The clinical value of serology and molecular tests for diagnosing Invasive Aspergillosis in at-risk hematology patients

曲霉菌是一种在土壤、农场和建筑工地上发现的真菌。在免疫系统受损的人中，它会导致严重感染。曲霉菌感染(称为侵袭性曲霉病)的高危人群是化疗或骨髓移植后的急性白血病患者。目前，15%的高危人群患有侵袭性曲霉病，58-93%的感染者死亡。死亡率高的主要原因是我们目前的诊断测试不善于检测感染，或者往往只在治疗无效的晚期才检测到感染。由于目前诊断试验的局限性，目前的做法是早期给予经验性抗真菌治疗(EAFT)来治疗侵袭性曲霉病。然而，研究表明，这种疗法只导致死亡率的轻微下降，而且它会造成严重的药物毒性。这是一种次佳的治疗方式。已经开发出新的测试方法来诊断侵袭性曲霉病。这些检测用于检测血液中的曲霉蛋白和检测血液中的曲霉DNA。现有数据表明，这些新的测试在检测侵袭性曲霉病方面是敏感的。此外，其他研究表明，这些新的测试可以做出早期诊断，似乎能够监测对治疗的反应。然而，到目前为止，还没有研究表明这些测试的使用可以影响重要的患者结局。这项试验旨在确定，与目前EAFT的标准诊断和治疗方法相比，使用新的测试来指导治疗是否有助于改善侵袭性曲霉病的治疗，减少药物毒性，并降低高危患者的死亡率。如果试验成功，那么这代表着白血病和骨髓移植患者的治疗和存活率方面的重大进步。

Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of Aspergillus infection (called Invasive Aspergillosis) are those with acute leukaemia on chemotherapy or post bone marrow transplantation. Currently 15% of those at high-risk get Invasive Aspergillosis and 58-93% of those infected die. The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it causes significant drug toxicity. It is a suboptimal treatment modality. New tests have been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in the blood. Available data suggests that these new tests are sensitive in the detection of Invasive Aspergillosis. Also other studies suggest that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been performed to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is designed to determine whether the use of the new tests to guide therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT. If the trial is successful then this represents a significant advancement in the treatment and survival of leukaemic and bone marrow transplantation patients.