Gupta Sandeep Kumar, Kumar K Deva
Department of Pharmacology, Heritage Institute of Medical Sciences, Varanasi, Uttar Pradesh, India.
Department of Pharmacology, Dhanalakshmi Srinivasan Medical College and Hospital, Perambalur, Tamil Nadu, India.
Int J Pharm Investig. 2017 Oct-Dec;7(4):193-197. doi: 10.4103/jphi.JPHI_81_17.
The primary objective of this study was to assess the causality of ADRs using World Health Organization-Uppsala Monitoring Centre (WHO-UMC), Naranjo and Liverpool ADR Causality Assessment Tool (LCAT). Other primary objective was to assess the agreement between the WHO-UMC criterion, Naranjo algorithm and LCAT. The secondary objective was to assess the reported adverse drug reactions in a tertiary care hospital in South India.
This was a cross-sectional retrospective study. All the ADRs which were reported by the Pharmacovigilance Unit between July 2016 and March 2017 were assessed. Causality assessment was performed by two well-trained independent pharmacologists by applying the three methods-WHO, Naranjo and LCAT. Concurrence between the two algorithms was compared using the Cohen's weighted kappa statistic.
Causality assessment of adverse reactions according to Naranjo criteria shows that 81% cases were of probable type, 9.5% cases were possible and 9.5% cases were unlikely. Causality assessment of adverse reactions according to WHO-UMC criteria shows that 85.7% cases were of probable type, 4.8% cases were possible, 4.8% cases were unlikely and 4.8% cases were definite. Causality assessment of adverse reactions according to Liverpool criteria shows that 61.9% cases were of probable type, 4.8% cases were possible and 33.3% cases were definite. Cohen's kappa test shows that negative and poor concurrence was seen between WHO and Naranjo causality comparison (κ = -0.161). Positive but poor concurrence based on kappa values was seen between Liverpool and Naranjo's causality comparison (κ = 0.133). Negative and poor concurrence based on kappa values was seen between WHO and Liverpool causality comparison (κ = -0.161).
The most frequent causality category observed by the WHO-UMC criteria, Naranjo as well as the Liverpool algorithm was "Probable." Full concurrence was not found between any of two scales of causality assessment.
本研究的主要目的是使用世界卫生组织-乌普萨拉监测中心（WHO-UMC）、纳朗霍和利物浦药物不良反应因果关系评估工具（LCAT）评估药物不良反应的因果关系。其他主要目的是评估WHO-UMC标准、纳朗霍算法和LCAT之间的一致性。次要目的是评估印度南部一家三级护理医院报告的药物不良反应。
这是一项横断面回顾性研究。对药物警戒部门在2016年7月至2017年3月期间报告的所有药物不良反应进行评估。由两名训练有素的独立药理学家应用WHO、纳朗霍和LCAT这三种方法进行因果关系评估。使用科恩加权kappa统计量比较两种算法之间的一致性。
根据纳朗霍标准对不良反应进行的因果关系评估显示，81%的病例为很可能类型，9.5%的病例为可能类型，9.5%的病例为不太可能类型。根据WHO-UMC标准对不良反应进行的因果关系评估显示，85.7%的病例为很可能类型，4.8%的病例为可能类型，4.8%的病例为不太可能类型，4.8%的病例为肯定类型。根据利物浦标准对不良反应进行的因果关系评估显示，61.9%的病例为很可能类型，4.8%的病例为可能类型，33.3%的病例为肯定类型。科恩kappa检验显示，WHO与纳朗霍因果关系比较之间存在负向且一致性差的情况（κ = -0.161）。利物浦与纳朗霍因果关系比较之间基于kappa值存在正向但一致性差的情况（κ = 0.133）。WHO与利物浦因果关系比较之间基于kappa值存在负向且一致性差的情况（κ = -0.161）。
WHO-UMC标准、纳朗霍以及利物浦算法观察到的最常见因果关系类别是“很可能”。在任何两种因果关系评估量表之间均未发现完全一致的情况。
