血液恶性肿瘤及造血干细胞移植患者侵袭性真菌感染的早期抗原诊断实验研究

本研究评价血清1,3-β-D葡聚糖(G)和半乳甘露聚糖(GM)联合检测用于血液恶性肿瘤及造血干细胞移植患者侵袭性真菌病(IFD)早期诊断的敏感度及特异度,确定GM阳性值、探讨G/GM测定前后诊断级别的变化及GM水平与疗效的关系。用双抗体夹心酶联免疫吸附分析(ELISA)测定患者血清G和GM值。结果表明:按照实验中测定的界值,G/GM联合检测的敏感度100%,特异度65.7%,阳性预测值67.6%,阴性预测值为100%;G/GM检测后临床诊断IFD由1例上升至24例,有12例非感染者上升为拟诊IFD;治疗前GM水平维持在较高水平,抗真菌治疗有效患者的GM值呈下降趋势,无效死亡患者GM值呈上升趋势。结论:G及GM实验联合检测提高了IFD诊断的敏感度,降低了假阴性的发生,具有早期诊断价值,动态监测G/GM值的变化可作为评价疗效的指标。

Early Antigen Diagnosis of Invasive Fungal Infection in Patients with Hematological Malignancies and Patients Receiving Hematopoietic Stem Cell Transplantation

This study was purposed to evaluate the sensitivity and specificity of G/（1,3-β-D glucan）/GM（galactomannan） combined detection for early diagnosis of invasive fungal disease（IFD）,determine the GM positive cut-off value,and investigate the change of diagnositc level before and after G/GM test and the ralation of GM value with therapeutic effect.The ELISA with double antibody sandwich was used to detect the serum levels of G and G/M.The results showed that according to determined GM positive cut-off value,the sensitivity,specificity,positive and negative predictive value of G/GM combined detection were 100%,65.7%,67.6% and 100%,respectively.The case number of the clinical diagnosis of IFD increased from 1 to 24 cases,the diagnosis of 12 non-infective patients was changed as suspected IFD with the help of G/GM combined detection;the GM cut-off value decreased in patients whose GM cut-off value was higher before therapy and antifungal therapy was effective,while the GM cut-off value increased in patients no-responded to therapy.It is concluded that G/GM combined detection can increased the sensitivity of the diagnosis and reduce false negative rate in the early diagnosis of IFD.The dynamically monitoring G/GM cut-off value can be used as evaluation indicator of therapeutic efficacy.