Department of Medical Microbiology and Infectious Diseases, Institute of Infection and Immunity, Cardiff University School of Medicine, Heath Park, Cardiff CF14 4XN, UK.
J Infect. 2013 Sep;67(3):206-14. doi: 10.1016/j.jinf.2013.04.020. Epub 2013 May 2.
The aim of this study was to assess the clinical utility of enhanced diagnostics on the management of invasive fungal disease in high risk patients within an integrated care pathway and to audit compliance and efficacy of antifungal prophylaxis.
A cohort of 549 high risk haematology and stem-cell transplant recipients was followed over a 5 year period. The routine standard of care involved the use of antimould prophylaxis and a neutropenic care pathway utilizing twice weekly antigen and PCR testing.
Prophylaxis with itraconazole was poorly tolerated and therapeutic levels could not be maintained. Antigen testing and PCR showed good clinical utility in the management of invasive aspergilosis with high sensitivity (98%) and negative predictive value (99.6%) when both tests were used together, allowing a diagnosis IA to be excluded and obviating the need for empirical antifungal agents. When used serially, multiple positive PCR and antigen test results enabled accurate diagnosis of IA with a specificity of 95% and a positive likelihood ratio of 11. Biomarkers preceded clinical signs in 85% of proven and probable invasive disease.
The combination of both tests showed optimum clinical utility for the diagnosis and management of IA in this high risk group.
本研究旨在评估强化诊断在高危患者侵袭性真菌病管理中的临床应用，并对真菌预防的依从性和疗效进行审核。
对 549 例高危血液病和干细胞移植受者进行了为期 5 年的随访。常规标准护理包括使用抗霉菌预防和利用每周两次抗原和 PCR 检测的中性粒细胞减少症护理途径。
伊曲康唑预防不耐受，无法维持治疗水平。抗原检测和 PCR 在侵袭性曲霉病的管理中具有良好的临床应用价值，当两种检测方法同时使用时，具有高灵敏度（98%）和阴性预测值（99.6%），可排除 IA 诊断，避免使用经验性抗真菌药物。连续使用时，多个阳性 PCR 和抗原检测结果可实现 IA 的准确诊断，特异性为 95%，阳性似然比为 11。生物标志物在 85%的确诊和可能的侵袭性疾病中先于临床症状出现。
在该高危人群中，这两种检测方法的联合使用为 IA 的诊断和管理提供了最佳的临床应用价值。
