Nghiên cứu tính an toàn, tác dụng điều chỉnh rối loạn lipid máu trên thực nghiệm và lâm sàng của cốm hạ mỡ máu tt tiếng anh

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1 INTRODUCTION In recent years, along with the development of economy, social life, the diet has become increasingly rich and unreasonable, causing an increase in dyslipidemia Regardless the fact that it is not an acute disease, dyslipidemia is one of the leading risk factors which cause formation and development of atherosclerosis In Vietnam, atherosclerotic disease with clinical manifestations such as coronary insufficiency, myocardial infarction, cerebral vascular accident, etc currently tends to increase rapidly according to the pace of social development With modern equipment, researchers have proved that treating dyslipidemia is not only limits the progression of atheroma but also stabilizes the plaque to prevent high fatal complications Modern medicine has found and used many drugs in different groups such as statins, fibrates, resin, etc These drugs have the effect of adjusting dyslipidemia at different levels but have side effects, such as digestive disorders, muscle pain, increase of liver enzymes, etc The “Ha mo mau” remedy was rooted from the “Nhi Tran” formula with additional ingredients The ingredients include: Pericarpium Citri Reticulatae perenne, Rhizoma Pinelliae, Poria Cocos, Radix Glycyrrhizae, Radix Achyranthes bidentatae, and Rhizoma Alocaciae odorae The remedy has the effect of potentially eliminating the sputum, rheumatism, lowering the blood pressure The remedy is produced in the form of melted granules The objectives of the research: To study the acute toxicity and semi-chronic toxicity of “Ha mo mau” granules in the experiment To assess the effect of reducing the dyslipidemia on the exogenous and endogenous hyperlipidemia models of “Ha mo mau” granules on the experimental animals Evaluate the therapeutic effects of “Ha mo mau” granules on patients with low parenteral dyslipidemia PRACTICAL MEANING AND NEW CONTRIBUTION OF THE THESIS In recent years, along with the rapid development of economy and society, the disease pattern in Vietnam has changed markedly; from infectious diseases to non-communicable diseases Dyslipidemia is the cause of cardiovascular complications The topic aims to treating a pathology that is very popular in the community Treatment with modern medicine brings good effects, but it also causes some side effects (increased liver enzymes, muscle pain, digestive disorders etc.) Therefore, continuing to seek effective and safe herbal medicines is always an urgent need and is the interest to national and international scientists The scientific work of the Thesis is studied in a systematic way, both in experimental and in clinical practices The medication is produced in a new form of granules containing six ingredients of traditional medicine available in the community to treat dyslipidemia Researching and applying a traditional medicine in clinical treatment, contributing to clarify the theory of traditional medicine and gradually modernize the traditional medicine is a meaningful and practical work STRUCTURE OF THE THESIS The Thesis consists of 128 pages: introduction of 02 pages, overview of 35 pages, subjects and methods of 17 pages, 38 pages for research results, 31 pages for discussion, 02 pages for conclusions and 01 page for recommends The Thesis has 145 references (64 in Vietnamese, 66 in English, 15 in Chinese), 54 tables, charts, 12 images, 04 diagrams, and appendices Chapter OVERVIEW 1.1 Blood Lipid Disorders (dyslipidemia) according to Modern Medicine * Definition: Dyslipidemia is an increase in Cholesterol (TC), Triglyceride (TG) plasma or both, or a decrease in high density lipoprotein (HDL-C), or an increase in low density lipoprotein (LDLC), causing an increase in the process of atherosclerosis * Causes of dyslipidemia - Primary dyslipidemia Primary dyslipidemia caused by gene mutation increases excessive synthesis of TC, TG, LDL-C or decreases TC clearance, TG, LDL-C or decreases synthesis of HDL-C or decreases HDL-C clearance - Secondary dyslipidemia The cause of secondary dyslipidemia is due to the sedentary lifestyle, high consumption of beer and alcohol, foods rich in saturated fat Other secondary causes include: diabetes, nephrotic syndrome, azotemia, hypothyroidism, obstructive liver disease, oral contraceptives, beta-sympathetic inhibitors etc * Blood Lipid Disorders (dyslipidemia) and cardiovascular disease Dyslipidemia is the main cause of cardiovascular complications A pooled analysis of more than 90,000 patients who participated in randomized trials assessing the effectiveness of statin drugs showed that for each 10% reduction in LDL, there was a 15.6% reduction in stroke risk In Heart Protection Study [HPS]), 20,536 patients with atherosclerotic arterial disease or diabetes were randomized to simvastatin (40 mg) or placebo The treatment helped reduce 18% of cardiac death, 38% of myocardial infarction rate and 22% of the rate requires re-vascular procedures * Treatment of dyslipidemia Treatment of dyslipidemia is to reduce cardiovascular events caused by atherosclerosis Treatment goals are based on testing and risk stratification for treatment LDL-C is the first treatment target TC is the target for treatment without other tests Non - HDL - C or Apo B is the second treatment target Adjust lifestyle, diet, living, limit or reduce animal fat, eggs, milk etc Avoid nervous stress, rest, etc Reduce/quit smoking, increase exercise, Ayurveda, massage Treatment with drugs: statins, fibric acid derivatives (fibrates) etc 1.2 Blood Lipid Disorders (dyslipidemia) according to Traditional Medicine * Causes and mechanisms of pathogenesis - Due to inconvenience of innate immunity (physical factors): inadequate inheriting of natural factors, natural air failure, kidney failure, and kidney yang fails to warm up spleen yang, failure spleen fails to balance the low hydro, causing low sputum - Inadequate eating: eating a lot of sweet and fatty foods, drinking a lot of alcohol hurts the spleen, the function of low hydration balance is disturbed, leading to endogenous low sputum - Emotional disorder (mental factor): emotional depression, excess liver qi hurt the spleen or cogitativeness and concern can cause effect on the spleen, the function of low hydration balance is disturbed, leading to low sputum, low sputum leads to stagnant meridians, causing diseases - At high age, physical weakness or long-term disease, genuine qi deteriorates, kidney-yang is deficient, unable to warm up the spleen, causing the disordered process of nutrient circulation * Clinical form according to traditional medicine - Internally blocking low sputum: obesity, headache, chest distiches, nausea or vomiting, un-thirsty dry mouth, heavy limbs, sebum tongue, whitish moss, active vessels - Phlegm-heat fu-organsthenia: heavy body with strong head, tension, irritation, red face, red eyes, bitter mouth, chest tightness, irritability, bloating, pink tongue yellow greasy, active vessels - Spleen and kidney yang deficiency: face edema, back and knee pain, fear of cold, tired spirit, belly loose, loose urine, nocturnal blanching, the edge of tongue has teeth point, white moss, deep vessels - Liver and kidney yin deficiency: pain in the back and knees, irritation, head pain, dizziness, body fatigue, buzzing, sweating, dry and thirsty mouth, red tongue, little moss tongue, blood vessels - Phlegm stagnation and blood stasis: body fat, heavy limbs, numbness or occasional angina, headache, dizziness, lingering tongue or bloody spots, thick moss, greasy active or waxed vessels - Liver-qi stagnation and spleen deficiency: pain in the ribs, unstable pain, headache, dizziness and dizziness, poor appetite, tired spirit, loose defecation, women with menstrual disorders, pale tongue, greasy tongue moss * Study medicine article Nhi Tran Thang is an ancient medicine written by the author Tran Su Van in Thai Binh Hue Dan Hoa Te Cuc Phuong in 1151 Rhizoma Pinelliae plays the role of monarch drug, aiming for dry dampness and expel phlegm, Pericarpium Citri Reticulatae perenne is the minister drug, that aims to regulation “qi”, dry dampness? Poria is an adjuvant, useful in strengthening spleen and stomach, excreting dampness Radix Glycyrrhizae is the guide drug, useful to regulate medicines, tonify and replenish spleen, strengthening the spleen, dissipating sputum The two added adjuvants: Alocasia odora for enhancing dry dampness and expelphlegm; Radix achyranthis bidentatae for active blood as the liquid phlegm is characterized by locating in system of acupuncture spots, making this system obstructed, difficult blood circulation and the dyslipidemia in the modern medicine is closely related to liquid phlegm from point of view of the traditional medicine In the redemy Ha Mo Mau granules Rhizoma Alocaciae odorae with Rhizoma Pinelliae all dry dampness and expelphlegm, plays the role of monarch drug and Radix Achyranthes bidentatae all work with active blood to coordinate with the Pericarpium Citri Reticulatae perenne effect of the gas as increasing the effect of transporting the new epidemic, play the role of a pharmacist Poria is the adept and Radix Glycyrrhizae is the guide taste Chapter RESEARCH SUBJECTS AND METHODS 2.1 Research materials - Research drug: Ha mo mau granule (HMM): 7.5g/pack of granules, 25 packs/box made and packed at the Pharmacy Department - Military Institute of Traditional Medicine, meeting the basic standards - Control drug: Experimental: Atorvastatin 10mg (Lipitad 10mg Stada Vietnam) Clinically: Atorvastatin 10mg (Lipitor 10mg Pfizer); Statin drugs 2.2 RESEARCH SUBJECTS 2.2.1 Research on animals Swiss white mice, both gender, healthy, 25 ± 2g, provided by the National Institute of Hygiene and Epidemiology Wistar white rats both gender healthy, weight 150 - 180 grams, provided by Military Medical University 2.2.2 Research on humans - Criteria for selecting patients: + According to modern medicine: age 40 or older regardless of gender, occupation, diagnosis of dyslipidemia is determined: blood test on hunger has or more of the following lipid indicators: TC> , mmol / l; TG> 2,3 mmol / l; LDL-C> 3,4 mmol / l; HDL-C
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