消核片相关肝损害的国内文献回顾与分析  

Liver damage related to Xiaohe tablets: domestic literature review and analysis

作　　者：童元元[1] 张力[2] 杨金生 杨晓晖[4] 孙震晓[5] 

机构地区：[1]中国中医科学院中医药信息研究所,北京100700 [2]国家食品药品监督管理局药品评价中心,北京100045 [3]中国中医学科学院,北京100700 [4]北京中医药大学东方医院,北京100078 [5]北京中医药大学中药学院,北京100102

出　　处：《药物不良反应杂志》2010年第3期175-177,共3页Adverse Drug Reactions Journal

摘　　要：目的:调查消核片相关肝损害的临床特点及发生原因,为临床合理用药提供参考。方法:以"消核片"为检索词,检索《CHKD期刊全文数据库》(1994-2009),《中国生物医学文献数据库(CBM)》(1978-2009),收集分析消核片相关肝损害的病例报告。结果:共收集到194例,均为女性患者,年龄17～55岁。68例标明用药剂量,2～7片/次,3次/d,用药时间为14～180d。患者用药50d左右出现恶心、腹胀等消化道症状;用药30～141d出现皮肤、巩膜黄染;生化检查示:丙氨酸转氨酶(ALT)68～1700U/L;天冬氨酸转氨酶(AST)40～1260U/L;总胆红素(TBil)8.0～795.4μmol/L;直接胆红素(DBil)2.3～391.8μmol/L。194例中有10例行肝组织病理检查,呈不同程度的肝细胞肿胀、胞质疏松、气球样变及肝细胞坏死。大多数患者在停药后10d至4个月内逐渐恢复正常,其中190例(97.9%)临床痊愈,3例(1.5%)好转,1例(0.5%)急性肝衰竭患者死于感染性休克。结论:消核片可引起肝损害,多为可逆性;其发生可能与用药剂量及疗程有关;肝病患者应避免使用该药;用药过程中应密切监测肝功能。Objective： To investigate the clinical characteristics and causes of liver damage related to Xiaohe tablets in order to provide reference for clinical rational drug use. Methods： ＂ Xiaohe tablets＂ were selected as the search words and the China Hospital Knowledge Database （ CHKD,1994-2009） and Chinese Biomedical Literature Database （ CBM,1978-2009） were searched. The case reports of liver damage associated with Xiaohe tablets were collected and analysed. Results： A total of 194 patients were collected. All patients were women with age of 17 to 55 years. Of them,68 were indicated the dosage of 2-7 pills thrice daily. The duration of drug use was 14-180 d. The patients presented with gastrointestinal symptoms such as nausea,abdominal distension after about 50 days of therapy and yellowish skin and sclera after 30-140 days of therapy. Biochemical test results were as follows： ALT 68-1 700U/L,AST 40-1 260 U/L,TBil 8. 0-795. 4 μmol/L,DBil 2. 3-391. 8 μmol/L. Of 194 patients,10 underwent pathological examination of liver tissue,showing hepatocyte swelling,scanty cytoplasm,ballooning degeneration,and hepatocyte necrosis. Most patients restored gradually 10 days to 4 months after drug discontinuation. Of them,190 （ 97. 9% ） were clinical cure,3 （ 1. 5% ） improved,and 1 （ 0. 5% ） with acute liver failure died of septic shock. Conclusion： Xiaohe tablets can induce liver damage,and most of them are reversible; the liver damage may be related to dosage and duration of drug therapy; the drug should be avoided to use for patients having liver disease; and the patients’liver function should be closely monitored during the drug use.

关 键 词：消核片 肝损害 文献回顾与分析 

分 类 号：R595.3[医药卫生—内科学]