CN103961655A - Medicament for treating femoral head necrosis and preparation method thereof - Google Patents

Abstract

The invention provides a medicament for treating femoral head necrosis. The medicament is prepared from the following traditional Chinese medicinal materials in parts by weight: 40-50 parts of pseudo-ginseng, 75-90 parts of suberect spatholobus stem, 75-90 parts of radix achyranthis bidentatae, 75-90 parts of medlar, 75-90 parts of teasel root, 75-90 parts of rhizoma drynariae (sand heated), 75-90 parts of salviae miltiorrhizae, 75-90 parts of Chinese angelica, 75-90 parts of ligusticum wallichii, 75-90 parts of cortex acanthopanacis, 115-130 parts of prepared rehmannia root, 115-130 parts of codonopsis pilosula, 75-90 parts of rhizoma atractylodis macrocephalae, 115-130 parts of prepared frankincense, 115-130 parts of prepared myrrh, 115-130 parts of corydalis tuber, 20-25 parts of rheum officinale, 75-90 parts of radix curcumae and 75-90 parts of costusroot. The medicament can be used for improving the testosterone of a rat caused by hydrocortisone, reducing T3 and T4, increasing the relative volume and average bone trabecula width, improving resistance of a kidney-deficiency mouse, improving relative bone volume reduction and average bone trabecula width reduction caused by tretinoin, improving contents of bone calcium and phosphor, improving microcirculation disturbance, diminishing swelling and relieving pain and improving immunity, and has a good curative effect in the aspect of treating femoral head necrosis.

Description

A kind of medicine for the treatment of femur head necrosis and preparation method thereof

Technical field

The invention belongs to technical field of Chinese medicines, be specifically related to a kind of medicine for the treatment of femur head necrosis, also relate to the preparation method of this medicine simultaneously.

Background technology

Ischemic necrosis of femoral head, refers to because the different causes of disease causes capital disturbance of blood circulation, makes femoral head that the pathological process of part or completeness ischemia occur.Main manifestations is the symptoms such as bones of the body joint pain, function limitation, lower limb muscles atrophy, and its course of disease is long, and disability rate is high, can bring great pain to patient.

Motherland's medical science is thought, primary disease genus " osteomyelitis " category, and its main pathogenesis is caused by liver and kidney deficiency, qi depression to blood stasis, bone mistake is moistened foster, or is hindered by violence, or infects excessive QI, or sexual strain, or congenital defect, all ischemic osteonecrosis can occur.At present, ischemic necrosis of femoral head has become one of orthopedics department common disease, owing to often causing bones of the body joint handicap after collapse of the femoral head distortion, is therefore more and more subject to the attention of medical science.

At present, the method that western medical treatment primary disease is comparatively popular is operative treatment, is broadly divided into following two classes: (1) improves femoral head blood supply: as synovectomy, core decompression art, vessel pedicle ilium transplantation, vascular bundle implantation; (2) improve mortar head and contain, improve femoral head at weight loading position: as district's osteotomy, marrow mortar shelf operation between femoral head rotor.Other is also being accepted by people gradually as artificial femoral head replacement, full bones of the body joint replacement, arthrodesis etc.Above-mentioned various operation is all to reach different curative effects by different means, and clinical manifestation shows better for patient, ambulation in early days, and the hospital stays is shorter.But be postoperatively prone to the complication such as the loosening dislocation of collapse of the femoral head, artificial thigh bone, cervical region fracture and infection, and be difficult to remedy.Therefore, pre-operative patients has doubt more, even can refuse operation.

Modern medicine is thought: femur head necrosis is the downright bad pathological process of active component (osteocyte, medullary cell and adipose cell) of bone, but up to the present still can not determine the exact cause that causes primary disease.General think relevant with the wound in bones of the body joint, some drugs (as adrenocortical hormone), various diseases, chronic alcoholism etc. more.The common pathological manifestations of femur head necrosis is have femoral head disturbance of blood circulation that a variety of causes causes and joint stress abnormal.Clinical pharmacology research shows: Chinese medicine is applicable to the overall process of primary disease treatment, and its effect comprises the blood circulation that improves bone, increases blood flow, reduces intra-osteal pressure, and anticoagulant, alleviates osteonecrosis degree, promotes the effects such as osteonecrosis reparation.

Summary of the invention

The object of the invention is for a kind of medicine for the treatment of femur head necrosis is provided, it is another object of the present invention that its corresponding preparation method is provided.

Based on above-mentioned purpose, the present invention has taked following technical scheme: a kind of medicine for the treatment of femur head necrosis, Chinese crude drug by following weight parts is made: 40～50 parts of Radix Notoginseng, 75～90 parts of Caulis Spatholobis, 75～90 parts of Radix Achyranthis Bidentataes, 75～90 parts of Fructus Lycii, 75～90 parts of Radix Dipsacis, 75～90 parts of Rhizoma Drynariae (husky scalding), 75～90 parts of Radix Salviae Miltiorrhizaes, 75～90 parts of Radix Angelicae Sinensis, 75～90 parts of Rhizoma Chuanxiongs, 75～90 parts of Cortex Acanthopanciss, 115～130 parts of Radix Rehmanniae Preparata, 115～130 parts of Radix Codonopsis, 75～90 parts of the Rhizoma Atractylodis Macrocephalaes, 115～130 parts of Olibanum (processed)s, 115～130 parts of Myrrha (processed)s, 115～130 parts of Rhizoma Corydalis, 20～25 parts of Radix Et Rhizoma Rhei, 75～90 parts of Radix Curcumaes, 75～90 parts of the Radix Aucklandiae.

Described medicine is made by the Chinese crude drug of following weight parts: 45 parts of Radix Notoginseng, 82 parts of Caulis Spatholobis, 82 parts of Radix Achyranthis Bidentataes, 82 parts of Fructus Lycii, 82 parts of Radix Dipsacis, 82 parts of Rhizoma Drynariae (husky scalding), 82 parts of Radix Salviae Miltiorrhizaes, 80 parts of Radix Angelicae Sinensis, 80 parts of Rhizoma Chuanxiongs, 82 parts of Cortex Acanthopanciss, 124 parts of Radix Rehmanniae Preparata, 124 parts of Radix Codonopsis, 80 parts of the Rhizoma Atractylodis Macrocephalaes, 120 parts of Olibanum (processed)s, 120 parts of Myrrha (processed)s, 120 parts of Rhizoma Corydalis, 22 parts of Radix Et Rhizoma Rhei, 80 parts of Radix Curcumaes, 80 parts of the Radix Aucklandiae.

The preparation method of the medicine of described treatment femur head necrosis, comprises the following steps: 1) Caulis Spatholobi, Radix Achyranthis Bidentatae, Fructus Lycii, Radix Dipsaci, Rhizoma Drynariae (husky scalding), Radix Salviae Miltiorrhizae, Radix Codonopsis, Cortex Acanthopancis, Radix Rehmanniae Preparata decoct with water, and get decocting liquid, concentrated, obtain clear paste; 2) Rhizoma Chuanxiong, Olibanum (processed), Myrrha (processed), Radix Et Rhizoma Rhei, Radix Notoginseng, Rhizoma Corydalis, Radix Curcumae, the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis are pulverized as end, sieve; 3) by step 2) gained medicinal powder mixs homogeneously with step 1) gained clear paste.

In described step 1), add 5～10 times of decoctings and boil 2～4 times, each 0.5～1.5h, filters, and merging filtrate concentrates and obtains the clear paste that 70～90 ℃ of heat survey relative densities are 1.30～1.35.

Described step 2) after pulverizing in, first medicinal powder is carried out to steam sterilization, and then mix with the clear paste of step 1).

In described step 3), medicinal powder dry, pulverize after mixing with clear paste, crosses 100 mesh sieves, then adds 75～95% ethanol to make soft material, and pill is dry, bag charcoal clothing, and polishing, obtains patent medicine.

the side of medicine of the present invention separates:

The mark of the existing qi depression to blood stasis of main pathogenesis of femur head necrosis is real, has again the deficiency in origin of caused by liver and kidney deficiency, thus suitable treating both the principal and the secondary aspects of a disease at the same time in treatment, reinforcement and elimination in combination.In side, sweet, the micro-hardship of Radix Notoginseng, warm in nature, enters liver, stomach, large intestine channel, has the merit of dissipating blood stasis, analgesic therapy, can control to fall and flutter blood stasis, carbuncle pain.The beautiful Chinese catalpa medicine of < < solution > > says its " with battalion's hemostasis, the clots absorbing of promoting blood circulation, clots absorbing blood and hold back fresh blood ".Caulis Spatholobi bitter in the mouth, sweet, warm in nature, enter heart spleen two warps, can relaxing muscles and tendons to promote blood circulation.< < A Supplement to the Compendium of Materia Medica > > says its " invigorate blood circulation, warm waist knee joint paralysis ".Above-mentioned two medicines are monarch drug altogether, all take blood circulation promoting and blood stasis dispelling, promoting blood circulation as primary, the Eradicates of take except at the blood stasis of warp, improve blood supply of the femoral head as main purpose.

Radix Achyranthis Bidentatae invigorating the liver and kidney, bone and muscle strengthening.< < Bencao Jingshu > >: " Radix Achyranthis Bidentatae, walks and can mend, and property is kind descending, therefore enter Liver and kidney.Main cold-damp flaccidity syndrome and arthralgia syndrome, spasm of the limbs, gonalgia unable to flex and stretch the extremities person." Radix Dipsaci invigorating the liver and kidney, reuniting the fractured tendons and bones, blood circulation regulating; Osteomiosis fills into Liver and kidney warp, invigorating kidney, promoting blood circulation; Fructus Lycii nourishing kidney lung moistening tonifying liver, with the moon of invigorating the liver and kidney.This four medicine for the caused by liver and kidney deficiency of femur head necrosis this, adjusting and reinforcing liver and kidney one training is mended and is consolidated, and is ministerial drug altogether.

The bitter temperature of Radix Salviae Miltiorrhizae, enters conscience warp, promoting blood circulation and breaking stagnation pain relieving again.< < does not record > > speech " Radix Salviae Miltiorrhizae; do not enter blood system; its merit is in the promoting the circulation of blood of invigorating blood circulation; interior reach chamber internal organs and blood stasis dispelling is stagnant; the stasis of blood is stagnant broken therefore gather clearly; outer profit joint and the network of promoting blood circulation, waist knee joint is strong and numbness row ", is the key medicine of blood circulation promoting and blood stasis dispelling.Radix Angelicae Sinensis is warm in nature, blood circulation promoting and enriching, and < < book on Chinese herbal medicine covers bamboo fish trap > > and says its " by traumatic injury blood clotting "; The pungent temperature of Rhizoma Chuanxiong, activating QI to alleviate the depression, dispeiling pathogenic wind and removing dampness, promoting blood circulation and stopping pain, the positive > > of < < book on Chinese herbal medicine say " Rhizoma Chuanxiong, its property is kind loose, walks again Liver Channel, the blood medicine in gas is also.Can hold by removing blood stasis with potent drugs, promoting blood circulation, separates stagnation of QI, by pain." power of the equal tool blood circulation promoting and blood stasis dispelling of three taste medicines.Radix Codonopsis, Rhizoma Atractylodis Macrocephalae air making-up and spleen enlivening, with the source of helping life, Radix Rehmanniae Preparata blood-supplementing blood-nourishing, take and nourish blood arteries and veins as use, these a few taste medicines, benefiting qi and nourishing blood is to consolidate the benefit marrow that promotes the production of body fluid.Olibanum, Myrrha, Rhizoma Corydalis for the product of loose blood and dissolving stasis, are arrogated to oneself pain relieving altogether especially, can alleviate clinical symptoms.Cortex Acanthopancis wind-damp dispelling, strengthening bone and muscle, blood circulation promoting and blood stasis dispelling, < < property of medicine opinion > > " can break by aversion to wind blood.Extremity not by, harmful wind is hurted sb.'s feelings, weak foot, waist, main blood stasis is for many years at musculus cutaneus, controls numbness not enough in wet.By void, win, children's can not go for three years old ".Cortex Acanthopancis not only has the function of blood circulation promoting and blood stasis dispelling, also has the effect of strengthening bone and muscle.We mostly are the medicine of Wen Tong and temperature compensation, Radix Et Rhizoma Rhei bitter cold, and the poison that purges heat, removing mass is stagnant, clots absorbing blood.< < Japan hanako materia medica > >: " sharp joint, lets out and stops up stagnant, aqueous vapor, extremity unbalanced cold and heat for logical all gas of a surname, blood circulation regulating ...." not only consumption is little in this side for Radix Et Rhizoma Rhei, and raw use, object is to alleviate fast purgation, its effect is changed and shift.The merit of getting stagnant, the capable stagnant blood of its removing mass, strengthens the energy in active blood stasis dispelling, sharp joint.And the property of its bitter cold not only can be prevented warm agent heat-dissipating impairment of YIN, also can antimagnetic greasy agent injure taste, play and mend and oiliness, the effect of invigorating the spleen and regulating the stomach.Above-mentioned all medicines are adjuvant drug altogether.

The capable blood of gas, the stagnation of QI is blood clotting.Radix Curcumae is arduous, promoting QI circulation for relieving depression, removing heat from blood removing blood stasis with potent drugs.Radix Aucklandiae promoting the circulation of QI to relieve pain, two medicines all with circulation of qi promoting for being good at, blood is brought about the desired sensation and to be gone.Altogether for making medicine.

Take a broad view of full side, take blood circulation promoting and blood stasis dispelling as main, focus on the mark of correcting downright bad femoral head stagnation of blood stasis, again with adjusting and reinforcing liver and kidney, benefiting qi and nourishing blood is auxiliary, and the blood of nourishing liver and kidney to be to consolidate, reinforcement and elimination in combination, and treating both the principal and the secondary aspects of a disease at the same time, pathogenesis hits.In side, all medicines mostly are the slow product of gentle property, without great Xin, large heat, Great Cold, high strong agent, in order to patient's long-term taking.

Pharmacodynamic study shows, medicine of the present invention can: (1) is improved rat TESTO element, T3 and the T4 that hydrocortisone causes and is declined, and improves relative volume and average bone trabecula width.(2) endurance of the mice of suffering from a deficiency of the kidney that raising hydrocortisone causes.(3) improve relative bone volume minimizing and the minimizing of bone trabecula mean breadth that retinoic acid causes, improve bone calcium, phosphorus content.(4) reduce the bone marrow content of hemoglobin that irradiation causes mouse bone marrow cells blood stasis, improve microcirculation disturbance.(5) reducing swelling and alleviating pain.(6) improve immunity.(7) to adrenal gland, cause the whole blood viscosity of blood stasis model rat all to have decline effect, RBC hematocrit is had clear improvement, fibrinogen content is significantly reduced.

The specific embodiment

Below in conjunction with specific embodiment, the invention will be further described.

embodiment 1

Treat a medicine for femur head necrosis, by the Chinese crude drug of following weight parts, made: 40 parts of Radix Notoginseng, 75 parts of Caulis Spatholobis, 75 parts of Radix Achyranthis Bidentataes, 75 parts of Fructus Lycii, 75 parts of Radix Dipsacis, 75 parts of Rhizoma Drynariae (husky scalding), 75 parts of Radix Salviae Miltiorrhizaes, 75 parts of Radix Angelicae Sinensis, 75 parts of Rhizoma Chuanxiongs, 75 parts of Cortex Acanthopanciss, 115 parts of Radix Rehmanniae Preparata, 115 parts of Radix Codonopsis, 75 parts of the Rhizoma Atractylodis Macrocephalaes, 115 parts of Olibanum (processed)s, 115 parts of Myrrha (processed)s, 115 parts of Rhizoma Corydalis, 20 parts of Radix Et Rhizoma Rhei, 75 parts of Radix Curcumaes, 75 parts of the Radix Aucklandiae.

Its preparation method comprises the following steps:

1) Caulis Spatholobi, Radix Achyranthis Bidentatae, Fructus Lycii, Radix Dipsaci, Rhizoma Drynariae (husky scalding), Radix Salviae Miltiorrhizae, Radix Codonopsis, Cortex Acanthopancis, Radix Rehmanniae Preparata add 5 times of water gagings and decoct 4 times, and each 0.5h, filters, and merging filtrate is concentrated, obtain relative density and be 1.32 clear paste (80 ℃ of heat are surveyed).

2) Rhizoma Chuanxiong, Olibanum (processed), Myrrha (processed), Radix Et Rhizoma Rhei, Radix Notoginseng, Rhizoma Corydalis, Radix Curcumae, the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis are pulverized as end, sieve, after steam sterilization, mix homogeneously with step 1) gained clear paste, dry, pulverize, cross 100 mesh sieves, then add 75% ethanol to make soft material, pill, dry, bag charcoal clothing, polishing, obtains.

embodiment 2

Treat a medicine for femur head necrosis, by the Chinese crude drug of following weight parts, made: 45 parts of Radix Notoginseng, 82 parts of Caulis Spatholobis, 82 parts of Radix Achyranthis Bidentataes, 82 parts of Fructus Lycii, 82 parts of Radix Dipsacis, 82 parts of Rhizoma Drynariae (husky scalding), 82 parts of Radix Salviae Miltiorrhizaes, 80 parts of Radix Angelicae Sinensis, 80 parts of Rhizoma Chuanxiongs, 82 parts of Cortex Acanthopanciss, 124 parts of Radix Rehmanniae Preparata, 124 parts of Radix Codonopsis, 80 parts of the Rhizoma Atractylodis Macrocephalaes, 120 parts of Olibanum (processed)s, 120 parts of Myrrha (processed)s, 120 parts of Rhizoma Corydalis, 22 parts of Radix Et Rhizoma Rhei, 80 parts of Radix Curcumaes, 80 parts of the Radix Aucklandiae.

Its preparation method comprises the following steps:

1) Caulis Spatholobi, Radix Achyranthis Bidentatae, Fructus Lycii, Radix Dipsaci, Rhizoma Drynariae (husky scalding), Radix Salviae Miltiorrhizae, Radix Codonopsis, Cortex Acanthopancis, Radix Rehmanniae Preparata add 8 times of water gagings and decoct 3 times, and each 1h, filters, and merging filtrate is concentrated, obtain relative density and be 1.30 clear paste (80 ℃ of heat are surveyed).

2) Rhizoma Chuanxiong, Olibanum (processed), Myrrha (processed), Radix Et Rhizoma Rhei, Radix Notoginseng, Rhizoma Corydalis, Radix Curcumae, the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis are pulverized as end, sieve, and mix, after steam sterilization, mix homogeneously with step 1) gained clear paste, dry, pulverize, cross 100 mesh sieves, then add 90% ethanol to make soft material, pill, dry, bag charcoal clothing, polishing, obtains.

embodiment 3

Treat a medicine for femur head necrosis, by the Chinese crude drug of following weight parts, made: 50 parts of Radix Notoginseng, 90 parts of Caulis Spatholobis, 90 parts of Radix Achyranthis Bidentataes, 90 parts of Fructus Lycii, 90 parts of Radix Dipsacis, 90 parts of Rhizoma Drynariae (husky scalding), 90 parts of Radix Salviae Miltiorrhizaes, 90 parts of Radix Angelicae Sinensis, 90 parts of Rhizoma Chuanxiongs, 90 parts of Cortex Acanthopanciss, 130 parts of Radix Rehmanniae Preparata, 130 parts of Radix Codonopsis, 90 parts of the Rhizoma Atractylodis Macrocephalaes, 130 parts of Olibanum (processed)s, 130 parts of Myrrha (processed)s, 130 parts of Rhizoma Corydalis, 25 parts of Radix Et Rhizoma Rhei, 90 parts of Radix Curcumaes, 90 parts of the Radix Aucklandiae.

Its preparation method comprises the following steps:

1) Caulis Spatholobi, Radix Achyranthis Bidentatae, Fructus Lycii, Radix Dipsaci, Rhizoma Drynariae (husky scalding), Radix Salviae Miltiorrhizae, Radix Codonopsis, Cortex Acanthopancis, Radix Rehmanniae Preparata add 10 times of water gagings and decoct 2 times, and each 1.5h, filters, and merging filtrate is concentrated, obtain relative density and be 1.28 clear paste (80 ℃ of heat are surveyed).

2) Rhizoma Chuanxiong, Olibanum (processed), Myrrha (processed), Radix Et Rhizoma Rhei, Radix Notoginseng, Rhizoma Corydalis, Radix Curcumae, the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis are pulverized as end, sieve, and mix, after steam sterilization with the extractum of step 1) gained, dry, pulverize, cross 100 mesh sieves, add again 95% ethanol to make soft material, pill, dry, bag charcoal clothing, polishing, obtains.

toxicology test

(1) acute toxicity test: the medicine of getting embodiment 1-3 carries out gavage to mice, gavage total amount reached 36g/kg on 1st, was adult 108 times of oral dose.Result of the test shows, none example of mice is dead, has no toxic reaction; Mice can tolerate the dosage of 36g/kg every day.

(2) long term toxicity test: rat was with the continuous gavage of dosage of 12g/kg/d and 6g/kg/d (quantity 36 times and 18 times) 6 months, after 6 months, rat serum routine, blood biochemical, body weight, main organs index are tested, assay is all within normal range, and each histology is normal configuration.After drug withdrawal 14 days, above-mentioned indices is showed no extremely, has no delayed toxicity reaction.

clinical trial

(1) criterion

1.1 diagnostic criteria

(1) can there is obvious trauma history (fracture or dislocation), or have long-term heavy drinking, use hormone medicine history.

(2) occur gradually or suddenly limping, hip joint pain, pain can be to groin and knee joint radiation.When bearing a heavy burden, walking, increase the weight of, after having a rest, alleviate.

(3) tenderness: often have tenderness in groin deep, Thomas sign is positive, the test of " 4 " word is positive, late period hip joint all directions limitation of movement, even amyotrophy.

(4) typical x-ray performance: Femoral head density increases relatively, and spotting point-like or concordance increase, but whole capital bone stricture of vagina structure is normal, and bone trabecula still keeps original skeleton.Mid-term: cartilage inferior segment cystis degeneration or meniscus sign appear in femoral head, and occur that with heavy burden district ladder subsides.In late period: inhomogeneous sclerosis appears in full head or subregion, and sequestrum is broken, and joint space is narrow, be finally loose mushroom or the distortion of gill fungus shape, and articular cartilage is downright bad, attenuation also, rough and uneven in surface, even occurs gauffer or be full of cracks.Because head becomes flat or subsides, femoral head moves outward and presents subluxation image.

1.2 tcm diagnosis standards

Stasis blocking venation type: hip pain, heavy burden, activity increase the weight of, rest is alleviated; Walk lamely, joint motion is limited, joint stiffness even deformity, amyotrophy, red tongue or have ecchymosis, white and thin fur, stringy and hesitant pulse or normal pulse.

1.3 symptoms, sign standards of grading

A. pain:

1. sitting and lying, the walking of standing was without pain (-) 0 minute;

2. sitting and lying are without pain, and the walking of standing is even pain or discomfort, or the pain more long afterwards of walking, but can adhere to walking (+)

1 minute;

3. have a rest without pain, pain after the walking of standing, can not adhere to walking (++) 2 minutes;

4. pain during rest, stands to hold up and turns (+++) 3 minutes;

Equal pain when 5. any, needs often to use analgesic (++++) 4 minutes.

B. walk lamely

1. without (-) 0 minute;

2. stealthy limping, slowly not aobvious, occurs at a quick pace (+) 1 minute;

3. slowly walk lamely, quick step more aobvious (++) 2 minutes;

4. walk lamely to hold up and singly turn (+++) 3 minutes;

5. walk lamely and need hold up crutches, walk obviously limited (++++) 4 minutes.

C. dysfunction

Hip joint bends and stretches, abduction, interior receipts, outward turning, Inner curl are counted summation and be greater than 260, hip joint function normal (-) 0 minute;

260 °～190 ° of the total number of degrees of hip joint, function is slightly limited, the basic self-care of life (+) 1 minute;

189 °～160 ° of the total number of degrees of hip joint, funtion part limited (++) 2 minutes;

159 °～130 ° of the total number of degrees of hip joint, function is limited (+++) 3 minutes obviously;

The total number of degrees of hip joint are less than 130 °, and function is limited (++++) 4 minutes seriously.

Note: hip joint range of movement normal value, anteflexion 130 °～140 °, bend and stretch 10 °～15 °, 30 °～40 ° of abductions, 20 °～30 ° of interior receipts, 40 °～50 ° of inward turnings, 260 °～320 ° of summations.

1.4 criterion of therapeutical effect

A. effective: clinical symptoms, sign are obviously improved, do not affect daily life and work, integration declines 70%;

B. effective: clinical symptoms, sign alleviate to some extent and improve, integration declines 40%～69%;

C. invalid: clinical symptoms, sign are unchanged, integration declines below 40%.

(2) selection of study subject

2.1 include case standard in

Meet diagnostic criteria, take traumatic, hormones and alcoholic-toxic femur head necrosis is the main object of observation, and femur skull is looked back chondritis (perthes is sick, coxa plana) and do not made the object of observation.

2.2 Excluded cases standards

A. the age is at under-18s or more than 70 years old; Gestation or women breast-feeding their children; After medication, this medicine is had to anaphylaxis person.

B. being associated with liver, kidney and cardiovascular and cerebrovascular disease, psychotic, can there is dysgenic Other diseases in medication, as used hormone therapy Other diseases.

C. the femur head necrosis that osteomyelitis, bone tuberculosis and bone tumor cause; The ischemic necrosis of femoral head that disease in the blood system causes, perthes is sick.

A. all inclusive criterias that do not meet, not medication in accordance with regulations, cannot judge that curative effect or data are not congruent to affect the treatment or safety judgement person.

(3) clinical trial protocol and result

3.1 clinical trials 1

(1) test site: the sick hospital of Zhengzhou traditional Chinese medical bone fracture.

(2) test method:

This test study subject combines with inpatient and patient in family, inpatient's 281 examples wherein, patient in family 179 examples.Family's case is made regular check on drug delivery to people, strictly controls variable factor.

Above-mentioned 460 routine patients are divided into two groups, test group 240 examples wherein, matched group 220.

The oral medicine of the present invention of test group (embodiment 1-3 medicine distributes at random) wherein, each 10g, every day 3 times, three months is a course for the treatment of, effective case is followed up a case by regular visits to one month; The oral reference substance of matched group (No. 02139206.4 patent working example 1-2 medicine of CN distributes at random), each 10g, every day 3 times, three months is a course for the treatment of, effective case is followed up a case by regular visits to one month.

(3) result of the test

A. soft tissue injury belongs to motherland's medical science " rheumatism involving the bone ", " osteomyelitis " category.In < < through the evil piece of writing of Ling Shu Miraculous Pivot or Divine Axis Ci Jiezhen > >: " among exogenous pathogen people also, aversion to cold with shivering, plays hair and sends out space between skin and muscles, its people is dark, Inner wins in bone, is rheumatism involving the bone." " people of exogenous pathogen is also dark in body, and cold and heat are fought mutually, stays for a long time and interior work ... interior injury of the bone person is osteomyelitis." formation of this disease is can factor body weakened body resistance, or the paathogenic factor damage human righteousness such as wound and medicine, control and work as blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain, reinforcing the kidney to strengthen the bone.Medicine provided by the invention has this effect.

B. this test is carried out three months clinical observation on the therapeutic effect to 460 routine ischemic necrosis of femoral head patients, and result shows, in the routine patient of test group 240, and effective 98 examples (40.8%), effective 107 examples (44.58%), total effective rate 85.38%.And in taking old side's (CN 02139206.4, is used for the treatment of medicine of ischemic necrosis of femoral head disease and preparation method thereof) matched group (220 example), effective 32 examples (14.5%), effective 96 examples (43.6%), total effective rate 58.1%.The two curative effect comparison, learns and processes by statistics, and difference has significant, P < 0.01, thereby explanation, and medicine of the present invention is used for the treatment of ischemic necrosis of femoral head, and its clinical efficacy is better than matched group medicine.

C. two groups in aspect comparisons such as pain, limping, functions, Epidemiological Analysis by statistics, have significant difference, P < 0.01, proves that medicine of the present invention can improve the S&Ss such as pain, limping and dysfunction of ischemic necrosis of femoral head well.

D. in the clinical observation of test group, find: curative effect and sex, the age state of an illness totally compare, learn and process by statistics, P > 0.05, there was no significant difference, but can find out that the age is little of older patient's good effect, the state of an illness is gently than the heavy patient's good effect of the state of an illness.

E. before and after treatment aspect the improving of x-ray, test group is compared with matched group, Epidemiological Analysis by statistics, significant difference, P < 0.01.Thereby illustrate, test group is better than matched group improving on the x-ray of ischemic necrosis of femoral head.

F. from matched group and test group, respectively get 30 examples and carry out CT and improve relatively, result shows, test group is promoting to be better than matched group aspect bone reparation.Meanwhile, carry out Nail Fold Microcirculation ring analysis, nail fold form, fluidised form, loop week and total mark are analyzed, found that and only have before and after test group fluidised form integrated value treatment variantly, illustrate that test group is improved microcirculation.

G. the two groups of patients' in experiment front and back body of the tongue, tongue fur and pulse condition are without significant change.

H. the effective case of test group was followed up a case by regular visits to and is shown after one month, and stable disease has 2.2% patient slightly to increase the weight of.Illustrate that medicine of the present invention is used for the treatment of ischemic necrosis of femoral head conservation rate high, relapse rate is low, and clinical efficacy is reliable.

Above result shows, medicine of the present invention is better than matched group medicine (No. 02139206.4 patent drug of CN) in treatment ischemic necrosis of femoral head.

3.2 clinical trials 2

(1) test site: No.1 Hospital Attached to He'nan Traditional Chinese Medical College.

(2) test method:

Choose 120 routine ischemic necrosis of femoral head patients as study subject, be divided at random two groups, test group 90 examples wherein, matched group 30 examples.

Test group: oral medicine of the present invention (embodiment 1-3 medicine distributes at random), each 10g, every day 3 times, three months is a course for the treatment of, effective case is followed up a case by regular visits to one month.

Matched group: oral reference substance (FUFANG DANSHEN PIAN), each 10g, every day 3 times, three months is a course for the treatment of, effective case is followed up a case by regular visits to one month.

(3) result of the test

A. effective 35 examples (accounting for 38.89%) in test group 90 examples, effective 41 examples (accounting for 45.56%), invalid 14 examples (accounting for 15.55%), total effective rate 84.45%; Effective 4 examples (accounting for 13.33%) in matched group 30 examples, effective 12 examples (accounting for 40.00%), invalid 14 examples (accounting for 46.67%).Two groups of curative effects are compared, and Epidemiological Analysis, has significant difference by statistics, (P < 0.001).Thereby illustrate, medicine provided by the invention is used for the treatment of ischemic necrosis of femoral head, and its clinical efficacy is obviously better than control drug FUFANG DANSHEN PIAN.

B. the pain of test group before and after treatment is compared with matched group aspect improving, and Epidemiological Analysis, has significant difference by statistics, (P < 0.001); In the improvement of limping, function, compare with matched group, Epidemiological Analysis, has significant difference by statistics, (P < 0.001).Thereby illustrate, medicine of the present invention is obviously better than control drug FUFANG DANSHEN PIAN matched group aspect the improving of clinical symptoms, wherein particularly outstanding with pain relieving performance).

C. in the clinical observation of test group, find, curative effect is compared with sex, Epidemiological Analysis by statistics, there was no significant difference (P > 0.05).Curative effect and sex non-correlation are described; Curative effect was compared with the age, Epidemiological Analysis by statistics, there was no significant difference (P > 0.05).But from whole distribution, can find out, less R value of age is larger, illustrates that little curative effect of age is better than older person; Curative effect is compared with the state of an illness, and Epidemiological Analysis, has significant difference by statistics, (P < 0.01).Illustrate that the state of an illness is lighter, curative effect is better, and the state of an illness is heavier, and curative effect is poorer.

D. before and after treatment aspect the improving of x-ray, test group is compared with matched group, and Epidemiological Analysis, has significant difference (P < 0.001) by statistics; On CT, false Zou's microcirculation change, test group is compared with matched group, and test group is obviously better than matched group.Thereby illustrate, test group medicine is better than matched group on false Zou's microcirculation improving the x-ray of ischemic necrosis of femoral head, CT.

E. before and after test, two groups of medicines are on to the change of body of the tongue, tongue fur and pulse condition, without significant change.

F. two groups of clinical cases after one month the situation of following up a case by regular visits to show, test group 35 examples, keep 33 examples (accounting for 94.28%), recurrence 2 examples (accounting for 5.71%); Matched group 4 examples, keep 3 examples (accounting for 75.00%), 1 case relapsed (accounting for 25.00%).Thereby illustrate, test group medicine is compared with contrasting medicine FUFANG DANSHEN PIAN in clinical treatment ischemic necrosis of femoral head, and the conservation rate of test group medicine is higher, and relapse rate is lower, and clinical efficacy is reliable.

Above result shows, test group medicine is obviously better than matched group medicaments compound Radix Salviae Miltiorrhizae Tabellae, thereby illustrates that medicine of the present invention is obviously better than FUFANG DANSHEN PIAN in clinical treatment ischemic necrosis of femoral head.

3.3 clinical trials 3

(1) test site: China Academy of TCM's orthopaedics institute.

(2) test method:

Choose 60 routine ischemic necrosis of femoral head patients as study subject, be equally divided into two groups, be i.e. test group 30 examples, matched group 30 examples.

Test group: oral medicine of the present invention (embodiment 1-3 medicine distributes at random), each 10g, every day 3 times, three months is a course for the treatment of, effective case is followed up a case by regular visits to one month.

Matched group: oral reference substance (FUFANG DANSHEN PIAN), each 10g, every day 3 times, three months is a course for the treatment of, effective case is followed up a case by regular visits to one month.

(3) result of the test

A. effective 11 examples (accounting for 36.67%) in test group 30 examples, effective 14 examples (accounting for 46.67%), invalid 5 examples (accounting for 16.66%), total effective rate 83.34%; Effective 3 examples (accounting for 10.00%) in matched group 30 examples, effective 14 examples (accounting for 46.67%), invalid 13 examples (accounting for 43.33%).Two groups of curative effects are compared, and Epidemiological Analysis difference has significant (P < 0.01) by statistics.Thereby illustrate, the clinical efficacy of test group Drug therapy ischemic necrosis of femoral head is obviously better than control drug FUFANG DANSHEN PIAN.

B. the pain of test group before and after treatment is compared with matched group aspect improving, and Epidemiological Analysis, has significant difference (P < 0.002) by statistics; Walking lamely, in the improvement of function, compare with matched group, Epidemiological Analysis by statistics, there was no significant difference (P > 0.05).That is to say, test group medicine pain improve aspect successful be better than control drug FUFANG DANSHEN PIAN.

C. test group is carried out to clinical observation, the curative effect of contrast different sexes and the state of an illness.Epidemiological Analysis by statistics, there was no significant difference (P > 0.05).Curative effect and sex non-correlation are described; Curative effect was compared with the age, Epidemiological Analysis by statistics, there was no significant difference (P > 0.05).But from whole distribution, can find out, less R value of age is larger, illustrates that little curative effect of age is better than older person.

D. before and after treatment aspect the improving of x-ray, test group is compared with matched group, and Epidemiological Analysis, has significant difference (P < 0.01) by statistics.Thereby illustrate, test group is better than matched group improving aspect the x-ray of ischemic necrosis of femoral head.

E. before and after test, two groups of medicines are on to the change of body of the tongue, tongue fur and pulse condition, without significant change.

F. two groups of clinical cases after one month the situation of following up a case by regular visits to show, test group 11 examples, keep 9 examples (accounting for 81.82%), recurrence 2 examples (accounting for 18.18%); Matched group 4 examples, keep 2 examples (accounting for 50.00%), recurrence 2 examples (accounting for 50%).Thereby illustrate, use treating caput femoris ischemic necrosis, test group is compared with control drug FUFANG DANSHEN PIAN, and the conservation rate of test group medicine is higher, and relapse rate is lower, and clinical efficacy is reliable.

Above result shows, the drug effect of test group medicine is obviously better than matched group medicaments compound Radix Salviae Miltiorrhizae Tabellae.That is to say, medicine provided by the invention is obviously better than FUFANG DANSHEN PIAN in clinical treatment ischemic necrosis of femoral head.

model case:

case 1:

Patient Mr. Ma, 36 years old, Beijing ChengJian Group workman.Because of right side arthralgia 4 years, over nearly 3 years, increase the weight of gradually, companion's difficulty of having squatted, limping, examined on May 29th, 2008 on foot.Through inquiry, learn, patient when the work of Beijing ChengJian Group building team, because of the accident of constructing, caused right side limbs to have an intense pain before 4 years, dare not be movable, by people, be sent to Beijing Jishuitan Hospital medical.After film making checks, be diagnosed as " right side fracture of femoral neck ", give the internal fixation treatment of threading a needle of right side neck of femur.Smoothly, it is good that postoperative wound recovers, and regularly takes out draw point in operation.But patient's right hips pain still loses alleviation, and with right hips limitation of activity, the difficulty of having squatted, right hips limitation of activity, walks and walks lamely.Patient before 3 years because San Affiliated Hospital of above-mentioned symptom Zeng Beijing Medical University is medical.After film making checks, be diagnosed as " right side ischemic necrosis of femoral head ".Accept traction, the treatment of Chinese medicine (FUFANG DANSHEN PIAN etc.) method, but patient symptom loses improvement, the state of an illness increases the weight of gradually, need often take analgesic (diclofenac, somedon etc.) alleviating pain every day.Meanwhile, hip joint is limited, and the difficulty of having squatted, has a strong impact on daily life, and patient Sui Laiwo institute (the sick hospital of Zhengzhou traditional Chinese medical bone fracture, lower same) is medical.Existing symptom is shown in: right hips pain, be persistence, and walking is walked lamely, the difficulty of having squatted, right hips limitation of activity, purplish tongue, thin white fur of tongue, stringy and hesitant pulse.Check finding: pad it is difficult, need hold up and turn walking, walk lamely, squat limited, 280 ° of left side hip joint anterior flexion and rear stretchings, abduction, interior receipts, outward turning, inward turning number of degrees summation, right hip joint is anteflexion, after stretch, 170 ° of abductions, interior receipts, outward turning, inward turning number of degrees summation.Before right hips, side, rear all have tenderness, right side heel percussion pain is positive, x-ray shows, right hip joint increase in density, the distortion of right lateral thigh bone, acetabular bone is rough.Before treatment, symptom integral shows: pain 4 minutes (++++), 3 minutes (+++) of walking lamely, dysfunction 2 minutes (++), always scores 9 minutes, and the state of an illness belongs to severe.

Tcm diagnosis: osteomyelitis (stasis blocking venation card).

Western medicine diagnose: ischemic necrosis of femoral head (bilateral).

Therapeutic Method: the medicine of oral embodiment 2, each 10 grams (80), every day three times, observe three months courses for the treatment of.

After patient's drug administration one week, right hips pain obviously alleviates, analgesic take medicine before every day need often take, after taking medicine, stop using.Take medicine after 2 weeks, right hips right hips without pain, is just felt discomfort or mild pain after the walking of standing when rest.Take medicine after 4 weeks, when right hips sitting and lying, rest, without pain, after the walking of standing, occasionally have discomfort and mild pain.Meanwhile, walk lamely and also obviously alleviate on foot.Need not hold up and turn, but can not adhere to walking, take medicine after 6 weeks, right hips, after walking is prolonged, just has mild pain, but still can adhere to walking, recessive limping, and slowly not aobvious, power-walking occurs.Meanwhile, right hips activity obviously improves, anteflexion, after stretch, 260 ° of abductions, interior receipts, outward turning, inward turning number of degrees summation.Take medicine after 8 weeks, right hips pain, the disappearance of walking lamely, walk accessible, and hip joint activity is clearly better, and daily life work is unrestricted.Take medicine after 12 weeks (three months), right hips pain disappears, and integration 0 minute (-) is walked lamely and disappeared, integration 0 minute (-), and dysfunction integration 1 minute (+), always scores 1 minute.Patient is before and after treatment, and the safety observation items such as routine blood test, routine urinalysis, stool routine, electrocardiogram, hepatic and renal function are all no abnormal.Meanwhile, in medication process, without any toxicity, occur.

Clinical efficacy: effective.Within one month, follow up a case by regular visits to, curative effect keeps.

case 2:

Patient Wang Nvshi, 50 years old, people from Tianmen, Hubei Province.Because of right hip pain 3 years, companion walked lamely medical on August 27th, 2008, once has hip to sprain history.Have a medical check-up, vital sign is normal, the difficulty of squatting down, hip joint limitation of activity.Film making prompting, right femoral head profile still can, bone density is inhomogeneous, has Cystic changes.With right ischemic necrosis of femoral head, accept for medical treatment and be in hospital, the medicine that gives embodiment 1 is for oral administration, and each 10 grams, every day 3 times, in therapeutic process, carry out suitable functional exercise, forbid to bear a heavy burden.Film making check on November 28th, 2008, right femoral head bone density trend is normal, and cystis degeneration disappears, and patient's subjective symptoms disappears, and clinical basic healing is left hospital.Before and after treatment, carry out the three large conventional hearts, liver, kidney function test, no abnormality seen, after January, follows up a case by regular visits to and has no recurrence.Suggestion continues to take medicine a course for the treatment of.

case 3:

Patient Song Xiansheng, 51 years old, people from Henan Province.Because two hips ache 4 years, in May, 2008, examine.There is double hip joint pain without obvious inducement before 4 years in patient, in Huixian, Henan Province county people's hospital, is diagnosed as " double hip joint synovitis ", gives hormone (prednisone) treatment three months.Meanwhile, there are sealing (lignocaine, meticortelone) 3 times part.The right hip arthralgia loses and alleviates, and increases the weight of gradually.Walking is walked lamely, and walking is stood to hold up singly and turned, the difficulty of squatting down, and lower limb exercise is limited.In Pingdingshan City, Henan Province, the second the People's Hospital is medical the year before, through film making inspection, is diagnosed as " bilateral femoral head ischemic necrosis ", and two weeks, double hip joint pain lose and alleviate to give FUFANG DANSHEN ZHUSHEYE intravenous injection.Double hip joint pain, need often take analgesic (indometacin, piroxicam etc.) relief of symptoms usually, and patient examines because of above-mentioned symptom.Existing symptom is shown in: double hip joint pain, walking is stood to hold up singly and is turned, walk lamely, the difficulty of squatting down, purplish tongue, thin white fur of tongue, stringy and hesitant pulse checks finding: difficulty in walking, slope row, left hip joint is anteflexion, after stretch, 140 ° of abductions, interior receipts, outward turning, inward turning number of degrees summation, right hip joint is anteflexion, after stretch, 145 ° of abductions, interior receipts, outward turning, inward turning number of degrees summation.Symptom integral before treatment: pain 3 minutes (+++), dysfunction 3 minutes (+++), slope row 3 minutes (+++), total mark 9 minutes.The state of an illness belongs to severe.X-ray shows: the visible Nang Xingqu of bilateral femoral head profile and harden zone, attach most importance in right side.

Tcm diagnosis: osteomyelitis (stasis blocking venation card).

Western medicine diagnose: ischemic necrosis of femoral head (bilateral).

Therapeutic Method: the medicine of oral embodiment 3, each 10 grams (80), every day three times, observe three months courses for the treatment of.

After patient's drug administration ten days, double hip joint pain obviously alleviates.After drug administration 20 days, during double hip joint rest, without pain, pain after the walking of standing, can not adhere to walking.After drug administration 30 days, double hip joint pain alleviates again to some extent, left hip joint function part is limited, hip joint is anteflexion, after stretch, 160 ° of abductions, interior receipts, outward turning, inward turning number of degrees summation, right hip joint is anteflexion, after stretch, 170 ° of abductions, interior receipts, outward turning, inward turning number of degrees summation.After drug administration 40 days, pain obviously alleviates, and during rest, without pain, the walking pain more long afterwards of standing, can not adhere to walking.Slowly walk lamely, more aobvious at a quick pace.After drug administration 60 days, sitting and lying are stood walking all without pain, and recessive limping, slowly walks lamely.After drug administration 90 days, sitting and lying, the walking of standing are without pain, recessive limping, slowly occurs, left hip joint is anteflexion, after stretch, 250 ° of abductions, interior receipts, outward turning, inward turning number of degrees summation, right hip joint is anteflexion, after stretch, abduction, interior receipts, outward turning, 260 ° of functions of inward turning number of degrees summation be few limited, life is basic takes care of oneself, pain integration: 0 minute (-), limping integration: 1 minute (+), dysfunction integration: 1 minute (+), always score: 2 minutes (++).Patient is before and after treatment, and the safety observation items such as routine blood test, routine urinalysis, stool routine, electrocardiogram, hepatic and renal function are all no abnormal.Meanwhile, in medication process, without any toxicity, occur.

Clinical efficacy: effective, after one month, to follow up a case by regular visits to, curative effect keeps.

case 4:

Patient Zhao Xiansheng, 45 years old, people from ZhangZhou, Fujian Province.Because of the left side hip arthralgia more than 1 year, companion's difficulty of squatting down, walked lamely, abduction is limited.On June 4th, 2008, examine, question closely medical history, once have long-term heavy drinking history.Film making prompting: femoral head profile still can, articular surface is crude, bone density is inhomogeneous, has Cystic changes.With " left side ischemic necrosis of femoral head ", admit to hospital, the medicine that gives embodiment 2 is for oral administration, each 10 grams, every day 3 times, forbids patient to bear a heavy burden in therapeutic process.JIUYUE in 2008 film making check on the 6th, fl skull density tendency is normal, and cystis degeneration dwindles, and patient's subjective symptoms disappears, and clinical basic healing is left hospital.Before and after treatment, carry out the inspections such as the three large conventional hearts, liver, renal function and electrocardiogram and be showed no extremely, after January, follow up a case by regular visits to and have no recurrence.

case 5:

Patient Mr. Liu, 50 years old, Changsha people.December in 2010 is walked lamely more than 1 year because of two hip pain on the 31st, holds up crutches to examine.Patient previously body is strong, but has the history of drinking history of more than 20 years and because treating the sick long-term steroid histories such as arthralgia.The positive levied in two " 4 " words of patient, in two lower limb abductions, receives limit, the difficulty of squatting down, and femoral head 2010.12.13X mating plate shows: bilateral femoral head deformation is flat, and double-ended is rough, double end internal skeleton Density inhomogeneity, visible a large amount of cystic lesions, double hip joint gap turn narrow.

Treatment to be to take the medicine of embodiment 2 orally, a 10g, 3 times on the one.The regular further consultation of patient, adheres to leaning on crutches walking, and traction, does the functional exercise of not bearing a heavy burden.Adhere to 2 courses for the treatment of, patient feels the state of an illness and takes a turn for the better gradually.At the beginning of 2013, can lose crutch, during December in 2013 consultation of doctors on the 24th, patient leans on crutch, visible freedom of movement, 2013.12.23 day pelvis ap sheet shows: bilateral femoral head shape is flat, and double-ended is smooth, double end internal skeleton even density, bone trabecula is clear, and double hip joint gap is narrow.Consultation of doctors result: patient can drug withdrawal, and check once later every half a year.

case 6:

Patient Mrs Ji, 54 years old, people from Zhengzhou City.On February 24th, 2011, because of right hip pain, left hip also does not feel like oneself, bed half a year, and many places seek doctor, do not feel any better, and with examining afterwards, wheelchair while coming.Patient previously body is strong, rear because of facial paralysis, once uses hormone therapy, and time-dose is not quite clear, and physical examination is visible, and the two lower limb of patient cannot be stood, and because of long-term bed, patient's lower limb function is very poor.The slice, thin piece on February 21st, 2011 shows: bilateral femoral head shape circle, and double-ended is smooth, visible a large amount of cystic lesions in double end, bone trabecula fracture is sparse, and double hip joint gap is normal.Treatment gives the medicine of oral embodiment 1, a 10g, 3 times on the one.The regular further consultation of patient, partner treatment, adheres to leaning on crutches walking, and traction, does the functional exercise of not bearing a heavy burden, and can hold up crutch walking after half a year, and two lower limb functions obviously improve, and continue medication treatment later, add that patient actively coordinates, and the state of an illness takes a turn for the better gradually.During December in 2013 consultation of doctors on the 24th, 2013.12.23 osteocomma normotopia is flat to be shown: bilateral femoral head shape circle, and double-ended is smooth, double end internal skeleton even density, visible a large amount of bone trabecula are filled and are passed through, and double hip joint gap is normal.Can not lean on crutch.

Consultation of doctors result: patient can drug withdrawal.

case 7:

Infant king so-and-so, man, 7 years old, people from Huludao Liaoning Province.

The first visit time: on July 5th, 2011.

Diagnosis: right lateral thigh bone, epiphysis aseptic ischemic necrosis.

Medical history: in the time of 5 years old, infants ' parents find to walk is walked lamely, because of the infant age little can not normal expression, the head of a family is with the infant treatment in 2 months of being in hospital to Beijing Jishuitan Hospital subsequently, has no positive effect.On July 5th, 2011, carry the treatment of local hospital bilateral pelvis ap Pian Daowo institute.Tentative diagnosis is on inspection: " right lateral thigh bone, epiphysis aseptic ischemic necrosis ".

Diagnosis and treatment processes: on July 4th, 2011 bilateral pelvis ap sheet: right lateral thigh bone becomes flat, increase in density, visible a plurality of cystis degenerations.Give the medicine of embodiment 1, oral, a 5g, 3 times on the one.

On March 8th, 2012 bilateral pelvis ap sheet: modern sheet and front contrast: right lateral thigh bone, epiphysis are repaired before, density before evenly.

JIUYUE in 2012 bilateral pelvis ap sheet on the 2nd: right lateral thigh bone increases, in head, density is evenly front, and gap is normal.

December in 2012 bilateral pelvis ap sheet on the 8th: right lateral thigh bone epiphysis thickness increases, and bone density is even, and women's head-ornaments are smooth.The better function of having a medical check-up, infant is without any discomfort.Rehabilitation drug withdrawal.

JIUYUE in 2013 bilateral pelvis ap sheet on the 7th: drug withdrawal check in 9 months.Stable disease, without uncomfortable, can participate in normal activity.Right lateral thigh bone x-ray shows: even density in right lateral thigh bone.

Follow up a case by regular visits to situation: drug withdrawal is walked without walking lamely without abnormal for 1 year.Can normally participate in school's activities.

case 8:

Infant Jiang, man, 6 years old, people from Urumqi City.In the time of four years old, the head of a family finds to walk and walks lamely, infant can not accurately be expressed, but tell sometimes skelalgia, therefore repeatedly go to see a doctor and be apprised of calcium deficiency, thereby adopt and to replenish the calcium two months, limping pain is not felt any better, and claps x-ray inspection and is diagnosed as left side aseptic ischemic caput femoris necrosis, then at Urumchi Duo Jia hospital admission, the treatment of invigorating blood circulation has no improvement.From in March, 2004, in the sick hospital of Zhengzhou traditional Chinese medical bone fracture, give the medicine of embodiment 1, oral, a 5g, 3 times on the one.To in July, 2010, check pelvis ap sheet and show that bilateral acetabular bone isogony is good, joint space is normally symmetrical, and head dummy is normally symmetrical, and women's head-ornaments are smooth, and bone density is even.Have a medical check-up: function is accessible, participate in normal person's activity and feel without any discomfort.

Claims (6)

1. a medicine for the treatment of femur head necrosis, Chinese crude drug by following weight parts is made: 40～50 parts of Radix Notoginseng, 75～90 parts of Caulis Spatholobis, 75～90 parts of Radix Achyranthis Bidentataes, 75～90 parts of Fructus Lycii, 75～90 parts of Radix Dipsacis, 75～90 parts of Rhizoma Drynariae (husky scalding), 75～90 parts of Radix Salviae Miltiorrhizaes, 75～90 parts of Radix Angelicae Sinensis, 75～90 parts of Rhizoma Chuanxiongs, 75～90 parts of Cortex Acanthopanciss, 115～130 parts of Radix Rehmanniae Preparata, 115～130 parts of Radix Codonopsis, 75～90 parts of the Rhizoma Atractylodis Macrocephalaes, 115～130 parts of Olibanum (processed)s, 115～130 parts of Myrrha (processed)s, 115～130 parts of Rhizoma Corydalis, 20～25 parts of Radix Et Rhizoma Rhei, 75～90 parts of Radix Curcumaes, 75～90 parts of the Radix Aucklandiae.

2. treat as claimed in claim 1 the medicine of femur head necrosis, it is characterized in that, described medicine is made by the Chinese crude drug of following weight parts: 45 parts of Radix Notoginseng, 82 parts of Caulis Spatholobis, 82 parts of Radix Achyranthis Bidentataes, 82 parts of Fructus Lycii, 82 parts of Radix Dipsacis, 82 parts of Rhizoma Drynariae (husky scalding), 82 parts of Radix Salviae Miltiorrhizaes, 80 parts of Radix Angelicae Sinensis, 80 parts of Rhizoma Chuanxiongs, 82 parts of Cortex Acanthopanciss, 124 parts of Radix Rehmanniae Preparata, 124 parts of Radix Codonopsis, 80 parts of the Rhizoma Atractylodis Macrocephalaes, 120 parts of Olibanum (processed)s, 120 parts of Myrrha (processed)s, 120 parts of Rhizoma Corydalis, 22 parts of Radix Et Rhizoma Rhei, 80 parts of Radix Curcumaes, 80 parts of the Radix Aucklandiae.

3. described in claim 1 or 2, treat the preparation method of femur head necrosis medicine, it is characterized in that, comprise the following steps: 1) Caulis Spatholobi, Radix Achyranthis Bidentatae, Fructus Lycii, Radix Dipsaci, Rhizoma Drynariae (husky scalding), Radix Salviae Miltiorrhizae, Radix Codonopsis, Cortex Acanthopancis, Radix Rehmanniae Preparata decoct with water, and get decocting liquid, concentrated, obtain clear paste; 2) Rhizoma Chuanxiong, Olibanum (processed), Myrrha (processed), Radix Et Rhizoma Rhei, Radix Notoginseng, Rhizoma Corydalis, Radix Curcumae, the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis are pulverized as end, sieve; 3) by step 2) gained medicinal powder mixs homogeneously with step 1) gained clear paste.

4. treat as claimed in claim 3 the preparation method of femur head necrosis medicine, it is characterized in that, in described step 1), add 5～10 times of decoctings and boil 2～4 times, each 0.5～1.5h, filter, merging filtrate, concentrates and obtains the clear paste that 70～90 ℃ of heat survey relative densities are 1.30～1.35.

5. treat as claimed in claim 3 the preparation method of femur head necrosis medicine, it is characterized in that, described step 2) in first medicinal powder is carried out to steam sterilization after pulverizing, and then mix with the clear paste of step 1).

6. as described in claim 4 or 5, treat the preparation method of femur head necrosis medicine, it is characterized in that, in described step 3), after medicinal powder mixes with clear paste, dry, pulverize, cross 100 mesh sieves, then add 75～95% ethanol to make soft material, pill, dry, bag charcoal clothing, polishing, obtains patent medicine.