使用含2.5%透明质酸凝胶的3.0%双氯芬酸对光化性角化病进行局部治疗。

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

作者信息

Rivers J K, Arlette J, Shear N, Guenther L, Carey W, Poulin Y

机构信息

Division of Dermatology, University of British Columbia and the Vancouver General Hospital, Faculty of Medicine, 835 West 10th Avenue, Vancouver, BC V5Z 4E8, Canada.

出版信息

Br J Dermatol. 2002 Jan;146(1):94-100. doi: 10.1046/j.1365-2133.2002.04561.x.

DOI:10.1046/j.1365-2133.2002.04561.x

PMID:11841372

Abstract

BACKGROUND

Actinic keratoses (AKs) are premalignant skin lesions, which, if left untreated, can develop into squamous cell carcinoma. Current treatments for AKs are destructive and are often associated with significant adverse events. The development of an effective and well-tolerated topical treatment for AK is desirable.

OBJECTIVES

To evaluate the efficacy and safety of 3.0% diclofenac in 2.5% hyaluronan gel as a treatment for AK.

METHODS

This was a multicentre, double-blind, placebo-controlled study in which 195 patients with at least five AKs in up to three designated treatment blocks were randomized to four treatment groups. Patients randomized into the active treatment groups A30 (n = 49) and A60 (n = 48) received topical treatment with 3.0% diclofenac in 2.5% hyaluronan gel 0.5 g twice daily for 30 or 60 days, respectively. Patients in the placebo (vehicle gel) groups V30 (n = 49) and V60 (n = 49) received topical treatment with 2.5% hyaluronan gel 0.5 g twice daily for 30 or 60 days, respectively. Treatment efficacy was assessed by target and cumulative lesion number scores (TLNS and CLNS, respectively) and lesion total thickness score (TTS). Investigator and patient global improvement indices (IGII and PGII) were also used to rate overall improvement.

RESULTS

Compared with placebo, significantly more patients given active treatment for 60 days had TLNS = 0 (33% vs. 10%, P < 0.05; an improvement of 64% compared with 34% with placebo), CLNS = 0 (31% vs. 8%, P < 0.05; an improvement of 54% compared with 23% with placebo) and TTS = 0 (25% vs. 6%, P < 0.05; an improvement of 59% compared with 31% with placebo). The IGII and PGII scores were also significantly better when active treatment was compared with placebo (P < 0.05). Both treatments were generally well tolerated and the incidence of the most common adverse events was similar between groups.

CONCLUSIONS

Treatment with 3.0% diclofenac in 2.5% hyaluronan gel was effective when used for 60 days and was well tolerated in patients with AK.

摘要

背景

光化性角化病（AKs）是癌前皮肤病变，若不治疗可发展为鳞状细胞癌。目前治疗AKs的方法具有破坏性，且常伴有显著不良事件。因此，开发一种有效且耐受性良好的AK局部治疗方法很有必要。

目的

评估3.0%双氯芬酸2.5%透明质酸凝胶治疗AK的疗效和安全性。

方法

这是一项多中心、双盲、安慰剂对照研究，195例在多达三个指定治疗区域至少有五个AKs的患者被随机分为四个治疗组。随机分为活性治疗组A30（n = 49）和A60（n = 48）的患者分别接受3.0%双氯芬酸2.5%透明质酸凝胶0.5 g，每日两次，共30或60天的局部治疗。安慰剂（赋形剂凝胶）组V30（n = 49）和V60（n = 49）的患者分别接受2.5%透明质酸凝胶0.5 g，每日两次，共30或60天的局部治疗。通过靶病变和累积病变数评分（分别为TLNS和CLNS）以及病变总厚度评分（TTS）评估治疗效果。还使用研究者和患者总体改善指数（IGII和PGII）对总体改善情况进行评分。

结果

与安慰剂相比，接受60天活性治疗的患者中，TLNS = 0的患者显著更多（33%对10%，P < 0.05；与安慰剂组的34%相比改善了64%），CLNS = 0的患者显著更多（31%对8%，P < 0.05；与安慰剂组的23%相比改善了54%），TTS = 0的患者显著更多（25%对6%，P < 0.05；与安慰剂组的31%相比改善了59%）。与安慰剂相比，活性治疗组的IGII和PGII评分也显著更好（P < 0.05）。两种治疗总体耐受性良好，各组最常见不良事件的发生率相似。