A prospective study of Photodynamic therapy for cervical squamous intraepithelial lesion.

Abstract Objective To evaluate the efficacy and safety of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) for the treatment of cervical squamous intraepithelial lesion (SIL). Methods We prospectively screened and enrolled patients with cervical SIL and persistent high-risk human papilloma virus (HR-HPV) infection to receive ALA–PDT from March 27, 2019, to January 23, 2020, at Beijing Youan Hospital, China. The primary outcome was the remission rate of SIL and HPV. The secondary outcome was the symptom improvement and adverse events of ALA-PDT in these cases. Results 54 patients with cervical SIL and persistent HR-HPV infection were enrolled and divided these individuals into three groups: high-grade squamous intraepithelial lesion (HSIL) group (10 patients), low-grade squamous intraepithelial lesion (LSIL) group (33 patients), and simple HR-HPV infection group (11 patients). 49 of 54 patients finished six sessions treatment and 46 of 49 patients complete the follow-up. After six sessions’ treatment, HR-HPV remission rates were 71.43%(5/7 )in the simple HR-HPV infection group, 63.64%(14/22) in the LSIL group, and 50%(4/8) in the HSIL group. The histology remission rates were 80%(4/5) in the simple HR-HPV infection group, 69.57%(16/23)in the LSIL group, and 75 % (6/8) in the HSIL group. Symptoms improvement rates in the simple HR-HPV infection, LSIL group, and HSIL group were 100%(5/5), 66.67%(5/15) and 71.43%(5/7). No severe adverse events or systemic side effects were observed in treatment. Conclusion Topical ALA-PDT is an effective and safe treatment for cervical SIL.