Maximos Mira, Pelletier Ryan, Elsayed Sameer, Maxwell Colleen J, Houle Sherilyn K D, McConnell Brie, Gamble John-Michael
School of Pharmacy, University of Waterloo, Kitchener, ON, Canada.
Women's College Hospital, Toronto, ON, Canada.
Br J Clin Pharmacol. 2025 Mar;91(3):684-697. doi: 10.1111/bcp.16366. Epub 2024 Dec 19.
Sex and gender may influence penicillin allergy label (PAL) prevalence and outcomes. This review evaluates the effectiveness and safety of direct delabelling (DD) and oral challenge (OC) for low-risk patients and examines sex and gender differences in reporting and outcomes.
We searched PubMed, Database of Abstracts of Reviews and Effects, ClinicalTrials.gov, Cochrane Database of Systematic Reviews, International Pharmaceutical Abstracts, medRxiv, Ovid MEDLINE, and Ovid EMBASE until February 2024 for studies including DD or OC compared to no intervention, skin testing or other methods. Two reviewers assessed quality. Meta-analyses were conducted, and subgroup analyses were carried out if I > 75%. Descriptive data was analysed using NVivo 14 and reported narratively.
From 1046 screened studies, 28 met inclusion criteria (two RCTs, 26 quasi-experimental studies). Sex at baseline was reported in 86% of studies, with 61% females: 18% disaggregated outcomes by sex with a female mean delabelling rate of 66%. Gender variables were not reported. OC was not found to be more or less as effective comparaed to skin testing in RCTs (risk ratio [RR] 1.04; 95% confidence interval [CI] 0.95, 1.13, I = 74%). DD interventions had a 27% delabelling rate (95% CI 10%, 50%, I = 96%), with nursing staff achieving 29% (95% CI 15%, 47%, I = 63%) and allergists/immunologists 6% (95% CI 0.00, 0.00, I = 20%). Quasi-experimental studies reported 90% delabelling for OC, with 59% by allergists/immunologists and 90% by pharmacists. Adverse events averaged 4% and were non-severe.
DD and OC are effective for delabelling low-risk penicillin allergies. Comprehensive data is lacking on sex and gender differences, indicating a need for further research.
性别可能会影响青霉素过敏标签(PAL)的患病率及相关结果。本综述评估了针对低风险患者进行直接去除标签(DD)和口服激发试验(OC)的有效性和安全性,并研究了报告情况及结果中的性别差异。
我们检索了截至2024年2月的PubMed、循证医学数据库、ClinicalTrials.gov、Cochrane系统评价数据库、国际药学文摘数据库、medRxiv、Ovid MEDLINE和Ovid EMBASE,以查找将DD或OC与无干预、皮肤试验或其他方法进行比较的研究。两名评审员评估质量。进行了荟萃分析,若I>75%则进行亚组分析。使用NVivo 14对描述性数据进行分析,并以叙述方式报告。
在1046项筛选的研究中,28项符合纳入标准(2项随机对照试验,26项准实验研究)。86%的研究报告了基线时的性别,其中61%为女性:18%按性别对结果进行了分类,女性的平均去除标签率为66%。未报告性别变量。在随机对照试验中未发现OC与皮肤试验相比效果更好或更差(风险比[RR]为1.04;95%置信区间[CI]为0.95,1.13,I=74%)。DD干预的去除标签率为27%(95%CI为10%,50%,I=96%),护理人员的去除标签率为29%(95%CI为15%,47%,I=63%),过敏症专科医生/免疫学家的去除标签率为6%(CI为0.00,0.00,I=20%)。准实验研究报告OC的去除标签率为90%,其中过敏症专科医生/免疫学家的去除标签率为59%,药剂师的去除标签率为90%。不良事件平均发生率为4%,且不严重。
DD和OC对于去除低风险青霉素过敏标签是有效的。缺乏关于性别差异的全面数据,表明需要进一步研究。