Grenouillet-Delacre Marieke, Verdoux Hélène, Moore Nicholas, Haramburu Françoise, Miremont-Salamé Ghada, Etienne Gabriel, Robinson Philip, Gruson Didier, Hilbert Gilles, Gabinski Claude, Bégaud Bernard, Molimard Mathieu
Université Victor Segalen Bordeaux 2, INSERM U657, 146 rue Léo Saignat, 33075 Bordeaux cedex, France.
Intensive Care Med. 2007 Dec;33(12):2150-7. doi: 10.1007/s00134-007-0787-8. Epub 2007 Jul 25.
To assess the characteristics of life-threatening adverse drug reactions in patients admitted to medical intensive care unit and to define those that could facilitate early identification.
A prospective 6-month observational study.
Of the 436 admissions to the teaching hospital medical intensive care unit, all patients aged over 15 years and who had received documented drug treatment were included (n = 405).
Characteristics of patients [age, gender, underlying diseases, organ failure(s), drugs taken, Severity Acute Physiologic Score II, length of stay, outcome at discharge] were prospectively collected using a standardised questionnaire. A panel of experts assessed putative serious adverse drug reaction(s) for each drug taken and each organ failure at admission by using a standardised causality assessment method. Characteristics of patients with and without serious adverse drug reactions at admission were compared using univariate and then stepwise descending multivariate logistic regression.
Of the 405 patients included, 111 (27.4%) presented an adverse drug reaction leading to organ failure. In 48% of cases adverse drug reactions were preventable, 23% were undiagnosed and 19% contributed to death. Age over 75 years [odds ratio (OR) 2.25; 95% confidence interval (CI) 1.15-4.38; p = 0.02], having more than three drugs (OR 6.90; 95% CI 1.44-33.00; p = 0.02) and a diagnosis of haematological malignancy (OR 6.19; 95% CI 2.07-18.53; p = 0.001) were independently associated with serious adverse drug reactions.
Preventable life-threatening adverse drug reactions were frequently involved in organ failure at admission to medical intensive care; many of them had not been identified.
评估入住医疗重症监护病房患者中危及生命的药物不良反应特征，并确定有助于早期识别的特征。
一项为期6个月的前瞻性观察研究。
在教学医院医疗重症监护病房收治的436例患者中，纳入所有年龄超过15岁且有药物治疗记录的患者（n = 405）。
使用标准化问卷前瞻性收集患者特征[年龄、性别、基础疾病、器官衰竭情况、服用药物、急性生理与慢性健康状况评分系统II、住院时间、出院结局]。一组专家采用标准化因果关系评估方法，对入院时服用的每种药物和每种器官衰竭的疑似严重药物不良反应进行评估。采用单变量分析，然后逐步降序多变量逻辑回归比较入院时发生和未发生严重药物不良反应的患者特征。
在纳入的405例患者中，111例（27.4%）出现导致器官衰竭的药物不良反应。在48%的病例中，药物不良反应是可预防的，23%未被诊断，19%导致死亡。75岁以上（比值比[OR] 2.25；95%置信区间[CI] 1.15 - 4.38；p = 0.02）、服用三种以上药物（OR 6.90；95% CI 1.44 - 33.00；p = 0.02）以及诊断为血液系统恶性肿瘤（OR 6.19；95% CI 2.07 - 18.53；p = 0.001）与严重药物不良反应独立相关。
可预防的危及生命的药物不良反应在入住医疗重症监护病房时经常导致器官衰竭；其中许多未被识别。
