ELISA试剂检测前S1抗原诊断乙型肝炎病毒复制价值的Meta分析  

Value of HBV Pre-S1Ag Tested by Enzyme-linked Immunosorbent Assay in Diagnosis of Hepatitis B Virus Replication: A Meta-Analysis

作　　者：王晓存 唐婧[2] 吴军[1] 

机构地区：[1]新疆医科大学公共卫生学院,乌鲁木齐830054 [2]新疆医科大学第一附属医院医学检验中心,乌鲁木齐830054

出　　处：《中国循证医学杂志》2014年第11期1318-1325,共8页Chinese Journal of Evidence-based Medicine

基　　金：新疆维吾尔自治区自然科学基金--医学基金资助项目(编号:2014211C009)

摘　　要：目的系统评价酶联免疫吸附试验(ELISA)试剂检测血清中乙型肝炎病毒(HBV)前S1抗原(Pre-S1Ag)对乙型肝炎病毒复制的诊断价值。方法计算机检索Pub Med、EMbase、h e Cochrane Library(2014年第3期)、CBM、CNKI、VIP和Wan Fang Data,全面收集ELISA试剂检测血清中HBV Pre-S1Ag诊断乙型肝炎病毒复制的诊断性试验,检索时限均为从建库至2014年5月1日。由2位评价者按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用Meta-Disc 1.4软件进行Meta分析。结果最终纳入15个研究,包括1 994例经金标准确认的乙型肝炎患者和526例非乙型肝炎对照者。Meta分析结果显示:Sen合并=0.76[95%CI(0.74,0.78)],Spe合并=0.90[95%CI(0.88,0.91)],+LR合并=8.54[95%CI(4.25,17.15)],–LR合并=0.17[95%CI(0.10,0.27)],DOR合并=65.12[95%CI(24.91,170.28)]。SROC曲线下面积AUC=0.943 0(SE=0.018 1),Q*=0.881 3(SE=0.023 4)。结论 ELISA试剂检测Pre-S1Ag对乙型肝炎病毒复制具有一定的诊断价值。但由于纳入研究存在较大的方法学缺陷,本研究结论尚需进一步开展高质量的诊断性试验进行验证。Objective To systematically review the diagnostic value of HBV Pre-S1Ag tested by enzyme-linked im- munosorbent assay （ELISA） in patients with hepatitis B virus replication. Methods Such databases as PubMed, EMbase, The Cochrane Library （Issue 3, 2014）, CBM, CNKI, VIP and WanFang Data were electronically and comprehensively searched for relevant studies on the diagnostic value of HBV Pre-S lAg tested by ELISA in patients with hepatitis B virus replication from inception to May 1st, 2014. Relevant iournals were also manually retrieved. Two reviewers independently screened literature according to inclusion and exclusion criteria, extracted data, and assessed methodological quality of in- cluded studies. Meta-analysis was then conducted using Meta-Disc 1.4 software. Results Finally, fifteen studies were included, involving 1 994 patients with hepatitis B diagnosed by the gold standard and 526 patients with non-hepatitis B diseases. The results of meta-analysis showed （Sen=0.76, 95%CI 0.74 to 0.78; Spe=0.90, 95%CI 0.88 to 0.91; ＋LR=8.54, 95%CI 4.25 to 17.15; -LR=0.17, 95%CI 0.10 to 0.27; DOR=65.12, 95%CI 24.91 to 170.28; AUC=0.943 0, SE=0.018 1; Q＊=0.881 3, SE=0.023 4）. Conclusion HBV Pre-S1Ag tested by ELISA has certain value in the diagnosis of patients with hepatitis B virus replication. Due to poor methodological quality of the included studies, the above conclusion should be verified by conducting high quality diagnostic tests.

关 键 词：乙型肝炎 HBV前S1抗原 酶联免疫吸附试验 META分析 诊断性试验 

分 类 号：R512.62[医药卫生—内科学]