摘要
目的探索真实世界中使用灯盏细辛注射液对肝功能的影响。方法选取来源自全国20家大型三甲医院的医院信息系统（hospital information system,HIS）数据中使用灯盏细辛注射液者21498例作为暴露组,选取年龄在18~80岁之间,并且使用灯盏细辛注射液前后间隔≥7 d至少有2次肝功能检测的患者1641例,提取谷草转氨酶（AST）和谷丙转氨酶（ALT）指标,采用logistic回归、不带协变量的GBM倾向评分加权logistic回归以及带协变量的GBM倾向评分加权logistic回归3种方法对比分析混杂因素,研究灯盏细辛对ALT、AST的影响。结果上述3种统计学方法分析结果 P值均小于0.05,差异有统计学意义。结论基于现有的HIS数据,灯盏细辛注射液对ALT和AST可能有影响。
Objective To explore the effect of Dengzhan Xixin Injection（DXI） on liver function of patients during clinical application. Methods From the hospital information system（HIS） of 20 nationwide grade-three class-A hospitals,a total of 21498 cases medicated by DXI were chosen as the observation group. And then we analyzed the serum levels of alanine aminotransferase（ALT）and aspartate aminotransferase（AST）of 1641 cases from 21498 patients that aged 18 to 80 years and having liver function testing at least twice during time interval ≥7 days before and after DXI treatment. Classic logistic regression analysis, and weighted logistic regression analysis based on generalized boosted models（GBM）of propensity scoring with or without concomitant variable were used for evaluating the influence of DXI on ALT and AST. Results The results of the three methods showed that P value was over 0.05 and the difference was statistically significant. Conclusion The existing electronic medical data of HIS indicated that DXI may have an effect on ALT and AST.
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2015年第3期401-405,共5页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
2015国家"重大新药创制"科技重大专项(2015ZX09501004-001-002)
中药上市后临床再评价关键技术创新团队(PY1303)
中国中医科学院基本科研业务费第9批自主选题项目(20406)
关键词
灯盏细辛注射液
医院信息系统
谷丙转氨酶
谷草转氨酶
GBM倾向性评分
Dengzhan Xixin Injection Hospital information system Alanine aminotransferase Aspartate aminotransferase Propensity scoring
作者简介
李永秀，女，硕士研究生，研究方向：中西医结合肿瘤。Email：liyongxiu10@163．com。
通讯作者：谢雁鸣，博士，教授，中医药临床评价。Email：datamining5288@163．com。
