评估解毒剂信号在医疗重症监护病房（ICU）中检测潜在药物不良反应（ADR）的阳性预测值。

Evaluating the positive predictive values of antidote signals to detect potential adverse drug reactions (ADRs) in the medical intensive care unit (ICU).

机构信息

School of Pharmacy, Center for Pharmacoinformatics and Outcomes Research, University of Pittsburgh, Pittsburgh, PA, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1185-91. doi: 10.1002/pds.1837.

DOI:10.1002/pds.1837

PMID:19728294

Abstract

PURPOSE

Signals are used to alert clinicians of potential ADRs. Positive predictive values (PPVs) of antidote signals in ICUs are unknown. The primary purpose was to determine PPVs of six signals. The secondary objective was to determine the sensitivity of various ADR detection strategies including manual chart review, administrative data review, and voluntary reporting at identifying the same ADRs discovered using antidotes as a signal.

METHODS

Adult patients admitted to a medical ICU from July 1, 2005 to June 30, 2006 who were prescribed select signals were eligible. Evaluated antidote signals included injectable diphenhydramine, protamine, phytonadione, dextrose 50%, injectable methylprednisolone, and sodium polystyrene. For each signal, a random sample of 50 patients was evaluated for the presence of an ADR. ADR occurrences were determined using two objective causality instruments through retrospective chart review. Agreement between the instruments was required for ADR consideration. PPVs were determined for each signal.

RESULTS

Two hundred and twenty three patients (52% male) were evaluated, with a mean +/- SD age of 60 +/- 17 years, and a median simplified acute physiology score (SAPSII) of 48. PPVs were 0.64, 0.50, 0.38, 0.26, 0.24, and 0.02 for protamine, sodium polystyrene, dextrose 50%, diphenhydramine, phytonadione, and methylprednisolone, respectively. Sensitivity of other detection strategies from highest to lowest was chart review for explicit documentation, administrative database review, and voluntary reporting.

CONCLUSIONS

Protamine and sodium polystyrene performed the best by detecting ADRs in at least one out of two evaluations. Detection strategies other than signals were not as sensitive at identifying the same ADRs as antidote signals.

摘要

目的

信号用于提醒临床医生注意潜在的药物不良反应。抗毒剂信号在重症监护病房（ICU）中的阳性预测值（PPV）尚不清楚。主要目的是确定六种信号的 PPV。次要目的是确定各种药物不良反应检测策略的敏感性，包括手动图表审查、行政数据审查和自愿报告，以确定使用抗毒剂作为信号发现的相同药物不良反应。

方法

符合条件的患者为 2005 年 7 月 1 日至 2006 年 6 月 30 日期间入住内科 ICU 的成年患者，处方了选择的信号。评估的抗毒剂信号包括可注射苯海拉明、鱼精蛋白、维生素 K、50%葡萄糖、可注射甲基强的松龙和聚苯乙烯磺酸钠。对于每个信号，随机抽取 50 名患者评估药物不良反应的发生情况。通过回顾性图表审查使用两种客观因果关系工具确定药物不良反应的发生情况。只有当两个工具都认为是药物不良反应时，才会考虑药物不良反应。为每个信号确定了 PPV。

结果

共评估了 223 名患者（52%为男性），平均年龄为 60 ± 17 岁，简化急性生理学评分（SAPSII）中位数为 48。苯海拉明、聚苯乙烯磺酸钠、50%葡萄糖、苯海拉明、维生素 K 和甲基强的松龙的 PPV 分别为 0.64、0.50、0.38、0.26、0.24 和 0.02。从最高到最低，其他检测策略的敏感性依次为明确记录的图表审查、行政数据库审查和自愿报告。