Department of Obstetrics and Gynecology, Peking University Third Hospital, 100191, 49 North Garden Rd., Haidian District, Beijing, China.
Department of Obstetrics and Gynecology, Peking University Third Hospital, 100191, 49 North Garden Rd., Haidian District, Beijing, China.
Photodiagnosis Photodyn Ther. 2021 Dec;36:102472. doi: 10.1016/j.pdpdt.2021.102472. Epub 2021 Aug 1.
Photodynamic therapy (PDT) mediated by 5-aminolevulinic acid (5-ALA) is a minimally-invasive treatment for cervical intraepithelial neoplasia (CIN). The present study was carried out to investigate the effect of 5-ALA-PDT on CIN2 and the factors influencing outcome of 5-ALA-PDT.
Patients diagnosed as CIN2 who met the inclusion criteria were enrolled in this study sequentially from January 2019 to April 2020. Patients were treated by PDT or cryotherapy according to their intentions. The primary endpoint was pathological regression. The secondary endpoint was HPV clearance. Affecting factors of the efficacy of PDT and adverse events were also assessed during treatment.
A total of 210 patients were enrolled, including 97 patients in PDT group and 101 patients in cryotherapy group, with 12 patients excluded. There was no statistical difference in population characteristics. The pathological regression rate in PDT group was 92.0% (80/87), compared with 81.4% (79/97) in cryotherapy group (P < 0.05). The HPV clearance rate was 64.4% (56/87) in PDT group and 57.8% (56/97) in cryotherapy group (P = 0.36). The main side effects of PDT were abdominal pain (24.1%, 21/87) and increased vaginal secretions (23.0%, 20/87). On univariate analysis, the risk for lesions persisting at 6 months after PDT was increased by recurrent genital tract inflammation (P = 0.004), smoking or passive smoking (P = 0.020), and multicentric lesions (P = 0.020).
PDT can be a safe and efficient treatment for CIN2. Risk factors for persisting HSIL after PDT include recurrent genital tract inflammation, smoking or passive smoking, and multicentric lesions.
5-氨基酮戊酸（5-ALA）介导的光动力疗法（PDT）是治疗宫颈上皮内瘤变（CIN）的一种微创治疗方法。本研究旨在探讨 5-ALA-PDT 对 CIN2 的疗效及影响 5-ALA-PDT 疗效的因素。
本研究为单中心、前瞻性队列研究，连续纳入 2019 年 1 月至 2020 年 4 月符合纳入标准的 CIN2 患者，根据意愿分别行 PDT 或冷冻治疗。主要终点为病理缓解，次要终点为 HPV 清除。同时评估治疗过程中 PDT 疗效的影响因素和不良反应。
共纳入 210 例患者，PDT 组 97 例，冷冻组 101 例，12 例患者失访。两组人群特征无统计学差异。PDT 组的病理缓解率为 92.0%（80/87），冷冻组为 81.4%（79/97）（P<0.05）。PDT 组 HPV 清除率为 64.4%（56/87），冷冻组为 57.8%（56/97）（P=0.36）。PDT 组主要不良反应为腹痛（24.1%，21/87）和阴道分泌物增多（23.0%，20/87）。单因素分析显示，PDT 后 6 个月病变持续存在的风险与复发性生殖道炎症（P=0.004）、吸烟或被动吸烟（P=0.020）和多中心病变（P=0.020）相关。
PDT 治疗 CIN2 安全有效。PDT 后 HSIL 持续存在的危险因素包括复发性生殖道炎症、吸烟或被动吸烟和多中心病变。
