values, total antivenom vials used, total vials used to gain control, transfused blood products, signs of acute allergy to antivenom, and any surgical procedures were abstracted. Data were analyzed using descriptive statistics.

RESULTS

Twenty-four patients were identified, and their mean age was 7.3 (range, 1.9-13) years. At presentation, all had swelling, 14 (58%) had a prothrombin time >13 seconds, two (8.3%) had a fibrinogen level <150 mg/dL, and three (12.5%) had platelet counts <150,000/mL. The mean number of total antivenom vials used was 12.3 (range, 4-24). Five patients had resolution of swelling, but platelet counts continued to fall despite antivenom treatment. No patient required blood products, debridement of skin, or fasciotomy. There was only one (4.2%) possible acute allergy to CroFab, and there were no deaths.

CONCLUSIONS

In this pediatric series, CroFab appears safe and effective, despite occasional resistant thrombocytopenia.

摘要

背景

自2000年10月被美国食品药品监督管理局批准以来,响尾蛇科多价免疫Fab(CroFab)已在很大程度上取代了先前使用的响尾蛇抗蛇毒血清。CroFab是更专门针对北美响尾蛇科毒蛇定制的,并且比全免疫球蛋白抗蛇毒血清的致敏性更低。然而,上市前和上市后研究都将儿童排除在外。

目的

描述CroFab在儿童响尾蛇科毒蛇咬伤中毒中的安全性和有效性。

方法

利用入院和计费记录,作者确定了2000年10月至2005年9月期间在一家儿科医院接受CroFab治疗的所有13岁及以下儿童。病历由两名经过培训的、不知情的提取人员进行审查。提取了有关年龄、中毒体征、实验室值、使用的抗蛇毒血清总瓶数、用于控制病情的总瓶数、输注的血液制品、对抗蛇毒血清急性过敏的体征以及任何外科手术的数据。使用描述性统计分析数据。

结果

确定了24例患者,他们的平均年龄为7.3岁(范围为1.9 - 13岁)。就诊时,所有人都有肿胀,14例(58%)凝血酶原时间>13秒,2例(8.3%)纤维蛋白原水平<150mg/dL,3例(12.5%)血小板计数<150,000/mL。使用的抗蛇毒血清总瓶数平均为12.3瓶(范围为4 - 24瓶)。5例患者肿胀消退,但尽管进行了抗蛇毒血清治疗,血小板计数仍继续下降。没有患者需要血液制品、皮肤清创或筋膜切开术。对CroFab可能的急性过敏仅有1例(4.2%),且无死亡病例。

结论

在这个儿科系列中,尽管偶尔会出现难治性血小板减少症,但CroFab似乎是安全有效的。

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