Delabeling Delayed Drug Hypersensitivity: How Far Can You Safely Go?
Delabeling Delayed Drug Hypersensitivity: How Far Can You Safely Go?
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DOI：
10.1016/j.jaip.2020.07.005
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发表时间：
2020-10
期刊：
影响因子：
--
通讯作者：
Phillips EJ
中科院分区：
文献类型：
--
作者：
Lehloenya RJ;Peter JG;Copascu A;Trubiano JA;Phillips EJ
延迟性免疫介导的药物不良反应(IM-ADRs)是指给药后6小时以上发生的反应。它们包括不同的临床表型，典型的是T细胞介导的反应，具有不同的机制，涉及从良性皮疹到威胁生命的皮肤或器官特异性疾病的各种严重程度。对于轻微的反应，如良性皮疹，去标记的考虑类似于立即反应，可能包括分级或单剂量药物挑战，有或没有事先的皮肤或贴片测试。对挑战性病例的评估，如患者在发生严重的延迟性IM-ADR时同时服用多种药物，应优先考虑临床确定最可能的表型和涉及的药物(S)。尽管斑贴试验、延迟皮肤试验和基于实验室的功能性药物分析或遗传试验等程序尚未得到广泛应用和验证，但它们可能会提供有价值的信息，帮助进一步帮助患者进行风险分层，并确定可能牵连的和/或交叉反应的药物(S)。决定将药物挑战作为IM-ADR严重延迟患者的诊断或去标签工具，应权衡风险-收益比，平衡潜在疾病治疗的严重性和优先顺序，以及替代有效和安全治疗的可用性。
Delayed immune mediated adverse drug reactions (IM-ADRs) are defined as reactions occurring more than 6 hours after dosing. They include heterogenous clinical phenotypes that are typically T-cell mediated reactions with distinct mechanisms across a wide spectrum of severity from benign exanthems through to life-threatening cutaneous or organ-specific diseases. For mild reactions such as benign exanthem, considerations for delabeling are similar to immediate reactions, and may include graded or single dose drug challenge with or without preceding skin or patch testing. Evaluation of challenging cases such as the patient who is on multiple drugs at the time a severe delayed IM-ADR occurs should prioritize clinical ascertainment of the most likely phenotype and implicated drug(s). Although not widely available and validated, procedures such as patch testing, delayed intradermal skin testing and laboratory-based functional drug assays or genetic (HLA) testing may provide valuable information to further help risk stratify patients and identify the likely implicated and/or cross-reactive drug(s). The decision to use drug challenge as a diagnostic or delabeling tool in a patient with a severe delayed IM-ADR should weigh the risk-benefit ratio, balancing the severity and priority for the treatment of the underlying, and the availability of alternative efficacious and safe treatments.
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