Berman Brian, Goldenberg Gary, Hanke C William, Tyring Stephen K, Werschler Wm Philip, Knudsen Kim Mark, Goncalves Joana, Larsson Thomas, Skov Torsten, Swanson Neil
J Drugs Dermatol. 2014 Feb;13(2):154-60.
Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions.
FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus cryosurgery followed by vehicle.
Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after cryosurgery. Treatment after cryosurgery was well tolerated.
Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone.
在美国，冷冻手术是治疗光化性角化病（AK）最常用的方法。冷冻手术的疗效因人而异，它是一种治疗单个可见病变的方式，但无法治疗亚临床病变。
FIELD研究1（NCT01541553）是一项3期、多中心、随机、双盲研究，评估了先用液氮冷冻手术治疗AK，随后使用鬼臼毒素凝胶，与冷冻手术后使用赋形剂相比，序贯治疗AK的短期（11周）和长期（12个月）疗效及安全性。
总体而言，329例患者在冷冻手术后3周被随机分为接受0.015%鬼臼毒素凝胶治疗组（n = 167）或赋形剂治疗组（n = 162）。各组基线特征均衡。在第11周时，鬼臼毒素凝胶治疗组治疗区域的完全清除率（100%）高于赋形剂治疗组（分别为60.5%和49.4%；P = 0.04）。鬼臼毒素凝胶治疗组与基线相比，AK数量减少的平均百分比在数值上也更高（82.7%对75.6%）。冷冻手术后3周观察到基线病变计数总体减少。冷冻手术后的治疗耐受性良好。
冷冻手术后，面部或头皮使用鬼臼毒素凝胶的短期（11周）AK清除率高于单纯冷冻手术。
