基层医疗机构216例药物性肝损伤不良反应分析与对策

Analysis and intervention measures on 216 cases of drug-induced liver injury in primary medical institutions

目的:了解某市基层医疗机构药物性肝损伤(DILI)类药品不良反应的发生情况与规律,为临床合理用药提供参考。方法:采用回顾性分析方法,对该市2013年1月–2017年6月期间通过国家药品不良反应监测系统上报的DILI报告进行收集,共计216例,分别从患者性别、年龄、药品品种、给药途径、DILI发生的时间、临床表现等进行分析。结果:DILI病例无明显性别差异,≥40岁的中老年人发生居多(70.37%)。导致DILI的前三种药物分别为抗感染药(36.79%)、治疗精神障碍药(16.98%)和心血管系统药(16.35%)。发生DILI的时间因药物种类不同而异,多在8周内,最快在用药后6 d,最慢在用药后7个月余。经保肝、降酶、退黄等治疗后患者恢复良好,及时停药是治疗的关键。结论:临床应提升用药安全意识,开展DILI预防与控制工作,以保障患者用药安全。

Objective： To analyze the feature and regularity of drug-induced liver injury （DILI） in primary medical institutions in our city for promoting clinical rational drug use. Methods： A total of 216 patients with DILI reports in one city were collected by national drug adverse reaction monitoring system of China from January 2013 to June 2017, and were analyzed in respect of patients＇ gender, age, drug type, administration route, occurrence time of DILI and clinical manifestations, etc. Results： In these DILI cases, there was no signifcant difference in gender. The incidence of DILI was higher in middle age and elderly patients aged≥ 40 years （70.37%）. The main types of medicines associated with DILI were anti-infective agents （36.79%）, antipsychotic drugs （16.98%） and cardiovascular drugs （16.35%）. The occurrence time of DILI varied with different types of drugs. Most DILI cases occurred within 8 weeks after medication, the fastest case occurred on the sixth day after medication, and the slowest case occurred on the seventh months after medication. These patients recovered well by treatment with protecting liver, reducing enzyme and removing jaundice. The key for successful treatment was withdrawal DILI related drugs timely. Conclusion： Clinicians should raise the safety awareness of medication, carry out the work of preventing and controlling DILI, in order to ensure the safety of medication.Drug-induced liver injury （DILI）; Adverse drug reaction （ADR）; Rational drug use