基于真实世界的丹参酮ⅡA磺酸钠注射液辅助治疗心力衰竭的临床研究  

The Clinical Efficacy of Sulfotanshinone Sodium Injection as an Adjuvant Treatment for Patients with Heart Failure:a Rea-l world Study

作　　者：盛松 黄烨[1] SHENG Song;HUANG Ye(Xiyuan Hospital,China Academy of Chinese Medical Science,Beijing 100091,China)

机构地区：[1]中国中医科学院西苑医院,北京100091

出　　处：《中西医结合心脑血管病杂志》2023年第10期1744-1749,共6页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：2019年国家中医药管理局全国中医药创新骨干人才项目(No.010100003)。

摘　　要：目的:基于一项回顾性队列探索丹参酮ⅡA磺酸钠注射液辅助治疗对心力衰竭病人的“硬终点”获益,包括28 d、3个月、6个月内死亡和再入院。方法:采用回顾性队列的二次分析,队列中连续收集2016年12月—2019年6月在自贡市第四人民医院住院的2008例心力衰竭病人的电子病历,根据用药记录分为对照组(西药)和观察组(西药+丹参酮ⅡA磺酸钠注射液),根据“加强观察性流行病学研究报告质量”声明采用Logistic回归展示未调整、调整Ⅰ和调整Ⅱ等多套回归结果,敏感性分析采用倾向性评分匹配和E值。结果:2008例病人中,对照组1438例,观察组570例。调整Ⅱ模型显示,观察组6个月内死亡风险明显低于对照组[OR=0.34,95%CI(0.14,0.81),P=0.015],而28 d内、3个月内死亡和28 d、3个月内和6个月内再入院差异均无统计学意义。倾向性评分调整回归与调整Ⅱ模型的效应量方向一致。调整Ⅱ模型中6个月内死亡效应量和置信区间对应E值为5.33。结论:丹参酮ⅡA磺酸钠注射液辅助治疗可以减少心力衰竭病人6个月内死亡率,但是未能减少28 d、3个月内死亡和28 d、3个月内、6个月内再入院。Objective:To explore the clinical efficacy of sulfotanshinone sodium injection(STSNI)as an adjuvant in the treatment of heart failure.Methods:The collected electronic health records of 2008 patients with heart failure admitted to Zigong Fourth People's Hospital from December 2016 to June 2019 were collected for a retrospective cohort study.Patients were divided into control group(western medicine only)and observation group(western medicine plus STSNI)according to their medication records.Based on strengthening the reporting of observational studies in epidemiology statement,the results of multiple logistic regressions models including unadjusted,adjustedⅠ,and adjustedⅡmodels were displayed.For the purpose of sensitivity analysis,propensity score matching,and E-value were performed.Results:Among the 2008 patients,there were 1438 patients in control group and 570 patients in observation group.The result of adjustedⅡmodel showed that the mortality within 6 months was lower in observation group than that in control group(OR=0.34,95%CI:0.14-0.81,P=0.015).No significant differences were observed in mortality within 28 days and 3 months,and readmission within 28 days,3 months,and 6 months between two groups.The direction of the effect sizes appeared to be the same across covariate adjustment using propensity score and adjustedⅡmodel.E-value for estimate and 95%CI of mortality within 6 months in adjustedⅡmodel was 5.33.Conclusion:STSNI as an adjuvant could significantly reduce mortality within 6 months in patients with heart failure but failed to reduce mortality within 28 days and 3 months,and readmission within 28 days,3 months,and 6 months.

关 键 词：心力衰竭 丹参酮ⅡA磺酸钠注射液 真实世界研究 硬终点 

分 类 号：R541.6[医药卫生—心血管疾病]