Haile Demissew Berihun, Ayen Wubeante Yenet, Tiwari Pramil
Lecturer, Department of Pharmacy, Mizan-Tepi University, Ethiopia.
Ethiop J Health Sci. 2013 Mar;23(1):39-48.
Adverse drug reactions account for the highest proportion among the causes of morbidity and mortality in clinical wards and are posing a considerable challenge. Hence, the objective of this study was to find out the prevalence of adverse drug reactions and the factors which contribute to their prevalence.
A prospective patient record review was carried out at a tertiary care hospital in North India from August 2010-May 2011. A total of 1033 subjects admitted to hospital for any kind of treatment were included while patients admitted in the ward because of adverse drug reactions were excluded. The ward where we collected the data includes multispecialty and cardiovascular wards. The causality, severity, and preventability of adverse drug reactions were assessed using Naranjo, modified Hartwig, and Schumock and Thornton criteria, respectively. Kolmogorov-Smyrnov, chi -square and multiple logistic regression tests were used to determine adverse drug reactions ascribed to drugs.
Out of 1033 patients whose records were assessed, 167(16.2%) experienced one or more adverse drug reactions. The metabolic systems, which accounted for 49(24.6%) were most frequently affected by adverse drug reactions, followed by gastrointestinal, 45(22.6%); hematological, 28(14.1%) and cutaneous, 21(10.6%) systems. The drug classes most frequently associated with the reactions were antibiotics 40(20.1%), diuretics 35(17.6%) and anticoagulants 30(15.1%). According to the selected preventability scale, 72(36.2%) adverse drug reactions were classified as probably or definitely preventable. About 165(83%) of the reactions were type A, which represents augmentation of the pharmacological action of a drug. Number of drugs, length of hospitalization and number of diagnosis were identified as significant predisposing factors for ADRs.
The result of this study suggested that adverse drug reactions were significant causes of superimposed health problems that occur following hospitalization. The major risk factors associated with ADR include number of drugs, length of hospitalization and number of diagnosis. Based on the findings a rigorous study is recommended to determine the burden and identify the risk factors of adverse drug reactions to target interventions.
在临床病房中，药物不良反应在发病和死亡原因中占比最高，构成了相当大的挑战。因此，本研究的目的是找出药物不良反应的发生率以及导致其发生的因素。
2010年8月至2011年5月在印度北部一家三级护理医院进行了一项前瞻性患者记录回顾。共纳入1033名因任何治疗入院的受试者，排除因药物不良反应入住病房的患者。我们收集数据的病房包括多专科病房和心血管病房。分别使用纳伦霍、改良哈特维希以及舒莫克和桑顿标准评估药物不良反应的因果关系、严重程度和可预防性。使用柯尔莫哥洛夫-斯米尔诺夫检验、卡方检验和多元逻辑回归检验来确定药物引起的不良反应。
在评估记录的1033名患者中，167名（16.2%）经历了一种或多种药物不良反应。受药物不良反应影响最频繁的是代谢系统，占49例（24.6%），其次是胃肠道系统，45例（22.6%）；血液系统，28例（14.1%）；皮肤系统，21例（10.6%）。与这些反应最常相关的药物类别是抗生素40例（20.1%）、利尿剂35例（17.6%）和抗凝剂30例（15.1%）。根据选定的可预防性量表，72例（36.2%）药物不良反应被分类为可能或肯定可预防。约165例（83%）反应为A型，代表药物药理作用的增强。药物数量、住院时间和诊断数量被确定为药物不良反应的重要诱发因素。
本研究结果表明，药物不良反应是住院后出现的叠加健康问题的重要原因。与药物不良反应相关的主要风险因素包括药物数量、住院时间和诊断数量。基于这些发现，建议进行一项严谨的研究，以确定药物不良反应的负担并识别其风险因素，从而进行针对性干预。
