CN102772491B - Traditional Chinese medicine composition for treating lower extremity atherosclerotic disease and application of composition - Google Patents
Traditional Chinese medicine composition for treating lower extremity atherosclerotic disease and application of composition Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for treating a lower extremity atherosclerotic disease (LEAD). The traditional Chinese medicine composition comprises 25-40 parts of radix astragali and 10-20 parts of mulberry, also can comprise 10-20 parts of radix salviae miltiorrhizae, 10-20 parts of Chinese angelica, 6-12 parts of earthworm and 5-8 parts of leech, and can further comprise 6-12 parts of rhizoma acori tatarinowii, 6-12 parts of rhizoma alismatis, 5-15 parts of tea tree root and 5-18 parts of radix achyranthis bidentatae in parts by weight. The invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating the LEAD. The traditional Chinese medicine composition provided by the invention has the advantages that the medicine offers syndrome differentiation and treatment with the characteristics of traditional Chinese medicine according to the symptoms of the LEAD, and has the effects of activating blood, dredging collaterals and resolving phlegm while placing extra emphasis on replenishing qi and tonifying deficiency so as to fundamentally improve the constitution of a patient, cut the links of worsening the phlegm, deficiency and stasis under a mutual effect, reduce the danger of transferring vessel impediment to heart in terms of prevention and control and realize an obvious curative effect; and the composition does not have toxic and side effects, is easily accepted by the patient, is made from few raw materials, is low in cost, and adopts a simple preparation technology.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and application thereof for the treatment of lower limb atherosclerosis disease, specifically, is to take the Chinese patent medicine that Chinese herbal medicine prepared as raw material.
Background technology
Lower limb atherosclerosis disease (Lower Extremity Atherosclerotic Disease, LEAD) refers to that lower limb atherosclerosis causes stricture of artery even inaccessible, makes lower limb tissue occur the disease of chronic or acute ischemia symptom.China's reported literature, the 60 years old above elderly population in Beijing is 16.4%, and metabolism syndrome crowd is 22.5%, and diabetic population is 19.4%, sickness rate ten/height.
In motherland's medical science successive dynasties medical book, do not have the record about " lower extremities disease ".According to the clinical manifestation of LEAD, primary disease should belong to motherland's medical science " necrosis ", " BI-syndrome involved the blood vessels " category, broadly also belongs to " syndrome of blood stasis " category.The holy agent of < < is always recorded in > > mono-book and is begun to have " BI-syndrome involved the blood vessels " word, and it is said: " courageous and upright Wen Zexuan stream, must tremble with fear that it is puckery to coagulate, coagulate puckery not all right, fur wither worried, muscle numbness ".< < Plain Questions numbness opinion > > point out " numbness be arteries and veins blood clotting and do not flow ".In < < General Treatise on the Cause and Symptoms of Diseases > > to being described as of limb ischemia disease " passages through which vital energy circulates is gone; all arise from brothers; asthenia is the vim and vigour damage that declines, can not its extremity of temperature, therefore extremity cold of the limbs also ".< < Ling Shu Miraculous Pivot or Divine Axis carbuncle piece of writing > > is described later in detail " necrosis ": " send out in toe, name is said thromb angintis and thromboarteriosclerosis.Its shape is red black, stubbornly refuses to control.Not red black, not dead.Do not wane, suddenly cut it, not dead.”。
Most scholar thinks that the Etiological of primary disease is that deficiency of spleen and stomach, expectorant stasis blocking are stagnant, and its pathogenesis character is deficiency in origin and excess in superficiality.Because " the kidney being the origin of congenital constitution " posted part by nephroyin and nephroyang, be the root of life, main store essential substances blood.Spleen is " the foundation of acquired constitution ", " source of generating QI and blood " " The spleen has the function to transport and transform nutrients ".LEAD is more common in old people, < < Plain Questions innocent opinion in ancient times > >: " seven or eight, irritability declines, the tendon being unable to move, and exhaustion of kidney-essence with promoting reproductive function, oligospermia, kidney declines, physique and configuration of the body being very feeble and atrophied."; < < Jing Yue's complete work > > cloud: " blood person essence-QI from water and grain also, come in a continuous stream, and realification is in spleen ".Old people's spleen is suffered from a deficiency of the kidney and is declined, and deficiency of the spleen causing weakness of QI is dysfunction of the spleen, the dysfunction of the spleen and raw humidogene expectorant, and phlegm-damp enters arteries and veins, and retardance blood normally moves, and blood is unfavorable, becomes blood stasis.Modern, because the dietary that dietary structure and operating pressure cause changes, causes eating and drinking without temperance, surfeit delicious food, lacks physical work in addition, and the exhaustion due to sexual indulgence person that stays up late again, causes asthenia of both the spleen and kidney body constitution.< < General Treatise on the Cause and Symptoms of Diseases > > says again: " all expectorant persons; this is jammed by blood vessels, drinking-water gathers and do not dissipate, and becomes expectorant also ", phlegm-turbidity and blood stasis blood agglomeration gathers in channels, forms the qi-asthenia phlegm stasis of blood.< < Ling Shu Miraculous Pivot or Divine Axis disorder of defensive QI opinion > > says: " people has fat, has cream, has meat ", and if fat is too much, body has change, at least " body is damp without cream ".Cream fat and body fluid homology, be the thick turbid person of body fluid, and it can dissolve in blood.If it is taken in too much, utilize, excretory function is not normal, can make blood fat raise and send out as expectorant is turbid, stagnation of phlegm is in venation, and venation is obstructed and the stasis of blood is stagnant in vascular, and phlegm and blood stasis is sent out as primary disease.Modern Chinese medicine doctor thinks that hyperlipemia and hypercoagulability belong to " the expectorant stasis of blood " category of the traditional Chinese medical science.Expectorant coagulates and blood stasis is that Atheromatosis reason is crucial, and the essence of " stasis of blood " is believed to comprise atherosclerotic plaque, thrombosis, high blood clotting and hyperlipemia etc. in interior pathological state.
Reported at present to be used for the treatment of LEAD Chinese medicine composition evident in efficacy less, Chinese patent literature application number: 200410072690.8, the applying date: 2004-11-09, a kind of vasculitis for the treatment of is disclosed, scleroderma and arteriosclerosis lower extremities vascular occlusion disease drug and preparation thereof, it is with Radix Salviae Miltiorrhizae, Caulis Spatholobi, Olibanum, Myrrha, Radix Curcumae is raw material according to every taste Chinese medicine different qualities, be ground into respectively fine powder, with after the pretreatment such as water extraction, be mixed in proportion again and make tablet, the dosage forms such as capsule, this Drug therapy Peripheral arterial occlusive disease is evident in efficacy.Chinese patent literature application number CN 200910017097.6, the applying date: 2009-07-24, a kind of Chinese medicine preparation for the treatment of type 2 diabetes mellitus lower limb atherosclerosis is disclosed, this Chinese medicine preparation is to be made by the component of following weight portion: 10～15 parts of Cortex Cinnamomis, 40～60 parts of the Radixs Astragali, 10～20 parts of Ramulus Cinnamomi, 30～50 parts of Herba Epimedii, 30～50 parts of Ramulus Euonymis, 5～10 parts of Radix Notoginseng, 10～20 parts, Flos Carthami, 6～10 parts of Rhizoma Chuanxiongs, 10～15 parts of Rhizoma Coptidis, 10～20 parts of Radix Cyathulaes, through efficacy experiment, show that this Chinese medicine preparation has its intimal hyperplasia of improvement, reduce the effect of plaque thickness and stabilize plaque.The flavour of a drug number of above-mentioned two kinds of medicines is more, makes troubles to the preparation of medicine, has also increased the cost of medicine.Therefore it is particularly important that, development treatment LEAD effect significantly also possesses the Chinese medicine composition of few, the easy preparation of taste number, the low advantage of cost simultaneously.
Summary of the invention
The object of the invention is for deficiency of the prior art, a kind of Chinese medicine composition for the treatment of lower limb atherosclerosis disease is provided.
One object more of the present invention is that a kind of purposes of above-mentioned Chinese medicine composition is provided.
For achieving the above object, the technical scheme that the present invention takes is:
Treat a Chinese medicine composition for lower limb atherosclerosis disease, it comprises the crude drug of following weight portion: Radix Astragali 25-40 part, Fructus Mori 10-20 part.
Preferably, the described Radix Astragali is that 27-35 part, described Fructus Mori are 13-17 parts.
Preferably, the described Radix Astragali is that 30 parts, described Fructus Mori are 15 parts.
Described Chinese medicine composition also can further comprise the crude drug of following weight portion: Radix Salviae Miltiorrhizae 10-20 part, Radix Angelicae Sinensis 10-20 part, Pheretima 6-12 part, Hirudo 5-8 part.
Preferably, described Radix Salviae Miltiorrhizae is that 12-18 part, described Radix Angelicae Sinensis are that 12-18 part, described Pheretima are that 8-11 part, described Hirudo are 6-7 parts.
Preferably, described Radix Salviae Miltiorrhizae is that 15 parts, described Radix Angelicae Sinensis are that 15 parts, described Pheretima are that 9 parts, described Hirudo are 6 parts.
Described Chinese medicine composition also can further comprise the crude drug of following weight portion: described Rhizoma Acori Graminei is that 6-12 part, described Rhizoma Alismatis are that 6-12 part, described Radix Camelliae sinensis are 5-15 parts, and described Radix Achyranthis Bidentatae is 5-18 part.
Preferably, described Rhizoma Acori Graminei is that 9 parts, described Rhizoma Alismatis are that 9 parts, described Radix Camelliae sinensis are 10 parts, and described Radix Achyranthis Bidentatae is 12 parts.
The medicament of described Chinese medicine composition can be tablet, capsule, granule, oral liquid, mixture or syrup.
For realizing above-mentioned second object, the technical scheme that the present invention takes is:
As above the application of arbitrary described Chinese medicine composition in preparation treatment lower limb atherosclerosis disease medicine.
The advantage of Chinese medicine composition of the present invention is:
1, according to LEAD symptom, give the determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs of tcm characteristic, when reducing phlegm, promoting blood circulation to remove obstruction in the collateral stresses QI invigorating tonify deficiency, thereby solve following problem: from General Symptoms, improve patients ' life quality, fundamentally improve patient's body constitution, from pathogenesis, block the phase of expectorant, void, the stasis of blood and suffer from each other the link that continues development, the danger of reduction BI-syndrome involved the blood vessels telepathy from preventing and treating, thus be harmonious with differentiation of tcm and preventive treatment of disease, go deep into that it is basic, curative effect is obvious;
2, by pure Chinese medicine, made, have no side effect, be easy to be accepted by patient;
3, raw material components is few, and abundant raw materials is easy to get, low price, and preparation technology is simple, is applicable to promoting the use of.
The specific embodiment
Below the specific embodiment provided by the invention is elaborated.
the preparation (one) of embodiment 1 Chinese medicine composition one of the present invention
25 parts of the Radixs Astragali, 20 parts of Fructus Mori, conventional method decocts.
the preparation (two) of embodiment 2 Chinese medicine composition one of the present invention
40 parts of the Radixs Astragali, 10 parts of Fructus Mori, conventional method decocts.
the preparation (three) of embodiment 3 Chinese medicine composition one of the present invention
25 parts of the Radixs Astragali, 10 parts of Fructus Mori, conventional method decocts.
the preparation (four) of embodiment 4 Chinese medicine composition one of the present invention
40 parts of the Radixs Astragali, 20 parts of Fructus Mori, conventional method decocts.
the preparation (five) of embodiment 5 Chinese medicine composition one of the present invention
27 parts of the Radixs Astragali, 17 parts of Fructus Mori, conventional method decocts.
the preparation (six) of embodiment 6 Chinese medicine composition one of the present invention
35 parts of the Radixs Astragali, 13 parts of Fructus Mori, conventional method decocts.
the preparation (seven) of embodiment 7 Chinese medicine composition one of the present invention
30 parts of the Radixs Astragali, 15 parts of Fructus Mori, conventional method decocts.
the preparation (one) of embodiment 8 Chinese medicine composition two of the present invention
25 parts of the Radixs Astragali, 20 parts of Fructus Mori, 10 parts of Radix Salviae Miltiorrhizaes, 20 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 8 parts of Hirudos, conventional method decocts.
the preparation (two) of embodiment 9 Chinese medicine composition two of the present invention
40 parts of the Radixs Astragali, 10 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 10 parts of Radix Angelicae Sinensis, 12 parts of Pheretimas, 5 parts of Hirudos, conventional method decocts.
the preparation (three) of embodiment 10 Chinese medicine composition two of the present invention
25 parts of the Radixs Astragali, 10 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 20 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 5 parts of Hirudos, conventional method decocts.
the preparation (four) of embodiment 11 Chinese medicine composition two of the present invention
40 parts of the Radixs Astragali, 10 parts of Fructus Mori, 10 parts of Radix Salviae Miltiorrhizaes, 10 parts of Radix Angelicae Sinensis, 12 parts of Pheretimas, 5 parts of Hirudos, conventional method decocts.
the preparation (five) of embodiment 12 Chinese medicine composition two of the present invention
40 parts of the Radixs Astragali, 20 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 18 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 5 parts of Hirudos, conventional method decocts.
the preparation (six) of embodiment 13 Chinese medicine composition two of the present invention
27 parts of the Radixs Astragali, 17 parts of Fructus Mori, 12 parts of Radix Salviae Miltiorrhizaes, 18 parts of Radix Angelicae Sinensis, 11 parts of Pheretimas, 7 parts of Hirudos, conventional method decocts.
the preparation (seven) of embodiment 14 Chinese medicine composition two of the present invention
35 parts of the Radixs Astragali, 13 parts of Fructus Mori, 18 parts of Radix Salviae Miltiorrhizaes, 12 parts of Radix Angelicae Sinensis, 8 parts of Pheretimas, 6 parts of Hirudos, conventional method decocts.
the preparation (eight) of embodiment 15 Chinese medicine composition two of the present invention
25 parts of the Radixs Astragali, 17 parts of Fructus Mori, 12 parts of Radix Salviae Miltiorrhizaes, 20 parts of Radix Angelicae Sinensis, 8 parts of Pheretimas, 7 parts of Hirudos, conventional method decocts.
the preparation (nine) of embodiment 16 Chinese medicine composition two of the present invention
25 parts of the Radixs Astragali, 13 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 10 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 8 parts of Hirudos, conventional method decocts.
the preparation (ten) of embodiment 17 Chinese medicine composition two of the present invention
30 parts of the Radixs Astragali, 15 parts of Fructus Mori, 15 parts of Radix Salviae Miltiorrhizaes, 15 parts of Radix Angelicae Sinensis, 9 parts of Pheretimas, 6 parts of Hirudos, conventional method decocts.
the preparation (one) of embodiment 18 Chinese medicine composition three of the present invention
25 parts of the Radixs Astragali, 20 parts of Fructus Mori, 10 parts of Radix Salviae Miltiorrhizaes, 20 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 8 parts of Hirudos, 6 parts of Rhizoma Acori Graminei, 12 parts of Rhizoma Alismatis, 5 parts of Radix Camelliae sinensiss, 18 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (two) of embodiment 19 Chinese medicine composition three of the present invention
40 parts of the Radixs Astragali, 10 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 10 parts of Radix Angelicae Sinensis, 12 parts of Pheretimas, 5 parts of Hirudos, 12 parts of Rhizoma Acori Graminei, 6 parts of Rhizoma Alismatis, 15 parts of Radix Camelliae sinensiss, 5 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (three) of embodiment 20 Chinese medicine composition three of the present invention
25 parts of the Radixs Astragali, 10 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 20 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 5 parts of Hirudos, 12 parts of Rhizoma Acori Graminei, 12 parts of Rhizoma Alismatis, 5 parts of Radix Camelliae sinensiss, 5 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (four) of embodiment 21 Chinese medicine composition three of the present invention
40 parts of the Radixs Astragali, 10 parts of Fructus Mori, 10 parts of Radix Salviae Miltiorrhizaes, 10 parts of Radix Angelicae Sinensis, 12 parts of Pheretimas, 5 parts of Hirudos, 12 parts of Rhizoma Acori Graminei, 6 parts of Rhizoma Alismatis, 5 parts of Radix Camelliae sinensiss, 18 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (five) of embodiment 22 Chinese medicine composition three of the present invention
40 parts of the Radixs Astragali, 20 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 18 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 5 parts of Hirudos, 12 parts of Rhizoma Acori Graminei, 12 parts of Rhizoma Alismatis, 15 parts of Radix Camelliae sinensiss, 5 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (six) of embodiment 23 Chinese medicine composition three of the present invention
27 parts of the Radixs Astragali, 17 parts of Fructus Mori, 12 parts of Radix Salviae Miltiorrhizaes, 18 parts of Radix Angelicae Sinensis, 11 parts of Pheretimas, 7 parts of Hirudos, 6 parts of Rhizoma Acori Graminei, 12 parts of Rhizoma Alismatis, 5 parts of Radix Camelliae sinensiss, 5 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (seven) of embodiment 24 Chinese medicine composition three of the present invention
35 parts of the Radixs Astragali, 13 parts of Fructus Mori, 18 parts of Radix Salviae Miltiorrhizaes, 12 parts of Radix Angelicae Sinensis, 8 parts of Pheretimas, 6 parts of Hirudos, 12 parts of Rhizoma Acori Graminei, 9 parts of Rhizoma Alismatis, 10 parts of Radix Camelliae sinensiss, 18 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (eight) of embodiment 25 Chinese medicine composition three of the present invention
25 parts of the Radixs Astragali, 17 parts of Fructus Mori, 12 parts of Radix Salviae Miltiorrhizaes, 20 parts of Radix Angelicae Sinensis, 8 parts of Pheretimas, 7 parts of Hirudos, 12 parts of Rhizoma Acori Graminei, 12 parts of Rhizoma Alismatis, 15 parts of Radix Camelliae sinensiss, 18 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (nine) of embodiment 26 Chinese medicine composition three of the present invention
25 parts of the Radixs Astragali, 13 parts of Fructus Mori, 20 parts of Radix Salviae Miltiorrhizaes, 10 parts of Radix Angelicae Sinensis, 6 parts of Pheretimas, 8 parts of Hirudos, 6 parts of Rhizoma Acori Graminei, 12 parts of Rhizoma Alismatis, 5 parts of Radix Camelliae sinensiss, 18 parts of Radix Achyranthis Bidentataes, conventional method decocts.
the preparation (ten) of embodiment 27 Chinese medicine composition three of the present invention
30 parts of the Radixs Astragali, 15 parts of Fructus Mori, 15 parts of Radix Salviae Miltiorrhizaes, 15 parts of Radix Angelicae Sinensis, 9 parts of Pheretimas, 6 parts of Hirudos, 9 parts of Rhizoma Acori Graminei, 9 parts of Rhizoma Alismatis, 10 parts of Radix Camelliae sinensiss, 12 parts of Radix Achyranthis Bidentataes, conventional method decocts.
It should be noted that, it is the manufacture method of Chinese medicine decoction routine that the conventional method described in embodiment 1-27 decocts, and is about to described crude drug and decocts with water into decoction.
embodiment 28 treatmentslEAD
the preparation of medicinal tablet/capsule
Get the arbitrary described medicine of embodiment 1-27, add 6-10 times of water gaging, decoct 1-3 hour, leach medicine juice; Add again 6-10 times of water gaging, decoct 0.5-2 hour, leach medicine juice; Merge secondary decocting liquid, standing, leaching supernatant, concentrated, let cool, add concentrated solution 2-3 and doubly measure ethanol, stir precipitation and spend the night; Get supernatant, be concentrated into thick extractum; Add pharmaceutic adjuvant (selecting pharmaceutic adjuvant according to conventional method), vacuum drying, pulverizes and granulates, and is pressed into tablet or fills encapsulated.
embodiment 29 treatmentslEAD
the preparation of drug particles
Get the arbitrary described medicine of embodiment 1-27, add 6-10 times of water gaging, decoct 1-3 hour, leach medicine juice; Add again 6-10 times of water gaging, decoct 0.5-2 hour, leach medicine juice; Merge secondary decocting liquid, standing, leaching supernatant, concentrated, let cool, add concentrated solution 2-3 and doubly measure ethanol, stir precipitation and spend the night; Get supernatant, be concentrated into thick extractum; Add pharmaceutic adjuvant (selecting pharmaceutic adjuvant according to conventional method), vacuum drying, pulverizes and granulates, and dry, granulate, obtains 20g granule, subpackage 10g/ bag.
embodiment 30 treatmentslEAD
the preparation of drug mixture/oral liquid/syrup
Get the arbitrary described medicine of embodiment 1-27, add 6-10 times of water gaging, decoct 1-3 hour, leach medicine juice; Add again 6-10 times of water gaging, decoct 0.5-2 hour, leach medicine juice; Merge secondary decocting liquid, standing, leaching supernatant, concentrated, let cool, add concentrated solution 2-3 and doubly measure ethanol, stir precipitation and spend the night; Get supernatant, be concentrated into thick extractum; Add suitable pharmaceutical aids (selecting pharmaceutic adjuvant according to conventional method), make mixture, oral liquid or syrup.
embodiment 31 treatment of the present inventionlEAD
the clinical trial of Chinese medicine composition
One, object of study
1. case is originated
2010-2012 Department of Aged wards of attached Yueyang hospitals of traditional Chinese and western medicine of Traditional Chinese Medicine in Shanghai university are collected in this research and the old LEAD deficiency of vital energy of outpatient service IIa phase is held expectorant blood stasis syndrome patient under the arm.
2. sample content
N=120 example.Set α=0.01, β=0.2, power=0.80, δ=2(μ
α+ μ
β) σ/√ N.
3. inclusive criteria
By American Heart Association (AHA) peripheral blood vessel practice guidelines in 1993, ABI≤0.90, there is the probability person of obstruction of artery; Meet the sick Fontaine method of lower limb atherosclerosis clinical stages belongs to IIa phase person (Fontaine method clinical stages--the I phase: asymptomatic, but can be with lower limb function complete or decline simultaneously; The IIa phase: slightly walk lamely; The IIb phase: in walk lamely to severe; The III phase: ischemic rest pain; The IV phase: ulcer or gangrene.) can be diagnosed as lower limb atherosclerosis sick selected.Syndrome of deficiency of QI and syndrome of intermin-gled phlegm and blood stasis standard in the < < State Standard of the People's Republic of China tcm clinical practice diagnosis and treatment term syndrome part > > (GB/T16751.2-1997) that issue according to State Bureau of Technical Supervision after selected, in conjunction with the related content of < < lower Extremity Arterial Diseases diagnosis and treatment principle > > in the old peripheral arteriosclerosis disease of Second China National in 2008 symposium, the genus deficiency of vital energy is held expectorant blood stasis syndrome person under the arm and is finally included object of study in.Final selected patient intends 120 examples, is divided at random four groups for the treatment of group one, treatment group two, treatment group three and matched groups, four groups of patient age 60-80 year, male or female, and complication, age ratio, compared with difference not statistically significant, have comparability.
4. exclusion standard
(1) get rid of belonging to the sick Fontaine method of lower limb atherosclerosis clinical stages belongs to other the clinical stages persons beyond the IIa phase; Get rid of other ischemic disease of limb such as thromboangiitis obliterans, Takayasu arteritis, raynaud disease, cold injured blood vessel disease;
(2) all patients all get rid of actute infection, tumor, severe cardiac hepatic and kidney function obstacle, operation or wound, connective tissue disease etc. affect the other diseases of immune factor level in the recent period.Except gestation, women breast-feeding their children, to this test Chinese medicine composition or Western medicine allergy sufferers, stupor, brain function serious hindrance person.The hyperlipidemia patient causing due to medicine (as phenothiazines, adrenocortical steroid and some contraceptive etc.); Hyperthyroidism person; Using heparin, thyroxine therapy and other patient who affects blood lipid metabolism medicine or use immunosuppressant, reinforcing agent.
5. randoming scheme grouping
First with computer, produce 120 random digits, according to random method, be divided into treatment group one, treatment group two, treatment group three and matched group, then result is put into preprepared envelope.The person of including in is numbered according to time sequencing, then extract envelope grouping.
Two, research method
1. arm index detects
Experimenter measures front 6h, and no smoking, drink, drink tea or coffee.The inactive vasodilation of 24h before checking.Patient's dorsal position, loosens at least 5min that has a rest, and standard desktop mercurial sphygmomanometer cuff is tied up in upper arm and lower limb ankle.Brachial artery is aimed at upper arm cuff air bag sign place, and cuff lower edge is apart from fossa cubitalis band 2～3cm, and cuff elasticity is advisable with the lucky finger of putting into; Lower limb cuff air bag sign place is positioned at preaxial, and cuff lower edge is apart from internal malleolus 1～2cm, and cuff elasticity is the same.Stethoscope is placed in brachial artery, pulsation of foot dorsal artery place.Ankle blood pressure, arm pressure value are respectively surveyed 3 times, average as ankle blood pressure, arm pressure value.The order of measuring has a certain impact to bilateral ankle arterial pressure, generally from right brachial arteries, right side dorsal artery of foot, right side posterior tibial artery, left side dorsal artery of foot, left side posterior tibial artery, the systolic pressure of left side brachial artery lower limb ankle tremulous pulse and the ratio of homonymy brachial artery systolic pressure successively, amount of calculation records ABI, gets low value analysis.Give respectively when object of study is included when research and off-test administration in on-test and detecting.
2. administering mode
Treatment group one, two, three is taken respectively the Chinese medicine composition of embodiment 7,17,27, and this Chinese medicine composition decocts to concentration as containing crude drug amount 0.25g/mL, every day 2 times, each 140ml is oral, add use: simvastatin (being provided by Mo Shadong company), every day 1 time, each 40mg is oral; Visit aspirin (Bayer A.G), every day 1 time, each 100mg is oral; Lisinopril (Five continents drugmaker provides), every day 1 time, each 10mg is oral.
Matched group is provided by simvastatin (being provided by Mo Shadong company), and every day 1 time, each 40mg is oral; Visit aspirin (Bayer A.G provides), every day 1 time, each 100mg is oral; Lisinopril (Five continents drugmaker provides), every day 1 time, each 10mg is oral; Each organizes administration 3 months.
3. tcm symptom scale assessment
According to syndrome of deficiency of QI and syndrome of intermin-gled phlegm and blood stasis standard in the < < State Standard of the People's Republic of China tcm clinical practice diagnosis and treatment term syndrome part > > (GB/T 16751.2-1997) of State Bureau of Technical Supervision's issue, related content in conjunction with < < lower Extremity Arterial Diseases diagnosis and treatment principle > > in the old peripheral arteriosclerosis disease of Second China National in 2008 symposium, make this test tcm symptom assessment scale, in Table 1.
Table 1 tcm symptom marking scales
Four groups of patient's on-tests and carry out respectively the scoring of tcm symptom scale while finishing, and carry out before and after self between comparison and group relatively.
Symptom classification and score, curative effect determinate standard (according to new Chinese medicine guideline of clinical investigations) are as follows:
Symptom classification and score are: severe is 3 minutes, and moderate is 2 minutes, are slightly 1 minute, and asymptomatic is 0 minute;
Curative effect determinate standard: control: clinical symptoms, sign disappear or substantially disappear, and syndrome integration reduces >=95%; Effective: clinical symptoms, sign are obviously improved, syndrome integration reduces >=70%; Effective: clinical symptoms, sign all take a favorable turn, syndrome integration reduces >=30%; Invalid: clinical symptoms, sign are not improved, even increase the weight of, syndrome integration reduces less than 30%.
4. in femoral artery-middle film (IMT) detects
Before on-test and while finishing, with color Doppler echocardiography (ATL5000/VIVID7 type) frequency probe 7.5～13MHz, detect.Person under inspection gets dorsal position, in demonstration femoral artery tube chamber and front and rear wall-middle film, measure IMT, repeated measure 3 times, gets its meansigma methods.Doppler sample volume is placed in to the above 1.0cm of femoral artery bifurcated plane place.
5. serum detection method
(1) ELLISA method detects IFN-γ, IL-4 and calculates its ratio.
(2) lipid determination (comprising triglyceride (Tc), cholesterol (TG), high density lipoprotein (HDL), low density lipoprotein, LDL (LDL)): the 7170s of Hitachi type, fully-automatic large-scale biochemistry analyzer.
Before experiment, experiment finishes each and detects once.
6. statistical analysis
Mean ± standard deviation for measurement data (
± S) represent, measurement data adopts t check, paired t-test; Enumeration data adopts X 2 test; Ranked data adopt Ridit to analyze.Adopt SPSS 16.0 statistical software statistical analysiss.
Three, result
1. tcm syndrome curative effect comparison
Each organizes tcm syndrome efficacy result in Table 2.As shown in Table 2, treatment group one 30 examples, effective 7 examples; Effective 17 examples; Invalid 4 examples; Increase the weight of 2 examples; Total effective rate is 80%.Treatment group 2 30 examples, effective 8 examples; Effective 16 examples; Invalid 4 examples; Increase the weight of 2 examples; Total effective rate is 80%.Treatment group 3 30 examples, effective 8 examples; Effective 17 examples; Invalid 3 examples; Increase the weight of 2 examples; Total effective rate is 83.33%.Matched group 30 examples, effective 6 examples; Effective 14 examples; Invalid 6 examples; Increase the weight of 4 examples; Total effective rate is 66.7%.Treatment group one, two, three respectively with matched group comparison, all there is significant difference (P<0.05), show that treatment group one, two, three tcm syndrome curative effects are all better than matched group.Between treatment group one, two, three, compare between two, difference is not remarkable.
Table 2 is respectively organized the comparison of tcm syndrome curative effect
Note: with matched group comparison,
▲p<0.05.
2. Smax(plaque area), IMT comparison
Each testing result of organizing Smax, IMT is in Table 3.As shown in Table 3, the equal no difference of science of statistics of Smax (P>0.05) before and after treatment group one, two, three treatments, but have downward trend.After treatment group one, two, three treatment, all there is significant difference (P<0.05) with comparing after treatment of control group respectively.The equal no difference of science of statistics of IMT (P>0.05) before and after treatment group one, two, three treatments, but have downward trend.After treatment group one, two, three treatment, all there is significant difference (P<0.05) with comparing after treatment of control group respectively.
Smax before and after each group treatment of table 3, IMT comparison (
± S)
Note: relatively front with treatment, ● P>0.05; With matched group comparison, ▲ P<0.05.
3. IL-4, IFN-γ comparison
IL-4, IFN-γ testing result are in Table 4.As can be seen from Table 4, after treatment group one, two, three treatments, levels of IL-4 all obviously raises, and IFN-γ level obviously lowers, and relatively has obvious significant difference (P<0.05, P<0.05) before and after treatment; After treatment group one, two, three treatments, levels of IL-4 all obviously raises, and IFN-γ level obviously lowers, and relatively has obvious significant difference (P<0.05, P<0.05) before and after treatment; Treatment group one, two, three respectively with after treatment of control group, compare each index and all have obvious significant difference (P<0.05, P<0.05).
IL-4 before and after each group treatment of table 4, IFN-γ comparison (
± S)
Note: relatively front with treatment, * P < 0.05; With matched group comparison, ▲ P<0.05.
4. blood fat (Tc, TG, HDL, LDL) relatively
Blood fat (Tc, TG, HDL, LDL) testing result is in Table 5.As can be seen from Table 5, Tc, TG, the equal no difference of science of statistics of HDL, LDL (P>0.05, P>0.05, P>0.05, P>0.05) before and after treatment group one, two, three treatments; Treatment group one, two, three is treated rear Tc, TG, HDL, LDL comparison, all no difference of science of statistics (P>0.05, P>0.05, P>0.05, P>0.05) with matched group respectively.
Tc, TG before and after each group treatment of table 5, HDL, LDL comparison (
± S)
Note: relatively front with treatment, ● P>0.05; With matched group comparison, ▲ P>0.05.
Above statistical result shows, traditional Chinese medicine composition for treating LEAD of the present invention, and through tcm symptom scoring, showing efficiency obviously increases, and Smax value, IMT value decline to some extent simultaneously, and IL-4, IFN-γ are increased significantly, and show that it is evident in efficacy.Its reason is mainly that this Chinese medicine composition is is spleen kidney asthenia as the principal aspect from LEAD, and the sick pathology and disease mechanism that the expectorant stasis of blood is mark is started with, and gives the determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs of tcm characteristic according to LEAD symptom, stresses QI invigorating tonify deficiency when promoting blood circulation to remove obstruction in the collateral reduces phlegm.In the crude drug of this Chinese medicine composition, the monarch drug Radix Astragali: Gan Wen, is apt to into taste, is invigorating the spleen and replenishing QI key medicine, can enter lung replenishing and restoring lung-QI again, and the gas of spleen lung promotes the defeated cloth of body fluid, the unlikely formation expectorant stasis of blood, and the Radix Astragali also can qi-supplementing, blood-engendering, tonifying QI to promote blood circulation; Monarch drug Fructus Mori: sweet, sour, cold, return liver, kidney channel, the moon of energy liver and kidney tonifying, holds concurrently and can bring down a fever by removing heat from blood, replenishing blood and nourishing liver; Minister is with Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Pheretima nourshing blood and promoting blood circulation, disperse blood stasis and dredge collateral; Radix Salviae Miltiorrhizae bitter cold wherein, both removing heat from blood and promoting blood circulation, heat clearing away eliminating carbuncle again, the kind blood vessels that can pass through, stasis-dispelling and pain-killing, share with the Radix Camelliae sinensis of kind promoting blood flow to regulate menstruation, heat-clearing and toxic substances removing, the common pyretic toxicity, the merit of dredging blood vessel of dispelling; The sweet Wen Zhirun of Radix Angelicae Sinensis, is longer than and enriches blood, and is the panacea of enriching blood, and Xin Hangwen is logical again, enriches blood and invigorates blood circulation, and dispersing cold for relieving pain, is the key medicine of blood-activating and qi-promoting, obtains the use of the Radix Astragali, enriches blood, circulation of qi promoting, the power of invigorating blood circulation be more special; Pheretima is salty, cold, and property is walked string, and the row network of being good at stimulating the menstrual flow, matches with the Radix Astragali, Radix Angelicae Sinensis, and the effect of more beneficial promoting blood circulation to remove obstruction in the collateral separately has the merit of diuresis, can make turbid damp go from urine; Assistant is with Rhizoma Acori Graminei, Radix Camelliae sinensis, Rhizoma Alismatis dispelling dampness and promoting diuresis, heat-clearing and toxic substances removing; The pungent temperature fragrance of Rhizoma Acori Graminei, kind removing dampness is turbid, the stomach of being amusing; Rhizoma Alismatis is sweet, cold, inducing diuresis to remove edema, eliminating dampness by diuresis, expels the heat-evil, and property is light oozes, and its diuretic effect is stronger, share Rhizoma Acori Graminei, Pheretima, Radix Camelliae sinensis, Radix Achyranthis Bidentatae, and turbid damp goes to the greatest extent, and has the use of assistant Radix Salviae Miltiorrhizae, Radix Camelliae sinensis heat clearing away; Radix Achyranthis Bidentatae is for making medicine: promoting blood circulation to restore menstrual flow, invigorating the liver and kidney, bone and muscle strengthening, relieving stranguria by diuresis, ignite (blood) are descending, are to be kidney channel guiding drug.All medicines share, with playing training, mend the effect that thin arteries and veins is invigorated blood circulation, thereby improve patients ' life quality from General Symptoms, fundamentally improve patient's body constitution, from pathogenesis, block the phase of expectorant, void, the stasis of blood and suffer from each other the link that continues development, the danger of reduction BI-syndrome involved the blood vessels telepathy from preventing and treating, is harmonious with differentiation of tcm and preventive treatment of disease.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, do not departing under the prerequisite of the inventive method; can also make some improvement and supplement, these improvement and supplement and also should be considered as protection scope of the present invention.
Claims (10)
1. a Chinese medicine composition for the treatment of lower limb atherosclerosis disease, is characterized in that, it is made by the crude drug of following weight portion: Radix Astragali 25-40 part, Fructus Mori 10-20 part.
2. Chinese medicine composition according to claim 1, is characterized in that, the described Radix Astragali is 27-35 part, and described Fructus Mori are 13-17 parts.
3. Chinese medicine composition according to claim 1, is characterized in that, the described Radix Astragali is 30 parts, and described Fructus Mori are 15 parts.
4. a Chinese medicine composition for the treatment of lower limb atherosclerosis disease, it is characterized in that, it is made by the crude drug of following weight portion: Radix Astragali 25-40 part, Fructus Mori 10-20 part, Radix Salviae Miltiorrhizae 10-20 part, Radix Angelicae Sinensis 10-20 part, Pheretima 6-12 part, Hirudo 5-8 part.
5. Chinese medicine composition according to claim 4, is characterized in that, described Radix Salviae Miltiorrhizae is that 12-18 part, described Radix Angelicae Sinensis are that 12-18 part, described Pheretima are that 8-11 part, described Hirudo are 6-7 parts.
6. Chinese medicine composition according to claim 5, is characterized in that, described Radix Salviae Miltiorrhizae is that 15 parts, described Radix Angelicae Sinensis are that 15 parts, described Pheretima are that 9 parts, described Hirudo are 6 parts.
7. a Chinese medicine composition for the treatment of lower limb atherosclerosis disease, it is characterized in that, it is made by the crude drug of following weight portion: Radix Astragali 25-40 part, Fructus Mori 10-20 part, Radix Salviae Miltiorrhizae 10-20 part, Radix Angelicae Sinensis 10-20 part, Pheretima 6-12 part, Hirudo 5-8 part, Rhizoma Acori Graminei 6-12 part, Rhizoma Alismatis 6-12 part, Radix Camelliae sinensis 5-15 part, Radix Achyranthis Bidentatae 5-18 part.
8. Chinese medicine composition according to claim 7, is characterized in that, described Rhizoma Acori Graminei is that 9 parts, described Rhizoma Alismatis are that 9 parts, described Radix Camelliae sinensis are 10 parts, and described Radix Achyranthis Bidentatae is 12 parts.
9. according to the arbitrary described Chinese medicine composition of claim 1-6, it is characterized in that, the medicament of described Chinese medicine composition is tablet, capsule, granule, oral liquid, mixture or syrup.
10. the application of the arbitrary described Chinese medicine composition of claim 1-6 in preparation treatment lower limb atherosclerosis disease medicine.
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