CN103599486B - A kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis - Google Patents

A kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis Download PDF

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CN103599486B
CN103599486B CN201310591177.9A CN201310591177A CN103599486B CN 103599486 B CN103599486 B CN 103599486B CN 201310591177 A CN201310591177 A CN 201310591177A CN 103599486 B CN103599486 B CN 103599486B
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radix
rhizoma
fructus
chinese medicine
medicine composition
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CN103599486A (en
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李婕
孙建光
张娇
任万华
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Shandong Provincial Hospital
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Abstract

The invention discloses a kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis.It is made up of following raw material medicaments: Radix Ginseng, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, the Cortex Eucommiae, Radix Dipsaci, Radix Bupleuri, Fructus Ligustri Lucidi, Fructus Lycii, Pericarpium Citri Reticulatae, Radix Aconiti Lateralis Preparata, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Poria, Caulis Spatholobi, Radix Clematidis, Radix Cyathulae, Radix Morindae Officinalis, Fructus Psoraleae, Rhizoma Drynariae, Radix Angelicae Sinensis, Rhizoma Curcumae Longae, Zaocys, Fructus Evodiae, Rhizoma Et Radix Notopterygii, Folium Artemisiae Argyi and Radix Glycyrrhizae.Adopt Chinese medicine composition of the present invention effectively can treat rheumatoid arthritis, total effective rate is 96.0%.

Description

A kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis
Technical field
The present invention relates to a kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis, belong to technical field of Chinese medicines.
Background technology
Rheumatoid arthritis (rheumatoidarthtitis, RA) be a kind of cause of disease not bright, based on the systemic disease of chronic, the repeated relapsing inflammation in joint.Pathological process shows as synovial tissue's paraplasm, finally causes gradual cartilage and bone injury.Along with spectrum of disease changes, musculoskeletal disease becomes common clinical.More than half in 65 years old crowds suffer from joint disease the most common, is to cause limitation of activity and the modal reason that disables, and all brings very large financial burden to sufferers themselves and entire society.Though China lacks similar statistics, the most conservative estimation at least also has 4,000,000 people to suffer from RA(prevalence 0.33%, lower than west).World Health Organization (WHO) ratifies and starts " B&J 10 years " (2000 ~ 2010) plan, is intended to for a change this situation and makes an effort, to benefit numerous uncared-for osteoarthritis patient.Recent two decades comes, the proposition of targeted therapy, the treatment of decompression bridge joint, sawtooth therapy suffices to show that the understanding of modern medicine to rheumatoid arthritis, no matter be pathogenesis aspect, or diagnostic method, treatment means aspect, all enter new stage, but due to RA be a kind of different substantiality disease, no matter adopt which kind of pattern, drug side effect and the complication caused thereof impel the main cause of patients stopping treatment often, " B&J 10 years " proposal for this reason medicine of state of an illness effect less side effect " development and application change ".The determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs characteristic of motherland's medicine few side effects and uniqueness thereof, makes the prophylactico-therapeutic measures excavating and inquire into rheumatoid arthritis from motherland's medical angle become inevitable.
Summary of the invention
The present invention further investigation rheumatoid arthritis pathogenetic basis on, develop a kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis, can more effective treatment rheumatoid arthritis.
Technical scheme of the present invention is: a kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis, it is characterized in that, be made up of the crude drug of following weight: Radix Ginseng 12-18g, Radix Rehmanniae Preparata 12-18g, Rhizoma Dioscoreae 8-12g, Radix Astragali 12-18g, Radix Et Caulis Acanthopanacis Senticosi 12-18g, Cortex Eucommiae 12-18g, Radix Dipsaci 8-12g, Radix Bupleuri 8-12g, Fructus Ligustri Lucidi 8-12g, Fructus Lycii 8-12g, Pericarpium Citri Reticulatae 8-12g, Radix Aconiti Lateralis Preparata 8-12g, Rhizoma Atractylodis Macrocephalae 8-12g, Radix Paeoniae Alba 12-18g, Poria 12-18g, Caulis Spatholobi 12-18g, Radix Clematidis 12-18g, Radix Cyathulae 8-12g, Radix Morindae Officinalis 8-12g, Fructus Psoraleae 8-12g, Rhizoma Drynariae 12-18g, Radix Angelicae Sinensis 8-12g, Rhizoma Curcumae Longae 8-12g, Zaocys 5-10g, Fructus Evodiae 8-12g, Rhizoma Et Radix Notopterygii 8-12g, Folium Artemisiae Argyi 5-10g and Radix Glycyrrhizae 3-8g.
Optimum ratio is: Radix Ginseng 15g, Radix Rehmanniae Preparata 15g, Rhizoma Dioscoreae 10g, Radix Astragali 15g, Radix Et Caulis Acanthopanacis Senticosi 15g, Cortex Eucommiae 15g, Radix Dipsaci 10g, Radix Bupleuri 10g, Fructus Ligustri Lucidi 10g, Fructus Lycii 10g, Pericarpium Citri Reticulatae 10g, Radix Aconiti Lateralis Preparata 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Paeoniae Alba 15g, Poria 15g, Caulis Spatholobi 15g, Radix Clematidis 15g, Radix Cyathulae 10g, Radix Morindae Officinalis 10g, Fructus Psoraleae 10g, Rhizoma Drynariae 15g, Radix Angelicae Sinensis 10g, Rhizoma Curcumae Longae 10g, Zaocys 8g, Fructus Evodiae 10g, Rhizoma Et Radix Notopterygii 10g, Folium Artemisiae Argyi 8g and Radix Glycyrrhizae 5g.
Preparation and instructions of taking: every day 1 dose, decoction at twice.Medication 30 days was 1 course for the treatment of.
The pharmacological action of each Chinese medicine:
Radix Ginseng: sweet, micro-hardship, tepor.Return spleen, lung, the heart, kidney channel.Function with cure mainly: strongly invigorating primordial QI, multiple arteries and veins takes off admittedly, and invigorating the spleen to benefit the lung, promotes the production of body fluid and nourish blood, Fructus Alpiniae Oxyphyllae of calming the nerves.For weak body and prostration, cold extremities faint pulse, insufficiency of the spleen lack of appetite, the deficiency of the lung is breathed with cough, and Tianjin wound is thirsty, and interior-heat is quenched one's thirst, deficiency of qi and blood, and prolonged illness void is won, palpitation with fear insomnia, sexual impotence cold womb.
Radix Rehmanniae Preparata: sweet, tepor.Return liver, kidney channel.Function with cure mainly: YIN nourishing of enriching blood, beneficial essence fills out marrow.For blood deficiency and yellow complexion, severe palpitation, menoxenia, metrostaxis, the hepatic and renal YIN deficiency, soreness of the waist and knees, osteopyrexia and fever, night sweat is passed out semen, and interior-heat is quenched one's thirst, dizzy, tinnitus, early whitening of beard and hair.
Rhizoma Dioscoreae: sweet, flat.Return spleen, lung, kidney channel.Spleen reinforcing nourishing the stomach, promote the production of body fluid lung benefiting, the kidney invigorating arresting seminal emission.For insufficiency of the spleen lack of appetite, incessant chronic diarrhea, the deficiency of the lung is breathed with cough, emission due to deficiency of the kidney, leukorrhagia, frequent micturition, and deficiency-heat is quenched one's thirst.
The Radix Astragali: sweet, tepor.Return lung, spleen channel.Function with cure mainly: tonifying Qi and lifting yang, strengthening superficial resistance to stop perspiration, inducing diuresis to remove edema, promotes the production of body fluid and nourishes blood, row stagnant blood stasis dispelling, expelling pus and toxin by strengthening QI, expelling pus and promoting granulation.Weak for the deficiency of vital energy, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, hemiplegia, and arthralgia pain is numb, and carbuncle difficulty is burst, and bursts for a long time and does not hold back.
Radix Et Caulis Acanthopanacis Senticosi: pungent, micro-hardship, temperature.Return spleen, kidney, heart channel.Replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization.Cure mainly: for deficiency of spleen-YANG and kidneyYANG, body void is weak, inappetence, soreness of waist and knee joint, insomnia and dreamful sleep.
The Cortex Eucommiae: sweet, temperature.Return liver, kidney channel.Function with cure mainly: invigorating the liver and kidney, bone and muscle strengthening, antiabortive.For deficiency of the liver and kindey, soreness of waist and knee joint, muscles and bones is unable, has a dizzy spell, blood leaking in gestation, frequent fetal movement.
Radix Bupleuri: bitter, is slightly cold.Return liver, gallbladder meridian.Function cures mainly: reconciling superficies and interior, soothing the liver, yang invigorating.For cold, fever, alternate attack of chill and fever, distending pain in the chest and hypochondrium, menoxenia, sub-official's prolapsus, proctoptosis.
Fructus Ligustri Lucidi: sweet, bitter, cold.Return liver, kidney channel.Nourishing the liver and kidney, improving eyesight black hair.For the hepatic and renal YIN deficiency, vertigo and tinnitus, soreness of the waist and knees, early whitening of beard and hair, poor vision, interior-heat is quenched one's thirst, osteopyrexia and fever.
Fructus Lycii: sweet is flat.Return liver, kidney channel.Nourishing the liver and kidney, replenishing vital essence to improve eyesight.For asthenia damage of essence.Doctor's knee joint soreness, vertigo and tinnitus, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, and blurred vision is failed to understand.
Pericarpium Citri Reticulatae: bitter, pungent, temperature.Return lung, spleen channel.Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
Radix Aconiti Lateralis Preparata: pungent, sweet is warm greatly; Poisonous.GUIXIN, kidney, spleen channel.Function: recuperating depleted YANG and rescuing the patient from collapse, mends fire supporing yang, dispersing cold for relieving pain.Cure mainly: for excess of YIN gram sun, loss of YANG due to profuse perspiration, vomiting and diarrhoea, it is inverse to faint, cold extremities faint pulse, trusted subordinate's cold type of pain, cold-dysentery, beriberi edema, anemofrigid-damp arthralgia, cold womb, and deficiency and coldness is vomited and diarrhoea, YIN-cold edema, yang deficiency diseases caused by exogenous pathogenic factor, the disease of carbuncle of yin nature skin infection and all chronic diseaseses.
The Rhizoma Atractylodis Macrocephalae: bitter, sweet, temperature.Return spleen, stomach warp.Invigorating the spleen and benefiting QI, dampness diuretic, hidroschesis, antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.
The Radix Paeoniae Alba: bitter, sour, is slightly cold.Return liver, spleen channel.Function with cure mainly: nourishing blood for regulating menstruation, astringing YIN to stop sweating, easing the affected liver to relieve pain, suppressing liver-YANG.For blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, stomachache, limb pain twin, has a headache dizzy.
Poria: sweet, light is flat.GUIXIN, lung, spleen, kidney channel.Function with cure mainly: promoting diuresis to eliminate damp pathogen, spleen invigorating, mind calming.For edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, have loose bowels in loose stool, irritability, palpitation with fear insomnia.
Caulis Spatholobi: bitter, sweet, temperature.Return liver, kidney channel.Function with cure mainly: blood circulation promoting and enriching, menstruction regulating and pain relieving, relaxing muscles and tendons and activating QI and blood in the collateral.For menoxenia, dysmenorrhea. amenorrhea, rheumatic arthralgia, paralysis and numbness, blood deficiency and yellow complexion.
Radix Clematidis: Xin Xian, temperature, poisonous.Enter urinary bladder channel.Wind-damp dispelling, the meridian dredging, expectorant saliva, the loose hypochondriac lump.Control gout, insensitive impediment, chills and pain of the waist and kness , lumps in the chest and abdomen, tetanus, tonsillitis, all a fishbone or other bone caught in the throat pharynxs.
Radix Cyathulae: sweet, micro-hardship, flat.Return liver, kidney channel.Function with cure mainly: eliminating blood stasis and inducing menstruation, easing joint movement, inducing diuresis for treating stranguria syndrome.For amenorrhea and mass in the abdomen, retention of placenta, arthralgia, flaccidity of the lower limbs clonic spasm of the muscle, hematuria stranguria with blood, injury from falling down.
Radix Morindae Officinalis: sweet, pungent, tepor.Return kidney, Liver Channel.Kidney-replenishing, bone and muscle strengthening, wind-damp dispelling.
Fructus Psoraleae: pungent, bitter, temperature.Return kidney, spleen channel.Function with cure mainly: warming the kidney to activate YANG, helping inspiration to relieve asthma, warming spleen and stopping diarrha; External pathogenic wind expelling speckle dispelling.For insufficiency of kidney-YANG, impotence and seminal emission, enuresis frequent micturition, chills and pain of the waist and kness, suffers from a deficiency of the kidney and breathes heavily. Diarrhoea; External curing vitiligo, alopecia areata.
Rhizoma Drynariae: the kidney invigorating, invigorates blood circulation, hemostasis.Control suffer from a deficiency of the kidney chronic diarrhea and lumbago, rheumatic arthralgia, toothache, tinnitus, traumatic injury sprain and contusion, bone injury, appendicitis, alopecia areata, clavus.
Radix Angelicae Sinensis: sweet, acrid, warm.Return liver, the heart, spleen channel.Function with cure mainly: enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, loosening bowel to relieve constipation.For blood deficiency and yellow complexion, dizzy cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, rheumatic arthralgia, injury from falling down, ulcer sores, dryness of the intestine constipation.Radix Angelicae Sinensis (processed with wine) promoting blood circulation to restore menstrual flow.For amenorrhea dysmenorrhea, rheumatic arthralgia, injury from falling down.
Rhizoma Curcumae Longae: pungent, bitter, temperature.Return spleen, Liver Channel.Function with cure mainly: removing blood stasis circulation of qi promoting, inducing menstruation to relieve menalgia.For the twinge of the breast side of body, obstruction of qi in the chest and cardialgia, dysmenorrhea amenorrhea, abdominal mass abdominal mass, rheumatism shoulder arm pain, tumbling and swelling.
Zaocys: sweet is flat.Return Liver Channel.Function with cure mainly: dispel the wind, dredging collateral, relieving convulsion.For rheumatoid arthritis stubborn, numbness contracture, apoplexy facial hemiparalysis, hemiplegia, tic spasm, tetanus, leprosy scabies, scrofula malignant boil.
Fructus Evodiae: pungent, bitter, heat; Slightly poisonous.Return liver, spleen, stomach, kidney channel.Dispersing cold for relieving pain, stopping nausea and vomiting by lowering the adverse flow of QI, supporing yang antidiarrheal.For headache due to JUE YIN disorder, colic of cold type is suffered from abdominal pain, the disturbance of lower legs due to pathogenic cold and dampness, abdominal pain during menstruation, abdominal distention, vomiting acid regurgitation, Diarrhoea, external treatment aphtha; Hypertension.
Rhizoma Et Radix Notopterygii: cold expelling, dispels the wind, dehumidifying, pain relieving.For anemofrigid cold headache, rheumatic arthralgia, aching pain in should and back.
Folium Artemisiae Argyi: pungent, bitter, temperature; Slightly poisonous.Return liver,spleen,kidney warp.Function with cure mainly: warming the meridian for stopping bleeding, dispersing cold for relieving pain.
Radix Glycyrrhizae: sweet, flat.GUIXIN, lung, spleen, stomach warp.Function with cure mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
The mechanism of action of Chinese medicine composition of the present invention, is mainly manifested in following four aspects:
1, antiinflammatory, analgesia
The large absolutely number medicine xylol of Chinese medicine composition of the present invention, the inflammation caused by Ovum Gallus domesticus album are inhibited.If Achyranthes Bidentata Saponins (ABS) is main active in Radix Achyranthis Bidentatae, rat and mouse acute inflammatory reaction can be alleviated, reduce rat agar granuloma weight, extend mice on hot plate and lick the sufficient time, improve rat blood rheological characteristic, there is anti-inflammatory and antalgic and the effect of invigorating blood circulation.Pachyman has inhibitory action to subcutaneous rat Granuloma formation caused by cotton balls, the mouse ear caused by dimethylbenzene also can be suppressed simultaneously to swell, have and suppress active chronic inflammation reagentia under low dose.Radix Aconiti Lateralis Preparata, Radix Angelicae Sinensis, Caulis Spatholobi, Radix Clematidis have strong, antiinflammatory and analgesic effect; The rat acute inflammation of Radix Paeoniae Alba on Carrageenan induction has inhibitory action, and its peritoneal macrophage can be made to generate H in a large number 2o 2, IL-1 and synovial cell's excessive secretion IL-1, TNF, PGE 2functional rehabilitation normal, the cellulose that can reduce inflamed joint oozes out, inflammatory cell infiltration and synovial hyperplasia.
The present invention is proved by test, and Chinese medicine composition of the present invention is obviously better than matched group improving in patient articular's pain, articular pain, illustrates that Chinese medicine composition analgesic activity of the present invention is stronger.After treatment, patient's arthroncus obviously improves simultaneously, points out Chinese medicine composition of the present invention also to have antiinflammatory action.
2, immunity moderation
The immunity of RA and immunoreation are subject to the adjustment of immunologically competent cell, neuroendocrine and neurotransmitter, cytokine, inflammatory mediator and many enzymes etc.When the immunne response of body and immunoloregulation function out of control time, cause the morbidity of RA.
Such as the Radix Ginseng of medicine selected by Chinese medicine composition of the present invention can act on cAMP and cGMP to play its immune equalizing effect, and by blocking the combination of LPS and AMC film, suppress the expression of the intracellular immunity inhibitive factor I-κ B of LPS induction, thus TNF-α secretion level is declined; The Rhizoma Atractylodis Macrocephalae can make TH cell obviously increase, and improves TH/Ts ratio, corrects T cell subgroup distribution disorders state, low IL-2 level can be made to significantly improve, and can increase the expression of T lymphocytic cell surface IL-2R; Radix Morindae Officinalis has adrenal cortex reinforcing function; Poria can adjustment cellular immunization.
This result of study shows, Chinese medicine composition of the present invention significantly can reduce the titre of serum immune globulin IgM, IgA, IgG, thus immunoglobulin, the generation of rheumatoid factor and the formation of immune complex can be reduced, decrease the deposition of cell active substance at synovial membrane, thus alleviate RA patient arthroncus, morning deadlock, the symptom such as pain.
3. the adjustment of pair blood circulation
First the pathologic basis of RA mainly joint is destruction and the depolymerisation of the whole body connective tissues such as synovial membrane.Pannus and pannus cell are main component and the basic substance of RA joint tissue destruction.During rheumatoid synovial, blood capillary proliferation, blood vessel endothelium swelling also charges into tube chamber, it is congested phenomenon that tube chamber is full of erythrocyte, and a large amount of cellular infiltration and pannus are formed, and are deep into subchondral plate in lobe sample, cause synovial membrane to thicken, chondrocyte dissolve, dead and bone erosion destroys, tendon and ligament injury fracture, joint injury is fibroid and Bony union, and course of disease person of a specified duration is merged with bone bridge form, becomes arthrosclerosis or bony ankylosis.And RA blood and joint, local fibre coagulate abnormal, and fibrin deposition often attracts the attack of inflammatory mediator thus mediate bone is attacked, and the autoantibody such as AECA, anti-phospholipid antibody forms thrombosis by many factors.
Research shows, in Chinese medicine composition of the present invention, the activating blood and removing stasis drug such as Caulis Spatholobi, the Radix Paeoniae Alba, Rhizoma Curcumae Longae, Radix Angelicae Sinensis, Zaocys has that blood vessel is derivative suppresses sample effect, by anticoagulant, Fibrinogen solidifies, and plays the effect promoting fibrinolytic, correct blood clotting exception.Visible, Chinese medicine composition of the present invention can by playing the effect that it blocks RA PD to the adjustment of blood circulation.
4, invigorating the liver and kidney spleen, fills blood, and strengthens resistance of human body
Liver and kidney, insufficiency of vital energy and blood, cause the lower for the resistance of human body, makes human body not drive heresy, and cold-damp is invaded in an opponent's defence deeply, kidney governing bones, and cold-evil enters kidney, stays house for a long time, and bone is become homeless foster, then can cause rheumatoid arthritis.Tonifying liver, the kidney invigorating, the spleen reinforcing such as Radix Ginseng, Radix Rehmanniae Preparata, Rhizoma Dioscoreae, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi, the Cortex Eucommiae, Radix Dipsaci, Radix Bupleuri, Fructus Ligustri Lucidi, Fructus Lycii, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, the Radix Paeoniae Alba, Radix Morindae Officinalis, Fructus Psoraleae and Radix Glycyrrhizae in prescription of the present invention, to fill blood, strengthen resistance of human body, Fructus Evodiae, Rhizoma Et Radix Notopterygii and Folium Artemisiae Argyi dispersing wind and cold simultaneously, Radix Clematidis, Radix Morindae Officinalis and Zaocys wind-damp dispelling.Above-mentioned Chinese medicine combined effect recovers function of human body, consolidates the curative effect of Drug therapy, thus fundamentally prevents and treats the generation again of rheumatoid arthritis, reach the effect for the treatment of both the principal and secondary aspects of a disease.
To sum up, Chinese medicine composition of the present invention may be by antiinflammatory, analgesia, immunomodulating, improve blood circulation, multipath, the too many levels such as to build up resistance suppress quasi-wind gateway synovial membrane inflammation, stops bone destruction, reaches the effect for the treatment of both the principal and secondary aspects of a disease.
The invention has the beneficial effects as follows: adopt Chinese medicine composition of the present invention effectively can treat rheumatoid arthritis, total effective rate is 96.0%.Its beneficial effect is further illustrated below in conjunction with clinical trial and model case.
One, clinical trial method
(1) physical data
Be selected from outpatient service and the inpatient of 2012.2-2013.2, meet inclusive criteria 144 routine RA patients are divided into treatment group and matched group at random.Wherein treatment group 75 example, wherein man 30 example, female 45 example; 18 ~ 65 years old age, average 40.35 ± 13.24 years old; Matched group 69 example, wherein man 29 example, female 40 example; 20 ~ 63 years old age, average 43.10 ± 11.92 years old; 2 groups of patients are outpatient service and inpatient, and the clinical datas such as age, sex, the state of an illness, function of joint classification, radioactivity classification are through X 2 test no significant difference (P>0.05).
(2) Therapeutic Method
Treatment group adopts Chinese medicine composition of the present invention, every day 1 dose, decoction at twice.Medication was 1 course for the treatment of in 30 days, followed up a case by regular visits to 6 months.Matched group YISHEN JUANBI WAN, is provided by Lianyun Harbour pharmacy head factory, every bag of 8g, each 1 bag, every day 3 times, oral meal.Medication natural law and the course for the treatment of same treatment group, 2 groups treatments period all stop using other treatment primary disease medicines.
Two, observation index
(1) safety observations
1. general physical examination;
2. observe the untoward reaction that may occur, comprise gastrointestinal irritation (Nausea and vomiting, poor appetite, gastric abscess, loose stool, constipation etc.), anaphylaxis (skin, mucosa and other tracts).
(2) health giving quality observation
1. tcm syndrome: arthralgia, arthroncus, articular pain, joint stuffiness, joint morning be stiff, walk with difficulty, pain increase in intensity under coldness etc.(above symptom is given a mark according to weight, and treatment is front and treat rear each inspection record 1 time);
2. main relevant sign: articular pain number, swelling number (bilateral near-end refer between, the palm refers to, wrist, elbow, shoulder, knee joint, counts 28 joints), the average grip of function of joint, both hands (mmHg).(treatment is front and treat rear each inspection 1 time);
3. physico-chemical examination: rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), c reactive protein (CRP), IgG, IgM and IgA.
(3) TCM syndrome evaluation standard
Primary symptom:
1. arthralgia when rest (refer to arthralgia)
0 point: joint not bitterly or pain disappear
3 points: pain is light, still can stand, or only tired or Changes in weather time pain, substantially do not affect work
6 points: pain is heavier, work and rest are all affected
9 points: pain is serious, is difficult to stand, have a strong impact on and have a rest and work, need with the use of analgesic drug products
2. arthroncus
0 point: joint disappears without swelling or swelling
3 points: joint mild swelling, skin texture shoal, ossa articularia mark is still obvious
6 points: obviously, skin texture disappears substantially, and bone mark is not obvious for joint moderate swelling, arthroncus
9 points: very, skin is tight, bone marks obliterated for joint severe swelling, arthroncus
3. articular pain
0 point: joint disappears without tenderness or tenderness
3 points: mild tenderness, patient claims there is pain
6 points: moderate tenderness, patient Shang Neng stands, and frowns uncomfortable
9 points: severe tenderness, pain can not be touched, and during extrusion joint, patient's very pain, draws back hands or limbs
4. joint joint stuffiness
0 point: joint motion is normal
3 points: joint motion is slightly limited, range of motion reduces <1/3
6 points: joint motion is obviously limited, range of motion reduces >1/3
9 points: joint motion critical constraints, range of motion reduces >=2/3, even stiff.
Secondary disease:
1. pain increase in intensity under coldness (under more than 15 DEG C states)
0 point: the cold pain of chance is unchanged
1 point: slight meet cold pain and increase, can exposed joint, but meet cold water pain and increase
2 points: moderate pain increase in intensity under coldness, can exposed joint, but meet wind pain and increase
3 points: severe pain increase in intensity under coldness, can not exposed joint, warming measure need be increased
2. morning is stiff
0 point: nothing
1 point: morning stiff <1h
2 points: morning deadlock >=1h, <2h
3 points: morning deadlock >=2h
3. walk with difficulty
From standing place, walk to 15 meters of terminal required times with stopwatch record, repeat 3 times, average;
0 point: 15 meters walking time≤9 seconds
1 point: 15 meters of walking time >9 seconds and≤15 seconds
2 points: 15 meters of walking time >15 seconds and≤25 seconds
3 points: 15 meters of walking time >25 seconds.
(4) main relevant sign
1. articular pain number: the total number in all tenderness joints;
2. arthroncus number: the total number of all swollen joint;
3. grip (mmHg): sphygmomanometer girding is inflated to 20mmHg, then by patient with the as possible each grip pressure 3 times of unsupported left hand and right hand, record the meansigma methods reached, be hand-grip strength number (mmHg).
(5) untoward reaction is recorded
Comprise gastrointestinal irritation (Nausea and vomiting, poor appetite, gastric abscess, loose stool, constipation etc.), anaphylaxis (skin, mucosa and other tracts) and other.
Three, instrument and equipment
Full-automatic esr analyzer DIESSE Italy model: Ves Matic 20;
Special protein instrument BINDING England model: MININEPH tM.
Four, efficacy assessment standard
With reference to " new Chinese medicine guideline of clinical investigations " (Ministry of Public Health bureau of drug policy & administration formulates, 2002) and " Chinese medical disease Standardization of diagnosis and curative effect " according to State Administration of Traditional Chinese Medicine's issue in 2012.Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%; Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%; Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%; Invalid: tcm clinical practice symptom, sign are all not improved, even increase the weight of, syndrome integral reduces less than 30%.Attached: tcm clinical practice symptom, sign refer to arthralgia, arthroncus, articular pain, joint joint stuffiness, morning stiff, pain increase in intensity under coldness and walking with difficulty.Syndrome integral reduces M and refers to that the syndrome integral of above index asks its meansigma methods after reducing (M) addition.
Note: computing formula (nimodipine method):
(3) efficacy determination of physico-chemical examination
Rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), c reactive protein (CRP) etc. are evaluated respectively according to check result.
Five, statistical method
index and result difference according to the observation, with the significance of parameters difference before and after paired t-test comparable group internal therapy; With X 2the significance of relevant parameters difference between inspection comparable group; Institute's measured value is all with x ± s(mean ± standard deviation) represent.Above result all has statistical package for social sciences (SPSS) analyzing and processing to complete.
Six, therapeutic outcome:
1, clinical efficacy:
By analysis, 2 groups of total effective rates have compared significant difference, and treatment group total effective rate (96.0%) is significantly higher than matched group (78.26%) (P<0.05).
2, before and after treatment, symptom and sign improve situation
Result shows: after two groups of patient treatments, indices has clear improvement before comparatively treating, and its difference has significance (P<0.05); After two groups of treatments, index compares respectively, treatment group is improved and is better than matched group in the number of arthralgia, articular pain, arthroncus, progression and walking 15mm time, hand-grip strength, function of joint classification, joint joint stuffiness, pain increase in intensity under coldness etc., and wherein the improvement of the number of pain, swelling, tenderness, walking 15mm time, hand-grip strength has significant difference (P<0.05).Chinese medicine composition of the present invention is pointed out to be better than YISHEN JUANBI WAN in treatment rheumatoid arthritis.
3, on the impact of lab index
Result shows: compare with before treatment, 2 groups all can be reduced ESR, RF, CRP and Ig, and difference has significance (P<0.05); Two groups treatment after indexs compare respectively, difference does not have significance, point out Chinese medicine composition of the present invention improve in laboratory indices similar to YISHEN JUANBI WAN effect.
4, safety observation
In 144 routine patients of all observations, there is not untoward reaction, without Nausea and vomiting, poor appetite, gastric abscess, loose stool etc., without the anaphylaxis such as skin, mucosa occur, the functions such as the heart, liver, kidney before the treatment after all normal.Point out the safety of traditional Chinese medicine composition for treating RA of the present invention good.
Model case:
Lee, man, 64 years old.Consultation time: in JIUYUE, 2012.Main suit: symmetry arthralgia more than 2 years, increases the weight of January.History of present illness: without obvious inducement, patient occurred that double knee joint swelled and ache before 2 years, gradually and both hands proximal interphalangeal joint, wrist, both shoulders joint.Be interrupted and take non-steroid antiinflammatory drug and wind-damp dispelling Chinese medicine, can temporary relief of symptoms.After 1 year, painful area relates to two joint such as ankle, two toes, and gradually occurs that both hands proximal joint is out of shape.Before January, patient feels that pain increases the weight of, can not walk and bend over, then hospitalization, disease opinion of being admitted to hospital: symmetry both hands proximal interphalangeal joint, carpal joint, two knee joint, shoulder arthralgia, companion is stiff for morning, and >1 hour every day, conscious aversion to wind is afraid of cold, joint pain increase in intensity under coldness, two just put down, receive food can, deep and stringy pulse.Major laboratories checks: RF 482IU/mL ESR 131mm/h CRP 21.28mg/L.Be diagnosed as rheumatoid arthritis.Through taking Chinese medicine composition of the present invention after 15 days, patient two examines: be afraid of cold without aversion to wind, and arthralgia alleviates, but morning, deadlock did not subtract, and diet is comparatively before clearly better, but walking still has arthralgia for a long time; After continuing to take 15 days, patient three examines, and states arthralgia and is clearly better, and only have both hands proximal interphalangeal joint to meet cold water pain obviously, double knee joint is without obvious pain, and walking for a long time also has no pain, and morning, deadlock disappeared, and check indices, RF and ESR all recovers normal.After following the service three side of examining medicine 15 days again, patient articular's pain disappears completely, follows up a case by regular visits to 1 year without recurrence.
Detailed description of the invention
Embodiment 1
Formula: Radix Ginseng 15g, Radix Rehmanniae Preparata 15g, Rhizoma Dioscoreae 10g, the Radix Astragali 15 g, Radix Et Caulis Acanthopanacis Senticosi 15 g, the Cortex Eucommiae 15 g, Radix Dipsaci 10g, Radix Bupleuri 10g, Fructus Ligustri Lucidi 10g, Fructus Lycii 10g, Pericarpium Citri Reticulatae 10g, Radix Aconiti Lateralis Preparata 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Paeoniae Alba 15g, Poria 15g, Caulis Spatholobi 15g, Radix Clematidis 15g, Radix Cyathulae 10g, Radix Morindae Officinalis 10g, Fructus Psoraleae 10g, Rhizoma Drynariae 15g, Radix Angelicae Sinensis 10g, Rhizoma Curcumae Longae 10g, Zaocys 8g, Fructus Evodiae 10g, Rhizoma Et Radix Notopterygii 10g, Folium Artemisiae Argyi 8g and Radix Glycyrrhizae 5g.
Preparation and instructions of taking: every day 1 dose, decoction at twice.Medication 30 days was 1 course for the treatment of.
Embodiment 2
Formula: Radix Ginseng 18g, Radix Rehmanniae Preparata 16g, Rhizoma Dioscoreae 12g, the Radix Astragali 16 g, Radix Et Caulis Acanthopanacis Senticosi 16 g, the Cortex Eucommiae 16 g, Radix Dipsaci 12g, Radix Bupleuri 10g, Fructus Ligustri Lucidi 12g, Fructus Lycii 12g, Pericarpium Citri Reticulatae 10g, Radix Aconiti Lateralis Preparata 12g, Rhizoma Atractylodis Macrocephalae 12g, Radix Paeoniae Alba 18g, Poria 16g, Caulis Spatholobi 16g, Radix Clematidis 15g, Radix Cyathulae 12g, Radix Morindae Officinalis 12g, Fructus Psoraleae 12g, Rhizoma Drynariae 12g, Radix Angelicae Sinensis 10g, Rhizoma Curcumae Longae 10g, Zaocys 10g, Fructus Evodiae 10g, Rhizoma Et Radix Notopterygii 10g, Folium Artemisiae Argyi 8g and Radix Glycyrrhizae 5g.
Preparation and instructions of taking: every day 1 dose, decoction at twice.Medication 30 days was 1 course for the treatment of.
Embodiment 3
Formula: Radix Ginseng 15g, Radix Rehmanniae Preparata 12g, Rhizoma Dioscoreae 10g, the Radix Astragali 12 g, Radix Et Caulis Acanthopanacis Senticosi 15 g, the Cortex Eucommiae 15 g, Radix Dipsaci 12g, Radix Bupleuri 10g, Fructus Ligustri Lucidi 12g, Fructus Lycii 8g, Pericarpium Citri Reticulatae 8g, Radix Aconiti Lateralis Preparata 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Paeoniae Alba 12g, Poria 12g, Caulis Spatholobi 15g, Radix Clematidis 15g, Radix Cyathulae 8g, Radix Morindae Officinalis 8g, Fructus Psoraleae 10g, Rhizoma Drynariae 12g, Radix Angelicae Sinensis 12g, Rhizoma Curcumae Longae 12g, Zaocys 8g, Fructus Evodiae 10g, Rhizoma Et Radix Notopterygii 10g, Folium Artemisiae Argyi 8g and Radix Glycyrrhizae 5g.
Preparation and instructions of taking: every day 1 dose, decoction at twice.Medication 30 days was 1 course for the treatment of.

Claims (2)

1. the Chinese medicine composition of an orally taken for curing rheumatoid arthritis, it is characterized in that, be made up of the crude drug of following weight: Radix Ginseng 12-18g, Radix Rehmanniae Preparata 12-18g, Rhizoma Dioscoreae 8-12g, Radix Astragali 12-18g, Radix Et Caulis Acanthopanacis Senticosi 12-18g, Cortex Eucommiae 12-18g, Radix Dipsaci 8-12g, Radix Bupleuri 8-12g, Fructus Ligustri Lucidi 8-12g, Fructus Lycii 8-12g, Pericarpium Citri Reticulatae 8-12g, Radix Aconiti Lateralis Preparata 8-12g, Rhizoma Atractylodis Macrocephalae 8-12g, Radix Paeoniae Alba 12-18g, Poria 12-18g, Caulis Spatholobi 12-18g, Radix Clematidis 12-18g, Radix Cyathulae 8-12g, Radix Morindae Officinalis 8-12g, Fructus Psoraleae 8-12g, Rhizoma Drynariae 12-18g, Radix Angelicae Sinensis 8-12g, Rhizoma Curcumae Longae 8-12g, Zaocys 5-10g, Fructus Evodiae 8-12g, Rhizoma Et Radix Notopterygii 8-12g, Folium Artemisiae Argyi 5-10g and Radix Glycyrrhizae 3-8g.
2. the Chinese medicine composition of a kind of orally taken for curing rheumatoid arthritis as claimed in claim 1, it is characterized in that, be made up of the crude drug of following weight: Radix Ginseng 15g, Radix Rehmanniae Preparata 15g, Rhizoma Dioscoreae 10g, Radix Astragali 15g, Radix Et Caulis Acanthopanacis Senticosi 15g, Cortex Eucommiae 15g, Radix Dipsaci 10g, Radix Bupleuri 10g, Fructus Ligustri Lucidi 10g, Fructus Lycii 10g, Pericarpium Citri Reticulatae 10g, Radix Aconiti Lateralis Preparata 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Paeoniae Alba 15g, Poria 15g, Caulis Spatholobi 15g, Radix Clematidis 15g, Radix Cyathulae 10g, Radix Morindae Officinalis 10g, Fructus Psoraleae 10g, Rhizoma Drynariae 15g, Radix Angelicae Sinensis 10g, Rhizoma Curcumae Longae 10g, Zaocys 8g, Fructus Evodiae 10g, Rhizoma Et Radix Notopterygii 10g, Folium Artemisiae Argyi 8g and Radix Glycyrrhizae 5g.
CN201310591177.9A 2013-11-22 2013-11-22 A kind of Chinese medicine composition of orally taken for curing rheumatoid arthritis Expired - Fee Related CN103599486B (en)

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