Streptokinase Adverse Reactions: A Review of Iranian Literature
AbstractThrombolytic agents are among the medications that are used widely for the treatment of thromboembolic disorders and myocardial infarction (MI). Despite the world-wide availability of newer specific agents, streptokinase (SK) is still the most frequently used medication from this class in Iran. Hence we conducted this study to review the adverse reactions to this medication which were reported in the Iranian studies. We preformed this study by searching the English resources such as Pubmed, Google scholar and Scopus. Additionally, we searched Google scholar, Scientific Information Database, Magiran and IranMedex to cover Persian articles.We found 50 articles from the mentioned resources after deleting the duplicated records. Nineteen articles remained after implementing the inclusion and exclusion criteria. In most of the studies the indication for SK treatment was MI. Assessment of streptokinase ADRs was the main focus of 7 studies. The most frequent adverse drug reaction (ADR) was related to the cardiovascular system. Among them arrhythmia and hypotension were the most frequent ones. The second most prevalent ADR was bleeding followed by allergic reactions. In two studies only a single system ADR was studied: neurologic adverse effects and elevation in liver enzymes. Only very limited number of studies assessed the causality of the ADRs which made the interpretation of the results difficult. Among the associated factors that were assessed as risk factors of ADRs, age was the focus of 2 studies. The Iranian studies reported frequent ADRs similar to previous reports. However, due to the heterogeneity of the studies we could not describe the frequency and severity of reported ADRs in a more clear and precise conclusion.
Mohebbi N, Shalviri G, Salarifar M, Salamzadeh J, Gholami K. Adverse drug reactions induced by cardiovascular drugs in cardiovascular care unit patients. Pharmacoepidemiol Drug Saf 2010; 19: 889-94.
Laslett LJ, Alagona P, Jr., Clark BA, 3rd, et al. The worldwide environment of cardiovascular disease: prevalence, diagnosis, therapy, and policy issues: a report from the American College of Cardiology. J Am Coll Cardiol 2012; 60: S1-49.
Lloyd-Jones DM, Larson MG, Beiser A, Levy D. Lifetime risk of developing coronary heart disease. Lancet 1999; 353: 89-92.
Khalili D, Sheikholeslami FH, Bakhtiyari M, Azizi F, Momenan AA, Hadaegh F. The incidence of coronary heart disease and the population attributable fraction of its risk factors in Tehran: a 10-year population-based cohort study. PLoS ONE 2014; 9: e105804.
Talaei M, Sarrafzadegan N, Sadeghi M, et al. Incidence of cardiovascular diseases in an Iranian population: the Isfahan Cohort Study. Arch Iran Med 2013; 16: 138-44.
Nascimento BR, de Sousa MR, Demarqui F, Nogueira b, Ribeiro ALP. Risks and Benefits of Thrombolytic, Antiplatelet, and Anticoagulant Therapies for ST Segment Elevation Myocardial Infarction: Systematic Review. ISRN Cardiol 2014; 2014: 416253..
Ali MR, Salim Hossain M, Islam MA, et al. Aspect of Thrombolytic Therapy: A Review. Scientific World Journal 2014; 2014: 8.
Kumolosasi E, Wei WS, Wee CE. The use of thrombolytic agents in acute myocardial infarction (AMI) patients. Int J Pharm Pharm Sci 2013; 5(2):63-7.
Hermentin P, Cuesta-Linker T, Weisse J, et al. Comparative analysis of the activity and content of different streptokinase preparations. Eur Heart J 2005; 26: 933-40.
Kunadian V, Gibson CM. Thrombolytics and Myocardial Infarction.Cardiovasc Ther 2012; 30: e81-8.
Van de Werf F. Recommendations for an efficient and safe use of fibrinolytic agents. Bangkok Medical Journal 2014; 3.
Bizjak ED, Mauro VF. Thrombolytic Therapy: A Review of Its Use in Acute Myocardial Infarction. Ann Pharmacother 1998; 32: 769-84.
Classen DC, Pestotnik SL, Evans RS, Burke JP. Computerized surveillance of adverse drug events in hospital patients. Qual Saf Health Care 2005; 14: 221-6.
Vahanian A. Thrombolytic therapy in Europe: current status. Eur Heart J 1996; 17: 21-7.
Spöhr F, Böttiger B. Safety of Thrombolysis during Cardiopulmonary Resuscitation. Drug Saf 2003; 26: 367-79.
Diwedi S, Hiremath J, Kerkar P, et al. Indigenous recombinant streptokinase Vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial. Indian Journal of Medical Sciences 2005; 59: 200-7.
Jianjaroonwong V. The Efficacy and Safety of Streptokinase in the Treatment of patients with Acute myocardial infarction at Lumplaimat Hospital, Burirum Province. Medical Journal of Srisaket Surin Buriram Hospitals 2011; 22: 169-81.
Tatu-Chitoiu G, Teodorescu C, Dan M, et al. Efficacy and Safety of a New Streptokinase Regimen with Enoxaparin in Acute Myocardial Infarction. J Thromb Thrombolysis 2003; 15: 171-9.
Thanvi BR, Treadwell S, Robinson T. Haemorrhagic transformation in acute ischaemic stroke following thrombolysis therapy: classification, pathogenesis and risk factors. Postgrad Med J 2008; 84: 361-7.
Weinstein J. Treatment of myocardial infarction with intracoronary streptokinase: Efficacy and safety data from 209 United States cases in the Hoechst-Roussel registry. Am Heart J 1982; 104: 894-8.
Feizi A, Nasr A, Sanei H, Mikaili P, Amirpoor A, Ghasemi N. Effect of Streptokinase on Short-term Outcomes in the Acute Myocardial Infarction with ST-Segment Elevation. J Rep Pharm Sci 2014; 3: 85-9.
Shojaei M, Abdi MH. A Survey of the Side Effects of Intravenous Streptokinase in Patients Older than 70 Years with Acute Myocardial Infarction. Journal of Jahrom University of Medical Sciences 2009; 7: 7-14.
Shemirani H, Hashemi SH, Beiki O. Intracranial hemorrhage in normotensive and hypertensive patients receiving Streptokinase after decreasing elevated blood pressure. JRMS 2005; 10: 297-2.
Salarifar M, Sadeghian S, Abbasi A, et al. Efficacy of Two Streptokinase Formulations in Acute Myocardial Infarction: A Double-Blind Randomized Clinical Trial. J Teh Univ Heart Ctr 2009; 4(1): 29-34.
Saffari M, Samei A, Abdoli H, Isfahani MA. Clinical effects of Streptokinase in acute myocardial infarction. Kashan University of Medical Sciences Journal (Feyz) 2003; 6: 6-10.
Nough H. Effect of Streptokinase on Liver Function in Patients with Acute Myocardial Infarction. Journal of Rafsanjan University of Medical Sciences 2002; 2: 61-7.
Noori N, Rozati A. Streptokinase treatment for femoral artery thrombosis after cardiac catheterization in children. Iranian Journal of Pediatrics 2006; 16: 51-6.
Nasiri M, Rahimian B, Bashiri T, Salmalian F. Adverse reactions of streptokinase in patients with or without hydrocortisone injection. Journal of Urmia Nursing And Midwifery Faculty 2011; 9: 43-8.
Moghadam M, Zeighami R, Azimian J, Jahani-Hashemi H, Fotuhi M. Side Effects of Intravenous Streptokinase in Different Age Groups Patients with Acute Myocardial Infarction Armaghane-danesh 2013; 18: 910-7.
Khani M, Taherkhaney D. The Survey Of The Effects Of Streptokinase On The Patients Suffering From Inferior Wall Infarction Associated With Right Ventricular Infarction. Journal Of Zanjan University Of Medical Sciences And Health Services 2001; 9: 4-9.
Karimzadeh I, Namazi S, Shalviri G, Gholami K. Cardiovascular drug adverse reactions in hospitalized patients in cardiac care unit. African Journal of Pharmacy and Pharmacology 2011; 5: 493-9.
Hakim S, Samadikhah G, Gafari S, Alizadeh A. Fibrinolytic Therapy in Acute Thrombosis of Mechanical Prosthetic Valve. Journal of Ardabil University of Medical Sciences 2006; 6: 19-23.
Ghaffari S, Kazemi B, Golzari IG. Efficacy of a New Accelerated Streptokinase Regime in Acute Myocardial Infarction: A Double Blind Randomized Clinical Trial. Cardiovasc Ther 2013; 31: 53-9.
Fayazi S, Abdi MH, Sayadi N, Rostami S. Complications of intravenous Streptokinase therapy in acute myocardial infarction patients admitted to the cardiac intensive care unit. J Cardiovasc Nurs 2012; 1: 14-20.
Shemirani H, Saravi SFB. Incidence of Neurological Syndromes After Thrombolytic Therapy In Elderly Patients With Acute Myocardial Infarction. Journal of Isfahan Medical School 2008; 26: 85-91.
Shalviri G,Valadkhani M, Dinarvand R. Ten years pharmacovigilance activities in Iran. Iranian J Publ Health 2009; 38: 162-6.
Shalviri G, Mohammad K, Majdzadeh R, Gholami K. Applying quantitative methods for detecting new drug safety signals in pharmacovigilance national database. Pharmacoepidemiol Drug Saf 2007; 16: 1136-40.
Garjani A, Abedinogli K, Shamsmohammadi M, Salimnejad M, Maleki N. The Study Of Adverse Drug Reaction To Streptokinase In Inpatients With Acute Myocardial Infarction In Shahid Madani Hospital For Cardiovascular Disease In Tabriz Between 1999 and 2001. Pharmaceutical Sciences 2005; 25-8.
Eshraghian A, Eshraghian H, Aghasadeghi K. Guillain-Barre syndrome after streptokinase therapy for acute myocardial infarction. Intern Med 2010; 49: 2445-6.
Schumock G, Thornton J. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992; 27: 538.
Jauch EC, Saver JL, Adams HP, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke 2013; 44: 870-947.
Ghosh M, Pulicherla K, Rekha V, Rao GV, Rao KS. A review on successive generations of streptokinase based thrombolytic agents. International Journal of Pharmacy and Pharmaceutical Sciences 2012; 4(3):38.
Rogers LQ, Lutcher CL. Streptokinase therapy for deep vein thrombosis: a comprehensive review of the English literature. Am J Med 1990; 88: 389-95.
Tsang TSM, Califf RM, Stebbins AL, et al. Incidence and Impact on Outcome of Streptokinase Allergy in the GUSTO-I Trial. Am J Cardiol 1997; 79: 1232-5.