Allergy Section, General University Hospital, UMH, Alicante, Spain
Allergy Service, Carlos Haya Hospital, Málaga, Spain
J Investig Allergol Clin Immunol. 2013;23(6):398-408.
Allergy to penicillin is the most commonly reported type of drug hypersensitivity. Diagnosis is currently confirmed using skin tests with benzylpenicillin reagents, ie, penicilloyl-polylysine (PPL) as the major determinant of benzylpenicillin and benzylpenicillin, benzylpenicilloate and benzylpenilloate as a minor determinant mixture (MDM).
To synthesize and assess the diagnostic capacity of 2 new benzylpenicillin reagents in patients with immediate hypersensitivity reactions to B-lactams: benzylpenicilloyl octa-L-lysine (BP-OL) as the major determinant and benzylpenilloate (penilloate) as the minor determinant.
Prospective multicenter clinical trial performed in 18 Spanish centers. Efficacy was assessed by detection of positive skin test results in an allergic population and negative skin test results in a nonallergic, drug-exposed population. Sensitivity, specificity, and negative and positive predictive values were determined.
The study sample comprised 94 allergic patients: 31 (35.23%) presented anaphylaxis, 4 (4.55%) anaphylactic shock, 51 (58.04%) urticaria, and 2 (2.27%) no specific condition. The culprit 8-lactams were amoxicillin in 63 cases (71.60%), benzypencillin in 14 cases (15.89%), cephalosporins in 2 cases (2.27%), other drugs in 3 cases (3.42%), and unidentified agents in 6 cases (6.82%). The results of testing with BP-OL were positive in 46 cases (52.3%); the results of testing with penilloate were positive in 33 cases (37.5%). When both reagents were taken into consideration, sensitivity reached 61.36% and specificity 100%. Skin testing with penilloate was significantly more often negative when the interval between the reaction and the study was longer.
The sensitivity of BP-OL and penilloate was 61%. Considering that amoxicillin was the culprit drug in 71% of reactions, these results indicate that most patients were allergic to the whole group of penicillins. These data support the use of benzylpenicillin determinants in the diagnosis of allergy to beta-lactams, even in predominantly amoxicillin-allergic populations.
青霉素过敏是最常见的药物过敏类型。目前，青霉素皮试使用苄青霉素试剂进行诊断，即青霉素酰基多聚赖氨酸（PPL）作为主要决定簇，苄青霉素、苯甲青霉素酯和苯甲青霉素作为次要决定簇混合物（MDM）。
合成并评估两种新的苄青霉素试剂在β-内酰胺类药物即刻过敏反应患者中的诊断能力：苯甲青霉素酰基八聚 L-赖氨酸（BP-OL）作为主要决定簇，苯甲青霉素酯（penilloate）作为次要决定簇。
在 18 个西班牙中心进行的前瞻性多中心临床试验。通过检测过敏人群的阳性皮肤试验结果和非过敏、药物暴露人群的阴性皮肤试验结果来评估疗效。确定了敏感性、特异性、阴性和阳性预测值。
研究样本包括 94 名过敏患者：31 名（35.23%）出现过敏反应，4 名（4.55%）出现过敏性休克，51 名（58.04%）出现荨麻疹，2 名（2.27%）无特殊情况。罪魁祸首 8-内酰胺是 63 例（71.60%）阿莫西林、14 例（15.89%）苯唑西林、2 例（2.27%）头孢菌素、3 例（3.42%）其他药物和 6 例（6.82%）未确定的药物。BP-OL 检测结果阳性 46 例（52.3%）；penilloate 检测结果阳性 33 例（37.5%）。当同时考虑两种试剂时，敏感性达到 61.36%，特异性为 100%。当反应与研究之间的间隔时间较长时，penilloate 的皮肤试验结果更常为阴性。
BP-OL 和 penilloate 的敏感性为 61%。考虑到阿莫西林是 71%反应的罪魁祸首药物，这些结果表明大多数患者对整个青霉素类药物过敏。这些数据支持在诊断β-内酰胺类药物过敏时使用苄青霉素决定簇，即使在主要对阿莫西林过敏的人群中也是如此。
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