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目的:运用倾向评分法分析真实世界中不同疗程使用参芪扶正注射液(以下简称参芪扶正)对谷丙转氨酶(alanine transaminase,ALT)和谷草转氨酶(aspartate amino transferase,AST)水平的影响。方法:基于全国18家医院的HIS(hospital information system,HIS)数据,选取年龄在18~80岁的患者,根据患者2次理化指标测定期间内的参芪扶正注射液用药时间是否>21 d,分为观察组和对照组。运用列联分析和广义增强模型(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回归估计结果是否具有统计学意义。结果:分析结果均显示观察组和对照组的ALT和AST异常变化无显著差异。结论:基于现有的HIS数据和研究方法认为,不同疗程使用参芪扶正对肝功能指标异常变化的影响不显著。该研究为回顾性研究,其临床安全性有待进一步的前瞻性、大样本的临床研究验证。
OBJECTIVE: To analyze the effects of Shenqi Fuzheng injection (ALD) on the levels of alanine transaminase (ALT) and aspartate amino transferase (AST) in different courses of the real world by propensity score method. Methods: Based on the data of HIS (hospital information system, HIS) from 18 hospitals across the country, patients aged 18 to 80 years were selected. According to the two physicochemical indexes of patients, the time of Shenqi Fuzheng injection was> 21 days, Divided into observation group and control group. Using the tandem analysis and generalized boosted models (GBM) propensity score weighting method, the bias of a large number of confounders was balanced and multivariate logistic regression was used to estimate whether the results were statistically significant. Results: The results of the analysis showed that there was no significant difference between the observation group and the control group in the abnormal changes of ALT and AST. Conclusion: Based on the existing HIS data and research methods, it is concluded that the use of Shenqi Fuzheng in different courses has no significant effect on the abnormal changes of liver function indexes. The study is a retrospective study, its clinical safety to be further prospective, large sample of clinical studies to verify.