Department of Dermatology, Venereology and Leprology, Dr. B.R Ambedkar State Institute of Medical Science, Mohali, Punjab, 160055, India.
Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India.
Arch Dermatol Res. 2023 Aug;315(6):1831-1836. doi: 10.1007/s00403-023-02549-x. Epub 2023 Feb 9.
Oral tranexamic acid (TXA) demonstrates promising results in melasma management. However, no clear consensus on the dosing and duration of maintenance doses of TXA therapy in melasma exists. In this study, we intend to evaluate and compare the efficacy of two different TXA dosing regimens in patients with melasma using the mMASI score. This was a randomized, open-label study wherein 50 patients (age > 18 years) with moderate to severe melasma were randomized into group A (250 mg TXA twice a day) and group B (500 mg TXA twice a day). Treatment was administered for 12 weeks and later followed up 4-weekly for next 12 weeks. The primary outcome measure was proportion of patients achieving 75% reduction in modified Melasma area and severity index (mMASI-75) at 12 weeks from baseline, reduction in mMASI and melasma quality of life (MelasQOL) score at 12 and 24 weeks. To assess the rate of relapse by end of 12 weeks post-treatment. Among 50 patients, proportion of patients achieving mMASI-75 at 12 weeks were 20% and 25% in group A and B, respectively (p-0.71). Both groups showed a significant reduction in mean mMASI (4.8 ± 2.2 in group A and 6.8 ± 3.4 in group B; p-0.02) at 12 weeks of treatment. mMASI remained stable after 12 weeks of follow-up and was 4.9 ± 2.43 and 4.93 ± 2.85 in group A and B, respectively (p-0.97). The mean percentage reduction in MelasQOL in group A and B were 41.8 ± 15.3 and 29.5 ± 21.5, respectively (p-0.03). No adverse effects were observed in both groups. Relapse rates was very less and comparable between both groups. Thus, we conclude that both dosing regimens showed comparable efficacy in terms of mMASI reduction at 12-weeks and the improvement achieved was well maintained even after 12-weeks of discontinuing treatment with very few patients relapsed. Hence, lower doses of TXA are equally effective and safe compared to higher doses and not all patients might require tapering or dosing maintenance.
口服氨甲环酸（TXA）在黄褐斑治疗中显示出良好的效果。然而，目前对于黄褐斑患者使用 TXA 治疗的维持剂量和疗程尚无明确共识。本研究旨在通过黄褐斑面积和严重度指数（mMASI）评分来评估和比较两种不同 TXA 剂量方案治疗黄褐斑的疗效。这是一项随机、开放性研究，共纳入 50 例年龄大于 18 岁的中重度黄褐斑患者，随机分为 A 组（TXA 250mg，每日 2 次）和 B 组（TXA 500mg，每日 2 次）。治疗持续 12 周，之后每 4 周随访 12 周。主要疗效指标为治疗 12 周时，与基线相比，mMASI 改善 75%（mMASI-75）的患者比例，治疗 12 周和 24 周时，mMASI 及黄褐斑生活质量（MelasQOL）评分的改善情况。评估治疗结束后 12 周内的复发率。在 50 例患者中，A 组和 B 组分别有 20%和 25%的患者在治疗 12 周时达到 mMASI-75（p-0.71）。两组患者的平均 mMASI 评分均显著降低（A 组为 4.8±2.2，B 组为 6.8±3.4；p-0.02）。治疗 12 周后，mMASI 保持稳定，A 组和 B 组分别为 4.9±2.43 和 4.93±2.85（p-0.97）。A 组和 B 组的 MelasQOL 评分平均百分比降低分别为 41.8±15.3 和 29.5±21.5（p-0.03）。两组均未观察到不良反应。两组的复发率均较低且相似。因此，我们得出结论，两种剂量方案在治疗 12 周时均可显著降低 mMASI，且即使在停止治疗 12 周后，治疗效果仍保持良好，仅有少数患者复发。因此，与高剂量相比，低剂量的 TXA 同样有效且安全，并非所有患者都需要逐渐减少剂量或维持剂量。
