基于文献挖掘的中成药致肝损害临床预警分析  

Clinical Early Warning Analysis of Liver Damage Caused by Chinese Patent Medicine based on Literature Mining

作　　者：杨亚蕾[1,2] 李瑞颖 李春晓 YANG Ya-lei;LI Rui-ying;LI Chun-xiao(The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Henan Province Engineering Laboratory for Clinical Evaluation Technology of Traditional Chinese Medicine,Henan Provincial Key Laboratory of Clinical Pharmacy of Traditional Chinese Medicine,Zhengzhou 450000,China;Provincial and Ministerial Construction Collaborative Innovation Center for Prevention and Treatment of Respiratory Diseases with Traditional Chinese Medicine,Zhengzhou 450000,China;Xuchang Hospital of Traditional Chinese Medicine,Xuchang 461000,China)

机构地区：[1]河南中医药大学第一附属医院,中药临床评价技术河南省工程实验室,河南省中药临床药学中医药重点实验室,郑州450000 [2]呼吸疾病中医药防治省部共建协同创新中心,郑州450000 [3]许昌中医院,许昌461000

出　　处：《中国合理用药探索》2022年第4期92-97,共6页Chinese Journal of Rational Drug Use

基　　金：重大新药创制专项子课题子任务(2015ZX09501004-001-007);河南省科技攻关项目(202102310182);河南中医药科学研究专项(2016ZY1006);河南省中医药拔尖人才培养项目{豫卫中医函[2021]15号}。

摘　　要：目的:通过统计分析中成药致药物性肝损害(DILI)文献数据,总结可导致DILI的中成药种类、患者情况、临床类型及表现、发生时间、转归时间,并进行综合研究分析,为临床合理使用中成药提供依据。方法:以“中成药致肝损害/药物性肝病/药物性肝炎”“转氨酶”“肝功异常”“不良反应”为主题词或关键词,在中国知网(CNKI)等6个数据库中模糊检索1994年1月~2021年2月期间收录的所有期刊文献,统计文献中记载引起DILI的中成药种类、患者情况、临床类型及表现、发生时间、转归时间。结果:本次检索筛选相关文献173篇,其中综合案例报道110篇,个案报道63篇,累计收集案例15130例。致DILI的中成药涉及16类、73个品种,其中使用壮骨关节丸者最多(1866例,19.37%);女性(6435例,56.44%)、60岁及以上患者(2990例,26.22%)更易发生不良反应;发病时间大多在用药后10~19天内(14例,20.59%);肝损害类型以肝细胞损害为主(10042例,66.37%);主要临床表现为乏力(4311例次,19.54%);转归时间多数在1个月以内(713例,36.16%)。结论:医生和临床中药师应加强对可能致肝毒性中成药品种的关注,并引导患者重视用药期间的异常情况,定期复查肝功能,重点关注特殊人群用药情况,使中成药在发挥疗效的同时尽可能减少对患者的肝损害。Objective:Through statistical analysis of literature data on liver damage caused by Chinese patent medicines,the types of Chinese patent medicines causing DILI,patient conditions,clinical types and manifestations,occurrence time,and outcome time were summarized,and comprehensive research and analysis was conducted so as to provide evidence for the rational use of Chinese patent medicine in clinic.Methods:Taking“liver damage caused by Chinese patent medicine/drug-induced liver disease/drug-induced hepatitis”,“transaminase”,“abnormal liver function”and“adverse reaction”as the subject words or keywords,all journal literatures collected from January 1994 to February 2021 were vaguely searched in six databases such as CNKI.The statistical literature recorded the types of Chinese patent medicine causing DILI,patient conditions,clinical types and manifestations,occurrence time and return time.Results:173 relevant literatures were screened,including 110 comprehensive case reports,63 case reports,and a total of 15130 cases.The Chinese patent medicine causing DILI involved 16 categories and 73 varieties,of which Zhuangguguanjie pill is the most used(1866 cases,19.37%);women(6435 cases,56.44%)and patients aged 60 and older(2990 cases,26.22%)were more prone to adverse reactions.The onset time of liver damage caused by Chinese patent medicine was 10~19 days(14 cases,20.59%).The main type of liver damage was hepatocyte damage(10042 cases,66.37%).The main clinical manifestation was fatigue(4311 cases,19.54%).The time of prognosis was mostly within one month(713 cases,36.16%).Conclusion:Doctors and Chinese pharmacists should pay more attention to the varieties of Chinese patent medicines related to hepatotoxicity,guide patients to pay attention to the abnormalities during medication,timely and regularly recheck liver function,and focus on the medication of special groups,so that Chinese patent medicines can exert their curative effect and reduce the liver damage to patients as much as possible.

关 键 词：中成药 肝损害 文献研究 临床预警 转氨酶 

分 类 号：R575[医药卫生—消化系统]