Serum Galactomannan Versus a Combination of Galactomannan and Polymerase Chain Reaction-Based Aspergillus DNA Detection for Early Therapy of Invasive Aspergillosis in High-Risk Hematological Patients: A Randomized Controlled Trial
Serum Galactomannan Versus a Combination of Galactomannan and Polymerase Chain Reaction-Based Aspergillus DNA Detection for Early Therapy of Invasive Aspergillosis in High-Risk Hematological Patients: A Randomized Controlled Trial
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DOI：
10.1093/cid/ciu833
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发表时间：
2015-02-01
影响因子：
11.8
通讯作者：
Cuenca-Estrella, Manuel
中科院分区：
文献类型：
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作者：
Maria Aguado, Jose;Vazquez, Lourdes;Cuenca-Estrella, Manuel
背景。血清半乳甘露聚糖（GM）检测与基于聚合酶链反应（PCR）的血清曲霉DNA检测相结合，在血液病高危患者侵袭性曲霉病（IA）早期诊断和治疗中的价值尚不明确。我们在13个西班牙中心进行了一项开放标签、对照、平行组随机试验。接受诱导治疗或异基因造血干细胞移植的急性髓系白血病和骨髓增生异常综合征的成年患者随机分为两组：“GM-PCR组”（向治疗医生提供一系列血清GM和PCR检测结果）和“GM组”（仅告知血清GM结果）。两种检测的阳性提示胸部计算机断层扫描和开始抗真菌治疗。不允许使用抗衰老药物。总体而言，219例患者接受了随机分组（GM- pcr组105例，GM组114例）。“证实”或“可能”IA（主要研究结果）的累积发生率在GM-PCR组中较低（4.2% vs 13.1%；优势比为0.29[95%可信区间，0.09 - 0.91]）。GM-PCR组从开始监测到诊断为IA的中位时间间隔较低（13天vs 20天，P = 0.022），经验性抗真菌治疗的使用也较低（16.7% vs 29.0%, P = 0.038）。GM-PCR组患者证实或可能的无ia生存率更高（P = 0.027）。基于血清GM和曲霉DNA的联合监测策略与高危血液病患者的早期诊断和较低的IA发生率相关。
Background. The benefit of the combination of serum galactomannan (GM) assay and polymerase chain reaction (PCR)-based detection of serum Aspergillus DNA for the early diagnosis and therapy of invasive aspergillosis (IA) in high-risk hematological patients remains unclear.Methods. We performed an open-label, controlled, parallel-group randomized trial in 13 Spanish centers. Adult patients with acute myeloid leukemia and myelodysplastic syndrome on induction therapy or allogeneic hematopoietic stem cell transplant recipients were randomized (1: 1 ratio) to 1 of 2 arms: "GM-PCR group" (the results of serial serum GM and PCR assays were provided to treating physicians) and "GM group" (only the results of serum GM were informed). Positivity in either assay prompted thoracic computed tomography scan and initiation of antifungal therapy. No antimold prophylaxis was permitted.Results. Overall, 219 patients underwent randomization (105 in the GM-PCR group and 114 in the GM group). The cumulative incidence of "proven" or "probable" IA (primary study outcome) was lower in the GM-PCR group (4.2% vs 13.1%; odds ratio, 0.29 [95% confidence interval, .09-.91]). The median interval from the start of monitoring to the diagnosis of IA was lower in the GM-PCR group (13 vs 20 days; P = .022), as well as the use of empirical antifungal therapy (16.7% vs 29.0%; P = .038). Patients in the GM-PCR group had higher proven or probable IA-free survival (P = .027).Conclusions. A combined monitoring strategy based on serum GM and Aspergillus DNA was associated with an earlier diagnosis and a lower incidence of IA in high-risk hematological patients.