Departments of Urology, Kochi Medical School, Nankoku, Kochi, 783-8505, Japan.
Departments of Urology, Kochi Medical School, Nankoku, Kochi, 783-8505, Japan.
Photodiagnosis Photodyn Ther. 2020 Dec;32:101999. doi: 10.1016/j.pdpdt.2020.101999. Epub 2020 Sep 10.
5-Aminolevulinic acid (ALA)-mediated photodynamic diagnosis (PDD) has recently been approved in Japan for the management of non-muscle invasive bladder cancer. As such, the current study aimed to investigate the real-world diagnostic accuracy and safety of ALA-PDD-assisted transurethral resection of bladder tumor (TURBT).
A total of 76 patients who underwent PDD-assisted TURBT were enrolled. ALA (20 mg/kg body weight) was orally administered before TURBT. Fluorescence observation and tissue collection were performed during surgery, after which diagnostic accuracy was determined. Potential side effects of ALA, including vomiting, hypotension, and liver toxicity, were carefully monitored.
The sensitivity, specificity, positive predictive value, and negative predictive value for detecting urothelial carcinoma were 90.1 %, 61.2 %, 55.1 %, and 92.2 % for fluorescence light (FL) and 65.4 %, 88.9 %, 75.7 %, and 83.9 %, for white light (WL) respectively. The mean number of tumors detected per patient was 1.92 and 1.39 for FL and WL (p < 0.05), respectively. No significant differences in the FL sensitivity and specificity were observe among the three patient groups classified according to ALA exposure time after oral administration (2-3, 3-4, and >4 h). ALA-related adverse effects included vomiting (seven cases), hypotension (seven cases, two of which were severe), and liver toxicity (four cases). All side effects disappeared shortly after standard treatment.
ALA-PDD showed sufficient diagnostic accuracy even after more than 4 h of ALA exposure prior to surgery, as well as acceptable safety profiles.
5-氨基酮戊酸（ALA）介导的光动力诊断（PDD）最近在日本获得批准，用于非肌肉浸润性膀胱癌的治疗。因此，本研究旨在调查 ALA-PDD 辅助经尿道膀胱肿瘤切除术（TURBT）的真实诊断准确性和安全性。
共纳入 76 例接受 PDD 辅助 TURBT 的患者。在 TURBT 前口服 20mg/kg 体重的 ALA。术中进行荧光观察和组织采集，然后确定诊断准确性。仔细监测 ALA 的潜在副作用，包括呕吐、低血压和肝毒性。
荧光（FL）检测尿路上皮癌的敏感性、特异性、阳性预测值和阴性预测值分别为 90.1%、61.2%、55.1%和 92.2%，白光（WL）检测分别为 65.4%、88.9%、75.7%和 83.9%。FL 组和 WL 组每位患者检测到的肿瘤平均数量分别为 1.92 个和 1.39 个（p<0.05）。根据口服 ALA 后暴露时间（2-3、3-4 和>4 h）将患者分为三组，FL 敏感性和特异性无显著差异。ALA 相关不良反应包括呕吐（7 例）、低血压（7 例，其中 2 例严重）和肝毒性（4 例）。所有不良反应在标准治疗后很快消失。
即使在手术前 ALA 暴露时间超过 4 小时后，ALA-PDD 仍具有足够的诊断准确性和可接受的安全性。
