CN102988696B - Traditional Chinese medicinal composition used for treating coronary heart disease angina pectoris, and its use - Google Patents
Traditional Chinese medicinal composition used for treating coronary heart disease angina pectoris, and its use Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicinal used for treating coronary heart disease angina pectoris, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicinal composition is prepared from raw medicines comprising Polygonum multiflorum Thunb, Snakegourd Fruit, mulberry, Chinese garlic, Radix Pseudostellariae, unprepared rehmannia root, Fructus Aurantii, Panax Notoginseng, Poria cocos, almond and the like, and has substantial treatment effects on the coronary heart disease angina pectoris caused by various reasons.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and uses thereof, particularly relate to a kind of Chinese medicine composition that is used for the treatment of angina pectoris and uses thereof, belong to the field of Chinese medicines.
Background technology
Coronary atherosclerotic heart disease is called for short coronary heart disease, and main clinical manifestation is myocardial ischemia, anoxia and the angina pectoris, the arrhythmia that cause, and myocardial infarction can occur severe patient, occurs multiple complications and threat to life.Primary disease is mainly in more than 40 years old person, and male is more than women.There are hypertension, hyperlipidemia, diabetes and long-term smoker easily to send out primary disease.Often because of heavy meal, catch cold, fatigue and its morbidity of direct stimulation.
The western medicine treatment of 1 angina pectoris
Angina pectoris is one of disease type of coronary heart disease, refer to due to coronary insufficiency, cardiac muscle sharply, temporary transient ischemia and the caused one group of clinical syndrome taking ictal chest pain or chest discomfort as main manifestations of anoxia.Sometimes angina pectoris is not true to type, can show as gas tight, faint, weak, belch, especially old people.
The typing of angina pectoris is comparatively complicated, generally can be divided into labour's property and non-labour's property (spontaneity) according to outbreak reason.Effort angina is often because the situation of motion or other increase myocardium requirementing keto quantities is brought out of short duration chest pain outbreak; The outbreak of spontaneous angina pectoris chest pain is with the increase of myocardium requirementing keto quantity without obvious relation, and it can occur separately or merge and exist with effort angina.
Meanwhile, effort angina can be divided into again to stable angina pectoris and unstable angina pectoris according to angina pectoris natural history.Stable angina pectoris refers to outbreak effort angina more than January, its outbreak position, frequency, the order of severity, persistent period, labour's size, can lenitive nitroglycerin consumption basicly stable of luring outbreak into.Unstable angina pectoris refers to original stable angina pectoris seizure frequency, persistent period, the order of severity to be increased, or the effort angina of new outbreak, or the angina pectoris showing effect when tranquillization.Unstable angina pectoris is further developing of stable angina pectoris, is also the omen of acute myocardial infarction.In recent years apply comparatively widely clinically unstable angina pectoris one word, refer to the clinical state between stable angina pectoris and acute myocardial infarction and sudden death, including first hair style, deterioration type angina pectoris and various spontaneous angina pectoris.
On Therapeutic Method, no matter which kind of angina pectoris, doctor trained in Western medicine is the symptom when taking nitroglycerin or nifedipine and carry out allevating angina pectoris outbreak generally; Later stage by pouring into again, the blood supply that improves or recover heart of the operation method such as heart transplantation.
The Chinese medicine treatment of 2 angina pectoris
The understanding angina pectoris of 2.1 ancient Chinese medicines belongs to the traditional Chinese medical science " thoracic obstruction ", " pained ", " precordial pain with cold limbs ", " angina pectoris " category.On the books in "Nei Jing" and " Medical Treasures of the Golden Chamber ".As " Ling Shu Miraculous Pivot or Divine Axis faint disease a section " description to precordial pain with cold limbs symptom " pain as sting its heart with awl ", " angina pectoris bluish colour of the limbs extending up to the elbows and knees, very pained, onset of disease in the morning and dying in the evening, onset of disease in the evening and dying in the next morning." thoracic obstruction one word is first appeared in " Medical Treasures of the Golden Chamber " book of Zhang Zhongjing, described this sick symptom in detail: " pain over the chest and back, loses heart for the disease of the thoracic obstruction, dyspnea and expectoration, pulse at CUN KOU being deep and slow, GUAN being pulse faint, tense and rapid " in book; " unable to tie down due to obstruction of QI in the chest, chest pain radiating to the back ", and etiology and pathogenesis is summarized as to " weak pulse at YANG and stringy pulse at YIN ", i.e. part of the body cavity above the diaphragm housing the heart and lungs YANG QI deficiency, part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels YIN-cold is arrogant, is the card of deficiency in origin and excess in superficiality.Further develop later age in treatment, and as the epigastric pain of heat type Sichuan Chinaberry Powder of fainting of " Lei Zheng Zhi Cai ", pain is blood stasis for a long time, and YIN pathogen is coalescent, uses Shenfu Rhizoma Zingiberis with the loose YIN pathogen of temperature; Effective Formulas Tested by Physicians for Generations chases after sudden pain Styrax Pilulae etc.
Before 2.2 TCM Syndrome Type and standard mesh, Types of TCM Syndromes in Patients with Coronary Heart Diseases there is no unified standard.For many years, each doctor is in the understanding of individual clinical practice and etiology and pathogenesis, thoracic obstruction pattern of syndrome has been had to the different criteria for classifying, but most of doctor progressively reaches unanimity to the understanding of coronary heart disease, mainly comprise following five kinds of pattern of syndrome, i.e. stagnation of heart-blood, stagnation of phlegm heart arteries and veins, cold stagnant heart arteries and veins, deficiency of YANG QI sorrow, type of deficiency of both QI and YIN.
The treatment of 2.3 pattern of syndrome is studied for above-mentioned pattern of syndrome, and main Therapeutic Method comprises at present: activating blood and removing stasis Method, dispelling turbid phlegm method, activating YANG with pungent and warm drugs method, wet positive QI invigorating method and supplementing QI and nourishing YIN method.
The deficiency of 3 existing treatment meanss
Due to the cause of disease complexity of angina pectoris, thereby the doctor trained in Western medicine traditional Chinese medical science all has weak point in treatment in this disease at present, and the more rule for the treatment of method for the treatment of of clinical needs, to jointly improving the level of preventing and treating to angina pectoris.
Summary of the invention
The object of this invention is to provide a kind of new Chinese medicine composition, said composition can be used for the treatment of angina pectoris.The object of the invention is to be achieved through the following technical solutions:
Be used for the treatment of a Chinese medicine composition for angina pectoris, the effective ingredient of said composition is to be made up of the crude drug of following weight proportion: Radix Polygoni Multiflori Preparata 13-17 part, Fructus Trichosanthis 13-17 part, Fructus Mori 13-17 part, Bulbus Allii Macrostemonis 11-13 part, Radix Pseudostellariae 13-17 part, Radix Rehmanniae 13-17 part.
Specifically, the crude drug proportioning of this Chinese medicine composition is: 15 parts of Radix Polygoni Multiflori Preparatas, 15 parts of Fructus Trichosanthis, 15 parts of Fructus Mori, 12 parts of Bulbus Allii Macrostemonis, 15 parts of Radix Pseudostellariaes, 15 parts of Radix Rehmanniae.
Inventor thinks, deficiency of kidney yin is the inherent Fundamentals that cause cardiovascular disease, and the temperature that the vital organs of the human body all must rely on kidney qi is grown, " heart relies it, and monarch is with bright ".Old people or overworked person's kidney Qi deficiency, show as Yinyang all not enough.The moon is tegmen, the shape of depletion of YIN essence, and sun is difficult to carry, therefore the kidney invigorating should be emphasized the deficiency of tonifying kidney-yin.Meanwhile, the vital essence of suffering from a deficiency of the kidney is held on not, cause the motive lose support, hypofunction of YANG QI in chest, cloudy turbid interior life, disorder of QI and blood, thereby the disease of causing obstruction of qi in the chest and cardialgia.Therefore, the method that should adopt nourishing kidney to activate yang in treatment, regulate yin-yang and QI and blood, giving consideration to both the incidental and fundamental, reinforcement and elimination in combination, can obtain special effect.In Chinese medicine composition of the present invention, taking Radix Polygoni Multiflori Preparata, Fructus Trichosanthis as monarch drug, nourishing kidney activates yang, relieving stuffiness of the chest by dispersing aggregation of pathogens, the Tibetan that heart kidney is extreme misery, the moon of kidney is the basic of the cloudy liquid of whole body, kidney water fills Sheng, can go up taste the heart-yin, makes heart-fire being not overabudant; The heart is that fire is dirty, and excessive fire in heart descends the kidney warming water, makes the kidney being not cold.Radix Polygoni Multiflori Preparata, Fructus Trichosanthis match, and play altogether nourishing kidney-yin, logical heart-yang effect; Fructus Mori, Bulbus Allii Macrostemonis, Radix Pseudostellariae, Radix Rehmanniae are ministerial drug, and Fructus Mori, Radix Pseudostellariae, Radix Rehmanniae help Radix Polygoni Multiflori Preparata enriching yin boost qi, and Bulbus Allii Macrostemonis helps Fructus Trichosanthis to lead to heart-yang.This Six-element medicine matches, and nourishing kidney-yin, logical heart-yang, giving consideration to both the incidental and fundamental can be used for treating the angina pectoris of all kinds, various degree.
On this basis, inventor can, according to the difference of concrete patient's body constitution, disease, by adding, adjusting adjuvant thing, thereby change the bias of this Chinese medicine composition, increases effect, suppresses side effect.As to not a surname person of breast sun, add Ramulus Cinnamomi with a surname's numbness cold expelling that activates yang, add the Rhizoma Pinelliae, Cortex Magnoliae Officinalis, Rhizoma Zingiberis Recens to open expectorant knot, the activating QI and eliminating phlegm in the heart; To the positive exhaustion of YIN person of exhausting, add Radix Aconiti Lateralis Preparata, Rhizoma Zingiberis, Radix Glycyrrhizae Preparata with recuperating depleted YANG and rescuing the patient from collapse; Can add Radix Ophiopogonis, Fructus Schisandrae Chinensis, Semen Platycladi, Semen Ziziphi Spinosae etc. with tranquilizing by nourishing the heart etc. to heart deficiency of the kidney yin person; Can also add Moschus, the Radix Linderae etc. for alleviating pain.In above-mentioned raw materials medicine, Radix Pseudostellariae can optionally replace with Radix Ginseng, Radix Codonopsis or the Radix Panacis Quinquefolii of equivalent, and can obtain close effect.
Inventor, through clinical practice experience for many years, has summed up the most effective a set of crude drug compound mode: Radix Polygoni Multiflori Preparata 13-17 part, Fructus Trichosanthis 13-17 part, Fructus Mori 13-17 part, Bulbus Allii Macrostemonis 11-13 part, Radix Pseudostellariae 13-17 part, Radix Rehmanniae 13-17 part, Fructus Aurantii 8-10 part, Radix Notoginseng 5-7 part, Poria 11-13 part, Semen Armeniacae Amarum 8-10 part.
Specifically, the crude drug weight proportion of this Chinese medicine composition is: 15 parts of Radix Polygoni Multiflori Preparatas, 15 parts of Fructus Trichosanthis, 15 parts of Fructus Mori, 12 parts of Bulbus Allii Macrostemonis, 15 parts of Radix Pseudostellariaes, 15 parts of Radix Rehmanniae, 9 parts of Fructus Aurantiis, 6 parts of Radix Notoginseng, 12 parts, Poria, 9 parts, Semen Armeniacae Amarum.
The party is taking Radix Polygoni Multiflori Preparata, Fructus Trichosanthis as monarch drug, nourishing kidney activates yang, relieving stuffiness of the chest by dispersing aggregation of pathogens, the Tibetan that heart kidney is extreme misery, and the moon of kidney is the basic of the cloudy liquid of whole body, kidney water fills Sheng, can go up taste the heart-yin, makes heart-fire being not overabudant; The heart is that fire is dirty, and excessive fire in heart descends the kidney warming water, makes the kidney being not cold.Radix Polygoni Multiflori Preparata, Fructus Trichosanthis match, and play altogether nourishing kidney-yin, logical heart-yang effect.Fructus Mori, Bulbus Allii Macrostemonis, Radix Pseudostellariae, Radix Rehmanniae are ministerial drug, and Fructus Mori, Radix Pseudostellariae, Radix Rehmanniae help Radix Polygoni Multiflori Preparata enriching yin boost qi, and Bulbus Allii Macrostemonis helps Fructus Trichosanthis to lead to heart-yang.Radix Notoginseng, Fructus Aurantii are adjuvant drug, and activating blood circulation to eliminate turbid blood stasis dispelling, the chest stuffiness relieving are regulated the flow of vital energy.Poria, Semen Armeniacae Amarum are adjuvant, in both can QI invigorating building, and again can sending down the abnormal ascending QI the chest stuffiness relieving.The merit of " nourishing kidney is invigorated blood circulation, and activating yang is turbid ", from heart affection of the kidney by cold-dampness hands, is played altogether by full side, and to angina pectoris, especially deficiency of kidney-YIN, heart-yang blood stasis blocking type angina pectoris have good therapeutic effect.
experimental example one:
Pay so-and-so, man, 62 years old, first visit on January 12 in 1998.Patient, in 1996, whenever the pareordia pain of feeling oppressed appears in work strain or fatigue, lasts several minutes at every turn, has a rest or buccal nitroglycerin can be alleviated, and nearly two months over, because of being busy with one's work, above-mentioned symptom increases the weight of, and shows effect frequently.Dripping sweat when outbreak, endurable, rest, buccal nitroglycerin all can not be alleviated, and then send rescue to hospital.Electrocardiogram report: front V3～V5 ST-Segment level moves down 1.5mv, T ripple is inverted, prompting chronic coronary artery blood supply insufficiency, clinical diagnosis " angina pectoris (instability mode) ".Since onset, hand held object is shaken, and the soreness of waist is soft unable, and xerostomia is defecated micro-dry, takes Western medicine curative effect not good enough.Previously there is hypertension history.Indagation: blood pressure 150/90mmHg (having taken depressor), spirit can, breathe hard, both hands tremble, body temperature is normal, tongue is without deflection, lip is without cyanosis, 85 beats/min of hearts rate, rule is neat, first heart sound is low, audible and fourth heart sound.Two lower limb pneumonedema.Thin lingual fur, stringy and thready pulse, taking the pulse heavily is unable.Dialectical: deficiency of kidney-YIN, hypofunction of YANG QI in chest.Method for the treatment of: nourishing kidney activates yang, vital energy regualting and blood circulation-promoting.Prescription: 16 grams of Radix Polygoni Multiflori Preparatas, 14 grams of Fructus Trichosanthis, 15 grams, Fructus Mori, 12 grams of Bulbus Allii Macrostemonis, 14 grams of Radix Pseudostellariaes, Radix Rehmanniae 14g, 12 grams of the Cortexs Eucommiae, 9 grams of Radix Salviae Miltiorrhizaes, 9 grams of the Rhizoma Pinelliaes, 9 grams of Radix Ophiopogonis, 4.5 grams of CHUANSHAO, 1 gram of Radix Notoginseng powder (taking after mixing it with water).20 days two January in 1998 examines: the spiritual amelioration after 7 doses of taking medicine, and uncomfortable in chest alleviating, seizure frequency reduces.Keep former side's plus-minus treatment 3 months, above-mentioned symptom is alleviated completely, repeatedly checks electrocardiogram, and it is normal that ST section is recovered, and T ripple transfers to uprightly gradually by being inverted, and daily routines are unrestricted.
experimental example two:
Chen, man, 65 years old.First visit on April 23 in 2008.Patient's repeated relapsing pareordia angor 9 years, increased the weight of more than January.Patient since nineteen ninety-nine shows effect pareordia drum bitterly repeatedly, after fatigue, more so, is sometimes the sense of feeling oppressed, and buccal nitroglycerin, nifedipine can be alleviated.Nearly heart stricture of vagina pain outbreak in January is frequent, and companion's soreness of waist is weak, and xerostomia anorexia is defecated micro-dry, takes western medicine result poor and seek medical advice.Western medicine diagnose is angina pectoris (instability mode).
Indagation: blood pressure 17.3/12.OkPa, spirit is poor, 120 beats/min of the hearts rate of breathing hard, left side body temperature is lower than right side, and left hand is held thing and is shaken, and antiperspirant is few, stringy and thready pulse, taking the pulse heavily is unable, thin lingual fur.Differential diagnosis in tcm: this belongs to old chronic deficiency of kidney-YIN, hypofunction of YANG QI in chest, vim and vigour discord, controls and should lead to heart-yang, QI and blood regulating, liver and kidney tonifying.Prescription: 13 grams of Radix Polygoni Multiflori Preparatas, 13 grams of Fructus Trichosanthis, 17 grams, Fructus Mori, 13 grams of Bulbus Allii Macrostemonis, 16 grams of Radix Pseudostellariaes, 16 grams of Radix Rehmanniae, 9 grams of Radix Angelicae Sinensis, 9 grams of Radix Achyranthis Bidentataes, 9 grams of Fructus Aurantiis, 9 grams of Radix Paeoniae Rubra, 4.5 grams of CHUANSHAO, 1 gram of Radix Notoginseng powder is taken after mixing it with water.
Two examine: enter 7 doses of medicines, and conscious spiritual amelioration, uncomfortable in chest, angina pectoris, the improvement of breathing hard, defence's plus-minus treatment half a year, above-mentioned symptom direct release, electrocardiogram check recovers normal.Take nine doses for consolidating curative effect and changing.Prescription: 45 grams of Radix Polygoni Multiflori Preparatas, 45 grams of Fructus Trichosanthis, 45 grams, Fructus Mori, 33 grams of Bulbus Allii Macrostemonis, 40 grams of Radix Panacis Quinquefoliis, 40 grams of Radix Rehmanniae, 30 grams, Poria, 30 grams of Radix Astragali, Sang Sheng posts 45 grams, 45 grams of Radix Achyranthis Bidentataes.Be smalls altogether, making pellets by mixing medical powder with honey, 10 grams, every ball, day takes 2 balls.
Medicine-feeding has taken three material, wants because of work thunder afterwards, more than the work half a year of going out, though there is fatigue also not fall ill again.
experimental example three:
Guo so-and-so, man, 57 years old, first visit on May 11 in 2010, uncomfortable in chest, chest pain is shown effect 3 years repeatedly.
History of present illness: precordial fullness pain appears in patient after cause fatigue in 3 years, going to a doctor in Beijing hospital diagnosis is " coronary heart disease ", rule is taken nitrate esters medicine, often in tired or when excited symptom increase the weight of, oral nitroglycerin sheet can be alleviated, now for asking Chinese traditional treatment, therefore go to a doctor in my Out-patient Department.Inscribe disease: even have uncomfortable in chest, chest pain, and tired postemphasis, breathes hard, weak, xerostomia, mouthful not bitter, perspire few, soreness of the waist and knees is unable, receive sleep can, large dry stool, urine is still adjusted.Tongue is dark red, has ecchymosis, white and thin fur, and stringy and thready pulse, taking the pulse heavily is unable.Take blood pressure 130/80mmHg after depressor, deny diabetes chronic diseases history; Deny medicine and food anaphylaxis history.
Auxiliary examination: routine blood test: roughly normal; Biochemical complete: total protein 63.4g/L, globulin 23.5g/L, total bilirubin 20.1umol/L, hs-CRP 4.51mg/L; Routine urinalysis: roughly normal; Just conventional: roughly normal.Electrocardiogram: sinus rhythm, 62 beats/min of hearts rate,
, V4, the V5 abnormality Q wave that leads, V4, V5, V6 ST-Segment move down and T ripple low flat.
Tcm diagnosis: the thoracic obstruction.
Dialectical: deficiency of kidney-YIN, hypofunction of YANG QI in chest, obstruction of collaterals by blood stasis.
Western medicine diagnose: coronary atherosclerotic heart disease (stable angina pectoris); Hypertension.
Method for the treatment of: nourishing kidney activates yang, blood circulation promoting and blood stasis dispelling
Side's medicine: Radix Polygoni Multiflori Preparata 16g, Fructus Trichosanthis 15g, Fructus Mori 15g, Bulbus Allii Macrostemonis 12g, Radix Pseudostellariae 15g, 15 grams of Radix Rehmanniae, Fructus Aurantii 8g, Radix Notoginseng 5g, Rhizoma Pinelliae 9g, Poria 12g, Semen Armeniacae Amarum 8g, Radix Glycyrrhizae Preparata 6g, be decocted in water for oral dose, day potion, copies square gauge rule after 7 doses and takes one month.
Further consultation on June 10 in 2010, after patient tells and takes medicine, occasionally has uncomfortable in chestly, without pain, before has strength, and mouth is dry, receive sleep can, large dry stool, urine is raised.Dimly red tongue, white and thin fur, stringy and thready pulse, front strong.Check routine blood test: roughly normal; Biochemical complete: total bilirubin 17.5umol/L; Routine urinalysis: roughly normal; Just conventional: roughly normal.Electrocardiogram before: V4, V5, V6 ST-Segment have no and move down.
experimental example four:
King so-and-so, man, 70 years old.First visit on March 29 in 2011.Patient is uncomfortable in chest, chest pain, and companion's shortness of breath and palpitation, is interrupted outbreak 1 year.There is feeling of oppression and pain in the chest before 1 year in patient, companion's cardiopalmus, breathes hard, excited and tired postemphasis, after buccal nitroglycerin, symptom can be alleviated, hypohidrosis, xerostomia, bitter taste, soreness of the waist and knees, tinnitus is as Cicadae, not dizzy not bitterly, anorexia, large dry stool, urine is still adjusted.Western medicine diagnose is angina pectoris (spontaneity).
Indagation: blood pressure 100/60mmHg, spirit still can, deep-thready pulse, dimly red tongue, has ecchymosis, thin fur.Auxiliary examination: routine blood test: roughly normal; Biochemical: T-CHOL 5.74mmol/L, low density lipoprotein, LDL 3.23mmol/L, Apolipoprotein A1 1.72g/L.Urine, feces routine: no abnormality seen.Electrocardio diagram: sinus bradycardia, 55 beats/min of hearts rate, V1, V2, V3:T ripple are inverted; Chinese medical discrimination is deficiency of kidney-YIN, and blockage of the cardiac vessels, controls with nourishing kidney and activate yang, blood circulation promoting and blood stasis dispelling.Prescription: 16 grams of the Radixs Polygoni Multiflori, 16 grams of Fructus Trichosanthis, 14 grams, Fructus Mori, 14 grams of Bulbus Allii Macrostemonis, 13 grams of Radix Pseudostellariaes, 13 grams of Radix Rehmanniae, 8 grams of Fructus Aurantiis, 12 grams, Poria, 8 grams, Semen Armeniacae Amarum, 5 grams of Radix Notoginseng powder are taken after mixing it with water.
Two examine: 7 doses of clothes medicine-feedings, and subjective symptoms is front improvement, and former side is constant, takes continuously two months, and patient's symptom is obviously improved, electrocardiogram: sinus rhythm, 65 beats/min of the rhythms of the heart, V1, V2, V3:T ripple are inverted.Continue to take medicine-feeding to consolidate curative effect.
experimental example five:
Lee so-and-so, man, 56 years old.First visit on May 10 in 2011.Patient's chest distress, precordialgia shows effect more than 5 years repeatedly.Patient's pareordia chest distress that since two thousand six repeatedly shows effect, precordialgia, after fatigue, more so, outbreak once, but can be alleviated after taking nitroglycerin and SUXIAO JIUXIN WAN weekly.Existing patient is with weak, and xerostomia, has palpitation, breathe hard, and soreness of waist and knee joint, large dry stool, urine is raised.Western medicine diagnose is angina pectoris (stable type).
Indagation: blood pressure 130/80mmHg, spirit poor, 69 beats/min of hearts rate, April 9 in 2011 Fu Wai cardiovascular diseases hospital routine blood test: roughly normal; Biochemical: HDL1 .03mmol/L; Urine, feces are conventional normal, and coronary artery CT shows: 1. coronary artery is unenhanced: 259 points of coronary artery calcification codepositions, long-pending 190 points of anterior descending branch calcification; 2. the right advantage type of coronary artery, anterior descending branch nearly section moderate stenosis (approximately 70%), in a section tube wall far away to be dispersed in calcification be main mixing speckle, luminal stenosis < 50%, a convolution nearly section is narrow approximately 65%, the expansion of narrow rear stage casing tube chamber, and stage casing tube wall is dispersed in punctate clacification speckle.3. the nearly section of right coronary artery is dispersed in punctate clacification, and tube chamber is narrow there are no meaning, stage casing tube wall noncalcified plaques, luminal stenosis approximately 75%; Coronarography: right coronary artery middle-end: section speckle far away, ramus descendens posterior arteriae coronariae dextrae: nearly section tubulose is eccentric irregular 60% narrow; pathological changes belongs to denovo pathological changes; ramus descendens anterior arteriae coronariae sinistrae middle-end: section speckle far away; rami circumflexus arteriae coronariae sinistrae: stage casing tubulose is eccentric irregular 50% narrow, and pathological changes belongs to denovo pathological changes; Electrocardio diagram: sinus rhythm,
, avL abnormality Q wave.Stringy and thready pulse, taking the pulse heavily is unable, and dimly red tongue has ecchymosis, white and thin fur.
Chinese medical discrimination: this belongs to old chronic deficiency of kidney-YIN, hypofunction of YANG QI in chest, controls with nourish liver and kidney, logical heart-yang.
Prescription: 14 grams of Radix Polygoni Multiflori Preparata, 15 grams of Fructus Trichosanthis, 15 grams, Fructus Mori, 13 grams of Bulbus Allii Macrostemonis, 14 grams of Radix Pseudostellariaes, 16 grams of Radix Rehmanniae, 9 grams of Fructus Aurantiis, 11 grams, Poria, 9 grams, Semen Armeniacae Amarum, 5 grams of Radix Notoginseng powder are taken after mixing it with water.
Rear patient's rule is taken medicine, and the existing all symptoms of patient are clearly better, for consolidating curative effect, and following the service top.
experimental example six:the clinical research of Guanxintong side's treatment angina pectoris
1. clinical data
1.1 physical data: this is organized in 50 examples has 30 examples for inpatient, and 20 examples are outpatient.All cases all meets World Health Organization (WHO) in 1979 about angina pectoris diagnostic criteria, wherein stablizes angina of effort 32 examples, spontaneous angina pectoris 18 examples; Man's 25 examples; Female's 25 examples.Minimum 39 years old of age, maximum 80 years old, 62 years old mean age.The course of disease is the longest 15 years, the shortest 2 months.Complicated hypertension person 30 examples, have glycosuria patient 10 examples concurrently, concurrent hyperlipidemia person 25 examples.
Clinical cardinal symptom: pareordia or retrosternal pain, pain emits to back and left upper extremity, the 3-5 minute that at every turn shows effect, part patient continues the longer time, and buccal nitroglycerin can be alleviated; And companion breathes hard, the soreness of waist is unable, has a dizzy spell, xerostomia anorexia, the dark HongShaoJin(SIC) of tongue, tongue are white, deep-thready pulse.
1.2 Therapeutic Method: control should nourishing kidney activate yang, blood circulation promoting and blood stasis dispelling.Substantially square: 13 grams of Radix Polygoni Multiflori Preparata, 17 grams of Fructus Trichosanthis, 17 grams of Fructus Mori, 12 grams of Bulbus Allii Macrostemonis, 12 grams of Radix Pseudostellariaes, 13 grams of Radix Rehmanniae, 8 grams of Fructus Aurantiis, 7 grams of Radix Notoginseng, 11 grams, Poria, 8 grams, Semen Armeniacae Amarum.
Dialectical plus-minus: hypertension person adds 12 grams, Rhizoma Gastrodiae, 9 grams of Radix Achyranthis Bidentataes, 12 grams of Ramulus Uncariae Cum Unciss, 20 grams, careless stone, 20 grams of Semen Cassiaes; The high person of blood fat adds 12 grams of Fructus Crataegis; Irritated insomniac adds 15 grams of Semen Ziziphi Spinosaes; The obvious person of cardiopalmus adds 9 grams of Radix Glycyrrhizae Preparatas, 18 grams of Radix Astragali.The 4-6 week course for the treatment of.
This group case all checks electrocardiogram or exercise stress electrocardiogram, blood pressure, blood fat before treatment.Each 1 time of measuring blood pressure, heart rate weekly during treatment, the situation of change of itemized record angina pectoris attacks situation and other symptoms.Treat 2 weeks and treat and finish all to check electrocardiogram or exercise stress electrocardiogram, blood pressure.Treatment finishes check triglyceride, cholesterol, high density lipoprotein level Pseudobulbus Bletillae (Rhizoma Bletillae) low density lipoprotein, LDL.During treatment, withdraw other Chinese medicines and Western medicine.To only a few patient oral nitroglycerin if desired.
1.3 criterions of therapeutical effect: " new Chinese medicine guideline of clinical investigations " with reference to Ministry of Health of the People's Republic of China's formulation in 1993 drafts following standard.
(1) symptom criterion of therapeutical effect
Effective: transference cure or substantially disappearance;
Effective: pain attack times, degree and persistent period have obviously and alleviate;
Invalid: symptom is substantially identical with before treatment;
Increase the weight of: pain is shown effect repeatedly, number of times, degree and persistent period reply to some extent.
(2) ECG curative effect evaluation criteria
Effective: electrocardiogram recovers normally or be roughly normal, or exercise stress test transfers feminine gender to by the positive;
Effective: forcing down of ST section, more than treating rear rise 0.05mv, but do not reach normal level, transfer to upright or change and reach more than 25% at the negative T wave that mainly leads, chamber or intraventricular block improver;
Invalid: electrocardiogram is substantially identical with before treatment;
Increase the weight of: ST section is treated front reduction more than 0.05mv, deepen to reach more than 25% or smooth T ripple becomes and is inverted and occurs ectopic cardiac rhythm, atrioventricular block or intraventricular block at the T ripple that mainly leads.
1.4 therapeutic outcomes:
(1) angina pectoris symptom improves, in 50 examples, and effective 18 examples (accounting for 36%), effective 29 examples (accounting for 58%), invalid 3 examples (accounting for 6%), total effective rate 94%.
(2) electrocardiogram improves, and in 50 examples, effective 16 examples (accounting for 32%), improve 23 examples (accounting for 46%), unchanged 11 examples (accounting for 22%).
(3) before and after hyperlipidemia treatment, change: cholesterol >5.73mmol/l before 26 example treatments, average 6.51mmol/l, average 5.42mmol/l after treatment; Triglyceride >1.66mmol/l before 12 example treatments, average 1.95mmol/l, average out to 1.60mmol/l after treatment.
This group is taking 4 weeks as 1 course for the treatment of.In 50 examples, treat 1 the courses for the treatment of 30 example, treat 6 weeks person's 8 examples, treat 2 the course for the treatment of above person's 12 examples.
Conclusion: overall merit, there is good therapeutic effect Guanxintong side to thoracic obstruction disease (being angina pectoris) and complication.
experimental example seven:the clinical research of Guanxintong side's treatment deficiency of kidney-YIN, heart-yang blood stasis blocking type angina pectoris
1 object and method
1.1 object of study
Select China Academy of Sciences Guanganmen Hospital Cardiological in April, 2009 to 2009 year December Cardiological to be in hospital and be diagnosed as coronary heart disease people angor patient 56 examples with door.Man's 26 examples, female's 30 examples, 67.12 ± 8.15 years old mean age, complicated hypertension 37 examples, account for 66.07%, merge hyperlipemia 24 examples, account for 42.86%, merge arrhythmia 6 examples, account for 10.71%, and complication with diabetes 18 examples, account for 32.14%.Be divided at random matched group and test group.When research finishes, 2 examples that come off, actual clinical observation 54 examples that complete, matched group 26 examples, test group 28 examples.Two groups of mean aves, sex, Body Mass Index, merges disease, and the course of disease, treats the aspect no difference of science of statistics such as front Seattle angina pectoris scale (SAQ) scoring, has comparability.
1.2 diagnostic criteria
1.2.1 angina pectoris diagnostic criteria: with reference to the relevant diagnostic criteria of WHO ischemic heart desease.Anginal diagnostic criteria is formulated with reference to ACC (ACC)/American Heart Association (AHA) diagnostic criteria of 2002.
1.2.2 the grade scale of angina pectoris
With reference to national therapy of combining Chinese and Western medicine coronary heart diseases and angina pectoris in 1979 and arrhythmia research forum " angina pectoris arrhythmia efficacy assessment standard " formulation.
(1) exertional angina pectoris
I level: daily routines are asymptomatic, the physical exertion heavy compared with daily routines causes angina pectoris, as trotted on level land, 3rd floor, quick or prudent Wu Shang, upper abrupt slope etc. cause angina pectoris.
II level: daily physical exertion causes angina pectoris, daily routines are slightly restricted, and as constant speed walking 3 ~ 4 stations (3 ~ 4 li) under normal operation, Shang Sanlou, upward slope etc. causes angina pectoris.
III level: the physical exertion light compared with daily routines causes angina pectoris, daily routines are obviously restricted.As constant speed walking 1 ~ 2 station (1 ~ 2 li) under normal operation, upper second floor, clivia etc. cause angina pectoris.
IV level: slight physical exertion (as in indoor jogging) causes angina pectoris, and angina pectoris also occurs when severe patient rest.
(2) noneffort angina (spontaneous angina pectoris)
Slight: have compared with classical angina outbreak, continue several minutes at every turn, at least show effect weekly 2 ~ 3 times, or show effect every day 1 ~ 3 time, but pain to be not heavy, sometimes needs to take nitroglycerin.Angina pectoris symptom integration is 8 points.
Moderate: have every day repeatedly compared with classical angina outbreak, each persistent period number minute was by 10 minutes, and pain is heavier, generally needs buccal nitroglycerin.Angina pectoris symptom integration is 9 ~ 16 points.
For example, compared with severe: have classical angina outbreak for several times every day, thereby affect activities of daily living (defecate, wear the clothes etc.), the persistent period of showing effect is longer, repeatedly buccal nitroglycerin of need at every turn.Angina pectoris symptom integration is 17 points.
Severe: this type of Principle of Pain attack times and degree all compare severe and attach most importance to, and do not classify the plan of this experimental observation as.
1.2.3 tcm diagnosis standard
According to distinguished veteran doctors of TCM experience in syndrome differentiation, in conjunction with Guanxintong prescription composition and effect, with reference to version " guideline of clinical investigations of new Chinese medicine treatment angina pectoris " formulation deficiency of kidney-YIN in 2002, the diagnostic criteria of heart-yang blood stasis blocking type angina pectoris.Primary symptom: the pain of feeling oppressed after pareordia or breastbone, to fix and do not move, pain is drawn the shoulder back of the body and/or arm inner side.Inferior disease: breathe hard, cardiopalmus, soreness of the waist and knees, dizziness and tinnitus.Picture of the tongue: tongue is dark red, white and thin fur.Pulse condition: deep-thready pulse.Primary symptom indispensability, has 1 or 1 with disease last time, in conjunction with picture of the tongue, and pulse condition, diagnosable.
1.2.4 TCM syndrome evaluation quantization method
(1) primary symptom
Chest pain
Normally (0 point): nothing.
Slightly (2 points): there is typical angina pectoris attacks, each persistent period number minute, pain is at least shown effect 2 ~ 3 times weekly, or shows effect every day 1 ~ 3 time, but pain is not heavy, sometimes needs containing nitroglycerin.
Moderate (4 points): have for several times more typical angina pectoris attacks every day, each persistent period number minute was by 10 minutes, and pain is heavier, generally needs buccal nitroglycerin.
Severe (6 points): have for several times classical angina outbreak every day, thereby affect activities of daily living (for example defecate, wear the clothes etc.), the persistent period of at every turn showing effect is longer, repeatedly buccal nitroglycerin of need.
Uncomfortable in chest
Normally (0 point): nothing
Slightly (2 points): slightly uncomfortable in chest
Moderate (4 points): uncomfortable in chest obviously have Sighing respiration, slightly breathes hard after activity
Severe (6 points): uncomfortable in chest as stopped up, sigh more than
(2) inferior disease
Breathe hard
Normally (0 point): without breathing hard
Slightly (1 point): slightly out of breath very brief
Moderate (2 points): out of breath and very brief
Severe (3 points): inability to breathe regularly due to shortness of breath, several and mutually not continuous
Cardiopalmus
Normally (0 point): nothing
Slightly (1 point): accidental cardiopalmus, sense of discomfort is slight
Moderate (2 points): happen occasionally, the persistent period is longer, and sense of discomfort is more obvious
Severe (3 points): often occur, fear and move, be difficult to calmness, very person affects life
Soreness of the waist and knees
Normally (0 point): without soreness of the waist and knees
Slightly (1 point): slightly soreness of the waist and knees, does not affect activity
Moderate (2 points): the soreness of waist is aching and limp, movable unable
Severe (3 points): soreness of the waist and knees, limitation of activity
Dizziness and tinnitus
Normally (0 point): without dizziness and tinnitus
Slightly (1 point): slightly dizziness and tinnitus, does not affect activity
Moderate (2 points): dizziness and tinnitus, walking is unstable
Severe (3 points): dizziness and tinnitus, stiff
(3) tongue arteries and veins
Tongue is dark red
0 point: nothing
1 point: have
Arteries and veins
0 point: nothing
1 point: heavy or thin
2 points: heavy thin
1.2.5 angina pectoris quantizes methods of marking
Angina pectoris attacks number of times
Normally (0 point): nothing outbreak in a week
Slightly (2 points): outbreak≤6 times weekly
Moderate (4 points): show effect 1-3 every day
Severe (6 points): show effect every day more than 4 times or 4 times
The angina pectoris persistent period
Normally (0 point): nothing
Slightly ((2 points): each pain continues≤5 minutes
Moderate (4 points): each pain continues to be greater than 5 minutes but is less than 10 minutes
Severe (6 points): each pain continues >=10 minutes
Angina pectoris pain degree
Normally (0 point): nothing
Slightly (2 points): alleviate and do not affect daily life through having a rest when outbreak
Moderate (4 points): need Drug therapy when outbreak, can continue normal activity after alleviation
Severe (6 points): outbreak is frequent, affects activities of daily living
Nitroglycerin consumption
Normally (0 point): nothing
Slightly (2 points): take weekly 1 ~ 4
Moderate (4 points): take weekly 5 ~ 9
Severe (6 points): take weekly more than 10
1.2.6 severity Scaling standard
According to tcm syndrome scoring criteria, the state of an illness is divided into three grades
Slight: tcm syndrome integration≤10 point;
Moderate: tcm syndrome integration > 10, <18 divides:
Severe: tcm syndrome integration >=18 point.
1.2.7 angina pectoris weight grade scale
According to angina pectoris scoring criteria, angina pectoris degree is divided into three grades
Slight: angina pectoris integration≤8 point;
Moderate: 9 ~ 16 points of angina pectoris integrations;
Compared with severe: angina pectoris integration >=17 point.
3 cases are included in and exclusion standard
1.3.1 case inclusive criteria
(1) all MethodsThe cases enrolled should meet angina pectoris diagnostic criteria;
(2) all MethodsThe cases enrolled should meet deficiency of kidney-YIN, heart-yang stasis blocking syndrome diagnostic criterion;
(3) all MethodsThe cases enrolled turn out to be 1 or 1 above arteria coronaria trunk diameter stenosis >=70% through coronary angiography, or left trunk diameter stenosis >=50% of arteria coronaria; On coronary angiography, be shown as 1 or 1 above arteria coronaria trunk diameter stenosis >=50%, but≤70%, coronary vasospasm or have acute Q wave myocardial infarction medical history should have radiography time;
(4) age is between 35 to 75 years old;
(5) signature Informed Consent Form.
1.3.2 case exclusion standard
(1) turn out to be on inspection chest pain person due to the other diseases such as other heart diseases, severe neurosis, climacteric syndrome, cervical spondylosis;
(2) severe cardiac insufficiency (cardiac function IV level), severe arrhythmia and affect hemodynamics (chamber speed, supraventricular tachycardia) person;
(3) coronary heart disease is through coronary artery bypass grafting, interventional therapy, after blood vessel is rebuild completely, without classical angina person;
(4) merge the serious primary disease such as liver, kidney, hemopoietic system, liver function (ALT, AST) >60u/L or renal insufficiency (losing the compensatory phase) person;
(5) gestation or women breast-feeding their children;
(6) in recent 4 weeks, did to perform the operation or have bleeding tendency person;
(7) psychosis or other can not compatibility test persons;
(8) concurrent infection, connective tissue disease, disease of immune system, tumor;
(9) in nearly one month, participate in other clinical trial person;
(10) allergic constitution or to trial drug composition allergy sufferers.
The rejecting of 1.4 cases and coming off
1.4.1 reject case standard
(1) do not meet inclusive criteria and the case by mistake included in;
(2) case of not taken medicine after including in though meet inclusive criteria;
(3) at viewing duration, used in scheme, ban use of in, Western medicine drug person.
1.4.2 case comes off and processing
(1) definition coming off: all patient's Informed Consent Forms of filling in, and screening enters the experimenter of clinical research, no matter when what is because exiting, and as long as no the experimenter in observation time limit who completes scheme defined, is all called the case that comes off.
(2) the come off processing of case: should, in conjunction with practical situation processing, should enter the statistics of untoward reaction as there is untoward reaction person when statistical analysis, complete 1/2 above person the course for the treatment of, should add up curative effect.
2. research method
2.1 EXPERIMENTAL DESIGN
Formulate case report form and research worker handbook, and research worker is unified to training, research worker does not participate in statistical analysis.Then adopt random, contrast, perspective study method to carry out clinical research.The relevant case information obtaining adopts the mode building database of double two-shipper typing.
(1) hiding of random packet, blind method and randomizing scheme
1. random packet: be divided into 2 groups of matched group, test group, be no more than 10% principle according to the case that comes off, the routine patient of sample content 56 of estimation, it is 1 ~ No. 56 according to including serial number in, adopt SAS6.12 software to carry out 1:1 random assortment, generate random number font size, by the regulation to sequence number, ((1=test group, 2=matched group) draws and includes the corresponding random assortment group of serial number in.Make random card, put into light tight envelope sealing.Serial number is attached to envelope outside, and group note is sealed in envelope on random card.2. blind method: all data are carried out typing by non-test professional is unified, and estimator and data processor are blind.3. distribute and hide: use light tight random envelope to carry out hiding of random assortment scheme to clinicist and patient.
(2) medication and administration time
Doctor trained in Western medicine Primary Care: clopidogrel bisulfate tablet, each 75 milligrams, once a day, and Aspirin Enteric-coated Tablets, each 100 milligrams, once a day, morning, 8:00 took medicine; Isosorbide mononitrate sheet, each 20 milligrams, every day twice, pravastatin sodium sheet, each 20 milligrams, every night once, evening, 8:00 took medicine.For complicated hypertension patient, give calcium ion antagonist, as still higher in blood pressure, add diuretic, for complication with diabetes patient, give sulfonylureas drugs for diabetes.For tachyarrhythmia, give propafenone hydrochloride treatment.Merge other diseases, the medication treatment of suiting the medicine to the illness.
Matched group: doctor trained in Western medicine Primary Care.
Test group: conventional doctor trained in Western medicine Primary Care adds Guanxintong square opening clothes (description embodiment ten fills a prescription according to the present invention, boils with decocting, gets decocting liquid), each time a payment, respectively takes 1 time sooner or later.All treat 1 month for 2 groups.
2.2 observed content
2.2.1 two groups of patient's comparability indexs
(1) physical data: comprise age, sex, constitutional index, merging disease etc.
(2) state of an illness data: the selected anginal state of an illness of coronary artery disease, the course of disease, tcm syndrome grade and scoring, angina pectoris degree, SAQ scoring etc.
(3) inflammatory factor: hs-CRP (hs-CRP), the plaques stabilize factor: GELB (MMP-9) and mortifier stromatin enzyme tissue inhibiting 1 (TIMP-1) thereof.
2.2.2 curative effect index and curative effect determinate standard
(1) curative effect observation
1. tcm syndrome individual event scoring and overall score, angina pectoris individual event scoring and overall score, nitroglycerin stop lapse rate, ECG curative effect, the scoring of Seattle angina pectoris scale.
2. inflammatory factor hs-CRP and plaques stabilize factor M MP-9, TIMP-1.
(2) curative effect determinate standard
1. tcm syndrome total effects criterion
Effective: therapeutic index (integrated value reduction) >=70%
Effective: therapeutic index (integrated value reduction) >=30%, <70%
Invalid: therapeutic index (integrated value reduction) <30%
According to nimodipine method: (before treatment after integration-treatment integration) front integration X 100% of/treatment
2. curative effect to treat angina pectoris standard
Angina pectoris symptom total mark is the summation of the dose 4 aspect integrations of angina pectoris pain degree, attack times, persistent period, nitroglycerin.
Slightly/I level
Effective: transference cure or substantially disappearance
Effective: pain attack times, degree and persistent period have obviously and alleviate
Invalid: symptom is substantially identical with before treatment
Increase the weight of: pain attack times, degree and persistent period are increased the weight of (or reaching " moderate ", " severe " standard) to some extent.
Moderate/II level
Effective: transference cure or substantially disappearance
Effective: symptom is relieved to the standard of " slightly "
Invalid: symptom is substantially identical with before treatment
Increase the weight of: pain attack times, degree and persistent period are all increased the weight of the standard of (or reach " severe ") to some extent
Compared with severe/III level
Effective: symptom substantially disappears or is relieved to the standard of " slightly "
Effective: symptom is relieved to the standard of " moderate/II level "
Invalid: symptom is identical with before treatment
Increase the weight of: pain attack times, degree and persistent period are all increased the weight of (or reaching " severe " standard) to some extent
3. ECG curative effect evaluation criteria
Effective: electrocardiogram returns to " roughly normal " or reaches " normal ECG "
Effective: ST section reduces, more than the rear rise 0.05mv for the treatment of
Invalid: electrocardiogram is substantially identical with before treatment
Increase the weight of: more than after treatment, ST section reduces 0.05mv.
4. individual event symptom efficacy assessment standard
Effective: original transference cure or symptom are improved at two more than grade
Effective: symptom is improved a grade but do not disappeared
Invalid: symptom is without change
2.2.3 safety evaluatio
Safety indexes: liver function (ALT, AST), renal function (Cr, BUN), routine blood test, routine urinalysis is respectively looked into 1 time before and after test.
2.3 MMP-9, TIMP-1 experimental technique
2.3.1 peripheral vein blood sample collection
The peripheric venous blood of (1 month) when the selected patient of collection tests front and off-test respectively.Room temperature is placed 30 minutes, and centrifugal 10 minutes of 3000r/min, gets supernatant in EP pipe, and-70 DEG C of cryogenic refrigerators save backup.
2.3.2 test material
(1) reagent
People MMP-9 ELISA test kit (specification 96T, 48T) (Shanghai Excell Biology Product Co., Ltd. provides, 223684), people TIMP-1 ELISA test kit (specification 96T lot number:, 48T) (Shanghai Excell Biology Product Co., Ltd. provides, lot number: 234653), distilled water.
(2) instrument
ELx808 absorbing light microplate reader (BIOTEK), ELx405 automatic washer (BIOTEK), DHP-9082; 7 DEG C of electro-heating standing-temperature cultivators (Shanghai Yi Heng experimental apparatus company limited), Eppendorf Research plus multiple tracks adjustable pipette (Lei get biotech firm), disposable tip, graph paper.
2.3.3ELISA experimentation
(1) from balance to the sealing bag of room temperature, take out the required lath of test, the lath of use and desiccant are not put back in aluminium foil bag and are sealed in 40 DEG C
(2) hole that blanks.
(3) respectively variable concentrations standard substance and specimen are added to (100ul/ hole) in respective aperture, seal reacting hole with shrouding gummed paper, 37 DEG C of incubators are hatched 90 minutes.
(4) within 30 minutes, prepare biotinylated antibody working solution in advance.
(5) wash plate 5 times.
(6), except blank well, add biotinylated antibody working solution (100ul/ hole).Seal reacting hole with shrouding gummed paper, 37 DEG C of incubators are hatched 60 minutes.
(7) within 30 minutes, prepare enzyme conjugates working solution in advance.Room temperature lucifuge is placed.
(8) wash plate 5 times.
(9), except blank well, add enzyme conjugates working solution (100ul/ hole).Seal reacting hole with shrouding gummed paper, 37 DEG C of incubators, lucifuge is hatched 30 minutes.
(10) wash plate 5 times.
(11) add chromogenic substrate (comprising blank well) 100ul/ hole, 37 DEG C of incubators, lucifuge is hatched 15 minutes.
(12) add stop buffer (comprising blank well) 100ul/ hole, after mixing, at once measure OD450 value (in 10 minutes).
3. statistical method
Adopt SPSS16.0 statistical software to analyze.Measurement data adopts
±
srepresent, meet normal state, the neat data of variance t checks, for normal state, heterogeneity of variance data t ' inspection, adopt Kruskal-Walls rank test for nonnormal distribution enumeration data, for enumeration data employing X 2 test or the accurate probabilistic method of Fisher.
4. result of the test
4.1 liang of group analysis of comparable
4.1.1 demography data analysis of comparable
Angina pectoris case 56 examples of this research inclusion criteria are collected underwent coronary radiography and are made a definite diagnosis, meet in this research altogether, 2 examples that come off altogether in the time that treatment finishes, and all from matched group, expulsion rate 3.57%.Finally can add up case 54 examples, matched group 26 examples, test group 28 examples.Two groups of cases are at the aspects such as sex, age, constitutional index, the state of an illness, the course of disease, merging disease, Epidemiological Analysis by statistics, no significant difference ((P>0.05).
4.2 efficacy analysis
4.2.1 individual event symptom score comparison
This research altogether selected chest pain, uncomfortable in chest, breathe hard, cardiopalmus, soreness of the waist and knees, dizziness and tinnitus, tongue are dark, 8 symptoms of deep pulse are as observed content.Treat after 1 month, with matched group comparison, test group improve chest pain, uncomfortable in chest, breathe hard, there is significant difference (P<0.05) aspect soreness of the waist and knees, dizziness and tinnitus symptom, and improving two groups of no difference of science of statistics (P>0.05) (in table 1) aspect cardiopalmus, picture of the tongue, pulse condition.
The comparison of table 1 symptom score
Note: with comparing before treatment, each item rating * P<0.05, * * P<0.01; Compare each item rating Δ P<0.05, Δ Δ P<0.01 with matched group.
4.2.2 angina pectoris scoring relatively
Anginal degree, anginal attack times, anginal persistent period, four aspects of nitroglycerin consumption have mainly been observed in this research.Treat after 1 month, with matched group comparison, test group is shortening the angina pectoris persistent period, reduce nitroglycerin consumption aspect and there is significant difference (P<0.05), and aspect improving chest pain degree, reducing chest pain attack times, the two no difference of science of statistics (P>0.05) (in table 2).
Table 2 angina pectoris scoring relatively
Note: with comparing before treatment, each item rating * P<0.05, * * P<0.01; Compare each item rating Δ P<0.05, Δ Δ P<0.01 with matched group.
4.2.3 treat tcm syndrome therapeutic evaluation after 1 month
Treat tcm syndrome curative effect after 1 month, through rank test, statistics has significant difference (P=0.00 < 0.05), and test group is obviously better than matched group.(in table 3)
4.2.4 the scoring of Seattle angina pectoris scale relatively
Seattle angina pectoris scale is the special scale of evaluating Angina, be divided into five dimensions, be body limitation of activity degree (Physical Limitation, PL), angina pectoris steady statue (Anginal Stability, AS), angina pectoris attacks situation (Anginal Frequeney, AF), five aspects such as the degree of awareness (Disease Perception, DP) for the treatment of satisfaction (Treatment Satisfaction, TS), disease.Treat after 1 month, with matched group comparison, test group can be improved patient's body limitation of activity degree, reduces anginal outbreak, the angina pectoris state of an illness is tended towards stability, thereby improves the satisfaction of patient to treatment.To the two groups of indifferences in degree of awareness aspect (in table 4) of disease.
Table 4 is treated two groups of SAQ scores comparison after 1 month
4.3 safety evaluatio
Routine blood test, routine urinalysis, the each index of hepatic and renal function before and after treatment are tested, P average > 0.05, no difference of science of statistics.Show this medicine on above-mentioned each index without obvious impact, be safe.Concrete numerical value is in Table 5-table 7.
Table 5 whole blood cell analysis safety evaluatio
Note: blood RBC, WBC, HGB, PLT before and after treatment, through t inspection, P average >0.05, no difference of science of statistics.
Table 6 hepatic and renal function safety evaluatio
Note: blood ALT, AST, CR, BUN before and after treatment, through t inspection, P average >0.05, no difference of science of statistics.
Table 7 routine urinalysis safety evaluatio
Note: routine urinalysis before and after treatment, through rank test, P average >0.05, no difference of science of statistics.
4.4 impacts on inflammatory factor in patients serum (hs-CRP), the plaques stabilize factor (MMP-9, TIMP-1)
Treat after 1 month, matched group hs-CRP value decreases, and MMP-9, TIMP-1 variation is not obvious.Test group hs-CRP, MMP-9 all have obvious reduction, and with matched group comparison, the amplitude that test group hs-CRP reduces is larger, TIMP-1 significantly raise (in table 8).
Before and after table 8 test, hs-CRP, MMP-9, TIMP-1 change
Hs-CRP, as atherosclerotic inflammatory mediator, is considered to the strong Inflammatory Mediators of predicting cardiovascular event and receives much attention.Each stage that inflammation occurs, develops in atherosclerosis is all being played the part of key player.Research shows, hs-CRP concentration can reflect the vulnerability of atherosclerotic lesions and the probability of plaque rupture.The predictive value of cardiovascular and cerebrovascular disease danger is significantly higher than to traditional biochemical indicator.This result of study shows, matched group and test group all can reduce patients serum hs-CRP level, but the amplitude that test group reduces is larger, shows that Guanxintong can obviously reduce nonspecific inflammation reaction in body.
MMP-9 is the material impact factor of arteria coronaria plaque stability.Be the Major Members of MMPs family, MMPs is mainly hydrolyzed IV, V, VII, X collagen and elastin laminin, is the main hydrolytic enzyme of substrate degradation, vulnerable plaque ulceration.Atheromatous plaque constantly makes progress just in the circulation of this ulceration and reparation.In blood, MMP-9 content and activity level change with the generation of speckle unstability and angina pectoris closely relatedly, are the important indicators of severity of coronary artery disease and prognosis evaluation.TIMP-1 is one of endogenous specificity suppressioning factor of MMP-9, the two composition of the ratio with 1:1 MMP-TIMP complex, thus blocking-up MMP-9 and Binding Capacity suppress the degraded of extracellular matrix.
In this research, after treatment, test group MMP-9 level is treated front obvious reduction, and TIMP-1 obviously raises; And indifference before and after treatment of control group.Infer that Guanxintong can be by reducing serum MMP-9, rising serum T IMP-1, reduce extracellular matrix degradation and stablize arteria coronaria speckle, reduce angina pectoris and show effect.
5 conclusions: result of study show test group (Guanxintong side) improve patient's chest pain, uncomfortable in chest, breathe hard, be obviously better than matched group (P<0.05) aspect soreness of the waist and knees, dizziness and tinnitus; And improving aspect cardiopalmus, picture of the tongue, pulse condition, reach matched group (Comprehensive Treatment) level (P>0.05), and can increase patient SAQ scoring, the quality of obviously making the life better; Can reduce the seizure frequency of angina pectoris simultaneously.Safety evaluatio find, this medicine on patient's hepatic and renal function, routine blood test, routine urinalysis without impact.Comprehensive prompting, the angina pectoris (traditional Chinese medical science disease belong to deficiency of kidney-YIN, heart-yang blood stasis blocking type) of visible Chinese medicine composition of the present invention to kind of a reason, type, degree all has therapeutic effect in various degree, and clinical drug safety is effective.
Clinical practice proves, following embodiment institute pharmacy all can be realized above-mentioned therapeutic effect.
Detailed description of the invention
embodiment mono-
Prescription: Radix Polygoni Multiflori Preparata 13g, Fructus Trichosanthis 13g, Fructus Mori 13g, Bulbus Allii Macrostemonis 11g, Radix Pseudostellariae 13g, Radix Rehmanniae 13g.
embodiment bis-
Prescription: Radix Polygoni Multiflori Preparata 17g, Fructus Trichosanthis 17g, Fructus Mori 17g, Bulbus Allii Macrostemonis 13g, Radix Pseudostellariae 17g, Radix Rehmanniae 17g.
embodiment tri-
Prescription: Radix Polygoni Multiflori Preparata 14g, Fructus Trichosanthis 16g, Fructus Mori 14g, Bulbus Allii Macrostemonis 11g, Radix Pseudostellariae 14g, Radix Rehmanniae 16g.
embodiment tetra-
Prescription: Radix Polygoni Multiflori Preparata 15g, Fructus Trichosanthis 15g, Fructus Mori 15g, Bulbus Allii Macrostemonis 12g, Radix Pseudostellariae 15g, Radix Rehmanniae 15g.
embodiment five
Prescription: Radix Polygoni Multiflori Preparata 15g, Fructus Trichosanthis 13g, Fructus Mori 13g, Bulbus Allii Macrostemonis 11g, Radix Panacis Quinquefolii 13g, Radix Rehmanniae 17g.
embodiment six
Prescription: Radix Polygoni Multiflori Preparata 16g, Fructus Trichosanthis 160g, Fructus Mori 14g, Bulbus Allii Macrostemonis 13g, Radix Ginseng 15g, Radix Rehmanniae 15g.
embodiment seven
Prescription: Radix Polygoni Multiflori Preparata 13g, Fructus Trichosanthis 13g, Fructus Mori 13g, Bulbus Allii Macrostemonis 11g, Radix Pseudostellariae 13g, Radix Rehmanniae 13g, Fructus Aurantii 8g, Radix Notoginseng 5g, Poria 11g, Semen Armeniacae Amarum 8g.
embodiment eight
Prescription: Radix Polygoni Multiflori Preparata 17g, Fructus Trichosanthis 17g, Fructus Mori 17g, Bulbus Allii Macrostemonis 13g, Radix Pseudostellariae 17g, Radix Rehmanniae 17g, Fructus Aurantii 10g, Radix Notoginseng 7g, Poria 13g, Semen Armeniacae Amarum 10g.
embodiment nine
Prescription: Radix Polygoni Multiflori Preparata 13g, Fructus Trichosanthis 17g, Fructus Mori 13g, Bulbus Allii Macrostemonis 11g, Radix Pseudostellariae 13g, Radix Rehmanniae 17g, Fructus Aurantii 10g, Radix Notoginseng 7g, Poria 11g, Semen Armeniacae Amarum 8g.
embodiment ten
Prescription: Radix Polygoni Multiflori Preparata 15g, Fructus Trichosanthis 15g, Fructus Mori 15g, Bulbus Allii Macrostemonis 12g, Radix Pseudostellariae 15g, Radix Rehmanniae 15g, Fructus Aurantii 9g, Radix Notoginseng 6g, Poria 12g, Semen Armeniacae Amarum 9g.
embodiment 11
Prescription: Radix Polygoni Multiflori Preparata 17g, Fructus Trichosanthis 17g, Fructus Mori 15g, Bulbus Allii Macrostemonis 13g, Radix Codonopsis 13g, Radix Rehmanniae 13g, Fructus Aurantii 9g, Radix Notoginseng 7g, Poria 12g, Semen Armeniacae Amarum 10g.
embodiment 12
Prescription: Radix Polygoni Multiflori Preparata 13g, Fructus Trichosanthis 13g, Fructus Mori 13g, Bulbus Allii Macrostemonis 13g, Radix Ginseng 17g, Radix Rehmanniae 17g, Fructus Aurantii 10g, Radix Notoginseng 7g, Poria 11g, Semen Armeniacae Amarum 8g.
The various embodiments described above medicine is the consumption of potion, and the used time, day took potion to be decocted in water for oral dose.
Claims (8)
1. be used for the treatment of a Chinese medicine composition for angina pectoris, the effective ingredient that it is characterized in that said composition is to be made up of the crude drug of following weight proportion: Radix Polygoni Multiflori Preparata 13-17 part, Fructus Trichosanthis 13-17 part, Fructus Mori 13-17 part, Bulbus Allii Macrostemonis 11-13 part, Radix Pseudostellariae 13-17 part, Radix Rehmanniae 13-17 part, Fructus Aurantii 8-10 part, Radix Notoginseng 5-7 part, Poria 11-13 part, Semen Armeniacae Amarum 8-10 part.
2. Chinese medicine composition according to claim 3, is characterized in that the weight proportion of each crude drug is: 15 parts of Radix Polygoni Multiflori Preparatas, 15 parts of Fructus Trichosanthis, 15 parts of Fructus Mori, 12 parts of Bulbus Allii Macrostemonis, 15 parts of Radix Pseudostellariaes, 15 parts of Radix Rehmanniae, 9 parts of Fructus Aurantiis, 6 parts of Radix Notoginseng, 12 parts, Poria, 9 parts, Semen Armeniacae Amarum.
3. Chinese medicine composition according to claim 1 and 2, is characterized in that the Radix Ginseng of the equivalent of the Radix Pseudostellariae in crude drug, Radix Codonopsis or Radix Panacis Quinquefolii to replace.
In claims 1 to 3 arbitrary described Chinese medicine composition in the application for the preparation of in treatment treating coronary heart disease and angina pectoris.
In claims 1 to 3 arbitrary described Chinese medicine composition in the application for the preparation of in treatment labour's property and/or non-labour's property treating coronary heart disease and angina pectoris.
6. the application of arbitrary described Chinese medicine composition in the medicine for the preparation for the treatment of stable angina pectoris in claims 1 to 3.
7. the application of arbitrary described Chinese medicine composition in the medicine for the preparation for the treatment of unstable angina pectoris in claims 1 to 3.
In claims 1 to 3 arbitrary described Chinese medicine composition in the application for the preparation of in treatment traditional Chinese medical science deficiency of kidney-YIN, heart-yang blood stasis blocking type treating coronary heart disease and angina pectoris.
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| CN103463568B (en) * | 2013-09-12 | 2015-03-11 | 张永雷 | Traditional Chinese medicine for treating coronary heart disease |
| CN106110133A (en) * | 2016-07-04 | 2016-11-16 | 满纪荣 | A kind of Chinese medicine treating unstable angina pectoris and preparation method thereof |
| CN108159246B (en) * | 2018-02-07 | 2021-04-23 | 江苏省中医药研究院 | Traditional Chinese medicine composition for preventing and treating cardiorenal syndrome |
| CN113144133A (en) * | 2020-12-18 | 2021-07-23 | 中国中医科学院广安门医院 | Traditional Chinese medicine composition for treating restenosis or angina after coronary heart disease interventional operation and application thereof |
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| CN101301420A (en) * | 2008-06-20 | 2008-11-12 | 吕英臣 | Medicament for treating angina pectoris of coronary heart disease |
| CN101675972A (en) * | 2008-09-18 | 2010-03-24 | 天津市中宝制药有限公司 | Blood-enriching tranquillizing traditional Chinese medicine composition |
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| CN101301420A (en) * | 2008-06-20 | 2008-11-12 | 吕英臣 | Medicament for treating angina pectoris of coronary heart disease |
| CN101675972A (en) * | 2008-09-18 | 2010-03-24 | 天津市中宝制药有限公司 | Blood-enriching tranquillizing traditional Chinese medicine composition |
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