Clinical Study Of Shenyuandan On Myocardial Protection During Elective PCI Perioperative Period Of Unstable Angina Pectoris And Its Influence On Intestinal Microecology

Background:1.To observe the efficacy and safety of SYD on elective PCI perioperative myocardial protection.in patients with unstable angina pectoris(UA).2.To explore the effect of SYD on intestinal microecology during PCI perioperative period.3.To explore the protective effect and potential mechanism of SYD on TMAO-induced human umbilical vein endothelial cell(HUVEC)injury.Objective:1.his subject adopts,randomized,placebo-controlled observation method,the object of study are affiliated to the capital university of medical sciences,Beijing Chinese medicine hospital cardiovascular division in January 2019 to November 2019 success of PCI therapy,TCM syndrome type belong to qi deficiency and blood stasis syndrome of patients with UA.Clinical observations include:(1)The incidence of PMI.(2)Changes of CK-MB before operation,4 hours after operation,24 hours after operation,and 7 days after operation.(3)TheTCM syndrome score and effect of the two groups before treatment and 30 days after surgery.(4)MACEs 30 days after surgery.(5)Safety monitoring.2.Ultimately 20 patients were randomized into standard SYD group and placebo.Clinical observation includes:Changes of TMAO before treatment and 3 days after operation.3.In vitro,a model of TMAO-induced HUVECs injury was established.Cells were then cultured with SYD in 25(?g/ml,50?/ml and 100?g/mlrespectively for 6 hours.The level of ROS,MDA,IL-1?,IL-18 were then examined.It was showed that SYD could decrease the level of ROS,MDA,IL-1?,IL-18 in HUVECs in a dose-dependentmanner Result:1.A total of 125 subjects completed the trial,including 60 in the SYD group and 65 in the placebo group.(1)Baseline conditions:there wereno statistically difference in thebaseline data of SYD group and placebo group in patients(P>0.05).The data were comparable.(2)the incidence of the perioperative myocardial injury:SYD group,the incidence of PMI was significantly lower than that in placebo group(P<0.05).(3)CK-MB:Comparison of CK-MB levels before PCI between the two groups was not significant(P>0.05),and was comparable.The levels of CK-MB at 4 and 24 hours after operation in SYD group were significant compared with those before operation(P<0.05);The CK-MB of the placebo group at 4 hours and 24 hours after surgery was higher than that before surgery(P<0.05).The CK-MB level at 7 days after surgery was lower than that at 24 hours after admission(P<0.05).The CK-MB level of SYD group was lower than that of placebo group at 4 hours and 24 hours after surgery(P<0.05).The CK-MB level of the two groups was lower than that of placebo at the same time point 7 days after surgery(P>0.05).(4)TCM syndrome score:Comparison of TCM syndrome score before treatment between the two groups was not significant(P>0.05),and was comparable.The scores of TCM symptoms in the two groups 30 days after surgery were lower than those before treatment(P<0.05).The decrease of TCM syndrome score in SYD group 30 days after operation was better than that in placebo group(P<0.05).The total effective rate of SYD group was higher than that of placebo group(P>0.05).(5)MACES events and safety detection:Two groups of postoperative incidence of 30-day MACEs not statistically difference(3.33%VS7.69%,P=0.29).Did not see SYD related adverse reactions occur,security is good.2.Twenty subjects completed the trial,including 9 in the SYD group and 11 in the placebo group.There was no statistical difference between the two groups in the baseline data(P>0.05),which was comparable.There was no statistically significant difference in TMAO levels between the SYD group and the placebo group at admission(P>0.05),and they were comparable.The TMAO levels in the SYD group and the placebo group increased at 24 hours after operation compared with those before the operation,and the difference was not statistically significant(P>0.05).The level of TMAO in the SYD group after 24 hours of operation was lower than that in the placebo group,and the difference was statistically significant(P<0.05).3.(1)Oxidative stress:Compared with the control group,the content of ROS and MDA in the model group increased,the difference was statistically significant(P<0.05).Compared with the model group,the ROS content of the SYD medium and high dose groups decreased,and the difference was statistically significant(P<0.05).The MDA content of each dose group of SYD decreased,and the difference was statistically significant(P<0.05).(2)Inflammatory factors:Compared with the control group,the content of IL-1? and IL-18 in the model group increased,and the difference was statistically significant(P<0.05).Compared with the model group,each dose group of SYD can reduce the content of IL-1?,and the difference was statistically significant(P<0.01).Each dose group of SYD had a tendency to reduce the content of IL-18,the difference was not statistically significant(P>0.05).Conclusion:1.SYD has a certain perioperative myocardial protective effect on UA patients with selective Qi deficiency and blood stasis syndrome,and has the potential to improve the prognosis of patients with selective PCI.It is safe to use.2.SYD can reduce the elevation of serum TMAO during PCI perioperative period,suggesting that SYD may have the potential to improve the intestinal microecology.3.SYD may reduce TMAO-induced HUVEC damage by inhibiting oxidative stress and inflammation.