Comparison of 5-ALA-PDT and LEEP of cervical squamous intraepithelial neoplasia (CIN2) with high-risk human papillomavirus infection in childbearing age women: A non-randomized controlled polit study

Background: 5-Aminolevulinic acid-mediated photodynamic therapy (5-ALA-PDT) is a possible minimally-invasive treatment for high-grade cervical intraepithelial neoplasia (HSIL). The present study was carried out to assess the effect of 5-ALA-PDT and loop electrosurgical excision procedure (LEEP) in cervical squamous intraepithelial neoplasia (CIN2) combined with high-risk human papillomavirus (HR-HPV) infection.

Methods: In this study, 190 patients with CIN2 and HR-HPV infection were finally included. They were divided into the LEEP Group (n = 116) and PDT Group (n = 74) according to gynecologist's recommendation and patient's willingness. All patients were followed up at 4-6 months and 12 months after treatment, including HPV testing, cytology, and colposcopy examination.

Results: (1) 4-6 months after treatment, the pathological regression rate was 97.30 % (72/74) in the PDT group and 98.28 % (114/116) in the LEEP group (P = 0.952). The HPV clearance rate was 81.08 % (60/74) in the PDT group and 80.17 % (93/116)in the LEEP group (P = 0.877). (2) 12 months after treatment, the pathological regression rate was 93.24 % (69/74) in the PDT group and 96.55 % (112/116) in the LEEP group (P = 0.486). The recurrence rate of CIN2 was 4.05 % (3/74) in the PDT group and 1.72 % (2/116) in the LEEP group (P = 0.608). The HPV clearance rate was 90.54 % (67/74) in the PDT group and 89.66 % (104/116)in the LEEP group (P = 0.843). The reinfection rate of HR-HPV was 5.41 % (4/74) in the PDT group and 1.72 % (2/116) in the LEEP group (P = 0.322). (3) The adverse reactions in the PDT Group were slightly lower than that in the LEEP Group (P = 0.4956), but the incidence of vaginal bleeding in the PDT group was lower than that in the LEEP group during follow-up.

Conclusions: The effectiveness of 5-ALA-PDT is similar to LEEP for CIN2 with less side effects. Therefore, 5-ALA-PDT, a non-invasive treatment, may be an effective method for CIN2 patients of childbearing age.