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微针联合外用4%氨甲环酸溶液与4%氢醌治疗黄褐斑的疗效:一项单盲随机临床试验。

Efficacy of microneedling plus topical 4% tranexamic acid solution vs 4% hydroquinone in the treatment of melasma: A single-blind randomized clinical trial.

作者信息

Shamsi Meymandi Simin, Mozayyeni Amirhossein, Shamsi Meymandi Manzumeh, Aflatoonian Mahin

机构信息

Pathology and Stem Cell Research Center, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.

Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.

出版信息

J Cosmet Dermatol. 2020 Nov;19(11):2906-2911. doi: 10.1111/jocd.13392. Epub 2020 May 13.

Abstract

BACKGROUND

There are various treatment modalities for melasma, but none of them are effective on dermal component of melasma.

AIMS

In this study, we decided to evaluate the efficacy of microneedling plus tranexamic acid in comparison with 4% hydroquinone in the treatment of melasma.

METHODS

This is a single-blind randomized clinical trial on 70 participants with 14% dropout, and therefore, 60 patients with melasma completed the study. Patients were randomized based on simple randomization in 2 groups of A (microneedling plus topical 4% tranexamic acid, monthly) and B (topical 4% hydroquinone, nightly). Evaluation of mean MASI score, patient and physician assessments was performed at 4th, 8th and12th weeks of the treatment. Statistical analysis was performed by paired t test, chi-square test and Fisher's exact test, respectively.

RESULTS

Sixty women (30 patients in each group) were completed the study. Mean MASI score in group A was significantly lower at the end of the treatment (6.84 ± 4.31) than at the baseline (12.89 ± 5.16) (P < .01). Mean MASI score in group B was significantly lower at the end of the treatment (7.16 ± 4.38) than at the baseline (13.56 ± 4.88) (P < .01). There was no statistical difference between 2 groups regarding MASI score, physician and patient assessments during the treatment. Percentage of patient satisfaction was significantly higher than physician satisfaction in both treatment groups (P < .01).

CONCLUSION

In our study, the combination of microneedling with tranexamic acid did not differ from 4% hydroquinone in the treatment of melasma.

摘要

背景

黄褐斑有多种治疗方式,但均对黄褐斑的真皮成分无效。

目的

在本研究中,我们决定评估微针联合氨甲环酸与4%氢醌治疗黄褐斑的疗效。

方法

这是一项针对70名参与者的单盲随机临床试验,有14%的脱落率,因此,60例黄褐斑患者完成了研究。患者通过简单随机化分为两组,A组(微针联合外用4%氨甲环酸,每月一次)和B组(外用4%氢醌,每晚一次)。在治疗的第4、8和12周进行平均MASI评分、患者和医生评估。分别采用配对t检验、卡方检验和Fisher精确检验进行统计分析。

结果

60名女性(每组30例患者)完成了研究。A组治疗结束时的平均MASI评分(6.84±4.31)显著低于基线时(12.89±5.16)(P<.01)。B组治疗结束时的平均MASI评分(7.16±4.38)显著低于基线时(13.56±4.88)(P<.01)。两组在治疗期间的MASI评分、医生和患者评估方面无统计学差异。两个治疗组中患者满意度百分比均显著高于医生满意度(P<.01)。

结论

在我们的研究中,微针联合氨甲环酸在治疗黄褐斑方面与4%氢醌没有差异。

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