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

作　　者：石鑫[1] 刘维丽[1] 高欣欣 秦琦瑜[1] SHI Xin, LIU Wei - li, GAO Xin - xin, QIN Qi - yu(Department of Hepatobiliary Surgery, The First Hospital of Hebei Medical University, Shijiazhuang 050031, Chin)

机构地区：[1]河北医科大学第一医院肝胆微创外科,石家庄050031

出　　处：《中国临床药理学杂志》2018年第9期1029-1031,1038,共4页The Chinese Journal of Clinical Pharmacology

基　　金：河北省医学科学研究重点课题计划基金资助项目(20170476)

摘　　要：目的观察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(ADILI)的临床疗效及安全性。方法将154例抗肿瘤药所致ADILI患者随机分为对照组77例和试验组77例。对照组予以门冬氨酸鸟氨酸注射液每次10.0 g,qd,静脉滴注;试验组在对照组治疗的基础上,给予熊去氧胆酸胶囊每次250 mg,tid,餐后口服。2组患者均治疗2周。比较2组患者的临床疗效、肝功能、T淋巴细胞亚群水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为90.91%(70例/77例)和76.62%(59例/77例),差异有统计学意义(P<0.05)。治疗后,对照组和试验组的谷丙转氨酶分别为(39.96±4.53)和(31.14±4.21)U·L^(-1),谷草转氨酶分别为(26.94±3.07)和(19.84±2.38)U·L^(-1),总胆红素分别为(11.15±1.31)和(7.66±1.01)μmol·L^(-1),碱性磷酸酶分别为(95.53±12.14)和(80.06±9.67)U·L^(-1),CD3^+分别为(51.47±6.84)%和(62.18±7.36)%,CD4^+分别为(29.06±3.28)%和(36.88±5.24)%,CD8^+分别为(25.98±3.22)%和(21.13±2.57)%,差异均有统计学意义(均P<0.05)。2组患者发生的药物不良反应以腹泻、乏力、肝部不适、恶心呕吐为主,试验组和对照组的总药物不良反应发生率分别为16.88%和10.39%,差异无统计学意义(P>0.05)。结论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ADILI的临床疗效确切,其能有效地改善肝功能及免疫功能,且不增加药物不良反应的发生率。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 totaleffective 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 Ur

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 

分 类 号：R975.5[医药卫生—药品]