Uter Wolfgang, Hildebrandt Stephan, Geier Johannes, Schnuch Axel, Lessmann Holger
Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nürnberg, Erlangen, Germany.
Contact Dermatitis. 2007 Oct;57(4):230-4. doi: 10.1111/j.1600-0536.2007.01228.x.
Disperse blue (DB) 106 and 124 are important textile dye allergens. However, the dye raw material is impure, leading to uncertainty regarding the actual patch test (PT) concentration. To examine, (i) the allergen content of previously and currently used DB 106 and 124 and a respective mix, and (ii) the frequency of positive PT reactions to the DB 106/124 mix and to the single compounds in consecutive PT patients. High performance liquid chromatography (HPLC) analysis and purification of DB 106 and 124, respectively. Descriptive analysis of PT data from the Information network of departments of dermatology obtained between January 2003 and December 2005. Retrospectively, 2 batches of the DB 106/124 mix proved to contain an amount of allergen different to the 1 declared (based on information of suppliers of raw material). However, since February 2005, DB 106 and 124, respectively, are available at a reliable concentration of 0.3% petrolatum. In 2005, the prevalence of positive PT reactions to both the mix (0.89%) and the single constituents combined (0.56%) did not qualify them for inclusion in the standard series. Quality control, providing accurate test concentrations of allergens based on technical grade purity raw materials is necessary for valid diagnosis of contact allergy and comparable epidemiological data.
分散蓝（DB）106和124是重要的纺织品染料过敏原。然而，染料原料不纯，导致实际斑贴试验（PT）浓度存在不确定性。目的在于：（i）检测先前和当前使用的DB 106和124及其混合物中的过敏原含量；（ii）在连续的PT患者中，检测对DB 106/124混合物和单一化合物的PT阳性反应频率。分别采用高效液相色谱（HPLC）对DB 106和124进行分析和纯化。对2003年1月至2005年12月期间从皮肤科信息网络获得的PT数据进行描述性分析。回顾性研究发现，2批DB 106/124混合物的过敏原含量与申报量（基于原料供应商提供的信息）不同。然而，自2005年2月起，DB 106和124分别以可靠的0.3%凡士林浓度供应。2005年，对混合物（0.89%）和单一成分组合（0.56%）的PT阳性反应患病率使其不符合纳入标准系列的条件。基于技术级纯度原料提供准确的过敏原检测浓度进行质量控制，对于接触性过敏的有效诊断和可比的流行病学数据是必要的。
