Department of Dermatology, Venereology and Leprosy, Dr. R. P. Govt. Medical College, Kangra (Tanda), 176001, Himachal Pradesh, India.
Arch Dermatol Res. 2021 Mar;313(2):109-117. doi: 10.1007/s00403-020-02078-x. Epub 2020 Apr 30.
Oral tranexamic acid (TXA) 250 mg twice daily has been used effectively for 4 weeks to 6 months to treat melasma. As relapses are frequent on discontinuation, a minimum effective dose of TXA that can be used safely for long time remains unknown. We compared the efficacy of oral TXA 250 mg once daily and 500 mg twice daily given for 16 weeks in 132 (m:f 23:109) adults with melasma. 42 patients in Group-A (TXA 250 mg/d) and 46 patients in Group-B (TXA 500 mg twice/d) completed the study. They were followed up at 4-week interval for percentage reduction in baseline Melasma Area Severity Index (MASI) and at 24 and 28 weeks for relapse. Therapeutic response, for both as per-protocol and intention-to-treat analysis, was scored as very good (> 75% reduction), good (51-75% reduction), moderate (25-50% reduction), mild (< 25% reduction) or no improvement. Reduction in mean MASI score at 4 weeks was not statistically significant in Group-A but it decreased significantly 8 weeks onwards and was comparable with that in Group-B. The relapse rate was higher in Group-B (10.8%) than Group-A (4.7%) at the end of 28 weeks. Oligomenorrhoea and abdominal discomfort in few patients did not necessitate treatment discontinuation. TXA 500 mg twice daily showed early reduction in mean MASI score compared to 250 mg given once daily with comparable safety and therapeutic efficacy at 16 weeks. Open-label cross-sectional design, no control arm, small number of patients in each group, MASI score being subjective assessment tool, short duration of treatment and follow-up are study limitations.
口服氨甲环酸（TXA）250mg，每日两次，已有效使用 4 至 6 个月治疗黄褐斑。由于停药后经常复发，因此仍不清楚可安全长期使用的最低有效 TXA 剂量。我们比较了口服 TXA 250mg，每日一次和 500mg，每日两次，分别治疗 132 例（男：女 23：109）黄褐斑患者 16 周的疗效。A 组（TXA 250mg/d）42 例和 B 组（TXA 500mg，每日两次）46 例完成了研究。他们在 4 周时随访以评估基线黄褐斑面积严重程度指数（MASI）的百分比降低，在 24 和 28 周时随访以评估复发情况。根据方案和意向治疗分析，治疗反应评分分别为极好（>75%减少）、好（51-75%减少）、中（25-50%减少）、轻度（<25%减少）或无改善。A 组在第 4 周时 MASI 评分的降低无统计学意义，但在第 8 周后显著降低，与 B 组相当。在第 28 周结束时，B 组（10.8%）的复发率高于 A 组（4.7%）。少数患者出现月经稀少和腹部不适，但无需停药。与每日一次 250mg 相比，每日两次 500mg 可更快地降低 MASI 评分均值，并且在 16 周时具有相同的安全性和疗效。开放性、交叉设计、无对照组、每组患者数量少、MASI 评分是主观评估工具、治疗和随访时间短是研究的局限性。
