头孢哌酮钠/舒巴坦钠相关肝损伤的自动监测研究

Automatic Surveillance of Liver Injury Related to Cefoperazone Sodium/Sulbactam Sodium

目的:高效获取大样本用药人群中头孢哌酮钠/舒巴坦钠相关肝损伤的真实世界发生率等风险数据。方法:借助"医疗机构ADE主动监测与智能评估警示系统"(ADE-ASAS),回顾性自动监测我院2013年7月~2018年6月使用注射用头孢哌酮钠/舒巴坦钠的住院患者,双人评价系统报警病例,获得头孢哌酮钠/舒巴坦钠相关肝损伤的发生率与发生特征;采用病例对照研究方法进行影响因素分析。结果:22573例次用药患者中发生肝损伤166例,发生率为0.74%。关联性评价结果:很可能34例,可能132例;肝损伤类型:肝细胞损伤型75例,胆汁淤积型80例,混合型11例。高龄、低体重指数(BMI)患者发生胆汁淤积型肝损伤的比例更高。多因素Logistic回归分析显示,用药时长为头孢哌酮钠/舒巴坦钠致肝损伤的影响因素,病例组用药≥5 d患者比例(83.73%)与对照组(61.18%)比较,差异有统计学意义(P<0.001)。结论:头孢哌酮钠/舒巴坦钠相关肝损伤发生率属偶见。高龄、低BMI患者可能更易发生胆汁淤积型肝损伤,用药时应重点监测AKP等相关指标、选择合适的保肝药物。合理控制用药时长,并重点关注用药≥5 d患者肝功能状况,减少肝损伤发生风险。

Objective:To obtain the real world incidence of liver injury related to cefoperazone sodium/sulbactam sodium in a large population.Methods:The incidence and characteristics of liver injury related to cefoperazone sodium/sulbactam sodium were obtained by retrospective automatic surveillance of inpatients who used cefoperazone sodium/sulbactam sodium for injection from July 2013 to June 2018 in our hospital with the aid of"ADE-ASAS"in medical institutions,and the influencing factors were studied by case-control study prime analysis.Results:There were 166 patients with liver injury among 22573 patients,the incidence was 0.74%.Correlation evaluation results:34 cases were likely,132 cases were possible;types of liver injury:75 cases of hepatocyte injury,80 cases of cholestasis type,11 cases of mixed type.Elderly,lower body mass index(BMI)patients had a higher rate of cholestatic liver injury.Multivariate Logistic regression analysis showed that the duration of medication was an influential factor for liver injury caused by cefoperazone sodium/sulbactan sodium.The proportion of patients with drug use≥5 d in the case group(83.73%)was significantly higher than that in the control group(61.18%)(P<0.001).Conclusion:The incidence of liver injury related to cefoperazone sodium/sulbactam sodium is rare.The elderly and low BMI patients may be more prone to cholestasis type liver injury,so we should focus on monitoring AKP related indicators and selecting appropriate liver protection drugs.In order to reduce the risk of adverse drug reaction,we should reasonably control the duration of medication and focus on the liver function of patients who have achieved 5 days of medication.