| 1.ObjectiveAdverse drug reaction(ADR)is one of the major problems in the medical field.The ADRs of Chinese herb injections have aroused wide concern,which are still serious according to the Adverse Drug Reaction Monitoring Center.In 2013,the national drug adverse reaction monitoring network received 121,000 cases of Chinese herb injections with serious reports accounted for 5.6%.In 2014,127,000 Chinese herb injections cases are received by monitoring network with serious reports accounted for 6.7%.In 2015,a total of 127,000 Chinese herb injections cases are received with serious reports accounted for 7.7%.In 2016,a total of 130,000 Chinese herb injections cases are received with serious reports accounted for 3.7%.In 2017,a total of 126,000 Chinese herb injections cases are received with serious reports accounted for 11.54%.In this paper,the epidemiological characteristics of Chinese herb injections ADR were studied.Apply the convenience and conception of big date and the mass drug adverse events to identify,storage,analysis and utilize the cases effectively.It is beneficial to promote the selection of ADR’s signal and the monitoring of ADR,and it can prevent the occurrence of ADR effectively.2.MethodsThe data of this study can be divided into two parts.The first part is provided by the National Center for Monitoring,China.There are detailed cases of Shuang Huanglian,Qing Kailing,Xue Saitong,Shen Mai and Dan Shen injections excerpted from 2006 to 2015.The second part of the data is retrieved from Chinese journal full-text database(CNKI),Chinese scientific and technological periodical database(VIP),Chinese biomedical journal database(CMCC)and Wanfang database.It includes detailed cases reports of puerarin injection,Shuang Huanglian,Qing Kailing,Chuan Huning,Shen Mai,Xue Saitong and Heat-clear injection from 1979 to 2015.The detailed ADR cases of Chinese herb injections are studied from the perspective of big data.Apply data mining method(Bayesian network,Neural network,Decision tree and Association rules)and nested case-control study(NCCS)to study the first part of the data to explore the epidemiological characteristics and risk factors of anaphylactic shock induced by Chinese herb injections.On the other hand,apply data mining method to study the second part of datas to discuss the epidemiological characteristics of ADR of Chinese herb injections.3.Results(Ⅰ)Study on the characteristics of anaphylactic shock induced by Chinese herb injections based on adverse reaction monitoring information.The results of data mining the epidemiological characteristics of anaphylactic shock induced by Shuang Huanglian injection show that the patient’s original disease is associated with anaphylactic shock,whose association coefficient is 0.175.The age of the patients is related to the patient’s original disease,whose coefficient is 0.26.The correlation coefficient of patients’ age and prognosis of ADR is 0.28.The dead patients mostly are between 20 and 29,and they are suffered from respiratory infections.70.18%of patients who do not combined medicine are recovered.The proportion of dead patients who combined medication was significantly greater than that of patients without combination therapy(P<0.05).The results of single factor Logistic regression analysis on Shuang Huanglian injection show that the protective factors of anaphylactic shock(i.e.,non-allergenic shock)include the patient’s original disease,drug delivery pathway,gender(male)and age.Risk factors include combined medication and the third quarter.The results of multiple Logistic regression analysis show that the protective factors of anaphylactic shock include the original disease and patients’gender.Risk factors include combined medication and the third quarter.The results of data mining epidemiological characteristics of anaphylactic shock induced by Qing Kailing injection show that the main factors are followed:patients’ age(0.435),the original disease(0.208),combined medication(0.156)and patients’ gender(0.086)according to the association coefficient of anaphylactic shock.The proportion of dead patients who was combined medication was significantly higher than that of patients without combination and the difference is statistically significant(P<0.05).The results of single factor Logistic regression analysis on Qing Kailing injection show that protective factors of anaphylactic shock include the delivery way,gender(male)and age.Risk factors include disease(other disease),combined medication and the third quarter.The results of multivariate Logistic regression analysis show that the protective factors of anaphylactic shock incude patients’ gender and age.Risk factors are the same as the results of single factor analysis.The results of data mining epidemiological characteristics of anaphylactic shock induced by Xue Saitong injection show that the main factors associated with ADR include gender,the patients’ original disease and age.There is a significant difference(P<0.05)in the outcome of adverse reactions(prognosis)according to the different original diseases.The proportion of dead patients who had the history of drug allergy was significantly greater than that of patients without allergic history(P<0.05).The results of single factor Logistic regression analysis on Xue Saitong injection show that the protective factors of anaphylactic shock include delivery way,history of drug allergy and gender(male).Risk factors include combined medication,prognosis(meaning that anaphylactic shock patients have poorer prognosis than patients without anaphylactic shock).The results of multivariate Logistic regression analysis show that the risk factors of anaphylactic shock include the patients’ original disease,combined medication,the first three quarters and the prognosis.The results of data mining the epidemiological characteristics of anaphylactic shock induced by Shen Mai injection show that the prognosis of anaphylactic shock is closely related to the patients’ age,the patients’ original disease and the history of drug allergy.The proportion of dead patients who have previous drug allergy history is significantly bigger than that of patients without previous history of drug allergy(P<0.05).There is a significant difference(P<0.05)in patient’s original disease between men and women.The results of single factor Logistic regression analysis on Shen Mai injection show that the protective factors of anaphylactic shock include delivery way,original disease and patients’gender.Risk factors include drug allergy history,combined medicationand and the first three quarters.The results of multivariate Logistic regression analysis show that the protective factors of anaphylactic shock include the original disease and gender.The risk factors include drug allergy history and the second and the third quarter.The results of data mining the epidemiological characteristics of anaphylactic shock induced by Dan Shen injection show that patients’ gender,age and the patients’ original disease are closely related to ADR.The proportion of dead male patients is significantly greater than that of female patients(P<0.05).The proportion of elderly dead patients(60 to 89 years old)is significantly greater than that of younger patients(10 to 59 years old)(P<0.05).There is a significant difference in the results of ADR(P<0.05)because of different original disease.The results of single factor Logistic regression analysis on Dan Shen injection show that protective factors of anaphylactic shock include delivery way,patients’ gender(female)and history of drug allergy.The risk factors include drug dosage forms,combine medicine.The results of multivariate Logistic regression analysis show that the protective factors of anaphylactic shock include the drug delivery pathway and the gender of the patient.The risk factors include combined medication and the age of patients.(2)Results of the epidemiological characteristics of Chinese herb injections adverse reactions retrieved from literature.The results of data mining Heat-clearing injection adverse reactions(ADR)show that the ADR cases diagnosed as anaphylactic shock happened in the first 10 minutes principally,cases diagnosed as respiratory damage occured in the first five minutes,and most of the adverse drug reactions happened in the first 30 minutes.The results of Neural network algorithm and decision tree show that occurrence time is the most important factor associated with severe ADR.Patients who suffered from adverse reactions within 15 minutes occupied 51.94%and 36.02%of them are suffered from anaphylactic shock.The results of data mining Shuang Huanglian injection ADR show that the proportion of male patients significantly greater than that of female patients in the cases diagnosed as anaphylactic shock.The percentage of female patients is significantly greater than that of male patients in cases diagnosed as circulatory system damage.The results of Bayesian network and decision tree show that the occurrence time of ADR is correlated to diagnosis tightly.In the periods of 0 to 10 min and 30 to 40 min,the proportion of anaphylactic shock is up to 32.022%.Patients who are suffered from pneumonia account for 6.68%and 52.63%of them are diagnosed as skin lesion.The results of data mining the Qing Kailing injection show that patients’ ages are different in different types of ADRs.Patients between 30 and 39 year-old are diagnosed as the respiratory system damage,and anaphylactic shock occupied highest percentage in all age groups.Patients who are diagnosed as skin lesion aged from 0 to 9 or from 20 to 29 occupied high proportions.The results of association rule show that the proportion of patients whose Liquor types is glucose and the patients who are diagnosed as skin lesion is 11.88%and 70.73%of them are male.The proportion of patients who are suffered from ADR within 5 min and combined medication is 15.36%,and 49.06%of them are diagnosed as anaphylactic shock.The results of data mining the Chuan Huning injection show that female patients diagnosed as anaphylactic shock are much more than male patients.The proportion of male patients who are diagnosed as respiratory system damage is much bigger than that of female patients.The results of Bayesian network,neural network and decision tree algorithm all show that the occurrence time of ADR is closely related to anaphylactic shock.The results of association rule algorithm show that the patients whose distribution concentration was 5%,dosage of the dispensing liquid was 250ml and ADR occurrence time was among 0-5min are occupied with 9.29%in all patients,and 88.24%of them were diagnosed as anaphylactic shock.The results of data mining the puerarin injection show that there is a significant difference in the composition of different ADR among different periods,such as the ADR of patients suffered from systemic lesion and skin and accessories damage mainly took place after again or multiple dosing.The ADR of patients with original coronary heart disease mainly occurred within 30 minutes.The results of association rule algorithm show that the clinical manifestation is related to the patients’ gender,age,allergy history,original disease and clinical medication information.The results of data mining the Shen Mai injection show that patients with original disease of coronary heart disease(CHD)are suffered from skin and its accessories damage mainly.Patients with original disease of tumor or cancer are mainly suffered from respiratory damage.Fatigue patients are almost suffered from systemic damage,heart rate and rhythm disorders and neurological disorders.Patients who are diagnosed as gastrointestinal system damage,systemic damage and respiratory system damage mainly with the 5%solution concentration.More patients are diagnosed as neurological disorders when the distribution concentration is 0.9%.The patients who are diagnosed as systemic lesion were mainly from Shan Dong and Zhe Jiang provinces.The patients suffered from heart rate and rhythm disorders are coming from Shan Dong province and He Bei province largely.The results of data mining the epidemiological characteristic of Xue Saitong injection adverse reaction show that the patients whose ADRs taken place from 0 to 10 minutes are recovering.Patients are healing whose ADRs take place from 10 to 30 minutes or in a few days.By chi-square test there was a significant difference in the composition of adverse reaction time(P<0.05)in different kinds of prognosis.The results of association rule algorithm show that patients whose primary disease is cerebral infarction and disappeared account for 12.04%,and 69.23%of them were 60-69 years.Moreover,patients of peripheral vascular injury accounted for 15.74%and 64.71%of them are begin in after a few days.4.ConclusionThe adverse reactions of Chinese herb injections are too complex to illuminate due to the complexity of traditional Chinese medicines.The adverse reactions are more complex than chemical drugs and its mechanism is unknown yet.The characteristics of adverse reactions of different Chinese herb injections have similarities preliminarily,such as:1)The ADRs of Chinese herb injections are related to patients’ age,gender,history of allergies,primary disease,combined medications,liquor concentration and the time of adverse reactions occurrence.2)The related factors can be summarized as the clinical factors and factors of the patients’ body.3)Combination therapy is a risk factor for Shuang Huanglian injection,Qing Kailing injection,Xue Saitong injection,Dan Shen injections,and Dan Shen injection.However,the specific characteristics of each injection are different.For example,in the adverse reactions of Chinese herb injection based on the Adverse Drug Reaction Monitoring Center,patients’ original disease is a protective factor for Shen Mai injection and Shuang Huanglian injection,but it is a risk factor for Qing Kailing injection and Xue Saitong injection,while it has no effect on Dan Shen injection.Results are inseparable from the quality of data submission and data processing methods.Therefore,the ADR reporting and monitoring system should be continuously improved,and the data should be submitted strictly and standardly.Production enterprises,operating companies,business enterprises and medical institutions should be encouraged to report ADR cases spontaneously and seriously... |
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