Abstract：
BACKGROUND: Ten % of the population is labeled as allergic to penicillin(s), when in fact 90% of these labels are inappropriate. Recent studies have shown that inpatient de-labelling by a direct drug challenge (dDC) is safe in low-risk patients. However, there is a need for outpatient and non-allergist de-labelling.
OBJECTIVE: To assess the safety of de-labelling low-risk adults by means of dDC in primary care.
METHODS: We searched MEDLINE, EMBASE and the Conchrane Library databases, from inception to March 15, 2022 (updated June 5, 2023) for studies performing dDC in adults in primary care or other outpatient settings. Two researchers independently screened studies for eligibility. The data extraction and critical appraisal was performed by one reviewer and we pooled the results in a meta-analysis.
RESULTS: Out of 2,138 results, 12 studies (1070 participants) were eligible for inclusion. Three studies evaluated de-labelling in primary care and 9 studies in an outpatient hospital setting. There were no critical adverse events during dDC. No reaction occurred in 97.13% of the 1070 patients, who previously labeled as penicillin-allergic, and were safely de-labelled. Ten patients (<1%) developed an immediate reaction: three had self-limiting reactions, and seven needed antihistaminics, steroids, epinephrine and/or salbutamol.
CONCLUSIONS: No serious allergic reactions are observed during direct amoxicillin challenge in adults in an outpatient setting. However, with the exception of one recent report, these studies are of low to moderate quality. Non-specialist de-labelling is promising but further research is required on correct risk stratification and safety assessment in large cohort studies evaluating dDC in primary care.
OBJECTIVE: To assess the safety of de-labelling low-risk adults by means of dDC in primary care.
METHODS: We searched MEDLINE, EMBASE and the Conchrane Library databases, from inception to March 15, 2022 (updated June 5, 2023) for studies performing dDC in adults in primary care or other outpatient settings. Two researchers independently screened studies for eligibility. The data extraction and critical appraisal was performed by one reviewer and we pooled the results in a meta-analysis.
RESULTS: Out of 2,138 results, 12 studies (1070 participants) were eligible for inclusion. Three studies evaluated de-labelling in primary care and 9 studies in an outpatient hospital setting. There were no critical adverse events during dDC. No reaction occurred in 97.13% of the 1070 patients, who previously labeled as penicillin-allergic, and were safely de-labelled. Ten patients (<1%) developed an immediate reaction: three had self-limiting reactions, and seven needed antihistaminics, steroids, epinephrine and/or salbutamol.
CONCLUSIONS: No serious allergic reactions are observed during direct amoxicillin challenge in adults in an outpatient setting. However, with the exception of one recent report, these studies are of low to moderate quality. Non-specialist de-labelling is promising but further research is required on correct risk stratification and safety assessment in large cohort studies evaluating dDC in primary care.
摘要：
背景：10%的人口被标记为对青霉素过敏，事实上，这些标签中有90%是不合适的。最近的研究表明，在低风险患者中，通过直接药物攻击（dDC）进行住院患者去标记是安全的。然而,有必要对门诊和非过敏症患者进行标签去除。
目的：评估在初级保健中通过dDC对低风险成人进行去标签的安全性。
方法：我们搜索了MEDLINE，EMBASE和Conchrane图书馆数据库，从开始到2022年3月15日(2023年6月5日更新),用于在初级保健或其他门诊的成人中进行dDC的研究.两名研究人员独立筛选研究的资格。数据提取和批判性评估由一名审阅者进行，我们将结果汇总在荟萃分析中。
结果：在2,138个结果中，12项研究（1070名参与者）符合纳入条件。三项研究评估了初级保健中的去标签，9项研究在门诊医院环境中进行了评估。dDC期间无严重不良事件。1070例患者中97.13%无反应发生,以前被标记为青霉素过敏的人，并被安全地取消了标签。10名患者（<1％）出现了立即反应：3名患者有自限性反应，七个人需要抗组胺药，类固醇,肾上腺素和/或沙丁胺醇。
结论：在成人门诊患者中，在阿莫西林直接激发过程中未观察到严重的过敏反应。然而,除了最近的一份报告外，这些研究质量低到中等。非专科医生去标签是有希望的，但在评估初级保健dDC的大型队列研究中，需要进一步研究正确的风险分层和安全性评估。
目的：评估在初级保健中通过dDC对低风险成人进行去标签的安全性。
方法：我们搜索了MEDLINE，EMBASE和Conchrane图书馆数据库，从开始到2022年3月15日(2023年6月5日更新),用于在初级保健或其他门诊的成人中进行dDC的研究.两名研究人员独立筛选研究的资格。数据提取和批判性评估由一名审阅者进行，我们将结果汇总在荟萃分析中。
结果：在2,138个结果中，12项研究（1070名参与者）符合纳入条件。三项研究评估了初级保健中的去标签，9项研究在门诊医院环境中进行了评估。dDC期间无严重不良事件。1070例患者中97.13%无反应发生,以前被标记为青霉素过敏的人，并被安全地取消了标签。10名患者（<1％）出现了立即反应：3名患者有自限性反应，七个人需要抗组胺药，类固醇,肾上腺素和/或沙丁胺醇。
结论：在成人门诊患者中，在阿莫西林直接激发过程中未观察到严重的过敏反应。然而,除了最近的一份报告外，这些研究质量低到中等。非专科医生去标签是有希望的，但在评估初级保健dDC的大型队列研究中，需要进一步研究正确的风险分层和安全性评估。
