Sugimoto Naomi, Kuribayashi Kazuhiko, Yamamoto Yuji, Nagayasu Satoshi, Suga Osamu, Fujimoto Yoko
Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan.
MinaCare Co. Ltd., 2-3-11 Nihonbashihoncho, Chuo-ku, Tokyo, 103-0023, Japan.
Drugs Real World Outcomes. 2018 Mar;5(1):45-54. doi: 10.1007/s40801-017-0127-4.
Topical ointments containing fradiomycin sulfate, such as fradiomycin sulfate/methylprednisolone (F/M) and fradiomycin sulfate/betamethasone sodium phosphate (F/B), are known to cause allergic contact dermatitis (CD) in some patients, especially when used for the periocular region. F/M is commonly prescribed to patients for various conditions; however, there are no reports with respect to the incidence of CD caused by F/M in actual practice.
The aim was to investigate the incidence of CD using a data-based retrospective cohort study.
Using a Japanese health insurance claims database [MinaCare Co. Ltd. healthcare database (MinaCare HDB)], a comparative assessment was conducted of F/M and another combination drug (F/B) and two single-drug treatments (ophthalmic ointments with either an antibiotic or a steroid). The total data set consisted of 1,176,082 individuals in the MinaCare HDB, with 54,016 having received prescriptions for one of the four investigational drug regimens.
Overall, the incidences of CD were similar in three of the four groups in this study (F/M 0.091; F/B 0.092; steroids 0.102), while being lower in the fourth group (antibiotics 0.060). Even after confirmation of a diagnosis of CD, prescriptions for the investigational drugs were repeatedly filled for some patients.
This study demonstrated that there was no clear difference in the incidence of CD after filling prescriptions for F/M, F/B, and ophthalmic ointment containing a steroid, while the incidence with antibiotics was lower by 0.03-0.04 compared with the other groups. Considering the observation that the investigational drugs were repeatedly prescribed even after the diagnosis of CD, it is critical that the risk of CD with these prescribed topical ointments is better understood by primary care physicians in order to take appropriate countermeasures.
含硫酸新霉素的外用软膏，如硫酸新霉素/甲泼尼龙（F/M）和硫酸新霉素/倍他米松磷酸钠（F/B），已知会在一些患者中引起过敏性接触性皮炎（CD），尤其是用于眼周区域时。F/M常用于治疗各种病症的患者；然而，在实际应用中，关于F/M引起CD的发生率尚无相关报道。
旨在通过基于数据的回顾性队列研究调查CD的发生率。
使用日本医疗保险理赔数据库[MinaCare有限公司医疗数据库（MinaCare HDB）]，对F/M与另一种复方药物（F/B）以及两种单药治疗（含抗生素或类固醇的眼用软膏）进行了比较评估。MinaCare HDB中的数据集总共包含1,176,082人，其中54,016人接受了四种研究药物方案之一的处方。
总体而言，本研究中四组中的三组CD发生率相似（F/M为0.091；F/B为0.092；类固醇为0.102），而第四组（抗生素为0.060）的发生率较低。即使在确诊CD后，仍有一些患者反复开具研究药物的处方。
本研究表明，开具F/M、F/B和含类固醇眼用软膏的处方后，CD的发生率没有明显差异，而抗生素组的发生率比其他组低0.03 - 0.04。考虑到即使在诊断出CD后仍反复开具研究药物的情况，基层医疗医生更好地了解这些外用软膏处方导致CD的风险至关重要，以便采取适当的应对措施。
