Research Of Normative Application On Danhong Injection

Objective： Based on the literature study of Danhong injection and centralizedmonitoring, to evaluate the basic information and the clinical efficacy and safety.Wewill formulate application guide specification of Danhong injection,in order to reducethe unreasonable use of drug risk,increa the clinical medication safety,play therapeuticadvantage of Danhong injection and promote the healthy development of Chinesemedicine injection industry.Methods：1、Research on the basic information:We searched all the published papersabout Danhong Injection to analyze and summary in2004September to2013June.The latest advances of Danhong injection were studied including Composition,composition, pharmacology, toxicology, pharmacokinetics, preparations,manufacturers, transportation, efficacy, indications, usage and dosage,contraindications, adverse reactions and precautions.2、 Research on the clinicalefficacy:We screened articles related to clinical application in2004September to2013June all about Danhong injection in the published papers.The selected articles wereclassified according to the indication and made the Meta analysis to find the Danhonginjection for clinical application of all indications and evaluation.3、 Research on thesafety:We screened articles related to adverse reactions reported in2004September to2013June all about Danhong injection in the published papers. The selected articleswereCombined30,888Danhong injectiong cases that were collected in the "11thFive-Yearproject " period "Drug post-marketing safety evaluation " to analyze andsummary.To find out the related factors that influence of Danhong injection in clinicalapplication safety.4、 According to the analysis of literature research and monitoringresults, make applications Standard Specification of Danhong injection. Results：1、 Research on the basic informationeventually included147publishedpapers, the results showed:①The main active ingredients of Danhong injection is anucleoside and salvianolic acid composition.②The pharmacological effect ofDanhong injection is more complex that mainly has obvious protective effect onexperimental atherosclerosis (AS), experimental myocardial infarction, myocardialischemia injury and so on.③In vivo (mouse) results show that Danhong injection ofLD50was39.5ml/kg, no long-term toxicity.④One of the main active ingredients ofDanhong injection: hydroxysafflor yellow A in the metabolic process of SD rats fittedto the two compartment open model.T1/2=0.96±0.14h, Cmax=7.63±0.58,AUC (0-t)=46.23±4.4, AUC (0-∞)=48.42±4.7.2、Research on the clinical efficacy:eventually included109published papers,theresults showed:After Meta analysis we found that Danhong injection can be used forclinical routine treatment of coronary heart disease(angina pectoris), diabeticperipheral neuropathy, acute coronary syndrome, cerebral infarction, heart failure,chronic obstructive pulmonary disease, chronic pulmonary heart disease and transientischemic attack safly and effectively. Itcan also be used for the adjuvant treatment ofcervical disease, deep vein thrombosis, high blood fat, myocardial infarction, cerebralvascular dementia, nephrotic syndrome, diabetic nephropathy, ischemiccardiomyopathy and fracture.3、 Research on the safety:The damage of skin and its appendages of Danhonginjection adverse reaction is most common.The pruritus and skin rash were highestincidence. The incidence of adverse reaction belongs to the "occasional" level was3.69‰.Most adverse events were mild or moderate and stop or symptomatictreatment can be fully restored.Adverse reactions much has happened in themedication after30minutesbelong to the immediate type. Probability of femalepatients, aged, a drug or food allergy history, family history of allergy, allergic diseasehistory of adverse reactions was higher relatively.Conclusion： The results of literature and centralized monitoring surveyindicateDanhong injection is safe and effective in clinical practice, low incidence rateof adverse reaction, but its toxicity and pharmacokinetic aspects still need furtherstudy.