Assessing the efficacy of oral tranexamic acid as an adjuvant to triple combination topical treatment in melasma: a meta-analysis of randomized controlled trials

评估口服氨甲环酸作为黄褐斑外用三联疗法辅助治疗的疗效：一项随机对照试验的荟萃分析

Melasma is a skin pigmentation disorder that lacks consistent treatment success, despite various methods used. Tranexamic acid (TXA) has shown hypopigmentation properties, but whether its administration should be combined with standard treatment has yet to be clarified. We aimed to perform an investigation of the effectiveness and safety of oral TXA as an adjuvant to triple combination cream (TCC) treatment in melasma. We searched PubMed, Embase and Cochrane (CENTRAL) for studies that compared TCC + adjuvant TXA to TCC treatment alone in patients with melasma. Outcomes of interest included change from the baseline Melasma Area and Severity Index (MASI) score, recurrence of melasma and adverse events. Statistical analysis was performed using R Studio 4.3.2. Four trials involving 490 patients were included. In the pooled analysis, the decrease from baseline in MASI score [mean difference -3.10, 95% confidence interval (CI) -5.85 to -0.35] was significantly higher in patients treated with oral TXA as an adjuvant to TCC compared with TCC alone. Melasma recurrence [risk ratio (RR) 0.28; 95% CI 0.16-0.49] was significantly lower in the group treated with TCC and TXA. Regarding erythema (RR 0.63, 95% CI 0.34-1.17) and burning (RR 0.59, 95% CI 0.30-1.17), no statistically significant difference was found. This meta-analysis demonstrated statistically significant benefits of TCC + TXA combination treatment compared with TCC alone. Furthermore, the results suggest that the addition of TXA to TCC treatment may reduce melasma recurrence.

背景：由于黄褐斑的多因素发病机制和复发性，其管理仍具有挑战性。既往研究显示A型肉毒毒素（BoNT-A）在治疗和预防紫外线诱导的色素沉着方面具有积极作用。

目的：评估辅助性皮内注射BoNT-A联合三联乳膏（TCC，4%氢醌、0.05%维A酸和0.01%氟轻松）治疗和预防黄褐斑复发的有效性，与单独外用三联乳膏治疗相比。

方法：在30例女性黄褐斑患者中开展了一项面部左右对照研究。一侧面部随机在黄褐斑受累区域外用TCC 12周（单药治疗），对侧在基线和第12周接受TCC联合皮内注射BoNT-A（联合治疗侧）。在基线和第2、4、8、12、16、20和24周进行评估。分别使用颧部MASI评分（MASIm）和色度计评估临床改善和黑素指数。同时评估患者满意度。

结果：28例受试者完成了研究。联合治疗侧在第2周显示MASIm显著下降（p = 0.0032），而单药治疗侧无显著变化。在第4周，与单药治疗侧（MASIm 11.68和11.79，恶化0.93%）相比，联合治疗侧观察到更大的MASIm降低（MASIm 14.5和11.54，降低20.41%）。在第12周，夏季期间两侧均观察到黄褐斑加重。在第24周（停用TCC后3个月），单药治疗侧MASIm为14.79（较基线恶化21.03%），联合治疗侧为9.14（改善36.97%，p = 0.0003）。研究结束时，联合治疗的患者满意度高于单药治疗（8.92 vs. 7.04，p < 0.0001）。未发生严重不良事件。

结论：与TCC单药治疗相比，皮内注射BoNT-A联合TCC在黄褐斑治疗和预防复发方面表现出更优的疗效。

Ribeiro Gonçalves O, de Souza MCF, Rocha AV, Alves GS, Freitas JLR, de Azevedo BB, Sobral MVS, Handocha AS, de Melo CB. Assessing the efficacy of oral tranexamic acid as an adjuvant to triple combination topical treatment in melasma: a meta-analysis of randomized controlled trials. Clin Exp Dermatol. 2024 Nov 22;49(12):1518-1524.

Clin Exp Dermatol 2024.pdf