Department of Dermatology, Instituto Lauro de Souza Lima, Bauru, SP, Brazil.
Department of Infectology, Dermatology, Radiotherapy and Diagnostic Imaging, Faculty of Medicine, Universidade Estadual Paulista, Botucatu, SP, Brazil.
An Bras Dermatol. 2024 Jul-Aug;99(4):527-534. doi: 10.1016/j.abd.2023.09.005. Epub 2024 Apr 12.
5-Fluorouracil (5-FU) is a first-line drug to treat cutaneous field cancerization (CFC). There are few clinical trials with topical colchicine (COL).
To evaluate the effectiveness of 0.5% COL cream versus 5% 5-FU cream in the treatment of CFC.
This was a randomized, open, self-controlled clinical trial. Forty-five patients (90 forearms), with three to ten actinic keratoses (AK) on each forearm, used 0.5% COL cream 2×/day for seven days on one forearm, and 5% 5-FU cream 2× /day, for 21 days, on the other forearm. The dosages were defined based on previous clinical trials for each drug. Adverse effects were evaluated after 14 days and outcomes after 90 days of inclusion. The primary outcome was complete AK clearance and the secondary outcomes were: partial clearance (≥50%), reduction in AK count, assessment of the Forearm Photoaging Scale (FPS), AK Severity Score (AKSS), and adverse effects.
After 90 days, there was complete clearance of AK in 37% (95% CI 24%-49%) and partial clearance in 85% (95% CI 76%-93%) of the forearms treated with 5-FU,versus 17% (95% CI 7%-27%) and 78% (95% CI 66%-88%) for COL (p > 0.07). There was a percentage reduction of 75% in the AK count of the forearms treated with 5-FU (95% CI 66%-83%) and 64% in those treated with COL (95% CI 55%-72%). Regarding FPS and AKSS, there was improvement in both groups, with no difference regarding FPS (p = 0.654), and 5-FU superiority for AKSS (p = 0.012).
Single-center study.
5-FU and COL are effective for treating CFC, with neither showing superiority regarding the reduction in AK counts.
5-氟尿嘧啶（5-FU）是治疗皮肤区域性癌变（CFC）的一线药物。很少有临床试验使用秋水仙碱（COL）进行局部治疗。
评估 0.5%COL 乳膏与 5%5-FU 乳膏治疗 CFC 的疗效。
这是一项随机、开放、自身对照的临床试验。45 名患者（90 只前臂），每只前臂有 3 至 10 处光化性角化病（AK），一只前臂每天使用 0.5%COL 乳膏 2 次，连续 7 天，另一只前臂每天使用 5%5-FU 乳膏 2 次，连续 21 天。两种药物的剂量均根据之前的临床试验确定。在第 14 天评估不良反应，在第 90 天评估结局。主要结局是 AK 完全清除，次要结局包括：部分清除（≥50%）、AK 计数减少、前臂光老化评分（FPS）、AK 严重程度评分（AKSS）和不良反应。
90 天后，5-FU 治疗组 AK 完全清除率为 37%（95%CI 24%-49%），部分清除率为 85%（95%CI 76%-93%），COL 治疗组分别为 17%（95%CI 7%-27%）和 78%（95%CI 66%-88%）（p>0.07）。5-FU 治疗组 AK 计数减少 75%（95%CI 66%-83%），COL 治疗组减少 64%（95%CI 55%-72%）。两组 FPS 和 AKSS 均有改善，FPS 无差异（p=0.654），AKSS 5-FU 组更优（p=0.012）。
单中心研究。
5-FU 和 COL 对 CFC 均有效，在减少 AK 计数方面无差异。
