目的:评价氨甲环酸单纯外用和联合射频治疗仪舒敏之星导入在改善面部黄褐斑方面的有效性和安全性.方法:本研究为单中心、自身面部左右随机对照研究,符合纳排标准并签署知情同意书的33名受试者于双侧面颊外用3%氨甲环酸精华液,抽签随机选取一侧面颊为试验侧,另一为对照侧;试验侧使用舒敏之星导入5%氨甲环酸精萃液,每周1次、共12次.在0、14、28、56和84 d进行随访,采集面部皮肤检测仪(VISIA)和皮肤色素分析仪(Antera 3D)照片,黄褐斑面积及严重程度(MASI)评分评价黄褐斑严重程度,检测皮肤颜色、经皮水分丢失(TEWL)等生理指标和受试者主观评价,收集研究期间所有的不良反应.采用重复测量方差分析、配对t检验和非参数检验进行统计分析.结果:外用氨甲环酸精华液联合舒敏之星导入氨甲环酸精萃液和外用氨甲环酸精华液都可以显著改善黄褐斑皮损,28 d MASI评分降低相较基线差异具有统计学意义,84 d随访结束时MASI评分分别下降0.86、0.70,联合舒敏之星导入5%氨甲环酸精萃液侧优于单纯外用3%氨甲环酸精华液,但两侧差异无统计学意义(P>0.05),联合导入在改善黄褐斑皮损部位L值方面更有效,56、84 d较基线差异有统计学意义(P<0.05),对于正常肤色也有一定改善.联合导入还可以改善皮肤屏障功能,降低TEWL值(P<0.05).试验侧80.7%和对照侧67.7%的受试者认为黄褐斑颜色变淡、面积缩小,两侧之间差异无统计学意义(P>0.05),受试者整体满意度好,试验期间未见不良反应.结论:氨甲环酸外用可以降低MASI评分改善黄褐斑,联合舒敏之星导入氨甲环酸精萃液疗效更好,表现为84 d MASI评分降低更明显,皮损部位L值升高,联合导入不仅可以提高氨甲环酸的效果,还可以改善皮肤屏障功能,降低TEWL值.
Effect of different topical methods of tranexamic acid in improving melasma
Objective:To evaluate the efficacy and safety of tranexamic acid alone and in combination with radiofrequency in improving facial melasma.Methods:This is a single-center,self-controlled,ran-domized,and before-after controlled study.The subjects who met the inclusion criteria and signed an informed consent form were recruited,and 3%tranexamic acid essence was applied on both cheeks.One side was randomly selected as the experimental side,and the other side served as the control side.The experimental side received the introduction of 5%tranexamic acid essence using the radiofrequen-cy(Shuminzhixing)import once a week for a total of 12 times.Follow-up visits were conducted on days 0,14,28,56,and 84,during which VISIA and Antera 3D photos were taken.The severity of melasma was evaluated using MASI scores,and physiological indicators such as skin color and TEWL,as well as subjective evaluations by the subjects,were collected.Adverse reactions that oc-curred during the study period were also recorded.Statistical analysis was conducted using repeated measures analysis of variance,paired t-tests,and non-parametric tests.Results:The topical applica-tion of tranexamic acid essence combined with SensiStar for the tranexamic acid essence significantly improved melasma skin lesions.The MASI score decreased significantly compared to baseline at the end of 28 days;at the end of 84 days,the MASI scores decreased by 0.86 on the experimental side and 0.70 control side,respectively.The combination of SensiStar for tranexamic acid essence was superi-or to the sole topical application of 3%tranexamic acid essence(P>0.05).Combined application was more effective in improving the L value of the melasma skin lesions,with statistical differences as com-pared with baseline at 56 days and 84 days(P<0.05),and also had some improvement for normal skin color.The combined application also improved skin barrier function and reduced TEWL value(P<0.05).Of the subjects,80.7%on the experimental side and 67.7%on the control side reported that the color of the melasma had become lighter and the area had become smaller,without a signifi-cant difference between the two sides(P>0.05).Overall,the subjects were satisfied and no adverse reactions were observed during the trial period.Conclusion:Topical application of tranexamic acid can reduce MASI score and improve melasma.The combined use of Tranexamic acid essence with radio-frequency results in better efficacy,as evidenced by a more significant reduction in MASI scores at 84 days,an increase in L value at the site of skin lesions,and an improvement in skin barrier function,as well as a decrease in TEWL value.This combination not only enhances the effect of tranexamic acid but also improves skin barrier function and reduces TEWL value.
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