Impacts of exposure to topical calcineurin inhibitors on metabolism in vitiligo infants
Impacts of exposure to topical calcineurin inhibitors on metabolism in vitiligo infants
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DOI：
10.1038/s41390-022-02133-5
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发表时间：
2022-06
影响因子：
3.6
通讯作者：
Wenting Hu;F. Lin;Jiehao Lei;A. Xu
中科院分区：
文献类型：
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作者：
Wenting Hu;F. Lin;Jiehao Lei;A. Xu
他克莫司软膏是一种最近开发的局部免疫调节剂，已被批准用于2岁以上白癜风患者。由于担心潜在的全身毒性作用，两岁以下儿童的治疗选择有限。我们想确定局部他克莫司治疗对2岁以下白癜风患者是否安全有效。方法通过为期6个月的临床试验，评价0.03%他克莫司治疗2岁以下儿童白癜风的疗效和安全性。同时，采集患者血清和尿液样本，采用液相色谱-质谱联用技术生成患者和健康对照者的血清和尿液代谢谱数据。结果6个月总有效率为100%，以色素沉着程度为标准。6个月后血液监测及代谢物检测结果显示，治疗组与对照组无差异。没有证据表明长期外用0.03%他克莫司软膏会引起体内代谢物或其他生理变化。结论司他莫司软膏治疗2岁以下儿童白癜风安全有效。试用注册http://www.chictr.org.cn标识符：ChiCTR 2100045920。我们首次报道了0.03%他克莫司软膏局部应用于以代谢物为特征的白癜风婴儿的有效性和安全性。没有证据表明长期外用0.03%他克莫司软膏会引起体内代谢物或其他生理变化。本研究为TCI治疗婴儿白癜风提供了依据。
BackgroundTacrolimus ointment is a recently developed topical immunomodulator that has been approved for use in patients with vitiligo older than 2 years. Concern regarding potential systemic toxic effects has limited treatment options for children younger than 2 years. We wanted to determine whether topical tacrolimus therapy is safe and effective in patients with vitiligo younger than 2 years.MethodsThe present 6-month clinical trial was conducted to evaluate the efficacy and safety of 0.03% tacrolimus in the treatment of vitiligo in children under 2 years of age. Meanwhile, serum and urine samples were collected, and liquid chromatography–mass spectrometry was performed to generate the serum and urine metabolic profile data of patients and healthy controls.ResultsThe overall response rate at the sixth month, which was defined by the degree of re-pigmentation, was 100%. As revealed by blood monitoring and metabolite detection 6 months later, there was no difference between the treatment group and the control group. There is no evidence that long-term topical application of 0.03% tacrolimus ointment will cause metabolite or other physical changes in the body.ConclusionsTacrolimus ointment appears to be effective and safe in the treatment of vitiligo in children younger than 2 year.Trial registrationhttp://www.chictr.org.cn identifier: ChiCTR 2100045920.ImpactWe first reported the efficacy and safety of topical application of 0.03% tacrolimus ointment in infants with vitiligo characterized by the metabolites.There is no evidence that long-term topical application of 0.03% tacrolimus ointment will cause metabolite or other physical changes in the body.This study provide evidence for the TCI treatment of infants with vitiligo.