Cardiac Function Effect Of Qi-Shen-Yi-Qi Dripping Pills On Acute ST Segment Elevated Myocardial Infarction Patients After Undergoing Percutaneous Coronary Intervention:A Multicenter,Double Blind And Placebo Control Trial

BackgroundAcute myocardial infarction(AMI),a lethal cardiologic disease that greatly threaten human’ s health,is one of the major causes of death in the worldwide.Performing Reperfusion therapy on AMI patients as soon as possible,especially on ST-segment elevated type,could significantly reduce AMI patients mortality rate,decrease the incidences of complications such as heart failure,severe arrhythmia and cardiac arrest,and improve AMI patients’ long-term outcome.Nowadays,percutaneous coronary intervention(PCI)has become the most direct and effective method among AMI’s reperfusion therapies.More and more mature coronary intervention technology,efficacious drugs and advanced instruments are applied in the PCI treatment to improve its therapeutic effect.However,PCI has also associated with some intractable problems,for example,slow-reflow or no-reflow phenomenon after PCI,long-term intrastent restenosis and major adverse cardiovascular events(MACE).Traditional Chinese Medicine(TCM)emphasize holism concept and try to achieve a balance of Yin and Yang within human body via syndrome differentiation therapy.TCM plays an important role in preventing complications,promoting recovery of cardiac function and improving quality of life after PCI treatment.Previous trials have found that Qi-Shen-Yi-Qi Dripping Pills(QSYQ)is capable of protecting myocardium,facilitating cardiac function recovery,inhibiting ventricular remodeling and improving quality of life.Nevertheless,till now there is no multicenter,double-blind,placebo control randomized trial to evaluate the cl ini cal efficacy of QSYQ on STEMI patients,via comparing differences among cardiac function,ventricular remodeling parameters,inflammatory indexes,MACE,quality of life and TCM syndromes.ObjectiveIn accordance with the principles of the evidence-based medicine,this prospective,multicenter,double-blind,placebo controlled randomized trial has chosen multidimensional index on STEMI patients who received PCI treatment,to evaluate the effect of QSYQ on cardiac function,ventricular remodeling parameters,inflammatory indexes,MACE,quality of life and TCM syndromes,and to provide evidence-based proof for the future TCM studies.MethodsThrough prospective analysis method,this study enrolled STEMI patients who undergone PCI therapy from June 2013 to March 2015 among 8 hospitals in China.Patients were randomly assigned to treatment group or placebo group.Both groups were administrated with routine therapies,including antiplatelet agents,Nitrates drugs,anticoagulant agents and lipid-lowering drugs.On the basis on the routine therapies,the treatment group received QSYQ(oral administration,0.5g/each time,3 times a day,treatment last for 6 months),while the control group took the placebo drug which was identically the same as QSYQ and with the same dosage and usage.Cardiac function differences between two groups after receiving treatment were estimated through MACE,NYHA heart function classification,cardiac ultrasound parameters,high sensitive C-reactive protein(Hs-CRP),brain natriuretic peptide(BNP)and myocardial infarction dimensional assessment scale(MIDAS).At the same time,syndromes or index in qi deficiency and blood stasis scale were also observed to evaluate the TCM efficacy.ResultsAmong the 216 enrolled patients,178 were male and the rest 38 were female,with mean age were 61.56±11.09 years old.The baseline differences between QSYQ group and placebo group on demographic characteristics,previous personal history,coexistent disease situation and laboratory examination results were identified with no statistical significance(P>0.05),which indicated that two group had baseline comparability.The NYHA heart function classification between two groups at baseline was found without significance(P>0.05),but it changed to be with statistical significance after the treatment(P<0.05).Moreover,compared with the control group,patients in QSYQ group were found to have a significantly lower score in physical activity and adverse reaction dimension of MIDAS(P<0.05),which suggested that QSYQ group had a better quality of life.ConclusionQSYQ could effectively promote STEMI patients’ cardiac function recovery and improve their quality of life after PCI treatment.Moreover,the result of this study suggest that based on the treating principles of supplementing Qi and activating Blood circulation,QSYQ might have a positive effect in promoting AMI patients’ cardiac resuscitation after PCI.