基于循证医学方法评价妊娠肝内胆汁淤积症生物标志物的诊断价值

Evaluation on the accuracy of the biomarkers of intrahepatic cholestasis of pregnancy based on evidence-based medicine

摘要:

目的：基于Meta分析结果，运用综合受试者工作特征曲线技术（summary receiver operating characteristic，SROC）5种技术方法评价妊娠肝内胆汁淤积症（intrahepatic cholestasis of pregnancy，ICP）中总胆汁酸（total bile acid，TBA）的诊断价值。方法：检索中文数据库：中国生物医学文献数据库（CBM）、万方、CNKI；英文数据库：PubMed，HighWire，Ovid，the Cochrane Library，Google scholar research。文献搜索的截至日期为2015年5月。对所纳入的文献进行质量评价和数据提取后，利用Meta分析所收集的TBA的灵敏度、特异度等数据信息，运用双变量随机效应模型的SROC 5种方法：η on ξ、ξ on η、D on S、R&G（Rutter and Gatso－nis）、主轴法，应用SAS的MIXED和NLMIXED过程步得到参数，建立5种模型，评价TBA对ICP的诊断价值。结果：通过Meta分析检索步骤，最终纳入6篇文献，根据5种方法计算出诊断评价结果曲线下面积（area under curve，AUC）值显示：η on ξ:0.711，ξ on η：0.448；D on S：0.730；R&G：0.801；主轴法：0.703，提示TBA的诊断准确性较高，而5种技术方法的AUC和SROC图形结果显示：R&G评价TBA准确性的效果较其他方法更好。结论：TBA诊断ＩＣＰ的准确性较好，但R&G的效果评价需进一步验证。

Abstract:

Objective：To use 5 methods of summary receiver operating characteristic（SROC） to evaluate the diagnostic value of the total bile acid（TBA） in intrahepatic cholestasis of pregnancy（ＩＣＰ） based on the Ｍeta-analysis. Methods：Articles were identified from searches of PubMed，HighWire，Ovid，the Cochrane Library，Google scholar research，the Chinese National Knowledge Infras－tructure，WanFang Dissertation Database and Chinese Biological Medical. The retrieval time was conducted at May 2015． Bivariate random effect models：η on ξ，ξ on η，D on S，R&G（Rutter’s and Gatsonis），major axis，were used based on the information of sensitivity，specificity，etc. SAS MIXED and NLMIXED procedure was applied to build 5 kinds of model to evaluate the diagnostic value of total bile acid of intrahepatic cholestasis of pregnancy. Results：The results area under curve（AUC） of diagnostic evaluation showed that η on ξ：0.711，ξ on η：0.448，D on S：0.730，Rutter and Gatsonis（R&G）：0.801，major axis：0.703，which indicated the di－agnostic accuracy of TBA was moderate，and 5 technical methods results of AUC and SROC curve showed that the effect of R&G was superior to other methods in evaluating the accuracy of TBA than. Conclusion：TBA is accurate when diagnosing intrahepatic choles-tasis of pregnancy，but the efficacy of R&G needs further consideration.