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新冠病毒感染临床综合征患者药物性肝损伤的因果关系确定。

The determination of causality of drug induced liver injury in patients with COVID-19 clinical syndrome.

机构信息

Clinical Pharmacy Department, Hamad Medical Corporation, Doha, Qatar.

School of Pharmacy, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.

出版信息

PLoS One. 2022 Sep 1;17(9):e0268705. doi: 10.1371/journal.pone.0268705. eCollection 2022.

Abstract

BACKGROUND

Drug induced liver injury (DILI) is a rising morbidity amongst patients with COVID-19 clinical syndrome. The updated RUCAM causality assessment scale is validated for use in the general population, but its utility for causality determination in cohorts of patients with COVID-19 and DILI remains uncertain.

METHODS

This retrospective study was comprised of COVID-19 patients presenting with suspected DILI to the emergency department of Weill Cornell medicine-affiliated Hamad General Hospital, Doha, Qatar. All cases that met the inclusion criteria were comparatively adjudicated by two independent rating pairs (2 clinical pharmacist and 2 physicians) utilizing the updated RUCAM scale to assess the likelihood of DILI.

RESULTS

A total of 72 patients (mean age 48.96 (SD ± 10.21) years) were examined for the determination of DILI causality. The majority had probability likelihood of "possible" or "probable" by the updated RUCAM scale. Azithromycin was the most commonly reported drug as a cause of DILI. The median R-ratio was 4.74 which correspond to a mixed liver injury phenotype. The overall Krippendorf's kappa was 0.52; with an intraclass correlation coefficient (ICC) of 0.79 (IQR 0.72-0.85). The proportion of exact pairwise agreement and disagreement between the rating pairs were 64.4%, kappa 0.269 (ICC 0.28 [0.18, 0.40]) and kappa 0.45 (ICC 0.43 [0.29-0.57]), respectively.

CONCLUSION

In a cohort of patients with COVID-19 clinical syndrome, we found the updated RUCAM scale to be useful in establishing "possible" or "probable" DILI likelihood as evident by the respective kappa values; this results if validated by larger sample sized studies will extend the clinical application of this universal tool for adjudication of DILI.

摘要

背景

药物性肝损伤(DILI)是 COVID-19 临床综合征患者发病率上升的原因之一。更新的 RUCAM 因果关系评估量表已被验证可用于普通人群,但在 COVID-19 和 DILI 患者队列中用于因果关系确定的效用仍不确定。

方法

本回顾性研究纳入了因疑似 DILI 到卡塔尔多哈威尔康奈尔医学附属哈马德综合医院急诊科就诊的 COVID-19 患者。所有符合纳入标准的病例均由两组独立的评分对(2 名临床药师和 2 名医生)通过使用更新的 RUCAM 量表进行比较评估,以评估 DILI 的可能性。

结果

共检查了 72 名(平均年龄 48.96 ± 10.21 岁)患者以确定 DILI 的因果关系。大多数患者的更新 RUCAM 量表概率为“可能”或“很可能”。阿奇霉素是最常报告的导致 DILI 的药物。中位 R-比值为 4.74,对应混合性肝损伤表型。整体 Krippendorf's kappa 值为 0.52;组内相关系数(ICC)为 0.79(IQR 0.72-0.85)。评分对之间的完全配对一致和不一致的比例分别为 64.4%、kappa 值 0.269(ICC 0.28 [0.18, 0.40])和 kappa 值 0.45(ICC 0.43 [0.29-0.57])。

结论

在 COVID-19 临床综合征患者队列中,我们发现更新的 RUCAM 量表可用于确定“可能”或“很可能”发生 DILI 的可能性,这一点可以从各自的 kappa 值中看出;如果通过更大样本量的研究进行验证,这将扩大该通用工具用于裁决 DILI 的临床应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/701e/9436150/a70c241ffb13/pone.0268705.g001.jpg

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