Safety Evaluation Of Adverse Drug Reaction For Polypeptide And Proteinic Drugs

In recent years,with the development of biotechnology and genetic engineering,large amounts of proteins and polypeptide drugs have been applied in clinical.The traditional polypeptide drugs mainly refer to some peptide hormones,as genomics,proteomics,bioinformatics research applied,effective technologies such as combinatorial chemistry,high-throughput screening and another techniques were used for the screening of varieties of peptides and proteins,increasing number of peptide and protein drugs used in disease diagnosis,treatment and prevention.Protein and peptide drugs development have become one of the most active areas in biotechnology and pharmaceutical industry,and showed great social and economic benefits.Compounds of Polypeptide,protein widely exist in nature,the mankind have found some biologically active peptides from fish,including muscle protein,polypeptide,collagen and some synthetic proteins,and many have been developed into clinical therapeutic drugs.Polypeptide,protein compounds can increase immune,enhance disease-resistant ability,safeguard human health.With the rapid development of modern technology,it has become one of the most promising industries in twenty-first Century,but as a result of this class of drugs complexity in structure and the small using dose,and a large number of similar organisms material interference,there are have some increased difficulty in their quality control and detection.Polypeptide drugs and protein drugs belong to biotechnology drugs,because of their biological activity,relatively low cost,target specificity,they has been successfully applied to genetic diseases,chronic diseases(tumor)and other chemical drug effect that is not significant in the field.The difference of polypeptide and protein drugs in the structure,function and mechanism of action with other drugs decide their clinical use in complexity,difficulty.With the effect of medicinal chemistry,biological stability,as well as the bioavailability and drug problems,adverse reactions of polypeptide,protein drugs subsequently grow,such as hypertension,arterial and venous thrombosis,proteinuria and other serious adverse drug reaction.However,through the literature research in our country,their adverse drug reactions have been reported rarely,therefore,the main purpose of this study is to explore safety evaluation of polypeptide and protein drugs.The purpose of this research: In view of lack of drug adverse reaction's systematic research on the present situation of polypeptide and protein drug,this study uses the literature research,drug adverse reaction data mining,Meta analysis and health statistics method to carry out the safety assessment of peptides and proteins adverse drug reaction,in order to provide experimental data for clinical rational medication.Results: 1)Clinical application and adverse drug reactions of polypeptide drugs and protein drugs;2)Adverse drug reaction reporting signal mining research on Polypeptides and proteins drugs;3)Safety review of bevacizumab in treating metastatic colorectal cancer;4)Adverse drug reaction analysis of bevacizumab.Conclusion: Through literature research,we find that at home and abroad the polypeptide and protein drug adverse reactions are rare,mainly research only case reports.Based on data mining research of the proportion of adverse drug reaction reports,Comparison of drug instructions,46 pairs adverse reaction signals were not included;through Meta analysis for colorectal cancer using bevacizumab,grade 3 or 4 adverse drug reaction has a slight risk,bleeding events,hypertension etc are rising;through the analysis of health statistics of bevacizumab adverse drug reaction,we verify the results of Meta analysis,and discover new drug adverse reaction signals.This study belongs to the basic research of clinical pharmacy,so need to be further clinical validating.