钆塞酸二钠的临床应用研究—对肝脏恶性肿瘤诊断价值的Meta分析及对肝细胞期适宜延迟时间的初步探讨

发布时间：2018-05-14 19:14

本文选题：Gd-EOB-DTPA + 普美显　；参考：《兰州大学》2014年硕士论文

【摘要】：目的：系统评价特异性肝胆对比剂Gd-EOB-DTPA(钆塞酸二钠)对肝脏恶性肿瘤(肝细胞肝癌,肝转移癌)的诊断价值。材料与方法：系统检索CNKI[2011.1(2011年Gd-EOB-DTPA在国内上市)～2013.5]、CBM (2011.1～2013.5)、VIP (2011.1～2013.5)、中华医学会数字化期刊库(2011.1～2013.5)、PubMed[20041((2004年开始Gd-EOB-DTPA首次在欧洲上市)～2013.5]、Cochrane Library(2012年第1期)、EMbase (2004.1～2013.5)等。并追溯纳入研究的参考文献,依据QUADAS质量评价标准评价纳入研究的质量,采用stata12.0软件进行Meta分析,分别统计合并的敏感度(Sensitivity, SEN),特异度(Specificity, SPE),阳性似然比(Positive Likelihood Ratio, PLR),阴性似然比(Negative Likelihood Ratio,NLR),诊断比值比(Diagnostic Odds Ratio, dOR), SROC曲线下面积(Areas Under Roc Curve, AUC)等数据评价Gd-EOB-DTPA对于肝脏恶性肿瘤的诊断价值。结果：共纳入19篇文献,分别来自6个国家,共包括1088名患者,2661个结节,Meta分析结果显示：Gd-EOB-DTPA对肝脏转移瘤组的合并敏感度为0.93[95%CI (0.88,0.96),特异度为0.91[95%CI (0.83,0.96),阳性似然比为10.66[95%CI (5.49,20.67),阴性似然比为0.075[95%CI (0.04,0.03),诊断OR值为142.530[95%CI (62.080,327.237)],SROC曲线下面积为0.97。Q*值为0.9171。亚组分析的结果表明对于小于10mm的结节合并敏感度为[0.66(95%CI：0.54-0.79),P=0.038],大于10mm的结节合并敏感度为[0.94(95%CI：0.90-0.99),P=0.211],两者之间的P值小于0.001。1.5T磁共振合并敏感度为[0.89(95%CI：0.85-0.94),P0.001].3.OT磁共振敏感度则为[O.99(95%CI：0.98-1.007),P=0.320]。两者之间的P值0.001；研究对象为欧洲人时合并敏感度为[O.89(95%CI：0.83-0.95),P0.001],当研究对象为亚洲人时合并敏感度为[0.94(95%CI：0.90-0.99),P=0.009],而回顾性研究的合并敏感度则为[0.93(95%CI：0.89-0.96),P0.001]。前瞻性研究的敏感度为0.88。两者之间P值=0.275。肝细胞肝癌组合并敏感度为0.92[95%CI(0.89,0.94)](图2),合并特异度为0.95[95%CI(O.93,0.97)],合并阳性似然比为18.87[95%CI(13.51,26.37)],合并阴性似然比为0.09[95%CI(0.07,0.12)],合并诊断OR值为212.13[95%CI(127.26,353.62)],SROC曲线下面积为0.98[95%CI(0.95,0.99)]。亚组分析的结果表明Gd-EOB-DTPA对于小于10mmm的结节合并诊断敏感度为[0.70(95%CI：0.52-0.87),P0.001],大于20mm的结节诊断合并敏感度为[0.98(95%CI：0.96-00),P=0.66],对于大小在1Omm与20mm之间的结节诊断敏感度为[0.93(95%CI：0.86-1.01),P=0.026]小于10mm结节与10mm-20mm结节之间P值为0.008,10mm-20mm结节与大于20mm结节之间P值为0.318,小于10mmm结节与大于20mm结节之间的P值则为0.002。当研究的对象为亚洲人时其合并敏感度为[0.90(95%CI:0.87-0.92), P=0.455]。当研究对象的为欧洲人时研究敏感度为[0.97(95%CI:0.90-0.99, P=0.237]。两者之间P值为0.013。前瞻性研究的合并敏感度为[0.95(95%CI:0.91-0.98), P=0.004],回顾性研究的合并敏感度为[0.90(95%CI:0.88-0.93), P=0.004]。两者之间P值为0.023。而1.5T磁共振合并诊断敏感度为[0.92(95%CI：0.88-0.95),P0.001].3.0T磁共振诊断敏感度则为[0.92(95%CI：0.89-0.95),P=0.602]。两者之间的P值大于0.99；结论：(1)Gd-EOB-DTPA对肝脏恶性肿瘤具有明确的诊断效能。(2)对于结节直径大于10mm的肝脏恶性肿瘤具有良好的诊断敏感度。(3)使用3.0T磁共振成像系统的肝转移瘤诊断敏感度较高。但是它仍然是一个新近上市的对比剂,需要更多高质量的研究来进一步证实它的临床应用价值目的：全面评价肝功能正常或不正常的患者Gd-EOB-DTPA增强检查肝细胞期适宜的延迟时间,从而满足临床需要。方法：连续选取2013年1月-2014年1月怀疑患有肝脏占位性病变行Gd-EOB-DTPA增强检查的患者45名,在收集三期动态对比增强图像的基础上延迟5、10、20分钟采集图像,分别评估每期肝脏、肌肉、结节信号值及胆总管不同排泄时间的信号变化,计算肝脏／肌肉信号比、对比噪声比(CNR),信噪比(SNR)；回顾性按Child-Pugh肝功能分级标准分级并分组,与肝细胞期信号变化比较、分析,判定其临床意义结果：共31位患者Child-Pugh肝功能分级被分为A级,共有13人肝功能被分为B级,1人肝功能被分为C级。我们根据肝功能分为肝功能A级组与肝功能B级组来进行研究：(1)肝功能A级组肝实质信号与增强前相比,延迟5分钟、10分钟及20分钟后肝实质增强百分比的中位数及四分位间距分别为：56.7%(IQR=0.17),57.8%(IQR=0.22)及60.1%(IQR=0.24),延迟10分钟与延迟20分钟之间差异不具有统计学意义(P=O.135)；肝功能B级组肝实质信号值与增强前相比,延迟5分钟、10分钟及20分钟后增强百分比的中位数及四分位间距分别为：54.6%(IQR=0.44),51.3%(IQR=0.47)及52.1(IQR=0.55),延迟10分钟与延迟20分钟之间差异不具有统计学意义(P=0.859)。肝功能A级组肝实质强化程度与肝功能B级组延迟10分钟与延迟20分钟比较差异没有统计学意义(P=0.767,P=0.594)。(2)肝细胞肝癌病灶5分钟与20分钟CNR值比较差异具有统计学意义(P=0.028)；肝转移瘤10分钟与20分钟比较差别具有统计学意义(P=0.011)。肝脏病灶在肝细胞期没有显示出新的强化特点。(3)肝功能A级组延迟10分钟61.3%胆总管开始显影,延迟20分钟90.3%的胆总管显影。有9.7%的胆总管始终未见显影。肝功能B级组的患者延迟10分钟时38.5%的胆总管开始显影,延迟20分钟时84.6%胆总管可见显影,15.4%的胆总管全程未见显影；结论：本次研究结合肝实质对Gd-EOB-DTPA的摄取、排泄和病灶增强特征。结果表明,肝功能Child-Pugh分级A级与B级的患者,Gd-EOB-DTPA增强检查延迟20分钟肝实质的强化程度与延迟10分钟没有明显统计学差异,同时延迟10分钟即能够明确肝脏结节的性质,故如果观察重点在于结节的性质和强化特点时,肝功能Child-Pugh A级或者B级的患者肝细胞期延迟10分钟检查即能够满足临床诊断的需要,本研究的结果还需要更多的临床研究进一步证实。
[Abstract]:Objective : To evaluate the diagnostic value of Gd - EOB - DTPA ( Gd - EOB - DTPA ) ( Gd - EOB - DTPA ) in the diagnosis of hepatic malignant tumor ( hepatocellular carcinoma and hepatic metastases ) .

Materials and Methods : The diagnostic value of Gd - EOB - DTPA in the diagnosis of hepatic malignant tumors was evaluated by using stata12 . 0 software for Meta - analysis , including sensitivity ( SEN ) , specificity ( SPE ) , positive likelihood ratio ( PLR ) , negative likelihood ratio ( NLR ) , diagnostic odds ratio ( PLR ) , negative likelihood ratio ( NLR ) , diagnostic odds ratio ( PLR ) , negative likelihood ratio ( NLR ) , diagnostic odds ratio ( AUC ) and so on .

Results : 19 literatures were included , and the sensitivity of Gd - EOB - DTPA to liver metastasis was 0.93 % 95 % CI ( 0 . 88 , 0.96 ) , specificity was 0 . 91 % 95 % CI ( 0 . 83 , 0 . 96 ) , the specificity was 0 . 91 % 95 % CI ( 0 . 08 , 327 . 237 ) , P = 0 . 089 ( 95 % CI : 0.85 - 0.94 ) , P = 0 .
The sensitivity of the retrospective study was 0 . 93 ( 95 % CI : 0.89 - 0.96 ) , P = 0 . 009 ) , while the sensitivity of the retrospective study was 0 . 93 ( 95 % CI : 0.89 - 0.96 ) , P = 0 . 009 ) , while the sensitivity of the prospective study was 0.88 .

The results showed that the sensitivity of the combination was 0 . 95 % CI : 0 . 95 % CI : 0 . 90 - 0 . 99 , P = 0 .

Conclusion : ( 1 ) Gd - EOB - DTPA has definite diagnostic efficacy on hepatic malignant tumor .

Objective : To evaluate the suitable delay time of Gd - EOB - DTPA in patients with normal or abnormal liver function in order to meet the clinical needs .

Methods : 45 patients with Gd - EOB - DTPA enhanced examination were continuously selected from January 2013 to January 2014 , and the images were collected on the basis of collecting three dynamic contrast enhanced images , and the signal changes of liver , muscle , nodule signal value and different excretion time of common bile duct were assessed , and the ratio of liver / muscle signal ratio , CNR and SNR were calculated .
The clinical significance of the classification and grouping of liver function in the liver and liver cells was reviewed and compared with the changes of liver cell phase signal .

Results : A total of 31 patients were classified into A - grade , with a total of 13 patients with liver function divided into B - grade , 1 - man liver function divided into C - grade .
There was no significant difference ( P = 0.859 ) between 10 minutes and 20 minutes after delayed 5 minutes , 10 minutes and 20 minutes after delayed 5 minutes , 10 minutes and 20 minutes compared with that before enhancement ( P = 0.859 ) . There was no significant difference between the 10 minutes and the delayed 20 minutes ( P = 0.767 , P = 0.594 ) . ( 2 ) There was a significant difference between the five minutes and 20 minutes of the liver cancer lesions ( P = 0.028 ) .
There was no significant difference in liver metastases between 10 minutes and 20 minutes ( P = 0 . 011 ) .

Conclusion : This study combined with liver parenchyma on the uptake , excretion and enhancement of Gd - EOB - DTPA . The results showed that there was no significant difference in the degree of enhancement of liver parenchyma between patients with liver function Child - A grade A and grade B , and that of Gd - EOB - DTPA was delayed for 10 minutes .

【学位授予单位】：兰州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R735.7;R445.2

【参考文献】