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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.

DOI:10.1016/j.jaad.2017.09.053
PMID:28987494
Abstract

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.

摘要

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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