血清半乳甘露聚糖检测诊断侵袭性曲霉病价值的荟萃分析

目的 评价ELISA法检测血清半乳甘露聚糖(GM)诊断侵袭性曲霉病(IA)的价值.方法 检索Medline生物医学数据库、医学文摘资料库(EMbase)、OVID全文期刊库、中国生物医学文献数据库、中国生物医学期刊文献数据库及万方数据库等,检索时间为1991年1月至2008年12月,收集关于GM试验诊断IA临床价值的相关文献,进行质量评价、异质性分析、合并效应量、绘制合并受试者工作特征曲线并进行亚组分析.结果 纳入文献36篇,包括4959例患者,总体研究人群的IA平均患病率为11%(532/4959).荟萃分析结果显示,各研究间存在中等度异质性(I2=48.6%,P＜0.01),合并诊断优势比为19.10(95%CI为12.67～28.79),合并敏感度为0.66(95%CI为0.61～0.70),合并特异度为0.90(95%CI为0.89～0.90),阳性似然比为5.48(95%CI为4.27～7.02),阴性似然比0.38(95%CI为0.29～0.50),合并受试者工作特征曲线下面积为0.89.GM试验诊断IA的漏诊率为34%(168/490),误诊率为10%(466/4469);当采用的诊断临界值升高时敏感度下降,特异度升高;2次连续GM试验阳性较单次阳性诊断IA的敏感度降低,但特异度升高;年龄对GM试验诊断IA的效力无明显影响(P＞0.05);预防性抗真菌治疗或抗真菌治疗对GM试验诊断IA的敏感度和特异度均无明显影响(P＞0.05).结论 现有文献的荟萃分析结果表明,在高危人群中ELISA法检测GM抗原诊断IA具有较高价值.

A systematic review of the accuracy of diagnostic test of serum galactomannan antigen detection for invasive aspergillosis

Objective To assess the value of galactomannan(GM) double-direct sandwich enzymelinked immunosorbent assay(ELISA) in the diagnosis of invasive aspergillosis(IA). Methods A search in MEDLINE,EMbase,OVID,CBMdisc and CHKD from Jan. 1991 to Dec. 2008 was conducted to collect all articles about diagnostic tests of serum GM detection. Then the methodological quality was assessed by QUADAS-items, sources of heterogeneity investigated, pooled effect quantities evaluated, and meta-analysis studies, SROC curves, and subgroup analysis performed. Results Thirty-six articles with a population of 4959 patients were included. The average prevalence of IA was 10% (532/4959). Our meta-analysis reported a median heterogeneity ( I2 = 48.6%, P ＜ 0.05 ), with a pooled DOR value of 19.10 ( 95% CI 12.67-28.79), a pooled sensitivity of 0.66(95% CI 0.61-0.70), a pooled specificity of 0.90(95% CI 0.89-0.90 ), a pooled positive likelihood ratio of 5.48 (95% CI 4.27-7.02 ), a pooled negative likelihood ratio of 0.38(95% CI 0.29-0.50) , and an area under curve of SROC 0.88. The rate of underdiagnosis of serum GM detection was 34% (168/490) and the rate of misdiagnosis was 10% (466/4469). With a rise in the cut-off value the sensitivity of GM test decreased and specificity increased. Two consecutive positive tests decreased the sensitivity but increased the specificity. Age had no significant effect on the diagnosis by GM test. Both antifungal prophylaxis and antifungal therapy had no significant effect on sensitivity and specificity of GM test for IA diagnosis. Conclusion Serum GM detection is an effective diagnostic tool for invasive aspergillosis in high-risk populations.