外用3%氨甲环酸精华液治疗黄褐斑的前瞻性研究

Topical Application of 3%Tranexamic Acid Extract for the Treatment of Melasma Prospective Study

目的:观察外用3%氨甲环酸精华液治疗黄褐斑的疗效及不良反应。方法:将2021年6月-2021年12月在湘雅医院皮肤科就诊的50例黄褐斑患者按随机数字表法分为两组,实验组外用3%仙瑟氨甲环酸精华液+保湿霜,每日2次;对照组仅外用同种保湿霜,每日2次。每4周回访1次,试验周期为8周,治疗8周停止治疗,随访至12周。回访时依据黄褐斑面积及严重程度评分(Melasma area severity index,MASI)评估疗效,并根据VISIA图评估实验组患者面部红斑改善程度。治疗12周回访时评估复发率、医生及患者满意率并记录不良反应。结果:治疗后4周、8周、12周,实验组的平均MASI均低于对照组,差异具有统计学意义(P<0.05),且实验组患者面部红斑改善情况均优于对照组。随着治疗时间的延长,实验组MASI逐步下降(P<0.05),患者面部红斑改善率逐渐升高。治疗12周回访时医生满意率为88%,患者满意率为92%。结论:外用氨甲环酸治疗黄褐斑疗效肯定,但是对于不同类型的黄褐斑,在起效时间、复发上可能存在不同。配方合理的复合制剂可能是氨甲环酸外用制剂的进一步研究方向。

Objective To observe the efficacy and adverse effects of topical application of 3%tranexamic acid serum in melasma.Methods Fifty patients with melasma attending the Department of Dermatology at Xiangya Hospital from June 2021to December 2021 were randomly divided into 2 groups according to the random number table method.Experimental group was treated with 3%Sencer tranexamic acid serum and moisturizing cream twice daily.Control group was treated with the same moisturizing cream only,twice daily.Returning every 4 weeks for a trial period of 8 weeks,with treatment discontinued at 8 weeks and followed up until the 12 weeks.At the follow-up visit,the efficacy of the treatment was assessed according to the Melasma Area Severity Index(MASI),and the improvement of facial erythema in the experimental group was assessed according to the VISIA chart.The recurrence rate,physician and patient satisfaction rates,and adverse effects were recorded at the return visit at week 12.Results At 4 weeks,8 weeks and 12 weeks of treatment,,the mean MASI of the experimental group was lower than that of the control group,and the difference was statistically significant(P<0.05),and the improvement of facial erythema in the experimental group was better than the control group.With the extension of the treatment time,the MASI of the experimental group gradually decreased(P<0.05),and the improvement rate of facial erythema of patients gradually increased.The physician satisfaction rate was 88%and the patient satisfaction rate was 92%at the return visit at week 12.Conclusion The efficacy of topical tranexamic acid in the treatment of melasma is positive,but there may be differences in the time of onset of effect and recurrence for different types of melasma.A reasonably formulated compound formulation may be a further research direction for topical tranexamic acid formulation.