Department of Obstetrics and Gynecology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China; Shanghai Key Laboratory of Gynecologic Oncology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Outpatient nursing department, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Photodiagnosis Photodyn Ther. 2021 Dec;36:102517. doi: 10.1016/j.pdpdt.2021.102517. Epub 2021 Sep 3.
To evaluate the histologic response rate of high-grade squamous intraepithelial lesion (HSIL)/cervical intraepithelial neoplasia 2 (CIN2) of the cervix after photodynamic therapy (PDT) treatment in women with fertility requirements.
A retrospective study was carried out comprising 31 female patients aged 20-38 years with histologically confirmed HSIL/CIN2 with high-risk human papillomavirus (hrHPV) infection. Patients were treated with three sessions of 20% 5-aminolevulinic acid (5-ALA) PDT at intervals of 7-14 days. All patients had a follow-up including cytology, HPV testing and colposcopy-directed biopsy after PDT treatment at the 6-month and 12-month follow-up points. The main outcome measure was efficacy, defined as complete histologic remission 12 months after PDT. Secondary outcomes were the remission of HPV infection and the adverse effects of PDT treatment.
At the 12-month follow-up, 21 out of 27 patients (77.78%) and 4 out of 27 patients (14.81%) showed histologic disappearance and histologic regression, respectively. Only 7.41% (2/27) patients persisted with HSIL/CIN2. In addition, no patients progressed to CIN3 or carcinoma. The total baseline HPV remission rate was 62.96% (17/27). The remission rate of HPV16/18 was statistically significant compared to the other hrHPV (57.14% vs. 100%, p = 0.016) in the group with HISL/CIN2 disappearance. Adverse events were mild, with increased vaginal secretion and abdominal pain being the most common complaints. There was no report of adverse events such as vaginal bleeding, colporrhagia, ulcer, or abdominal pain after PDT treatment.
5-ALA-PDT shows a favorable efficacy and safety profile and represents a promising alternative to observation and surgical procedures in patients with HSIL/CIN2 who have fertility requirements.
评估有生育要求的高级别鳞状上皮内病变（HSIL）/宫颈上皮内瘤变 2 级（CIN2）患者行光动力疗法（PDT）治疗后的组织学应答率。
回顾性研究纳入了 31 例年龄 20-38 岁、经组织学证实的高级别鳞状上皮内病变/宫颈上皮内瘤变 2 级（CIN2）合并高危型人乳头瘤病毒（hrHPV）感染的患者。所有患者均接受了 3 次 20% 5-氨基酮戊酸（5-ALA）PDT 治疗，治疗间隔为 7-14 天。所有患者均在 PDT 治疗后进行了包括细胞学、HPV 检测和阴道镜下活检的随访，随访时间分别为 6 个月和 12 个月。主要结局指标为 12 个月时的疗效，定义为 PDT 治疗后完全组织学缓解。次要结局指标为 HPV 感染的缓解情况和 PDT 治疗的不良反应。
在 12 个月的随访中，27 例患者中有 21 例（77.78%）和 4 例（14.81%）分别显示组织学消失和组织学消退。仅 7.41%（2/27）的患者持续存在 HSIL/CIN2。此外，无患者进展为 CIN3 或癌。总的基线 HPV 缓解率为 62.96%（17/27）。在 HSIL/CIN2 消失组中，HPV16/18 的缓解率与其他高危型 HPV 相比具有统计学意义（57.14%比 100%，p=0.016）。不良反应轻微，以阴道分泌物增多和腹痛最常见。无 PDT 治疗后阴道出血、阴道撕裂、溃疡或腹痛等不良反应的报告。
5-ALA-PDT 具有良好的疗效和安全性，是有生育要求的 HSIL/CIN2 患者的一种有前途的替代观察和手术治疗的方法。
