抗结核药物引起肝损伤的临床特点及相关因素

Clinical characteristics and correlative factors of drug-induced liver injury caused by anti-tuberculosis drugs

目的了解抗结核药物引起药物性肝损伤的临床特征,探寻可能的诱因。方法回顾性收集2016年收治于上海市公共卫生临床中心接受抗结核药物治疗患者的资料。分析其人口学、治疗方案、生化指标等数据。组间比较运用t检验(正态分布)、Mann-Whitney法(非正态分布)和Fisher精确检验(非数值型),相关因素分析用logistic回归。结果筛选后共48例纳入本研究,其中药物性肝损伤组18例,对照组30例。平均年龄(36.65±21.62)岁,男女比例为2∶1。5.56%(1/18)病例为肝细胞损伤型,22.22%(4/18)病例为混合型,72.22%(13/18)病例为胆汁淤积型。重度肝损伤(严重程度3级及以上)患者占50.00%(9/18)。以"异烟肼+乙胺丁醇"组合为基础的抗结核药物方案采用率较高(16.67%vs.0,P=0.05)。多因素logistic回归分析提示,年龄及性别是药物性肝损伤发生的相关因素(OR=50.04,95%可信区间1.35~1 852.83,P=0.03;OR=128.36,95%可信区间1.33~12 347.14,P=0.04)。外周血基线IgG水平升高者药物性肝损伤发生的风险亦可能升高(OR=26.38,95%可信区间0.99~706.25,P=0.05)。结论年龄及性别是药物性肝损伤发生的相关因素,外周血IgG水平升高者药物性肝损伤发生的风险亦可能升高。

Objective To ascertain the clinical characteristics and correlative factors of drug- induced liver injury caused by anti-tuberculosis drugs and explore the possible causes. Methods A retrospective review was made on anti -tuberculosis drug -induced liver injury treated in Shanghai Public Health Clinical Center during 2016, focusing on demographic information, clinical data, and laboratory data. Comparisons among groups were made with t-test, Mann-Whitney test, and Fisher＇s exact test. Risk factors were analyzed with multivariate logistic regression. Results Forty-eight patients were enrolled in the study, including eighteen drug-induced liver injury （DILI ） cases and thirty controlled cases, who received anti-tuberculosis treatment . The average onset age was （36.65± 21.62 ） years old. Among eighteen DILI cases, 72.22% were cholestatic, 5.56% hepatocellular injury, and the rest were the mixed type. Half of the DILI cases were severe ones . There were more INH ＋ EMB combinations in DILI groups （ 16.67% vs 0, P = 0.05 ）. Multivariate logistic regression showed that age and gender were correlative factors of DILI（ OR = 50.04, 95 % CI： 1.35 - 1 852. 83, P = 0.03 ; OR = 128.36,95 % 可信区间1.33 12 347. 14, P = 0. 04} and those with higher baseline IgG level were more likely to have DILI （ OR = 26.38, 95% CI：O. 99 - 706. 25, P = 0.05 ）. Conclusion Age and gender were correlative factors of DILI and baseline IgG level probably was a correlative factor.