Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.
Pharmacol Res Perspect. 2018 Feb;6(1). doi: 10.1002/prp2.373.
It is difficult to determine adverse drug reactions (ADRs) in daily complicated clinical practice in which many kinds of drugs are prescribed. We evaluated how well the Naranjo Algorithm (NA) categorized ADRs among suspected ADRs. The Japan Adverse Drug Events (JADE) study was a prospective cohort study of 3459 inpatients. After all suspected ADRs were reported from research assistants, a single physician reviewer independently assigned an NA score to each. After all NA score of suspected ADRs were scored, two physician reviewers discussed and determined ADRs based on the literature. We investigated the sensitivity and specificity of NA and each component to categorize ADRs among suspected ADRs. A total of 1579 suspected ADRs were reported in 962 patients. Physician reviewers determined 997 ADRs. The percentage of ADRs was 94% if the total NA score reached 5. The modified NA consisted of 5 components that showed high classification abilities; its area under the curve (AUC) was 0.92 for categorizing ADRs, the same as the original. When we set the total NA score cut-off value to 5, specificity was 0.95 and sensitivity was 0.59. When we reclassified NA components as binary variables, the specificity increased to 0.98 with a cut-off value of 4 and yielded an AUC of 0.93. In conclusion, we showed that both NA and modified NA could categorize ADRs among suspected ADRs with a high likelihood in daily clinical practice.
在日常复杂的临床实践中，由于开具了多种药物，很难确定药物不良反应（ADR）。我们评估了 Naranjo 算法（NA）在疑似 ADR 中分类 ADR 的效果如何。日本药物不良事件（JADE）研究是一项针对 3459 名住院患者的前瞻性队列研究。在研究助理报告所有疑似 ADR 后，由一名医生独立对每个疑似 ADR 进行 NA 评分。在对所有疑似 ADR 的 NA 评分进行评分后，两名医生评审员根据文献讨论并确定 ADR。我们研究了 NA 和每个成分在疑似 ADR 中分类 ADR 的敏感性和特异性。在 962 名患者中报告了 1579 例疑似 ADR。医生评审员确定了 997 例 ADR。如果总 NA 评分达到 5，ADR 的比例为 94%。改良的 NA 由 5 个组成部分组成，具有较高的分类能力；其区分 ADR 的曲线下面积（AUC）为 0.92，与原始 NA 相同。当我们将总 NA 评分截断值设置为 5 时，特异性为 0.95，敏感性为 0.59。当我们将 NA 成分重新分类为二进制变量时，特异性提高到 0.98，截断值为 4，AUC 为 0.93。总之，我们表明，无论是 NA 还是改良的 NA，都可以在日常临床实践中高度可能地对疑似 ADR 中的 ADR 进行分类。
