基于真实世界的脉络舒通丸对肝功能指标影响的研究

Effect of Mailuo Shutong Pill on liver function index based on real world

目的应用医院信息医疗系统电子数据开展真实世界脉络舒通丸对肝功能指标影响的安全性临床研究。方法基于全国14家大型三级甲等医院的医疗电子数据库,将服用脉络舒通丸患者作为脉络舒通丸组,未服用脉络舒通丸者作为对照组,以性别相同、年龄±5岁为匹配条件,按照1∶1比例分组后2组均为2387例,以用药后肝功能指标[碱性磷酸酶(alkaline phosphatase,ALP)、丙氨酸氨基转移酶(alanine transaminase,ALT)、天冬氨酸氨基转移酶(aspartate transaminase,AST)、谷氨酞转移酶(gamma-glutamyl transferase,GGT)、总胆红素(total bilirubin,TBIL)]作为结局评价指标,通过倾向性评分方法控制研究中存在的混杂因素,采用3种统计学方法进行安全性分析。结果筛选出12个影响程度较高的混杂因素,加权平衡了全部的混杂因素,3种统计学方法得到的结果均为P>0.05,两组差异不具有统计学意义。结论不能认为脉络舒通丸导致肝功能指标异常变化,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,不排除存在未知偏倚可能,需开展相关前瞻性主动监测进一步获得其临床安全性证据,从而指导脉络舒通丸的安全、科学、合理用药。

Objective To conduct a clinical study on the safety in real world of Mailuo Shutong Pill(脉络舒通丸)on liver function indexes by using the electronic data of hospital information medical system.Methods Based on the medical electronic database of 14 large grade AAA hospitals in China,the patients were treated with Mailuo Shutong Pill as Mailuo Shutong Pill group,the patient were not treated with Mailuo Shutong Pill as the control group.Under the matching conditions of the same sex and±5 years old,there were 2387 cases in both groups according to the ratio of 1∶1.The liver function indexes of alkaline phosphatase(ALP),alanine transaminase(ALT),aspartate transaminase(AST),gamma-glutamyl transferase(GGT)and total bilirubin(TBIL)were used as outcome evaluation indexes.The confounding factors in this study were controlled by propensity scoring method,and the safety was analyzed by three statistical methods.Results Twelve confounders with high influence were screened by the propensity scoring method,and all the confounders were weighted and balanced.The results obtained by three statistical methods were all P>0.05,which meant the difference between the two groups was not statistically significant.Conclusion Mailuo Shutong Pill did not lead to abnormal changes of liver function index,but given the propensity score method can only control the known potential confounders,unable to realize unknown confounders,so unknown bias may exist.It needs to carry out related prospective active monitoring further evidence for its clinical safety,thereby guiding the safe,scientific and rational use of Mailuo Shutong Pill.