背景:在治疗皮肤药疹时,识别罪魁祸首药物至关重要。已经提出了因果关系评估方法(CAM),包括基于实验室的技术。然而,没有共识准则。
目的:确定并绘制基于实验室的CAM的功能和可行性。
方法:进行范围审查以确定罪魁祸首药物鉴定方法。分析了基于实验室方法的出版物。Medline,Embase,并检索了Cochrane中央对照试验注册数据库。
结果:25篇出版物符合纳入标准。研究了九种基于实验室的CAM,包括淋巴细胞转化试验,细胞因子测量(ELISpot,ELISA,珠子阵列测定),修饰的IFN-ELISpot,CellScan,组胺释放,颗粒酶B-ELISpot,细胞内颗粒溶素,淋巴细胞毒性试验,和HLA等位基因基因分型。报告了8/9方法的诊断准确性。临床评估和操作算法通常用作验证基准。基于实验室的方法在药疹的不同阶段进行了评估,包括在急性(18.1%),回收率(27.3%),急性和恢复(27.3%),或未指定的阶段(27.3%)。淋巴细胞转化试验(特异性30%~100%,灵敏度27%至73%)和细胞因子测量(特异性76%至100%,灵敏度20%至84%)是最常用的研究方法。
结论:基于实验室的CAM可能是低风险的,有效,和临床方法的补充。需要高质量的研究来充分开发和验证这些工具用于临床实践。
BACKGROUND: Identification of culprit drugs when managing cutaneous drug eruptions is essential. Causality assessment methods (CAMs) have been proposed, including lab-based techniques. However, no consensus guidelines exist.
OBJECTIVE: To identify and map the functionality and feasibility of lab-based CAMs.
METHODS: A scoping
review was conducted to identify culprit drug identification methods. Publications on lab-based methods were analyzed. Medline, Embase, and Cochrane Central Register of Controlled Trials databases were searched.
RESULTS: Twenty-five publications met inclusion criteria. Nine lab-based CAMs were studied, including lymphocyte transformation test, cytokine measurement (ELISpot, ELISA, beads array assay), modified IFN-ɣ ELISpot, CellScan, histamine release, granzyme B-ELISpot, intracellular granulysin, lymphocyte toxicity assay, and HLA allele genotyping. Diagnostic accuracy was reported for 8/9 methods. Clinical assessment and operational algorithms were commonly used as validation benchmarks. Lab-based methods were assessed at different phases of a drug eruption including in the acute (18.1%), recovery (27.3%), acute and recovery (27.3%), or an unspecified phase (27.3%). Lymphocyte transformation test (specificity 30% to 100%, sensitivity 27% to 73%) and cytokine measurement (specificity 76% to 100%, sensitivity 20% to 84%) were the most common methods studied.
CONCLUSIONS: Lab-based CAMs can be low-risk, effective, and complementary of clinical methods. High-quality studies are needed to adequately develop and validate these tools for clinical practice.