中国临床药理学杂志2018，Vol.34Issue(9)：1029-1031,1038,4.DOI:10.13699/j.cnki.1001-6821.2018.09.006
熊去氧胆酸胶囊联合门冬氨酸鸟氨酸注射液治疗抗肿瘤药所致急性药物性肝损伤的临床研究
Clinical trial of ursodeoxycholic acid capsules combined with ornithine aspartate injection in the treatment of acute drug-induced liver injury caused by antineoplastic agents
摘要
Abstract
Objective To observe the clinical efficacy and safety of ursodeoxycholic acid capsules combined with ornithine aspartate injection in the treatment of acute drug-induced liver injury (ADILI) caused by antineoplastic agents.Methods One hundred and fifty-four patients with ADILI caused by antineoplastic agents were randomly divided into control and treatment groups with 77 cases per group.Control group was treated with ornithine aspartate injection 10.0 g each group,qd,intravenous drip.Treatment group was treated with ursodeoxycholic acid capsules 250 mg each time,tid,postprandial oral,on the basis of control group.Two groups were treated for 2 weeks.The clinical efficacy,liver functions,levels of T lymphocyte subsets and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates in treatment and control groups were 90.91％ (70 cases/77 cases) and 76.62％ (59 cases/77 cases) with statistical difference (P ＜ 0.05).After treatment,the main indexes in control and treatment groups were compared,the levels of alanine aminotransferase were (39.96 ± 4.53) and (31.14 ± 4.21)U · L-1,the levels of aspartate aminotransferase were (26.94 ± 3.07) and (19.84 ± 2.38) U · L-1,the levels of total bilirubin were (11.15 ± 1.31) and (7.66 ± 1.01) μmol · L-1,the levels of alkaline phosphatase were (95.53 ± 12.14) and (80.06 ± 9.67) U · L-1,the levels of CD3 ± were (51.47 ± 6.84) ％ and (62.18 ± 7.36) ％,the levels of CD4 ±were (29.06 ±3.28)％ and(36.88 ±5.24)％,the levels of CD8± were (25.98 ±3.22)％ and(21.13 ±2.57)％,the differences were statistically significant (all P ＜ 0.05).The adverse drug reactions of two groups were based on diarrhea,fatigue,liver discomfort,nausea and vomiting,the total incidences of adverse drug reactions in treatment and control groups were 16.88％ and 10.39％ without significant difference (P ＞ 0.05).Conclusion Ursodeoxycholic acid capsules combined with ornithine aspartate injection have a definitive clinical efficacy in the treatment of ADILI caused by antineoplastic agents,which can significantly improve the liver functions and immunologic functions,without increasing the incidences of adverse drug reactions.关键词
熊去氧胆酸胶囊/门冬氨酸鸟氨酸注射液/急性药物性肝损伤/安全性Key words
ursodeoxycholic acid capsule/ornithine aspartate tablet/acute drug-induced liver injury/safety分类
医药卫生引用本文复制引用
石鑫,刘维丽,高欣欣,秦琦瑜..熊去氧胆酸胶囊联合门冬氨酸鸟氨酸注射液治疗抗肿瘤药所致急性药物性肝损伤的临床研究[J].中国临床药理学杂志,2018,34(9):1029-1031,1038,4.基金项目
河北省医学科学研究重点课题计划基金资助项目(20170476) （20170476）
