Department of Dermatovenerology, Chengdu First People's Hospital, Chengdu, China.
Department of Orthopedics surgery, West China Hospital of Sichuan University, Chengdu, China.
J Cosmet Dermatol. 2024 Jan;23(1):33-43. doi: 10.1111/jocd.15965. Epub 2023 Aug 16.
Microneedling with topical tranexamic acid (TXA) is a novel treatment option for melasma; however, the efficacy and safety of this combined administration therapy is in controversial. This study is conducted to address this issue of this technique in melasma.
An extensive literature review was performed to identify relevant trials, including randomized split-face studies, randomized controlled trials and prospective non-randomized split-face studies, comparing microneedling plus topical TXA to routine treatments or placebo. The primary outcomes were changes of the Melasma Area Severity Index (MASI)/modified MASI (mMASI)/hemi MASI between before and after treatment, as well as the changes between a particular treatment and microneedling plus TXA. The mean differences (MDs) and 95% confidence intervals (CIs) were calculated for the reduction of melasma severity scores from baseline to each time point. In contrast, the standard mean differences (SMDs) and 95% CIs were calculated for the differences in reduction in melasma severity scores between the experimental and control groups at each time point.
A total of 16 trials were included in the systematic review and data synthesis. The pooled analysis demonstrated that MASI, mMASI, and hemiMASI scores decreased significantly at 4 weeks (MD = 1.85; 95% CI = 1.15-2.54), 8 weeks (MD = 3.28; 95% CI = 2.31-4.24), 12 weeks (MD = 4.73; 95% CI = 2.79-6.50), 16 weeks (MD = 3.18; 95% CI = 1.50-4.85), and 20 weeks (MD = 3.20; 95% CI = 1.95-4.46) after treatment when compared with baseline. The reduction in melasma severity scores of microneedling with TXA group at 4 weeks was more significant than the routine treatment group (SMD = 0.97; 95% CI = 0.09-1.86), while insignificant at 8 weeks (SMD = 1.21; 95% CI = -0.17 to 2.59), 12 weeks (SMD = 0.63; 95% CI = -0.03 to 1.29), 16 weeks (SMD = 0.61; 95% CI = -2.85 to 4.07), or 20 weeks (SMD = 1.04; 95% CI = -1.28 to 3.36).
Despite the high heterogeneity across these studies, the current findings indicated that microneedling with topical TXA is an alternative treatment option for melasma treatment; and more well-designed studies are needed to confirm it.
微针刺联合局部氨甲环酸（TXA）是治疗黄褐斑的一种新的治疗选择；然而，这种联合治疗的疗效和安全性存在争议。本研究旨在探讨这种技术在黄褐斑中的应用。
进行了广泛的文献综述，以确定相关试验，包括随机分面研究、随机对照试验和前瞻性非随机分面研究，比较微针刺联合 TXA 与常规治疗或安慰剂。主要结局是治疗前后黄褐斑面积严重程度指数（MASI）/改良 MASI（mMASI）/半 MASI 的变化，以及特定治疗与微针刺联合 TXA 之间的变化。从基线到每个时间点的黄褐斑严重程度评分的减少用均数差（MD）和 95%置信区间（CI）表示。相反，在每个时间点，实验和对照组之间的黄褐斑严重程度评分的减少差异用标准均数差（SMD）和 95%CI 表示。
共纳入 16 项试验进行系统评价和数据综合分析。荟萃分析表明，4 周（MD=1.85；95%CI=1.15-2.54）、8 周（MD=3.28；95%CI=2.31-4.24）、12 周（MD=4.73；95%CI=2.79-6.50）、16 周（MD=3.18；95%CI=1.50-4.85）和 20 周（MD=3.20；95%CI=1.95-4.46）时 MASI、mMASI 和半 MASI 评分均显著降低与基线相比。微针刺联合 TXA 组在 4 周时的黄褐斑严重程度评分降低比常规治疗组更显著（SMD=0.97；95%CI=0.09-1.86），而在 8 周（SMD=1.21；95%CI=0.17-2.59）、12 周（SMD=0.63；95%CI=0.03-1.29）、16 周（SMD=0.61；95%CI=2.85-4.07）或 20 周（SMD=1.04；95%CI=1.28-3.36）时不显著。
尽管这些研究之间存在高度异质性，但目前的研究结果表明，微针刺联合局部 TXA 是治疗黄褐斑的一种替代治疗选择；需要更多设计良好的研究来证实这一点。
