Allergy Unit, IBIMA-Regional University Hospital of Malaga UMA, Málaga, Spain.
Research Unit for Allergic Diseases, IBIMA-Regional University Hospital of Malaga UMA, Málaga, Spain.
J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):1010-1018.e2. doi: 10.1016/j.jaip.2017.08.009. Epub 2017 Sep 28.
Reports of selective reactions to clavulanic acid (CLV) have increased in recent decades because of its increased prescription in combination with amoxicillin (AX) as AX-CLV. Basophil activation test (BAT) is used for diagnosing beta-lactam immediate hypersensitivity and is the only available in vitro assay for diagnosing patients with immediate hypersensitivity to CLV. However, few studies, and with limited numbers of patients have been published.
The aim of this study was to establish the sensitivity, specificity, and negativization rates of BAT to AX and CLV.
We studied 115 patients with immediate allergic reactions after AX-CLV treatment, 57 with selective reactions to AX (group A), 58 with selective reactions to CLV (group B), and 28 tolerant subjects. BAT was performed with AX in group A and with CLV in group B. A 4-year follow-up study was performed in patients with an initial positive BAT result.
The overall sensitivity of BAT was 55%, specificity 89%, and positive predictive value (PPV) 96%. For group A, sensitivity was 47%, specificity 93%, and PPV 93%; for group B, sensitivity was 62%, specificity 89%, and PPV 92%. Follow-up study showed a faster negativization rate of BAT for group A, with around 40% of patients becoming negative at 12 months in both groups.
The high PPV of BAT to CLV shows its potential value as a complementary tool to the allergological workup of patients with immediate allergic reactions after AX-CLV treatment. Importantly, the assay should be done within the first 12 months after the reaction to reduce false-negative results.
由于克拉维酸(CLV)与阿莫西林(AX)联合使用的处方增加,近年来选择性反应的报告有所增加,即 AX-CLV。嗜碱性粒细胞活化试验(BAT)用于诊断β-内酰胺即刻超敏反应,是诊断对 CLV 即刻超敏反应患者的唯一可用的体外检测方法。然而,发表的相关研究较少,且纳入的患者数量有限。
本研究旨在建立 BAT 对 AX 和 CLV 的敏感性、特异性和阴性预测值。
我们研究了 115 例因 AX-CLV 治疗后发生即刻过敏反应的患者,其中 57 例对 AX 有选择性反应(A 组),58 例对 CLV 有选择性反应(B 组),28 例为耐受者。在 A 组中进行 BAT 检测 AX,在 B 组中进行 BAT 检测 CLV。对初始 BAT 结果阳性的患者进行了为期 4 年的随访研究。
BAT 的总体敏感性为 55%,特异性为 89%,阳性预测值(PPV)为 96%。对于 A 组,敏感性为 47%,特异性为 93%,PPV 为 93%;对于 B 组,敏感性为 62%,特异性为 89%,PPV 为 92%。随访研究表明,A 组 BAT 的阴性预测值更快,两组中约有 40%的患者在 12 个月时转为阴性。
BAT 对 CLV 的高 PPV 表明其作为 AX-CLV 治疗后即刻过敏反应患者过敏反应评估的辅助工具具有潜在价值。重要的是,应在反应发生后的头 12 个月内进行检测,以减少假阴性结果。