The clinical trial on the safety and effectiveness of the photodynamic diagnosis of non-muscle-invasive bladder cancer using fluorescent light-guided cystoscopy after oral administration of 5-aminolevulinic acid (5-ALA)
The clinical trial on the safety and effectiveness of the photodynamic diagnosis of non-muscle-invasive bladder cancer using fluorescent light-guided cystoscopy after oral administration of 5-aminolevulinic acid (5-ALA)
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DOI：
10.1016/j.pdpdt.2015.12.011
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发表时间：
2016-03-01
影响因子：
3.3
通讯作者：
Shuin, Taro
中科院分区：
文献类型：
--
作者：
Inoue, Keiji;Matsuyama, Hideyasu;Shuin, Taro
目的：目的：探讨口服5-氨基乙酰丙酸（5-ALA）（ALA-PDD）在非肌层浸润性膀胱癌（NMIBC）中的应用价值和安全性。通过与使用白光（WL）源的常规诊断方法进行比较，评价了诊断潜力。还检查了临床推荐剂量。口服5-ALA（1.0 g/50 mL）进行前180-240分钟FL-膀胱镜检查，阳性或阴性结果进行判断使用WL-源和基于存在或不存在的红色荧光暴露于蓝色FL-source.Results：关于安全性，药物不良反应被观察到1级瘙痒1例（0.6%）。至于有效性，特异性和阳性预测性低于WL源，但灵敏度高于FL源。仅通过FL-膀胱镜检查检出肿瘤的患者比例大于仅通过常规WL-膀胱镜检查检出肿瘤的患者比例。此外，不仅灵敏度，而且仅通过FL-膀胱镜检查检测到的肿瘤患者的比例，在接受5-ALA>= 20 mg/kg/body.Conclusions的患者中最高：ALA-PDD被证明是安全有效的。此外，PDD的诊断准确性随着5-ALA剂量的增加而增加，在本研究中，推荐剂量确定为>= 20 mg/kg/体。(C)2016爱思唯尔B. V.保留所有权利。
Objective: To examine the utility and safety of photodynamic diagnosis (PDD) after oral administration of 5-aminolevulinic acid (5-ALA) (ALA-PDD) of non-muscle-invasive bladder cancer (NMIBC) using fluorescent-light (FL)-cystoscopy.Methods: The study was a single-arm, open-label, multi-center prospective study on ALA-PDD of NMIBC, with safety as the primary endpoint and efficacy as the secondary endpoint. Diagnostic potential was evaluated through comparisons with the conventional diagnostic method using a white-light (WL)-source. Clinically recommended doses were also examined. Oral administration of 5-ALA (1.0 g/50 mL) was performed 180-240 min before FL-cystoscopy, and positive or negative results were judged using a WL-source and based on presence or absence of red fluorescence on exposure to a blue FL-source.Results: Regarding safety, the adverse drug reactions were observed as grade 1 pruritus in 1 patient (0.6%). As for efficacy, specificity and positive predictability were lower than those of a WL-source, but sensitivity was higher with a FL-source than with a WL-source. The proportion of patients with tumors detected only by FL-cystoscopy was greater than the proportion of patients with tumors detected only by conventional WL-cystoscopy. Moreover, not only sensitivity, but also the proportion of patients with tumors detected only by FL-cystoscopy, was highest among patients who received 5-ALA at >= 20 mg/kg/body.Conclusions: ALA-PDD was shown to be safe and effective. Furthermore, diagnostic accuracy of PDD increased with increased dose of 5-ALA, and the recommended dose was determined as >= 20 mg/kg/body in the present study. (C) 2016 Elsevier B.V. All rights reserved.