Lanctôt K L, Naranjo C A
Department of Pharmacology, University of Toronto, Ontario, Canada.
Clin Pharmacol Ther. 1995 Dec;58(6):692-8. doi: 10.1016/0009-9236(95)90026-8.
The differential diagnosis of severe adverse drug events can be based on clinical judgment, algorithms, or the Bayesian approach. The Bayesian Adverse Reactions Diagnostic Instrument (BARDI) calculates the posterior probability (PsP) in favor of a specific drug cause based on background (e.g., epidemiologic) and case information (e.g., time of onset). Although BARDI discriminates between drug- and nondrug-induced adverse events, its apparent complexity may limit its use. BARDI results were compared with those from an algorithm for rating the probability that an adverse drug event is drug-induced (Adverse Drug Reaction Probability Scale, or APS) that is still commonly used. APS scores were obtained by two independent raters for 106 challenging cases that had been analyzed from 1 to 5 years ago with BARDI (91 cases of hypersensitivity, 12 cases of hematologic toxicity, and three cases of pulmonary toxicity); 130 ratings were generated because of the use of multiple drugs. APS scores for the two raters were highly correlated (r = 0.79; p < 0.0001). Probabilities of drug causation with use of BARDI versus average APS scores were significantly correlated (rs = 0.45; p < 0.0001). However, BARDI better distinguished cases that were highly probable (n = 83; PsP > or = 0.75) or highly improbable (n = 30; PsP < or = 0.25), whereas the APS rated the majority of these cases in the midrange (n = 128; range of APS, 1 to 8.9). These results suggest that APS and BARDI evaluations are concordant. Thus the APS may be an effective screening tool, although BARDI can better discriminate drug from nondrug-induced cases and may be more appropriate for serious cases of adverse drug reactions.
严重药物不良事件的鉴别诊断可基于临床判断、算法或贝叶斯方法。贝叶斯不良反应诊断工具（BARDI）根据背景信息（如流行病学信息）和病例信息（如发病时间）计算支持特定药物病因的后验概率（PsP）。虽然BARDI能区分药物性和非药物性不良事件，但其明显的复杂性可能限制其应用。将BARDI的结果与一种目前仍常用的评定药物不良事件为药物所致可能性的算法（药物不良反应概率量表，即APS）的结果进行比较。由两名独立评估者对106例具有挑战性的病例获取APS评分，这些病例在1至5年前已用BARDI进行分析（91例超敏反应、12例血液学毒性和3例肺毒性）；由于使用了多种药物，共生成130个评分。两名评估者的APS评分高度相关（r = 0.79；p < 0.0001）。使用BARDI得出的药物因果概率与平均APS评分显著相关（rs = 0.45；p < 0.0001）。然而，BARDI能更好地区分极有可能（n = 83；PsP≥0.75）或极不可能（n = 30；PsP≤0.25）的病例，而APS将这些病例中的大多数评定为中等范围（n = 128；APS范围为1至8.9）。这些结果表明APS和BARDI评估结果一致。因此，APS可能是一种有效的筛查工具，尽管BARDI能更好地区分药物性和非药物性病例，可能更适用于严重的药物不良反应病例。
