基于电子医疗数据的真实世界仙灵骨葆胶囊对肝功能影响临床实效研究

Research on Clinical Application of Effect of Xianling Gubao Capsule on Liver Function:A Real-World Study Based on Electric Medical Records

目的:旨在应用医院信息系统电子医疗数据开展真实世界仙灵骨葆胶囊对肝功能影响的临床实效研究,为仙灵骨葆胶囊的临床合理应用提供参考借鉴。方法:提取全国范围24家大型三甲医院电子医疗数据,基于用药前后两次检测的碱性磷酸酶(ALP)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、谷氨酰转肽酶(GGT)、总胆红素(TBIL)结果作为结局指标,应用GBM倾向性评分法平衡混杂因素,对比分析真实世界使用仙灵骨葆胶囊是否直接影响患者肝功能。结果:倾向性评分加权结合协变量调整后Logistic回归分析结果显示,使用仙灵骨葆胶囊并未对肝功能产生直接影响。结论:该研究为品种的临床合理应用提供了重要借鉴,但鉴于倾向性评分法仅能控制已知潜在混杂因素,无法实现对未知混杂因素的平衡,故不除外存在未知偏倚可能,尚需其他安全性监测结果支持,从而为仙灵骨葆胶囊在临床安全、合理应用提供证据。

Objective:The present study aims to develop an outcomes research about the influence of Xianling Gubao Capsule on liver function in the real world based on hospital information system database and provide the reference for prospective study.Methods:We extracted the electronic medical data from patients using Xianling Gubao Capsule from 24 large-scale hospitals nationwide based on the HIS established by Institute of Basic Research in Clinical Medicine,China Academy of Traditional Chinese Medical Sciences.Using alkaline phosphatase(ALP),glutamic-pyruvic transaminase(ALT),glutamic oxalacetic transaminase(AST),glutamic oxalacetic transaminase(GGT) and total bilirubin(TBIL) as the outcome indicators,we assayed both before and after taking medicine.GBM propensity score method was used to balance the confounding factors.And then we compared and analysed if it would directly affect the liver function of patients by using Xianling Gubao Capsule in the real word.Results:After the weighted combination of the inclination score and the covariate adjustment,the results of Logistic regression analysis showed that there was no direct effect on liver function in the use of Xianling Gubao Capsule.Conclusion:Our research provided an important reference for the clinical application of variety,but the propensity score method can only controls known potential confounding factors,the equilibrium of unknown confounding factors cannot be realized.Therefore unknown bias is possible to exist,and requires other safety monitoring results to provide the evidence for safety and rational application of Xianling Gubao Capsule in clinic.