| ObjectiveIn this study,the relationship between sepsis immune dysfunction and Traditional Chinese Medicine "acute deficiency syndrome" as the starting point,we select Shenfu injection with the effect of Tonifying qi and warming yang to treat the patients with sepsis,which To explore the effect and safety of Shenfu injection on the immune function of sepsis patients and provide the clinical research basis for the treatment of sepsis by Traditional Chinese Medicine.MethodUsing prospective randomized controlled trial,42 patients with sepsi s who were eligible for inclusion were divided into treatment group and c ontrol group according to the principle of 1:1 random grouping principle.The control group was treated with conventional western medicine,while t he treatment group was given with Shenfu injection(0.9%Nacl 100ml+shenfu injection 50ml ivd Bid)on the basis of routine treatment of western med icine.The course of treatment for two groups both took 7 days.Observing the changes of inflammatory parameter(WBC,PCT,CRP),T ly mphocyte subsets(CD4+,CD8+,CD4+CD8+),CD14+/HLA-DR,Coagulation parameter(A PTT,PT,INR,FIB,D-dimer,PLT),Lac and APACHE Ⅱ scores between treatm ent group and control group after the third day and the seventh day.Besi des,recording the incidence of death within 7 days,the incidence of mul tiple organ dysfunction(MODS),follow-up of the mortality and the hospit alization days in 28 days and the adverse reactions and adverse events du ring the treatment period,which is to fully evaluate the effect of Shenf u injection on Immune Function and Clinical Efficacy of Patients with Sep sis.The data was established by SPSS 17.0 and analyzed statistically.Th e measurement data was described as mean ± standard deviation.The data was consistent with the normal distribution and variance homogeneity,the comparison between groups used two independent sample t test and intra-g roup comparison used paired t test.Data was non-normal or variance analy sis with rank sum test.The data accord with Multiple observation points was compared by repeated measures ANOVA.Count data was expressed in term s of frequency and composition ratio.The classification data was analyze d by chi-square test or exact probability method.Rank data was analyzed by rank sum test.Take P<0.05 indicates that the difference was statistic ally significant.Result1.Analysis of general baseline data before treatmentThere was no statistically significance in the difference of the sex,age,inflammatory parameter(WBC,PCT and CRP),T lymphocyte subsets(C D4+,CD8+ and CD4+CD8+),CD14+/HLA-DR,Coagulation index(APTT,PT,INR,FIB,D-dimer and PLT),Lac and APACHE IIrelated scores between the two group s(P>0.05).2.Analysis between groups after treatment for third daysThere was statistically significance in the difference of Blood coagu lation index(PT,D-dimer),CD14+/HLA-DR and APACHE Ⅱ related scores betwee n the two groups(P<0.05).While there was no statistically significance in the difference of the levels of inflammation(WBC,PCT and CRP),T lymp hocyte subsets(CD4+,CD8+,and CD4+CD8+)and blood coagulation index(APTT,I NR,FIB,PLT and Lac)between the two groups(P>0.05).3.Analysis between groups after treatment for seventh daysThere was statistically significance in the difference of CD4+CD8+ and D-dimer between the two groups(P<0.05).While there was no statistically significance in the difference of the levels of inflammation(WBC,PCT an d CRP),T lymphocyte subsets(CD4+,CD8+),CD14+/HLA-DR,blood coagulation index(APTT,INR,FIB,PLT and Lac)and APACHE II related scores between the two groups(P>0.05).The incidence of MODS and the 7 day mortality r ate in the treatment group were lower than those in the control group wit hin 7 days,though there was no significant difference between the two gr oups(P>0.05).4.Analysis within the group before and after treatmentInflammation index.Before and after treatment of WBC,there is stati stically significant difference in the observation group(P<0.05),while there is no statistically significant difference in the control group(P>0.05).Before and after treatment of CRP,there is statistically signif icant difference both in the observation group and in the control group(P<0.05).Before and after treatment of PCT,there is statistically sig nificant difference both in the observation group and in the control grou p(P<0.05).T lymphocyte subsets and CD14+/HLA-DR.Before and after treatment of CD 4+,There was no statistically significance both in the observation group and in the control group(P>0.05).Before and after treatment of CD8+,th ere is no statistically significant difference in the observation group(P>0.05),while there is statistically significant difference in the con trol group(P<0.05).Before and after treatment of CD4+CD8+,there is no s tatistically significant difference both in the observation group and in the control group(P>0.05).Before and after treatment of CD14+/HLA-DR,t here is statistically significant difference in the observation group(P<0.05),while there is no statistically significant difference in the co ntrol group(P>0.05).Coagulation index and lactic acid.Before and after treatment of APT T,there is no statistically significant difference both in the observati on group and in the control group(P>0.05).Before and after treatment o f PT,there is statistically significant difference in the observation gr oup(P<0.05),while there is no statistically significant difference in thecontrol group(P>0.05).Before and after treatment of INR,there is s tatistically significant difference in the observation group(P<0.05),w hilethere is no statistically significant difference in the control group(P>0.05).Before and after treatment of FIB,there is statistically sign ificant difference both in the observation group and in the control group(P<0.05).Before and after treatment of D-dimer,there is statistically significant difference in the observation group(P<0.05),while there i s no statistically significant difference in the control group(P>0.05).Before and after treatment of PLT,there is no statistically significant difference in the observation group(P>0.05),while there is statistical ly significant difference in the control group(P<0.05).Before and after treatment of Lac,there is statistically significant difference in the o bservation group(P<0.05),while there is no statistically significant d ifferencein the control group(P>0.05).APACHE Ⅱ score.Though the APACHE II scores decreased compared with the previous ones both in the observation group and in the control group,there is statistically significant difference in the observation group(P<0.05),while there is no statistically significant difference in the control group(P>0.05).5.Safety observation.No adverse reactions such as drug allergy were observed in the treatment group.Among them,the death of the patients du ring the observation period was caused severe illness by the clinical ana lysis,which was not related to the drug.Conclusion1.In the conventional treatment of Western medicine,Shenfu injection was used for the treatment of sepsis,and the curative effect was quite satisfactory.At the same time,combined with Shenfu injection can reduced the level of inflammatory reaction of sepsis,improved the coagulation dysfunction and microcirculation of the body,increased the level of CD4+CD8+and CD14+/HLA-DR in sepsis patients and effectively improved the immunosuppressive and immunopathic state of the sepsis body,reduce the severity of sepsis patients.2.Shenfu injection can adjust the immune status of sepsis as a whole.Chinese Medicine is based on the understanding that Acute Deficiency Patt erns is the pathogenesis of sepsis,thus,righting method is a new direct ion to treat sepsis by Traditional Chinese Medicine,which is worthy of f urther clinical exploration and promotion. |
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