Efficacy of different 5-aminolevulinic acid photodynamic therapy regimens in managing HSIL/CIN2 among reproductive-age women: A retrospective study

Lihua Qiu · 2025-07-30

High-grade squamous intraepithelial lesion (HSIL) is a precancerous lesion that requires timely and effective intervention. Photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) has emerged as a non-invasive, fertility-preserving alternative to excisional procedures. However, the ALA-PDT regimen remains to be optimized. To compare the efficacy and safety of three treatment strategies-three-session PDT (3PDT), six-session PDT (6PDT), and a single CO This retrospective cohort study included 158 women aged 20-45 years with biopsy-confirmed cervical HSIL/CIN2. Participants received one of three regimens: 3PDT (n = 49), 6PDT (n = 47), or Laser + 6PDT (n = 54). Lesion regression and high-risk HPV (hrHPV) clearance were assessed at 3-6 and 9-12 months post-treatment. A subset of patients was followed up to 18-24 months. Adverse events were also recorded. At the 3-6 months follow-up, the complete remission (CR) rates were 67.35 % (3PDT), 74.47 % (6PDT), and 79.63 % (Laser + 6PDT), with hrHPV clearance rates of 67.35 %, 72.34 %, and 77.78 %, respectively. Differences among groups were not statistically significant (P > 0.05). By 9-12 months, CR rates reached ≥90 % in all groups, and hrHPV clearance exceeded 80 %. At 18-24 months, hrHPV clearance reached 100 % in the 6PDT group, while three patients in the 3PDT group experienced HPV recurrence. All regimens were well tolerated, with only mild adverse events reported. All three ALA-PDT-based regimens were effective and safe in treating HSIL/CIN2 in reproductive-age women. Although not statistically significant, six-session PDT with or without laser pretreatment showed a trend toward higher lesion remission and hrHPV clearance. Individualized treatment decisions based on disease severity, patient preference, and cost factors are recommended to optimize outcomes.
Authors
Funding

Shanghai Pudong New Area Health Commission

PW2022D-03

Shanghai Jiao Tong University

YG2023ZD08

Renji Hospital

National Natural Science Foundation of China

School of Medicine, Shanghai Jiao Tong University

RJPY-DZX-002

Hebei Provincial Natural Science Foundation

82072865