Zeitouni Nathalie C, Schlesinger Todd, Kheterpal Meenal, Jolly Puneet S, Jagdeo Jared
Medical Dermatology Specialists, 1331 N 7th Street, Suite 290, Phoenix, AZ 85006, USA; University of Arizona College of Medicine, Phoenix, AZ, USA.
Clinical Research Center of the Carolinas, Charleston, SC, USA.
Photodiagnosis Photodyn Ther. 2025 Aug;54:104649. doi: 10.1016/j.pdpdt.2025.104649. Epub 2025 May 24.
5-aminolevulinic acid photodynamic therapy (ALA-PDT) is used off-label in the US to treat basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and Bowen disease (BD). We performed a systematic review to assess the efficacy and safety of published ALA-PDT protocols for these conditions.
A PubMed search was conducted through August 8, 2024, to identify studies evaluating 10 % or 20 % ALA-PDT in BCC, SCC, and BD. Randomized controlled trials, observational studies, and case series with >5 patients were included. Quality assessment was performed using the Grading of Recommendations Assessment, Development, and Evaluation approach.
Fifty-eight studies were included in the analysis (BCC, n = 40; SCC; n = 9, BD, n = 27). Considerable heterogeneity was observed in ALA concentration, light sources, incubation times, and pretreatment strategies, precluding a standardized synthesis of outcomes. ALA-PDT achieved high clearance rates for superficial BCC and BD, with superior cosmetic outcomes compared to surgery or cryosurgery. Studies of ALA-PDT for SCC were limited with short follow-up times. Nodular BCC and SCC lesions demonstrated lower response rates, particularly with ALA-PDT monotherapy. Recurrence rates varied widely and were highest in patients with SCC. The most frequent adverse events were erythema, pain, and scaling.
This review provides a comprehensive summary of evidence-based ALA-PDT protocols for BCC, BD, and SCC, but published protocols are heterogeneous without a clear consensus. While ALA-PDT is effective, safe, and cosmetically favorable for less invasive tumors, protocol variability underscores the need for further randomized controlled trials to determine optimal treatment parameters.
5-氨基酮戊酸光动力疗法（ALA-PDT）在美国被用于非标签治疗基底细胞癌（BCC）、鳞状细胞癌（SCC）和鲍温病（BD）。我们进行了一项系统评价，以评估已发表的针对这些病症的ALA-PDT方案的疗效和安全性。
通过检索截至2024年8月8日的PubMed，以识别评估10%或20%的ALA-PDT用于BCC、SCC和BD的研究。纳入随机对照试验、观察性研究以及患者人数超过5例的病例系列。使用推荐分级评估、制定和评价方法进行质量评估。
分析纳入了58项研究（BCC，n = 40；SCC，n = 9；BD，n = 27）。在ALA浓度、光源、孵育时间和预处理策略方面观察到相当大的异质性，这使得无法对结果进行标准化综合分析。ALA-PDT对浅表性BCC和BD实现了高清除率，与手术或冷冻手术相比，美容效果更佳。针对SCC的ALA-PDT研究有限，随访时间较短。结节性BCC和SCC病变的反应率较低，尤其是ALA-PDT单药治疗时。复发率差异很大，在SCC患者中最高。最常见的不良事件是红斑、疼痛和脱屑。
本综述全面总结了基于证据的针对BCC、BD和SCC的ALA-PDT方案，但已发表的方案存在异质性，没有明确的共识。虽然ALA-PDT对侵袭性较小的肿瘤有效、安全且美容效果良好，但方案的变异性突出了进一步进行随机对照试验以确定最佳治疗参数的必要性。
