Schnuch A, Gefeller O, Uter W
Zentrale des IVDK, Institut an der Universität Göttingen, Göttingen.
Dtsch Med Wochenschr. 2005 Dec 16;130(50):2881-6. doi: 10.1055/s-2005-923320.
Bufexamac is a non-steroidal, anti-inflammatory drug used in the topical treatment of atopic dermatitis, stasis dermatitis and perianal eczema. The substance is known to cause severe allergic contact dermatitis (ACD) as an adverse effect (AE), which may be indistinguishable from the eczema which is to be treated. Hence the diagnosis of this AE is often considerably delayed. In order to estimate the quantitative importance of ACD to bufexamac, data of the Information Network of (German) Departments of Dermatology (IVDK) from July 1999 to December 2004 were analysed.
During the study period, 39,392 unselected patients from 40 German departments of the IVDK were patch tested with bufexamac (5 % pet). The results of the reading after 72 hours were analysed. The dichotomized patch test result was further assessed for possible risk factors from the patients' history and clinical diagnosis by Poisson regression analysis.
In 560 of 39,392 patients contact allergy to bufexamac was diagnosed, i. e. 1.4 % (95 % confidence interval: 1.3 - 1.5), standardized for sex and age. The Poisson regression analysis revealed a significantly increased risk associated with the following factors: multiple sensitization, perianal eczema, underlying atopic dermatitis, leg dermatitis, female gender and residence in areas of Germany other than Eastern Germany. The latter observation can be explained by low prescription rates in Eastern Germany.
Bufexamac is an important allergen. Extrapolating the frequency of 1.4 % in our data to the whole German population by the CE-DUR approach yields an estimate of about 6000 cases per year. In view of the high frequency of sensitization, the pitfalls in diagnosis, the severity of the course of disease and the lack of efficacy of this drug, the risk to benefit ratio is obviously critical.
丁苯羟酸是一种非甾体类抗炎药，用于局部治疗特应性皮炎、淤积性皮炎和肛周湿疹。已知该物质会引起严重的过敏性接触性皮炎（ACD），作为一种不良反应（AE），这可能与待治疗的湿疹难以区分。因此，这种不良反应的诊断往往会被大大延迟。为了评估ACD对丁苯羟酸的定量重要性，分析了德国皮肤科部门信息网络（IVDK）1999年7月至2004年12月的数据。
在研究期间，对来自IVDK的40个德国科室的39392名未经挑选的患者进行了丁苯羟酸（5%凡士林）斑贴试验。分析了72小时后读数的结果。通过泊松回归分析，进一步评估二分法斑贴试验结果与患者病史和临床诊断中可能的风险因素。
在39392名患者中，有560名被诊断为对丁苯羟酸接触过敏，即1.4%（95%置信区间：1.3 - 1.5），按性别和年龄标准化。泊松回归分析显示，与以下因素相关的风险显著增加：多重致敏、肛周湿疹、潜在的特应性皮炎、腿部皮炎、女性性别以及居住在德国除东德以外的地区。后一种观察结果可以用东德地区较低的处方率来解释。
丁苯羟酸是一种重要的变应原。通过CE - DUR方法将我们数据中的1.4%频率外推至整个德国人口，估计每年约有6000例。鉴于致敏频率高、诊断中的陷阱、疾病过程的严重性以及该药物缺乏疗效，风险效益比显然很关键。
