Vemuri Preeti, Harris Kathleen E, Suh Lydia A, Grammer Leslie C
Division of Allergy-Immunology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, USA.
Allergy Asthma Proc. 2004 May-Jun;25(3):165-8.
The manufacturing of PrePen (benzylpenicilloyl-polylysine) was suspended from September 2000 through November 2001 because of Food and Drug Administration intervention. PrePen is penicilloyl bound to polylysine and is considered to be the major determinant of penicillin metabolism; it is used as a skin-testing reagent to detect immunoglobulin E antibodies in people with a history of penicillin allergy. Because of the uncertainty of whether PrePen would be made available in the future, we attempted to make benzylpenicilloyl-polylysine in our laboratory using a modification of a previously described method. Subsequently, we compared our preparation with PrePen by enzyme-linked immunosorbent assay and skin testing. Using a patient previously documented to have a positive reaction to PrePen by history and intradermal skin testing, a puncture test to PrePen as well as dilutions of benzylpenicilloyl-polylysine was negative. Positive intradermal tests were performed on PrePen and benzylpenicilloyl-polylysine at 5 mg/mL. The enzyme-linked immunosorbent assay was performed to compare the antigenicity of PrePen and benzylpenicilloyl-polylysine and revealed similar binding to both. Subsequently, cutaneous testing on 10 additional penicillin-allergic people was performed, with corroborative results. Our benzylpenicilloyl-polylysine production methodology could prove useful to those who do not have access to PrePen or another similar reagent.
由于美国食品药品监督管理局的干预，PrePen（苄青霉素酰聚赖氨酸）的生产于2000年9月至2001年11月期间暂停。PrePen是与聚赖氨酸结合的青霉素酰，被认为是青霉素代谢的主要决定因素；它被用作皮肤测试试剂，以检测有青霉素过敏史者体内的免疫球蛋白E抗体。由于不确定未来是否能获得PrePen，我们尝试在实验室中采用一种对先前描述方法的改良方法来制备苄青霉素酰聚赖氨酸。随后，我们通过酶联免疫吸附测定和皮肤测试将我们的制剂与PrePen进行比较。使用一名先前经病史和皮内皮肤测试记录对PrePen有阳性反应的患者，对PrePen以及苄青霉素酰聚赖氨酸的稀释液进行的点刺试验均为阴性。对5mg/mL的PrePen和苄青霉素酰聚赖氨酸进行皮内试验呈阳性。进行酶联免疫吸附测定以比较PrePen和苄青霉素酰聚赖氨酸的抗原性，结果显示两者的结合相似。随后，对另外10名青霉素过敏者进行了皮肤测试，结果得到证实。我们生产苄青霉素酰聚赖氨酸的方法可能对那些无法获得PrePen或其他类似试剂的人有用。
