分次二氧化碳激光联合卤米松乳膏治疗中度至重度慢性手部湿疹的疗效和安全性：一项前瞻性、单中心、平行组、开放标签随机试验

Efficacy and Safety of Fractional CO Laser Combined with Halometasone Cream for Treatment of Moderate-to-Severe Chronic Hand Eczema: A Prospective, Single-Center, Parallel-Group, Open-Label Randomized Trial.

作者信息

Tang Gongfeng, Chang Yuan, Wu Haixuan, Liang Xuelei, Liu Yi, Zhuo Fenglin

机构信息

Department of Dermatology, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong'an Road, Xicheng District, Beijing, China.

出版信息

Dermatol Ther (Heidelb). 2023 Aug;13(8):1789-1799. doi: 10.1007/s13555-023-00944-w. Epub 2023 Jun 24.

DOI:10.1007/s13555-023-00944-w

PMID:37354295

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10366065/

Abstract

INTRODUCTION

The purpose of this study was to assess the efficacy and safety of fractional CO laser combined with halometasone cream in patients with moderate-to-severe chronic hand eczema (CHE).

METHODS

A prospective, single-center, parallel-group, open-label randomized trial including 67 patients with moderate-to-severe CHE was carried out. Patients were randomly assigned to group A (n = 33, fractional CO laser once every 4 weeks 1-2 times and halometasone cream twice daily for 8 weeks) or group B (n = 34, halometasone cream alone twice daily for 8 weeks). The primary endpoint was the proportion of patients achieving treatment success at week 12 in each group. Secondary endpoints included differences between groups in the change of hand eczema severity index (HECSI), patient global assessment (PaGA), dermatology life quality index (DLQI), and quality of life in hand eczema questionnaire (QOLHEQ) from baseline to week 12. Relapse rate and adverse effects were also recorded.

RESULTS

A total of 29 patients in each group completed the trial. At week 12, the treatment success rate was 62.1% (18/29) in group A and 27.6% (8/29) in group B (p = 0.009). At week 12, HECSI, PaGA, DLQI, and QOLHEQ all decreased compared with baseline in both groups (p < 0.05). HECSI, DLQI, and QOLHEQ decreased more in group A than group B (p = 0.014, 0.010, and 0.014, respectively), but there was no significant difference in change of PaGA between the two groups (1.0 versus 3.0, p = 0.419). Among patients achieving treatment success, 11.1% (2/18) patients in group A and 50.0% (4/8) patients in group B relapsed at week 24 (p = 0.011). Skin pigmentation was the most common adverse effect.

CONCLUSIONS

For patients with moderate-to-severe CHE, fractional CO laser combined with halometasone cream is more effective than halometasone cream alone, with few adverse effects.

TRIAL REGISTRATION NUMBER

ChiCTR2100051948.

摘要

引言

本研究旨在评估分次二氧化碳激光联合卤米松乳膏治疗中重度慢性手部湿疹（CHE）患者的疗效和安全性。

方法

开展了一项前瞻性、单中心、平行组、开放标签的随机试验，纳入67例中重度CHE患者。患者被随机分配至A组（n = 33，每4周进行1 - 2次分次二氧化碳激光治疗，并每日两次外用卤米松乳膏，共8周）或B组（n = 34，仅每日两次外用卤米松乳膏，共8周）。主要终点是每组在第12周达到治疗成功的患者比例。次要终点包括两组从基线到第12周手部湿疹严重程度指数（HECSI）、患者整体评估（PaGA）、皮肤病生活质量指数（DLQI）以及手部湿疹生活质量问卷（QOLHEQ）变化的组间差异。还记录了复发率和不良反应。

结果

每组共有29例患者完成试验。在第12周时，A组的治疗成功率为62.1%（18/29），B组为27.6%（8/29）（p = 0.009）。在第12周时，两组的HECSI、PaGA、DLQI和QOLHEQ均较基线下降（p < 0.05）。A组的HECSI、DLQI和QOLHEQ下降幅度大于B组（分别为p = 0.014、0.010和0.014），但两组间PaGA变化无显著差异（1.0对3.0，p = 0.419）。在治疗成功的患者中，A组11.1%（2/18）的患者和B组50.0%（4/8）的患者在第24周复发（p = 0.011）。皮肤色素沉着是最常见的不良反应。