| Background:Acute myocardial infarction (AMI), a cardiovascular disease, being named "the first killer" in the developed country and the leading cause of mortality cause in global countries, severely damage human health.. Although the incidence of AMI in Chinese is lower than it in Europe or America, the incidence had a rapid growth tendency during the past decades. And the increase of AMI incidence lay serious burden of medical cost on the shoulder of individuals, families and society. To improve the prevention and cure of AMI and to control its medical cost has become a hot research topic in the field of cardiovascular disease and health supervision.Guangdong Provincial Hospital of Chinese Medicine firstly carried out Percutaneous coronary intervention(PCI) in the national-wide Chinese Medicine(CM) system in 1997 and proposed the theory that PCI was classified into CM clinic system and Qi-deficiency and blood-stasis was the main pathogenesis in patients with coronary heart disease after PCI, establishing benefiting qi and promoting blood circulation as the main treatment after PCI, under the guidance of the theory of blood-activating and stasis-resolving and academic thought of'heart and spleen-related'. This treatment program has been widely used in management of patients after PCI in the field of basic and clinical research and achieved a better clinical effect.Purpose:To construct and evaluate the efficacy of optimized management of integrated Chinese and Western Medicine for patients with AMI by the way of syndrome surveys, literature research and expert consultation, combining with the distinguished Chinese academic thought and based on previous research results, which provide a basis for the form to the AMI clinical pathway with integrated Chinese and Western Medicine. Subject and methods:1 Syndrome Information Collection in Patients with AMI around the Reperfusion Treatment Period Form was formulated to observe the characteristic symptoms and the rules of evolvements for AMI in the perio-reperfusion by the clinical epidemiology and explore the combination rules of AMI syndrome elements by cluster analysis, meanwhile, possible influencing factors were explored by Logistic regression analysis.2 Based on the integration and optimization of previous research results, optimized management of Integrated Chinese and Western Medicine for patients with AMI was initially established through literature research with evidence-based medicine method and expert consultation with delphi evaluation.3 The efficacy of the optimized management of Integrated Chinese and Western Medicine for patients with AMI was evaluated by retrospective and prospective controlled study according to clinical epidemiology or DME approach.Results:1 Study on the law of distribution and evolvement of syndrome elements during peri-reperfusion period1.1 Distribution and evolvement of syndrome elements There were significant differences in the frequency of syndrome elements of qi-deficiency, blood-stasis phlegm-heat and phlegm-cold between the third day after reperfusion and before (P<0.05); However, there were no statistic difference in the frequency of yang-deficiency, yin-deficiency, cold-coagulation and qi-stagnation (P>0.05).1.2 Clustering analysis of syndrome elements If syndrome elements of patients after reperfusion were clustered into three categories, one was qi-deficiency and blood-stasis, the other is phlegm-cold with other syndromes as the remaining.1.3 Regression analysis of the impact factors of syndrome elements Regression analysis of the impact factors of syndrome elements revealed that: the impact factor of qi-deficiency syndrome was left ventricular ejection fraction (EF) [OR=0.90,95%CI (0.84-0.97)] and impact factors of yin-deficiency syndrome were diabetes [OR=90×109,95%CI(0.00-∞)] and fasting blood glucose[OR=1.39×109,95%CI (1.01-1.90)], with renal dysfunction [OR= 238.45,95%CI (1.13-1304.11)] and EF [OR=0.81,95%CI (0.71-0.91)] for yang-deficiency syndrome, smoking [OR=10.00,95%CI (1.15-86.88)] and hyperlipidemia[OR=4.0×109,95%CI(0.00-∞)] for phlegm-heat syndrome, arrhythmias [OR=2.70,95%CI(0.94-7.75)] and renal dysfunction [OR= 68.02,95%CI (1.31-3524.48)] for cold-coagulation syndrome, age [OR=0.24,95%CI (0.07-0.80)] for qi-stagnation syndrome.2 Study of expert consultation concerning optimized management of integrated Chinese and Western Medicine for patients with AMI.2.1 The first round of expert consultation A total of 10 questionnaires were mailed and returned, therefore, the positive coefficient of experts were 100%. With regard to the basic syndrome elements of AMI, the frequency selected by the experts ranked as follows:blood-stasis > qi-deficiency> phlegm-turbidity> yin-deficiency, yang-deficiency> cold-coagulation>qi-stagnation. Regarding to the main Chinese syndromes of AMI based on the differential syndrome treatment, the frequency selected by the experts ranked as follows:qi-deficiency and blood-stasis>qi-deficiency and phlegm-blood-stasis>blockage of phlegm>blood-stasis>cold-coagulation > qi-yin-deficiency> heart-yang-deficiency. The choice of primary CM treatment pattern for patients after reperfusion therapy sorted as follows: activating blood>enforcing Qi>diffusing phlegm>warming yang>enriching Yin>dispersing cold> clearing heat and removing toxin. Lastly, all the experts did not endorse the therapeutic efficacy of acupuncture on patients with AMI.2.2 The second round of expert consultation Similarly, a sum of 10 questionnaires were mailed and returned, therefore, the positive coefficient of experts were 100%. All the experts approved "Blood-stasis syndrome is a basic syndrome element of AMI," "Qi-deficiency syndrome is also the basic one". Most of the experts adopted a new simplified differential syndrome program for AMI:Qi-deficiency and blood-stasis is the basic syndrome with phlegm-turbidity, yin-deficiency and yang-deficiency as the main syndrome elements, covering the majority of CM syndromes of AMI by differential combination of the basic syndrome with a single or more syndrome elements and recognized optimized management of integrated Chinese and Western Medicine for patients with AMI after reperfusion therapy:the basic treatment method is to benefit qi and promote blood circulation with the supplemental therapy of minor elements such as activating yang and diffusing phlegm or removing heat-phlegm, enriching yin and warming yang.3 Evaluation of the efficacy of management of integrated Chinese and Western Medicine for patients with AMI 218 cases of AMI patients were included based on the inclusion criteria, among which the treatment group was 152 patients with 66 patients in control group. The treatment group was afforded with the optimized integrative medicine treatment based on benefiting qi and promoting blood circulation and the control group received the treatment of activating blood and resolving stasis. There was no significant difference between two groups concerning gender, age, infarction type, infarction site, pump function, risk factors of CHD, infarct-related target vessel, location of lesion, coronary artery disease score (Gensini score), reperfusion therapy pattern, cardiac function, myocardial enzyme and lipid parameters. In other words, the baseline data of two groups was balanced and comparable.3.1 Hospital stayThere was statistically significant difference between two groups in the average hospital stay (8.13±4.52 days vs.10.36±6.77days, P<0.05). In subgroup analysis, the difference of the hospital stay was statistically significant between two groups with pump function class I (P＜0.05). Therefore, compared with the control group, the average stay of the treatment group with pump function Class I was relatively short.3.2 Hospital chargesThe comparison between the treatment group and the control group in average hospital charges showed statistically significant difference (48570.69±18982.81 Yuan vs.56706.27±28232.13 Yuan, P<0.01). In subgroup analysis, there was significant statistical difference of.the average hospital costs between two groups with pump function I class (P<0.05) and the cost of treatment group was less than control group.3.3 The syndrome score of qi-deficiency and the syndrome score of blood-stasis Repeated measures analysis of qi-deficiency syndrome score between two groups showed that model difference was significant (F=287.90, P=0.000). After correcting the covariate, there was statistically significant difference in qi-deficiency syndrome score between two groups (P<0.01) and qi-deficiency syndrome score of treatment group was lower than the control group after treatment.Repeated measures analysis of blood-stasis syndrome score between two groups disclosed that the model difference was significant (F=54.18, P=0.000) and the difference was no statistically significant in blood-stasis syndrome score between two groups (P> 0.05) after correcting the covariate. 3.4 Major adverse cardiac eventsMajor adverse cardiac events (MACE) was defied as death, non-lethal re-myocardial infarction, target vessel revascularization and stroke. During hospitalization,9 patients died and 3cases of target vessel revascularization in the treatment group and 3 patients died and 2 cases of target vessel revascularization in control group. The difference of frequency of MACE between two groups was not statistically significant (P> 0.05) 3.5 Predicting factors of major adverse cardiac eventsThe results of logistics regression analysis of predicting factors of MACE revealed that preoperative blood stasis syndrome scores[OR= 1.13, P<0.0l,95%CI (1.031,1.237)] and the pump function classification [OR= 4.94, P<0.001,95%CI (2.69,9.07)] were important factors impacting MACE events and the ratio of the frequency of MACE in patients whose blood-stasis syndrome scores> 25 to the that of MACE in patients whose blood-stasis syndrome scores≤25 was 2.2.Conclusions:1 The Study on the regularity of distribution and evolvements of syndrome elements during peri-reperfusion period shows that reperfusion therapy plays a role of activating blood and diffusing phlegm in terms of CM theory and Qi-deficiency and blood-stasis develop to the major syndrome after reperfusiontherapy.2 Expert consultation and consensus conclude that qi-deficiency and blood-stasis is the basic syndrome type with phlegm-turbidity, yin-deficiency and yang-deficiency as the main syndrome elements, which covers the majority of CM syndromes of AMI by differential combination of the basic syndrome with a single or more syndrome elements and optimized management of integrated Chinese and Western Medicine for patients with AMI after reperfusion therapy is that the basic treatment method is to benefit qi and promote blood circulation with the supplemental therapy of syndrome element such as activating yang and diffusing phlegm or removing heat-phlegm, nourishing yin and warming yang.3 The results of clinical controlled trials reveal that the optimized management of integrated Chinese and Western Medicine based on benefiting qi and promoting blood circulation could reduce the stay of hospitalization and hospital costs of AMI patients and improve qi-deficiency symptoms.4 Blood-stasis syndrome score>25 and cardiac shock may be the significant predictors of major adverse cardiovascular events.
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