Egger Tobias, Dormann Harald, Ahne Gabi, Runge Ulrich, Neubert Antje, Criegee-Rieck Manfred, Gassmann Karl G, Brune Kay
Department of Experimental and Clinical Pharmacology and Toxicology, University Erlangen-Nuremberg, Erlangen, Germany.
Drugs Aging. 2003;20(10):769-76. doi: 10.2165/00002512-200320100-00005.
Geriatric patients with multiple comorbidities are at high risk of experiencing an adverse drug reaction (ADR) during hospitalisation. The aim of the study was to compare the rate of ADRs as predicted by a computerised pharmacological database to the actual rate determined by direct observation in a sample of geriatric patients.
During a 4-month period, geriatric patients were monitored using prospective observation. Patients were intensively screened for ADRs by a pharmacoepidemiological team (PET), consisting of two pharmacists and a physician. Actual ADRs detected by the PET were compared with those predicted by a computerised drug database. Furthermore, the set of actual ADRs, which resulted from drug-drug interactions (DDIs), were contrasted with potential DDIs signalled by the database. The main outcome measures were the incidence of actual ADRs. For the detection rate of the database we focused on frequent ADRs (>1% according to product information and database) and all DDIs indicated automatically by the database.
163 patients (121 female), mean age 79.8 +/- 7.1 years (range 60-98), were included in the study which was conducted on a geriatric rehabilitation hospital ward. The mean duration of hospitalisation was 24.3 +/- 8.4 days. Elderly patients received an average of 14.0 drugs (range 2-35) during their hospital stay. Of all patients, 60.7% experienced at least one ADR. The PET detected a total of 153 ADRs, with a mean of 0.9 ADRs per patient (range 0-5). The computerised drug database predicted an average of 309 potential ADRs for each patient; however, only 21 ADRs per patient were of high frequency. In 48% of ADR-positive patients (defined by PET) at least one of these frequent ADRs occurred.DDIs were detected by the PET in 14.7% of patients. Our database indicated a mean of 12 potential DDIs per patient. In 14 out of 24 DDI-positive patients, at least one signal indicated a real DDI. The database sensitivity was consequently 58.3%.
In geriatric patients the incidence of ADRs is high. Computerised drug databases are a useful tool for detecting and avoiding ADRs. Our software, however, also produced a large number of signals that did not relate to actual ADRs found by the PET. The sheer number of these 'false' signals shows the need for refinement and optimisation of databases for daily clinical use.
患有多种合并症的老年患者在住院期间发生药物不良反应(ADR)的风险很高。本研究的目的是比较计算机化药理学数据库预测的ADR发生率与通过对老年患者样本进行直接观察确定的实际发生率。
在4个月的时间里,采用前瞻性观察对老年患者进行监测。由两名药剂师和一名医生组成的药物流行病学团队(PET)对患者进行ADR的密集筛查。将PET检测到的实际ADR与计算机化药物数据库预测的ADR进行比较。此外,将由药物相互作用(DDI)导致的实际ADR集与数据库发出信号的潜在DDI进行对比。主要观察指标是实际ADR的发生率。对于数据库的检测率,我们关注频繁发生的ADR(根据产品信息和数据库,发生率>1%)以及数据库自动提示的所有DDI。
本研究在一家老年康复医院病房进行,纳入了163例患者(121例女性),平均年龄79.8±7.1岁(范围60 - 98岁)。平均住院时间为24.3±8.4天。老年患者在住院期间平均服用14.0种药物(范围2 - 35种)。所有患者中,60.7%至少经历过一次ADR。PET共检测到153例ADR,平均每位患者0.9例ADR(范围0 - 5例)。计算机化药物数据库预测每位患者平均有309种潜在ADR;然而,每位患者只有21种ADR是高频的。在48%的ADR阳性患者(由PET定义)中,至少发生了一种这些频繁出现的ADR。PET在14.7%的患者中检测到DDI。我们的数据库显示每位患者平均有12种潜在DDI。在24例DDI阳性患者中的14例中,至少有一个信号提示存在真正的DDI。因此,数据库的敏感性为58.3%。
老年患者中ADR的发生率很高。计算机化药物数据库是检测和避免ADR的有用工具。然而,我们的软件也产生了大量与PET发现的实际ADR无关的信号。这些“假”信号的数量之多表明需要对数据库进行优化和完善,以用于日常临床应用。