血清人附睾分泌蛋白4(HE4)对人卵巢癌诊断价值的Meta分析

摘要

Objective: To quantitatively evaluate the diagnostic accuracy of the serum Epididymal Secretory Protein E4, for human epithelial ovarian cancer ( OEC ). Methods: A systematic search for relevant studies published between January 1997 and March 2011 was performed using the Medline, Embase, and China National Knowledge Infrastructure ( CNKI ) databases, among others. The criteria for inclusion were established based on the validity criteria for diagnostic research published by the Cochrane Methods Group on Screening and Diagnostic Test. Two reviewers independently assessed the methodological quality of each study by QUADAS ( Quality Assessment of Diagnostic Accuracy Studies ). Statistical analysis was performed employing MATLAB Review Manager 4.2 and Me-ta-Discl.4. A meta-analysis of the reported sensitivity and specificity of each study and the Summary Receiver Operating Characteristic ( SROC ) curve was performed. Results: A total of 14 studies with benign control, and 14 with benign and healthy control were included. The area under the curve ( AUC ) of SROC was 0.8882 ±0.0150, with Q index 0.8188 ±0.0155 for benign control, and AUC was 0.8903 ± 0.0346 with Q index 0.8210 ± 0.0359 for benign and healthy control. Detection assay and population groups were the causes of heterogeneity by meta regression analysis. Conclusion: The assay method of race and country was the important source of heterogeneity. With the relative high AUC and Q index of HE4 antibody in patients with ovarian cancer, the positive HE4 antibody might be a useful parameter for the clinical diagnosis of patients with epithelial ovarian cancer.%目的:通过Meta分析评价血清人附睾分泌蛋白4(HE4)对人卵巢癌的诊断价值.方法:系统检索Cochrane图书馆、Medline、Embase和中国生物医学文献数据库等数据库,选择以血清HE4诊断卵巢癌的临床诊断学试验.由两位评价者分别检索收集资料.用QUADAS评价文献质量,进行Meta分析,绘制综合受试者工作曲线(SROC).主要是对SROC的曲线下面积(AUC)和诊断Q指数,其次是敏感性(Sen)、特异性(Sep)、诊断比值比(OR)进行分析.结果:共有26个诊断学试验纳入,对照组可分为良性盆腔病变和良性盆腔病变+健康为对照.良性盆腔病变为对照,整体诊断效率:AUC=0.888 2±0.015 0;Q指数0.818 8±0.0155.存在阈值效应引起的异质性.HE4的测量方法是引起阈值效应的原因.诊断旱期(Ⅰ+Ⅱ期)卵巢癌:AUC=0.7634±0.0960;Q指数0.7046±0.0804.诊断绝经前卵巢癌:AUC=0.892 2±0.091 1;O指数0.8230±0.095 1.绝经后的卵巢癌:AUC:0.824 4±0.0371;Q指数0.757 5±0.033 5.在以良性盆腔病变+健康为对照的研究中,AUC=0.890 3±0.034 6;Q指数0.821 0±0.035 9,无阈值效应.人群是异质性的原因.诊断早期(Ⅰ+Ⅱ期)卵巢癌:AUC=0.883 4±0.0460;Q指数0.8140±0.0469.结论:血清HE4对于卵巢癌的临床诊断均具有较高的曲线下面积和诊断Q指数.对卵巢癌诊断具有较高的临床价值.检测方法、民族地域是异质性的主要来源.