背景：关于儿童使用环吡罗明的信息很少。
目的：本研究的目的是评价1%环吡罗明乳膏治疗小儿皮肤真菌病的有效性和安全性。
方法：多中心，非随机化，开放标签，第三阶段的研究是在3个月至9岁的患者诊断为皮肤真菌病通过直接显微镜和培养证实，并用1%环吡唑明乳膏治疗28天。在开始治疗之前进行临床和微生物学评估，在开始治疗后7、14和28天，完成后28天。
结果：纳入21例患者，中位年龄为2.7岁（范围3个月-9岁）。最常见的真菌病位置是腹股沟区（72％）。最常见的病原体是念珠菌。（71%）。62%的患者未报告不良事件。在轻度和中度报告的不良事件中，只有一个,刺激性皮炎，被认为可能与治疗有关。95%的患者安全性评价良好，良好的5%。治疗的第一周后，13名患者中有12名（92%）表现出临床改善，7人中有5人(71%)有临床和真菌学改善.在治疗结束时,9例患者中有7例(78%)临床治愈.没有复发。
结论：环吡罗明乳膏1%是一种安全可行的治疗浅表皮肤真菌感染的方法，尤其是念珠菌属。感染,年龄在3个月至10岁之间的儿童。
BACKGROUND: There is scarce information on the use of ciclopirox olamine in children.
OBJECTIVE: The aim of this
study was to evaluate the efficacy and safety of ciclopirox olamine cream 1% for the treatment of dermatomycosis in pediatric patients.
METHODS: A multicenter, non-randomized, open-label, phase iii
study was conducted on patients aged 3 months to 9 years diagnosed with dermatomycosis confirmed by direct microscopy and culture, and treated with ciclopirox olamine cream 1% for 28 days. Clinical and microbiological evaluations were performed before starting the treatment therapy, at 7, 14 and 28 days after starting the treatment, and 28 days after its completion.
RESULTS: Twenty-one patients with a median age of 2.7 years (range 3 months-9 years) were included. The most frequent mycosis location was the inguinal region (72%). The most frequently isolated etiological agent was Candida spp. (71%). No adverse events were reported in 62% of the patients. Among the mild and moderate reported adverse events, only one, irritative dermatitis, was considered as possibly related to the treatment. Safety evaluation was excellent in 95% of the patients, and good in 5%. After the first week of treatment, 12 patients out of 13 (92%) showed a clinical improvement, and 5 out of 7 (71%) had both clinical and mycological improvements. At the end of the treatment, clinical cure was observed in 7 out of 9 patients (78%). No relapses occurred.
CONCLUSIONS: Ciclopirox olamine cream 1% is a safe and feasible treatment for superficial cutaneous mycotic infections, especially Candida spp. infection, in children aged between 3 months and 10 years.
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