Efficacy And Safety Of Qishen Yiqi Drop Pills In Acute Myocardial Infarction Patients After Percutaneous Coronary Intervention

Objective By observing the differences between Qishen Yiqi drop pills and the placebo, both plus standardized western medicine in ST-segment elevation myocardial infarction(STEMI) patients,using these indicators: Platelet aggregation, blood lipids, heart function, inflammatory factor,major adverse cardiovascular events, bleeding events, To explore the efficacy and safety of Qishen Yiqi drop pills in acute myocardial infarction patients after percutaneous coronary intervention.Methods Between November 2013 and June 2014 at Guangzhou Red Cross hospital, 60 STEMI patients with the treatment of primary Percutaneous Coronary Intervention(PCI) and implantation of drug-eluting stents(DES), were randomized into two groups, the therapeutic group and control group, 30 patients per a group. In the therapeutic group,30 patients were given Qishen Yiqi drop pills 1package 3 times a day plus conventional western medicine therapy, while the control group were using the placebo(the same dosage) instead of Qishen Yiqi drop pills. After 14 days,60 patients’ platelet aggregations were measured by whole blood impedance aggregometry(WBIA), to observe the results activated by adenosine diphosphate(ADP), arachidonic acid(AA),collagen(COL); After 30 days, observing laboratory results, such as blood lipid, brain natriuretic peptide(BNP); Major adverse cardiac events(MACE) include deterioration of cardiac function,target vessels reascularization(TVR) and bleeding events. By analyzing these data, the differences of efficacy and safety between the therapeutic group and control group were compared.Results1. During the follow-up, 1 case was lost in therapeutic group; 2 cases were lost in control group.Two Follow-up rates were similar(P > 0.05).2. The differences of general clinical data and laboratory results in first day were without statistical significance.3. The platelet aggregation after 14 days’ therapy:The ADP-induced platelet aggregation of therapeutic group were lower than the control group, the difference was statistically significant(Z=-3.783, P = 0.000).The AA-induced platelet aggregation results in the two groups also had statistically different(Z =-2.082, P = 0.037); The difference of the COL-induced platelet aggregation in the two groups were statistically significant(t =-3.271, P = 0.002), the platelet aggregation of the therapeutic group under three inductors were all lower than the control group.4. Changes in blood lipids: the results of two groups at triglyceride(TG), total cholesterol(TC),low-density lipoprotein cholesterol(LDL- C), high density lipoprotein cholesterol(HDL- C) in the first day had no obvious difference(P > 0.05); After 30 days’ treatments, two group had statistical differences in these blood lipids results compared with the first day in hospital(P <0.05); The treatment group was higher than the control group in the level of declining TC, LDL-C,but had no statistical difference(P = 0.061, 0.590); TG, HDL- C was lower than those in control group, but they were still no statistical different(P = 0.462, 0.472).5. The changes of NT-pro BNP: two groups’ results of the blood inspection in 1 hour after PCI,had no statistical differences(P > 0.05); After 30 days’ treatment, NT-pro BNP results of two groups were statistically significant compared with the first inspection; When comparing the NT-pro BNP level, treatment group was less than the control group, but had no statistical significance(t = 0.322, P = 0.322).6. The hs- CRP changes: the hs-CRP level of the treatment group was similar with the control group in the second day morning in hospital, two groups had no significant statistical difference(P > 0.05); After 30 days’ following up, two groups’ hs-CRP results were both statistically significant compared with the second day morning(P < 0.05);Compared two groups of the after30 days’ treatment,the level of treatment group was lower than the control group,but had no significant statistical difference(t =-1.482, P = 0.144).7. Major adverse cardiovascular events:During 30 days’ follow up, two groups were neither had target vessels reascularization, nonfatal myocardial infarction, stroke, nor cardiac deaths. The treatment group had 3 cases of recurrent angina pectoris, 1 case of deterioration of cardiacfunction; The control group had 5 cases of recurrent angina, 3 cases of cardiac function deterioration. Neither an end point event rate nor total incidence of MACE had statistical difference(P > 0.05).8. Bleeding events:During 30 days’ follow up, 5 cases of minimal bleeding and 1 case of minor bleeding were found in the treatment group; 4 cases of minimal bleeding and 3 cases of minor bleeding were found in the control group. Neither these bleeding events’ rates nor the total bleeding rates had significant difference.9. During the follow-up, neither the therapeutic group nor the control group occurred drug-related adverse reaction. The liver and kidney function, urine routine, stool routine, blood coagulation function at 30 days after therapy were similar with the first 24 hours in hospital(P >0.05).Conclusions For these acute myocardial infarction patients after PCI therapy, conventional western medicine therapy plus qishen yiqi drop pills strengthen the inhibition of platelet aggregation, at the same time, Qishen yiqi drop pills has a certain security.