社團法人臺灣臨床藥學會

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【原著】Naranjo Score 與WHO-UMC Causality Criteria 用於藥物不良反應評估之相關性分析
Correlation between Two Adverse Drug Reaction Assessment Tools: Naranjo Score and WHO-UMC Criteria
藥物不良反應,Naranjo score,WHO-UMC causality criteria、Adverse Drug Reactions, Naranjo Score, WHO-UMC Causality Criteria
李佳玲Chia-Ling Li* 、王明賢Ming-Shyan Wang 、孫淑慧Shu-Hui Sun
1醫療財團法人徐元智先生醫藥基金會亞東紀念醫院藥學部
目的: 臨床上有使用許多量表去評估藥物與不良反應間之相關性,最常被使用的為Naranjo score,而世界衛生組織也制定WHO-UMC causality criteria,目前並未有文獻明確比較其差異。故本文將就某醫學中心的藥物不良反應通報系統資料庫,將兩種廣泛使用的因果關係評估量表應用在臨床案例,並分析討論兩種評估結果之差異性與適切性。
方法: 自2013 年4 月1日至2014 年6 月30 日,從藥物不良反應通報系統資料庫中,擷取同時使用兩評估量表評估之案件,以Pearson’s 相關係數評估兩評估量表之間的相關性,以Kappa 確定其評估者間信度一致性。
結果: 共收入354 件個案,其中WHO-UMC causality criteria 級別,以「極有可能」之190 件 (45.9%) 最多;而Naranjo score 件數,以「極有可能」之259 件 (62.6%) 最多。兩評估量表間的Pearson’s 為0.712(p < 0.001) ,表示兩評估量表間具有顯著高度相關性;Kappa 為0.491 (p < 0.001) ,評估者信度達中度一致性。藥物不良反應嚴重程度次族群分析,「輕度」的Pearson’s 相關係數為0.832 (p < 0.001) 、「中度」0.668 (p < 0.001) ,而「重度」則為0.605 (p < 0.001) ,表示藥物不良反應程度並不會影響到兩評估量表間的相關性。
結論: 依本研究結果顯示Naranjo score 與WHO-UMC causality criteria 的相關性高,故藥師於評估時,或許可擇其一應用。而評估結果僅能代表其相關程度,仍需臨床醫療人員專業判斷,以確保用藥安全。
 
Objective: There are a number of algorithms available to determine drug causality for adverse drug reactions. The Naranjo score is currently the most commonly used assessment tool. The World Health Organization has also developed another assessment tool for drug causality: the WHOUMC causality criteria. Current literature has not compared the differences between the two algorithms. The aim of this study is to compare these two widely used causality assessment scale in clinical cases and assess the differences, applicability and relevance.
Methods: Adverse drug reactions that were assessed with both Naranjo score and WHO-UMC causality criteria from April 1, 2013 to June 30 2014 were retrieved from an adverse drug reaction reporting database. Pearson´s coefficient was used to assess the correlation and the Kappa coefficient was used to assess consistency between Naranjo score and WHO-UMC causality criteria.
Results: A total of 354 adverse drug reaction reports (including 414 medications) were retrieved from the adverse drug reaction database. WHO-UMC causality criteria indicated “very probable” in 190 (45.9%) cases, compared to 259 (62.6%) cases with the Naranjo score. The Pearson´s co-relation coefficient is 0.712 (p < 0.001) which shows that the two assessment tools are highly correlated.The Kappa coefficient is 0.491 (p < 0.001) which indicate moderate consistency.
Conclusion: This study shows that there is a high correlation between Naranjo score and WHO-UMC causality criteria. When evaluating adverse drug reactions, pharmacists can use either assessment tool.
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