Department of Dermatovenerology, Chengdu First People's Hospital, Chengdu, China.
Department of Orthopedics surgery, West China Hospital, Sichuan University, Chengdu, China.
J Clin Pharm Ther. 2021 Oct;46(5):1263-1273. doi: 10.1111/jcpt.13430. Epub 2021 May 7.
Tranexamic acid (TXA) is a novel treatment option for melasma; however, no consensus exists on its use. This study evaluates the efficacy and safety of TXA for melasma.
A comprehensive literature review was conducted to search for randomized controlled trials comparing TXA alone, TXA as adjuvant to routine treatment and placebo. Changes in the Melasma Area Severity Index (MASI)/modified MASI (mMASI) between pre- and post-treatment and between a certain melasma treatment and TXA were the primary outcomes. Twenty-four trials comparing oral, topical or intradermal TXA with routine treatment were included in the meta-analysis.
The change in MASI/mMASI scores at 4 (MD, 3.58; 95% confidence interval (CI), 2.15-5.01), 8 (MD, 5.08; 95% CI, 3.34-6.81), 12 (MD, 4.89; 95% CI, 3.80-5.97) and 16 (MD, 6.55; 95% CI, 2.62-10.48) weeks after treatment was all less than the baseline scores, regardless of the delivery route. The reduction in the MASI/mMASI scores between TXA adjuvant and routine treatment at 4 (MD, -0.43; 95% CI, -0.79 to -0.08), 8 (MD, -0.81; 95% CI, -1.09 to -0.54), 12 (MD, -1.10; 95% CI, -1.78 to -0.43) and 16 (MD, -1.12; 95% CI, -1.51 to -0.74) weeks was significant. However, the superiority of TXA was not detected when the topical or intradermal route was adopted. No serious adverse events occurred with the use of TXA.
These results suggest that oral TXA is an available, effective and safe alternative treatment for melasma.
氨甲环酸（TXA）是治疗黄褐斑的一种新的治疗选择；然而，其应用尚未达成共识。本研究评估了 TXA 治疗黄褐斑的疗效和安全性。
对比较 TXA 单独使用、TXA 作为常规治疗辅助治疗和安慰剂的随机对照试验进行了全面的文献综述。主要结局为治疗前后、某一黄褐斑治疗与 TXA 治疗之间的黄褐斑面积严重程度指数（MASI）/改良 MASI（mMASI）变化。纳入了 24 项比较口服、局部或皮内 TXA 与常规治疗的试验进行荟萃分析。
治疗后 4 周（MD，3.58；95%置信区间（CI），2.15-5.01）、8 周（MD，5.08；95%CI，3.34-6.81）、12 周（MD，4.89；95%CI，3.80-5.97）和 16 周（MD，6.55；95%CI，2.62-10.48）时的 MASI/mMASI 评分变化均小于基线评分，无论给药途径如何。TXA 辅助治疗与常规治疗在 4 周（MD，-0.43；95%CI，-0.79 至-0.08）、8 周（MD，-0.81；95%CI，-1.09 至-0.54）、12 周（MD，-1.10；95%CI，-1.78 至-0.43）和 16 周（MD，-1.12；95%CI，-1.51 至-0.74）时的 MASI/mMASI 评分降低均有统计学意义。然而，当采用局部或皮内途径时，并未发现 TXA 的优越性。TXA 治疗未发生严重不良事件。
这些结果表明，口服 TXA 是一种可行、有效和安全的黄褐斑替代治疗方法。
