| Objective: To analyze the correlation between polygonum multiflorum,caulis polygoni multiflori and the risk of liver injury.And to find out the possible factors which would lead to liver injury,so that to provide some reference for clinical treatment.Methods: This retrospective study collected data of patients who had taken drugs which containing polygonum multiflorum or caulis polygoni multiflori orally in Shuguang hospital and Longhua hospital affiliated to Shanghai University of Traditional Chinese Medicine from January 2017 to December 2017.A RACUM score ≥ 3 was used as the criterion to select effective cases.Clinical characteristics of patients who had suffered liver injury were analyzed,including gender,age,underlying diseases,combination use of drugs,allergic history and sydrome differentiation of traditional Chinese medicine.So that to found out factors which may be related to the occurrence of liver injury.Results: 1.A total of 12,330 outpatients taking polygonum multiflorum were collected in this study,including 29,940 prescriptions.Among these 29,940 prescriptions,17(1.31%)were High Risk prescriptions.Univariate analysis showed that:(1)There was no correlation between the dose index of polygonum multiflorum and ALT(W = 11.5,P= 1.000).The correlation between the dose index of polygonum multiflorum and ALP cannot be determined due to the limited sample size.(2)There was no correlation between the dose index of polygonum multiflorum after processing and ALT or ALP(W = 231380,P = 0.050;W = 36799,P= 0.210).(3)The prescription of polygonum multiflorum and polygonum multiflorum after processing was analyzed,compared with low risk population,the dose index of polygonum multiflorumwas higher in high risk population(W = 7200,P = 0.015),the proportion of patients with liver or neoplastic diseaseswere higher(P < 0.001),the proportion of female was more(P = 0.03),and patients were older(W = 7600,P= 0.034).Multivariate analysis showed that the occurrence of liver injury was correlated with the sex,age,index dose of polygonum multiflorum and complications in patients taking polygonum multiflorum(P<0.05).Female were at higher risk than male.And the higher the index dose,the higher the risk of liver injury;patients with liver or neoplastic diseases were at higher risk than other diseases(P<0.05).Among patients with liver or neoplastic diseases,dose index of polygonum multiflorum was associated with the occurrence of liver injury.The higher the dose index,the higher the risk of liver injury.Female and elderly patients were at higher risk of developing liver injury(P>0.05).2.A total of 269 inpatients taking polygonum multiflorum were collected in this study.Among them,32 cases occurred liver injury.6(2.23%)inpatients with RUCAM score≥3 were analyzed.The clinical characteristics were analyzed and the results showed that among these patients,4 cases’ s RUCAM score were 5(66.66%),1 case’s RUCAM score was 4(16.67%),1 case’s RUCAM score was 3(16.67%).Type of the liver injury of all these 6 patients was cholestasis,and all the TCM sydrome differentiation was deficiency syndrome,2 penicillin anaphylaxis(33.33%).All patiens with tumors have used hepatotoxic anti-tumor drugs while taking polygonum multiflorum.6 cases with normal liver function who took polygonum multiflorum during the same period were treated as control group.Compared with the control group,the risk of liver injury was not significantly affected by gender,age,history of allergy,the doze index of polygonum multiflorum and the combination use of drugs(P> 0.05).3.A total of 48,220 outpatients taking caulis polygoni multiflori were collected in this study,including 165,355 prescriptions.Among these 165,355 prescriptions,280(2.16%)were High Risk prescriptions.Univariate analysis showed that:(1)There was no correlation between the dose index of caulis polygoni multiflori and ALT or ALP(W = 14544000,P= 0.108;W = 4380200,P= 0.081).(2)Compared with low risk prescribing population,the proportion of patients with liver or neoplastic diseases and male were higher in high risk prescribing population(p< 0.001).There was no significant difference in the dose index of caulis polygoni multiflori and age between these two groups(P>0.05).Multivariate analysis showed that the occurrence of liver injury was correlated with the sex,age and complications in patients taking caulis polygoni multiflori(P< 0.05).There was no correlation between the dose index of caulis polygoni multiflori and the occurrence of liver injury(P>0.05).Male were at higher risk than female.Patients with liver or neoplastic diseases were at higher risk than other diseases(P< 0.05).Among patients with liver or neoplastic diseases,dose index of caulis polygoni multiflori was associated with the occurrence of liver injury.The higher the index dose,the higher the risk of liver injury(P<0.05).4.A total of 1,968 inpatients taking caulis polygoni multiflori were collected in this study.Among them,127 cases occurred liver injury.12(0.61%)inpatients with RUCAM score≥3 were analyzed.Among these patients,7 cases’ s RUCAM score were 4(58.33%),3 cases’ s RUCAM score were 5(25%),1 case’s RUCAM score was 6(8.33%),1 case’s RUCAM score was 7(8.33%).Type of the liver injury of 7 patients was cholestasis(58.33%),4 cases(33.33%)were mixed type.9 cases(75%)had tumor related diseases and had used anti-tumor drugs while taking caulis polygoni multiflori.3 cases(25%)had used non-tumor related drugs which may cause liver dysfunction(Antibiotics combined with drugs for mental disorder(8.33%),digestive system drugs(8.33%)and hormones with immunosuppressive agents(8.33%).)TCM sydrome differentiation of 10 cases was deficiency syndrome(83.33%),2 cases were excess syndrome(16.67%).No case had penicillin anaphylaxis.12 cases with normal liver function who took caulis polygoni multifloriduring the same period were treated as control group.There was no significant difference in the dose index of caulis polygoni multiflori between the abnormal liver function group and the control group(W = 70.5,P= 0.953).12 patients were divided into the tumor subgroup and non-tumor subgroup according to disease type,results showed that the risk of liver injury was not significantly affected by gender,age,history of allergy,the doze index of polygonum multiflorum and the combination use of drugs(p>0.05).Conclusions: 1.The occurence rate of liver injury was 2.23% in 269 patients treated with polygonum multiflorum,0.61% in 1968 patients treated with caulis polygoni multiflori.There was no significant influence on the risk of liver injury by gender,age,history of allergy,the doze index of polygonum multiflorum and the combination use of drugs,which suggesting that the occurrence of liver injury may be related to the patient’s specific constitution.2.In the population with liver disease or tumor,the drug intensity of polygonum multiflorum and caulis polygoni multiflori might be correlated with the occurencerisk of liver injury. |
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