PDF(Pubmed)
Abstract：
OBJECTIVE: Infections are common complications in patients following liver transplantation (LTX). The early diagnosis and prognosis of these infections is an unmet medical need even when using routine biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT). Therefore, new approaches are necessary.
METHODS: In a prospective, observational pilot study, we monitored 30 consecutive patients daily between days 0 and 13 following LTX using the 29-mRNA host classifier IMX-BVN-3b that determine the likelihood of bacterial infections and viral infections. True infection status was determined using clinical adjudication. Results were compared to the accuracy of CRP and PCT for patients with and without bacterial infection due to clinical adjudication.
RESULTS: Clinical adjudication confirmed bacterial infections in 10 and fungal infections in 2 patients. 20 patients stayed non-infected until day 13 post-LTX. IMX-BVN-3b bacterial scores were increased directly following LTX and decreased until day four in all patients. Bacterial IMX-BVN-3b scores detected bacterial infections in 9 out of 10 patients. PCT concentrations did not differ between patients with or without bacterial, whereas CRP was elevated in all patients with significantly higher levels in patients with bacterial infections.
CONCLUSIONS: The 29-mRNA host classifier IMX-BVN-3b identified bacterial infections in post-LTX patients and did so earlier than routine biomarkers. While our pilot study holds promise future studies will determine whether these classifiers may help to identify post-LTX infections earlier and improve patient management.
UNASSIGNED: German Clinical Trials Register: DRKS00023236, Registered 07 October 2020, https://drks.de/search/en/trial/DRKS00023236.
METHODS: In a prospective, observational pilot study, we monitored 30 consecutive patients daily between days 0 and 13 following LTX using the 29-mRNA host classifier IMX-BVN-3b that determine the likelihood of bacterial infections and viral infections. True infection status was determined using clinical adjudication. Results were compared to the accuracy of CRP and PCT for patients with and without bacterial infection due to clinical adjudication.
RESULTS: Clinical adjudication confirmed bacterial infections in 10 and fungal infections in 2 patients. 20 patients stayed non-infected until day 13 post-LTX. IMX-BVN-3b bacterial scores were increased directly following LTX and decreased until day four in all patients. Bacterial IMX-BVN-3b scores detected bacterial infections in 9 out of 10 patients. PCT concentrations did not differ between patients with or without bacterial, whereas CRP was elevated in all patients with significantly higher levels in patients with bacterial infections.
CONCLUSIONS: The 29-mRNA host classifier IMX-BVN-3b identified bacterial infections in post-LTX patients and did so earlier than routine biomarkers. While our pilot study holds promise future studies will determine whether these classifiers may help to identify post-LTX infections earlier and improve patient management.
UNASSIGNED: German Clinical Trials Register: DRKS00023236, Registered 07 October 2020, https://drks.de/search/en/trial/DRKS00023236.
摘要：
目的：感染是肝移植（LTX）后患者常见的并发症。即使使用常规生物标志物如C-反应蛋白(CRP)和降钙素原(PCT),这些感染的早期诊断和预后也是未满足的医学需求。因此,新的方法是必要的。
方法：在前瞻性中，观察性试点研究，我们使用29-mRNA宿主分类器IMX-BVN-3b测定细菌感染和病毒感染的可能性,在LTX后第0-13天,每天监测30例连续患者.使用临床裁决确定真实感染状态。结果与有或无细菌感染的患者的CRP和PCT的准确性进行了比较。
结果：临床判定证实10例患者有细菌感染，2例患者有真菌感染。20名患者保持未感染直到LTX后第13天。在所有患者中，IMX-BVN-3b细菌评分在LTX后直接增加，直到第4天下降。细菌IMX-BVN-3b评分在10名患者中的9名患者中检测到细菌感染。PCT浓度在有或没有细菌的患者之间没有差异，而所有患者的CRP均升高，细菌感染患者的CRP水平明显升高。
结论：29-mRNA宿主分类器IMX-BVN-3b鉴定了LTX后患者的细菌感染，并且比常规生物标志物更早。虽然我们的初步研究有希望，但未来的研究将确定这些分类器是否有助于更早地识别LTX后感染并改善患者管理。
■德国临床试验注册：DRKS00023236，注册2020年10月7日，https://drks。去/搜索/en/试用版/DRKS00023236.
方法：在前瞻性中，观察性试点研究，我们使用29-mRNA宿主分类器IMX-BVN-3b测定细菌感染和病毒感染的可能性,在LTX后第0-13天,每天监测30例连续患者.使用临床裁决确定真实感染状态。结果与有或无细菌感染的患者的CRP和PCT的准确性进行了比较。
结果：临床判定证实10例患者有细菌感染，2例患者有真菌感染。20名患者保持未感染直到LTX后第13天。在所有患者中，IMX-BVN-3b细菌评分在LTX后直接增加，直到第4天下降。细菌IMX-BVN-3b评分在10名患者中的9名患者中检测到细菌感染。PCT浓度在有或没有细菌的患者之间没有差异，而所有患者的CRP均升高，细菌感染患者的CRP水平明显升高。
结论：29-mRNA宿主分类器IMX-BVN-3b鉴定了LTX后患者的细菌感染，并且比常规生物标志物更早。虽然我们的初步研究有希望，但未来的研究将确定这些分类器是否有助于更早地识别LTX后感染并改善患者管理。
■德国临床试验注册：DRKS00023236，注册2020年10月7日，https://drks。去/搜索/en/试用版/DRKS00023236.
