Department of Urology, University at Lübeck, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
Eur Urol. 2010 Apr;57(4):595-606. doi: 10.1016/j.eururo.2009.11.041. Epub 2009 Dec 2.
The clinical benefit of photodynamic diagnosis (PDD) with 5-aminolevulinic acid or hexaminolevulinate in addition to white-light cystoscopy (WLC) in bladder cancer has been discussed controversially.
To assess in a systematic review the effect of PDD in addition to WLC on (1) the diagnosis and (2) the therapeutic outcome of primary or recurrent non-muscle-invasive bladder cancer investigated by cystoscopy or transurethral resection.
An electronic database search of Medline, Embase, the Cochrane Library, and CancerLit was undertaken, plus hand searching of relevant congress abstracts and urologic journals. Trials were included if they prospectively compared WLC with PDD in bladder cancer. The review process followed the guidelines of the Cochrane Collaboration. Two reviewers evaluated independently both trial eligibility and methodological quality and data extraction.
The primary end point of diagnostic accuracy was additional detection rate. The primary end points of therapeutic outcome were residual tumour at second resection and recurrence-free survival (RFS). Seventeen trials were identified. Twelve diagnostic trials used WLC and PDD with the same patients. Seven reported results for the subgroup of patients with carcinoma in situ (CIS). Five randomised trials studied therapeutic outcome. The results were combined in random effects meta-analyses if end points, designs, and populations were comparable. Twenty percent (95% confidence interval [CI], 8-35) more tumour-positive patients were detected with PDD in all patients with non-muscle-invasive tumours and 39% (CI, 23-57) more when only CIS was analysed. Heterogeneity was present among diagnostic studies even when the subgroup of patients with CIS was investigated. Residual tumour was significantly less often found after PDD (odds ratio: 0.28; 95% CI, 0.15-0.52; p<0.0001). RFS was higher at 12 and 24 mo in the PDD groups than in the WLC-only groups. The combined p value of log-rank tests of RFS was statistically significant (0.00002).
PDD detects more bladder tumour-positive patients, especially more with CIS, than WLC. More patients have a complete resection and a longer RFS when diagnosed with PDD.
在膀胱癌中，光动力诊断（PDD）联合白光膀胱镜检查（WLC）的临床获益一直存在争议。
通过系统评价评估 PDD 联合 WLC 对（1）通过膀胱镜或经尿道切除术检查的原发性或复发性非肌肉浸润性膀胱癌的诊断和（2）治疗结果的影响。
对 Medline、Embase、Cochrane 图书馆和 CancerLit 进行电子数据库检索，以及对相关会议摘要和泌尿科杂志进行手工检索。如果前瞻性比较了膀胱癌中 WLC 与 PDD，则纳入试验。审查过程遵循 Cochrane 协作组的指南。两名评审员独立评估试验的纳入标准和方法学质量以及数据提取。
诊断准确性的主要终点是额外的检出率。治疗结果的主要终点是第二次切除时的残余肿瘤和无复发生存率（RFS）。确定了 17 项试验。12 项诊断试验使用 WLC 和 PDD 对相同的患者进行检查。有 7 项试验报告了原位癌（CIS）亚组的结果。5 项随机试验研究了治疗结果。如果终点、设计和人群可比，则将结果组合在随机效应荟萃分析中。PDD 可使所有非肌肉浸润性肿瘤患者的肿瘤阳性患者增加 20%（95%置信区间 [CI]，8-35），仅分析 CIS 时增加 39%（95%CI，23-57）。即使在研究 CIS 亚组的情况下，诊断研究之间也存在异质性。PDD 后残余肿瘤明显减少（比值比：0.28；95%CI，0.15-0.52；p<0.0001）。PDD 组的 12 个月和 24 个月的 RFS 更高。RFS 的对数秩检验的合并 p 值具有统计学意义（0.00002）。
PDD 比 WLC 检测到更多的膀胱癌阳性患者，特别是更多的 CIS 患者。PDD 诊断的患者有更多的完全切除和更长的 RFS。
