Alnaieb Ziad, Osman Elsawi, Medani Shima
Department of Urology, King Hamad University Hospital, Busaiteen, Kingdom of Bahrain.
Department of Urology, University Medical Centre, Arab Gulf University, Manama, Kingdom of Bahrain.
Urol Ann. 2025 Jul-Sep;17(3):173-178. doi: 10.4103/ua.ua_24_25. Epub 2025 Jul 18.
This retrospective study aimed at comparing orally administered 5-aminolevulinic acid (5-ALA) to the intravesical (IV) route for the photodynamic diagnosis (PDD), follow-up, and guided transurethral resection of bladder tumors.
A comparative retrospective review was conducted on adult patients who underwent 5-ALA-assisted cystoscopy for bladder tumor detection. Participants were divided into Group A, who received oral (ALA onco) powder, while Group B received 5-ALA intravesically. A comprehensive assessment, including patient history, physical examination, cytological urine analysis, ultrasound, and computed tomography scans, was performed. The sensitivity and specificity of white light cystoscopy were compared to PDD cystoscopy using both 5-ALA administration routes. Furthermore, the diagnostic accuracy of the oral versus the intarvesical route was directly compared. The associated toxicities were also identified. Patients were further categorized based on the morphological presence of muscle invasion. A further subgroup statistical analysis for the nonmuscle invasive category was carried out. Chi-square test was used to calculate () value for statistical significance, while Cohen's d was used to assess the effect size. The confidence interval (CI) was denoted as 95%.
A total of 88 participants were included. Group A comprised 10 patients (8 males, aged 40-70 years), while Group B included 78 patients (58 males, aged 29-75 years). Oral 5-ALA demonstrated a sensitivity of 96%, compared to 60% for white light with a statistically significant difference ( = 0.025) with (95% CI 0.201-0.519). In terms of specificity, oral 5-ALA was statistically superior at 94%, compared to 80% with = 0.024 (95% CI 0.160-0.519). On the other hand, IV 5-ALA showed 85.12% sensitivity compared to 70% for white light, which is statistically significant ( = 0.021) and (95% CI 0.231-0.279). There was no difference between white light and IV 5 ALA with regard to specificity (50% for both). On direct comparison, there was a statistically significant difference in favor of the oral form in terms of specificity ( = 0.008) with (95% CI 0.256, 0.624), whereas the oral 5-ALA showed higher sensitivity with no statistical difference. PDD significantly outperformed white light in detecting nonmuscle-invasive tumors as it picked up 24% additional lesions. During 15-24 months of follow-up, no recurrence was observed in Group A, while 29 patients (approximately one-third) in Group B experienced recurrence. No significant adverse effects were reported. Patients with bilharzia-associated bladder carcinoma did not behave differently.
PDD using oral 5-ALA demonstrated superior diagnostic accuracy compared to IV administration and white light cystoscopy along with lower recurrence rate, making it the preferable option while larger scale and more powered studies are awaited.
本回顾性研究旨在比较口服5-氨基乙酰丙酸(5-ALA)与膀胱内(IV)给药途径在膀胱肿瘤光动力诊断(PDD)、随访及引导经尿道膀胱肿瘤切除术方面的效果。
对接受5-ALA辅助膀胱镜检查以检测膀胱肿瘤的成年患者进行了一项比较性回顾研究。参与者被分为A组,接受口服(ALA onco)粉末,而B组接受膀胱内注射5-ALA。进行了全面评估,包括患者病史、体格检查、尿液细胞学分析、超声和计算机断层扫描。比较了使用两种5-ALA给药途径时白光膀胱镜检查与PDD膀胱镜检查的敏感性和特异性。此外,还直接比较了口服与膀胱内给药途径的诊断准确性。同时确定了相关毒性。根据肌肉浸润的形态学表现对患者进行进一步分类。对非肌肉浸润类别进行了进一步的亚组统计分析。采用卡方检验计算()值以确定统计学意义,同时使用科恩d值评估效应大小。置信区间(CI)设定为95%。
共纳入88名参与者。A组包括10名患者(8名男性,年龄40 - 70岁),而B组包括78名患者(58名男性,年龄29 - 75岁)。口服5-ALA的敏感性为96%,相比之下白光的敏感性为60%,差异具有统计学意义(= 0.025),(95% CI 0.201 - 0.519)。在特异性方面,口服5-ALA在统计学上更优,为94%,而白光为80%,= 0.024(95% CI 0.160 - 0.519)。另一方面,膀胱内注射5-ALA的敏感性为85.12%,白光为70%,差异具有统计学意义(= 0.021),(95% CI 0.231 - 0.279)。在特异性方面,白光与膀胱内注射5-ALA无差异(均为50%)。直接比较时,在特异性方面口服形式具有统计学意义上的优势(= 0.008),(95% CI 0.256, 0.624),而口服5-ALA显示出更高的敏感性但无统计学差异。PDD在检测非肌肉浸润性肿瘤方面明显优于白光,因为它多发现了24%的病变。在15 - 24个月的随访期间,A组未观察到复发,而B组有29名患者(约三分之一)复发。未报告明显不良反应。血吸虫病相关膀胱癌患者的表现无差异。
与膀胱内给药和白光膀胱镜检查相比,使用口服5-ALA的PDD显示出更高的诊断准确性以及更低的复发率,在等待更大规模和更有力研究的同时,使其成为更优选择。