Amann C, Hasford J, Stausberg J
Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, München.
Gesundheitswesen. 2012 Oct;74(10):639-44. doi: 10.1055/s-0031-1286275. Epub 2011 Oct 20.
In developed countries 1-5% of all hospital admissions are due to adverse drug events (ADE). An ADE is defined as an injury resulting from medical intervention related to a drug. The established reporting systems and study designs only capture selective data. The objective of the current analysis was to evaluate the rate, distribution and correlations of ADE related admissions by using German routine data.
ADEs were identified by an array of 502 specified codes of the ICD-10-GM. The evaluation included only verified codes and was carried out by remote queries of the German DRG-Statistics 2006. Hospital admission due to an ADE was identified via the primary diagnosis.
Of all hospital admissions 0.92% were revealed to be certainly caused by an adverse drug event. The average age between affected and non-affected was nearly identical for women 53.48 vs. 53.67 years, for men it was reduced by 4 years (48.38 years). The average hospital stay was lower for cases with an ADE, being reduced by 1.3 days for women (6.26 days vs. 7.55 days) and 1.5 days for men (5.91 days vs. 7.42 days). While mortality with an odds ratio (OR) of 0.59 (95% CI 0.57-0.62) was lower in ADE cases, the rate of emergency admissions due to ADE was increased, the OR being 3.10 (95% CI 3.07-3.13). The wards with excess rates of ADE cases were internal medicine, paediatrics, dermatology, intensive care and neurology.
Younger age, reduced hospital stay and lower mortality of ADE cases are contrary to findings in the relevant literature. The DRG-Statistics also comprise populations which often are excluded in established study designs, in particular, children and cases due to medication errors, overdose, poisoning and allergic reactions. As these cases respond easily to prevention and are of significant interest to pharmacovigilance, the use of routine data is valuable for more intense research of ADE.
在发达国家，所有住院病例中有1%-5%是由药物不良事件（ADE）所致。药物不良事件被定义为与药物相关的医疗干预导致的损伤。现有的报告系统和研究设计仅能获取部分数据。当前分析的目的是利用德国常规数据评估与药物不良事件相关的住院率、分布情况及相关性。
通过国际疾病分类第十次修订本德国版（ICD-10-GM）的502个特定编码识别药物不良事件。评估仅包括已核实的编码，通过对2006年德国疾病诊断相关分组（DRG）统计数据进行远程查询来开展。通过主要诊断确定因药物不良事件导致的住院情况。
在所有住院病例中，0.92%被证实是由药物不良事件所致。受影响女性与未受影响女性的平均年龄几乎相同，分别为53.48岁和53.67岁；受影响男性的平均年龄比未受影响男性小4岁（48.38岁）。药物不良事件病例的平均住院时间较短，女性减少了1.3天（6.26天对7.55天），男性减少了1.5天（5.91天对7.42天）。虽然药物不良事件病例的死亡率较低，比值比（OR）为0.59（95%可信区间0.57 - 0.62），但因药物不良事件导致的急诊住院率有所增加，OR为3.10（95%可信区间3.07 - 3.13）。药物不良事件病例发生率过高的科室为内科、儿科、皮肤科、重症监护科和神经科。
药物不良事件病例年龄较小、住院时间缩短及死亡率较低，这与相关文献中的研究结果相反。疾病诊断相关分组统计数据还涵盖了在现有研究设计中常被排除的人群，特别是儿童以及因用药错误、过量用药、中毒和过敏反应导致的病例。由于这些病例对预防措施反应良好且对药物警戒具有重要意义，利用常规数据对于更深入研究药物不良事件具有重要价值。
