运用倾向评分法研究真实世界参芪扶正注射液对门冬氨酸氨基转移酶的影响

Research on the Effect of Shenqi Fuzheng Injection on Aspartate Aminotransferase in Real World:With Propensity Score Analysis

目的运用倾向评分法分析真实世界中参芪扶正注射液对门冬氨酸氨基转移酶（AST）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,将使用参芪扶正注射患者作为观察组;将使用1种功效类似的中药注射剂患者作为对照组。运用广义增强模型（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,分析参芪扶正注射液对AST水平的影响。结果平衡57个混杂因素后,数据显示使用参芪扶正注射液比使用1种功效类似的中药注射剂导致AST发生异常变化的可能性要小,但差异无统计学意义。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,使用参芪扶正注射液对AST指标异常变化的影响不显著。

Objective To study the effect of Shenqi Fuzheng Injection（ 参芪扶正注射液,SFI） on aspartate aminotransferase（ AST） in real world with propensity score analysis.Methods Patients aged 18 to 80 years and injected with SFI were selected as the observation group according to Hospital Information System（ HIS） in 20 hospitals.Patients used other traditional Chinese medicine injections with similar efficacy were chosen as the control group.The bias of confounding factors was balanced with propensity score analysis.The effect of SFI on AST level was analyzed with Logistic regression.Results The abnormality of AST was small in the observation group as compared with the control group after balancing 57 confounding factors,but with no significant difference between groups.Sensitivity analysis was not sensitive to the potential bias.There was no unobserved variable in this study.Conclusion The effect of SFI Injection on the abnormality of AST is not significant according to HIS data and research.