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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 understand the clinical features of drug-induced liver injury caused by anti-TB drugs and explore possible causes. Methods The retrospective data of patients admitted to Shanghai Public Health Clinical Center receiving anti-TB drug in 2016 were retrospectively collected. Analysis of its demographics, treatment options, biochemical indicators and other data. T-test (normal distribution), Mann-Whitney (non-normal distribution) and Fisher’s exact test (non-numerical) were used to compare between groups. Logistic regression was used to analyze the relevant factors. Results After screening, a total of 48 cases were included in this study, including 18 cases of drug-induced liver injury and 30 cases of control group. The average age was (36.65 ± 21.62) years old, the ratio of male to female was 2:1.5.56% (1/18), the rate of hepatocellular injury was 22.22% (4/18), mixed type was 72.22% (13/18) Cholestasis type. Patients with severe liver injury (grade 3 and above) accounted for 50.00% (9/18). The anti-TB regimen based on a combination of “isoniazid + ethambutol” had a higher adoption rate (16.67% vs.0, P = 0.05). Multivariate logistic regression analysis showed that age and sex were the related factors of drug-induced liver injury (OR = 50.04, 95% confidence interval 1.35-1852.83, P = 0.03; OR = 128.36, 95% confidence interval 1.33-12 347.14, P = 0.04). Increased baseline IgG levels in peripheral blood may also increase the risk of drug-induced liver injury (OR = 26.38, 95% confidence interval 0.99 to 706.25, P = 0.05). Conclusions Age and sex are the related factors of drug-induced liver injury. The risk of drug-induced liver injury may increase with the increase of peripheral blood IgG levels.