基于GBM倾向评分法对疏血通注射液导致谷丙转氨酶异常变化的影响分析

Impact analysis of Shuxuetong injection on abnormal changes of ALT based on generalized boosted models propensity score weighting

该文通过估计使用疏血通注射液对肝功能指标谷丙转氨酶(ALT)异常变化的处理效应,探讨临床真实世界中使用疏血通注射液是否可能对人体的肝功能有损害,为疏血通注射液安全应用于临床提供指导。根据选取的全国18家大型三甲医院信息管理系统(hospital information system,HIS)中的中药注射剂临床使用信息,该文采用回顾性研究,以ALT异常变化为结局指标,基于generalized boosted models(GBM)倾向评分加权法,平衡大量混杂因素的偏倚,利用多元Logistic回归估计使用疏血通注射液对ALT指标异常变化的处理效应,并探讨导致ALT指标异常变化的可能影响因素。该研究以疏血通注射液为实例,阐述GBM倾向评分加权法的优势及应用过程,并利用其估计消除了大多数混杂变量在组间的差异,并本质上修改了使用疏血通注射液对ALT指标异常变化的处理效应估计,使结果更加贴近临床真实情况。研究结果显示基于HIS数据库的大样本临床观察性数据,使用疏血通注射液对ALT的异常变化没有显著影响。

Objective： To estimate treatment effects of Shuxuetong injection on abnormal changes on ALT index, that is, to ex- plore whether the Shuxuetong injection harms liver function in clinical settings and to provide clinical guidance for its safe application. Method： Clinical information of traditional Chinese medicine（TCM） injections is gathered from hospital information system （HIS） of eighteen general hospitals. This is a retrospective cohort study, using abnormal changes in ALT index as an outcome. A large number of confounding biases are taken into account through the generalized boosted models （GBM） and multiple logistic regression model （MLRM） to estimate the treatment effects of Shuxuetong injections on abnormal changes in ALT index and to explore possible influen- cing factors. Result： The advantages and process of application of GBM has been demonstrated with examples which eliminate the bia- ses from most confounding variables between groups. This serves to modify the estimation of treatment effects of Shuxuetong injection on ALT index making the results more reliable. Conclusion： Based on large scale clinical observational data from HIS database, signifi- cant effects of Shuxuetong injection on abnormal changes in ALT have not been found.