Department of Dermatology, Berlin University Medical Centre, Berlin, Germany.
Eur J Dermatol. 2012 May-Jun;22(3):370-4. doi: 10.1684/ejd.2012.1707.
Actinic keratoses (AK) have been classified as early in situ squamous cell carcinomas and should be treated.
To evaluate the clinical benefit of 5-fluorouracil 0.5%/salicylic acid 10.0% (5-FU/SA) versus 3% diclofenac/hyaluronic acid (HA) for the treatment of AK and report patients' assessments of efficacy, tolerability and practicability.
Randomised, placebo-controlled, double-blind, parallel-group, multicentre trial. Patients received topical 0.5% 5-FU/SA once daily, its vehicle or diclofenac/HA twice daily for maximum of 12 weeks. Lesion recurrence rates were evaluated at 6 and 12 months after end of treatment (EOT). Patients' assessments were evaluated at 6 weeks, EOT, post-treatment (PT) visit, 6 and 12 months.
At 12 months 85.8% of lesions did not recur in the 5-FU/SA group compared to 79.8% (p=0.04419) in the vehicle and 81.0% (p=0.02476) in the diclofenac/HA groups. At PT visit 93.2% patients (n=163/175) in the 5-FU/SA group rated clinical improvement as "very good" or "good" compared to vehicle (66.7%, n=62/93, p<0.0001) and diclofenac/HA (81.6%, n=142/174, p<0.0001). Local side effects (inflammation and burning) were more common with 0.5% FU/SA but in general did not lead to discontinuation of therapy. Overall, patients were satisfied with the therapy. At 12 months, there were no differences in practicability and handling between treatments.
Topical 0.5% 5-FU/SA demonstrated superior sustained clinical efficacy versus diclofenac/HA with acceptable tolerability. Patient satisfaction was high.
光化性角化病（AK）已被归类为早期原位鳞状细胞癌，应予以治疗。
评估 5-氟尿嘧啶 0.5％/水杨酸 10.0％（5-FU/SA）与 3％双氯芬酸/透明质酸（HA）治疗 AK 的临床获益，并报告患者对疗效、耐受性和实用性的评估。
这是一项随机、安慰剂对照、双盲、平行组、多中心试验。患者接受 0.5％5-FU/SA 每日一次、其赋形剂或双氯芬酸/HA 每日两次治疗，最长 12 周。在治疗结束后 6 和 12 个月评估病变复发率。在 6 周、治疗结束时、治疗后（PT）访视、6 和 12 个月评估患者评估。
在 12 个月时，5-FU/SA 组中 85.8％的病变未复发，而赋形剂组为 79.8％（p=0.04419），双氯芬酸/HA 组为 81.0％（p=0.02476）。在 PT 访视时，5-FU/SA 组 93.2％（n=163/175）的患者认为临床改善为“非常好”或“好”，而赋形剂组为 66.7％（n=62/93，p<0.0001），双氯芬酸/HA 组为 81.6％（n=142/174，p<0.0001）。与 0.5％FU/SA 相比，局部副作用（炎症和烧灼感）更为常见，但总体上并未导致治疗中断。总体而言，患者对治疗满意。在 12 个月时，治疗之间的实用性和处理没有差异。
与双氯芬酸/HA 相比，局部 0.5％5-FU/SA 显示出优越的持续临床疗效，且耐受性可接受。患者满意度高。
