Clinical Application Monitoirng And Safety Evaluation Of Shen Qi Fu Zheng Injection

Objective: Carry out the registration centralized monitoring programs, summarizethe clinical application of Shenqifuzheng Injection, and obtain adverse reactionsoccurrence and influencing factors of Shenqifuzheng Injection, in order to providereasonable medication recommendations, as much as possible to avoid the occurrence ofadverse reactions, and improve the safety and rationality of clinical application.Methods: Statistics August1,2013to December31,2013all the hospitalizedpatients in affiliated hospital of Shandong university of traditional Chinese medicine whoused Shenqifuzheng Injection.There is no exclusion criteria.By retrieving electronicmedical records system to fill in the survey, statistics covering age,gender,patient’scondition,hospitalization,days of medication, Chinese and Western diagnosis,TCMSyndromes distribution,consolidation diseases,combination therapy,adverse reactions andmany other indicators. By cluster analysis, correlation analysis, logistic regressionanalysis, to analyze clinical application of Shenqifuzheng Injection and adverse factors,finally to provide reference for clinical practice.Results:1.we collceted1171patients using the ShenQi Fuzheng Injection.There are496male patients,675female patients in our discovery.The mean age of the patients was53.77years old. There are75.41%of all patients concentrated between46and81ages. Allpatients used the ShenQi Fuzheng Injection in the way of intravenous.2. Most patientswho used Shenqifuzheng Injection mainly were with stable disease, accounting for81.04%.Oncology has the most widely used, accounting for19.13%. It is20.28days ofhospitalization in average, and81.34%of patients hospitalized in28days or less. Thecourse of Shenqifuzheng Injection was8.27days on average. There are85.39%of thepatients within14days of drug treatments, and71.82%of the patients in the treatment time window within4days.3.The common diseases in patients who used ShenqifuzhengInjection are breast cance（r9.39%）lung cance（r9.39%）, gastric cance（r5.64%).The mostcommon traditional chinese medicine diagnosis were Feiji (9.48%),Ruyan (8.97%),Feiwei(7.86%).4.Merge disease association analysis showed that the concomitant diseases ofpatients used Shenqifuzheng Injection were hypertension, coronary heart disease, diabetesand other diseases. Correlation analysis of combination therapy showed that thecombination usage of drugs were Matrine, Danhong, L-carnitine and other drugs.5.Syndromes distribution shows the differentiation of patients using the ShenqifuzhengInjection mostly were Qi-Yin deficiency Syndrome（15.37%）,Qi stagnation card(11.87%), Qi deficiency syndrome (7.01%). Disease resistance syndrome factors mostlywere Qi deficiency, Blood stasis, Phlegm. Disease-bit syndrome factors were based onlung, kidney, heart, spleen. In patients using Shenqifuzheng Injection, symptom frequencydistribution show fatigue, chest tightness, cough, sputum, dry mouth had higherfrequency.Cluster analysis showed symptoms factor can be clustered into three categories:pulmonary syndrome, heart syndrome and stomach lines syndrome.6. In this monitoringthere were three irrational of drug usage. Such as fever patients, long drug usage andbleeding tendency patients.The percentage of irrational drug was12.21%.7. In thismonitoring there were31cases of adverse events. Most clinical manifestations weregastrointestinal reactions. The adverse events constitute male17, female14.The mean agewas62.23years old, More concentrated in55to72age group (67.74%), Cancer patientshave29adverse events, the most adverse events occurred in2hours after administrationwith20cases.25cases’s recover time are less than four hours.29patients who occuredadverse events got better or healed after giving symptomatic treatment or discontinuationdrugs, only two patients were dead. Logistic regression analysis show antineoplastictreatment time and antineoplastic drugs may be associated with the occurrence of adverseevents.Conclusion:1. Majority usage of Shenqifuzheng Injection were women, and elderlypatients use more.2. Shenqifuzheng Injection can be used in patient with onset of disease, mainly usedin patients with stable disease.3. Patients using Shenqifuzheng Injection merger occurs hypertension, coronaryheart disease, diabetes and other diseases,clinical applications should be noted withantihypertensive, antidiabetic, arrhythmic drug interactions between control.4. Shenqifuzheng Injection jointed use Matrine, Danhong, L-carnitine and otherneoadjuvant therapies, improve myocardial metabolism of drugsdrugs,and chinesemedicine injection with detoxification, blood circulation effect.5. Combined syndrome symptom frequency distribution and cluster analysis, tipsthat patients use Shenqi Fuzheng Injection patientsmainly based Qi deficiency, meantimedisease location mainly related lung, heart and spleen.6. Shenqifuzheng Injection widely used in clinical. The clinical useage of drugs iscommonly in line with the instructions. But there are ultra-applicable conditions, such asusing in fever patients, long term usage and patients with bleeding tendency. It promptthat we should use differential treatment, give drugs according to instructions, so that canavoid irrational drug use. This survey also shows that it can expand the scope of theinstructions applicable in clinical application.7. Evaluation of adverse reactions: Shenqifuzheng Injection in the clinicalapplication showed higher security. All adverse events were mild benign, there were nospecific adverse performances. Adverse events have a better outcomes.However, theclinical application of medication treatment show us that we need to pay attention not usethem too long, and care the impact of anticancer drugs to patients.