Analysis Of The Occurrence Status And Related Influencing Factors On Adverse Drug Reactions Caused By Anti Tuberculosis Drugs In Changzhou

Objective: To investigate the distribution of ADRs caused by anti tuberculosis chemotherapy drugs in patients with confirmed pulmonary tuberculosis,and to explore the factors related to the occurrence of ADRs in Changzhou,Jiangsu.To provide basic data for identifying high-risk groups,and preventing ADRs caused by anti tuberculosis drugs.Methods: The design of retrospective cohort study was used in this study.From January 2015 to December 2015,the cases of pulmonary tuberculosis diagnosed in Changzhou Third Hospital and treated with anti tuberculosis drugs for chemotherapy were selected as the objects of investigation.The medical records of the patients,such as the course record,prescription note,laboratory sheet and so on,were collected.Demographic statistics data,living habits and behaviors,tuberculosis prevalence,drug use,laboratory testing indicators and ADRs situation of the objects were also collected.Univariate logistic regression analysis was used to screen suspicious factors into multivariate logistic regression analysis,so as to explore the possible factors associated with ADRs.Results:1.In 750 subjects enrolled in this study,there were 361 cases with varying degrees of ADRs.The overall incidence of ADRs in the study sample was 48.13%.The incidence of liver damage,gastrointestinal reaction,allergic reaction,nerve system damage,motor system damage,blood system damage and kidney injury in various ADRs types were23.47%,15.07%,11.73%,9.20%,5.20%,3.07%,and 1.73% respectively.The first time of all kinds of ADRs was concentrated in the intensive period of anti tuberculosis treatment.Among them,the median time of gastrointestinal reaction was first,it occurred at the 4th day after taking medicine,motor system damage at the the 7th day,allergic reaction at the10 th day,liver injury at the 22 th day,nerve system damage at the 28 th day,renal damage at the 32 th day,blood system damage was the last,it occurred at the 62 th day.According tothe classification criteria of ADRs severity,the incidence of mild,moderate and severe were38.80%,8.40% and 0.93%.Mild injuries were observed in 80.61% of the ADRs in this study.2.Chi square test showed that there were significant differences between the ADRs group and the normal group in the eight aspects: whether or not to have spouse,alcohol-preferring behavior,HBsAg,type of anti tuberculosis drug preparation,original value of AST,ALT,GGT,and BUN.(P<0.05)3.Univariate logistic regression analysis showed that HBsAg positive,take fixed-dose combination,ULN<ALT?2×ULN,ALT>2×ULN,AST>2×ULN,ALP>2×ULN,and BUN>ULN were the factors influencing the occurrence of ADRs.(P<0.05)4.Multivariate logistic regression analysis showed that HBsAg positive(OR=3.153,95%CI:1.787 ~ 5.562),take fixed-dose combination(OR=0.630,95%CI:0.428 ~ 0.926),AST>2×ULN(OR=4.630,95%CI:1.312~16.344),BUN>ULN(OR=6.518,95%CI:2.127~19.970)were the independent correlative factors for ADRs.(P<0.05)Conclusion: The overall incidence of ADRs caused by anti tuberculosis drugs in patients with pulmonary tuberculosis is higher in Changzhou,Jiangsu.HBsAg positive,AST >2×ULN,and BUN >ULN are the independent risk factors,while use fixed-dose combination is a protective factor for ADRs.It is recommended to take fixed-dose combination for anti tuberculosis chemotherapy in high-risk patients with HBsAg positive,AST>2×ULN,and BUN>ULN in clinical practice.The liver and renal function indexes should be closely followed up during the first two-month period of anti tuberculosis chemotherapy treatment.Active monitoring should be carried out to prevent and control ADRs caused by anti tuberculosis drugs,so as to ensure the standardized anti tuberculosis treatment complete successfully.