Yu Fu1, Yingqiu Bao1, Ying Hui2, Xiaoman Gao1, Min Yang1, Jianmin Chang3. 1. Department of Dermatology, Beijing Hospital, China. 2. Department of Obstetrics and Gynecology, Beijing Hospital, China. 3. Department of Dermatology, Beijing Hospital, China. Electronic address: changjianmin@medmail.com.cn.
Abstract
OBJECTIVE: To investigate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) for cervical high-risk HPV (HR-HPV) infection. METHODS: In this prospective study, a total of 76 patients with persistent cervical HR-HPV infection were randomly divided into two groups. The treatment group (39 patients) received three treatments of ALA-PDT at two-week intervals. The control group (37 patients) received no treatment. All patients were followed up for 9 months. Hybrid Capture HPV DNA Assay and ThinPrep cytology test (TCT) were performed for both groups. Patients with abnormal TCT results received colposcopic biopsy before treatment and during follow-ups. RESULTS:HR-HPV remission rates were 64.10% (25/39) in the treatment group and 24.32% (9/37) in the control group at 3 month follow-up. Complete remission rates were 76.92% (30/39) and 32.40% (12/37), respectively, in the two groups at 9 month follow-up. There was a statistically significant difference between the two groups (P<0.01). Conversion rates of abnormal TCT results were 81.81% (9/11) in the treatment group and 12.50% (1/8) in the control group at 3 months, and 90.90% (10/11) and 25.00% (2/8), respectively, at 9 months. Five of six patients with CIN I in the treatment group and no patients in the control group achieved complete response at 9 months. There was a statistically significant difference between the two groups (P<0.01). CONCLUSION:Topical ALA-PDT is an effective, safe and well tolerated treatment for cervical HR-HPV infection.
RCT Entities:
OBJECTIVE: To investigate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) for cervical high-risk HPV (HR-HPV) infection. METHODS: In this prospective study, a total of 76 patients with persistent cervical HR-HPV infection were randomly divided into two groups. The treatment group (39 patients) received three treatments of ALA-PDT at two-week intervals. The control group (37 patients) received no treatment. All patients were followed up for 9 months. Hybrid Capture HPV DNA Assay and ThinPrep cytology test (TCT) were performed for both groups. Patients with abnormal TCT results received colposcopic biopsy before treatment and during follow-ups. RESULTS:HR-HPV remission rates were 64.10% (25/39) in the treatment group and 24.32% (9/37) in the control group at 3 month follow-up. Complete remission rates were 76.92% (30/39) and 32.40% (12/37), respectively, in the two groups at 9 month follow-up. There was a statistically significant difference between the two groups (P<0.01). Conversion rates of abnormal TCT results were 81.81% (9/11) in the treatment group and 12.50% (1/8) in the control group at 3 months, and 90.90% (10/11) and 25.00% (2/8), respectively, at 9 months. Five of six patients with CIN I in the treatment group and no patients in the control group achieved complete response at 9 months. There was a statistically significant difference between the two groups (P<0.01). CONCLUSION: Topical ALA-PDT is an effective, safe and well tolerated treatment for cervical HR-HPV infection.