Evaluation of the efficacy and safety of photodynamic therapy after laser pretreatment for treating cervical high-grade intraepithlial lesions in patients of childbearing age: a non-randomized controlled prospective study.
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OBJECTIVE: This study aimed to evaluate the efficacy, safety, and fertility-related outcomes of laser pretreatment followed by photodynamic therapy versus LEEP in reproductive-aged women with cervical HSIL. MATERIALS AND METHODS: This non-randomized controlled prospective study enrolled 79 eligible patients (January 2022 - June 2025) from Minhang Hospital Affiliated to Fudan University, assigned to PDT after laser pretreatment group (Group 1, n = 38) or LEEP (Group 2, n = 41). One-to-one propensity score matching (PSM) was performed to balance baseline characteristics. The primary efficacy endpoint was histological regression (cure) at 6 and 12 months; HR-HPV clearance was a secondary endpoint. Post-PSM paired analyses used McNemar's test for categorical variables and paired t-test for continuous variables. Safety and fertility-related anxiety were assessed at 1 month. RESULTS: After PSM (32 matched pairs), the 6‑month histological cure rate was 90.63% in Group 1 and 93.75% in Group 2 (P = 0.617). At 12 months, all patients achieved histological cure in both groups (100% vs. 100%, P = 1.000). The 12‑month HR‑HPV clearance rate was 96.88% versus 87.50% (P = 0.134). The incidence of adverse reactions was significantly lower in Group 1 (3.13% vs. 25.00%, P = 0.034), with no cervical adhesions or bleeding observed. Fertility‑related anxiety scores were also lower in Group 1 (1.6 ± 1.1 vs. 4.2 ± 1.2, P < 0.001); these results were obtained using an unvalidated study‑specific scale and should be regarded as preliminary. CONCLUSION: Laser pretreatment combined with PDT is non-inferior to LEEP in eradicating cervical HSIL and clearing HR-HPV, while offering superior safety profiles. This organ-preserving strategy represents a reliable option for childbearing-aged women with Type I/II transformation zone HSIL.