随机、安慰剂对照、双盲研究口服氨甲环酸治疗中重度黄褐斑。
Randomized, placebo-controlled, double-blind study of oral tranexamic acid in the treatment of moderate-to-severe melasma.
机构信息
Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas.
Department of Dermatology, St. Vincent's Hospital, Melbourne, Victoria, Australia; The Skin and Cancer Foundation Inc, Melbourne, Victoria, Australia; The Royal Children's Hospital, Melbourne, Victoria, Australia.
出版信息
J Am Acad Dermatol. 2018 Feb;78(2):363-369. doi: 10.1016/j.jaad.2017.09.053. Epub 2017 Oct 4.
BACKGROUND
Melasma is a common pigmentary disorder that is often difficult to treat. Tranexamic acid (TA) has emerged as a promising treatment for melasma; however, few controlled studies exist.
OBJECTIVE
To determine the efficacy of oral TA in patients with moderate-to-severe melasma.
METHODS
Patients with moderate-to-severe melasma were treated with 250 mg of TA or placebo capsules twice daily for 3 months and sunscreen followed by 3 months of treatment with sunscreen only. The primary outcome measure was the modified Melasma Area and Severity Index (mMASI) score.
RESULTS
A total of 44 patients were enrolled and 39 completed the study. At 3 months, there was a 49% reduction in mMASI score in the TA group versus 18% in the control group. Patients with severe melasma improved more than those with moderate melasma. Three months after treatment was stopped, there was a 26% reduction in mMASI score in the TA group compared with the baseline visit versus a 19% reduction in the placebo arm. No serious adverse events were noted in either group.
LIMITATIONS
Single-center study enrolling predominantly Hispanic women.
CONCLUSIONS
Oral TA appears to be an effective treatment for moderate-to-severe melasma with minimal side effects.
背景
黄褐斑是一种常见的色素沉着性疾病，通常难以治疗。氨甲环酸（TA）已成为治疗黄褐斑的一种有前途的方法；然而，很少有对照研究。
目的
确定口服 TA 治疗中重度黄褐斑患者的疗效。
方法
中重度黄褐斑患者每天服用 250mg TA 或安慰剂胶囊两次，持续 3 个月，并使用防晒霜，然后仅使用防晒霜治疗 3 个月。主要结局指标是改良黄褐斑面积和严重程度指数（mMASI）评分。
结果
共有 44 名患者入组，39 名患者完成了研究。在 3 个月时，TA 组的 mMASI 评分降低了 49%，而对照组降低了 18%。重度黄褐斑患者的改善程度大于中度黄褐斑患者。治疗停止 3 个月后，TA 组的 mMASI 评分较基线访视时降低了 26%，而安慰剂组降低了 19%。两组均未出现严重不良事件。
局限性
单中心研究，主要纳入西班牙裔女性。
结论
口服 TA 似乎是一种治疗中重度黄褐斑的有效方法，副作用极小。
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