摘要
为了解真实世界中舒血宁注射液对肝功能的影响,选取来源于全国20家大型三甲医院的医院信息系统(hospital information system,HIS)中使用舒血宁注射液的患者信息(5 353例)作为暴露组,与未使用舒血宁注射液的患者信息(4 683例)作为非暴露组进行对比研究,以谷丙转氨酶(alanine aminotransferase,ALT)、谷草转氨酶(aspartate aminotransferase,AST)是否发生异常变化作为结局指标,采用分层分析、经典logistic回归分析分析、GBM倾向评分加权的logistic回归,以及generalized boosted models(GBM)倾向评分加权结合协变量调整的logistic回归对混杂因素进行控制后,分析舒血宁注射液对肝功能的影响。通过对舒血宁注射液对ALT分析发现,倾向评分前经典logistic回归分析中回归系数-0.232(P=0.017),倾向评分后回归系数-0.150(P=0.370);对AST异常变化影响分析中,倾向评分前经典logistic回归分析中回归系数-0.034(P=0.767),倾向评分后回归系数-0.091(P=0.538)。由于倾向评分对大量混杂进行了控制,其结果更接近临床,因此基于现有的电子医疗数据,未发现使用舒血宁注射液对ALT及AST有影响。
To assess whether the Shuxuening injection influences liver function,this paper analyzes the hospital information system（HlS） data from 20 national hospitals.The patients were divided two groups：patients（5 353 cases） using Shuxuening injection acted as the exposed group,then the patients（4 863 cases） not using Shuxuening injection acted as the unexposed group.Take the abnormal changes of alanine aminotransferase and aspartate aminotransferase indexes as the result.Control confounding factors by stratification analysis,classic logistic regression analysis,before logistic regression based on propensity score weighting method and logistic regression based on generalized boosted models（GBM） of propensity score weighted combination of covariate adjustment.Then,the study analyzes the effects of Shuxuening injection on liver function by observing the changes of the indexes.Analysis of the impact of parenterally administered Shuxuening on ALT shows that,before logistic regression based on propensity score,then the regression is- 0.232（P value is 0.017）.However,after logistic regression based on propensity score method the regression became-0.150（P value is0.370）.Whereas,analysis of the impact of parenterally administered Shuxuening on AST shows that,before logistic regression based on propensity score,then the regression is-0.034（P value is 0.767）.However,after logistic regression based on propensity score method the regression became- 0.091（P value is 0.538）.Thus,propensity score method can control a large number of confounding factors,making the results more close to the clinic.Hence,based on existing electronic medical data,this study didn＇t find that parenterally administered Shuexuening influences ALT and AST.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2014年第18期3609-3615,共7页
China Journal of Chinese Materia Medica
基金
国家"重大新药创制"科技重大专项(2015ZX09501004-001-002)
中国中医科学院基本科研业务费自主选题项目(ZZ0808016)
中国中医科学院博士研究生创新人才培养基金项目
关键词
舒血宁注射液
谷丙转氨酶
谷草转氨酶
电子医疗数据
倾向性评分
队列研究
Shuxuening injection
alanine aminotransferase
aspartate aminotransferase
electronic medical data
propensity score
cohort study
