Division of Allergy and Immunology, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.
Division of Allergy and Clinical Immunology, Johns Hopkins Hospital, Baltimore, Md.
J Allergy Clin Immunol Pract. 2019 Jan;7(1):236-243. doi: 10.1016/j.jaip.2018.05.008. Epub 2018 May 23.
Unconfirmed penicillin allergy poses substantial public health consequences. The most widely accepted protocol to evaluate penicillin allergy is skin testing followed by an amoxicillin challenge.
To evaluate the safety of direct oral graded challenges to amoxicillin.
A prospective single-blind clinical trial with historical controls of patients ≥7 years old with historical non-life-threatening reactions to penicillin was conducted. Patients received placebo followed by a 2-step graded challenge to amoxicillin. The allergic reaction rate was compared with the rate observed in our previous study that included skin testing and with the currently reported penicillin allergy prevalence in the US population.
Of the 155 participants who completed an amoxicillin challenge, 120 patients (77.4%) experienced no reaction whereas 31 patients (20%) experienced nonallergic reactions to either placebo (n = 16) or amoxicillin (n = 15). Four patients (2.6%) developed mild allergic reactions. Significantly (P = .03) fewer patients (4 of 155, 2.6%, 95% confidence interval [CI]: 1.0%, 6.5%) were determined to be allergic compared with 14 of 170 subjects (8.2%, 95% CI: 5.0%, 13.4%) in our previous study where patients were determined to be allergic based on either positive skin tests (n = 11) or allergic challenge reactions after negative skin tests (n = 3). This 2.6% reaction rate was also significantly less than the 10% reported US prevalence of penicillin allergy (P = .003).
Placebo-controlled oral graded challenges to amoxicillin without prior skin testing may be safe for patients ≥7 years old with non-life-threatening historical reactions to penicillin. Amoxicillin can be tolerated by the majority of patients with self-reported penicillin allergy.
未经证实的青霉素过敏会产生严重的公共卫生后果。评估青霉素过敏最广泛接受的方案是皮肤测试，然后进行阿莫西林挑战。
评估直接口服分级阿莫西林挑战的安全性。
对≥7 岁、有非危及生命的青霉素过敏史的患者进行了一项前瞻性、单盲临床试验，并进行了历史对照。患者先接受安慰剂，然后进行两步分级阿莫西林挑战。将过敏反应率与我们之前的研究（包括皮肤测试）以及目前美国人群中报告的青霉素过敏流行率进行比较。
在完成阿莫西林挑战的 155 名参与者中，120 名患者（77.4%）没有反应，31 名患者（20%）对安慰剂（n=16）或阿莫西林（n=15）有非过敏性反应。4 名患者（2.6%）出现轻度过敏反应。显著（P=0.03）较少的患者（155 例中有 4 例，2.6%，95%置信区间[CI]：1.0%，6.5%）被确定为过敏，而在我们之前的研究中，根据阳性皮肤测试（n=11）或阴性皮肤测试后过敏反应（n=3）确定过敏的 170 名患者中有 14 名（8.2%，95%CI：5.0%，13.4%）被确定为过敏。这一 2.6%的反应率也显著低于美国报告的 10%青霉素过敏流行率（P=0.003）。
对于有非危及生命的青霉素过敏史的≥7 岁患者，在无皮试的情况下，进行安慰剂对照的口服分级阿莫西林挑战可能是安全的。大多数自我报告有青霉素过敏的患者可以耐受阿莫西林。
