放射免疫法检测血清神经元特异性烯醇酶诊断小细胞肺癌价值的系统评价

Diagnosis Value of Tumor Marker:The Serum Neuron Specific Enolase of Small Cell Lung Cancer in RIA:A Systematic Review

目的系统评价放射免疫法(RIA法)检测血清神经元特异性烯醇酶(NSE)诊断小细胞肺癌(SCLC)的临床价值。方法计算机检索Cochrane图书馆、PubMed、MEDLINE、EMbase、Cancerlit,中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库,并辅以手工检索和附加检索,检索时限为1966年～2008年3月。纳入以肺组织病理诊断为金标准,对比NSE诊断SCLC的诊断性试验。按照Cochrane协作网推荐的诊断试验质量评价标准对纳入研究进行质量评价,提取相关信息后,采用MetaDisc软件进行合并分析,计算合并的敏感度、特异度、阳性似然比和阴性似然比,绘制汇总受试者工作特征曲线(SROC),并计算曲线下面积。结果共纳入6篇文献,其中英文4篇、中文1篇、日文1篇,文献质量均为C级,包括2366例患者,其中经金标准确认的SCLC患者共519例,非SCLC患者1847例。Meta分析结果显示,各纳入研究间存在异质性(P=0.005,I2=70.4%),6个研究的合并敏感度为0.59[95%CI(0.55,0.64)],合并特异度为0.88[95%CI(0.87,0.90)],合并阳性似然比为8.17,合并阴性似然比为0.31,汇总SROC曲线下面积为0.9050。平均漏诊率较高(41%),而平均误诊率较低(12%),表明RIA法检测NSE对SCLC具有一定的早期诊断价值。结论现有有限证据表明,NSE在早期诊断SCLC中可作为较重要的参考指标之一,但其尚需高质量的研究加以验证。

Objective To evaluate diagnostic value of tumor marker-- the serum neuron specific enolase （NSE） in patients with suspected small cell lung cancer with lung pathological diagnosis as the gold standard. Methods A search in The Cochrane Library, PubMed, OVID, MEDLINE, EMbase, Cancerlit, China National Knowledge Infrastructure （CNKI）, and CBM, was conducted from 1966 to 2008. Hand searches and additional searches were also conducted. Criteria for inclusion were established based on validity criteria for diagnostic research published by the Cochrane Methods Group on Screening and Diagnostic Tests. Subsequently, the characteristics of the included articles were appraised and extracted. Statistical analysis was performed employing Revman 4.2 software. Heterogeneity of the included articles was tested, which was used to select the proper effect model to calculate pooled weighted sensitivity and specificity. The Summary Receiver Operating Characteristic （SROC） curve was performed and the area under the curve （AUC） was calculated. Finally, sensitivity analysis was performed. Results Six articles entered this meta-analysis： four English articles, one Japanese article and one Chinese article. The quality level of the articles was C. the studies involving 2,366 patients （579 SCLC and 1,847 NSCLC patients that were diagnosed by using the gold standard） were included. The metaanalysis reported that the heterogeneity among studies was high （P=0.005, F=70.4%）, pooled sensitivity was 0.59, 95%CI 0.55 to 0.64, and pooled specificity was 0.88, 95%CI 0.87 to 0.90. The likelihood ratio was 8.17 and 0.31, respectively. The summary ROC of the meta-disc software and the area under the curve was 0.905 0. These data suggested that NSE had a relatively high false negative rate （41%） and a relatively low false positive rate （12%）. Conclusion The tumor marker NSE is has diagnostic value of small cell lung cancer, but more high quality trials are required.