Summary of the invention
The object of the present invention is to provide a kind of new purposes that contains the Chinese medicine composition of invigorating the spleen for dissipating phlegm composition.
To achieve these goals, the invention provides the purposes of Chinese medicine composition in the medicine of preparation treatment early metaphase femur head necrosis that contains the invigorating the spleen for dissipating phlegm composition, described Chinese medicine composition is made by following raw materials in weight portion medicine:
Poria 10~20 Ramulus Cinnamomi 5~15 Rhizoma Atractylodis Macrocephalaes 10~20 Radix Glycyrrhizaes 3~9
Rhizoma Pinelliae Preparatum 5~15 Radix Codonopsis 15~25 Radix Angelicae Sinensis 5~15 Rhizoma Chuanxiongs 5~15
Radix Rehmanniae Preparata 10~20 Radix Paeoniae Rubra 6~18 Eupolyphaga Seu Steleophagas 15~25 Colla cornus cervis 15~25.
The preferred weight portion proportioning of crude drug is:
Poria 15 Ramulus Cinnamomi 10 Rhizoma Atractylodis Macrocephalaes 15 Radix Glycyrrhizaes 6
Rhizoma Pinelliae Preparatum 10 Radix Codonopsis 20 Radix Angelicae Sinensis 10 Rhizoma Chuanxiongs 10
Radix Rehmanniae Preparata 15 Radix Paeoniae Rubra 12 Eupolyphaga Seu Steleophagas 10 Colla cornus cervis 20.
Weight portion of the present invention can be the known unit of weights of field of medicaments such as μ g, mg, g or kg.
Medicine of the present invention preferably uses oral formulations, comprises water decoction, pill, capsule, granule, electuary or oral liquid etc., and above-mentioned dosage form all can prepare by this area conventional method.Wherein, be preferably water decoction (decoction), its preparation method is: will other crude drug except that Colla cornus cervi add the water of 5~7 times of weight, soaked 1~1.5 hour, decocted then 30 minutes, filter; Medicinal residues add the water of 3~5 times of weight again, decoct 20 minutes, filter; Merge filtrate twice, molten pours Colla cornus cervi then, makes water decoction.It is a course of treatment that day is obeyed twice, 6 month.
The tcm syndrome of the inventor through discovering early metaphase femoral head patient in a large number mainly shows as: arthralgia, lower limb are miserable, the joint is heavy, fatigue and asthenia, soreness of the waist and knees, lack of appetite are indigestion and loss of appetite, abdominal distention after meal, spontaneous perspiration, cardiopalmus, breathe hard, heavy, enlarged tongue has indentation, pale tongue or tongue dark, greasy fur, stringy pulse, heavy, sliding, thin.From the syndrome analysis, though the performance of suffering from a deficiency of the kidney is arranged,, belong to temper and lose empty, phlegm stagnation in collateral card based on insufficiency of the spleen syndrome, consider that its pathogenesis is " spleen deficiency generating phlegm is because of expectorant causes the stasis of blood, because of the stasis of blood causes numbness ".
Chinese medicine composition of the present invention, it is according to above-mentioned pathogenesis theory, and modern Chinese medicine is to the new development of femur head necrosis research, in conjunction with clinical research for many years, adopts invigorating the spleen for dissipating phlegm, promoting blood circulation to remove obstruction in the collateral, the Chinese medicine that is equipped with effect such as kidney and bone health is made.Prove that through animal experiment study Chinese medicine composition of the present invention has the blood lipid regulation metabolism disorder, improves effects such as hemorheology state; Clinical practice research also shows, Chinese medicine composition of the present invention to improve patient's symptom, delay PD, improving the quality of living has remarkable result, have better effect for early metaphase femur head necrosis patient; In reaching 3 years follow up a case by regular visits to, obtained image coefficient of stabilization 78.85%, function of joint satisfaction rate (Harris scoring) reaches the good efficacy about 80%, its therapeutic effect is suitable with international the most frequently used at present surgical effect; Zoopery confirms that also said composition has the morphologic effect of the femur head necrosis of improvement animal model femoral head pathological tissue.
Chinese medicine composition of the present invention is a monarch drug with Ramulus Cinnamomi, Radix Paeoniae Rubra; With Poria, the Rhizoma Atractylodis Macrocephalae, the Rhizoma Pinelliae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Codonopsis, Radix Rehmanniae Preparata, Colla cornus cervi, Eupolyphaga Seu Steleophaga is ministerial drug, and assistant is with Radix Glycyrrhizae.Wherein, Ramulus Cinnamomi, Poria, Radix Paeoniae Rubra blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain; The Rhizoma Pinelliae, Poria invigorating the spleen for dissipating phlegm; Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Poria, Radix Glycyrrhizae invigorating the spleen and replenishing QI; Radix Angelicae Sinensis, Radix Rehmanniae Preparata nourish conscience, and add Rhizoma Chuanxiong and go into blood system and regulate the flow of vital energy tonify without causing stagnation; Colla cornus cervi, Eupolyphaga Seu Steleophaga temperature compensation Liver and kidney, benefiting essence-blood, removing blood stasis with potent drugs blood, reuniting the fractured tendons and bones.
Chinese medicine composition of the present invention, it is the crucial pathogenesis " the expectorant stasis of blood " according to femur head necrosis and the inventor's " removing both phlegm and blood stasis at the same time " that propose a principle, and modern Chinese medicine theory, obtain through a large amount of compatibility researchs, it has effects such as invigorating the spleen for dissipating phlegm, promoting blood circulation to remove obstruction in the collateral, kidney and bone health, to improve patient's symptom, delay PD, improving the quality of living has remarkable result, have better effect for early metaphase femur head necrosis patient; And toxic and side effects is little, cheap.
The specific embodiment
Below further specify the present invention by specific embodiment, but be not used for limiting the scope of the invention.
Embodiment 1
Poria 15g Ramulus Cinnamomi 10g Rhizoma Atractylodis Macrocephalae 15g Radix Glycyrrhizae 6g
Rhizoma Pinelliae Preparatum 10g Radix Codonopsis 20g Radix Angelicae Sinensis 10g Rhizoma Chuanxiong 10g
Radix Rehmanniae Preparata 15g Radix Paeoniae Rubra 12g Eupolyphaga Seu Steleophaga 10g Colla cornus cervi (melting) 20g.
Will other crude drug except that Colla cornus cervi add the water of 5 times of weight, soak after 1.5 hours, decocted 30 minutes, filter; Medicinal residues add the water of 3 times of weight again, decoct 20 minutes, filter; Merge filtrate twice, molten pours Colla cornus cervi then, makes water decoction.
Embodiment 2
Poria 10g Ramulus Cinnamomi 5g Rhizoma Atractylodis Macrocephalae 10g Radix Glycyrrhizae 3g
Rhizoma Pinelliae Preparatum 5g Radix Codonopsis 15g Radix Angelicae Sinensis 5g Rhizoma Chuanxiong 5g
Radix Rehmanniae Preparata 10g Radix Paeoniae Rubra 6g Eupolyphaga Seu Steleophaga 15g Colla cornus cervi (melting) 15g.
Make water decoction by embodiment 1 method.
Embodiment 3
Poria 20g Ramulus Cinnamomi 15g Rhizoma Atractylodis Macrocephalae 20g Radix Glycyrrhizae 9g
Rhizoma Pinelliae Preparatum 15g Radix Codonopsis 25g Radix Angelicae Sinensis 15g Rhizoma Chuanxiong 15g
Radix Rehmanniae Preparata 20g Radix Paeoniae Rubra 18g Eupolyphaga Seu Steleophaga 25g Colla cornus cervi (melting) 25g.
Will other crude drug except that Colla cornus cervi add the water of 7 times of weight, soak after 1 hour, decocted 30 minutes, filter; Medicinal residues add the water of 5 times of weight again, decoct 20 minutes, filter; Merge filtrate twice, molten pours Colla cornus cervi then, makes water decoction.
Embodiment 4
Qiu, the woman, 29 years old, after repeatedly using glucocorticoid dexamethasone, prednisone sheet etc., two hip pain, limitation of activity appear, on inspection, be diagnosed as: bilateral femoral head necrosis (II phase).Take the water decoction of embodiment 1 every day at twice, half serve on a course of treatment (6 months) at every turn.Patient's pain symptom is alleviated, and activity freely.It is stable to follow up a case by regular visits to iconography in 2 years.
Zhang, the man, 23 years old, do not have obvious inducement and the hip arthralgia occurs, be diagnosed as on inspection: bilateral femoral head necrosis (right II B phase, left III B phase).Take the water decoction of embodiment 1 every day at twice, half serve on a course of treatment (6 months) at every turn, and it is stable to follow up a case by regular visits to iconography in 2 years, and the patient does not have special discomfort.
Below further specify the present invention by drug effect and clinical experiment.
The influence that experimental example 1 pair of corticosteroid femur head necrosis chicken model blood fat and hemorheology are learned
The water decoction of 1 material: embodiment 1 (heating in water bath is concentrated into and contains crude drug 1g/mL), Healthy female leghorn (Beijing Mei Lilaiweitong laboratory animal technology company limited).
2 methods and result
2.1 method
Adopt the method for medrat sodium succinate intramuscular injection to set up chicken corticosteroid femur head necrosis animal model, it is divided into 3 groups at random, give water decoction (of the present invention group), lovastatin (lovastatin group) and the distilled water (model group) of embodiment 1 respectively, and establish normal group in contrast.Continuously gastric infusion is after 8 weeks, fasting 12 hours, and vein is got blood under the wing, carries out blood fat and blood viscosity and detects and (detect if be used for hemorheology, then add the anticoagulant sodium citrate of 0.4mL in advance before blood drawing in syringe; If be used for lipids detection, then do not add anticoagulant).
2.2 result
2.2.1 influence to femur head necrosis chicken model blood fat
Detect TC, TG, HDL-C and the LDL-C value of normal group, model group, lovastatin group and of the present invention group respectively, the result is as shown in table 1.
The influence of table 1 pair femur head necrosis chicken model blood fat (
N=8)
Annotate: compare with normal group: △ P<0.05, △ △ P<0.01; Compare with model group: * P<0.05, * * P<0.01; Compare with the lovastatin group: ★ P<0.05.
As can be seen from Table 1: model group and normal group comparison TC, TG, LDL-C all raise, and difference has statistical significance (P<0.05); HDL-C reduces, and difference has statistics meaning (P<0.05).Of the present invention group and model group comparison, TC, TG obviously reduce, and difference has statistical significance (P<0.01); LDL-C reduces, and difference has statistical significance (P<0.05); HDL-C has rising trend, and difference does not have statistics meaning (P>0.05).
2.2.2 influence to femur head necrosis chicken model blood viscosity
Detect whole blood viscosity, plasma viscosity and the packed cell volume of normal group, model group, lovastatin group and of the present invention group respectively, the result is as shown in table 2.
The influence of table 2 pair femur head necrosis chicken model blood viscosity (
N=8)
Annotate: compare with normal group: △ P<0.05, △ △ P<0.01; Compare with model group: * P<0.05, * * P<0.01; Compare with the lovastatin group: ★ P<0.05.
As can be seen from Table 2: model group and normal group compare, and plasma viscosity obviously raises, and difference has statistics meaning (P<0.01); Whole blood is low cut viscosity, in cut viscosity and packed cell volume all raises, difference has statistical significance (P<0.05); The whole blood height is cut viscosity rising trend, difference not statistically significant (P>0.05).Of the present invention group with model group relatively, plasma viscosity, whole blood be low cut viscosity, in cut viscosity, height cuts blood viscosity and packed cell volume all reduces, difference has statistical significance (P<0.05 or P<0.01).
3 conclusions
The present composition is learned abnormality to femur head necrosis chicken model metabolism disorder of blood lipid, hemorheology and is had regulating action.
The clinical experimental study of 2 pairs of early metaphase femur head necrosiss of experimental example
Chinese medicine composition of the present invention from January, 2002 to 2008 a year December prove that in clinical practice treatment early metaphase femur head necrosis satisfactory effect has wherein carried out the follow-up investigation in 1~3 year to 299 examples (485 hip) early metaphase femur head necrosis.Concrete research approach is as follows:
1 case data
In early metaphase femur head necrosis patient 299 examples (485 hip) of Chinese department of Chinese medicine institute's bone injury institute and Wangjing Hospital, China Academy Of Traditional Chinese Medicine treatment, wherein, male's 198 examples, women's 101 examples, 15~78 years old age.
2 methods
2.1 diagnostic criteria
2.1.1 imaging diagnosis is with reference to the standard of propositions such as Mont
(1) specific index
1. collapse of the femoral head;
2. subchondral bone low-density line (meniscus sign);
3. sequestrum appears in the preceding inboard of femoral head;
4. bone scanning presents the low-density shadow that is held by the high density shadow, promptly pines for having cold (ColdinHot);
5. two-wire occurs on the T2 picture of MRI and levy (DoubleBand);
6. regional osteocyte crypts inanition is seen in the bone biopsy, involves contiguous many bone trabecula necrosis.
(2) non-specificity index (Non~specificCriteria)
1. collapse of the femoral head companion joint space is narrow;
2. mottled low-density shadow or high density shadow appear in the femoral head;
3. bone scanning shows high absorption signal;
4. MRI checks and shows bone marrow edema or fibrosis signal;
5. hip joint activity pain, X ray examination are no abnormal;
6. long-term excessive drinking is arranged or use the hormone history;
7. the bone biopsy shows non-specific pathological changes, prompting bone marrow edema or fibrosis.
A diagnosis of satisfying simultaneously in specific index and the non-specificity index can be set up.
2.1.2 femur head necrosis is by stages with reference to international bone circulation science meeting (ARCO) standard
0 phase: except that pathology showed osteonecrosis, all the other were all acted normally.
The I phase: nucleic is or/and the positive performance of MRI; Going up the femoral head degree (area) of getting involved according to MRI is divided into: I a<15%; I b 15%~30%; I c>30%.
The II phase: show on the X-ray film that bone density changes but nothing is subsided, nucleic is or/and the positive performance of MRI; Be divided into according to the MRI degree of getting involved: II a<15%; II b 15%~30%; II c>30%.
The III phase: show subchondral bone folding (being meniscus sign) companion collapse of the femoral head on the X-ray film; Be divided into according to meniscus sign scope and collapse of the femoral head degree: III a<15%, subside<2mm; III b15%~30%, 2~4mm subsides; III c>30% subsides>4mm.
The IV phase: show on the X-ray film that femoral head obviously subsides, the joint space is narrow, and acetabular bone sclerosis, capsule become and hyperosteogeny.
2.2 the standard of including in
(1) meets femur head necrosis Mont diagnostic criteria;
(2) two hip normotopias of X line and breast-stroke bit slice all information have MRI or CT data simultaneously;
(3) ARCO I phase, II phase, III phase patient by stages.
2.3 exclusion standard
(1) do not meet femur head necrosis Mont diagnostic criteria;
(2) imaged image is fuzzy, can not recognize hardenability band and cystis degeneration's periphery person;
The femoral head pathological changes that reasons such as (3) one property crossed synovitis, slipped femoral epiphysis disease, bone tuberculosis, bone tumor, the heavy person's property villonodular synovitis of pigment, acetabular dysplasia, ankylosing spondylitis, hip joint osteoarthritis cause.
2.4 rejecting standard
Because infull person of a variety of causes clinical data and the true person of acatalepsia.
2.5 Therapeutic Method
Give the Chinese medicine decoction of embodiment 1 for the patient who meets the standard of including in, every day is oral at twice, takes half at every turn, and serveing on 6 months is a course of treatment.
2.6 case collection method
Two hip normotopias of X line and breast-stroke bit slice when the patient is admitted to hospital, MRI or CT data; Treat two hip normotopias of X line and the breast-stroke bit slice in back 1 year, 2 years, 3 years; When the patient is admitted to hospital and the scoring of the Harris when treating back a year, 2 years, 3 years.
2.7 therapeutic evaluation index
2.7.1 imaging evaluation index
The standard that evaluation criterion is formulated according to expert group of Beijing Municipal Health Bureau's " osteonecrosis behind the SARS ", specific as follows:
Stable: 1. necrotic area (capsule becomes the district) bone density is improved; 2. hardenability band is fuzzy; 3. the performance of X line is roughly the same before and after the treatment, is in steady statue; 4. grade is improved by stages: ARCO is converted into the I phase by the II phase by stages, or is converted into B or A by the C of II phase.
Increase the weight of: osteoarthritis performances such as joint hyperplasia 1. occur; 2. collapse of the femoral head appears; 3. due to illness feelings increase the weight of pain, range of motion difference etc. to occur and carry out joint replacement.
2.7.2Harris scoring index
According to internationally recognized Harris evaluation criterion, concrete standard is as follows:
Clinical recovery: the last mark is more than 90 minutes;
Produce effects: the last mark is more than 70 minutes, and mark is increased in more than 20 minutes or 20 minutes;
Effectively: the last mark is more than 70 minutes, and mark was increased in more than 10 minutes, below 20 minutes;
Invalid: mark does not have increase.
3 results
3.1 iconography Follow-up results
Curative effect behind the early metaphase femur head necrosis patient treatment is carried out imaging evaluation, and the result is as shown in table 3.
The influence of table 3 pair femur head necrosis patient iconography
As can be seen from Table 3: follow up a case by regular visits to 1 year case totally 299 hips, press the image evaluation criteria, stablize 256 hips after the treatment, coefficient of stabilization 85.62%; Increase the weight of 43 hips, add-on 14.38%.Follow up a case by regular visits to 2 years cases totally 134 hips, stablize 110 hips after the treatment, coefficient of stabilization 89.09%; Increase the weight of 24 hips, add-on 17.91%.Follow up a case by regular visits to 3 years cases totally 52 hips, stablize 41 hips after the treatment, coefficient of stabilization 78.85%; Increase the weight of 11 hips, add-on 21.15%.
3.2Harris scoring assessment result
Press Harris scoring evaluation criteria, the effect behind the patient treatment is estimated, the result is as shown in table 4.
The influence that table 4 couple femur head necrosis patient Harris divides
As can be seen from Table 4: follow up a case by regular visits to 1 year case totally 299 hips, clinical produce effects 52 hips in treatment back, clinical obvious effective rate 17.39%; Effective 202 hips, effective percentage 67.56%; Invalid 45 hips, inefficiency 15.50%.Follow up a case by regular visits to 2 years case 134 hips, clinical produce effects 28 hips in treatment back, clinical obvious effective rate 20.89%; Effective 84 hips, effective percentage 62.68%; Invalid 22 hips, inefficiency 16.42%.Follow up a case by regular visits to 3 years case 52 hips, clinical produce effects 9 hips in treatment back, clinical obvious effective rate 17.30%; Effective 52 hips, effective percentage 61.54%; Invalid 11 hips, inefficiency 21.15%.
To sum up, be changed to the therapeutic evaluation index with Harris scoring and iconography, the result shows: after taking this medicine, the iconography coefficient of stabilization in 1 year, 2 years, 3 years is not for being 85.62%, 89.09%, 78.85%; Patient's local pain, viability and locomotor activity all are improved, and Harris scoring clinical recovery rate and the effective percentage in 1 year, 2 years, 3 years are respectively: 17.39% and 67.56%, 20.89% and 62.68%, 17.30% and 61.54%.
4 conclusions
With the present composition femur head necrosis patient is treated, in reaching 3 years follow up a case by regular visits to, Harris scoring index effective percentage reaches about 80%, and the iconography coefficient of stabilization reaches 78.85%.The above only is a preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the technology of the present invention principle; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.