Bates D W, Miller E B, Cullen D J, Burdick L, Williams L, Laird N, Petersen L A, Small S D, Sweitzer B J, Vander Vliet M, Leape L L
Department of Medicine, Brigham and Women's Hospital, Boston, Mass 02115, USA.
Arch Intern Med. 1999 Nov 22;159(21):2553-60. doi: 10.1001/archinte.159.21.2553.
Adverse drug events (ADEs) are common in hospitalized patients, but few empirical data are available regarding the strength of patient risk factors for ADEs.
We performed a nested case-control study within a cohort that included 4108 admissions to a stratified random sample of 11 medical and surgical units in 2 tertiary care hospitals during a 6-month period. Analyses were conducted on 2 levels: (1) using a limited set of variables available for all patients using computerized data available from 1 hospital and (2) using a larger set of variables for the case patients and matched controls from both hospitals. Case patients were patients with an ADE, and the matched control for each case patient was the patient on the same unit as the case patient with the most similar prevent length of stay. Main outcome measures were presence of an ADE, preventable ADE, or severe ADE.
In the cohort analysis, electrolyte concentrates (odds ratio [OR], 1.7), diuretics (OR, 1.7), and medical admission (OR, 1.6) were independent correlates of ADEs. Independent correlates of preventable ADEs in the cohort analysis were low platelet count (OR, 4.5), antidepressants (OR, 3.3), antihypertensive agents (OR, 2.9), medical admission (OR, 2.2), and electrolyte concentrates (OR, 2.1). In the case-control analysis, exposure to psychoactive drugs (OR, 2.1) was an independent correlate of an ADE, and use of cardiovascular drugs (OR, 2.4) was independently correlated with severe ADEs. For preventable ADEs, no independent predictors were retained after multivariate analysis.
Adverse drug events occurred more frequently in sicker patients who stayed in the hospital longer. However, after controlling for level of care and preevent length of stay, few risk factors emerged. These results suggest that, rather than targeting ADE-prone individuals, prevention strategies should focus on improving medication systems.
药物不良事件（ADEs）在住院患者中很常见，但关于患者发生ADEs风险因素强度的实证数据很少。
我们在一个队列中进行了一项巢式病例对照研究，该队列包括在6个月期间对2家三级护理医院的11个内科和外科科室进行分层随机抽样的4108例入院病例。分析在两个层面进行：（1）使用从1家医院获取的计算机化数据中所有患者可用的一组有限变量；（2）对来自两家医院的病例患者和匹配对照使用一组更大的变量。病例患者为发生ADEs的患者，每个病例患者的匹配对照是与病例患者在同一科室且住院时间最相似的患者。主要结局指标为是否存在ADEs、可预防的ADEs或严重ADEs。
在队列分析中，电解质浓缩剂（比值比[OR]，1.7）、利尿剂（OR，1.7）和内科入院（OR，1.6）是ADEs的独立相关因素。队列分析中可预防ADEs的独立相关因素为血小板计数低（OR，4.5）、抗抑郁药（OR，3.3）、抗高血压药（OR，2.9）、内科入院（OR，2.2）和电解质浓缩剂（OR，2.1）。在病例对照分析中，接触精神活性药物（OR，2.1）是ADEs的独立相关因素，使用心血管药物（OR，2.4）与严重ADEs独立相关。对于可预防的ADEs，多变量分析后未保留独立预测因素。
药物不良事件在病情较重、住院时间较长的患者中更频繁发生。然而，在控制了护理水平和事件前住院时间后，几乎没有出现风险因素。这些结果表明，预防策略应侧重于改善用药系统，而不是针对易发生ADEs的个体。
