Department of Education and Research Center for Pharmacy Practice, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Japan.
School of Pharmacy, Hyogo University of Health Sciences, Kobe, Japan.
Anticancer Res. 2022 May;42(5):2737-2741. doi: 10.21873/anticanres.15752.
BACKGROUND/AIM: Bendamustine-associated skin damage occurs frequently in Japan and can have a profound impact on health-related quality of life. To our knowledge, there are no reports on the timing of skin damage caused by bendamustine. This study assessed trends in and the time to onset of skin damage caused by bendamustine using the Japanese Adverse Drug Reaction Reporting Database (JADER).
Data related to skin damage with more than five reported cases from April 2004 to March 2021 were extracted from JADER, and the relative risk of adverse events was estimated using the reporting odds ratio and 95% confidence interval. The data were analyzed for time to onset of skin damage.
JADER included a total of 2,450 reports of adverse drug reactions from bendamustine. Of these, 170 skin ailments of 10 types were reported to be associated with bendamustine. Significant associations for skin damage were found for rash, herpes zoster, and infusion-related reactions. The reporting odds ratios (with 95% confidence interval) for rash, herpes zoster, and infusion-related reaction were 1.63 (1.19-2.21), 3.25 (2.20-4.78), and 7.25 (4.84-10.85), respectively. The median onset (interquartile range) of rash, herpes zoster, and infusion-related reactions caused by bendamustine were 13 (10-28), 60 (28-107), and 6 (1-28) days, respectively.
A comprehensive study using a pharmacovigilance approach enabled us to identify that a rash or infusion-related reaction may be expected within 2 weeks of treatment with bendamustine and that the onset of herpes zoster occurs at a median of 2 months after treatment with bendamustine.
背景/目的：苯达莫司汀相关皮肤损伤在日本频繁发生，并对健康相关生活质量产生深远影响。据我们所知，目前尚无关于苯达莫司汀引起皮肤损伤时间的报告。本研究使用日本不良药物反应报告数据库（JADER）评估了苯达莫司汀引起的皮肤损伤的趋势和发病时间。
从 2004 年 4 月至 2021 年 3 月，从 JADER 中提取了超过 5 例皮肤损伤不良事件相关数据，并使用报告比值比和 95%置信区间估计不良事件的相对风险。对皮肤损伤发病时间进行数据分析。
JADER 共包含 2450 例来自苯达莫司汀的不良药物反应报告。其中，报告了 10 种类型的 170 种皮肤疾病与苯达莫司汀相关。皮疹、带状疱疹和输注相关反应与皮肤损伤显著相关。皮疹、带状疱疹和输注相关反应的报告比值比（95%置信区间）分别为 1.63（1.19-2.21）、3.25（2.20-4.78）和 7.25（4.84-10.85）。苯达莫司汀引起的皮疹、带状疱疹和输注相关反应的中位发病时间（四分位间距）分别为 13（10-28）、60（28-107）和 6（1-28）天。
使用药物警戒方法进行综合研究，使我们能够确定在接受苯达莫司汀治疗后 2 周内可能会出现皮疹或输注相关反应，并且在接受苯达莫司汀治疗后 2 个月左右会出现带状疱疹。
