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摘要：
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摘要：目的 分析药物性肝损伤（drug induced liver injury，DILI）合并自身免疫病患者的临
床特点。方法 以2014年12月至2018年12月首都医科大学附属北京地坛医院收治的肝功能
异常并经肝穿刺诊断为DILI的403例患者为研究对象。将入组患者根据肝组织病理结果分
为DILI组和DILI合并自身免疫病组，比较两组患者的人口学信息及实验室检查结果，包
括丙氨酸氨基转移酶（alanine aminotransferase，ALT）、天门冬氨酸氨基转移酶（aspartate
aminotansferase，AST）、国际标准化比值（international normalized ratio，INR）、凝血酶
原活动度（prothrombin time activity，PTA）、免疫球蛋白G（immunoglobulinsG，IgG）、
免疫球蛋白A（immunoglobulins A，IgA）等。比较两组患者6个月后DILI慢性化率。结
果 共入组403例患者，其中DILI组376例，DILI合并自身免疫病组27例，DILI合并自身免
疫病组中中年患者（45～59岁）占66.7%（18/27），女性占88.9%（24/27），黄疸患者占
77.8%（21/27），自身抗体阳性患者占74.1%（20/27）。DILI合并自身免疫病组患者年龄
[（52.3 ± 9.9）岁 vs（44.8 ± 13.2）岁；t = -3.71，P = 0.001]、女性患者比例 [88.9%（24/27）
vs 67.0%（252/376）；χ
2
= 5.581，P = 0.018] 及自身抗体阳性比例 [74.1%（20/27） vs
48.9%（184/376）；χ
2
= 6.368，P = 0.012] 均显著高于DILI组患者。DILI合并自身免疫
病组患者ALT（中位数：154.5 U/L vs 382.0 U/L；z = -2.197，P = 0.028）和PTA [（80.7 ±
27.9）% vs （89.8 ± 21.3）%；t = 2.098，P = 0.037] 水平显著低于DILI组患者；INR（中位
数：1.09 vs 1.03；z = -2.047，P = 0.041）、IgG（中位数：19.6 g/L vs 13.4 g/L；z = -3.595，
P ＜ 0.001）和IgA（中位数：3.01 g/L vs 2.47 g/L；z = -2.167，P = 0.03）水平显著高于DILI
组患者。DILI组与DILI合并自身免疫病组患者发生慢性化比例差异无统计学意义 [34.8%
（131/376） vs 33.3%（9/27）；χ
2
= 0.025，P = 0.874]。结论 DILI合并自身免疫病组患者
年龄更大，女性患者占比更高，IgG水平较高，但ALT水平较低。
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Abstract: Objective To analyze the clinical characteristics of drug-induced liver injury (DILI)
patients combined with autoimmune disease. Methods Total of 403 patients with abnormal liver
function and diagnosed by liver puncture as DILI in Beijing Ditan Hospital, Capital Medical
University from December 2014 to December 2018 were selected and divided into DILI group
and DILI with autoimmune disease group according to the results of liver biopsy. The clinical
characteristics including alanine aminotransferase (ALT), aspartate aminotansferase (AST),
international normalized ratio (INR), prothrombin time activity (PTA), immunoglobulins G (IgG)
and immunoglobulins A (IgA) were compared between patients in two groups. The rate of DILI
chronicity after 6 months was compared between the two groups. Results A total of 403 patients were
enrolled in the study, including 376 cases in DILI group and 27 cases in DILI with autoimmune disease
group. In DILI with autoimmune disease group, middle-aged patients (45～59 years old) accounted for
66.7% (18/27), women accounted for 88.9% (24/27), patients with jaundice accounted for 77.8% (21/27)
and patients with autoantibody positive accounted for 74.1% (20/27). The age [(52.3 ± 9.9) years old vs
(44.8 ± 13.2) years old; t = -3.71, P = 0.001], proportion of female [88.9% (24/27) vs 67.0% (252/376);
χ
2
= 5.581, P = 0.018] and positive rate of autoantibody [74.1% (20/27) vs 48.9% (184/376); χ
2
= 6.368,
P = 0.012] of patients in DILI with autoimmune disease group were significantly higher than those of
DILI group. ALT (median: 154.5 U/L vs 382.0 U/L; z = -2.197, P = 0.028) and PTA [(80.7 ± 27.9）%
vs (89.8 ± 21.3)%; t = 2.098, P = 0.037] levels of patients in DILI with autoimmune disease group
were significantly lower than those of DILI group, INR (median: 1.09 vs 1.03; z = -2.047, P = 0.041),
IgG (median: 19.6 g/L vs 13.4 g/L; z = -3.595, P ＜ 0.001) and IgA (median: 3.01 g/L vs 2.47 g/L;
z = -2.167, P = 0.03) levels were significantly higher. There was no difference in the rate of chronicity
between patients in DILI group and DILI with autoimmune disease group [34.8% (131/376) vs 33.3%
(9/27); χ
2
= 0.025, P = 0.874]. Conclusions Patients in DILI with autoimmune disease group were
older, with higher proportion of female and IgG level, and lower ALT level.
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