| Part Ⅰ The current status and efficacy evaluation of TCM treatment for STEM I in ChinaObjectiveBased on the support of National Center for Cardiovascular Diseases and Fuwai Hospital of Chinese Academy of Medical Sciences,a multicenter and real-world research("National Twelfth Five-Year" Plan for Science&Technology Support,China AMI Registration Research,China Acute Myocardial Infarction Registry,CAMI),as a branch center in this research,our hospital shared national database to observe the use of traditional Chinese medicine upon STEMI patients from 2013 to 2015,then we explore whether the intervention of traditional Chinese medicine could reduce outcome events and improve the prognosis of patients who were onset within 12h and received medical emergency of PCI,it provided a large number of samples and multicenter evidence-based medicine evidence support for the promotion of clinical rational use of traditional Chinese medicine.MethodsFrom 01/01/2013 to 31/12/2015,we collected AMI patients within 7 days which included in the CAMI study from more than 100,including provincial,municipal and county hospitals derived from 31 provinces,municipalities and autonomous regions,and screened out those who diagnosed as STEMI.Firstly,according to the demography,the characteristics of the disease,treatment information,emergency reperfusion therapy,drug therapy,past medical history,the situation at the time of discharge and other general information of the two groups of patients registered in the CRF table of CAMI network system,we proceeded an epidemiological investigation about the domestic patients with STEMI from 2013 to 2015 and understood the utilization of traditional Chinese medicine.Secondly,we classed the patients who were onset within 12h and received medical emergency of PCI in western hospital and intravenous traditional Chinese medicine or oral traditional Chinese medicine during hospitalization as combination therapy group(observation group).Patients without use any traditional Chinese medicine during hospitalization were classified as control group(control group).We focused on the end point events and the impact of health economics of two groups which including:1.the occurrence of major adverse cardiovascular events(MACE):the primary end points were death that associated with STEMI;the secondary end points were recurrent myocardial infarction,severe arrhythmia,new or aggravated heart failure,heart sexual shock,mechanical complications,cardiac arrest,cerebro-vascular events,severe bleeding events and etc.;2.hospitalization days and hospitalization expenses.Logistic regression was used to accomplish the single factor and multifactor analyze of the influence upon MACE in the hospital.Results1.From 2013 to 2015,our study screened 18297 patients from 20004 STEMI patients as research objects which were admitted in 106 medical units from the national province,city and county.The study revealed several problems including:the use of traditional Chinese medicine upon STEMI patients in domestic west hospital accounted for 55.64%,however,the provincial hospital utilization rate is the lowest(34.9%)compared with the city and county hospitals(64.2%).Our study results revealed the relatively lower recognition and use of traditional Chinese medicine in better medical conditions and levels of provincial hospitals compared with higher use of traditional Chinese medicine in the city and county hospitals.Traditional Chinese medicine injection was the main use of traditional Chinese medicine treatment(52%of patients),however,only 15.6%of patients received oral traditional Chinese medicine.2.From the mentioned above 18297 patients,we selected 5562 STEMI cases those who were onset within 12h in western hospital and received medical emergency of PCI.We divided the patients into two groups,2531 cases were observation group and 3031 cases were control group.After ruled out the influence of confounding factors with Logistic regression,we confirmed that Chinese medicine was independent protective factor in reducing death in hospital[OR=0.640(0.452,0.906),P=0.0119*]and cardiogenic shock[OR=0.741(0.550,0.998),P=0.0484*].Intervention of traditional Chinese medicine to the myocardial infarction during hospitalization[OR=0.809(0.339,1.932)],mechanical complications after myocardial infarction[OR=0.364(0.098,1.357)],cardiac arrest[OR=0.893(0.550,1.451)],complicated with cerebrovascular events/stroke[OR=0.840(0.394,1.790)]and other bleeding events[OR=0.953(0.584,1.555)]were shown to have protective effects,but it was no statistically significance.However,the influence of Chinese medicine on new or worsen cardiac failure[OR=1.179(0.965,1.441),P=0.1074]and severe arrhythmia[OR=1.444(1.171,1.781),P=0.0006*]were shown as adverse factors,and the reason was worth to discuss deeply.3.From the perspective of health economics,we compared two groups of patients also underwent emergency PCI,observation group stay longer in hospital but their hospital costs were significantly lower than control group.Conclusion1.Our research reveals that the present utilization of traditional Chinese medicine is still not optimistic upon domestic STEMI patients,the low utilization rate of provincial hospital(34.9%)and oral traditional Chinese medicine(15.6%)are the main characteristic.2.Adding traditional Chinese medicine can reduce the incidence of hospital mortality,hospital cardiogenic shock and lower medical costs for patients who were onset within 12h and received medical emergency of PCI.Part Ⅱ The Prospective multicenter cohort and follow-up study with respect to the intervention of heat-clearing and blood-activating therapy on STEMIObjectiveBased on the research platform of CAMI and through prospective multicenter cohort study,we evaluated heat-clearing and blood-activating therapy which proceeded follow-up for 1 year upon the influence of end point MACE.MethodsFrom 01/01/2013 to 31/12/2015,we selected the patients with STEMI within 7 days and hospitalized in the first affiliated hospital of Guangzhou university of traditional Chinese medicine in sequence.Based on the normalization treatment of western medicine guidelines,we considered it as toxic heat and blood stasis syndrome according to the《clinical pathway of thoracic obstruction and angina pectoris》and gave it heat-clearing and blood-activating therapy of traditional Chinese medicine for one week,which we called observation group.Then we classified patients with STEMI who stayed in the same period with six Western Hospitals from Guangdong,Guangxi,Hunan,Jiangxi,Fujian provinces(Guangdong General Hospital,Central Hospital of Jiangmen city in Guangdong Province,First Affiliated Hospital of Guangxi Medical University,Central Hospital of Xiangtan city in Hunan Province,Second Affiliated Hospital of Nanchang University and Xiamen Heart Center)and only followed western medicine guide standardized treatment without using any traditional Chinese medicine as control group.We registered lots of general information by CAMI network system including patient demographics,clinical characteristic,diagnosis information,emergency treatment way of reperfusion,coronary artery disease in hospital,medical care,examination,medical history,discharge situation and so on.Then We completed follow-up according to the time of onset including 30 days,6 months,1 year time.We made further group in queue by the definition of exposure.Firstly,patients who received heat-clearing and blood-activating therapy in the observation group and intervention time was 30 days or more were classified as strong exposure group.Secondly,patients who received heat-clearing and blood-activating therapy in the observation group and intervention time was less than 30 days were classified as weak exposure group.Thirdly,patients without the intervention of traditional Chinese medicine were classified as non-exposed group.Then we made a comparison among groups of the impact on the MACE incident.We also drew the survival curve,conducted single factor and multiple factors regression analysis and established Cox regression model.ResultsIn this study,186 cases were included in the observation group,and 176 cases were classified as the control group.The rate of emergency PCI in our hospital was significantly higher than that in the control group(81.2%vs 58.5%,P<0.05),This may be associated with a higher number of patients in the control group who are referred by the primary hospital,and treatment time has been missed of emergency PCI.But the DTB time in our hospital is longer,the median time was 110min,Only 31.8%can be in the international guide standard within 90min to complete of DTB time.There were significant gap when camparing with control group.The observation group decreased hospital mortality and follow-up mortality after 12 months than the control group(1.1%vs 1.7%),(2.7%vs 5.7%).2.Cox regression analysis showed that the use of heat-clearing and blood-activating therapy was an independent protection factor for long-term death in STEMI patients[HR=0.271(0.074,0.997),P=0.0495].But the risk of new myocardial infarction[HR=4.391(1.149,16.784),P=0.0306]and heart failure[HR=1.664(1.066,2.597),P=0.0249]was higher in the observation group than in the control group at 12 months follow-up.From the survival curve and Log-Rank test,it can be seen that the probability of death and recurrent myocardial infarction in the observation group was similar to that in the control group at 12 months,and the mortality was lower than that of the control group,but no statistical difference was observed,The incidence of heart failure was higher than that of the control group.3.153 strong exposure group,33 weak exposure group and 176 non-exposed group were made further group in queue by the definition of exposure.It was found that the death patients in strong exposure group were significantly lower than those in the exposed group(P<0.05).The patients in the strong exposure group had significantly lower MACE than those in the weak exposure group(P<0.05).However,the incidence of heart failure in the strong exposure group was higher than that in the non-exposed group(P<0.05).There was no significant difference about mortality between the weak exposure group and the non-exposed group,but the incidence of heart failure and recurrent myocardial infarction were higher in the weak exposure group(P<0.05).The reasons include:(1)MACE in non-exposed group was relatively heavy,more deaths,so recurrent myocardial infarction and heart failure were relatively less;(2)Comprehensive treatment level may be higher of the selected hospital in non-exposure group,some of the factors that reflect the poor treatment in our hospital were difficult to register or missing too much,in addition,the researchers on the death of the registration w more direct and objective,but the definition of other variables or the implementation of the understanding of the standard may be different,such as the emergence of heart failure discrimination,etc.which were likely to cause a certain bias on the outcome.ConclusionThere still existed a certain gap between our hospital and provincial and municipal grade A hospitals in south of China on the overall treatment conditions for STEMI.Even so,long-term mortality in our hospital with strong heat-clearing and blood-activating therapy was significantly lower than the control group of the six hospitals in the five provinces.The use of heat-clearing and blood-activating therapy was an independent protection factor for long-term death in STEMI patients,could correct our own conditions of treatment deficiencies to provide patients with the greatest benefit from the prognosis. |
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