Teste de provocação oral direto com beta-lactâmicos em crianças e adolescentes brasileiros

Abstract

Beta-lactams (BL) are the class of antibiotics most commonly associated with drug hypersensitivity reactions (DHR). Approximately 10% of the general population self-report as allergic to BL, but up to 90% of these individuals are found to be tolerant after investigation. Allergy investigation to BL typically includes skin testing before an oral provocation test (OPT), but due to its low sensitivity and negative predictive value, some researchers have proposed performing the OPT directly, i.e., without prior skin tests. To date, there are no consistent data on direct OPT for BL in Brazilian children and adolescents, nor is there consensus on the ideal duration of the test. The main objective of this study is to describe the safety profile of direct OPT in this population and aspects related to its extended use in this group. Method: A cross-sectional study was conducted with patients aged 1 to 17 years with a history of mild immediate or delayed reactions to penicillin, excluding patients with a history of severe reactions. Reactions were recorded using the European Network of Drug Allergy (ENDA) questionnaire, which includes data on the clinical and laboratory aspects of the reaction, as well as socio-demographic data. Fifty-four OPTs with amoxicillin (AMX), 50 mg/kg/day, were conducted, starting with 10% of the total dose and administering the remaining 90% 20 minutes later. Those who did not show an immediate reaction were released and were instructed to continue the medication at home for an additional 5 days. The entire procedure was performed by allergy specialists at Policlínica Piquet Carneiro (PPC). Continuous variables were described by their means and standard deviations. Bivariate analysis between test positivity and other study variables was conducted using the Chi-square test, odds ratio, and their respective 95% confidence intervals (CI95%). A p-value < 0.05 was considered significant. All legal guardians signed the informed consent form. Results: Most patients undergoing the OPT had no history of atopy (55.6%) or a family history of DHR (63%), and 57.4% were male. AMX was the most involved antibiotic (59.2%), with a mean age of 5.8 years. A total of four OPTs were positive (7.5%), and one was considered indeterminate; all responded rapidly to second-generation antihistamines, with no severe reactions. All positive reactions were in boys, and they exhibited delayed reactions, with three presenting symptoms on the first day of the test.Conclusion: More than 90% of the sample was desensitized from being labeled allergic to BL. There were no severe reactions, confirming the safety of direct OPT in this age group. Among the reactors, 75% showed manifestations on the first day of the test and 25% on the last day, indicating that further studies are needed to determine the optimal duration of the OPT.