Health Services Research Unit, University of Aberdeen, Foresterhill, AB25 2ZD Aberdeen, United Kingdom.
Int J Technol Assess Health Care. 2011 Jan;27(1):3-10. doi: 10.1017/S0266462310001364. Epub 2011 Jan 25.
The aim of this study was to assess the test performance and clinical effectiveness of photodynamic diagnosis (PDD) compared with white light cystoscopy (WLC) in people suspected of new or recurrent bladder cancer.
A systematic review was conducted of randomized controlled trials (RCTs), nonrandomized comparative studies, or diagnostic cross-sectional studies comparing PDD with WLC. Fifteen electronic databases and Web sites were searched (last searches April 2008). For clinical effectiveness, only RCTs were considered.
Twenty-seven studies (2,949 participants) assessed test performance. PDD had higher sensitivity than WLC (92 percent, 95 percent confidence interval [CI], 80-100 percent versus 71 percent, 95 percent CI, 49-93 percent) but lower specificity (57 percent, 95 percent CI, 36-79 percent versus 72 percent, 95 percent CI, 47-96 percent). For detecting higher risk tumors, median range sensitivity of PDD (89 percent [6-100 percent]) was higher than WLC (56 percent [0-100 percent]) whereas for lower risk tumors it was broadly similar (92 percent [20-95 percent] versus 95 percent [8-100 percent]). Four RCTs (709 participants) using 5-aminolaevulinic acid (5-ALA) as the photosensitising agent reported clinical effectiveness. Using PDD at transurethral resection of bladder tumor (TURBT) resulted in fewer residual tumors at check cystoscopy (relative risk [RR], 0.37, 95 percent CI, 0.20-0.69) and longer recurrence-free survival (RR, 1.37, 95 percent CI, 1.18-1.59), compared with WLC.
PDD detects more bladder tumors than WLC, including more high-risk tumors. Based on four RCTs reporting clinical effectiveness, 5-aminolaevulinic acid-mediated PDD at TURBT facilitates a more complete resection and prolongs recurrence-free survival.
本研究旨在评估与白光膀胱镜检查(WLC)相比,光动力诊断(PDD)在疑似新发或复发性膀胱癌患者中的检测性能和临床效果。
对比较 PDD 与 WLC 的随机对照试验(RCT)、非随机对照研究或诊断性横断面研究进行了系统评价。检索了 15 个电子数据库和网站(最后检索日期为 2008 年 4 月)。对于临床效果,仅考虑 RCT。
27 项研究(2949 名参与者)评估了检测性能。与 WLC 相比,PDD 的敏感性更高(92%,95%置信区间[CI],80-100% 对 71%,95%CI,49-93%),但特异性较低(57%,95%CI,36-79% 对 72%,95%CI,47-96%)。对于检测高危肿瘤,PDD 的中位范围敏感性(89%[6-100%])高于 WLC(56%[0-100%]),而对于低危肿瘤则大致相似(92%[20-95%]对 95%[8-100%])。四项使用 5-氨基酮戊酸(5-ALA)作为光敏剂的 RCT(709 名参与者)报告了临床效果。与 WLC 相比,在经尿道膀胱肿瘤切除术(TURBT)中使用 PDD 可使膀胱镜检查时的残余肿瘤更少(相对风险[RR],0.37,95%CI,0.20-0.69),无复发生存时间更长(RR,1.37,95%CI,1.18-1.59)。
与 WLC 相比,PDD 可检测到更多的膀胱肿瘤,包括更多的高危肿瘤。基于四项报告临床效果的 RCT,5-ALA 介导的 PDD 在 TURBT 中可促进更完全的切除并延长无复发生存时间。