Tanghetti Emil A, Hamann Carolyn, Tanghetti Margo
J Drugs Dermatol. 2015 Nov;14(11):1241-4.
Topical Fluorouracil 5% cream (5-FU) and 20% aminolevulinic acid (ALA)/ photodynamic therapy (PDT) are both FDA approved for the treatment of Actinic Keratosis (AK). We have studied the use of these 2 agents alone and in a sequential manner. We have also used a 5-FU re-challenge 3 months after treatment to highlight the efficacy of these treatments.
This was an investigator-blinded randomized study in which 30 patients were randomized 1:1:1 into the following groups: Group 1 patients pretreated for 6-7 days with 5-FU, ALA applied with incubation of 2 hours, ALA removed with wet gauze, illuminated treated areas with 10 J/cm(2) with Blu-U device; Group 2 patients treated with 5-FU BID for 6-7 days and no ALA/PDT; Group 3 patients received no pretreatment, ALA applied with incubation of 2 hours, ALA removed with wet gauze, illuminated treated areas with 10 J.cm2 with Blu-U device. Patients were seen at screening/baseline, treatment for ALA/PDT, 24 hours post treatment, 1 week post treatment and 3 months post treatment. All subjects were then given a re-challenge course of 5-FU for 6 days and reassessed.
AK counts in all groups were dramatically decreased and similar at 1 and 3 months post treatment. The re-challenge brought a significant difference with many subclinical lesions in the area of activity in the ALA and 5-FU alone groups.
All three arms appeared equal in treating visible AKs. These data strongly suggests a synergistic role of 5-FU with ALA/PDT over ALA/PDT or 5-FU alone in treating the subclinical lesions demonstrated on a 5-FU re-challenge. Treatment of these subclinical lesions should result in a longer remission. The data also suggests that a 5-FU re-challenge could be a clinical tool to judge the efficacy of treatment for AK if these subclinical lesions are proven to be an AK precursor.
5%氟尿嘧啶（5-FU）乳膏和20%氨基酮戊酸（ALA）/光动力疗法（PDT）均获美国食品药品监督管理局（FDA）批准用于治疗光化性角化病（AK）。我们研究了单独使用这两种药物以及序贯使用它们的情况。我们还在治疗3个月后进行5-FU再激发治疗，以突出这些治疗方法的疗效。
这是一项研究者设盲的随机研究，30例患者按1:1:1随机分为以下几组：第1组患者先用5-FU预处理6 - 7天，涂抹ALA并孵育2小时，用湿纱布去除ALA，使用蓝光治疗仪（Blu-U）以10 J/cm(2)照射治疗区域；第2组患者每天两次使用5-FU治疗6 - 7天，不进行ALA/PDT治疗；第3组患者不进行预处理，涂抹ALA并孵育2小时，用湿纱布去除ALA，使用蓝光治疗仪（Blu-U）以10 J/cm2照射治疗区域。在筛查/基线、进行ALA/PDT治疗时、治疗后24小时、治疗后1周和治疗后3个月对患者进行观察。然后对所有受试者给予为期6天的5-FU再激发治疗疗程并重新评估。
所有组的AK计数在治疗后1个月和3个月时均显著下降且相似。再激发治疗使单独使用ALA组和单独使用5-FU组的活动区域出现许多亚临床病变，存在显著差异。
在治疗可见的AK方面，所有三个治疗组似乎效果相当。这些数据有力地表明，在5-FU再激发治疗中，5-FU与ALA/PDT联合使用在治疗亚临床病变方面比单独使用ALA/PDT或5-FU具有协同作用。治疗这些亚临床病变应能带来更长时间的缓解。数据还表明，如果这些亚临床病变被证明是AK的前驱病变，5-FU再激发治疗可能是一种判断AK治疗效果的临床工具。
