外用3.0%双氯芬酸溶于2.5%透明质酸凝胶治疗光化性角化病。

Topical 3.0% diclofenac in 2.5% hyaluronan gel in the treatment of actinic keratoses.

作者信息

Wolf J E, Taylor J R, Tschen E, Kang S

机构信息

Department of Dermatology, Baylor College of Medicine, Houston, TX 77030-3411, USA.

出版信息

Int J Dermatol. 2001 Nov;40(11):709-13. doi: 10.1046/j.1365-4362.2001.01324.x.

DOI:10.1046/j.1365-4362.2001.01324.x

PMID:11737438

Abstract

BACKGROUND

Actinic keratoses (AKs) are epidermal skin lesions with the potential to develop into invasive squamous cell carcinoma (SCC). Treatment at an early stage may prevent development of SCC. Current treatment options are highly destructive and associated with significant side-effects. Early studies with topical diclofenac were encouraging and led to its evaluation for the treatment of actinic keratosis. Previous studies have demonstrated that 3% diclofenac in 2.5% hyaluronan gel is effective and well tolerated in the treatment of AK. The present study was designed to further explore the therapeutic potential of this gel.

METHODS

This randomized, double-blind, placebo-controlled trial involved outpatients with a diagnosis of five or more AK lesions contained in one to three 5 cm(2) blocks. Patients received either active treatment (3% diclofenac gel in 2.5% hyaluronan gel) or inactive gel vehicle (hyaluronan) as placebo (0.5 g b.i.d. in each 5 cm(2) treatment area for 90 days). Assessments included the Target Lesion Number Score (TLNS), Cumulative Lesion Number Score (CLNS), and Global Improvement Indices rated separately by both the investigator (IGII) and patient (PGII).

RESULTS

Results obtained from 96 patients at follow up (30 days after end of treatment) indicated that a significantly higher proportion of patients who received active treatment had a TLNS = 0 compared to the placebo group (50% vs. 20%; P < 0.001). There was also a significant difference between the two groups in CLNS, with 47% of patients in the active treatment group having a CLNS = 0 compared with only 19% in the placebo group (P < 0.001). The proportion of patients with an IGII score of 4 (completely improved) at follow-up was 47% in the active treatment group compared with only 19% in the placebo group (P < 0.001); for PGII these values were 41% vs. 17%, P < 0.001. Both treatments were well tolerated, with most adverse events related to the skin.

CONCLUSIONS

Topical 3% diclofenac in 2.5% hyaluronan gel was effective and well tolerated for the treatment of AK.

摘要

背景

光化性角化病（AK）是一种表皮皮肤病变，有发展为浸润性鳞状细胞癌（SCC）的可能。早期治疗可预防SCC的发生。目前的治疗方法具有高度破坏性且伴有明显的副作用。早期关于外用双氯芬酸的研究令人鼓舞，并促使对其治疗光化性角化病进行评估。既往研究表明，2.5%透明质酸凝胶中的3%双氯芬酸在治疗AK方面有效且耐受性良好。本研究旨在进一步探索该凝胶的治疗潜力。

方法

这项随机、双盲、安慰剂对照试验纳入了诊断为一至三个5平方厘米区域内有五个或更多AK病变的门诊患者。患者接受活性治疗（2.5%透明质酸凝胶中的3%双氯芬酸凝胶）或无活性凝胶载体（透明质酸）作为安慰剂（在每个5平方厘米治疗区域每天两次，每次0.5克，共90天）。评估包括目标病变数量评分（TLNS）、累积病变数量评分（CLNS）以及分别由研究者（IGII）和患者（PGII）评定的整体改善指数。

结果

96例患者在随访（治疗结束后30天）时获得的结果表明，与安慰剂组相比，接受活性治疗的患者中TLNS = 0的比例显著更高（50%对20%；P < 0.001）。两组在CLNS方面也存在显著差异，活性治疗组中47%的患者CLNS = 0，而安慰剂组仅为19%（P < 0.001）。随访时IGII评分为4（完全改善）的患者比例在活性治疗组为47%，而安慰剂组仅为19%（P < 0.001）；PGII的这些值分别为41%对17%，P < 0.001。两种治疗耐受性均良好，大多数不良事件与皮肤有关。