| Objective:To investigate characteristics of drug-induced liver injury(DILI)and the characteristics and situations of adverse drug reaction(ADR)caused by fluoroquinol ones.The automatic surveillance of the key fluoroquinolones was finished to get th e incidence,and analyze the incidence and related factors of ADR caused by the k ey fluoroquinolones.Method:(1)The cases of 1110 DLLI and 11962 fluoroquinolones ADR spontaneou s reports were collected and then analyzed retrospectively to have a preliminary un derstanding of the DILI and fluoroquinolones ADRs.Then target drugs and their A DRs were identified.(2)The data of hospitalized patients with levofloxacin in our hospital from October in 2015 to September in 2016 were extracted and analyzed with inpatient's active surveillance and assessment system retrospectively.Incidence of adverse drug reactions and related factors of liver impairment caused by levoflox acinw were analyzed.(3)According to the method for levofloxacin,the data of hos pitalized patients using moxifloxacin from January to June in 2016 were extracted a nd analyzed retrospectively.The method also was used in multi-center hospitals(4)The data of hospitalized patients with moxifloxacin from January in 2015 to Decem ber in 2016 were extracted and analyzed to require the incidence of moxifloxacin-re lated adverse skin reactions and anaphylactic shock with the "skin impairment" and"anaphylactic shock" module.Nested case-control study was adopted to analyze the risk factors of moxifloxacin-related adverse skin reactions.Results:(1)Among 1110 DILI cases,the predominant drugs were atorvastatin,rifa mpicin,moxifloxacin and levofloxacin orderly.In 11962 ADR reports of fluoroquin olones,the number of ADR cases caused by ranking the top 2 drugs were levoflox acin,moxifloxacin.The main clinical manifestations of ADR are pruritus,rash.The main clinical manifestations of severe ADR were abnormal liver function and anaph ylactic shock.Moxifloxacin is the positive signal of DILI in the mining of liver im pairment risk signals.(2)For 2675 levofloxacin cases,the incidence of DILI,throm bopenia,anemia,leukopenia and neutropenia was respectively 1.93%,0.75%,1.34%,1.82%and 1.59%.BMI was significantly associated with DILI risk(P=0.022).(3)For 2263 moxifloxacin cases,the incidence of DILI,thrombopenia,anemia,and leukopenia was respectively 4.70%,0.54%,3.26%and 0.98%.Male patients are mo re vulnerable to DILI caused by moxifloxacin than female patients(P=0.014).Th e incidence of DILI,thrombopenia,anemia,and leukopenia in multi-center hosiptals was respectively 3.88%,0.49%,2.21%and 0.95%.(4)A total of 7774 cases usin g moxifloxacin were automatically surveilled.the incidence of adverse skin reaction s and anaphylactic shock was respectively 0.53%and 0.015%.The multivariate logi stic regression analysis showed alcohol was associated with moxifloxacin-related adv erse skin reactions(OR:5.968;95%CI:1.213-29.371).Conclusion:Based on the empirical analysis results of spontaneous reporting data,Then target drugs and their ADRs were identified.This study took the lead in the use of an automatic monitoring system to quickly,accurately,and accurately obtain the incidence of ADR related to fluoroquinolones such as levofloxacin and moxiflox acin;The system can not only finish the automatic surveillance of moxifloxacin-rela ted and levofloxacin-related DILI with high speed and efficiency,but also can finis h the automatic surveillance of adverse skin reactions with data mining.The system with the HIS historical database can achieve larger sample drug population and th e results also provide verification of the effectiveness of the automated monitoring system.The spontaneous reports of ADR data are an indispensable evidence for pot ential risk signal screening,and the automatic monitoring system based on informati on technology is an effective tool for monitoring key drug. |
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