中华皮肤科杂志 ›› 2025, Vol. 58 ›› Issue (9): 829-833.doi: 10.35541/cjd.20250099

• 研究报道 • 上一篇    下一篇

纳米微针与超声波导入氨甲环酸治疗黄褐斑的疗效与安全性比较：一项随机对照研究

钟洁敏    李薇    张淑娟    杨艳    薛如君    李欣怡    柯娅楠    陈晓吟    陈荃   

  1. 广州市皮肤病医院皮肤科  广州医科大学皮肤病研究所，广州  510095
  • 收稿日期:2025-02-27 修回日期:2025-07-06 发布日期:2025-09-01
  • 通讯作者: 陈荃 E-mail:quanchen1985@gmail.com
  • 基金资助:
    广州市卫生健康科技一般引导项目（20241A010056）；广州市皮肤病医院科技项目（202202）；白求恩公益基金免疫炎症性疾病科研支持项目（J202301E036）

Comparison of the efficacy and safety of nanomicroneedle- versus ultrasound-mediated delivery of tranexamic acid for the treatment of melasma: a randomized controlled study

Zhong Jiemin, Li Wei, Zhang Shujuan, Yang Yan, Xue Rujun, Li Xinyi, Ke Yanan, Chen Xiaoyin, Chen Quan   

  1. Department of Dermatology, Guangzhou Dermatology Hospital, Institute of Dermatology, Guangzhou Medical University, Guangzhou 510095, China
  • Received:2025-02-27 Revised:2025-07-06 Published:2025-09-01
  • Contact: Chen Quan E-mail:quanchen1985@gmail.com
  • Supported by:
    Guangzhou Health Science and Technology Project （20241A010056）; Guangzhou Dermatology Hospital Science and Technology Project （202202）; Bethune Foundation for Immune Inflammatory Diseases Research Support Project （J202301E036）

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摘要： 【摘要】 目的 探究纳米微针导入氨甲环酸治疗黄褐斑的临床疗效及安全性。方法 将2023年3月至2024年5月于广州市皮肤病医院皮肤科就诊的80例黄褐斑患者，采用随机数表法分为纳米微针组（纳米微针导入氨甲环酸）和超声波组（超声波导入氨甲环酸），每组各40例。两组治疗均每周1次，共8次。治疗12周后对比两组黄褐斑面积和严重指数（MASI）、疗效、VISIA棕色斑评分、疼痛度及不良反应。统计分析采用两独立样本t检验、秩和检验及卡方检验。结果 治疗12周后，两组MASI评分均较治疗前下降，纳米微针组MASI评分中位数[5.80（4.20，9.35）]分低于超声波组[8.65（5.70，10.80）]分，差异有统计学意义（Z=2.50，P=0.012）。纳米微针组总有效率（97.5%，39/40）高于超声波组（55.0%，22/40），差异有统计学意义（?2 = 19.95，P < 0.001）。纳米微针组左、右侧面部VISIA棕色斑评分（126.18±36.54、138.50±40.76）均低于超声波组（142.37±32.40、157.13±39.59），差异有统计学意义（t=-2.10、-2.07，P=0.039、0.041）。纳米微针组疼痛度评分为（4.12±1.47）分。纳米微针组患者术后出现不同程度的红斑、水肿、干燥等不良反应，均于48h内自行缓解。超声波组未见不良反应。结论 纳米微针导入氨甲环酸治疗黄褐斑的临床疗效显著, 安全性良好，为黄褐斑治疗提供了更多的选择。

关键词: 黄褐斑, 治疗, 氨甲环酸, 纳米微针, 超声导入, 纳晶微针, 透皮给药

Abstract: 【Abstract】 Objective To explore the clinical efficacy and safety of nano-microneedles in the treatment of melasma with tranexamic acid. Methods A total of 80 patients with chloasma who were treated in the Department of Dermatology, Guangzhou Dermatology Hospital from March 2023 to May 2024 were randomly divided into nano-microneedle group (nano-microneedle introduced tranexamic acid) and ultrasound group (ultrasound introduced tranexamic acid), with 40 cases in each group. Both groups were treated once a week for a total of 8 times. Two independent sample t test, rank sum test and chi-square test were used for statistical analysis. Results After 12 weeks of treatment, the MASI scores of the two groups were lower than those before treatment. The median MASI score of the nano-microneedle group [5.80 (4.20, 9.35)] was lower than that of the ultrasound group [8.65 (5.70, 10.80)], and the difference was statistically significant (Z=2.50, P=0.012).The total effective rate of nano-microneedles group (97.5%, 39/40) was higher than that of ultrasound group (55.0%, 22/40), and the difference was statistically significant (?2 = 19.95, P < 0.001). The left and right facial VISIA brown spot scores of the nano-microneedle group (126.18±36.54, 138.50±40.76) were lower than those of the ultrasound group (142.37±32.40, 157.13±39.59), and the difference was statistically significant (t=-2.10, -2.07; P=0.039, 0.041). The pain score of the nano-microneedle group was（4.12±1.47）.The patients in the nano-microneedle group had different degrees of adverse reactions such as erythema, edema and dryness after operation, which were all relieved within 48 hours. No adverse reactions were observed in ultrasound group. Conclusion Nano-microneedle tranexamic acid has significant clinical efficacy and good safety in the treatment of melasma, which provides more options for the treatment of melasma.

Key words: Chloasma, Therapy, Tranexamic acid, Nanomicroneedles, Ultrasonic induction, Nanocrystalline microneedles, Transdermal drug delivery

引用本文

钟洁敏 李薇 张淑娟 杨艳 薛如君 李欣怡 柯娅楠 陈晓吟 陈荃. 纳米微针与超声波导入氨甲环酸治疗黄褐斑的疗效与安全性比较：一项随机对照研究[J]. 中华皮肤科杂志, 2025,58(9):829-833. doi:10.35541/cjd.20250099

Zhong Jiemin, Li Wei, Zhang Shujuan, Yang Yan, Xue Rujun, Li Xinyi, Ke Yanan, Chen Xiaoyin, Chen Quan. Comparison of the efficacy and safety of nanomicroneedle- versus ultrasound-mediated delivery of tranexamic acid for the treatment of melasma: a randomized controlled study[J]. Chinese Journal of Dermatology, 2025, 58(9): 829-833.doi:10.35541/cjd.20250099