Department of Clinical Pharmacy, College of Pharmacy, Tehran University of Medical Sciences, Iran.
Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):889-94. doi: 10.1002/pds.1916.
To detect the type, rate, seriousness, and preventability of adverse drug reactions (ADRs) attributable to cardiovascular drugs in cardiovascular care unit; and to determine the relationship between patient factors and detected ADRs.
Patients admitted to cardiovascular care units in Tehran Heart Center over an eight month period who received at least one cardiovascular drug were eligible to enter the study. ADRs were recorded based on information collected by interviewing patients, reviewing patients' charts, laboratory test monitoring, and confirmation by physicians. The World Health Organization definition for ADR, its seriousness and casualty criteria, was used to evaluate the reactions. The preventability was estimated based on Schumock and Thornton questioning. The relationship between possible risk factors and ADRs occurrence were assessed by statistical analysis.
During the study period, 677 patients entered the study. A total number of 189 ADRs were registered of which 22.2% were serious. The highest ADR rates were observed with Streptokinase (59.3%). The rate of preventable ADRs was 6.9%. Multivariate logistic regression analysis showed that patients with lower weight (OR = 0.95, 95%CI: 0.9-0.99) and patients with smoking history who had concurrent diseases (OR = 8.72, 95%CI: 1.53-49.52) had a higher risk of experiencing ADRs.
The rate of ADRs induced by cardiovascular drugs in this study was 24.2%. This study has shown that anti-arrhythmic and thrombolytic agents need more attention.
检测心血管护理单元中与心血管药物相关的不良反应(ADR)的类型、发生率、严重程度和可预防程度;并确定患者因素与检测到的 ADR 之间的关系。
在 8 个月的时间里,符合条件的患者为在德黑兰心脏中心心血管护理单元住院且至少接受一种心血管药物治疗的患者。ADR 通过访谈患者、回顾患者病历、实验室检测监测以及医生确认等方式记录。采用世界卫生组织对 ADR 的定义、其严重程度和因果关系标准来评估反应。根据 Schumock 和 Thornton 的提问来估计可预防性。通过统计分析评估可能的危险因素与 ADR 发生之间的关系。
在研究期间,共有 677 名患者入组。共记录了 189 例 ADR,其中 22.2%为严重 ADR。观察到最高 ADR 发生率的药物为链激酶(59.3%)。可预防 ADR 的发生率为 6.9%。多变量逻辑回归分析显示,体重较低的患者(OR = 0.95,95%CI:0.9-0.99)和有吸烟史且患有合并症的患者(OR = 8.72,95%CI:1.53-49.52)发生 ADR 的风险更高。
本研究中心血管药物引起的 ADR 发生率为 24.2%。本研究表明,抗心律失常药和溶栓剂需要更多关注。