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Abstract：
BACKGROUND: Immune cell functional assay (ImmuKnow®) is a non-invasive method that measures the state of cellular immunity in immunosuppressed patients. We studied the prognostic value of the assay for predicting non-cytomegalovirus (CMV) infections in lung transplant recipients.
METHODS: A multicenter prospective observational study of 92 patients followed up from 6 to 12 months after transplantation was performed. Immune cell functional assay was carried out at 6, 8, 10, and 12 months.
RESULTS: Twenty-three patients (25%) developed 29 non-CMV infections between 6 and 12 months post-transplant. At 6 months, the immune response was moderate (ATP 225-525ng/mL) in 14 (15.2%) patients and low (ATP<225ng/mL) in 78 (84.8%); no patients had a strong response (ATP≥525ng/mL). Only 1 of 14 (7.1%) patients with a moderate response developed non-CMV infection in the following 6 months compared with 22 of 78 (28.2%) patients with low response, indicating sensitivity of 95.7%, specificity of 18.8%, positive predictive value (PPV) of 28.2%, and negative predictive value (NPV) of 92.9% (AUC 0.64; p=0.043). Similar acute rejection rates were recorded in patients with mean ATP≥225 vs. <225ng/mL during the study period (7.1% vs. 9.1%, p=0.81).
CONCLUSIONS: Although ImmuKnow® does not seem useful to predict non-CMV infection, it could identify patients with a very low risk and help us define a target for an optimal immunosuppression.
METHODS: A multicenter prospective observational study of 92 patients followed up from 6 to 12 months after transplantation was performed. Immune cell functional assay was carried out at 6, 8, 10, and 12 months.
RESULTS: Twenty-three patients (25%) developed 29 non-CMV infections between 6 and 12 months post-transplant. At 6 months, the immune response was moderate (ATP 225-525ng/mL) in 14 (15.2%) patients and low (ATP<225ng/mL) in 78 (84.8%); no patients had a strong response (ATP≥525ng/mL). Only 1 of 14 (7.1%) patients with a moderate response developed non-CMV infection in the following 6 months compared with 22 of 78 (28.2%) patients with low response, indicating sensitivity of 95.7%, specificity of 18.8%, positive predictive value (PPV) of 28.2%, and negative predictive value (NPV) of 92.9% (AUC 0.64; p=0.043). Similar acute rejection rates were recorded in patients with mean ATP≥225 vs. <225ng/mL during the study period (7.1% vs. 9.1%, p=0.81).
CONCLUSIONS: Although ImmuKnow® does not seem useful to predict non-CMV infection, it could identify patients with a very low risk and help us define a target for an optimal immunosuppression.
摘要：
背景：免疫细胞功能测定（ImmuKnow®）是一种非侵入性方法，可测量免疫抑制患者的细胞免疫状态。我们研究了预测肺移植受者非巨细胞病毒（CMV）感染的方法的预后价值。
方法：对移植后6~12个月随访的92例患者进行多中心前瞻性观察研究。在6、8、10和12个月时进行免疫细胞功能测定。
结果：23例患者（25%）在移植后6至12个月之间发生了29例非CMV感染。6个月时,14例(15.2%)患者的免疫应答中等(ATP225~525ng/mL),78例(84.8%)患者的免疫应答低(ATP<225ng/mL);无患者出现强应答(ATP≥525ng/mL).14例中度反应患者中只有1例（7.1％）在接下来的6个月内出现非CMV感染，而78例患者中有22例（28.2％）反应低，指示灵敏度为95.7%，特异性18.8%，阳性预测值（PPV）为28.2%，阴性预测值（NPV）为92.9%（AUC0.64；p=0.043）。在平均ATP≥225的患者中记录了类似的急性排斥率。研究期间<225ng/mL（7.1%vs.9.1%，p=0.81）。
结论：尽管ImmuKnow®对于预测非CMV感染似乎并不有用，它可以识别风险非常低的患者，并帮助我们确定最佳免疫抑制的目标。
方法：对移植后6~12个月随访的92例患者进行多中心前瞻性观察研究。在6、8、10和12个月时进行免疫细胞功能测定。
结果：23例患者（25%）在移植后6至12个月之间发生了29例非CMV感染。6个月时,14例(15.2%)患者的免疫应答中等(ATP225~525ng/mL),78例(84.8%)患者的免疫应答低(ATP<225ng/mL);无患者出现强应答(ATP≥525ng/mL).14例中度反应患者中只有1例（7.1％）在接下来的6个月内出现非CMV感染，而78例患者中有22例（28.2％）反应低，指示灵敏度为95.7%，特异性18.8%，阳性预测值（PPV）为28.2%，阴性预测值（NPV）为92.9%（AUC0.64；p=0.043）。在平均ATP≥225的患者中记录了类似的急性排斥率。研究期间<225ng/mL（7.1%vs.9.1%，p=0.81）。
结论：尽管ImmuKnow®对于预测非CMV感染似乎并不有用，它可以识别风险非常低的患者，并帮助我们确定最佳免疫抑制的目标。
