Research Of Comprehensive Evaluation Of Shuxuetong Injection

Objective:To collect the Shuxuetong injection information of drug basic information,effectiveness and safety systematically to comprehensively evaluating.To investigate the clinical application of Shuxuetong injection to factors of disease,safety information and influence.To develop guidelines for application of Shuxuetong injection specification.To explore the establishment of comprehensive evaluation method of traditional Chinese medicine injection and carry out clinical evaluation research of traditional Chinese medicine injection demonstration.Methods:In this study,we use the methods of literature research,Meta analysis,data mining and centralized monitoring of hospital synthetically.Literature research method was used in the research of drug basic information.Consult the existing drug specifications and pre clinical research data.We collected in September 1979 to December 2015 the Shuxuetong injection of chemical ingredients,pharmacology,toxicology,pharmacokinetics,drug dosage forms and production manufacturers,indications,usage and dosage,storage,transportation,valid,contraindications,adverse reactions and precautions of the latest research progress,analyze and summarize the relevant literature.The literature research method and the Meta analysis method of evidence-based medicine were used in the study:We collected from September 1979 to December 2015 all the clinical application of Shuxuetong Injection.The selected articles to adapt to disease classification,and then performing a Meta-analysis.The comprehensive research of safety research has three methods,which are literature research,data mining and hospital centralized monitoring.Firstly,the method of literature research is adopted.We selected articles about ADR from September 1979 to December 2014 all the relevant reports of Shuxuetong injection,combined with the description on ADR effectiveness of Shuxuetong injection,analyzed and summarized;Using the data mining method of clinical application status of Shuxuetong injection:We extracted using Shuxuetong injection patients information from three hospitals in HIS system and analyzed the basic information of the patients,indications,combined drug use and other statistical analysis.Then the hospital central monitoring method of five general hospitals in Henan Province 10111 cases using Shuxuetong injection of hospitalization of patients on the drug monitoring.Collect the relevant information and Shuxuetong injection found monitoring data in ADR/ADE,correlation evaluation method recommended by SFDA adverse reaction evaluation center,to organize medical experts and pharmaceutical experts to evaluate all the adverse reactions,finally determine the type,performance and severity of ADR,logistic regression analysis was used to analyze the influencing factors of adverse reactions.Eventually we comprehensive evaluation the Shuxuetong injection drug basic information and effective and safety in the three aspects of the results,inductively established Shuxuetong injection standardized clinical application guide.Results:1.Drug basic information results:The main active ingredients of Shuxuetong injection consists of hirudin and other macromolecules ingredients and pteridine small molecule chemical composition,a variety of enzymes and proteins.It's pharmacological effects are mainly on ischemia reperfusion injury,improve the blood rheology,anticoagulant,antiplatelet aggregation,protects the kidney,promote fibrinolysis,anti arthritis and protect brain cells,apoptosis resistance,improvement on learning and memory function,reducing blood sugar,promote the growth of blood vessels,etc.The solution should be used within 6 hours.The relative lack of research literature,toxicology,pharmacokinetics,drug interactions,incompatibility and other aspects,is the basis for the following research direction.2.The clinical efficacy results showed:Shuxuetong injection for acute cerebral infarction,unstable angina,coronary heart disease,diabetes peripheral vascular disease clinical indications for these three kinds of efficacy,worthy of clinical application.It has a certain clinical effect on transient ischemic,chronic renal failure,deep venous thrombosis of lower limb,nephrotic syndrome and sudden deafness.3.Clinical application results showed:Shuxuetong injection patient population is mainly 45 years old or older,Mainly used in circulation after ischemia,nephrotic syndrome,coronary heart disease,diabetes,retinal detachment,sensorineural deafness,transient ischemic episodes.Combined multi-drug and anti-platelet,lowering blood pressure,lowering blood sugar class,improve circulation category,anticoagulation,acid and other drugs combined.4.Safety results showed:The adverse reaction rate of Shuxuetong injection in low level are sporadic,but fast,rapid progress.The main clinical manifestations were:?skin and its appendages:rash,facial flushing,cyanosis,phlebitis.?digestive system:nausea,vomiting,gastrointestinal bleeding.?circulatory system:heart palpitations,suffocation,difficulty breathing,brain hemorrhage.?blood system:bleeding gums,epistaxis,hematoma.?nervous system:dizziness,headache.?features:laryngospasm.?Other:anaphylactic shock,fever,chills.5.Safety influencing factors study results show that:There is a history of allergies,family history of patients with Shuxuetong injection is more prone to adverse reactions.6.To compile the "guide":According to the evidence from this study recommended level is divided into five grades compartmentalized acute cerebral infarction,diabetic peripheral vascular disease,coronary heart disease not stable angina,transient cerebral ischemia,chronic renal failure,lower limb deep vein thrombosis formation,nephrotic syndrome,and so on seven indications.Describes the ADR performance of the 14 systems,and gives the method to avoid or reduce the ADR,the taboo and note also make clear provisions.Conclusion:1.Shuxuetong injection is widespread in clinical use in manual phenomenon,involving a variety of diseases.The contents of the current specification can not effectively guide clinical rational drug use.The research method of this topic has successfully realized the comprehensive evaluation of traditional Chinese medicine injections.Our comprehensive evaluation of the latest research results of the integration of traditional Chinese medicine injections,which has overcome the "fragmentation" of traditional Chinese medicine injections and provides a comprehensive basis for clinical medication.It is a suitable method for the study of clinical drug use of traditional Chinese medicine injections.2.The research content of the framework of comprehensive evaluation includes the content of the basic research,the effectiveness of the drug,the security research and so on;Data sources require the basic research and clinical application of the multi center large sample data and comprehensive literature comprehensive evaluation.The current study is lack of injection Shuxuetong injection toxicology,pharmacokinetics and drug interactions of the,therefore need more in-depth study to improve the content of the"guide",and offer the reference for the rational use of Shuxuetong injection.