Work

A non-inferiority study of 5-aminolevulinic acid photodynamic therapy (5-ALA-PDT) for high-grade squamous intraepithelial lesions of the cervix in patients of childbearing age: A non-randomized controlled prospective study

Year: 2025

Type: article

Abstract: • The present non-randomised controlled prospective study was conducted with a view to evaluating the efficacy of 5-ALA-PDT and LEEP in the treatment of cervical HSIL. • A comparison study was conducted that demonstrated the efficacy of 5-ALA-PDT and LEEP in women of childbearing age who were diagnosed with cervical HSIL and Type I/II transformation zone. • No significant difference was observed in HPV clearance rates and cure rates between the two regimens, indicating that 5-ALA-PDT is effective for patients of reproductive age. • In the 5-ALA-PDT group, the incidence of adverse reactions was found to be significantly lower than in the LEEP group. This finding is of particular significance as it has the potential to prevent cervical adhesions, bleeding, and infection risks. The objective of this study was to compare the effectiveness of 5-aminolevulinic acid photodynamic therapy (5-ALA-PDT) and loop electrosurgical excision procedure (LEEP) for treating cervical high-grade intraepithelial lesions (HSIL) in patients of childbearing age. We conducted a prospective study of 67 women diagnosed with cervical HSIL from January 2022 to June 2024 in Minhang Hospital, Affiliated to Fudan University. A total of 60 patients were finally included in this clinical trial. They were assigned to two groups. 30 cases received 5-ALA-PDT, and 30 cases underwent LEEP. All patients were followed up at 6 months and 12 months after treatment, including HPV testing, cytology, and colposcopy examination. 6 months after treatment, the HPV clearance rates in the 5-ALA-PDT group were similar to the LEEP group, both groups were 80.00% (P = 1.00). The cure rates in both groups were 80.00%, and the improvement rates were 20.00% (P = 1.00). 12 months after treatment, the HPV clearance rate in the 5-ALA-PDT group was marginally higher than the rate observed in the LEEP group (90.00% vs. 83.33%, P = 0.448). The cure rate in the 5-ALA-PDT group was marginally higher than that in the LEEP group (86.67% vs. 83.33%, P = 0.718). The incidence of adverse reactions in the 5-ALA-PDT group was significantly lower than that in the LEEP group for the treatment of cervical HSIL (3.33% vs. 30.00%, P < 0.05). For patients of reproductive age with cervical HSIL, 5-ALA-PDT treatment for cervical HSIL is an effective and safe treatment option.

Source: Photodiagnosis and Photodynamic Therapy

DOI: 10.1016/j.pdpdt.2025.105280