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Abstract：
BACKGROUND: 5-Fluorouracil (5-FU) is a first-line drug to treat cutaneous field cancerization (CFC). There are few clinical trials with topical colchicine (COL).
OBJECTIVE: To evaluate the effectiveness of 0.5% COL cream versus 5% 5-FU cream in the treatment of CFC.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: Single-center study.
CONCLUSIONS: 5-FU and COL are effective for treating CFC, with neither showing superiority regarding the reduction in AK counts.
OBJECTIVE: To evaluate the effectiveness of 0.5% COL cream versus 5% 5-FU cream in the treatment of CFC.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: Single-center study.
CONCLUSIONS: 5-FU and COL are effective for treating CFC, with neither showing superiority regarding the reduction in AK counts.
摘要：
背景：5-氟尿嘧啶（5-FU）是治疗皮肤野癌变（CFC）的一线药物。很少有局部秋水仙碱（COL）的临床试验。
目的：评价0.5%COL乳膏与5%5-FU乳膏治疗CFC的疗效。
方法：这是一个随机的，打开,自我对照临床试验。45名患者（90名前臂），每个前臂上有三到十个光化性角化病（AK），在一个前臂上使用0.5％COL乳膏2次/天，持续7天，和5%5-FU霜2次/天，21天,在另一个前臂上。基于每种药物的先前临床试验定义剂量。14天后评估不良反应，90天后评估结果。主要结果是完全AK清除，次要结果是：部分清除（≥50％），减少AK计数，前臂光老化量表（FPS）的评估，AK严重性评分(AKSS),和不利影响。
结果：90天后，用5-FU治疗的前臂有37%（95%CI24%-49%）的AK完全清除和85%（95%CI76%-93%）的部分清除，COL的17%（95%CI7%-27%）和78%（95%CI66%-88%）（p>0.07）。用5-FU治疗的前臂AK计数减少75%(95%CI66%-83%),用COL治疗的前臂AK计数减少64%(95%CI55%-72%)。关于FPS和AKSS，两组都有改善，关于FPS没有差异(p=0.654)，AKSS的5-FU优势(p=0.012)。
结论：单中心研究。
结论：5-FU和COL对治疗CFC有效，在AK计数减少方面均未显示出优势。
目的：评价0.5%COL乳膏与5%5-FU乳膏治疗CFC的疗效。
方法：这是一个随机的，打开,自我对照临床试验。45名患者（90名前臂），每个前臂上有三到十个光化性角化病（AK），在一个前臂上使用0.5％COL乳膏2次/天，持续7天，和5%5-FU霜2次/天，21天,在另一个前臂上。基于每种药物的先前临床试验定义剂量。14天后评估不良反应，90天后评估结果。主要结果是完全AK清除，次要结果是：部分清除（≥50％），减少AK计数，前臂光老化量表（FPS）的评估，AK严重性评分(AKSS),和不利影响。
结果：90天后，用5-FU治疗的前臂有37%（95%CI24%-49%）的AK完全清除和85%（95%CI76%-93%）的部分清除，COL的17%（95%CI7%-27%）和78%（95%CI66%-88%）（p>0.07）。用5-FU治疗的前臂AK计数减少75%(95%CI66%-83%),用COL治疗的前臂AK计数减少64%(95%CI55%-72%)。关于FPS和AKSS，两组都有改善，关于FPS没有差异(p=0.654)，AKSS的5-FU优势(p=0.012)。
结论：单中心研究。
结论：5-FU和COL对治疗CFC有效，在AK计数减少方面均未显示出优势。
