Clinical Research Of Ziningjiangzhi Powder For Treated Hyperlipidemia

ObjectiveHyperlipidemia is due to abnormal fat metabolism or abnormal transport which causing one or more kind of lipid in plasma became higher than normal, can be reflected as hypercholesterolemia,hypertriglyceridemia, or both (mixed high lipemia). In recent years, with the development of people's living standards,the aging of societ have became worse and worse and the changed mode of the disease, contagious disease has tapered while cerebrovascular diseases has increased year by year, which become one of the three diseases of hightest effection on affecting human health, harming to human life, attacking rate, death rate and mutilation rate. A lot of research data was showed that hyperlipidemia was one of the independent risk factor of sudden cardiac death, myocardial infarction, coronary heart disease and so on, using lipid lowering drugs to correct dyslipidemia was a good powerful measure to the first-level prevention and the second-level prevention of cerebrovascular diseases by improving endothelial dysfunction, slowing porridge the progress of atherosclerotic plaque and reducing myocardial ischemia and acute coronary syndrome and mortality rates. Medical science community paid more attention on the research of the hyperlipemia which has important significance of preventing cardiovascular disease. The liver is an important site for blood-fat metabolism and adjusting cholesterol. The hepatotoxicity was a main reason for obstruct its clinical application. Traditional Chinese Medicine has its unique understanding on hyperlipoidemia which has been confirmed has the better curative effect on a large number of small sample size clinical research. The study that used Ziningjiangzhi powder (ZNP) was to observe the abnormal effect of blood-fat hoping to provide a safe and effective lipid lowering drugs for clinic. Literature review:Studied the Chinese medicine on the pathogenesis of hyperlipidemia and the information of determination of treatment based in pathogenesis obtained through differentiation of symptom and sign, we had a more comprehensive understanding of high blood lipids and overview of the development of recent drug using in disease, and summed up summary and statement. From the western medicine, provided comprehensive overview on the concept of hyperlipidemia,classification and diagnosis, also summed up the progress of drug therapy of lowering fat and got the review evaluation from clinical trials in recent years.MethodsTo observe the efficacy and safety of Ziningjiangzhi powder for treated Hyperlipidemia in order to provide the pharmacodynamic and safety basis for clinical application. Methods1. Cases internalized criteria (also subject to the following four titles)(1) Meeting the diagnostic criteria of TCM and western medicine and consisting with the diagnosis of hyperlipidemia hyperlipidemia.(2) During 18 to70 years old.(3) Although taken lipid lowering drugs, stopped using more than two weeks, the level of blood fat still met the diagnostic criteria.(4) Subjects were volunteers and signed informed consent.2. Cases exclusion criteria (in accordance with any of the following one)(1) Not meet the diagnostic criteria of TCM and western medicine, and do not meet these diagnostic criteria and inclusion standards.(2)Suffered from myocardial infarction,cerebrovascular accidents,major trauma or major surgery during six months.(3) Nephrotic syndrome, thyroid dysfunction, acute and chronic liver and gallbladder disease, diabetes and gout patients.(4)Hyperlipemia induced by drugs.(5)Patients were used heparin and other drug that treating thyroid or effecting blood-fat metabolism for nearly 4 weeks(6) Patients were used other lipid-lowering measures.(7) Pregnant and lactating women.(8)The people that were associated with other serious organic disease and doctors diagnosed as incompetence(9) Patients who had allergies and mental disease. 3. Case divided60 patients were all collected in Taiwan Dongyang clinic in TCM and diagnosed as hyperlipidemia in western medicine with typed of repression for the sputum,asdthenic splenonephro-yang,hepatic and renal yin deficiency,qi-stagnancy and blood stasis,asthenic yin causing predominant yang in TCM. The qualified patients were randomly divided at 1:1 ratio into 2 groups:the treatment group and the control group, each group was 30 cases and no cases of absence. Two groups of patients in demographics,general life signs,the condition data and so on have no significant difference(P> 0.05).4. Treatment methods:(1) The treatment group:given ZNP in caps orally,9g for each time,3 times a day,60days as a course of treatment.(2) The control group:given cholesterol clearing pellet (Manufacturer:Canada Omega Inc, Specification:240/bottle,450mg/tablets, quasi-number:300091)5. Observation of index1. Safety tested:(1) General physical examination items (including weight, blood pressure, heart rate).(2) Blood, urine, stool routine tests.(3) Electrocardiogram test, liver and kidney function tests. Before treatment, above 3 days, at the end of treatment±3 days, once at each test, two times in total.2. Observation of effect (do statistical analysis related observation)(1) Symptoms and signs:to observe and record one time in 3 days before treatment, and record symptoms and signs one time in every two weeks during the treatment, till the end.(2) Weight:to observe and record one time in 3 days before treatment, and record one time in every two weeks during the treatment, till the end.(3) Blood-fat test:detection (calculated) TC, TG, HDL-c, LDL-c, etc., one time respectively in before and end of 3 days of the treatment time.(4) To measure the apolipoprotein apoAI, apoB100 one time in before and end of 3 days of the treatment time respectively.(5) Hemorrheology:detection of whole blood viscosity (high shear, low shear), plasma viscosity, erythrocyte sedimentation rate and hematocrit one time respectively in before and end of 3 days of the treatment time. Results1. There was significant differences between two groups of before and after treatment by the using rank sum test (P<0.01), and the total curative effect effective comparison of two groups by chi-square test was statistically significant. It was considered that the curative effect in the treatment group was higher than that of in the control group.2. Using rank sum test to compare the treatment group with the control group in efficacy of individual symptoms of Traditional Chinese Medicine, there was statistically significance between than two groups in dizziness, abdominal distension and anorexia symptoms, headache, heavy limbs numbness symptoms, palpitation, insomnia, chest pain symptoms, urine and stool abnormal symptoms (P<0.05). It was considered the treatment group of efficacy of individual symptoms of Traditional Chinese Medicine improved individual symptoms better than that of the control group.3. Using chi square test to compare one group with the other group in the disappearance rate of efficacy of individual symptoms of Traditional Chinese Medicine after treatment, shows that in dizziness, headache, heavy limbs numbness, insomnia, chest pain, abnormal symptoms in the urine and stool, we compare the rate of%, the difference was statistically significance (P<0.05), can be considered individual symptoms in the treatment group rate was higher.4. There was statistical significance compared before treatment with after treatment in tongue demonstration and pulse tracings,in which tongue pale, creamy fur, slippery pulse rate% loss of comparison by using chi square test to two group(P<0.05). It was considered the disappearance rate of the treatment group was higher.5. There was statistical significance compared with the lipid parameters (TC, TG, HDL-C, LDL-C, Lp (a)) changes before and after treatment in both group by using paired t-test(P<0.05). It was showed that two cases of high blood lipid status had significantly improved. There was statistical significance between the two groups by t-test on the difference of TC> HDL-C. (P<0.05)6. There was statistical significance between two groups using paired t test on the change of apolipoprotein (apoAI, apoB100) before and after treatment (P<0.05). It was showed that the two groups were remarkable improvements after treatment. The difference between groups had not statistical significance compared with two groups after treatment by using group t-test. (P>0.05). 7. There was significant difference between two groups of changes before and after treatment on the Hemorheological indexes (whole blood viscosity, high shear, low shear whole blood viscosity, plasma viscosity) by using paired t-test (P<0.05). It was showed that the two groups of such case indicators were improving significantly after treatment. The difference of plasma viscosity, erythrocyte sedimentation rate, hematocrit product, fibrinogen had statistical significance compared within groups after treatment by using paired t-test. (P<0.05)ConclusionThe clinical study had shown that Jiang ZNP could effectively reduce the bulk lipid of the relevant laboratory index and could improve the syndrome symptoms and treatment of hyperlipidemia. In the process of taken medication, there was not significantly difference on the liver-kidney function, blood routine test, It was a safe and effective treatment medicine promoting the advantage of TCM and provided the theoretical basis for the further clinical application.