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Quantitative Evaluation of Initial Symptoms as Predictors to Detect Adverse Drug Reactions Using Bayes’ Theory: Expansion and Evaluation of Drug-Adverse Drug Reaction?Initial Symptom Combinations Using Adverse Event Reporting System Database

机译:使用贝叶斯理论对作为检测不良药物反应的预测因素的初始症状进行定量评估:药物不良药物反应的扩展和评估?不良事件报告系统数据库的初始症状组合

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摘要

In prescription dispensing in Japan, to avoid adverse drug reactions (ADR) pharmacists provide patients with information concerning the initial symptoms (IS) of any ADR that might be caused by the drugs they have been prescribed. However, the usefulness of such information for preventing ADR has not been quantitatively evaluated. We previously performed a trial calculation of the usefulness of rash as a predictor of drug-induced liver disorders by applying Bayes’ theorem and showed that the predictive utility of IS can be quantitatively evaluated using likelihood ratios. However, for other drug-ADR-IS combinations it was difficult to obtain the information required for the calculations from Japanese data alone. In this study, using the Adverse Event Reporting System (AERS) database of the U.S. Food and Drug Administration (FDA), we evaluated 132 drug-ADR-IS combinations that were considered to be potentially clinical significant. Regarding bezafibrate-associated rhabdomyolysis and cibenzoline-associated hypoglycemia, these ADR were not detected in cases involving monotherapy. For 58 combinations, no events that were considered to be IS of the target ADR developed. Fever, nausea, and decreased appetite were the IS of many ADR, making them very useful predictors. In contrast, pruritus and rash were not very useful. Fever might be a predictor of thiamazole-induced agranulocytosis or levofloxacin- or terbinafine-induced liver disorder, tremors might be useful for predicting paroxetine-induced serotonin syndrome, and decreased appetite might be a useful indicator of terbinafine-induced liver dysfunction.
机译:在日本进行处方分发时,为避免药物不良反应(ADR),药剂师应向患者提供有关可能由处方药引起的任何ADR初始症状(IS)的信息。但是,这种信息对于预防ADR的有用性尚未得到定量评估。我们以前通过应用贝叶斯定理对皮疹作为预测药物性肝病的有用性进行了试验性计算,结果表明可以使用似然比来定量评估IS的预测效用。但是,对于其他药物-ADR-IS组合,仅从日本数据中就很难获得计算所需的信息。在这项研究中,我们使用了美国食品药品监督管理局(FDA)的不良事件报告系统(AERS)数据库,评估了132种被认为具有潜在临床意义的药物-ADR-IS组合。关于苯扎贝特相关的横纹肌溶解症和环苯并林相关的低血糖症,在单药治疗中未检出这些ADR。对于58种组合,没有发生被认为是目标ADR的IS的事件。发烧,恶心和食欲不振是许多ADR的症结所在,使其成为非常有用的预测指标。相反,瘙痒和皮疹不是很有用。发烧可能是噻唑诱导的粒细胞缺乏症或左氧氟沙星或特比萘芬诱导的肝脏疾病的预兆,震颤可能对帕罗西汀诱导的5-羟色胺综合征的预测有用,而食欲下降可能是特比萘芬诱导的肝功能障碍的有用指标。

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