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异甘草酸镁治疗自身免疫样药物性肝损伤的效果和安全性
Clinical effect and safety of magnesium isoglycyrrhizinate in treatment of autoimmune-like drug-induced liver injury
文章发布日期:2020年06月13日  来源:  作者:杜晓菲,陈杰,黄春洋,等  点击次数:184次  下载次数:45次

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【摘要】:目的 探索异甘草酸镁治疗自身免疫样药物性肝损伤的临床疗效和安全性。方法 选取首都医科大学附属北京佑安医院2016年7月-2019年1月住院的自身免疫样药物性肝损伤患者 53例为观察组,另选不伴有自身免疫现象的药物性肝损伤患者50例为对照组。所有患者给予异甘草酸镁200 mg/d,治疗4周。观察治疗前后患者肝功能情况,观察治疗前后观察组患者的免疫学指标,记录两组患者的不良反应。治疗结束后每月随访肝功能,随访时间6个月。正态分布计量资料组间比较采用t检验,非正态分布的计量资料采用Mann-Whitney U检验,计数资料组间比较采用χ2检验或Fisher精确概率检验。结果 观察组治疗后与治疗前比较,ALT[35.4(29.2~42.0)U/L vs 289.0(226.6~460.3)U/L, Z=-8.661,P<0.001]、AST[46.3(15.6~183.5) U/L vs 306.3(32.2~589.8) U/L,Z=-5.271, P<0.001]、GGT[77.0(53.2~183.2) U/L vs 129.0(77.8~232.5)U/L,Z=-3.437, P=0.001)]、ALP[83.1(64.9~83.1U/L vs 119.4(104.9~146.9)U/L, Z=-3.485, P<0.001]和TBil[(27.5±10.3)μmol/L vs (59.7±18.6)μmol/L, t=6. 673, P<0.001]水平均明显降低;对照组患者治疗后与治疗前比较,ALT[33.1(14.9~106.4)U/L vs 300.6(206.8~679.5)U/L, Z=-8.232, P<0.001]、AST[44.1(20.8~151.6)U/L vs 321.7(36.2~553.2)U/L,Z=-3.549, P<0.001]、GGT[82.7(50.6~168.5)U/L vs 133.5(72.2~254.2)U/L,Z=-2.364, P=0.018]、ALP[87.6(74.3~139.4)U/L vs 128.0(106.3~201.4)U/L, Z=-4.303, P<0.001]和TBil[(23.8±10.9)μmol/L vs (58.3±19.8)μmol/L, t=-8.450, P<0.001]水平也明显降低。但治疗后两组间比较差异均无统计学意义(P值均>0.05)。治疗后观察组患者IgG水平由(15.8±3.2)g/L降至(14.2±2.0)g/L,治疗前IgG水平升高(>16 g/L)患者22例中18例(81.8%)恢复正常。36例ANA阳性患者19例(52.7%)阴转。两组患者均无严重不良反应。行肝穿病理检查患者中,观察组患者中性粒细胞和(或)嗜酸性粒细胞浸润(17/32,53.1%)明显高于对照组(3/17,17.5%)(χ2=5.785,P=0.016)。结论 异甘草酸镁用于治疗自身免疫样药物性肝损伤安全有效,是临床治疗的可选择方案。
【Abstract】:Objective To investigate the clinical effect and safety of magnesium isoglycyrrhizinate in the treatment of autoimmune-like drug-induced liver injury. Methods A total of 53 patients with autoimmune-like drug-induced liver injury who were hospitalized in Beijing YouAn Hospital, Capital Medical University, from July 2016 to January 2019 was enrolled as observation group, and 50 patients with drug-induced liver injury who had no autoimmune symptoms were enrolled as control group. All patients were given magnesium isoglycyrrhizinate (200 mg/d) for 4 weeks. Liver function and immunological indices were observed before and after treatment, and adverse reactions were recorded for all patients. Liver function was followed up every month for 6 months after treatment. The t-test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups. Results After treatment, the observation group had significant reductions in alanine aminotransferase (ALT) [35.4 (29.2-42.0) U/L vs 289.0 (226.6-460.3) U/L, Z=-8.661, P<0.001], aspartate aminotransferase (AST) [46.3 (15.6-183.5) U/L vs 306.3 (32.2-589.8) U/L, Z=-5.271, P<0.001], gamma-glutamyl transpeptidase (GGT) [77.0 (53.2-183.2) U/L vs 129.0 (77.8-232.5) U/L, Z=-3.437, P=0.001], alkaline phosphatase (ALP) [83.1 (64.9-83.1) U/L vs 119.4 (104.9-146.9) U/L, Z=-3.485, P<0.001], and total bilirubin (TBil) (27.5±10.3 μmol/L vs 59.7±18.6 μmol/L, t=6.673, P<0.001), and the control group also had significant reductions in ALT [33.1 (14.9-106.4) U/L vs 300.6 (206.8-679.5) U/L, Z=-8.232, P<0.001], AST [44.1 (20.8-151.6) U/L vs 321.7 (36.2-553.2) U/L, Z=-3.549, P<0.001], GGT [82.7 (50.6-168.5) U/L vs 133.5 (72.2-254.2) U/L, Z=-2.364, P=0.018], ALP [87.6 (74.3-139.4) U/L vs 128.0 (106.3-201.4) U/L, Z=-4.303, P<0.001], and TBil (23.8±10.9 μmol/L vs 58.3±19.8 μmol/L, t=-8.450, P<0.001); however, there were no significant differences between the two groups after treatment (P>0.05). For the observation group, the level of IgG decreased from 15.8±3.2 g/L before treatment to 14.2±2.0 g/L after treatment, and among the 22 patients with elevated IgG (>16 g/L) before treatment, 18 (81.8%) had an IgG level back to normal. Among the 36 patients with positive anti-nuclear antibody, 19 (52.7%) achieved negative conversion. No serious adverse reaction was observed in the two groups. In terms of the patients who underwent liver biopsy, the observation group had a significantly higher proportion of patients with neutrophil and/or eosinophil infiltration than the control group [53.1% (17/32) vs 17.5% (3/17), χ2=5.785, P=0.016]. Conclusion Magnesium glycyrrhizinate is safe and effective in the treatment of autoimmune-like drug-induced liver injury and can thus be selected as an alternative treatment method in clinical practice.
【关键字】:化学性与药物性肝损伤; 自身免疫疾病; 治疗学; 异甘草酸镁
【Key words】:chemical and drug induced liver injury; autoimmune diseases; therapeutics; magnesium isoglycyrrhizinate
【引证本文】:DU XF, CHEN J, HUANG CY, et al. Clinical effect and safety of magnesium isoglycyrrhizinate in treatment and safety of autoimmune-like drug-induced liver injury[J]. J Clin Hepatol, 2020, 36(6): 1330-1333. (in Chinese)
杜晓菲, 陈杰, 黄春洋, 等. 异甘草酸镁治疗自身免疫样药物性肝损伤的效果和安全性[J]. 临床肝胆病杂志, 2020, 36(6): 1330-1333.

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