目的:运用倾向评分法分析参芪扶正注射液(以下简称SQFZ)对谷丙转氨酶(alaninetransaminase,ALT)水平的影响。方法:基于全国20家医院的医院信息系统(HIS)数据,选取年龄在18—80岁之间的患者,按使用SQFZ或者使用1种功效类似的中药注射剂(以下简称DZY)的病例分为观察组(51898例)和对照组(56232例),运用广义增强模型(generalizedboostedmodels,GBM)倾向评分加权法,平衡大量混杂因素的偏倚,利用多re,Logistic回归估计结果是否具有统计学意义,采用敏感分析是否存在潜在偏倚,得出真实世界中SQFZ对ALTT~平的影响。结果:平衡57个混杂因素后,数据显示使用SQFZL~使用DZY导致ALT发生异常变化的可能性要小,无统计学差异。敏感性分析对潜在偏倚不敏感,认为本研究可能不存在没有观测到的变量。结论:基于现有的HIS数据和研究方法认为,使用SQFZ对ALT指标异常变化的影响不显著。
Objectives: To explore the effect of Shenqi Fuzheng injection (SQF-Z) on Alanine transaminase (ALT) level of real worlds by propensity score methods. Methods: Based on the HIS data from 20 hospitals, patients ranging from 18 to 80 years were divided into treatment group (51 898 cases) and control group (56 232 cases). The treatment group was given SQFZ, the control group received other similar efficacy of Chinese medicine injection (DZY). A large number of confounding biases were taken into account through the Generalized Boosted Models (GBM) and Multiple Logistic Regression Model to estimate the treatment effects of SQFZ on abnormal changes in ALT index and to explore the possible influencing factors. Results: 57 confounding factors had been counterpoised, stratified analysis showed that the abnormal changes of treatment group were lower than that of control group, but without statistically significant. Sensitivity analysis showed that the variables not yet been observed in this study may not exist. Conclusion: Analysis of HIS database shows that the significant effects of SQFZ on abnormal changes in ALT had not been found.