| Coronary heart disease is the type of heart disease which is caused by myocardial ischemia, hypoxia or necrosis. The reason of that pathological change is due to stenosis or obstruction or spasm of coronary artery, which is based on Coronary atherosclerosis. The incidence of the disease increased significantly year by year, and it has become a major killer to people’s health. Although blood stasis is the most common TCM syndromes of coronary heart disease, but we only have the1986revision of the "diagnostic criteria of blood stasis syndrome" to guide the clinical treatment. In recent years, the relevant researchers following the concept of evidence-based medicine, using method of literature research, expert advice, clinical epidemiology investigation, mathematical statistics, have set up a "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" based on the theory of combination of TCM syndrome and disease criteria preliminary.However,"diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" hasn’t got a clinical evaluation, and the universality of guiding clinical practice remains unclear, especially for the relevance with the CAG characteristics, are lack of clinical practice based on evidence-based medicine. This research adopts the design of the cross-sectional study and randomized double-blind control study. Using the curative effect to explane reason, evaluats the clinical applicability of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease".Reaserch ICorrelation research between TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and the Gensini score of coronary angiography in coronary heart disease patients without intervention Objective:In order to reduce influence of PCI on the Gensini score and score ofblood stasis syndrome, we only study the patients without PCI history. In order toprovide the basis for syndrome differentiation and clinical treatment, we analysis thecorrelation of Gensini score and blood stasis score and TCM blood stasis syndromescore made by "diagnostic criteria of blood stasis syndrome for patients with coronaryheart disease" and TCM syndrome distribution. Method:Select209patients from Anzhen hospital which are diagnosed withCHD using CAG, from March2011to June2012,and make the collection of clinicalinformation.Make the Gensini score according to the result of CAG, record TCMsyndromes, and calculate of the score of blood stasis syndrome and the " diagnosticcriteria of blood stasis syndrome for patients with coronary heart disease ".Analysis thecorrelation between the Gensini score and score of blood stasis syndrome, the "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease "score and TCM syndrome distribution. Results:209cases of CHD patients were involved, including15cases of chronicstable angina,163cases of unstable angina,31cases of acute myocardial infarction,and11cases of old myocardial infarction.The common TCM syndrome types in209patients was144cases with blood stasis (68.9%),93cases with phlegm turbidity(44.5%), and8cases with Qi stagnation (3.8%),74cases with Qi deficiency (35.4%),17cases with Yin deficiency (8.1%),21cases with Yang deficiency (10%),0caseswith cold, case with Yang exhausted(0.5%).Qi deficiency, blood stasis and phlegmturbidity is the most common TCM syndrome type in this study, and often combinedwith each other, which is similar to the prior research. CHD patients are divided into6groups, including blood stasis and non bloodstasis, phlegm turbidity and non phlegm turbidity, qi stagnation and non qi stagnation,qi deficiency and non qi deficiency, Yang deficiency and non Yang deficiency, Yindeficiency and non Yin deficiency. Analysis the CAG characteristics in each group, andfound that patients with blood stasis syndrome have higher Gensini score and coronarystenosis than patients without blood stasis (P<0.05), patients with phlegm turbidityhave higher Gensini score and coronary stenosis than patients without phlegm turbidity (P<0.05).We conclude that blood stasis, phlegm turbidity is the main pathogenesis of CHD.Bivariate correlation analysis of blood stasis syndrome score and the Gensini score showed that they have obvious correlation with each other (Pearson correlation coefficient is0.68, P=0.0128).Bivariate correlation analysis of TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and the Gensini score showed that they have obvious correlation with each other (Pearson correlation coefficient was0.72, P=0.0054).Conclusion:Qi deficiency, blood stasis and phlegm turbidity is the most common TCM syndrome type in this study, and often combined with each other. Patients with blood stasis syndrome have higher Gensini score and coronary stenosis than patients without blood stasis, patients with phlegm turbidity have higher Gensini score than patients without phlegm turbidity.Both blood stasis syndrome score and TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" have significant correlation with CAG Gensini score, but compared with the blood stasis syndrome score, the TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" can reflect the severity of coronary lesions better.Research ⅡRandomized double-blind placebo-controlled study of Guanxin salvia drop pillObjective:On the basis of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)", using curative effect to explane reason, Using TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and clinical curative effect as a reason,evaluate the universality of guiding clinical practice of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)". Methods:Using multicenter,prospective, randomized,double-blind, Placebo-controlled study design, according to the GCP process, after approved by the ethics committee,240patients with coronary heart disease in stable period was selected from Anzhen hospital, Fuwai hospital, China-Japan friendship hospital, and Xiyuan hospital, from September2011to September2011. The two groups were both given western medicine therapy, treatment group were given Guanxin salvia drop pill (0.04g/pill),10pills each time,3times daily,1month; Control group were given placbo,(0.04g/pill),10pills each time,3times daily,1month.Having follow-up14days later,28days later, record angina score, primary TCM symptom score, blood stasis syndrome score, TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and experimental index observation (including hsCRP, TC, TG, LDL, HDL) and security index were observed. SPSS13.0is used to make statistical analysis.Results:According to the cases excluding standard, a total of28patients were excluded.212patients were involved in the study according to the study standard, including the treatment group of108cases, the placebo group of104cases. Comparison shows that in the group, the two groups’ score of angina pectoris, primary TCM symptom, the blood stasis syndrome and "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score was lower than treatment (P<0.05). According to the comparison between two groups, treatment group has a tendency of lowing angina score to superior to control group, but did not reach statistical difference (P=0.055). Treatment group has a tendency of lowing primary TCM symptom score to superior to control group, but did not reach statistical difference (P=0.065).After treatment, blood stasis syndrome score was lower in treatment group than in control group (P=0.002), and in term of lowing the degree of blood stasis syndrome score, treatment group is better than control group(P=0.001). After treatment,"diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score was lower in treatment group than in control group (P=0.034), and in term of lowing the degree of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score, treatment group is better than control group(P=0.006). There are no adverse reaction and ending index occurred in two groups of patients during treatment and after treatment.Comparative analysis of curative effect of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and Clinical curative effect in two group suggests that in term of curative effect of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and Clinical curative effect, treatment group is better than control group(95.4%vs82.7%, P=0.011;97.2%vs86.5%, p=0.014).Conclusion:Guanxin salvia drop pill could reduce angina score, TCM syndrome score, blood stasis syndrome score,"Diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and improve clinical symptoms."Diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score can reflect the degree of illness, and it is the quantitative index which can have objective evaluations of clinical curative effect of coronary heart disease, and "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" has a good clinical universality. |
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