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基于贝叶斯定理的药物不良反应检测概率增加的研究:药物不良反应发生时间信息的有用性评估

Study on the Increased Probability of Detecting Adverse Drug Reactions Based on Bayes' Theorem: Evaluation of the Usefulness of Information on the Onset Timing of Adverse Drug Reactions.

作者信息

Oshima Shinji, Enjuji Takako, Negishi Akio, Akimoto Hayato, Ohara Kousuke, Okita Mitsuyoshi, Numajiri Sachihiko, Inoue Naoko, Ohshima Shigeru, Terao Akira, Kobayashi Daisuke

机构信息

Department of Analytical Pharmaceutics and Informatics, Faculty of Pharmaceutical Sciences, Josai University.

Laboratory of Drug Metabolism, Faculty of Pharmaceutical Sciences, Josai International University.

出版信息

Biol Pharm Bull. 2017 Sep 1;40(9):1389-1398. doi: 10.1248/bpb.b17-00165. Epub 2017 Jun 3.

Abstract

In order to avoid adverse drug reactions (ADRs), pharmacists are reconstructing ADR-related information based on various types of data gathered from patients, and then providing this information to patients. Among the data provided to patients is the time-to-onset of ADRs after starting the medication (i.e., ADR onset timing information). However, a quantitative evaluation of the effect of onset timing information offered by pharmacists on the probability of ADRs occurring in patients receiving this information has not been reported to date. In this study, we extracted 40 ADR-drug combinations from the data in the Japanese Adverse Drug Event Report database. By applying Bayes' theorem to these combinations, we quantitatively evaluated the usefulness of onset timing information as an ADR detection predictor. As a result, when information on days after taking medication was added, 54 ADR-drug combinations showed a likelihood ratio (LR) in excess of 2. In particular, when considering the ADR-drug combination of anaphylactic shock with levofloxacin or loxoprofen, the number of days elapsed between start of medication and the onset of the ADR was 0, which corresponded to increased likelihood ratios (LRs) of 138.7301 or 58.4516, respectively. When information from 1-7 d after starting medication was added to the combination of liver disorder and acetaminophen, the LR was 11.1775. The results of this study indicate the clinical usefulness of offering information on ADR onset timing.

摘要

为避免药物不良反应(ADR),药剂师正在根据从患者收集的各类数据重建与ADR相关的信息,然后将此信息提供给患者。提供给患者的数据中包括开始用药后ADR的发生时间(即ADR发生时间信息)。然而,迄今为止,尚未有关于药剂师提供的发生时间信息对接受该信息的患者发生ADR概率影响的定量评估报告。在本研究中,我们从日本药品不良事件报告数据库的数据中提取了40种ADR - 药物组合。通过将贝叶斯定理应用于这些组合,我们定量评估了发生时间信息作为ADR检测预测指标的有用性。结果,当加入用药后天数的信息时,54种ADR - 药物组合的似然比(LR)超过2。特别是,当考虑左氧氟沙星或洛索洛芬引起过敏性休克的ADR - 药物组合时,用药开始至ADR发生之间经过的天数为0,相应的似然比(LR)分别增加到138.7301或58.4516。当将用药后1 - 7天的信息加入到对乙酰氨基酚与肝脏疾病的组合中时,LR为11.1775。本研究结果表明提供ADR发生时间信息具有临床实用性。

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