| Objective: To explore the clinical characteristics and risk factors of atorvastatin induced liver injury,and to explore the monitoring mode of adverse durg reactions prevention and treatment.Methods: 1.Literature study: To search the clinical research literature of statin induced liver injury,the diagnostic criteria of drug-induced liver injury,get familiar with the epidemiological characteristics of statin induced liver injury,and the status quo of the application of real world research on adverse drug reactions.2.Research on risk factors: the use of Chinese Hospital Pharmacovigilance System(Chinese Hospital Pharmacovigilance System,CHPS)build atorvastatin liver damage caused by the active monitoring model,five big 3 armour Hospital to guangzhou Hospital nearly three years of atorvastatin treatment of hospitalized patients with electronic medical records were retrospectively analyzed,including 1 single center study,the remaining four multicenter study.Factors analyzed included gender,age,weight,diagnosis,and drug combination.Univariate analysis was performed by chi-square test,multivariate analysis was performed by Logistics regression analysis,Kaplan Meier survival curve and Log Rank test were used to analyze the time of liver damage,and Cox regression analysis was used for multivariate test.A P value less than 0.05 was considered statistically significant.3.Pharmaceutical practice: the constructed active monitoring model was used to monitor the inpatients in a third-class A hospital,case review was conducted for the patients suspected of liver damage detected,and pharmaceutical care was provided for the patients confirmed to be liver damage caused by atorvastatin after review in cooperation with clinicians.Results: 1.Single center study of 661 patients with the use of atorvastatin in 34 cases of liver damage,the incidence was 5.14%,the single factor chi-square analysis of gender,age,weight,BMI,dosage and the diagnosis on the influence of atorvastatin liver damage,the results show that the weight is less than 55 kg,and CYP3A4 inducers/inhibitors of atorvastatin induce liver damage(P < 0.05);the important factors Univariate analysis showed that the combination of atorvastatin and CYP3A4 inhibitors was significantly associated with a 3.6-3.8 fold increase in the incidence of liver damage.Kaplan Meier survival curve and Log Rank test showed that the combination of hypertension and CYP3A4 inhibitors was a factor affecting the occurrence time of liver damage(P < 0.05),with hazard ratios of 3.9 and 4.7,respectively.Multivariate Cox regression analysis showed that hypertension was a factor affecting the occurrence time of liver damage(P < 0.05),hazard ratio was 10.8.2.1164 patients treated with atorvastatin were included in the multicenter study,of which 20 patients developed liver damage(1.7%).Single factor results showed that combination with CYP3A4 inhibitor was an important factor in atorvastatin induced liver damage(P < 0.05),with a 3.1-fold increase in the incidence.Kaplan Meier survival curve and Log Rank test did not find any factors affecting the occurrence time of liver damage.Multivariate Cox regression analysis showed that body weight /BMI,combined with CYP3A4 inhibitors may be the factors affecting the occurrence time of liver damage(P < 0.05).3.The patients with liver damage caused by atorvastatin were successfully monitored by the active monitoring model.After the clinical pharmacist cooperated with the physician to conduct pharmaceutical intervention for the patients,the patient’s prognosis was improved and the liver function gradually recovered.Conclusion: The use of CYP3A4 inhibitors is associated with atorvastatin induced liver damage.CHPS can actively monitor the adverse reactions in the real world and provide reference for rational and safe drug use in clinical practice.Clinical pharmacists can detect ADR early by combining CHPS with pharmaceutical practice,improve medication safety and outcome of patients. |
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