Association Between Shenfu Injection And 28-Day Mortality In Septic Shock Patients:A Retrospective Cohort Study Based On Propensity Score Matching

ObjectiveBased on the sepsis database collected from Guangdong Provincial Hospital of Chinese Medicine,we evaluated the association between Shenfu injection and mortality among sepsis shock patients.MethodsThe retrospective cohort study evaluated consecutive adult patients admitted to Guangdong Provincial Hospital of Chinese Medicine with diagnosis of septic shock from 2013 to 2018.Patients were divided into two groups depending on whether Shenfu injection was administered as adjuvant therapy or not.Propensity score method was conducted to compare the difference of 28-day mortality,7-day mortality,hospital stay,duration of mechanical ventilation between two groups.In order to explore the heterogeneity in treatment effects across different population,several subgroup analyses were performed.To evaluate how the lactate level impact outcomes,we conducted a subgroup analysis of two cohorts determined based on high lactate level and low lactate level.To assess how the association differed by mechanical ventilation,we conducted a subgroup analysis of whether to receive mechanical ventilation.A subgroup analysis by different mode of administration were also conducted.ResultsThe study using retrospective sepsis database developed by Guangdong Provincial Hospital of Chinese Medicine,which collected 8445 cases admitted from Jan 1,2013 to Dec 31,2018.Among them,2701 cases younger than 18 years old or those lacking of laboratory results related to admission Sequential Organ Failure Assessment score(SOFA)and admission Acute Physiology and Chronic Health Evaluation score(APACHE)within 24 hours were excluded.Among then,4833 patients with sepsis related diagnosis were identified by ICD code,which elaborated a Sepsis 2.0 database.After examining records from this database,we included 401 cases who fulfilled Sepsis 3.0 criteria for septic shock.29 Cases missing primary outcome data were excluded.Finally,a total of 372 cases were included,with 76 cases in the Shenfu injection treatment group and 296 cases in the routine care group.SOFA,source of infection,whether received blood purification,whether received CPR,whether received dopamine,whether received epinephrine and other confounding factors were included as covariates in the primary analysis,finally 59 cases were included in Shenfu injection treatment group and the routine care group,respectively.In this analysis,there was no difference between two groups in 28-day mortality,7-day mortality,hospital stay and duration of mechanical ventilation.In the subgroup analyses,patients were divided into two groups according to lactate levels(Lac<4.5mmol/L,Lac≥4.5mmol/L).Patients with Lac<4.5mmol/L have no difference in prognosis between two groups(P>0.05);and Shenfu injection treatment group with Lac≥4.5mmol/L were found to have significantly longer duration of mechanical ventilation(P<0.05).In septic patients who did not require mechanical ventilation,7-day mortality in Shenfu injection treatment group was significantly lower than routine care group(P<0.05).And there was no statistical difference in 28-day mortality,hospital stay and duration of mechanical ventilation(P>0.05).In septic patients who dependent on mechanical ventilation,no significantly difference was observed between two groups(P>0.05).ConclusionThere is no difference in 28-day mortality,7-day mortality,hospital stay,duration of mechanical ventilation in patients with septic shock.However,in the treatment of septic shock patient not required mechanical ventilation,administration of Shenfu injection as adjuvant therapy may improve their 7-day survival.