血清分化抑制因子-1蛋白作为前列腺癌肿瘤标志物的临床研究

The clinical study of serum Id-1 protein as a new tumor marker of prostate cancer

目的 探讨临床检测血清分化抑制因子-1（Id-1）蛋白作为诊断前列腺癌新方法的可能性. 方法 选取2011年5月至2012年1月行前列腺穿刺活检患者223例.根据病理检查结果分为穿刺阳性组105例,年龄52～88岁,平均72岁,PSA中位数为58.24μg/L,Gleason评分5～10分；穿刺阴性组118例,年龄40～87岁,平均67岁,PSA中位数为11.66 μg/L,其中单纯BPH 60例,BPH伴炎症58例.选取同期健康体检男性196例（体检组）作为对照,年龄24～86岁,平均46岁,PSA中位数为0.73 μg/L.通过酶联免疫吸附法（ELISA）定量分析研究受试者的血清Id-1蛋白水平,比较各组间血清Id-1蛋白的差异.结合Gleason评分、PSA水平分析血清Id-1蛋白水平与肿瘤恶性程度、炎症、年龄等方面的关系.并利用受试者工作特征（ROC）曲线评价血清Id-1蛋白的诊断效能. 结果 穿刺阳性组、穿刺阴性组、体检组血清Id-1蛋白水平中位数分别为45.61、22.41、11.15 μg/L,差异有统计学意义（P＜0.05）.穿刺阳性组血清Id-1蛋白水平与Gleason评分呈中等程度正相关（r=0.6582,P＜0.05）.穿刺阴性组中,单纯BPH组和BPH伴炎症组血清Id-1蛋白水平中位数分别为19.63、26.74（μg/L）,差异有统计学意义（P＜0.05）.体检组血清Id-1蛋白水平与年龄无明显相关性（r=0.1106,P＞0.05）.血清Id-1蛋白水平的ROC曲线下面积为0.8761（95％CI0.8399～0.9123）,以血清Id-1蛋白水平24 μg/L作为ROC曲线最佳临界点时,敏感性为87.6％（92/105）,特异性为72.9％（229/314）. 结论 穿刺阳性组、穿刺阴性组、体检组患者间存在血清Id-1蛋白水平表达差异.血清Id-1蛋白水平与Gleason评分存在正相关,能反映肿瘤恶性程度.炎症可能会影响血清Id-1蛋白表达水平.血清Id-1蛋白水平与年龄无明显相关性.ELISA法检测血清Id-1蛋白水平对诊断前列腺癌有一定预测效力,但有临床意义的临界点尚需更大样本量及前瞻性研究.

Objective To explore the possibility of serum Id-1 protein as a new bio-marker for prostate cancer. Methods 223 cases of prostate biopsy patients were collected and divided into 2 groups according to pathology result. Biopsy positive group （adenocarcinoma of prostate） contained 105 cases, the mean age was 72 （52--88） years, the PSA median was 58.24μg/L, and the Gleason score was 5--10. Biopsy negative group contained 118 cases, the mean age was 67（40--87）years, the PSA median was 11.66 μg/L. 196 cases of community men at different age stages were collected. The mean age was 46（24--86） years, the median PSA was 0.73μg/L. The serum Id-1 protein was detec- ted by Id-1 ELISA Kit of all cases. The differences of Id-1 protein serum concentrations among these groups were compared. ROC curve was used to evaluate the diagnosis efficiency of serum Id-1 protein.Results Among biopsy positive group, biopsy negative group and community men group, the median number of serum concentrations of Id-1 protein was 45.61 ~tg/L, 22.41 btg/L, 11.15 bLg/L respective- ly. The differences of three groups had statistical significance （P^0.05）. In 105 cases of biopsy posi- tive patients, serum Id-1 protein level was positively correlated with Gleason score （r^0.6582, P~ 0.05）. In 118 cases of biopsy negative patients, 60 cases were uncomplicated BPH, 58 cases were BPH associated with inflammation. The median number of serum concentrations of Id-1 protein of two groups were 19.63 ~g/L and 26.74 /;g/L respectively. The difference had statistical significance （P~ 0.05）. In community men group, the result of correlation analysis suggested that serum Id-1 protein level had no correlation with age （r=0.1106, P^0.05）. The area under the ROC curve of serum con- centrations of Id-1 protein was 0.8761 （95%CI 0.8399--0.9123）. When the serum concentration of Id- 1 protein was 24 ~g/L, it made the best critical point from ROC curve, sensitivity was 87.6% （92/ 105） and specificity was 72.9% （229/314）. Conclusions The difference of serum Id-1 protein level between biopsy positive patients, biopsy negative patients and community men group had statistical significance. Serum Id-1 protein level was moderately positively correlated with Gleason score, indica- ting that it could reflect the degree of malignancy of prostate cancer. Inflammation may affect serum Id-1 expression level. Serum Id-1 protein level had no obvious correlation with age. The results showed that ELISA quantitative detection of serum concentration of Id-1 protein might have a certain ability to diagnose prostate cancer, but needs further prospective studies.