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目的:了解真实世界中参附注射液对肝功能的影响。方法:以全国18家三甲医院中使用参附注射液的医院信息系统数据为研究对象,选取18~80岁的患者数据,分为暴露组(使用参附组)、非暴露组(未使用参附组),以谷丙转氨酶(ALT)和谷草转氨酶(AST)作为结局指标,运用经典logistic回归、GBM倾向性评分加权logistic回归、带协变量调整的GBM倾向性评分加权logistic回归3种方法分析数据。结果:以ALT为指标时,3种方法均P>0.05,从统计学角度可以认为:使用参附注射液对ALT指标异常变化无显著性影响;以AST为指标时,方法1得到的P>0.05,而方法2和方法3得到的均P<0.05,因此,从统计学角度可以认为:参附注射液对AST指标的异常变化有显著性影响。结论:基于现有数据和分析方法,发现使用参附注射液可能造成患者AST的异常变化。临床用药时,需严格遵照说明书规定的用法用量,若用于老年人、儿童、病情危重、肝功能异常的患者时,更应结合患者实际情况,谨慎用药。
Objective: To understand the impact of Shenfu injection in the real world on liver function. Methods: The data of hospital information system using Shenfu injection in 18 top three hospitals in China were selected as the research object. The data of 18 ~ 80 years old patients were selected and divided into exposure group (using Shenfu group), non-exposed group (ALT) and aspartate aminotransferase (AST) were used as the outcome measures. The three methods of classic logistic regression, GBM propensity score weighted logistic regression, covariate adjusted GBM propensity score weighted logistic regression data. Results: ALT as an indicator, the three methods were P> 0.05, from a statistical point of view can be considered: the use of Shenfu injection on ALT abnormalities did not change significantly; AST as an indicator, the method of 1 P> 0.05, while the mean values of P <0.05 obtained by Tier 2 and Tier 3, therefore, from the statistical point of view, we can conclude that Shenfu Injection has a significant effect on the abnormal changes of AST. CONCLUSIONS: Based on available data and analysis methods, it was found that the use of Shenfu Injection may cause abnormal changes in patients with AST. Clinical medication, the need to strictly follow the instructions prescribed dosage, if used for the elderly, children, critically ill patients with liver dysfunction, patients should be combined with the actual situation, the use of caution.