Aslanabadi Naser, Safaie Naser, Talebi Fereshteh, Dousti Samaneh, Entezari-Maleki Taher
Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Iran J Pharm Res. 2018 Winter;17(Suppl):53-63.
Acute myocardial infarction (AMI) is one of the main leading causes of mortality and morbidity. Despite the progress in the treatment of AMI, streptokinase is still being used in many countries. Because of the critical condition of patients with AMI and complications of streptokinase therapy, this study was performed to evaluate the pattern of adverse drug reaction (ADRs) induced by streptokinase and its associated risk factors in patients with acute ST elevation MI. A prospective cross-sectional study in a 14-month period was done at the university affiliated referral cardiovascular center. The Naranjo probability scale and Food and drug administration (FDA) criteria for severity of ADRs were performed for assessing the ADRs. The linear and logistic regression tests were used to evaluate the correlation between ADRs and study risk factors. During the study period, 217 patients who received streptokinase were entered. The majority of patients (n = 191) experienced at least one ADR. Six patients died in-hospital mainly because of cardiac causes. The history of drug allergy was the main predictor in occurring of ADRs (Odds ratio: 3.26; 95% CI: 1.48-457.6; =0.026). The most serious ADR was hemorrhagic stroke with a 1.4% incidence. Hypotension was one of the most occurred ADR (n = 75). Anaphylactic shock was not detected in this study. In summary, our study showed that the history of drug allergy is the main predictor in occurring of ADRs by streptokinase. Furthermore, streptokinase therapy was associated with a higher rate of hemorrhagic stroke in Iranian population.
急性心肌梗死(AMI)是导致死亡和发病的主要原因之一。尽管在AMI治疗方面取得了进展,但链激酶仍在许多国家使用。由于AMI患者病情危急以及链激酶治疗的并发症,本研究旨在评估急性ST段抬高型心肌梗死患者中链激酶引起的药物不良反应(ADR)模式及其相关危险因素。在大学附属的心血管转诊中心进行了为期14个月的前瞻性横断面研究。采用Naranjo概率量表和美国食品药品监督管理局(FDA)的ADR严重程度标准来评估ADR。使用线性和逻辑回归测试来评估ADR与研究危险因素之间的相关性。在研究期间,纳入了217例接受链激酶治疗的患者。大多数患者(n = 191)至少经历了一次ADR。6例患者在住院期间死亡,主要原因是心脏相关原因。药物过敏史是发生ADR的主要预测因素(比值比:3.26;95%可信区间:1.48 - 457.6;P = 0.026)。最严重的ADR是出血性中风,发生率为1.4%。低血压是最常发生的ADR之一(n = 75)。本研究未检测到过敏性休克。总之,我们的研究表明药物过敏史是链激酶引起ADR的主要预测因素。此外,在伊朗人群中,链激酶治疗与较高的出血性中风发生率相关。