Oral Tranexemic Acid With Triple Combination Cream (Flucinolone+Hydroquinone+Tretinoin) Versus Triple Combination Cream Alone In Treatment Of Melasma

口服氨甲环酸联合三联乳膏（氟轻松+氢醌+维A酸）与单用三联组合霜治疗黄褐斑的比较

Background: Melasma is an acquired cutaneous disorder characterized by hyperpigmentation of the face predominantly affecting the areas exposed to direct sun light. The triple combination cream, i.e., a mid-potency corticosteroid (Fluocinolone acetonide 0.01%), a retinoid (Tretinoin 0.05%), and Hydroquinone 4% is one of the widely used topical medicament for melasma treatment world over. Tranexamic acid is another agent found to be effective in melasma treatment when used topically, intra-lesionally or orally. This study has been conducted to compare mean decrease in Melasma Area Severity Index (MASI) score when tranexamic acid is combined with triple combination cream versus triple combination cream alone for melasma treatment.

Methods: A randomized controlled trial was conducted in a tertiary care hospital of Pakistan. Sixty-three patients of melasma who met the inclusion criteria and gave written informed consent for the study were enrolled. These patients were randomly divided into 2 treatment groups. Group A was given triple combination cream and oral tranxemic acid while Group B was given triple combination cream for duration of 8 weeks. Severity of melasma was assessed by MASI, which was calculated at baseline and at the end of week 8. Mean decrease in MASI score was calculated in both groups and statistically analysed employing SPSS 20.

Results: Sixty patients, 30 in both groups, completed the study. Study participants were predominantly female (81.67%), with mean age of 30.46±6.24 years in group A while 31.90±4.53 in group B. No statistically

 significant difference was noted in both treatment groups for mean decrease in the MASI score (6.4933±4.38358 in group A compared to 5.7833±5.04251 in the group B; p-value 0.56).

Conclusions: The addition of oral tranexamic acid did not contribute significantly in decrease in MASI score when used in combination with topical triple regimen. It may have a role as an adjuvant to topical triple combination cream.

背景：黄褐斑是一种获得性皮肤障碍，以面部色素沉着为特征，主要累及直接暴露于阳光的区域。三联乳膏，即中等强度糖皮质激素（氟轻松0.01%）、维A酸类药物（维A酸0.05%）和氢醌4%，是全世界广泛使用的黄褐斑外用治疗药物之一。氨甲环酸是另一种在局部、病灶内或口服使用时对黄褐斑治疗有效的药物。本研究旨在比较氨甲环酸联合三联乳膏与单用三联乳膏治疗黄褐斑时黄褐斑面积严重程度指数（MASI）评分的平均下降值。

方法：在巴基斯坦一家三级医院开展了一项随机对照试验。共纳入63例符合纳入标准并签署书面知情同意书的黄褐斑患者。这些患者被随机分为2个治疗组。A组给予三联乳膏联合口服氨甲环酸，B组给予三联乳膏，疗程8周。采用MASI评估黄褐斑严重程度，分别在基线和第8周结束时计算。计算两组的MASI评分平均下降值，并使用SPSS 20进行统计分析。

结果：60例患者（每组30例）完成了研究。研究参与者以女性为主（81.67%），A组平均年龄为30.46±6.24岁，B组为31.90±4.53岁。两治疗组之间MASI评分的平均下降值无统计学显著差异（A组为6.4933±4.38358，B组为5.7833±5.04251；p值0.56）。

结论：在与外用三联方案联合使用时，加用口服氨甲环酸并未对MASI评分的下降产生显著贡献。它可能作为外用三联组合霜的辅助治疗发挥作用。

Basit A, Rahman A, Uddin R. Oral Tranexemic Acid With Triple Combination Cream (Flucinolone+Hydroquinone+Tretinoin) Versus Triple Combination Cream Alone In Treatment Of Melasma. J Ayub Med Coll Abbottabad. 2021 Apr-Jun;33(2):293-298. 

202104-口服氨甲环酸三联乳膏和单独三联乳膏比较.pdf