CN110934982A

CN110934982A - Traditional Chinese medicine composition for treating ankylosing spondylitis and application thereof

Info

Publication number: CN110934982A
Application number: CN201911391949.8A
Authority: CN
Inventors: 王康平
Original assignee: Individual
Current assignee: Individual
Priority date: 2019-12-30
Filing date: 2019-12-30
Publication date: 2020-03-31

Abstract

The invention provides a traditional Chinese medicine composition for treating ankylosing spondylitis and application thereof, and relates to the technical field of traditional Chinese medicines, wherein the composition comprises the following raw materials in parts by mass: 15-30 parts of ligusticum wallichii, 15-30 parts of turmeric, 15-30 parts of teasel root, 15-30 parts of semen cuscutae, 20-30 parts of prepared monkshood and 20-30 parts of bighead atractylodes rhizome. The traditional Chinese medicine composition provided by the invention has a certain curative effect on the treatment of the Ankylosing Spondylitis (AS), after 24 weeks of treatment, the standard reaching rate of ASAS20 is 86.75%, and the total effective rate of the traditional Chinese medicine syndrome curative effect is 85.47%; the traditional Chinese medicine composition has obvious improvement effects on traditional Chinese medicine syndrome integral, BASDAI score, BASFI score, BASMI score, PGA, night pain and spinal pain of AS patients, can well reduce the disease activity of the patients, can obviously improve the functional conditions of the patients, and also has improvement effects on laboratory indexes ESR and CRP.

Description

Traditional Chinese medicine composition for treating ankylosing spondylitis and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating ankylosing spondylitis and application thereof.

Background

Ankylosing spondylitis is a disease caused by chronic systemic immune system disorder and is manifested by the destruction of bones such as the spine and sacroiliac joints. Western medicine diagnosis Standard "guidelines for clinical research on New drug of traditional Chinese medicine": lower back pain persists for at least 3 months and can be relieved after activity (rather than rest); the movement of the lumbar vertebra in the vertical and horizontal planes is limited; the chest expansion degree is normally reduced compared with the same age and sex; x-ray has unilateral grade III-IV or bilateral grade II-III sacroiliac arthritis: I. suspicious or minimal sacroiliac arthritis; II. Mild sacroiliac arthritis (blurred margins of joints, hardening of the near joint area, mild narrowing of the joint space); grade III and moderate sacroiliac arthritis (obviously blurred joint edges, hardening of a near joint area, obviously narrowed joint space and obviously damaged bone); IV, sacroiliac joint fusion or enforcement, with or without cirrhosis; morning stiffness is more than or equal to 30 minutes, the sleep is affected due to pain and stiffness, ESR is more than or equal to 30mm/1h, CRP is more than or equal to 20mg/l, and IgA is more than or equal to 3.9 g/l. The Chinese medicine diagnosis standard & lt guidance principles of clinical research of new Chinese medicines & gt: lumbosacral pain, spinal pain, limited movement of the lumbar spine, morning stiffness, which is aggravated by cold, reduced by heat, and heel pain; lassitude, lusterless complexion, thirst or dry mouth without desire for drinking, heavy limbs, dry and lusterless skin; red tongue with white coating, yellow or thick coating, wiry and slippery pulse/deep, thready or rapid pulse. At present, non-steroidal anti-inflammatory drugs, chemotherapeutic drugs and biological agents are mainly used for western medicine treatment, and the western medicine treatment is poor in curative effect and large in side effect.

Disclosure of Invention

In view of the above, the present invention aims to provide a Chinese medicine composition for treating ankylosing spondylitis and an application thereof. The traditional Chinese medicine composition provided by the invention has a good effect and no side effect when used for treating the ankylosing spondylitis.

In order to achieve the above object, the present invention provides the following technical solutions:

the invention provides a traditional Chinese medicine composition for treating ankylosing spondylitis, which comprises the following raw materials in parts by mass: the composite material comprises the following raw materials in parts by mass: 15-30 parts of ligusticum wallichii, 15-30 parts of curcuma longa, 15-30 parts of teasel root, 15-30 parts of semen cuscutae, 20-30 parts of prepared monkshood, 20-30 parts of bighead atractylodes rhizome, 15-30 parts of wolfberry fruit, 15-30 parts of salvia miltiorrhiza, 10-20 parts of white peony root, 15-30 parts of angelica, 10-20 parts of radix angelicae pubescentis, 1-10 parts of asarum, 10-20 parts of rhizoma atractylodis, 10-20 parts of poria cocos, 10-20 parts of semen coicis, 20-30 parts of rhizoma alismatis, 10-20 parts of radix clematidis, 1-10 parts of gentiana macrophylla, 10-20 parts of fructus amomi, 15-30 parts of astragalus mongholicus, 20-30 parts of ginseng, 1-10 parts of honey-fried licorice root, 10-20 parts of cassia twig, 10-20 parts of loranthus parasiticus, 10-20 parts of pawpaw, 15.

The invention also provides application of the traditional Chinese medicine composition in the technical scheme in preparation of a medicine for treating the ankylosing spondylitis.

Preferably, the dosage forms of the medicine comprise tablets, pills, capsules, powder, granules and oral liquid.

The invention provides a traditional Chinese medicine composition for treating ankylosing spondylitis and application thereof. In the invention, ginseng, astragalus and bighead atractylodes rhizome are used as five monarch drugs for tonifying deficiency, and prepared aconite root and oriental waterplantain rhizome are used for warming interior and dispelling cold. Angelica and prepared rhizome of rehmannia enrich the blood, eucommia bark, dodder, medlar and himalayan teasel root tonify the liver and kidney essence and blood, strengthen the bones and muscles, szechuan lovage rhizome, turmeric, suberect spatholobus stem and salvia miltiorrhiza activate blood and remove stasis, and notoginseng activates blood without breaking blood, and the eleven medicaments are ministerial medicaments. Clematis root, pawpaw and parasitic loranthus have the effects of relaxing muscles and tendons, dispelling rheumatism and relieving arthralgia, poria cocos, coix seed, rhizoma atractylodis and fructus amomi have the effects of promoting diuresis and excreting dampness, and cassia twig and notopterygium root have the effects of warming the sun channel to dredge blood vessels, dispelling wind and cold, relieving muscles and stopping pain; the radix paeoniae alba benefits ying-yin, harmonizes blood vessels and relieves spasm urgency, the ten medicines are adjuvant medicines, the asarum and the gentiana macrophylla descend to clear and activate the channels and collaterals, the guiding medicines directly reach the focus, the honey-fried licorice root regulates the medicines to directly reach the focus, and the three medicines are guiding medicines. The results of the embodiments of the invention show that the traditional Chinese medicine composition provided by the invention has a certain curative effect on the treatment of the Ankylosing Spondylitis (AS), the standard reaching rate of the ASAS20 is 86.75% after 24 weeks of treatment, and the total effective rate of the traditional Chinese medicine syndrome curative effect is 85.47%; the traditional Chinese medicine composition has obvious improvement effects on traditional Chinese medicine syndrome integral, BASDAI score, BASFI score, BASMI score, PGA, night pain and spinal pain of AS patients, can well reduce the disease activity of the patients, can obviously improve the functional conditions of the patients, and also has improvement effects on laboratory indexes ESR and CRP.

Detailed Description

The traditional Chinese medicine composition comprises 15-30 parts of ligusticum wallichii, preferably 20-25 parts, and more preferably 23 parts. The source of the ligusticum wallichii is not specially limited, and the ligusticum wallichii is prepared by adopting a conventional commercially available product. In the invention, the ligusticum wallichii has the functions of dispelling wind and relieving pain.

The traditional Chinese medicine composition comprises 15-30 parts of turmeric, preferably 20-25 parts, and more preferably 23 parts. The source of the turmeric in the present invention is not particularly limited, and a commercially available product may be used. In the invention, the turmeric has the functions of dispelling wind, removing arthralgia, dredging collaterals and relieving pain.

The traditional Chinese medicine composition comprises 15-30 parts of teasel roots, preferably 20-25 parts, and more preferably 23 parts. The source of the teasel roots is not specially limited, and the teasel roots can be obtained by adopting conventional commercial products. In the invention, the teasel root has the functions of nourishing liver and kidney, strengthening bones and muscles and dispelling wind-damp.

The traditional Chinese medicine composition comprises 15-30 parts of semen cuscutae, preferably 20-25 parts of semen cuscutae, and more preferably 23 parts of semen cuscutae. The source of the dodder is not particularly limited, and the dodder can be obtained by adopting a conventional commercial product. In the invention, the dodder has the functions of tonifying yang and nourishing yin.

The traditional Chinese medicine composition comprises 20-30 parts of prepared monkshood, preferably 22-28 parts, and more preferably 25 parts. The source of the prepared monkshood is not particularly limited, and the common commercial product is adopted. In the invention, the prepared aconite has the functions of dispelling cold and relieving pain.

The traditional Chinese medicine composition comprises 20-30 parts of bighead atractylodes rhizome, preferably 22-28 parts of bighead atractylodes rhizome, and more preferably 25 parts of bighead atractylodes rhizome. The source of the bighead atractylodes rhizome is not particularly limited in the invention, and the source can be obtained by adopting a conventional commercial product. In the invention, the bighead atractylodes rhizome has the functions of tonifying qi and strengthening spleen.

The traditional Chinese medicine composition comprises 15-30 parts of wolfberry, preferably 20-25 parts, and more preferably 23 parts. The source of the medlar is not particularly limited, and the medlar can be obtained by adopting a conventional commercial product. In the invention, the wolfberry has the functions of nourishing liver and kidney and strengthening bones and muscles.

The traditional Chinese medicine composition comprises 15-30 parts of salvia miltiorrhiza, preferably 20-25 parts, and more preferably 23 parts. The source of the salvia miltiorrhiza is not particularly limited, and the salvia miltiorrhiza can be prepared by adopting a conventional commercial product. In the invention, the salvia miltiorrhiza has the functions of activating blood and removing stasis.

The traditional Chinese medicine composition comprises 10-20 parts of white peony root, preferably 12-18 parts, and more preferably 15 parts. The source of the white paeony root is not particularly limited, and the white paeony root can be prepared from conventional commercial products. In the invention, the white paeony root has the effects of nourishing blood, astringing yin, softening liver and relieving pain.

The traditional Chinese medicine composition comprises 15-30 parts of angelica sinensis, preferably 20-25 parts, and more preferably 23 parts. The source of the angelica is not particularly limited, and the angelica can be obtained by adopting a conventional commercial product. In the invention, the angelica has the functions of enriching the blood, promoting blood circulation and relieving pain.

The traditional Chinese medicine composition comprises 10-20 parts of radix angelicae pubescentis, preferably 12-18 parts, and more preferably 15 parts. The source of the notopterygium root is not particularly limited, and the notopterygium root can be obtained by adopting a conventional commercial product. In the invention, the notopterygium root has the functions of expelling wind-damp and relieving pain.

The traditional Chinese medicine composition comprises 1-10 parts of asarum, preferably 2-8 parts, and more preferably 5 parts. The source of the asarum is not particularly limited in the present invention, and a conventional commercially available product can be used. In the invention, the asarum has the effects of dispelling cold and relieving pain.

The traditional Chinese medicine composition comprises 10-20 parts of rhizoma atractylodis, preferably 12-18 parts, and more preferably 15 parts. The source of the rhizoma atractylodis is not particularly limited, and the rhizoma atractylodis can be obtained by adopting a conventional commercially available product. In the invention, the rhizoma atractylodis has the functions of drying dampness and strengthening spleen, and dispelling dampness and dryness.

The traditional Chinese medicine composition comprises 10-20 parts of poria cocos, preferably 12-18 parts of poria cocos, and more preferably 15 parts of poria cocos. The source of the poria cocos is not particularly limited, and the poria cocos can be obtained by adopting a conventional commercial product. In the invention, the poria cocos has the effects of promoting diuresis and excreting dampness.

The traditional Chinese medicine composition comprises 10-20 parts of coix seeds, preferably 12-18 parts, and more preferably 15 parts. The source of the coix seeds is not particularly limited, and the coix seeds can be obtained by adopting conventional commercial products. In the invention, the coix seed has the functions of tonifying spleen and removing paralysis.

The traditional Chinese medicine composition comprises 20-30 parts of rhizoma alismatis, preferably 22-28 parts of rhizoma alismatis, and more preferably 25 parts of rhizoma alismatis. The source of the alisma orientale is not particularly limited in the invention, and the alisma orientale can be obtained by adopting a conventional commercial product. In the invention, the rhizoma alismatis has the effects of promoting diuresis and excreting dampness.

The traditional Chinese medicine composition comprises 10-20 parts of clematis root, preferably 12-18 parts of clematis root, and more preferably 15 parts of clematis root. The source of the clematis root is not particularly limited in the invention, and the clematis root can be obtained by adopting a conventional commercial product. In the invention, the clematis root has the functions of dispelling wind-damp and stopping arthralgia.

The traditional Chinese medicine composition comprises 1-10 parts of gentiana macrophylla, preferably 2-8 parts, and more preferably 5 parts. The source of the gentiana macrophylla is not particularly limited, and the gentiana macrophylla is prepared by adopting a conventional commercially available product. In the invention, the gentiana macrophylla has the functions of expelling wind-damp and relaxing tendons and collaterals.

The traditional Chinese medicine composition comprises 10-20 parts of fructus amomi, preferably 12-18 parts, and more preferably 15 parts. The source of the fructus amomi is not specially limited, and the fructus amomi can be obtained by adopting a conventional commercial product. In the invention, the fructus amomi has the functions of eliminating dampness and promoting qi circulation.

The traditional Chinese medicine composition comprises 15-30 parts of astragalus membranaceus, preferably 20-25 parts, and more preferably 23 parts. The source of the astragalus is not particularly limited, and the astragalus can be obtained by adopting a conventional commercial product. In the invention, the astragalus has the functions of tonifying qi, invigorating yang, benefiting wei and strengthening exterior.

The traditional Chinese medicine composition comprises 20-30 parts of ginseng, preferably 22-28 parts of ginseng, and more preferably 25 parts of ginseng. The source of the ginseng is not particularly limited, and the ginseng can be obtained by adopting a conventional commercial product. In the invention, the ginseng has the functions of tonifying yang and tonifying spleen.

The traditional Chinese medicine composition comprises 1-10 parts of honey-fried licorice root, preferably 2-8 parts, and more preferably 5 parts. The source of the honey-fried licorice root is not specially limited, and the honey-fried licorice root can be prepared by adopting a conventional commercial product. In the invention, the honey-fried licorice root has the effect of harmonizing the medicines.

The traditional Chinese medicine composition comprises 10-20 parts of cassia twig, preferably 12-18 parts, and more preferably 15 parts. The source of the cassia twig is not particularly limited, and the cassia twig can be prepared by adopting a conventional commercial product. In the present invention, the cassia twig has the effects of warming meridians and activating yang.

The traditional Chinese medicine composition comprises 10-20 parts of parasitic loranthus, preferably 12-18 parts of parasitic loranthus, and more preferably 15 parts of parasitic loranthus. The source of the parasitic loranthus is not particularly limited, and the parasitic loranthus can be obtained by adopting a conventional commercial product. In the invention, the parasitic loranthus has the functions of nourishing liver and kidney and strengthening bones and muscles.

The traditional Chinese medicine composition comprises 10-20 parts of pawpaw, preferably 12-18 parts, and more preferably 15 parts. The source of the pawpaw is not particularly limited, and the pawpaw is prepared by adopting a conventional commercial product. In the invention, the pawpaw has the functions of relaxing tendons and activating collaterals.

The traditional Chinese medicine composition comprises 15-30 parts of prepared rehmannia root, preferably 20-25 parts, and more preferably 23 parts. The source of the prepared rehmannia root is not particularly limited, and the conventional commercial product is adopted. In the invention, the prepared rehmannia root has the functions of replenishing essence and benefiting marrow.

The traditional Chinese medicine composition comprises 15-30 parts of pseudo-ginseng, preferably 20-25 parts, and more preferably 23 parts. The origin of the pseudo-ginseng is not particularly limited, and the pseudo-ginseng can be obtained by adopting a conventional commercial product. In the invention, the pseudo-ginseng has the functions of promoting blood circulation and relieving pain.

The traditional Chinese medicine composition comprises 15-30 parts of caulis spatholobi, preferably 20-25 parts, and more preferably 23 parts. The source of the caulis spatholobi is not particularly limited, and the caulis spatholobi can be obtained by adopting a conventional commercially available product. In the invention, the caulis spatholobi has the functions of promoting blood circulation, enriching blood and strengthening bones and muscles.

The traditional Chinese medicine composition comprises 15-30 parts of eucommia ulmoides, preferably 20-25 parts of eucommia ulmoides, and more preferably 23 parts of eucommia ulmoides. The source of the eucommia ulmoides is not particularly limited, and the eucommia ulmoides can be obtained by adopting a conventional commercial product. In the invention, the eucommia ulmoides has the effects of tonifying liver and kidney and strengthening bones and muscles.

The invention also provides application of the traditional Chinese medicine composition in the technical scheme in preparation of a medicine for treating the ankylosing spondylitis. The dosage form of the medicine provided by the invention preferably comprises tablets, pills, capsules, powder, granules and oral liquid. The auxiliary materials of the preparation are not specially limited, and the auxiliary materials corresponding to the preparation can be prepared conventionally.

In the invention, the use method of the traditional Chinese medicine composition is preferably that the traditional Chinese medicine composition is directly eaten after being ground, the grain size of the ground traditional Chinese medicine composition is preferably 100-300 meshes, more preferably 200 meshes, and the use amount is preferably 4-8 g, more preferably 6 g.

The invention also provides application of the traditional Chinese medicine composition in the technical scheme in preparation of a medicine for treating ankylosing spondylitis. In the invention, the traditional Chinese medicine composition accounts for 0.1-99% of the total mass of the medicine.

The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

Chinese medicinal composition

15g of ligusticum wallichii, 15g of curcuma longa, 15g of teasel root, 15g of semen cuscutae, 20g of prepared monkshood, 20g of bighead atractylodes rhizome, 15g of wolfberry fruit, 15g of salvia miltiorrhiza, 10g of white paeony root, 15g of angelica, 10g of radix angelicae pubescentis, 1g of asarum, 10g of rhizoma atractylodis, 10g of poria cocos, 10g of semen coicis, 20g of rhizoma alismatis, 10g of radix clematidis, 1g of gentiana macrophylla, 10g of fructus amomi, 15g of astragalus membranaceus, 20g of ginseng, 1g of honey-fried licorice root, 10g of cassia twig, 10g of loranthus parasiticus.

Preparation method

Pulverizing the above Chinese medicinal materials into 200 mesh powder, respectively, and mixing to obtain the Chinese medicinal composition.

Example 2

30g of ligusticum wallichii, 30g of curcuma longa, 30g of teasel root, 30g of semen cuscutae, 30g of prepared monkshood, 30g of bighead atractylodes rhizome, 30g of wolfberry fruit, 30g of salvia miltiorrhiza, 20g of white paeony root, 30g of angelica, 20g of radix angelicae pubescentis, 10g of asarum, 20g of rhizoma atractylodis, 20g of poria cocos, 20g of semen coicis, 30g of rhizoma alismatis, 20g of radix clematidis, 10g of gentiana macrophylla, 20g of fructus amomi, 30g of astragalus membranaceus, 30g of ginseng, 10g of honey-fried licorice root, 20g of cassia twig, 20g of loranthus parasiticus.

Preparation method

Example 3

20g of ligusticum wallichii, 30g of curcuma longa, 20g of teasel root, 20g of semen cuscutae, 25g of prepared monkshood, 25g of bighead atractylodes rhizome, 20g of wolfberry fruit, 20g of salvia miltiorrhiza, 10g of white paeony root, 20g of angelica, 10g of radix angelicae pubescentis, 6g of asarum, 10g of rhizoma atractylodis, 10g of poria cocos, 10g of semen coicis, 25g of rhizoma alismatis, 10g of radix clematidis, 6g of gentiana macrophylla, 10g of fructus amomi, 25g of astragalus membranaceus, 25g of ginseng, 6g of honey-fried licorice root, 10g of cassia twig, 10g of loranthus parasitic.

Preparation method

Example 4

1. Western medicine diagnosis Standard "guidelines for clinical research on New drug of traditional Chinese medicine": 1. the low back pain persists for at least 3 months and can be relieved after activity (rather than rest). 2. The movement of the lumbar vertebrae in the vertical and horizontal planes is limited. 3. The chest expansion degree is normally reduced compared with the same age and sex. X-ray sacroiliac arthritis with unilateral grade III-IV or bilateral grade II-III: I. suspicious or minimal sacroiliac arthritis. II. Mild sacroiliac arthritis (blurred margins of joints, hardening of the proximal joint area, mild narrowing of the joint space). Grade III, moderate sacroiliac arthritis (obviously blurry joint margin, hardening near joint area, obviously narrowed joint space and obviously damaged bone). IV, sacroiliac joint fusion or forced, with or without cirrhosis. 4. Morning stiffness is more than or equal to 30 minutes, the sleep is affected due to pain and stiffness, ESR is more than or equal to 30mm/1h, CRP is more than or equal to 20mg/l, and IgA is more than or equal to 3.9 g/l.

2, the inclusion standard (1) meets the diagnosis standard of western medicine; (2) according with the typing standard of damp-heat stasis syndrome; (3) age 18-50 years; (4) voluntarily attending the clinical study and signing an informed consent;

(5) the disease condition is in an active stage, the judgment standard of the disease activity is that the activity index (BASDAl) of the disease of the Bath ankylosing spondylitis is larger than 4, and the score of the rachiopalgia is 24; (6 Sulfasalazine (SASP), Methotrexate (MTX), and leflunomide (Lef) were used once, and the composition was administered after 1 month;

the biological preparation can be used for more than 3 months; using non-steroidal anti-inflammatory drugs (NSAIDS), the drug should be stopped for 2 weeks before the drug is administered.

3 the rejection criteria (1) meets the diagnostic criteria but does not meet the inclusion criteria; (2) unwilling to use the test drugs together or to participate in clinical tests; (3) the compliance was poor.

4 exclusion criteria (1) female patients in gestational lactation; (2) other seronegative spondyloarthropathies; (3) patients with advanced disease, strong and straight spine and serious joint deformity; (4) those with combined acute ophthalmia who need to be treated by adrenocortical hormone; (5) combined with serious primary diseases of heart, cerebral vessels, liver, kidney, hemopoietic system, etc.

380 cases of AS patients are selected from the Wangzhi school chapter traditional Chinese medicine clinic in 2010, 5 months to 2013, 5 months and are diagnosed in 380 cases of general data, and the patients are randomly divided into the traditional Chinese medicine and the western medicine according to the ratio of 1: 1. 190 cases of traditional Chinese medicines, 190 cases of western medicines, 190 cases of traditional Chinese medicines, 139 cases of men, 51 cases of women, the age of 17-43 years, the average age (30.3 +/-8.4) years, the course of disease of 7 months-11 years and the average course of disease of 7.25 years. 190 western medicines, 119 men and 71 women, 18-66 years old, 31.9 + -10.5 years old, 5-23 months to 8.36 years old.

5. The Chinese medicinal composition of the invention in example 3 is administered to the TCM group at 6g once and 2 times daily. The western medicine groups take the salicylic nitrogen, 0.25g, Shanghai, Zhongxi three-dimensional pharmacy Co., Ltd, the batch number: 20100203) orally, 1g is taken each time, 2 times a day, and 2 groups of treatment courses are all 4 weeks. Evaluation was performed at 4, 12, 24 weeks.

6. Observation item and detection method

6.1 case of shedding.

6.2 scoliosis score, nighttime pain score and PGA pain was represented by 1-line using Visual Analogue Scale (VAS). The line segment is divided into 10 segments, 0 is painless, 1-3 is mild pain, 4-6 is moderate pain, 7-9 is severe pain, 10 is 1 extreme pain, points representing the intensity of pain are marked on the line, and the distance from 0 to the point marked 2 is measured to be the pain intensity score value.

6.3BASDAI assessment, the observations include 6 items, namely the patient's degree of physical fatigue over the past 1 week, the degree of pain in the neck and back marrow joints, the degree of pain or swelling in other joints, tenonitis, the degree of morning stiffness and morning stiffness time. Assessment method each score was the patient's self-assessed VAS (0-10) score, BASDAl ═ 0.2x [ 1 st + 2 nd + 3 rd + 4 th +0.5x (5 th + 6 th) ].

6.4BASFI assay, including 10 questions, the first 8 questions assessing the patient's functional activity, the last 2 questions assessing the patient's ability to address daily living, each item scoring the patient's self-assessed VAS (0-10) score, the average of the 10 question scores as BASFI.

6.5BASMI measurement, including the patient's cervical vertebra rotation degree (degree), tragus-wall distance (cm), lumbar lateral bending (cm), lumbar anteflexion (cm), ankle distance (cm), and convert into corresponding score (0 ~ 10), BASMI ═ 0.2x each item score sum.

6.6 the score standard of the syndrome integrals of the traditional Chinese medicine is made according to the guideline of clinical research of new drugs in traditional Chinese medicine. Symptoms 4 to be observed, namely waist general, low back, neck pain and nighttime pain (0.2.4.6 points given by degree), joint limitation and morning stiffness (0.1.2.3 points given by degree); the traditional Chinese medicine syndrome curative effect is divided into 4 grades, clinical relief is carried out, wherein the middle clinical symptoms and physical signs disappear or basically disappear, and the syndrome integral is reduced by 95 percent; the traditional Chinese medicine has obvious effects that the clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved, and the syndrome product is reduced by 70 to 95 percent; the method has the following advantages: the clinical symptoms and physical signs of the traditional Chinese medicine are all changed, and the syndrome integral is reduced by 30 to 69 percent; and (4) invalidation: no obvious improvement or even aggravation of the clinical symptoms and signs of the traditional Chinese medicine exists, the reduction of the syndrome integral is less than 30 percent, and a nimodipine method is adopted for calculation (the formula is (integral before treatment-integral after treatment) integral before treatment is multiplied by 100 percent).

6.7 disease efficacy assessment criteria for efficacy of ASAS20 presented by the ASAS working group were used to determine efficacy. ASAS20 refers to the improvement of 3 of 4 indices > 20% compared to initial values in 4 aspects of PGA, spinal pain VAS score, BASFI, spinal inflammation score (morning stiffness and duration), and absolute score of at least 1 improvement; but not 20% improvement, no deterioration compared with the initial diagnosis. The ASAS20 standard is reached to be valid, otherwise, the ASAS20 standard is judged to be invalid.

6.8 the laboratory index ESR is detected by Weishi method, CRP is detected by enzyme-linked immunosorbent double antibody sandwich method (ELISA).

6.9 adverse reaction the routine of blood and urine, the function of liver (ALT) and kidney (Cr, BUN) and electrocardiogram of the patients are observed.

7. The statistical method is performed by SAS statistical analysis software.

The data of the measured data are expressed by X +/-s, and are compared between two groups and before and after treatment, wherein t test is adopted when the data accord with normal distribution, and non-parameter test is adopted when the data do not accord with normal distribution. The count data is expressed in frequency (composition ratio) by x²Using x as inspection and grade counting data²A test or a non-parametric test. P<A difference of 0.05 is statistically significant.

Results

1. The trial included 351 patients, 30 patients who dropped off, including 23 missed visits, 5 quitters who had no conscious effect, and 2 quitters who had quitted due to adverse events.

2. After 4, 12 and 24 weeks of the two-effect evaluation treatment, 203 patients (86.7%) with the traditional Chinese medicine group meeting the ASAS20 standard and 78 patients (66.67%) with the western medicine group.

3. The traditional Chinese medicine group integral comparison before and after treatment (table 1) after treatment for 4, 12 and 24 weeks, the traditional Chinese medicine syndrome integral is obviously reduced compared with that before treatment, and the difference has statistical significance (P is less than 0.01); after 12 and 24 weeks of treatment, the traditional Chinese medicine composition score is obviously lower than that of the western medicine composition, and the differences have statistical significance (P is less than 0.01).

TABLE 1 integral comparison of syndromes before and after treatment (minutes, xts)

P <0.01 compared to group before treatment; compared with the western medicine group, the p is less than 0.01.

4. Comparison of BASDAI BASFI, BASMI, spine pain, night pain, and PGA before and after treatment in two groups (table 2) after treatment for 4, 12, and 24 weeks, BASDAI, BASFI, spine pain, and night pain PGA in two groups of patients were all significantly improved, and the difference was statistically significant (P < 0.01); after 12 and 24 weeks of treatment, BASMI of patients in western medicine group is obviously improved compared with that before treatment, and the differences have statistical significance (P <0.05, P < 0.01); after 12 and 24 weeks of treatment, the traditional Chinese medicine groups BASDAI and BASFI have spinal pain, night pain and PGA which are obviously lower than those of the western medicine groups, and the differences have statistical significance (P < 0.01); after 24 weeks of treatment, the traditional Chinese medicine group BASMI is significantly lower than that of the western medicine group, and the difference has statistical significance (P < 0.05).

TABLE 2 comparison of BASDAI, BASFI, BASMI, spina pain, nocturnal pain, PGA before and after two groups of treatments

Note that P is less than 0.01 compared with the group before treatment, and △ P is less than 0.01 compared with the western medicine group at the same time.

5. Comparison of CRP and ESR measurements before and after treatment in both groups (Table 3) after 12 and 24 weeks of treatment, both CRP and ESR measurements were reduced compared to those before treatment, and the differences were statistically significant (P < 0.01); compared with the traditional Chinese medicine and western medicine groups, the difference has no statistical significance (P is more than 0.05) in 12-24 weeks of treatment.

TABLE 3 comparison of CRP and ESR measurements before and after treatment (x. + -. s)

Note that P was <0.01 compared to this group before treatment.

6. In the traditional Chinese medicine with adverse reactions, 6 patients have mild liver function abnormality (ALT:41-80UnL), and after symptomatic treatment, the liver function is normal; 1 case of western medicine group has urine protein, 1 patient has allergy, and the test is quit. Urinary infection was observed in 1 patient, which was not treated specifically. Moderate liver dysfunction (ALT:135UL) appeared in 1 patient, and after taking withdrawal of the drug and symptomatic treatment, liver function became normal. The proportion of adverse events of the Chinese medicine group and the western medicine group is 2.54 percent (6/236) and 3.39 percent (4/17), and the difference has no statistical significance (P is more than 0.05).

From the above results, the traditional Chinese medicine composition provided by the invention can effectively treat the ankylosing spondylitis.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating ankylosing spondylitis is characterized by comprising the following raw materials in parts by mass: 15-30 parts of ligusticum wallichii, 15-30 parts of curcuma longa, 15-30 parts of teasel root, 15-30 parts of semen cuscutae, 20-30 parts of prepared monkshood, 20-30 parts of bighead atractylodes rhizome, 15-30 parts of wolfberry fruit, 15-30 parts of salvia miltiorrhiza, 10-20 parts of white peony root, 15-30 parts of angelica, 10-20 parts of radix angelicae pubescentis, 1-10 parts of asarum, 10-20 parts of rhizoma atractylodis, 10-20 parts of poria cocos, 10-20 parts of semen coicis, 20-30 parts of rhizoma alismatis, 10-20 parts of radix clematidis, 1-10 parts of gentiana macrophylla, 10-20 parts of fructus amomi, 15-30 parts of astragalus mongholicus, 20-30 parts of ginseng, 1-10 parts of honey-fried licorice root, 10-20 parts of cassia twig, 10-20 parts of loranthus parasiticus, 10-20 parts of pawpaw, 15.

2. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for the treatment of ankylosing spondylitis.

3. The use of claim 2, wherein the medicament is in a dosage form selected from the group consisting of tablets, pills, capsules, powders, granules, and oral liquids.