University of California Los Angeles, School of Medicine, Los Angeles, California, USA.
J Dermatolog Treat. 2010 Sep;21(5):267-71. doi: 10.3109/09546630903341937.
Actinic keratoses (AKs) are common and may progress to squamous cell carcinoma (SCC). While cryotherapy is the most commonly used treatment for AKs, it is only suitable for treating a few lesions at a time. Topical medications such as 5-fluorouracil (5-FU) allow for more generalized treatment of AKs in the setting of multiple lesions.
To evaluate and discuss clinical trials examining the efficacy of 5-FU cream formulations (0.5% and 5%), as 5% 5-FU has four times greater systemic absorption.
We conducted Pubmed and Embase searches (1965 to 13 April 2009) to find studies evaluating the efficacy of 5-FU cream monotherapy (0.5% and 5%) in treating multiple AKs of the face and scalp. We only included studies employing standard treatment regimens (as per the US FDA), with an endpoint of complete clearance.
Nine studies met our criteria. At 4 weeks post-treatment, complete clearance rates of 0.5% and 5% 5-FU ranged from 16.7% to 57.8% and 43% to 100%, respectively. As the various studies employed different measurements of tolerability, we were unable to pool this data. In the only split-face study comparing both formulations, both treatments produced equivalent rates (43%) of complete clearance, but 5% 5-FU had higher rates of adverse events.
Despite evidence suggesting the superior efficacy of 5% 5-FU over 0.5% 5-FU, high-powered clinical trials comparing both treatments are lacking. Furthermore, tolerability rates between formulations warrant further examination given the possible enhanced systemic absorption of 5% 5-FU over 0.5% 5-FU. Such studies will enable dermatologists to appropriately balance the risks and benefits of each respective treatment to provide optimal solutions to patients with multiple AKs.
光化性角化病（AK）是一种常见疾病，可能进展为鳞状细胞癌（SCC）。冷冻疗法是治疗 AK 最常用的方法，但它一次只适合治疗少数病变。5-氟尿嘧啶（5-FU）等局部药物可在多处病变的情况下更广泛地治疗 AK。
评估和讨论临床试验，研究 5-FU 乳膏制剂（0.5%和 5%）的疗效，因为 5%的 5-FU 具有四倍的全身吸收率。
我们进行了 Pubmed 和 Embase 检索（1965 年至 2009 年 4 月 13 日），以寻找评估 5-FU 乳膏单一疗法（0.5%和 5%）治疗面部和头皮多发性 AK 的疗效的研究。我们只纳入了采用标准治疗方案（根据美国 FDA）的研究，以完全清除为终点。
有 9 项研究符合我们的标准。在治疗后 4 周，0.5%和 5% 5-FU 的完全清除率分别为 16.7%至 57.8%和 43%至 100%。由于各种研究采用了不同的耐受性测量方法，我们无法对这些数据进行汇总。在唯一一项比较两种制剂的分割面研究中，两种治疗方法的完全清除率均为 43%，但 5%的 5-FU 不良反应发生率更高。
尽管有证据表明 5%的 5-FU 优于 0.5%的 5-FU，但缺乏比较这两种治疗方法的高影响力临床试验。此外，鉴于 5%的 5-FU 可能比 0.5%的 5-FU 具有更高的全身吸收率，制剂之间的耐受性率需要进一步研究。这些研究将使皮肤科医生能够适当平衡每种治疗方法的风险和益处，为多发性 AK 患者提供最佳解决方案。
