背景:目前尚无用于确认/去标记β-内酰胺超敏反应(BL-HSR)的药物激发试验(DPT)的标准化持续时间。
目的:本荟萃分析和系统评价旨在研究延长日比单日DPT对成人和儿童BL-HSR的确认/脱标签的附加诊断价值。
方法:MEDLINE,EMBASE,WebofScience,从开始到2023年3月15日,我们搜索了CINAHL在线数据库,寻找进行延长日DPT以确认/delabelBL-HSR的研究。使用风险差异和风险比比较单日或延长日DPT确诊为BL-HSR的患者比例。
结果:共纳入42项研究的10,371例DPT。延长的DPT为2-7天,或只要报告指标反应(最长10天)。确诊的BL-HSR的总体患病率为6.96%(第一天DPT期间为3.31%,延长日DPT期间为3.65%)。在延长的DPT期间,大约一半的阳性反应发生在第二天/第三天。延长DPT产生的确认BL-HSR的检测池患病率增加为0.03(95CI:0.02-0.04%;I2=57.69%,p<0.001),延长日和单日DPT之间的阳性反应风险比为1.94(95CI:1.62-2.33;I2=36.26%,p<0.001)。BL-HSR患病率每增加1%,风险差异增加0.6%(95CI:0.4-0.7%;p<0.001)。DPT期间发生了23次严重反应,在延长的DPT期间仅发生2次严重反应(0.02%)。需要额外的28天延长DPT来鉴定一个轻度反应。
结论:在延长日DPT期间观察到的确诊BL-HSR的患病率增加可能归因于第一天DPT。作为一个结果,我们的研究结果并不最终支持在单日DPT中使用延长日DPT.进一步研究,合并了一个清洗期,需要全面比较这两种方法。
There is currently no standardized duration of drug provocation test (DPT) for
confirming/delabeling beta-lactam hypersensitivity reaction (BL-HSR).
This meta-analysis and systematic review aimed to investigate the added diagnostic value of extended-day over single-day DPT for
confirming/delabeling BL-HSR in adults and children.
The MEDLINE, EMBASE, Web of Science, and CINAHL online databases were searched from inception to March 15, 2023, for studies that performed extended-day DPT to confirm/delabel BL-HSR. Risk difference and risk ratio were used to compare the proportions of patients with confirmed BL-HSR by single-day or extended-day DPT.
A total of 10,371 DPTs from 42 studies were included. Extended-day DPTs ranged from 2 to 7 days, or as long as index reactions were reported (maximum 10 days). The overall prevalence of confirmed BL-HSR was 6.96% (3.31% during the first-day DPT, and 3.65% during extended-day DPT). Approximately half of the positive reactions during extended-day DPT occurred during the second/third day. The increased detected pool prevalence of confirmed BL-HSR yielded by extended-day DPT was 0.03 (95% CI, 0.02%-0.04%; I2 = 57.69%; P < .001), and the risk ratio of positive reactions between extended-day and single-day DPT was 1.94 (95% CI, 1.62-2.33; I2 = 36.26%; P < .001). The risk difference increased per 1% increase in prevalence of BL-HSR by 0.6% (95% CI, 0.4%-0.7%; P < .001). Twenty-three severe reactions occurred during DPT, and only 2 severe reactions (0.02%) occurred during extended-day DPT. An additional 28 extended-day DPTs were needed to identify 1 mild reaction.
The increased prevalence of confirmed BL-HSR observed during extended-day DPT could be attributed to the first-day DPT. As a result, our findings do not conclusively support the use of extended-day DPT over single-day DPT. Further studies, incorporating a washout period, are required to comprehensively compare these 2 approaches.