ial complete clearance,ICC)和治疗后12个月的持续完全清除(sustained complete clearance,SCC)来评估疗效。同时收集患者治疗前的临床及病理学特征,采用单因素和多因素逻辑回归分析探讨Olsen 3级AK患者ALA-PDT治疗失败的危险因素,通过亚组分析进一步探索导致治疗抵抗和复发的危险因素。本临床试验在中国临床试验注册中心注册(注册号:ChiCTR1800019213)。本研究严格遵循《加强流行病学中观察性研究报告质量》(Strengthening the Reporting of Observational Studies in Epidemiology,STROBE)指南中的各项条目。
Actinic keratosis (AK) is a precancerous condition with the potential to develop into cutaneous squamous cell carcinoma. 5-Aminolevulinic acid photodynamic therapy (ALA-PDT) has emerged as a new treatment option for AK due to its high clearance rates and non-invasive cosmetic advantages. However
its efficacy in treating Olsen grade 3 AK
characterized by hyperkeratosis
remains controversial. This study aimed to investigate the efficacy and safety of ALA-PDT in treating Olsen grade 3 AK and to identify factors influencing treatment outcomes.
Methods:
A total of 38 patients with Olsen grade 3 AK who visited the Department of Dermatology
Huashan Hospital
Fudan University
between January 2020 and July 2023 underwent four consecutive sessions of ALA-PDT and were followed up for one year post-treatment (ethics number: 2019-491). All patients met the inclusion and exclusion criteria. Treatment efficacy was assessed by the initial complete clearance (ICC) at 3 months and the sustained complete clearance (SCC) at 12 months after treatment. Baseline clinical and pathological characteristics were collected. Univariate and multivariate logistic regression analyses were performed to explore r
isk factors for treatment failure in Olsen grade 3 AK patients receiving ALA-PDT. Subgroup analyses were conducted to further investigate risk factors associated with treatment resistance and recurrence. This study was registered on Chinese Clinical Trial Registry (chiCTR1800019213). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was followed for this study.
Results:
A total of 38 patients were included in this study
including 8 in the case group and 29 in the control group. One patient was lost to follow-up 6 months after treatment. At 3 months post-treatment
86.84% of patients achieved ICC (33/38). At the 12-month follow-up
87.88% of the patients who achieved ICC maintained SCC (29/33). No serious adverse reactions were reported during treatment and follow-up. Multivariate logistic regression analysis indicated that lesions located in multiple anatomical subunits was an independent risk factor for treatment failure (
P
=0.02
OR=28.43). Subgroup analysis confirmed that this factor was independently associated with treatment resistance (
P
=0.03
OR=97.54).
Conclusion:
ALA-PDT is effective and safe for treating Olsen grade 3 AK
offering a non-invasive treatment option for these patients. However
patients with lesions located in multiple anatomical subunits are more prone to treatment failure
warranting increased clinical attention in this population.
关键词
Keywords
references
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