一种含有倍他米松二丙酸酯的透皮水凝胶贴剂治疗慢性手部湿疹的疗效：一项单盲、随机对照试验。

The efficacy of a transdermal hydrogel patch containing betamethasone dipropionate for treatment of chronic hand eczema: A single-blind, randomized and controlled trial.

机构信息

Department of Dermatology, Faculty of Medicine, Srinakharinwirot University, Bangkok, Thailand.

Faculty of Pharmacy, Srinakharinwirot University, Ongkharak, Thailand.

出版信息

Contact Dermatitis. 2024 Feb;90(2):153-160. doi: 10.1111/cod.14438. Epub 2023 Oct 12.

DOI:10.1111/cod.14438

PMID:37828631

Abstract

BACKGROUND

Topical corticosteroids under occlusion have been used to enhance the treatment of eczema. However, no study has investigated the efficacy of a steroid-containing transdermal patch for the treatment of chronic hand eczema.

METHODS

We conducted a randomized, controlled, assessor-blinded trial to determine the efficacy of a transdermal patch containing betamethasone dipropionate compared to topical betamethasone dipropionate ointment in the treatment of mild to moderate chronic hand eczema. The patients were included and assigned to receive either the transdermal patch once daily at night or the ointment twice daily for a period of 8 weeks. The outcomes were assessed using the Hand Eczema Severity Index (HECSI), Physical Global Assessment (PGA) score, self-reported compliance, level of patient satisfaction, quality of life, and side effects.

RESULTS

Fifty-six patients completed this study. At 8 weeks, there was a significant reduction in the HECSI scores in both the transdermal patch and topical ointment groups compared to those measured at baseline (14.61 to 1.86, p < 0.001; 18.46 to 3.43, p < 0.001, respectively) without a statistically significant difference between the two groups. Similarly, the two groups did not show any significant difference in the PGA scores, quality of life and side effects. However, the transdermal patch group reported better compliance and a higher level of patient satisfaction than the topical ointment group.

CONCLUSION

The transdermal corticosteroid patch has proven to be a safe and effective treatment, comparable to topical corticosteroids, after 8 weeks of use. Its sustained-release properties, along with once-daily use, can improve patient satisfaction and promote greater adherence to the treatment.

TRIAL REGISTRATION

This study was registered with the Thai Clinical Trials Registry (www.

CLINICALTRIALS

in.th) under registration number TCTR20220413003.

摘要

背景

局部皮质类固醇封闭治疗已被用于增强湿疹的治疗效果。然而，目前尚无研究调查含有皮质类固醇的透皮贴剂治疗慢性手部湿疹的疗效。

方法

我们进行了一项随机、对照、评估者盲法试验，以确定含有二丙酸倍他米松的透皮贴剂与局部二丙酸倍他米松软膏治疗轻度至中度慢性手部湿疹的疗效。将患者纳入并分配接受每晚一次透皮贴剂或每天两次软膏治疗，持续 8 周。使用手部湿疹严重指数（HECSI）、身体整体评估（PGA）评分、自我报告的依从性、患者满意度、生活质量和副作用来评估结果。

结果

56 例患者完成了这项研究。在 8 周时，与基线相比，透皮贴剂和局部软膏组的 HECSI 评分均显著降低（分别为 14.61 降至 1.86，p<0.001；18.46 降至 3.43，p<0.001），两组之间无统计学差异。同样，两组在 PGA 评分、生活质量和副作用方面也没有显著差异。然而，透皮贴剂组的依从性和患者满意度均高于局部软膏组。