Detecting adverse drug reactions on paediatric wards -: Intensified surveillance versus computerised screening of laboratory values
Detecting adverse drug reactions on paediatric wards -: Intensified surveillance versus computerised screening of laboratory values
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DOI：
10.2165/00002018-200528050-00008
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发表时间：
2005-01-01
期刊：
影响因子：
4.2
通讯作者：
Th端rmann, PA
中科院分区：
文献类型：
--
作者：
Haffner, S;von Laue, N;Th端rmann, PA
背景：药物不良反应（adr）对患者发病率和死亡率以及医疗保健系统的成本有重要影响。我们的目的是评估儿科医院人群中不良反应的类型和发生率，通过两种不同的方法来比较确定。方法：我们的前瞻性研究纳入了德国HELIOS Klinikum Wuppertal教学医院普通儿童病房（46张床位）和儿科重症监护病房（6张床位）的所有患者，研究为期3个月。我们采用两种方法检测adr。强化的监测系统依靠训练有素的医生进行查房和评估患者图表。病理实验室参数的计算机辅助筛查使用略低于或高于年龄特异性正常范围的值作为潜在不良反应的触发信号，随后由训练有素的人员进行评估。结果：通过同时应用这两种方法，我们观察到14.1%的儿童在住院期间发生了ADR， 2.7%的儿童因ADR入院。加强监测，在11.9%的患者中发现101例不良反应，主要表现为胃肠道症状、皮肤和中枢神经系统疾病；在5.7%的患者中，计算机辅助筛查发现45个不良反应，主要是药物性血液不良反应和肝损害。此外，与计算机化方法观察到的不良反应相比，强化方法检测到的不良反应更严重，影响到更年幼的儿童，并显示出更密切的因果归因性。所涉及的药物光谱相似，抗感染药被怀疑最多。强化监测系统和计算机化监测筛查的敏感性分别为67.2%和44.8%，计算机辅助筛查的特异性为72.8%。计算机辅助筛查监测下病理实验室值的平均阳性预测值为18.6%。大约25%的不良反应相关药物被用于标签外适应症。结论：使用已发表的文献进行比较，我们发现儿科患者和成人患者发生不良反应的频率相同。在儿科环境中应用的强化监测和计算机化监测显示其检测特异性存在实质性差异。强化监测比计算机监测可以发现更多数量和更严重的不良反应，但需要更多的人力资源。
Background: Adverse drug reactions (ADRs) contribute significantly to patient morbidity and mortality, as well as to costs for healthcare systems. Our aim was to evaluate the type and incidence of ADRs in a paediatric hospital population, comparatively ascertained by two different methodological approaches.Methods: Our prospective study enrolled all patients admitted to two of the general children wards (46 beds) and the paediatric intensive care unit (6 beds) at the HELIOS Klinikum Wuppertal teaching hospital in Germany, over the study period of 3 months. We used two methods to detect ADRs. The intensified surveillance system relied on a trained physician conducting ward rounds and assessing patient charts. The computer-assisted screening of pathological laboratory parameters used values slightly below or above the age-specific normal range as a trigger signal for a potential ADR, which was subsequently assessed by trained personnel.Results: By applying both methods simultaneously we observed that 14.1% of children experienced an ADR while they were hospitalised and 2.7% of children were admitted to hospital because of the ADR. Intensified surveillance resulted in the detection of 101 ADRs in 11.9% of patients, predominantly presenting with gastrointestinal symptoms, skin and CNS disorders; computer-assisted screening identified 45 ADRs in 5.7% of patients, mainly with drug-induced blood dyscrasia and liver damage. Furthermore, the ADRs detected by the intensified method were more severe, affected younger children and showed a closer causal attributability to the reaction than the ADRs observed by the computerised method. The spectra of drugs involved were similar, with the anti-infectives being suspected most frequently. The sensitivities of the intensified surveillance system and the computerised surveillance screening came to 67.2% and 44.8%, respectively, with computer-assisted screening having a specificity of 72.8%. The mean positive predictive value of the pathological laboratory values under surveillance by computer-assisted screening was 18.6%. Approximately 25% of ADR-related drugs administered were used for off-label indications.Conclusion: Using the published literature for comparison, we found that ADRs occur as frequently in paediatric patients as in adult patients. Intensified surveillance and computerised surveillance applied in the paediatric setting show substantial differences in their detection specificities. A higher number of and more severe ADRs can be detected by, intensified surveillance than by computerised surveillance, but require higher personnel resources.