| Objective1.To recognize the uses of Shenwei Shenmai injection in clinical practices(such as such as population characteristics,usage and dosage of medication,treatment,etc).2.To clarify the adverse drug reaction incidance and main clinical features,treatment and prognosis of Shenwei Shenmai injection,the main influencing factors,and to evaluate the clinical application safety of the injection;3.To analyze the influencing factors of Adverse Drug Reactions of Shenwei Shenmai Injection,and to provide the suggestions for the treatment,guiding the uses of clinical.4.To analyze the adverse reactions of Chinese medicine injection,the conection of TCM syndrome and the traditional Chinese medicine injection.MethodsThe prospective cohort study and the case-control study were conducted by prospective and centralized monitoring,and by the doctors/nurses or pharmacists who used Shenwei Shenmai Injection Hospital Ward,Of the patients were observed and reported adverse reactions in patients,fill out the "Shenwei Shenmai injection safety re-evaluation of the listing after the data collection form table "A",if no adverse events after the use of the patient,the patient’s monitoring can end.If any adverse events occur after use,table "B" and drug administration(SFDA)of the adverse drug reaction/event reporting form must be immediately fill out.At the same time,two patients with the same batch of Shenwei Shenmai injection,the original disease and adverse events occurred in patients with the same or similar patients,fill out the table "C" in order to use case-control study method for analysis.Patients who had any adverse events were followed up for 1 week.The collection of all the survey data and statistical analysis of the work,based on statistical results Centralized Monitoring Summary Report.ConcentsThe research mainly refers to the Notice on the Re-evaluation of the Safety of Traditional Chinese Medicine Injection and the Basic Technical Requirement for Re-evaluation of Safety of Traditional Chinese Medicine Injection in Appendix 2 issued by the State Food and Drug Administration.1.Through analysising the adverse reactions(ADR)of Shenwei Shenmai injection,to clear the possible risk factors for ADR,to provide the basis factors for the observation table.2.Through the combination of cohort study and case-control study,the use of Shenwei Shenmai injection and the incidence of adverse reactions were evaluated objectively by prospective and centralized monitoring.3.To clarify the actual use of Shenwei Shenmai injection through data collation,statistics and analysis,as well as the characteristics of the people using the drug and the characteristics of the susceptible population using the drug to further analyze the adverse effects of the drug Factors and the relationship between the rational use of the drug come to the guiding conclusions.4.Monitoring tools and monitoring contentTo make a monitoring form of "Shenwei Shenmai injection safety re-evaluation of the postmarket of the table(A,B,C)",monitoring include:(1)The main clinical symptoms of adverse reactions(2)The laboratory indexing of the patients who use the Shenwei Shenmai injection.(3)The adverse events/adverse reaction characteristics of the patients,recording of the patient’s age,sex and other basic demographic information,and past history,family history,the original disease,whether the use of dialectical.(4)The adverse reaction factors of Shenwei Shenmai injection:The dosage,the speed of drug administration,the type of dilution solution,the storage time,the concentration of drug,the speed of drug administration,the combination of medication and the combined treatment were recorded in detail.ResultsThis study focused on monitoring the collection of Shenwei Shenmai injection of patients with a total of 3116 observation table,33 were duplicition.According to the number of hospitalized patients,the number of hospitalized patients,including 2791 different patients,a total of 3083 cases of records.Among 2791 patients,there were 1513 males and 1278 females,accounting for 54.3%of males.The average age was 58.85±16.39 years old,the age group was 50 to 80 years old,accounting for 66.4%.And reported in the literature to middle-aged(40 to 79-year-old)a higher incidence of similar.The patients were diagnosed with tumor and cardiovascular diseases mostly,tumor(32.6%),cardiovascular system(21.3%),neurologicalsystem(9.1%),digestive system(6.8%),nephropathy(5.4%),Diabetes(5.2%),respiratory system(4.4%),and blood system(4.2%).Of which 40.7%of patients with other diseases,53.7%of patients with a history of previous history of allergic patients with 10.2%.It can be seen that Shenmai injection can improve the immunological function of tumor patients,the most clinical disease is malignant tumor,and it has synergistic effect when used in combination with chemotherapy drugs.Second,for cardiovascular and cerebrovascular diseases,can improve the heart and brain and other vital organs of the blood supply,improve microcirculation and anticoagulant effect.This study shows that the basic clinical use of Shenmai injection within the scope of the instructions,but there are also beyond the scope of the use of drug instructions.The main purpose of Shenmai injection was as the auxiliary drug of chemotherapy and the treatment of Qi-Yin deficiency,chemotherapy auxiliary and coronary heart disease,accounting for 29.3%,24.5%and 17%respectively.The most commonly used solvent is glucose solution(86.4%),followed by sodium chloride solution(10.1%),in addition to compatibility with fructose injection,insulin,invertase,sodium potassium potassium magnesium calcium glucose solution,vitamin C and peony injection Liquid and the like.The order of single dose was 50ml(37.9%),60ml(27.9%),100ml(18.4%)and 40ml(15.8%).The average duration of continuous use of Shenwei Shenmai injection was 6.73±6.38 days,the number of cases was 2051 cases,accounting for 66.5%,followed by 8-15 days and more than 16 days.In this study,59 adverse events were reported in all patients,and the incidence of adverse events was 1.9%.Adverse events were divided into mild,moderate and severe types,including mild in 26 cases,moderate in 19 cases,severe in 8 cases,6 cases did not evaluate the state of adverse events.All the adverse events were evaluated by relevance to determine whether adverse events caused by the use of Shenwei Shenmai injection,the results show that 13 patients with adverse events would be revenlce with the use of Shenwei Shenmai injection.Accounting for 0.4 percent of all observed cases.59 cases of adverse events were mainly respiratory system,circulatory system,digestive system damage,the three total of 39 times,accounting for 66.1%of the total number of adverse events.13 cases of adverse reactions to skin and accessories damage,circulatory system,respiratory system,nervous system performance(84.6%).Consistent with the relevant literature[3,6].Adverse reactions should occur immediately in the course of treatment,suggesting that Shenmai injection of ADR/ADE to the rapid onset of allergy-based,suggesting that the first 30min in the course of treatment should be closely observed.Among the 59 adverse events,46 were evaluated as having "unrelated"use of the drug.The outcomes included recovery(7 cases,15.2%),improvement(26 cases,56.5%)and death(12 cases,26.1%).The other 13 adverse reactions were considered as "possible".The prognosis of the adverse reactions was better(53.8%)and better(46.2%).No serious adverse events occurred.The study of case-control study found that single factor conditional logistic regression analysis to explore the possible factors of adverse reactions for the length of treatment and whether the basis of traditional Chinese medicine dialectical.The variables of P<0.10 in univariate analysis were analyzed by multivariate conditional logistic regression analysis,and the gender,age and dosage were included in the model.The results showed that after adjusting for the influence of other factors,And traditional Chinese medicine is still an independent factor in the occurrence of adverse reactions.ConclusionThis study suggest that Shenwei Shenmai injection has good clinical safety,adverse reactions occur is not high,did not find the different types of adverse reactions from the instructions.However,it should be noted that the study observed in patients is not enough,the adverse reaction cases were so rare,so it can’t do further analysis of its characteristics,This will require further observation and analysis in future postmarketing evaluations. |
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