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局部凝血酶制剂诱导产生抗体的风险及临床意义。

Risk and clinical significance of developing antibodies induced by topical thrombin preparations.

作者信息

Dorion R P, Hamati H F, Landis B, Frey C, Heydt D, Carey D

机构信息

Department of Laboratory Medicine and the Henry Hood, MD, Research Program, Geisinger Medical Center, Danville, PA 17822, USA.

出版信息

Arch Pathol Lab Med. 1998 Oct;122(10):887-94.

PMID:9786349
Abstract

OBJECTIVE

TO determine the clinical relevance, prevalence, and risk of antibody development in patients exposed to topical bovine thrombin preparations.

DESIGN

A prevalence study of individuals previously exposed to topical bovine thrombin was done by screening using Western blot assay to detect antibodies against bovine thrombin preparations.

SETTING

A large tertiary care center.

PATIENTS

A convenience sample of 120 stored blood specimens from patients previously exposed to topical bovine thrombin was identified from hospital records. A control sample of 114 stored blood specimens from nonexposed patients was used. Case reviews for 2 exposed patients with severe bleeding complications and difficult clinical management are presented.

RESULTS

Twelve of the bovine thrombin-exposed patients were found to have antibodies directed against bovine thrombin and other coagulation factors (95% CI, 4.6%-15.4%). Patients receiving multiple exposures were 8 times more likely to develop antibodies than were patients with a single exposure (P < .001).

CONCLUSIONS

(1) Topical bovine thrombin is associated with formation of antibodies to coagulation factors; (2) Patients receiving multiple exposures are more likely to develop antibodies to coagulation factors; and (3) Topical bovine thrombin use may cause severe bleeding problems and should be avoided if there has been previous exposure.

摘要

目的

确定接触局部用牛凝血酶制剂的患者中抗体产生的临床相关性、发生率及风险。

设计

通过使用蛋白质印迹法进行筛查以检测抗牛凝血酶制剂抗体,对既往接触过局部用牛凝血酶的个体进行一项发生率研究。

地点

一家大型三级医疗中心。

患者

从医院记录中确定了120份既往接触过局部用牛凝血酶的患者的储存血液标本作为便利样本。使用了114份未接触过的患者的储存血液标本作为对照样本。还介绍了2例有严重出血并发症且临床处理困难的接触过牛凝血酶患者的病例回顾。

结果

在接触牛凝血酶的患者中,有12例被发现存在针对牛凝血酶及其他凝血因子的抗体(95%可信区间,4.6% - 15.4%)。接受多次接触的患者产生抗体的可能性是单次接触患者的8倍(P < .001)。

结论

(1)局部用牛凝血酶与凝血因子抗体的形成有关;(2)接受多次接触的患者更易产生凝血因子抗体;(3)如果既往有接触史,应避免使用局部用牛凝血酶,因为其可能导致严重出血问题。

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