Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Tsuruma-cho 65, Showa-ku, Nagoya 466-8550, Japan; Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University 8-35-1 Sakuragaoka, Kagoshima City, 890-8520, Japan.
Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Tsuruma-cho 65, Showa-ku, Nagoya 466-8550, Japan.
Photodiagnosis Photodyn Ther. 2020 Dec;32:102004. doi: 10.1016/j.pdpdt.2020.102004. Epub 2020 Oct 3.
5-Aminolaevulinic acid (5ALA) is a precursor of the strong sensitizer protoporphyrin IX (PpIX) in the heme synthesis pathway. We conducted aclinical trial designed to evaluate the efficacy and safety of 5ALA photodynamic therapy (PDT) using a light-emitting diode (LED) in patients with cervical intraepithelial neoplasia (CIN).
Data for 51 CIN patients who underwent 5ALA-PDT between 2012 and 2017 were prospectively analysed. After a 20 % 5ALA jelly formulation was topically applied to the cervix, the region was irradiated with red light at approximately 633 nm to excite PpIX for treatment. We estimated outcomes by cytology, pathology, and human papilloma virus (HPV) testing after PDT.
Patients underwent two PDT sessions at one-week intervals during outpatient treatment and achieved favourable results without photosensitivity and severe adverse events. Over a long follow-up period, 96.1 % of all patients showed some positive effects, including approximately 70 % with a complete response (CR), 10 % with a partial response, and 15 % with downgrades. The HPV clearance rate in patients with CR was 79.4 %. Recurrence occurred in five patients who mostly remained HPV-positive after PDT.
Based on our study, topical 5ALA-PDT using an LED light source potentially represents a safe treatment for CIN on an outpatient basis.
5-氨基酮戊酸（5ALA）是血红素合成途径中强敏化剂原卟啉 IX（PpIX）的前体。我们进行了一项临床试验，旨在评估使用发光二极管（LED）的 5ALA 光动力疗法（PDT）在宫颈上皮内瘤变（CIN）患者中的疗效和安全性。
前瞻性分析了 2012 年至 2017 年间接受 5ALA-PDT 的 51 例 CIN 患者的数据。在宫颈表面涂抹 20%的 5ALA 凝胶制剂后，用大约 633nm 的红光照射该区域以激发 PpIX 进行治疗。我们通过 PDT 后的细胞学、病理学和人乳头瘤病毒（HPV）检测来评估结果。
患者在门诊治疗期间每间隔一周接受两次 PDT 治疗，在没有光敏性和严重不良事件的情况下取得了良好的效果。在长期随访期间，所有患者中有 96.1%表现出了一些积极的效果，包括约 70%的完全缓解（CR）、10%的部分缓解和 15%的降级。CR 患者的 HPV 清除率为 79.4%。在 PDT 后，大多数患者仍为 HPV 阳性的 5 名患者中出现了复发。
根据我们的研究，基于 LED 光源的局部 5ALA-PDT 可能是一种安全的门诊治疗 CIN 的方法。
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