EIA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

Diagnostic Value of Serum Neuron Specific Enolase in Small Cell Lung Cancer Patients:A Systematic Review

目的评价EIA法检测血清神经元特异性烯醇酶诊断小细胞肺癌的价值。方法检索MEDLINE、EMbase、Cochrane图书馆等数据库,检索时间为1966年～2008年3月,收集关于EIA法检测血清神经元特异性烯醇酶诊断小细胞肺癌价值的相关研究文献并进行质量评价,采用Cochrane协作网提供的RevMan4.2.7软件进行异质性分析,MetaDisc进行Meta分析及绘制SROC曲线。结果共纳入15篇文献,包括4221例患者,其中经金标准确认的SCLC患者共672例,非SCLC者3549例。Meta分析结果显示,各纳入研究均存在不同程度的质量问题,导致各研究间存在异质性(P=0.0002,I2=66.1%),15个研究的合并灵敏度是0.67,95%CI(0.64,0.71),合并特异度是0.91,95%CI(0.90,0.92)。亚组分析结果显示,4个使用北京军事医学科学院放射医学研究所提供试剂的研究间未见统计学异质性(P=0.33,I2=13.4%),SROC曲线下面积0.9672,SE=0.0393;4个使用瑞士Roche公司提供试剂的研究间未见统计学异质性(P=0.23,I2=29.9%),SROC曲线下面积0.8311,SE=0.0836。结果表明其平均漏诊率为35.1%,平均误诊率为7.4%,有一定的诊断价值。结论现有有限证据表明:血清神经元特异性烯醇酶(NSE)在早期诊断小细胞肺癌中有一定的参考价值,可作为较重要的参考指标之一,但需要更多高质量的研究加以验证。

Objective To evaluate the diagnostic value of serum neuron specific enolase （NSE） in patients with small cell lung cancer. Methods We searched MEDLINE, EMBASE, The Cochrane Library and other databases （1966 to March 2007） to collect studies which evaluated the diagnostic value of NSE in patients with small cell lung cancer. The heterogeneity of included studies was tested by the Cochrane Collaboration＇s software RevMan 4.2. The Summary Receiver Operating Characteristic （SROC） curve and meta-analyses were performed by MetaDisc. Results Fifteen studies involving 4221 patients （672 SCLC and 3549 NSCLC patients, all diagnosed by the gold standard） were included. Meta-analyses showed that the heterogeneity among studies was high （P-0.O00 2,/2=66.1%）, the pooled sensitivity was 0.67 （95%CI 0.64 to 0.71） and the pooled specificity was 0.91 （95%CI 0.90 to 0.92）. Subgroup analyses indicated that 4 of the studies which used the reagent supplied by The Academy of Military Medical Sciences （P=0.33, F=13.4%, AUC= 0.9672, SE=0.0393） and another 4 which used the reagent supplied by Roche （P=0.23,I^2=29.9%, AUC=0.8311, SE=0,0836） had no heterogeneity. Conclusion NSE could be regarded as one of the reference tests in patients with small cell lung cancer, but more high quality trials are required.