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

Abstract 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.