Institute for Prevention and Occupational Medicine of the German Social Accident Insurance, Institute of the Ruhr University Bochum IPA, Bochum, Germany.
BJU Int. 2011 Aug;108(4):546-52. doi: 10.1111/j.1464-410X.2010.09971.x. Epub 2011 Jan 11.
Study Type - Diagnostic (validating cohort).
1b. What's known on the subject? and What does the study add? Microscopic haematuria (µH) is frequently detected in elderly adults. The American Urological Association recommends the follow-up of subjects with µH on bladder cancer. Whereas gross haematuria is considered an important sign of the presence of bladder cancer, the disease-predictive value of µH is less clear. No association of µH with the development of bladder tumours in a prospective screening cohort of chemical workers was observed. The positive predictive value of µH for bladder cancer was as low as 1.2%. Haematuria interfered with NMP22 but not with cytology and UroVysion(TM) test results.
• To assess the positive predictive value (PPV) of microhaematuria (µH) and gross haematuria (GH) in bladder cancer screening and the influence of haematuria on tumour tests in a prospective study.
• From September 2003 to January 2010, 1323 men took part in an annual voluntary bladder cancer screening programme for chemical workers with former exposure to aromatic amines. • In 5315 urine samples haematuria was determined with a dipstick, followed by a microscopic blood cell count in the sediment. Haematuria was categorized into traces, µH and GH. • Urinary leukocytes and other factors were investigated as potential predictors of haematuria using a generalized estimating equation model for repeated urinalysis. The risk of haematuria for positive tumour tests was analysed correspondingly. • The bladder cancer risk was estimated for the highest degree of haematuria occurring during the study with Poisson regression.
• As of July 2010, 15 bladder tumours were detected in 14 participants. • GH was found in four out of nine high-grade tumours and associated with a rate ratio of 3.82, 95% confidence interval (CI) 0.50-29.15 for the development of bladder lesions. • The PPV of GH was 11.4%, but only 1.2% for µH. µH occurred in 18.8% of urine samples and was not associated with bladder cancer [rate ratio (RR) 0.72, 95% CI 0.11-4.78]. • Abundant urinary leukocytes were associated with µH [odds ratio (OR) 8.34, 95% CI 2.26-30.69] and even stronger with GH (OR 22.25, 95% CI 6.42-77.06). • Haematuria and leukocytes influenced NMP22 positivity (µH: OR 1.63, 95% CI 1.06-2.51, abundant leukocytes: OR 8.90, 95% CI 1.58-50.16), but not test results for urine cytology and UroVysion(TM) .
• While the PPV of µH for bladder cancer was low, there was a strong influence of haematuria and leukocytes on the protein-based tumour test NMP22®. • Erythrocytes and leukocytes should be determined at least semi-quantitatively for the interpretation of positive NMP22 test results. • In addition, a panel of tumour tests that includes methods not affected by the presence of erythrocytes or leukocytes such as cytology and UroVysion(TM) would improve bladder cancer screening.
研究类型 - 诊断（验证队列）。
1b。关于这个主题，我们已经知道了什么？这项研究有什么新发现？在老年人群中经常发现微量血尿（µH）。美国泌尿协会建议对 µH 的患者进行膀胱癌随访。虽然肉眼血尿被认为是膀胱癌存在的重要标志，但 µH 的疾病预测价值尚不清楚。在一个化学工人前瞻性筛查队列中，没有观察到 µH 与膀胱肿瘤的发展有关。µH 对膀胱癌的阳性预测值（PPV）低至 1.2%。血尿干扰了 NMP22 但不干扰细胞学和 UroVysion（TM）检测结果。
评估微量血尿（µH）和肉眼血尿（GH）在膀胱癌筛查中的阳性预测值（PPV），以及血尿对肿瘤检测的影响，这是一项前瞻性研究。
从 2003 年 9 月至 2010 年 1 月，1323 名男性参加了一项针对有芳香胺既往暴露史的化学工人的年度自愿性膀胱癌筛查计划。在 5315 份尿液样本中，使用尿液试纸法检测血尿，随后在沉淀物中进行显微镜下血细胞计数。血尿分为痕迹、µH 和 GH。使用广义估计方程模型对重复尿液分析进行研究，以确定尿液白细胞和其他因素是否为血尿的潜在预测因素。相应地分析了血尿对肿瘤检测阳性的风险。使用泊松回归估计研究期间发生的最高程度血尿的膀胱癌风险。
截至 2010 年 7 月，在 14 名参与者中发现了 15 个膀胱癌。GH 在 9 个高级别肿瘤中的 4 个中发现，与膀胱病变发展的比率比为 3.82，95%置信区间（CI）为 0.50-29.15。GH 的 PPV 为 11.4%，但 µH 仅为 1.2%。µH 发生在 18.8%的尿液样本中，与膀胱癌无关（RR 0.72，95%CI 0.11-4.78）。大量的尿液白细胞与 µH 相关（OR 8.34，95%CI 2.26-30.69），与 GH 更强相关（OR 22.25，95%CI 6.42-77.06）。血尿和白细胞会影响 NMP22 的阳性结果（µH：OR 1.63，95%CI 1.06-2.51，大量白细胞：OR 8.90，95%CI 1.58-50.16），但不会影响尿细胞学和 UroVysion（TM）的检测结果。
虽然 µH 对膀胱癌的 PPV 较低，但血尿和白细胞对基于蛋白质的肿瘤检测 NMP22®有很强的影响。为了解释 NMP22 阳性检测结果，应至少半定量测定红细胞和白细胞。此外，包含不受红细胞或白细胞存在影响的方法的肿瘤检测组合，例如细胞学和 UroVysion（TM），将提高膀胱癌筛查的准确性。
