CN102631623B - Traditional Chinese medicine composite for treating thyroid associated ophthalmopathy and preparation method thereof - Google Patents
Traditional Chinese medicine composite for treating thyroid associated ophthalmopathy and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composite for treating thyroid associated ophthalmopathy and a preparation method of the traditional Chinese medicine composite. The traditional Chinese medicine composite is prepared from the following traditional Chinese medicines in parts by weight: 30-60 parts of radix curcumae, 30-60 parts of root of common peony, 30-80 parts of salviae miltiorrhizae, 60-120 parts of semen coicis, 20-60 parts of thunberg fritillary bulb, 10-30 parts of stiff silkworm and 30-80 parts of semen litchi. The invention designs a multi-time extraction technical route by taking water as a solvent. The traditional Chinese medicine composite disclosed by the invention can effectively lower the exophthalmos degree of the disease eye of the thyroid associated ophthalmopathy, and the total effective rate is 86.9%; the total effective rate of the main eye symptom and the sign integral curative effect of the disease eye of the thyroid associated ophthalmopathy is 91.8%; the total effective rate of the Chinese medicine syndrome integral curative effect of the thyroid associated ophthalmopathy patient is 90.3%; the lesion activity grade of the disease eye of the thyroid associated ophthalmopathy can be effectively improved; and the thyroid function of the patient can be improved. The traditional Chinese medicine composite has high safety. The invention also discloses a preparation method for the traditional Chinese medicine composite granule.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, relate in particular to a kind of preparation treatment Thyroid-related Ophthalmopathy (thyriod associated ophthalmopathy, Chinese medicine composition TAO) and preparation method thereof.
Background technology
(thyriod associated ophthalmopathy is a kind of organ specificity autoimmune disease relevant with abnormal thyroid function TAO) to Thyroid-related Ophthalmopathy, is to cause the pop-eyed common cause of the simple eye and eyes of adult.Claim thyroid dependency immunity orbital disease, infiltrative exophthalmos, Graves oculopathy etc. again.Because The development in society and economy, rhythm of life are accelerated, operating pressure increases, iodine is taken in factors such as increase, the patient of abnormal thyroid function obviously increases, and the sickness rate of associated TAO also rises year by year.The prevalence of TAO has reached 1%, TAO has according to statistics become the modal orbit diseases of domestic and international adult.
The definite pathogenesis of TAO it be unclear that, but present research data shows: TAO is a kind of multi-factor disease that may be relevant with gene, autoimmune, eye socket fibroblast increased activity, environmental factors etc.Though TAO is the multifactor a kind of disease that causes, but it has common histopathology to change---extraocular muscles edema, lymphocytic infiltration, myodegeneration necrosis and fibrosis, fat and connective tissue fibroblast are active behind the socket of the eye endosphere, mucopolysaccharide deposition and edema.The extraocular muscles limitation of activity of edema causes diplopia, extraocular muscles contracture, further can cause exposure keratitis, and extraocular muscles and eye socket tissue edema also can be oppressed optic nerve to cause visual function impaired etc.
The course of disease two stages of experience of TAO: be active stage in early days, mainly show as eye lymphocytic infiltration, glycosaminoglycan deposition and edema; Then show as the deposition of retrobulbar tissue's fibrosis and fat late period.In the treatment of this disease, emphasize that early stage active and effective treatment is the important measures of its complication of prevention.Can carry out the judge of pathological changes activeness point system according to eye symptom such as pain, hyperemia, edema, expophthalmos degree and the eye function state etc. of TAO clinically.
Because its immunosuppressant therapy that adopts of pathological changes different times or radiocurable curative effect difference, and the Therapeutic Method difference taked of pathological changes weight.Therefore, often adopt treatment by stages clinically, emphasize active stage TAO is treated.Its treatment measure mainly comprises: (1) eye protection treatment.(2) medicine anti-inflammatory treatment, namely during the eye socket acute inflammation, whole body is used glucocorticoid or immunosuppressant, to alleviate the infringement of extraocular muscles, alleviates edema and to the compressing of optic nerve.But whole body is widely applied, and the side effect of glucocorticoid is big, relapse rate height after the drug withdrawal, also have the doctor to adopt Ciclosporin A treatment Thyroid-related Ophthalmopathy to obtain curative effect preferably, but the side effect of Ciclosporin A is also big and expensive.(3) operation and radiotherapy.Along with a large amount of patients TAO are difficult to tolerate disease relapse after the side effect of using glucocorticoid or immunosuppressant and the drug withdrawal or use situations such as the curative effect of glucocorticoid or immunosuppressant is unsatisfied with increasing, the TAO patient who seeks therapy of combining Chinese and Western medicine obviously increases.Therefore, developmental research can improve the TAO therapeutic effect and toxicity is little, the Chinese medicine of side effect that can obviously reduce glucocorticoid and immunosuppressant is imperative.
Though motherland's medical science does not have the record of primary disease name of disease, in ancient books, record its similar clinical manifestation, say as Effective Formulas Tested by Physicians for Generations: " wheel can not be changed one's position firmly, and this is that Gu (h ǔ) eye coagulates eyeball "; " order is through great achievement " meaning: " this disease stiffness of the nape, flushed complexion is dry, order such as fire expand between eyelid, can not open and close, if wild mausoleum demon with the order of flower cylinder change fish, dashes forward and fixed coagulating, so say eye unclosed due to exophthalmos ".Symptom that these documents are described and sign are similar to modern medicine active stage TAO.The new century whole nation high Chinese medicine universities and colleges' planning teaching materials " ophthalmology of Chinese medicine " are thought that primary disease is similar to and are cured nationality contained " orbital pseudotumor or tumor " ancient times.
The clinical research of Chinese medicine thyroid-associated ophthalmopathy mostly is the case report, and most reports are not established matched group.Comprehensive existing research report can be summarized as: (1) determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs; (2) folk prescription treatment; (3) according to the treatment by stages of pathological changes situation.(Wang Dezhen. the cognition of Chinese medicine thyroid eye diseas, " modern combination of Chinese and Western medicine magazine ", 2009,18 (11): 1261; Once flat, etc. the clinical observation of the early stage thyroid-associated ophthalmopathy of Chinese traditional treatment, " Chinese TCM Ophthalmology magazine ", 2008,18 (2): 67; Yuan Xiaohui, etc. therapy of combining Chinese and Western medicine Thyroid-related Ophthalmopathy, " Chinese TCM Ophthalmology magazine ", 2006,16 (1): 16; Zhou Huaxiang, etc. TCM Ophthalmology to understanding and the treatment of orbital pseudotumor or tumor, " the Sichuan traditional Chinese medical science ", 2006,24 (12): 19)
The present patent application people realizes in the research for the treatment of TAO for many years and clinical practice: thyroid-associated ophthalmopathy is mainly in young and middle-aged people, since the patient of this age bracket be in enter a higher school, periods such as promotion of employment and career, often stay up late all day, overworked eyes, excessive thinking, so the morbidity of primary disease is relevant with the liver spleen.Because of liver controlling conveyance and dispersion, main muscle, harmonizing the functional activities of vital QI.The irritability bar reaches, and then QI and blood is relaxed soft with smooth, muscle.If depressed emotion, depression of liver-QI loses bar and reaches, and catharsis mistake department is then qi-blood disharmony, move not smooth, qi depression to blood stasis; Transverse invasion of hyperactive liver-QI is violated spleen, or the excessive thinking impairment of the spleen, dysfunction of the spleen in transportation, and water liquid fortuneization mistake department, endogenous damp formation, the poly-drink that forms is given birth to expectorant, phlegm and blood stasis, venation plug knot, muscle convulsion are unfavorable, are second-class disease so occur that the order pearl is given prominence to, rotation is ineffective, look one.Therefore, the primary disease pathogenesis mostly is qi depression to blood stasis, retention of water-damp in the body, phlegm and blood stasis, and the muscle convulsion is unfavorable.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition for the treatment of Thyroid-related Ophthalmopathy (TAO) and preparation method thereof.Use this traditional Chinese medicine composition for treating TAO can not only obviously alleviate the most outstanding symptom of this disease---eyeball protrusion and eye cardinal symptom and sign, and can also obviously reduce the TAO activeness and mark, improve patient's tcm syndrome, alleviate patient's general malaise symptom.
The objective of the invention is to be achieved through the following technical solutions:
Chinese medicine composition of the present invention is made up of the following traditional Chinese medicines compositions: Radix Curcumae, Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Bulbus Fritillariae Thunbergii, Semen Coicis, Bombyx Batryticatus, Semen Litchi, water surplus.
Each composition parts by weight of further Chinese medicine composition of the present invention are: Radix Curcumae 30-60 part, Radix Paeoniae Rubra 30-60 part, Radix Salviae Miltiorrhizae 30-80 part, Semen Coicis 60-120 part, Bulbus Fritillariae Thunbergii 20-60 part, Bombyx Batryticatus 10-30 part, Semen Litchi 30-80 part, water surplus.
Most preferably each composition parts by weight of Chinese medicine composition of the present invention are: 60 parts of Radix Curcumaes, 45 parts of Radix Paeoniae Rubra, 30 parts of Radix Salviae Miltiorrhizaes, 120 parts of Semen Coiciss, 20 parts of Bulbus Fritillariae Thunbergiis, 15 parts of Bombyx Batryticatus, 80 parts of Semen Litchis, water surplus.
The main effective ingredient of the present invention dissolves in boiling water, takes all factors into consideration character and the preparation technology of we when clinical use of combination of Chinese medicine thing effective ingredient, is the extraction process route of solvent with water so designed.Preparation technology's flow process is as follows:
(1) gets described each the composition weight umber mix homogeneously of above-mentioned Chinese medicine composition;
(2) step (1) mixture is added 8 times of water yields of mixture total weight amount umber and decocted 1～1.5 hour, filter, filtrate is stand-by;
(3) step (2) filtering residue is added 6 times of water yields of step (1) mixture total weight amount umber again and decocted 1～1.5 hour, filter, filtrate is stand-by;
(4) above-mentioned twice filtrate is merged Chinese medicine composition solution;
(5) step (4) is merged to such an extent that Chinese medicine composition solution concentration to relative density is 1: 1, make extractum;
(6) above-mentioned extractum is placed the spray dryer spray do, obtain the sugar-free granule.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as pill, powder, tablet, capsule, oral liquid etc.
Though motherland's medical science does not have the record of primary disease name of disease, in ancient books, record its similar clinical manifestation, the new century whole nation high Chinese medicine universities and colleges' planning teaching materials " ophthalmology of Chinese medicine " are thought that primary disease is similar to and are cured nationality contained " Gu (h ǔ) eye coagulates eyeball " ancient times.Primary disease is mainly in young and middle-aged people and since the patient of this age bracket be in enter a higher school, periods such as promotion of employment and career, often stay up late all day, overworked eyes, excessive thinking.Because of liver controlling conveyance and dispersion, main muscle, harmonizing the functional activities of vital QI, the irritability bar reaches, and then QI and blood is relaxed soft with smooth, muscle.If depressed emotion, depression of liver-QI loses bar and reaches, and catharsis mistake department is then qi-blood disharmony, move not smooth, qi depression to blood stasis; Transverse invasion of hyperactive liver-QI is violated spleen, or the excessive thinking impairment of the spleen, dysfunction of the spleen in transportation, and water liquid fortuneization mistake department, endogenous damp formation, the poly-drink that forms is given birth to expectorant, phlegm and blood stasis, venation plug knot, muscle convulsion are unfavorable, are second-class disease so occur that the order pearl is given prominence to, rotation is ineffective, look one.Therefore, the primary disease pathogenesis mostly is qi depression to blood stasis, retention of water-damp in the body, phlegm and blood stasis, the muscle convulsion is unfavorable, therefore, the present invention is main method for the treatment of with promoting QI circulation for relieving depression, activating blood and promoting diuresis, hard masses softening and resolving, the slow convulsion of Shujin, determine at last to be made up of Radix Curcumae, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Semen Coicis, Bulbus Fritillariae Thunbergii, Bombyx Batryticatus, Semen Litchi seven flavor Chinese medicines, and carry out drug screening in conjunction with the pharmacology, it is evident in efficacy.
Medicament selection Radix Curcumae of the present invention, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra, Semen Coicis, Bulbus Fritillariae Thunbergii, Bombyx Batryticatus, Semen Litchi make up.Make each efficacy of drugs produce synergism these drug regimens, thereby can effectively treat thyroid-associated ophthalmopathy.Wherein selecting Radix Curcumae for use, is because Radix Curcumae nature and flavor suffering, hardship are cold, has the effect that promoting QI circulation for relieving depression, promoting blood circulation and stopping pain, removing heat from blood clear away heart-fire, and is called as " the blood medicine in the gas "; Select Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra for use, be because of Radix Salviae Miltiorrhizae nature and flavor hardship, be slightly cold, have the merit of removing heat from blood and promoting blood circulation blood stasis dispelling, nourishing blood to tranquillize the mind; Radix Paeoniae Rubra nature and flavor hardship, be slightly cold, have the merit of clearing away heat and cooling blood, stasis-dispelling and pain-killing, the stasis of blood in order stagnates to disappear; The Semen Coicis nature and flavor are sweet, light, are slightly cold, can promoting diuresis with drugs of tasteless flavour, again can the slow convulsion of Shujin, and reach the merit of promoting QI circulation for relieving depression, blood circulation promoting and blood stasis dispelling, promoting diuresis to eliminate damp pathogen, the slow convulsion of Shujin with Radix Curcumae, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra compatibility; Selecting Bulbus Fritillariae Thunbergii, Bombyx Batryticatus, Semen Litchi for use, is because Bulbus Fritillariae Thunbergii nature and flavor hardship is cold, has the merit of dissipating phlegm and resolving masses; The Bombyx Batryticatus nature and flavor are salty, hot, and are flat, have the merit of the eliminating stagnation of expellingging wind and relieving convulsion; Semen Litchi nature and flavor suffering, temperature has the merit of promoting QI to circulate and dispersing the agglomeration of the pathogens, dispersing cold for relieving pain.All medicines share, not only promoting QI circulation for relieving depression, blood circulation promoting and blood stasis dispelling, promoting diuresis to eliminate damp pathogen, and can dissipating phlegm and resolving masses, the slow convulsion of Shujin, reach the purpose for the treatment of both the principal and secondary aspects of a disease, evident in efficacy to thyroid-associated ophthalmopathy.
In sum, Chinese medicine composition of the present invention can effectively reduce thyroid-associated ophthalmopathy suffer from the exophthalmos degree of eye, improve the patient tcm syndrome, alleviate eye cardinal symptom and the sign of suffering from eye, the ill symptoms incidence rate that alleviates glucocorticoid.Safe, untoward reaction is few, and is cheap, is a kind of active drug for the treatment of thyroid-associated ophthalmopathy.
The specific embodiment
The present invention is further described below in conjunction with the specific embodiment, and the specific embodiment is to the further specifying of the principle of the invention, and does not limit the present invention in any way, or similar techniques identical with the present invention all do not exceed the scope of protection of the invention.
Embodiment 1:
The preparation of drug solns among the present invention.Get Radix Curcumae 60 gram, Radix Paeoniae Rubra 45 grams, Radix Salviae Miltiorrhizae 30 grams, Semen Coicis 120 grams, Bulbus Fritillariae Thunbergii 20 grams, Bombyx Batryticatus 15 grams, Semen Litchi 80 grams and mix, with said mixture add 8 times namely the 2960 gram water yields decocted 1～1.5 hour, filter, filtrate is stand-by; Above-mentioned filtering residue is added 6 times of i.e. 2220 gram water yields decoctions 1～1.5 hour again, filter, filtrate is stand-by; With above-mentioned twice filtrate merge Chinese medicine composition solution.
Embodiment 2:
The preparation of Chinese medical concrete of the present invention.Get Radix Curcumae 30 gram, Radix Paeoniae Rubra 60 grams, Radix Salviae Miltiorrhizae 80 grams, Semen Coicis 60 grams, Bulbus Fritillariae Thunbergii 60 grams, Bombyx Batryticatus 10 grams, Semen Litchi 30 grams and mix, with said mixture add 8 times namely the 2640 gram water yields decocted 1～1.5 hour, filter, filtrate is stand-by; Above-mentioned filtering residue is added 6 times of i.e. 1980 gram water yields decoctions 1～1.5 hour again, filter, filtrate is stand-by; With above-mentioned twice filtrate merge Chinese medicine composition solution; Being concentrated into relative density after above-mentioned twice filtrate merged is 1: 1, makes extractum.
Embodiment 3:
The preparation of Chinese medicine sugar-free granule of the present invention.Get Radix Curcumae 400 gram, Radix Paeoniae Rubra 350 grams, Radix Salviae Miltiorrhizae 300 grams, Semen Coicis 1000 grams, Bulbus Fritillariae Thunbergii 200 grams, Bombyx Batryticatus 100 grams, Semen Litchi 600 grams and mix, with said mixture add 8 times namely the 23600 gram water yields decocted 1～1.5 hour, filter, filtrate is stand-by; Above-mentioned filtering residue is added 6 times of i.e. 17700 gram water yields decoctions 1～1.5 hour again, filter, filtrate is stand-by; With above-mentioned twice filtrate merge Chinese medicine composition solution; Being concentrated into relative density after above-mentioned twice filtrate merged is 1: 1, makes extractum; Place the spray dryer spray to do above-mentioned extractum, make the sugar-free granule.
Embodiment 4:
The clinical efficacy of traditional Chinese medicine composition for treating thyroid-associated ophthalmopathy of the present invention and safety testing.
1. test method
1.1 this test case is included standard in:
TAO diagnostic criteria with reference to " practical Ophthalmologic Diagnostics ", " orbital disease ": (1) suffers from eye burning sensation, husky puckery sense, photophobia symptom such as shed tears; (2) the simple eye or eyes proptosis ocular of carrying out property; (3) eyelid swelled, retraction of upper eyelid, slow, the blink reflex minimizing of falling, bulbar conjunctiva congestion and edema; (4) extraocular muscles is got involved, limitation of activity, diplopia or stravismus are occurred; (5) CT shows 2 above extraocular muscles and is the fusiformis hypertrophy.
1.2 this test case exclusion standard:
(1) gestation, nursing women; Or the age is below 18 one full year of life.
(2) blood and urine routine, stool blood, hepatic and renal function, Electrocardioscopy are obviously unusual.
(3) mental disease maybe can not cooperation person.
(4) merge serious disease, malignant tumor such as the heart, brain, kidney, blood system.
(5) other serious oculopathy (as keratitis, glaucoma, cataract, diabetic renal papillary necrosis, uveitis, detachment of retina etc.) are arranged.
Select "Yes" as above any one answer, then this experimenter can not participate in test.
1.3 the grouping of this test case and Therapeutic Method
1.3.1 case grouping: adopt the method for random packet, MethodsThe cases enrolled is divided into test group and Primary Care matched group at random.
1.3.2 Therapeutic Method
All experimenters all keep thyroid protopathy treatment, and use the corresponding group number medicine of going into.
Primary Care matched group (hereinafter to be referred as matched group): prednisone 30mg/ time, once-a-day, 8 of mornings are oral, continuous 2 weeks; Prednisone 25mg/ time, once-a-day, 8 of mornings are oral, continuous 2 weeks; Prednisone 20mg/ time, once-a-day, 8 of mornings are oral, continuous 2 weeks; Prednisone 15mg/ time, once-a-day, 8 of mornings are oral, continuous 4 weeks; Prednisone 10mg/ time, once-a-day, 8 of mornings are oral, keep for 2 weeks and (annotate: observe though test carried out for 12 weeks.But experimental period finishes the back patient still will be continued to keep 6-8 week for 10mg/ time/day with prednisone again)
Test group: in prednisone Primary Care (method is consistent with the Primary Care matched group), sugar-free granule 1 bag that makes in the administration embodiment of the invention 3/time (being equivalent to crude drug 98.33 grams), three times on the one.
1.3.3 observing time
Test period was 12 weeks.
1.4 the requirement of drug combination
(1) duration of test bans use of immunosuppressant
(2) all drug combination of duration of test all should itemized record, comprise reason, time started, termination time of medicine name, dosage, use etc.
1.5 the observation index of this test
1.5.1 general health check-up project: body temperature, breathing, heart rate, blood pressure.
1.5.2 safety indexes: urine and routine blood test, stool blood, liver function (ALT), kidney merit (Cr, BUN), electrocardiogram, the treatment front and back are respectively once.
The merging disease that 1.5.3 detailed probability existed before on-test or the test back occurs.
1.5.4 any untoward reaction that the itemized record duration of test occurs, and carry out comparison between two groups in the 28th day (all around) after the treatment.
1.5.5 laboratory detects index: free triiodothyronine (FT
3), serum free thyroxine (FT
4), thyrotropin (TSH), before and after the treatment each once, and with its average
Carry out statistical procedures comparison between two groups.
1.5.6 clinical efficacy index and efficacy evaluation method
(1) efficacy evaluation of eyeball protrusion
Before and after treatment, respectively survey eyeball protrusion one time with the Hertel meter.
Produce effects: treatment back eyeball protrusion reduction value 〉=3mm;
Effectively: treatment back exophthalmos figure reduction value is 1～＜3mm;
Invalid: treatment back eyeball protrusion reduction value＜1mm.
The comparison of (2) two groups for the treatment of front and back TAO activeness scorings
Clinical score standard [the Bartalena L of the TAO activeness that the European thyroid eye diseas group of reference proposes, Baldeschi L, Dickinson A, et al.Consensus statement of the European Group on Graves ' orbitopathy (EUGOGO) on management of GO.Eur J Endocrinol, 2008,158 (3): 273-285.] mark: pain behind the spontaneous eyeball; During ocular movement with pain; Eyelid hyperemia; Blepharoedema; The hyperemia of conjunctiva diffusivity; Chemosis; Lacrimal caruncle swelling.More than every each 1 minute, totally 7 minutes.Before and after treatment, respectively carry out a TAO activeness scoring, and with its average
Carry out statistical procedures comparison between two groups.
(3) tcm syndrome integration and efficacy evaluation
Use before and after treatment corresponding symptom is carried out the integration evaluation, standard is as follows:
Distending pain in the chest and hypochondrium: no distending pain in the chest and hypochondrium, counted 0 fen; Breast is coerced slight distending pain, counts 1 fen; Distending pain in the chest and hypochondrium more obviously can be stood, and counts 2 fens; Distending pain in the chest and hypochondrium obviously is difficult to stand, and counts 3 fens;
The eyeball distending pain: no eyeball distending pain, counted 0 fen; The slight distending pain of eyeball was counted 1 fen; The eyeball distending pain more obviously can be stood, and counts 2 fens; The eyeball distending pain obviously is difficult to stand, and counts 3 fens
Irascible temperament: the asexual moment of desperation is hot-tempered, counts 0 fen; Irascible temperament was counted 1 fen once in a while; Often irascible temperament but still can automatic control was counted 2 fens; Often irascible temperament is difficult to automatic control, counts 3 fens.
Body of the tongue: light red, counted 0 fen; Purple dark, counted 1 fen.
Tongue fur: thin coating, counted 0 fen; Thick fur was counted 1 fen.
Efficacy evaluation method and standard:
Total mark * 100% before tcm syndrome curative effect rate=(total mark before the treatment-treatment back total mark)/treatment
Produce effects: treatment back tcm syndrome curative effect rate 〉=51%
Effectively: treatment back tcm syndrome curative effect rate 21%-50%
Invalid: treatment back tcm syndrome curative effect rate＜20%
(4) main eye manifestation integration and efficacy evaluation
Use before and after treatment corresponding symptom is carried out the integration evaluation, standard is as follows:
Pain behind the spontaneous eyeball: do not have pain behind the spontaneous eyeball, counted 0 fen; Pain behind the slight spontaneous eyeball is only arranged, counted 1 fen; Pain behind the more tangible spontaneous eyeball is arranged but can stand, counted 2 fens; Pain was difficult to and can stands after tangible spontaneous eyeball was arranged, score.
During ocular movement with pain: without pain, counted 0 fen during ocular movement; Only with mild pain, counted 1 fen during ocular movement; With pain significantly but can stand, counted 2 fens during ocular movement; Be difficult to and can stand with tangible pain during ocular movement, counted 3 fens.
Eyelid hyperemia: the anophthalmia hyperemia of eyelid, counted 0 fen; The eyelid mild hyperaemia was counted 1 fen; Eyelid hyperemia is more obvious, counts 2 fens; Eyelid is obviously congested, counts 3 fens.
Blepharoedema: no blepharoedema, counted 0 fen; The eyelid Mild edema was counted 1 fen; Blepharoedema is more obvious, and fissura palpebrae slightly diminishes, and counts 2 fens; The obvious edema of eyelid, fissura palpebrae obviously diminishes, and eyelid is the semi-closed state, counts 3 fens.
Conjunctival congestion: no conjunctival congestion, counted 0 fen; The conjunctiva mild hyperaemia is pale red, counts 1 fen; The hyperemia of conjunctiva diffusivity more obviously takes on a red color, and counts 2 fens; The hyperemia of conjunctiva diffusivity obviously is kermesinus, petechia is arranged, and counts 3 fens.
Chemosis: no chemosis, counted 0 fen; The bulbar conjunctiva Mild edema was counted 1 fen; Chemosis is more obvious, does not protrude from outside the eyelid but have bulbar conjunctiva during catacleisis, counts 2 fens; Chemosis is obvious, has bulbar conjunctiva to protrude from outside the eyelid during catacleisis, counts 3 fens.
Retraction of upper eyelid: no upper eyelid is shunk back, and counts 0 fen; Retraction of upper eyelid amount＞1mm but≤2mm, counted 1 fen; Retraction of upper eyelid amount＞2mmm but≤3mm, counted 2 fens; Retraction of upper eyelid amount＞3mmm counted 3 fens.
Efficacy evaluation method and standard:
Total mark * 100% before main eye manifestation curative effect rate=(total mark before the treatment-treatment back total mark)/treatment
Produce effects: treatment back tcm syndrome curative effect rate 〉=51%
Effectively: treatment back tcm syndrome curative effect rate 21%-50%
Invalid: treatment back tcm syndrome curative effect rate＜20%
1.6 statistical method: measurement data is calculated average and standard deviation
With t check or F check.Relatively adopt before and after the treatment and between two groups and compare.
2 result of the tests:
2.1 clinical physical data
This test is collected observation 62 examples altogether and is met the above-mentioned thyroid-associated ophthalmopathy patient who includes standard in.The oldest person is 55 years old, and reckling is 19 years old, 35.3 years old mean age; Man's 15 examples, women 57 examples; Simple eye morbidity 2 examples, all the other are the eyes morbidity.Wherein, 36.1 years old test group average patient age, simple eye morbidity 1 example, all the other are the eyes morbidity; 35.3 years old patient's mean age of Primary Care matched group, simple eye morbidity 2 examples, all the other are the eyes morbidity.
2.2 the comparison of two groups of eyeball protrusion curative effects (seeing Table 1)
The comparison of table 1 liang group treatment back eyeball protrusion curative effect
N (eye number)
Annotate: compare with matched group
*P＜0.01,
*P＜0.05
As seen from Table 1, after treatment, the total effective rate of the eyeball protrusion curative effect of test group and obvious effective rate all obviously are better than matched group, and its difference all has statistical significance (P＜0.05, P＜0.01).Illustrate that Chinese medicine composition of the present invention obviously is better than matched group in the effect that improves aspect TAO patient's eyeball protrusion curative effect.
2.3 the comparison (seeing Table 2) of two groups for the treatment of front and back TAO activeness scorings
The comparison of TAO activeness scoring before and after the table 2 liang group treatment
N (eye number)
Annotate: compare with matched group
*Compare before and after the internal therapy on the same group (P＜0.05)
△(P＜0.05)
As seen from Table 2, before the treatment, its difference not statistically significant (P＞0.01) is compared in the scoring of TAO activeness between test group and matched group; Relatively interior on the same group before and after the treatment, the TAO activeness scoring after treatment of test group and matched group all has decline in various degree, and its difference has statistical significance (P＜0.05); After treatment, relatively, test group TAO activeness is marked than the obvious reduction of matched group between test group and the matched group, and its difference has statistical significance (P＜0.05).
Above presentation of results: test group and matched group patient's pathological changes activeness scoring no significant difference before treatment has comparability between two groups; The Therapeutic Method that matched group and test group adopt all can effectively reduce the pathological changes activeness of thyroid-associated ophthalmopathy, but test group is better than matched group in the effect that improves aspect the pathological changes activeness of thyroid-associated ophthalmopathy.
2.4 two groups of tcm syndrome integration curative effects compare (seeing Table 3)
The comparison n (routine number) of table 3 liang group tcm syndrome integration curative effect
Annotate: compare with matched group
*P＜0.01
As seen from Table 3, total effective rate and the obvious effective rate of the tcm syndrome integration curative effect of test group all obviously are better than matched group, and its difference has statistical significance (P＜0.01).Illustrate that Chinese medicine composition of the present invention obviously is better than matched group in the effect that improves aspect patient's tcm syndrome.
2.5 two groups of eye cardinal symptoms and sign integration curative effect be (seeing Table 4) relatively
The comparison n of table 4 liang group eye cardinal symptom and sign integration curative effect (eye number)
Annotate: compare with matched group
*P＜0.01,
*P＜0.05
As seen from Table 4, total effective rate and the obvious effective rate of the eye cardinal symptom of test group and sign integration curative effect all obviously are better than matched group, and its difference has statistical significance (P＜0.05, P＜0.01).Illustrate that Chinese medicine composition of the present invention obviously is better than matched group aspect patient's eye cardinal symptom and the sign improving.
2.6 the comparison (seeing Table 5) of two groups for the treatment of front and back thyroid functions
The comparison of thyroid function before and after the table 5 liang group treatment
The n=31 example
Annotate: compare with matched group
*Compare before and after the internal therapy on the same group (P＜0.05)
△(P＜0.05)
As seen from Table 5, before the treatment, between two groups of FT3 value, FT4 value and the TSH values relatively, the equal not statistically significant of its difference (P＞0.05).Before and after the treatment more on the same group in, the FT3 value of test group is obvious reduction before the treatment after treatment, its difference has statistical significance (P＜0.05); The THS value of test group obviously raises before the treatment after treatment, and its difference has statistical significance (P＜0.05); The FT4 value of test group is no significant difference (P＞0.05) before and after treatment.The FT3 value of matched group, FT4 value and TSH value be no significant difference (P＞0.05) before and after treatment.After the treatment, between two groups of the FT3 values, FT4 value relatively, the equal not statistically significant of its difference (P＞0.05), but TSH value test group obviously raises than matched group, its difference has statistical significance (P＜0.05).
Above presentation of results: test group and matched group patient's thyroid function no significant difference before treatment has comparability between two groups; Chinese medicine composition of the present invention can obviously reduce patient's FT3 value, rising TSH value, improves thyroid function, and obviously is better than matched group in the effect aspect the adjusting TSH.
2.7 the comparison (seeing Table 6) of two groups of ill symptoms incidence rates (%) after treatment
The comparison n=31 example of table 6 liang group adverse reaction rate
Annotate: compare with matched group
*(P＜0.05),
*(P＜0.01)
Aspect the ill symptoms incidence rate, test group is starkly lower than matched group, and its difference all has statistical significance (P＜0.05, P＜0.01).
2.8 the comparison (seeing Table 7) of two groups for the treatment of front and back safety indexes
The comparison n=31 example of safety indexes before and after the table 7 liang group treatment
As seen from Table 7, test group and matched group safety indexes before and after treatment is all normal.
To sum up, can draw following clinical research conclusion:
1, Chinese medicine composition of the present invention can effectively reduce the eyeball protrusion that thyroid-associated ophthalmopathy is suffered from eye, and the obvious effective rate of test group is 42.6%, obviously is better than matched group (23%), and its difference has statistical significance (P＜0.01); The total effective rate of test group is 86.9%, obviously is better than matched group (68.9%), and its difference has statistical significance (P＜0.05).
2, Chinese medicine composition of the present invention can effectively improve thyroid-associated ophthalmopathy and has a trouble in one's eyesight and become the activeness scoring, and obviously is better than matched group (P＜0.05).
3, Chinese medicine composition of the present invention can effectively improve thyroid-associated ophthalmopathy patient's tcm syndrome.The total effective rate of tcm syndrome integration curative effect, test group are 90.3%, and matched group is 29.1%, and test group obviously is better than matched group (P＜0.01); The obvious effective rate of tcm syndrome integration curative effect, test group are 67.7%, and matched group is 9.7%, and test group obviously is better than matched group (P＜0.01); Illustrate that Chinese medicine composition of the present invention improves the patient and has remarkable advantages aspect the tcm syndrome.
4, Chinese medicine composition of the present invention can effectively improve eye cardinal symptom and the sign integration curative effect of thyroid-associated ophthalmopathy, the total effective rate of eye cardinal symptom and sign integration curative effect, test group is 91.8%, and matched group is 73.8%, and test group obviously is better than matched group (P＜0.05); The obvious effective rate of eye cardinal symptom and sign integration curative effect, test group are 62.3%, and matched group is 37.7%, and test group obviously is better than matched group (P＜0.01); Illustrate that Chinese medicine composition of the present invention has remarkable advantages aspect patient's eye cardinal symptom and the sign integration improving.
5, Chinese medicine composition of the present invention can obviously reduce patient's FT3 value, rising TSH value, improves patient's thyroid function, and obviously is better than matched group (P＜0.05) in the effect aspect the adjusting TSH.
6, Chinese medicine composition ill symptoms incidence rate of the present invention is starkly lower than matched group (P＜0.05, P＜0.01).
In sum, Chinese medicine composition of the present invention not only can effectively reduce thyroid-associated ophthalmopathy and suffer from eye the most outstanding symptom---eyeball protrusion and eye cardinal symptom and sign, and can also obviously reduce TAO pathological changes activeness and mark, improve patient's tcm syndrome, alleviate patient's general malaise symptom.Safe, untoward reaction is few, and is cheap, is the active drug for the treatment of thyroid-associated ophthalmopathy.
Claims (4)
1. Chinese medicine composition for the treatment of thyroid-associated ophthalmopathy, it is characterized in that compositions is made by the Chinese medicine of following portions by weight: Radix Curcumae 30-60 part, Radix Paeoniae Rubra 30-60 part, Radix Salviae Miltiorrhizae 30-80 part, Semen Coicis 60-120 part, Bulbus Fritillariae Thunbergii 20-60 part, Bombyx Batryticatus 10-30 part, Semen Litchi 30-80 part.
2. the Chinese medicine composition for the treatment of thyroid-associated ophthalmopathy according to claim 1, it is characterized in that compositions is made by the Chinese medicine of following portions by weight: 60 parts of Radix Curcumaes, 45 parts of Radix Paeoniae Rubra, 30 parts of Radix Salviae Miltiorrhizaes, 120 parts of Semen Coiciss, 20 parts of Bulbus Fritillariae Thunbergiis, 15 parts of Bombyx Batryticatus, 80 parts of Semen Litchis.
3. aforesaid right requires 1 or the preparation method of claim 2 Chinese medicine composition, it is characterized in that may further comprise the steps:
(1) gets each component and mix homogeneously by claim 1 or the described combination weight umber of claim 2;
(2) step (1) mixture is added up 8 times of water yields of parts by weight and decocted 1～1.5 hour, filter, filtrate is stand-by;
(3) step (2) filtering residue is added 6 times of water yields of step (1) mixture total weight amount umber again and decocted 1～1.5 hour, filter, filtrate is stand-by;
(4) above-mentioned twice filtrate is merged Chinese medicine composition solution;
(5) step (4) is merged to such an extent that Chinese medicine composition solution concentration to relative density is 1: 1, make extractum;
(6) above-mentioned extractum is placed the spray dryer spray do, obtain the sugar-free granule.
4. the application of Chinese medicine composition according to claim 1 and 2 in the medicine of preparation treatment thyroid-associated ophthalmopathy.
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| CN103432531B (en) * | 2013-09-06 | 2015-05-20 | 河南中医学院 | Traditional Chinese medicine for treating thyroid-associated ophthalmopathy used in stable phase |
| CN107050377A (en) * | 2017-02-14 | 2017-08-18 | 四川双鑫生物科技有限公司 | A kind of new medicine composition and preparation method for treating thyroid-associated ophthalmopathy |
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| CN101530489A (en) * | 2008-03-13 | 2009-09-16 | 上海中医药大学附属龙华医院 | Chinese medicine composition used for treating non-active stage infiltrative exophthalmos of thyroid-associated ophthalmopathy and preparation method thereof |
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Non-Patent Citations (4)
| Title |
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| 中医药治疗甲亢突眼的进展;薛科辉;《湖南中医杂志》;20060930;第22卷(第5期);86-87 * |
| 中医药治疗甲状腺相关眼病现状;陈虹林;《现代中西医结合杂志》;20090831;第18卷(第24期);2988-2990 * |
| 薛科辉.中医药治疗甲亢突眼的进展.《湖南中医杂志》.2006,第22卷(第5期),86－87. |
| 陈虹林.中医药治疗甲状腺相关眼病现状.《现代中西医结合杂志》.2009,第18卷(第24期),2988－2990. |
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