Analysis, Assessment Of Adverse Drug Reaction Of Antithrombotics And Procoagulant Drugs,2005-2011, Hunan

ObjectiveTo extend our knowledge about the conditions where the ADRs are triggered by Antithrombotics and Procoagulant drugs in Hunan Province, further organized and analyzed for the purpose to detect the correlations among patients, drugs, treatments and ADRs, and to study the ADR-involved systemic lesions and clinical manifestations, incubation period, severity, treatments and consequences each individually related to ADRs.Findings were gathered and screened to discover the new possibilities of safer drug prescriptions in order to provide valuable information as to more effective and safer approach to use Antithrombotics and Procoagulant drugs for clinical purpose.MethodsWe extracted2392ADR reports from those submitted to National ADR Monitoring Network by Hunan Province dated from April2005to May2011that were possibly related to the use of Antithrombotics and Procoagulant drugs for reorganizing and retrospective analysis.Summarization and assessments were undertaken to respond to the9kinds of Antithrombotics, say, Low-molecular-weight heparin sodium,Low-molecular-weight heparin caliu,Warfarin Sodiu,Urokinase,Aspirin,Alprostadil, Clopidogrel Sulfate,Cilostazol,Dipyridamole;5kinds of Procoagulant Drugs, say, tranexamic acid, Aminomethylbenzoic Acid, Etamsylate, Vitamin K1,Protamine.Comprehensive standard methodologies were adopted to detect notable signs from14kinds of drugs ADR as stated above.Results1. The method detected72Drug-ADR combinations meeting the minimum criteria,of which27were not marked in the production instruction.And27Drug-ADR combinations are Aminomethylbenzoic acid and palpitations; Aminomethylbenzoic acid and chills; Aminomethylbenzoic acid and nausea; Aminomethylbenzoic acid and vomiting; Aminomethylbenzoic acid and red spotted; Etamsylate and fever; Etamsylate and palpitations; Etamsylate and difficulty in breathing; Etamsylate and high fever; Etamsylate and local numbness; Vitamin K1and breathing excitement; Vitamin K1and Partial numbness; Vitamin K1and injection site infection; Vitamin K1and dermatitis; Vitamin K1and hypoventilation; Vitamin K1and palpitations;Vitamin K1and pale;Vitamin K1and chills;Vitamin K1and fever;Vitamin K1and pain;Urokinase and dizziness;Urokinase and pneumothorax;Alprostadil and phlebitis;Alprostadil and superficial phlebitis;Alprostadil and vasculitis;Alprostadil and chills;Aspirin and cough.2. Significant difference in the proportions was detected between male and female Procoagulant drugs users ranging from different age groups(P=0.000, x2=90.279). Significant difference in the proportions was detected between male and female with various age groups taking urokinase (P=0.017, x2=8.120),etamsylate (P=0.010,x2=20.089),vitamin K1(P=0.000,x2=93.491)Conclusion27Drug-ADR combinations that were not marked in the production instruction are the new signals of risk.We Should strengthen the monitoring of ADR in the clinical application of Prostaglandin E1,Aspirin,Urokinase,Aminomethylbenzoic acid, Etamsylate and Vitamin K1.