Pimecrolimus Cream 1% for Treatment of Vulvar Lichen Simplex Chronicus: An Open-Label, Preliminary Trial
Pimecrolimus Cream 1% for Treatment of Vulvar Lichen Simplex Chronicus: An Open-Label, Preliminary Trial
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吡美莫司%20乳膏%201%%20for%20治疗%20of%20外阴%20地衣%20Simplex%20慢性：%20An%20开放标签，%20初步%20试用
DOI：
10.1159/000106487
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发表时间：
2007
影响因子：
2.1
通讯作者：
L. Burrows
中科院分区：
文献类型：
--
作者：
A. Goldstein;A. Parneix‐Spake;Calogera L. McCormick;L. Burrows
背景：评价1%吡美莫司乳膏每日两次治疗外阴慢性单纯性苔藓（LSC）的有效性和安全性。方法：在这项为期12周的开放标签研究中，患者有活检证实的外阴LSC。入选标准为患者报告的瘙痒缓解视觉模拟量表≥ 3（VAS-PR，0 cm =无瘙痒至10 cm =重度瘙痒）和研究者总体评估≥ 2（伊加，0 =无疾病至3 =重度疾病）。通过不良事件报告和吡美莫司血药浓度测量评价安全性。结果：12名年龄25-53岁的女性入组。中位瘙痒评分（VAS-PR）从6分（最小4.9分，最大4.9分）下降到10分（最大4.9分）。9.0)基线至第4周0 cm（最大值）4.2），第8周（最大3.1)第12周（Max. 2.1）。7例患者报告瘙痒在第4周完全消退。中位伊加从2.5（最小值2，最大值2）下降到2.5（最大值2）。3)基线至0（最小值0，最大值2)在第12周。所有患者的红斑、表皮脱落和苔藓样变均得到改善。所有样本的吡美莫司血药浓度均低于定量限0.3 ng/ml。未报告不良事件。结论：在这项探索性研究中，所有女性外阴LSC的体征和症状均得到改善，吡美莫司乳膏显示出良好的安全性特征。需要更大规模的前瞻性研究来进一步评价吡美莫司治疗外阴LSC的效果。
Background: To evaluate efficacy and safety of pimecrolimus cream 1% twice daily for treatment of vulvar lichen simplex chronicus (LSC). Methods: Patients in this 12-week, open-label study had biopsy-proven vulvar LSC. Inclusion criteria were patient-reported Visual Analog Scale for Pruritus Relief ≧3 (VAS-PR, 0 cm = no itching to 10 cm = severe itching) and Investigator’s Global Assessment ≧2 (IGA, 0 = no disease to 3 = severe disease). Safety was evaluated by adverse event reports and pimecrolimus blood level measurements. Results: Twelve women aged 25–53 years were enrolled. The median pruritus score (VAS-PR) decreased from 6 (min. 4.9, max. 9.0) at baseline to 0 cm at week 4 (max. 4.2), week 8 (max. 3.1) and week 12 (max. 2.1). Seven patients reported complete resolution of pruritus by week 4. Median IGA decreased from 2.5 (min. 2, max. 3) at baseline to 0 (min. 0, max. 2) at week 12. Erythema, excoriation, and lichenification improved for all patients. Pimecrolimus blood concentration for all samples was below the limit of quantification, 0.3 ng/ml. No adverse events were reported. Conclusions: In this exploratory study, signs and symptoms of vulvar LSC improved for all women and pimecrolimus cream showed a favorable safety profile. Larger prospective studies are needed to further evaluate pimecrolimus for treatment of vulvar LSC.