Efficacy and safety of 5‐aminolevulinic acid‐based photodynamic therapy for cervical low‐grade squamous intraepithelial lesions with <scp>HPV</scp> infections

To assess the effectiveness and safety of 5-aminolevulinic acid-based photodynamic therapy (5-ALA PDT) for cervical low-grade squamous intraepithelial lesions (LSIL) patients with high-risk human papillomavirus (HR-HPV) infection and to investigate independent factors that influence the efficacy of PDT treatment. A retrospective analysis was conducted on 530 patients with pathologically confirmed LSIL and HR-HPV infection, treated between March 2017 and January 2024. All patients underwent 5-ALA PDT at an interval of 7-14 days, for a total of 3 to 6 sessions. Follow-ups were conducted 3 and 12 months post-treatment. The efficacy was assessed using HPV genotyping, ThinPrep cytology test (TCT) and colposcopy-directed biopsy. The HPV remission rate was 52.08% at 3 months' follow-up and increased to 69.84% at 12-month follow-up, surpassing the rate at 3-month follow-up (p < 0.001). The LSIL regression rate was 75.85% at 3 months' follow-up and rose to 86.77% at 12-month follow-up, exceeding the rate at 3-months' follow-up (p < 0.001). Multivariate analysis revealed that single HPV infection (OR 2.296 [95%CI 1.550-3.402]) was an independent predictor of HPV remission after 5-ALA PDT treatment. Single HPV infection (OR 1.690 [95% CI 1.077-2.652]), type III transformation zone (OR 3.094 [95% CI 1.899-5.041]), HPV remission after PDT treatment (OR 4.938 [95% CI 3.099-7.870]) were independent predictors of LSIL participants receiving total lesion regression after PDT treatment. Adverse reactions were all mild. 5-ALA PDT is an effective and non-invasive therapy for LSIL patients with HR-HPV infection. Identifying predictors of treatment success may optimize patient selection, ultimately improving clinical outcomes.