5066例药物性肝损伤严重程度的影响因素分析

目的:分析严重药物性肝损伤(DILI)的影响因素,为严重DILI的临床防治提供参考。方法:从山东省药品不良反应监测中心数据库中提取并筛选出2013年1月1日至2018年7月31日上报DILI案例,收集患者的社会人口学及临床特征,包括性别、年龄、体质量、民族、既往史、用药品种数、药品类别、给药途径、潜伏期、原患疾病等因素。采用单因素卡方检验和多因素非条件Logistic回归分析法分析DILI严重程度的影响因素。根据单因素分析结果选择有统计学意义的研究变量进入多因素Logistic回归分析。结果:从5530例上报案例中筛选出符合DILI诊断标准的5066例,其中严重的667例,一般的4399例。单因素分析显示,年龄、体质量、潜伏期、药物类别、原患疾病等是发生严重DILI的影响因素(P均<0.05);多因素Logistic分析结果显示,体质量、潜伏期、药物类别和原患疾病是发生严重DILI的影响因素(P均<0.05)。结论:患者的体质量、潜伏期、药物类别和原患疾病是发生严重DILI的影响因素。在临床诊治过程中需对存在严重DILI影响因素的患者开展重点监护和防控,保障其用药安全。

Influencing factors analysis of severity in 5 066 cases with drug-induced liver injury

OBJECTIVE To analyze the influencing factors of severe drug-induced liver injury (DILI), and to provide reference for the clinical prevention and treatment of severe DILI.METHODS The reported DILI cases from January 1, 2013 to July 31, 2018 were extracted and screened from the database of Shandong Center for ADR monitoring, and the sociodemographic and clinical characteristics of the patients, including gender, age, body mass, ethnicity, past history, number of drug varieties, drug class, route of administration, incubation period, primary disease and other factors, were collected.Univariate chi-square test and multivariate unconditional logistic regression analysis were used to analyze the influencing factors of DILI severity.Statistically significant study variables were selected into multivariate logistic regression analysis based on the results of univariate analysis.RESULTS From 5 530 reported cases, 5 066 met DILI diagnostic criteria, of which 667 were severe DILI and 4 399 were general DILI. Univariate analysis showed that age, weight, latency, drug category and primary disease were the influencing factors of severe DILI (P<0.05). Multivariate logistic analysis showed that weight, latency, drug category and primary disease were the influencing factors of severe DILI (P<0.05).CONCLUSION Weight, latency, drug category and primary disease were the influencing factors of severe DILI. The patient with these factors should be monitored intensively during clinical treatment, to ensure their medication safety.