Yasutaka Kuniyoshi1,2, Yasushi Tsujimoto3,4,5, Masahiro Banno3,6,7, Shunsuke Taito3,8, Takashi Ariie3,9, Takafumi Kubota3,10, Natsuki Takahashi11, Haruka Tokutake11. 1. Department of Pediatrics, Tsugaruhoken Medical COOP Kensei Hospital, 2-2-2 Ougi-machi, Hirosaki, Aomori, 036-8511, Japan. yasutakakuniyoshi@yahoo.co.jp. 2. Scientific Research WorkS Peer Support Group (SRWS-PSG), Osaka, Japan. yasutakakuniyoshi@yahoo.co.jp. 3. Scientific Research WorkS Peer Support Group (SRWS-PSG), Osaka, Japan. 4. Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe cho, Sakyo-ku, Kyoto, 606-8501, Japan. 5. Department of Nephrology and Dialysis, Kyoritsu Hospital, Chuo-Cho 16-5, Kawanishi, Hyogo, 666-0016, Japan. 6. Department of Psychiatry, Seichiryo Hospital, Tsurumai 4-16-27, Showa-ku, Nagoya, 466-0064, Japan. 7. Department of Psychiatry, Nagoya University Graduate School of Medicine, Tsurumai-cho 65, Showa-ku, Nagoya, 466-8560, Japan. 8. Division of Rehabilitation, Department of Clinical Practice and Support, Hiroshima University Hospital, 1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan. 9. Department of Physical Therapy, School of Health Sciences at Fukuoka, International University of Health and Welfare, 137-1 Enokizu, Okawa-shi, Fukuoka, 831-8501, Japan. 10. Department of Neurology, Tohoku University Graduate School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan. 11. Department of Pediatrics, Tsugaruhoken Medical COOP Kensei Hospital, 2-2-2 Ougi-machi, Hirosaki, Aomori, 036-8511, Japan.
Abstract
BACKGROUND: Most cases of beta-lactam allergy in children are likely to be mislabeled. This study aimed to assess the prevalence of true positives, as determined by drug challenge tests, and the rate of false negatives in children with suspected allergies and confirm the safety of the drug challenge test. METHODS: We conducted a systematic review and meta-analysis according to established procedures. Study participants were children with suspected beta-lactam allergy who underwent a drug challenge. PubMed MEDLINE, Dialog EMBASE, Cochrane Central Register of Controlled Trials, World Health Organization International Clinical Trials Registry Platform, and clinicaltrials.gov were searched from inception until March 5, 2021. RESULTS: The pooled prevalence of (a) positive results in the first challenge was 0.049 (95% CI, 0.041-0.057; I2 = 71%) from 78 studies; (b) serious adverse events was 0.00 (95% CI, 0.00-0.00; I2 = 0.0%) from 62 studies; and (c) positive results in the second challenge after the first negative result was 0.028 (95% CI, 0.016-0.043; I2 = 38%) from 18 studies. CONCLUSIONS: The prevalence of children with suspected beta-lactam allergy with true-positive results and false-negative results from the drug challenge test was very low. Serious adverse events resulting from drug challenge tests were also very rare. IMPACT: Most children with suspected beta-lactam allergy were likely to be mislabeled. Serious adverse events caused by the drug challenge test were rare. Few false-negative results were obtained from the drug challenge test.
BACKGROUND: Most cases of beta-lactam allergy in children are likely to be mislabeled. This study aimed to assess the prevalence of true positives, as determined by drug challenge tests, and the rate of false negatives in children with suspected allergies and confirm the safety of the drug challenge test. METHODS: We conducted a systematic review and meta-analysis according to established procedures. Study participants were children with suspected beta-lactam allergy who underwent a drug challenge. PubMed MEDLINE, Dialog EMBASE, Cochrane Central Register of Controlled Trials, World Health Organization International Clinical Trials Registry Platform, and clinicaltrials.gov were searched from inception until March 5, 2021. RESULTS: The pooled prevalence of (a) positive results in the first challenge was 0.049 (95% CI, 0.041-0.057; I2 = 71%) from 78 studies; (b) serious adverse events was 0.00 (95% CI, 0.00-0.00; I2 = 0.0%) from 62 studies; and (c) positive results in the second challenge after the first negative result was 0.028 (95% CI, 0.016-0.043; I2 = 38%) from 18 studies. CONCLUSIONS: The prevalence of children with suspected beta-lactam allergy with true-positive results and false-negative results from the drug challenge test was very low. Serious adverse events resulting from drug challenge tests were also very rare. IMPACT: Most children with suspected beta-lactam allergy were likely to be mislabeled. Serious adverse events caused by the drug challenge test were rare. Few false-negative results were obtained from the drug challenge test.
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