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复方倍他米松微针透皮给药治疗斑秃的随机对照试验

Microneedle transdermal delivery of compound betamethasone in alopecia areata-A randomized controlled trial.

作者信息

Qiao Rui, Zhu Jiaping, Fang Jing, Shi Hualing, Zhang Ziye, Nie Jin, Ge Yiping, Lin Tong, Jiang Yiqun

机构信息

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.

出版信息

J Am Acad Dermatol. 2025 Feb;92(2):269-275. doi: 10.1016/j.jaad.2024.09.059. Epub 2024 Oct 10.

Abstract

BACKGROUND

Alopecia areata (AA) places a considerable burden on patients. While intralesional glucocorticoid injection is an important therapy, it can cause severe pain.

OBJECTIVE

To compare the efficacy and pain levels of microneedle transdermal delivery of compound betamethasone versus traditional intralesional injection in mild-to-moderate AA.

METHODS

We conducted a randomized controlled trial in AA patients with a Severity of Alopecia Tool (SALT) score <50. Both groups received monthly compound betamethasone injections: group A via intralesional injections and group B via transdermal microneedle delivery. The primary outcome was the reduction in SALT score after 3 months.

RESULTS

With 80 patients enrolled, baseline SALT scores were similar between group A (9.250 ± 5.300) and group B (10.65 ± 9.445). After 3 months, the mean SALT reduction was 7.000 ± 4.5017 in group A and 8.075 ± 8.014 in group B, with no statistical difference. Remission rates for SALT30/50/75/90 were 92.50/90.00/57.50/42.50% in group A and 95.00/87.50/72.50/40% in group B, with no significant difference. Group B had a significantly lower visual analog scale pain score than group A (4.000 ± 1.174 vs 5.281 ± 2.098, P = .0047).

LIMITATIONS

The study focused on mild-to-moderate patchy AA, limiting insights into severe cases.

CONCLUSION

Microneedle transdermal delivery of compound betamethasone in mild-to-moderate patchy AA demonstrates efficacy comparable to traditional intralesional injection with reduced pain.

摘要

背景

斑秃(AA)给患者带来了相当大的负担。虽然皮损内注射糖皮质激素是一种重要的治疗方法,但它会引起严重疼痛。

目的

比较复方倍他米松微针透皮给药与传统皮损内注射治疗轻至中度斑秃的疗效和疼痛程度。

方法

我们对脱发严重程度工具(SALT)评分<50的斑秃患者进行了一项随机对照试验。两组均每月注射复方倍他米松:A组采用皮损内注射,B组采用透皮微针给药。主要结局是3个月后SALT评分的降低。

结果

80例患者入组,A组(9.250±5.300)和B组(10.65±9.445)的基线SALT评分相似。3个月后,A组SALT平均降低值为7.000±4.5017,B组为8.075±8.014,无统计学差异。A组SALT30/50/75/90的缓解率分别为92.50/90.00/57.50/42.50%,B组分别为95.00/87.50/72.50/40%,无显著差异。B组的视觉模拟评分疼痛得分显著低于A组(4.000±1.174 vs 5.281±2.098,P = 0.0047)。

局限性

该研究聚焦于轻至中度斑块状斑秃,限制了对严重病例的深入了解。

结论

复方倍他米松微针透皮给药治疗轻至中度斑块状斑秃的疗效与传统皮损内注射相当,但疼痛减轻。

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