The Follow-up Study Of The Efficacy And Safety Of Traditional Chinese Medicine On Coronary Heart Disease With Multiple Risk Factors

ObjectiveThrough the retrospective research methods, we want to counts those risk factors and the distribution of traditional Chinese medicine syndrome elements of outpatients and inpatients who undergoing coronary heart disease with multiple risk factors in our hospital between April 2012 and January 2012. In order to evaluate the efficacy and safety of Chinese medicine, we intent to follow up the clinical effect of long-term use of traditional Chinese medicine and its influence on the liver and kidney function. The main purpose of our research is to provide clinical basis for the long-term using of traditional Chinese medicine on the treatment of patients who undergoing coronary heart disease with multiple risk factors.MethodsThrough retrieve the outpatient and inpatient medical records, our research include those patients who undergoing coronary heart disease with multiple risk factors of our hospital between April 2012 and January 2012. According to the content of the questionnaire, we need to collect the basic information of patients (age, gender, weight, height, occupation, outpatient or inpatient number, contact information), and record risk factors (hypertension, diabetes, dyslipidemia, the history of stroke or TIA, overweight or obese, smoking history, family history,lack of physical activity), therapeutic schedule, TCM syndrome types. We will divide those patients into TCM+ western medicine group (taking traditional Chinese medicine (TCM) at least three months) and western medicine group (including the once taking Chinese traditional medicine but did not reach the standard set of Chinese traditional medicine patients), and conduct the follow-up study until to in April 2015. In the study, we need to observe the primary end point events (cardiovascular death, myocardial infarction, stroke) and the secondary end point events (recurrence angina, myocardial revascularization, readmission), and record cardiovascular events、liver and kidney functions and the change of blood、urine、stool.Through analyze the information collected by the questionnaires,we research those risk factors and the distribution of traditional Chinese medicine syndrome elements and compare the incidence rates of cardiovascular end events and cardiovascular events in different follow up points、liver and kidney functions and the change of blood、urine、stool. The we can evaluate the efficacy and safety of Chinese medicine.Results1. Our study include 475 patients who undergoing coronary heart disease with multiple risk factors.The average amount of risk factors is 3.4+0.98. Among those patients, there are 307 patients with hypertension(64.6%),177 diabetes(37.3%),313 dyslipidemia(65.9%),48 the history of stroke or TIA(10.1%),216 patients who smoke(45.5%),73 patients with family history of cardiovascular disease (15.4%),64 patients(13.5%) who lack of physical activity and 112 obese people (23.6%). TCM+western medicine group contains an average of 3.5±1.0 risk factors. pure western medicine group contains an average of 3.4±0.94 risk factors.There is no statistically significant difference between two groups.2. Distribution of syndromes:among the 475 patients of our study, blood stasis syndrome and toxic heat are in the majority. Congealing cold and Yang deficiency syndrome are in the minority. Specific numbers as follows:448 cases of blood stasis syndrome, accounting for 94.3%; 247 cases of toxic heat syndrome, accounting for 52.0%; 119 cases of phlegm turbidity syndrome, accounting for 25.1%; 76 cases of Qi deficiency syndrome, accounting for 16.0%; 45 cases of Yin deficiency syndrome, accounting for 9.5%,34 cases of Qi stagnation, accounting for 7.4%; 5 cases of Yang deficiency syndrome, accounting for 1.1%;3 cases of congealing cold, accounting for 0.6%.3. The occurrence of end point events and cardiovascular events at different follow up points:our study is a retrospective follow-up study, the average follow-up time is 1.38 years. The cumulative incidence of primary endpoint events have no statistically significant difference between two groups(p> 0.05). The compare of cumulative incidences of secondary endpoint events between two groups:TCM+western medicine group significantly lower than the pure western medicine group(p<0.05); The compare of cumulative incidences of joint end events between two groups:TCM+western medicine group significantly lower than the pure western medicine group(p< 0.05). TCM+ western medicine group recurrence angina and readmission rates are lower than the pure western medicine group, the difference is statistically significant (p<0.05). The compare of the numbers of admissions between two groups:Chinese medicine+western medicine group obviously less than pure western medicine group, the difference is statistically significant (p<0.05). The compare of the cumulative incidence of cardiovascular events at different follow-up points:there is no statistically significant difference (p> 0.05) in 3 months;TCM+western medicine group are lower than pure western medicine group in 6 months,1 year,2 years and 3 years, the difference has statistical significance (p> 0.05).4. The evaluation of security and adverse reactions:during follow-up period, the patients of TCM+western medicine group taken Chinese traditional medicine at least 3 consecutive months, the longest 2.5 years. We do not find any patient who occurs severe liver and kidney function damage associated with taking traditional Chinese medicine (TCM) and the change of blood、urine、 stool during treatment. Among those patients, there are 15 patients who happened diarrhea, nausea, vomiting and so on. Twenty-six patients happened bloated with discomfort when taking Chinese formulated productsConclusionAmong these patients who undergoing coronary heart disease with multiple risk factors, hypertension diabetes^ dyslipidemia and smokers are in the majority. The result proves the close relationship between these risk factors and coronary heart disease once again. They are the main risk factors of coronary heart disease.Among the patients who undergoing coronary heart disease with multiple risk factors of our hospital, most of traditional Chinese medicine syndrome is Shi pattern. And blood stasis、toxic heat, phlegm turbidity are in the majority;Qi stagnation and congealing cold are less. Among Deficiency syndrome, the amount of Qi deficiency and Yin deficiency are more, Yang deficiency syndrome is less.Long-term use of traditional Chinese medicine (TCM) can not lower the incidence of the primary end point event, but this study preliminarily suggests long-term use of traditional Chinese medicine can reduce the incidence of secondary endpoint events、recurrence of angina pectoris, number of admissions and improve the patient’s long-term symptoms. At the same time, traditional Chinese medicine can improve patients quality of life.This study preliminarily suggests that long-term mormal use of traditional Chinese medicine (TCM) has no severe damage to the liver and kidney function and no serious adverse reactions.