Heidelberg University, Medical Faculty Heidelberg, Department of Anesthesiology, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany.
Inflammatix, Sunnyvale, CA, USA.
Langenbecks Arch Surg. 2024 Jun 12;409(1):185. doi: 10.1007/s00423-024-03373-1.
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.
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.
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.
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.
German Clinical Trials Register: DRKS00023236, Registered 07 October 2020, https://drks.de/search/en/trial/DRKS00023236.
感染是肝移植（LTX）后患者常见的并发症。即使使用 C 反应蛋白（CRP）和降钙素原（PCT）等常规生物标志物，这些感染的早期诊断和预后仍是未满足的医疗需求。因此，需要新的方法。
在一项前瞻性、观察性的试点研究中，我们在 LTX 后第 0 天至第 13 天期间，使用 29-mRNA 宿主分类器 IMX-BVN-3b 对 30 例连续患者进行每日监测，该分类器可确定细菌感染和病毒感染的可能性。通过临床判断确定真实感染状态。将结果与因临床判断而发生细菌感染和无细菌感染的患者的 CRP 和 PCT 的准确性进行比较。
临床判断确认 10 例患者存在细菌感染，2 例患者存在真菌感染。20 例患者在 LTX 后第 13 天之前保持未感染状态。所有患者的 LTX 后直接增加了 IMX-BVN-3b 细菌评分，并在第 4 天降至正常。IMX-BVN-3b 细菌评分在 10 例患者中的 9 例中检测到细菌感染。PCT 浓度在有无细菌感染的患者之间无差异，而 CRP 在所有患者中均升高，且在细菌感染患者中升高更明显。
29-mRNA 宿主分类器 IMX-BVN-3b 可识别 LTX 后患者的细菌感染，且早于常规生物标志物。虽然我们的试点研究有希望，但未来的研究将确定这些分类器是否可以更早地识别 LTX 后感染并改善患者管理。
德国临床试验注册处：DRKS00023236，注册于 2020 年 10 月 7 日，https://drks.de/search/en/trial/DRKS00023236。
