Department of Dermatology, Tokyo Women's Medical University, Tokyo.
Data Science Department, Maruho Co. Ltd, Kyoto, Japan.
J Dermatol. 2017 Nov;44(11):1212-1218. doi: 10.1111/1346-8138.13996. Epub 2017 Aug 9.
Benzoyl peroxide (BPO) has been well established as a common medication for acne vulgaris in many countries (e.g. in Europe and the USA), where clinical data have been accumulated over a long time. In Japan, the use of BPO for acne treatment was approved in 2014, and the results of clinical trials in Japanese patients have recently been reported. This review compares clinical study results between Japanese and Western patients. Clinical studies that had been performed in Western countries were searched on the basis of the criteria, double-blind studies of BPO monotherapy and comparison with a vehicle group. Two reports of Japanese studies were also selected by using the same criteria. Efficacy was assessed by comparing the mean difference between the BPO and the vehicle groups for reduction rate in the number of lesions from baseline, and there were no differences between Japanese and Western patients. Safety assessment also showed that the incidence of adverse events was higher in Japanese patients than in Western patients, but the characteristics of the adverse events were not different. Therefore, we conclude that there are no significant differences in the efficacy and safety of BPO between these patient populations. The efficacy and safety of long-term use in Japanese patients are also expected to be applicable to those in Western patients.
过氧化苯甲酰（BPO）已在许多国家（如欧洲和美国）被广泛用作治疗寻常痤疮的常用药物，长期以来积累了大量的临床数据。在日本，BPO 于 2014 年被批准用于痤疮治疗，最近报告了日本患者的临床试验结果。本综述比较了日本和西方患者的临床研究结果。根据标准，检索了在西方国家进行的临床研究，即 BPO 单药治疗的双盲研究，并与对照组进行比较。还按照相同的标准选择了两项日本研究的报告。通过比较 BPO 组与对照组从基线开始的皮损数量减少率的均数差异来评估疗效，日本患者与西方患者之间没有差异。安全性评估还表明，日本患者不良反应的发生率高于西方患者，但不良反应的特征没有差异。因此，我们得出结论，BPO 在这两种人群中的疗效和安全性没有显著差异。日本患者长期使用的疗效和安全性也有望适用于西方患者。
