Clinical Study On The Efficacy And Safety Of Shenfu Injection In The Treatment Of Septic Shock (Yangqi Sudden Loss Syndrome

BackgroundSeptic shock refers to acute circulatory failure and cell metabolic disorder caused by severe infection.It is clinically manifested as hypotension and elevated lactic acid.It has a high mortality rate in intensive care unit and brings heavy burden to society,family and individuals.Although scholars both domestically and internationally have conducted extensive basic research and clinical exploration on the pathogenesis and corresponding treatment measures of sepsis and septic shock in recent years,the Surviving Sepsis Campaign is constantly updating the latest treatment concepts and consensus.However,our understanding of the specific pathogenesis and pathophysiological process of sepsis and septic shock is still very limited,and a variety of new ideas and new methods are still being explored.How to find treatment methods and drugs that can relieve the acute symptoms of septic shock and reduce the mortality of patients is the focus of current research and the biggest difficulty.Due to the limitations of western medicine treatment,many clinicians have shifted their attention to traditional Chinese medicine interventions with multi-target and multi-pathway treatment effects,and have achieved certain results in practice.However,more clinical data are needed to support the effect of traditional Chinese medicine intervention on patients with septic shock.ObjectiveTo clarify the effect of Shenfu injection on the prognosis and organ protection of patients with septic shock(syndrome of sudden collapse of Yang-Qi)on the basis of conventional western medicine treatment,and to evaluate its clinical safety,so as to provide evidence-based medical evidence for the rational clinical application of Shenfu injection.MethodsThis study was a prospective,single-center,randomized,open-label,parallel controlled study.Forty septic shock patients with syndrome of sudden collapse of Yang-Qi were randomly divided into experimental group and control group according to the ratio of 1:1.The experimental group was treated with conventional treatment combined with Shenfu injection,and the control group was treated with conventional treatment plus normal saline.The conventional treatment included:Early fluid resuscitation,use of vasoactive drugs,empirical antibiotic therapy,positive inotropic drugs,respiratory support therapy,nutritional support therapy,and symptomatic treatment.The clinical efficacy,inflammatory indexes,myocardial injury indexes,liver and kidney function and other laboratory examination indexes were compared between the two groups after treatment,and the therapeutic effect and clinical safety of Shenfu injection in patients with septic shock(syndrome of sudden collapse of Yang-Qi)were evaluated.ResultsIn terms of efficacy indicators,the CRP and WBC of the two groups showed a downward trend on the third day of treatment,and the CRP and WBC of the experimental group were significantly lower than those of the control group,the difference was statistically significant(P<0.05).The TnI and CK-MB of the two groups showed a downward trend on the third day of treatment,and the TnI and CK-MB of the experimental group were significantly lower than those,of the control group,and the differences were statistically significant(P<0.05).The TCM syndrome scores of the two groups showed a downward trend,and the improvement of TCM syndrome scores in the experimental group was more obvious,and the difference was statistically significant(P<0.05).During the whole observation period,the total dose of norepinephrine in the experimental group was lower than that in the control group,and the difference was statistically significant(P<0.05).However,there were no significant differences in 28-day mortality,length of hospital stay and duration of mechanical ventilation between the two groups(P>0.05).In terms of safety indicators,there was no significant difference in liver and kidney function indicators between the two groups on the third day of treatment(P>0.05),and no adverse events occurred in the two groups during the whole observation period.Conclusion(1)Shenfu injection in the treatment of septic shock(syndrome of sudden collapse of Yang-Qi)can help to reduce the dosage of norepinephrine,but has no significant effect on the prognosis of patients,the length of hospital stay,and the duration of mechanical ventilation.2.Shenfu injection in the treatment of septic shock(syndrome of sudden collapse of Yang-Qi)can reduce the level of inflammatory indicators,reduce the inflammatory reaction of patients,and improve the progress of the disease to a certain extent.3.Shenfu injection in the treatment of septic shock(syndrome of sudden collapse of Yang-Qi)can reduce the level of myocardial injury indicators and play a protective role in the heart.4.Shenfu injection in the treatment of septic shock(syndrome of sudden collapse of Yang-Qi)can help to reduce the TCM syndrome score and relieve the clinical symptoms of patients.5.Compared with conventional treatment,Shenfu injection has no obvious liver and kidney function damage,does not increase the incidence of adverse events,and has high clinical safety.