Center for Anesthesiology, Clinical Centre, Kragujevac, Serbia.
Pharmacoepidemiol Drug Saf. 2009 Nov;18(11):1026-33. doi: 10.1002/pds.1816.
The aim of our study was to find drug-associated changes in serum levels of major electrolytes using clinical-event monitoring method.
During 1-year period, electrolyte disturbances in serum samples from patients of Clinical Center Kragujevac, Serbia, were monitored in central biochemical facility. A sample of 982 patients was randomly selected from total population of 43,120 patients whose electrolyte serum levels were measured in the facility during the study period.
Clinically important drug-associated electrolyte disturbances were detected in 181 patient. There were 25 significant associations between the drugs and electrolyte values outside the reference range. However, only four causal connections were established: use of normal saline infusion with hypernatremia (OR 6.97, 95%CI 2.24-21.67), theophylline with acid-base disturbances (7.75, 1.46-41.02), polygeline infusion with decrease in bicarbonate levels (4.08, 1.42-11.73), and association of risperidone and hypocalcemia (4.10, 1.42-11.81).
Although clinical-event monitoring method is far from optimal, it could quantify the known risks and provide evidence for credible hypothesis of drug adverse reactions, based on both relevant biological pathways and reasonable clinical thinking, as it was the case in our study.
本研究旨在使用临床事件监测方法发现与药物相关的血清电解质水平变化。
在一年期间,我们在中心生化设施中监测了塞尔维亚克拉古耶瓦茨临床中心患者的血清电解质紊乱情况。从该设施在研究期间测量电解质血清水平的 43120 名患者的总人群中随机抽取了 982 名患者作为样本。
在 181 名患者中发现了与药物相关的临床重要电解质紊乱。有 25 种药物与电解质值超出参考范围之间存在显著关联。然而,仅建立了四个因果关系:生理盐水输注与高钠血症(OR 6.97,95%CI 2.24-21.67)、茶碱与酸碱紊乱(7.75,1.46-41.02)、聚乙二醇输注与碳酸氢盐水平降低(4.08,1.42-11.73)以及利培酮与低钙血症的关联(4.10,1.42-11.81)。
尽管临床事件监测方法远非最佳,但它可以根据相关的生物学途径和合理的临床思维,量化已知的风险,并为药物不良反应的可信假设提供证据,就像我们的研究一样。