University of South Dakota, Sanford School of Medicine, Sioux Falls, SD, 57105, USA.
UCSF, Dermatology Department, San Francisco, CA, 94143-0989, USA.
Regul Toxicol Pharmacol. 2021 Apr;121:104867. doi: 10.1016/j.yrtph.2021.104867. Epub 2021 Jan 16.
Allergic contact dermatitis, a Type IV delayed hypersensitivity reaction, can result in dermatologic signs/symptoms for patients/workers. The likelihood of this phenomenon has been estimated/predicted for numerous chemicals/drugs by animal model and human patch testing protocols developed over the last century. Karl Landsteiner initiated testing with guinea pig studies; further studies based on his initial concept were in continual development. John Draize extended Landsteiner's guinea pig studies (which led to development of blood transfusions) to a human assay documenting irritant and allergic contact dermatitis potential - for drugs, chemicals, mixtures and products. We performed a literature search of major Draize derived protocols of the human repeat insult patch test (HRIPT). Our results reveal minor and major differences between protocols and lack of international standardization. Key clarification and principles post-Draize modified and improved usefulness of the HRIPT. Without a standard method of performing the HRIPT, it is problematic to generalize results of studies summarized here. Furthermore, we suggest a potential standardization procedure/protocol combining the work of the most satisfactory HRIPT methods. As the HRIPT constitutes a key parameter in current quantitative risk assessment for chemicals/drugs, such standardization should aid potential prediction of allergic contact dermatitis potential.
变应性接触性皮炎是一种 IV 型迟发型超敏反应，可导致患者/工人出现皮肤科体征/症状。在过去一个世纪中，通过动物模型和人体斑贴试验方案，已经对许多化学物质/药物进行了这种现象的可能性估计/预测。Karl Landsteiner 通过豚鼠研究开始了测试；基于他最初的概念的进一步研究一直在不断发展。John Draize 将 Landsteiner 的豚鼠研究（导致了输血的发展）扩展到了一种人体测定法，用于记录刺激性和变应性接触性皮炎的潜力-用于药物、化学物质、混合物和产品。我们对主要的 Draize 衍生的人体重复刺激斑贴试验 (HRIPT) 协议进行了文献检索。我们的研究结果揭示了协议之间的细微和主要差异，以及缺乏国际化标准化。Key 澄清和原则在 Draize 之后修改和提高了 HRIPT 的有用性。如果没有执行 HRIPT 的标准方法，概括这里总结的研究结果就存在问题。此外，我们建议采用一种潜在的标准化程序/协议，结合最令人满意的 HRIPT 方法的工作。由于 HRIPT 是当前化学物质/药物定量风险评估的关键参数，因此这种标准化应该有助于潜在预测变应性接触性皮炎的潜力。
