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比较利物浦因果评估工具与 Naranjo 量表预测不良反应可能性:一项回顾性队列研究。

Comparison of the Liverpool Causality Assessment Tool vs. the Naranjo Scale for predicting the likelihood of an adverse drug reaction: A retrospective cohort study.

机构信息

Departments of Paediatrics, Physiology & Pharmacology and Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, Ontario, Canada.

出版信息

Br J Clin Pharmacol. 2023 Aug;89(8):2407-2412. doi: 10.1111/bcp.15704. Epub 2023 Mar 22.

Abstract

AIMS

The aim of this study is to compare the Liverpool Causality Assessment Tool vs. Naranjo Scale for screening suspected adverse drug reaction (ADR) cases.

METHODS

We retrospectively reviewed patient charts with a history of suspected ADR, scored using both tools, and determined how each correlates with laboratory and other investigations. A total of 924 charts from the Clinical Pharmacology Clinic at the London Health Sciences Centre were reviewed, and 529 charts contained objective findings to support or against the diagnosis of ADR. The participant age ranged from 1 month to 93 years. We determined that the sensitivity (SN) and specificity (SP) of Liverpool and Naranjo tools for predicting ADRs with scores ranging from Possible to Definite were considered positive and Unlikely/Doubtful as negative for ADR. These results were confirmed by laboratory or clinical (re-challenge) testing in 529 cases.

RESULTS

Liverpool causality tool had SN of 97.2 ± 2.4% and SP of 2.3 ± 1.57%. The positive (PPV) and negative predictive values (NPV) were 34.1 and 61.5%, respectively. The Naranjo Scale had SN of 81.2 ± 5.69% and SP of 13.2 ± 3.56%. PPV and NPV were 32.7 and 57.5%, respectively.

CONCLUSION

The Liverpool Causality Assessment Tool is a more sensitive tool than the Naranjo Scale in the assessment of possible ADRs, but both tools have poor SP. The Liverpool Tool can be a useful screening tool in settings where other tests may not be readily available. However, the low PPV and NPV of both tools suggest that to pursue further testing is needed to confirm or deny an ADR.

摘要

目的

本研究旨在比较利物浦因果关系评估工具与 Naranjo 量表在筛查疑似药物不良反应 (ADR) 病例中的作用。

方法

我们回顾性地审查了使用这两种工具进行评分的疑似 ADR 病史患者的病历,并确定了每种工具如何与实验室和其他检查相关。共审查了伦敦健康科学中心临床药理学诊所的 924 份病历,其中 529 份病历包含支持或反对 ADR 诊断的客观发现。参与者年龄从 1 个月到 93 岁不等。我们确定,对于评分范围为可能到确定的 ADR,利物浦和 Naranjo 工具的灵敏度 (SN) 和特异性 (SP) 为阳性,而不确定/可疑为阴性。在 529 例病例中,通过实验室或临床(再挑战)检测证实了这些结果。

结果

利物浦因果关系工具的 SN 为 97.2±2.4%,SP 为 2.3±1.57%。阳性预测值 (PPV) 和阴性预测值 (NPV) 分别为 34.1%和 61.5%。Naranjo 量表的 SN 为 81.2±5.69%,SP 为 13.2±3.56%。PPV 和 NPV 分别为 32.7%和 57.5%。

结论

在评估可能的 ADR 时,利物浦因果关系评估工具比 Naranjo 量表更敏感,但两种工具的 SP 都较差。在其他测试可能不易获得的情况下,利物浦工具可以作为有用的筛选工具。然而,两种工具的 PPV 和 NPV 均较低,表明需要进一步测试以确认或排除 ADR。

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