比较修复膏与局部抗菌药物对术后伤口安全性和有效性的随机对照试验

Randomized-Controlled Trial Comparing Safety and Efficacy of Repairing Balm vs Topical Antimicrobial for Post-Procedural Wounds.

作者信息

Lynde Charles W, Andriessen Anneke, Guenther Lyn, Dayeh Nour, Skotnicki Sandra, Nigen Simon, Sibbald Gary R

出版信息

J Drugs Dermatol. 2025 May 1;24(5):507-515. doi: 10.36849/JDD.8746.

DOI:10.36849/JDD.8746

PMID:40327581

Abstract

BACKGROUND

Actinic keratoses (AK) are pre-cancerous, intraepidermal lesions that exist on a continuum with squamous cell carcinoma. Cryotherapy using liquid nitrogen freezing is the most common method for treating AKs. Following cryotherapy, wound care often involves antimicrobial ointments as prophylactics against infection. However, given the rise in antibacterial resistance and possible contact dermatitis, equivalent alternatives should be identified. Cutaneous wound healing is important in dermatologic conditions.

OBJECTIVE

Evaluate the safety (adverse events) and efficacy (erythema and oozing/crusting, speed of recovery) of post-procedural wound healing of AK lesions, when using either a topical antibiotic (PSO), or a nonprescription repairing balm containing panthenol, madecassoside, and metal salts (CB5).

METHODS

A multicenter, intra-individual, randomized control trial was conducted. Sixty participants with at least 3 AK lesions on each arm were enrolled. Following cryotherapy, 3 lesions were selected on each arm for study and control treatment. The treatment of the right or left arm was randomly assigned to either the control group (PSO) or the investigational group (CB5), so that each subject participated in both the investigational and control arms. At each visit, the physician assessed the skin condition (erythema, oozing/crusting) and adverse events, and subject satisfaction was recorded. Results: There were no clinically significant differences in time to lesion healing, erythema, or oozing/crusting between groups. On day 21, 100% of patients agreed that their lesions had improved. No adverse events related to the study products were reported throughout the trial. Conclusion: Post-procedural treatment with CB5 and PSO demonstrated equivalent wound healing in participants undergoing liquid nitrogen cryotherapy for AKs without the potential for further adverse effects.

CITATION

Lynde CW, Andriessen A, Guenther L, et al. Randomized-controlled trial comparing safety and efficacy of repairing balm versus topical antimicrobial for post-procedural wounds. J Drugs Dermatol. 2025;24(5):507-515. doi:10.36849/JDD.8746R1.

摘要

背景

光化性角化病（AK）是癌前表皮内病变，与鳞状细胞癌存在连续谱关系。使用液氮冷冻的冷冻疗法是治疗AK的最常见方法。冷冻治疗后，伤口护理通常涉及使用抗菌软膏作为预防感染的措施。然而，鉴于抗菌耐药性的增加以及可能的接触性皮炎，应确定等效的替代方法。皮肤伤口愈合在皮肤病中很重要。

目的

评估使用局部抗生素（PSO）或含有泛醇、积雪草苷和金属盐的非处方修复膏（CB5）时，AK病变术后伤口愈合的安全性（不良事件）和有效性（红斑、渗出/结痂、恢复速度）。

方法

进行了一项多中心、个体内随机对照试验。招募了双臂各有至少3个AK病变的60名参与者。冷冻治疗后，每只手臂选择3个病变进行研究和对照治疗。右臂或左臂的治疗随机分配到对照组（PSO）或研究组（CB5），以便每个受试者同时参与研究组和对照组。每次就诊时，医生评估皮肤状况（红斑、渗出/结痂）和不良事件，并记录受试者的满意度。