Efficacy of the Topical Calcineurin Inhibitors Tacrolimus and Pimecrolimus in the Treatment of Vitiligo in Infants Under 2 Years of Age: A Randomized, Open-Label Pilot Study
Efficacy of the Topical Calcineurin Inhibitors Tacrolimus and Pimecrolimus in the Treatment of Vitiligo in Infants Under 2 Years of Age: A Randomized, Open-Label Pilot Study
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局部钙调神经磷酸酶抑制剂他克莫司和吡美莫司治疗 2 岁以下婴儿白癜风的疗效：一项随机、开放标签试点研究
DOI：
10.1007/s40261-019-00845-x
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发表时间：
2019-12-01
影响因子：
3.2
通讯作者：
Xu, Ai-E
中科院分区：
文献类型：
--
作者：
Hu, Wenting;Xu, Yongping;Xu, Ai-E
背景外用钙调磷酸酶抑制剂（TCIs）治疗2岁以下婴儿白癜风的疗效仍有待完全确定。目的本初步研究的目的是评估tci他克莫司和吡美莫司对2岁以下白癜风婴儿的疗效和耐受性。方法年龄< 2岁的白癜风患儿随机分为0.03%的他克莫司软膏组和1%的吡美莫司软膏组，治疗6个月。在此期间，每天进行两次局部治疗。记录治疗病变的体表面积比例、部位和可能出现的不良反应。此外，采用视觉模拟量表（VAS）对患者家长的总体满意度评分进行评估。结果本研究纳入46例白癜风患儿。他克莫司组和吡美莫司组的总有效率（> 50%）分别为69.6%和65.2%，总有效率（> 50%）为100%。头颈白癜风、躯干白癜风和四肢白癜风的有效率分别为70%、64.3%和50%，非节段性白癜风和节段性白癜风的有效率分别为74.4%和28.6%。在治疗过程中，仅报告了低发生率的局部不良反应（包括轻度发红和抠皮）。结论0.03%的他克莫司软膏或1%的吡美莫司乳膏治疗婴儿白癜风疗效良好，且在6个月的应用期内达到了适当的安全性和耐受性。因此，tci被证明是2岁以下婴儿白癜风的一种治疗选择。
BackgroundThe efficacy of topical calcineurin inhibitors (TCIs) for the treatment of infants with vitiligo aged less than 2 years remains to be fully determined.ObjectiveThis aim of this pilot study was to assess the efficacy and tolerability of the TCIs tacrolimus and pimecrolimus in infants with vitiligo aged under 2 years.MethodsInfants with vitiligo aged < 2 years were randomly assigned to receive either tacrolimus ointment 0.03% or pimecrolimus cream 1% for a period of 6 months. During this period, topical treatment was applied twice daily. The proportion of body surface area of the treated lesions, locations, and possible adverse effects were recorded. In addition, the overall satisfaction scores of the patients’ parents was evaluated by virtue of the visual analog scale (VAS).ResultsForty-six infants with vitiligo were enrolled in this study. The overall response rate (> 0% repigmentation) was 100%, while the effective rate (> 50% repigmentation) of the tacrolimus and pimecrolimus groups was 69.6% and 65.2%, respectively. Meanwhile, the effective rates for vitiligo located on the head and neck, trunk, and extremities were 70%, 64.3% and 50%, respectively, while the response rates for non-segmental and segmental vitiligo were 74.4% and 28.6%, respectively. Only a low incidence of local adverse reactions (including mild redness and skin picking) was reported during the treatment process.ConclusionsTopical tacrolimus ointment 0.03% or pimecrolimus cream 1% have efficacy for vitiligo in infants, which serves to achieve an appropriate level of safety and tolerability during the 6-month period of applications. Thus, TCIs proved to be a therapeutic option for vitiligo in infants under 2 years of age.