Szeimies Rolf-Markus, Dirschka Thomas, Prechtl Andreas, Melzer Antje
Department of Dermatology and Allergology, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen.
J Dtsch Dermatol Ges. 2015 May;13(5):430-8. doi: 10.1111/ddg.12685.
In Germany, the number of actinic keratoses (AKs) diagnosed and dermatologically treated has steadily risen in recent years. As AKs represent an early form of squamous cell carcinoma, prompt initiation of treatment is pivotal. The objective of this non-interventional study (NIS) was to determine the efficacy of a low-dose (0.5 %) fluorouracil/10 % salicylic acid (low-dose 5-FU/SA) solution in the treatment of AKs (clinical grade I and II according to Olsen) in relation to treatment duration.
This NIS followed 1,051 AK patients from 212 centers who were treated with low-dose 5-FU/SA. Data were collected at the start of treatment, at an optional follow-up appointment during the treatment period, at the end of treatment, and during the final assessment.
During the observation period, there was a decrease in the mean number of lesions by approximately 70 % and in mean size by approximately 80 %. Roughly one-half of the patients were treated for less than six weeks. In the final global assessment, efficacy was rated as very good or good in approximately 89 % of patients; tolerability as very good or good in 87 %.
Under routine clinical conditions, treatment with low-dose 5-FU/SA effectively reduced AK lesions even during short treatment periods, while exhibiting good tolerability. These findings are in keeping with results obtained from a clinical phase III trial.
在德国，近年来诊断并接受皮肤科治疗的光化性角化病（AK）数量稳步上升。由于AK是鳞状细胞癌的早期形式，及时开始治疗至关重要。这项非干预性研究（NIS）的目的是确定低剂量（0.5%）氟尿嘧啶/10%水杨酸（低剂量5-FU/SA）溶液治疗AK（根据奥尔森分级为临床I级和II级）的疗效与治疗持续时间的关系。
这项NIS跟踪了来自212个中心的1051名接受低剂量5-FU/SA治疗的AK患者。在治疗开始时、治疗期间的一次可选随访预约时、治疗结束时以及最终评估期间收集数据。
在观察期内，病变的平均数量减少了约70%，平均大小减少了约80%。大约一半的患者治疗时间不到六周。在最终的整体评估中，约89%的患者疗效被评为非常好或好；耐受性方面，87%的患者被评为非常好或好。
在常规临床条件下，低剂量5-FU/SA治疗即使在短治疗期内也能有效减少AK病变，同时耐受性良好。这些发现与一项临床III期试验的结果一致。
