A traditional Chinese medicine composition for treating cervical spondylosis, a preparation method thereof and use thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition for treating cervical spondylosis and its preparation method and use, belong to the field of traditional Chinese medicine.The traditional Chinese medicine composition of the present application is prepared from the following weight ratio of raw medicinal materials: Huangqi 14.4-21.6 parts, Baishao 14.4-21.6 parts, Jixueteng 14.4-21.6 parts, Gegen 14.4-21.6 parts, Sangzhi 14.4-21.6 parts, Gouqi 7.2-10.8 parts, Tianma 7.2-10.8 parts, Chuanqiong 7.2-10.8 parts, Lingshenteng 7.2-10.8 parts, Zexie 7.2-10.8 parts, Baizhu 7.2-10.8 parts, Sanqi 2.4-3.6 parts.The present application also provides the preparation method and use of the traditional Chinese medicine composition.The present application is aimed at the complex syndrome type of "deficiency of liver and kidney combined with phlegm-dampness blocking meridians cervical spondylosis", introduces Zexie and Baizhu drug pair, and combines water and removes dampness, and has the effect of invigorating spleen and drying dampness, is specially used for treating phlegm-dampness dizziness, and the compatibility of "Tianma" significantly enhances the ability of resolving phlegm, calming wind and stopping dizziness.At the same time, Chuanqiong is introduced to promote blood circulation and qi, and goes up to head and eyes to stop pain, and Jixueteng, Lingshenteng and Gegen form synergistic compatibility, the medicinal property is mild, the curative effect is remarkable, the side effect risk is low, and it is suitable for long-term nursing of cervical spondylosis.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for treating cervical spondylosis, belonging to the field of traditional Chinese medicine. Background Technology

[0002] Cervical spondylosis is caused by degeneration of the cervical intervertebral discs, leading to dynamic and static instability of the cervical vertebrae and soft tissues. This instability can then induce pathological conditions such as disc herniation, ligament hypertrophy and calcification, and bone hyperplasia, stimulating or invading surrounding spinal cord, nerves, and blood vessels, resulting in a series of symptoms and signs. Cervical spondylosis is currently a common disease among middle-aged and elderly people. According to research statistics, the incidence rate of cervical spondylosis in my country has reached 13.76%, and it is increasingly affecting younger people. Traditional Chinese medicine (TCM) has a long history of treating cervical spondylosis and has enormous potential for development. Treatment methods for cervical spondylosis in domestic and international literature mainly focus on massage, exercise therapy, and acupuncture, but recommendations are inconsistent. Many domestic guidelines for cervical spondylosis only recommend massage and exercise therapy, without covering TCM herbal remedies or techniques.

[0003] In Traditional Chinese Medicine (TCM), cervical spondylosis is usually classified into different types based on its etiology, symptoms, and constitution. Common types include wind-cold-dampness obstruction, qi stagnation and blood stasis, phlegm-dampness obstruction, liver and kidney deficiency, qi and blood deficiency, spleen and kidney deficiency, and phlegm-fire stagnation. For example, Wu Yicheng et al., "Observation on the efficacy of acupuncture treatment based on TCM syndrome differentiation in the treatment of vertebral artery type cervical spondylosis," *Health Medicine Research and Practice*, July 2022, Vol. 19, No. 7, reported that acupuncture treatment based on TCM syndrome differentiation can effectively relieve the clinical symptoms of CSA patients with dizziness, headache, and insomnia. The main syndrome differentiation types disclosed in the report are qi and blood deficiency, wind-phlegm disturbance, and liver yang hyperactivity. The treatment should be based on the principles of promoting blood circulation, regulating qi, and clearing the meridians. Feng Wenyuan et al., "Experience of Zhao Jirong in Treating Vertebral Artery Type Cervical Spondylosis," *Inner Mongolia Journal of Traditional Chinese Medicine*, Vol. 44, February 2025, No. 2, emphasized that regulating the spleen qi should be integrated throughout the entire treatment process. Due to the complexity of the diagnosis of cervical spondylosis, various treatment methods and prescriptions vary.

[0004] Application No.: CN98112028.8, Invention Title: A Medicine for Treating Cervical Spondylosis and its Preparation Process. The invention discloses a formula composed of *Spatholobus suberectus*, *Astragalus membranaceus*, *Paeonia lactiflora*, *Pueraria lobata*, *Clematis chinensis*, *Polygonum multiflorum*, *Salvia miltiorrhiza*, *Carthamus tinctorius*, *Luffa cylindrica*, *Epimedium brevicornu*, *Lycium barbarum*, *Polygonum multiflorum* (processed), *Lilium brownii*, *Panax notoginseng*, and *Morus alba* twigs. The formula is extracted and concentrated into an extract, then dextrin and white sugar are added to form granules, which are then dried. It possesses the effects of nourishing blood and qi, tonifying the kidneys and strengthening the Du meridian, resolving phlegm and promoting blood circulation, and relaxing muscles and tendons. It relieves the pressure on nerve roots and vertebral arteries caused by cervical spondylosis, improves cerebral blood supply, restores cervical spine function, and eliminates symptoms such as headache, dizziness, neck, shoulder, and arm pain, and numbness and weakness of the limbs. It is suitable for treating cervical spondylosis.

[0005] Application No.: CN202411824279.5, Invention Title: A Traditional Chinese Medicine Composition for Treating Cervical Spondylosis and Its Preparation Method, discloses a traditional Chinese medicine composition for treating cervical spondylosis and its preparation method. Made from the following raw materials in the indicated weight ratios: Pinellia ternata 45-55 g, Atractylodes macrocephala 45-55 g, Gastrodia elata 45-55 g, Uncaria rhynchophylla 45-55 g, Poria cocos 45-55 g, Polygonum multiflorum 95-105 g, Salvia miltiorrhiza 95-105 g, Angelica sinensis 45-55 g, Ligusticum chuanxiong 45-55 g, Prunus persica 45-55 g, Carthamus tinctorius 45-55 g, Paeonia lactiflora 45-55 g, Notopterygium incisum 45-55 g, Curcuma longa 45-55 g, Panax notoginseng 25-35 g, Hirudo medicinalis 25-35 g, Pueraria lobata 95-105 g, Ginkgo biloba 95-105 g, Clematis chinensis 95-105 g, Pheretima aspergillum 45-55 g, Drynaria fortunei 45-55 g, Lycopodium clavatum 55-65 g, Haliotis diversicolor 95-105 g, Astragalus membranaceus 115-125 g. g, deer antler powder 25~35 g, chicken blood vine 95~105 g, cinnamon twig 45~55 g, tortoise shell 45~55 g, angelica pubescens 45~55 g, gentian root 45~55 g, white peony root 45~55 g, clematis root 20~30 g, saposhnikovia root 45~55 g.

[0006] Among them, the patent with application number CN98112028.8 has a relatively broad syndrome differentiation, which is more inclined to the "deficiency of both qi and blood, and deficiency of kidney and blood stasis" type of cervical spondylosis. Although the prescription mentions "phlegm-resolving", there is no truly powerful phlegm-resolving and dampness-removing drug to support it, and it is not targeted enough for the "phlegm-dampness" pathogenic factor. The patent with application number CN202411824279.5 has a syndrome differentiation that clearly focuses on "wind-phlegm disturbance" and "severe blood stasis obstructing the collaterals", and can even be said to have the three evils of "wind, phlegm and blood stasis" all prevalent. Moreover, it focuses on attacking the evil and has insufficient tonifying power, which can easily deplete the patient's qi and blood. Summary of the Invention

[0007] This invention provides a traditional Chinese medicine composition for treating cervical spondylosis, especially for treating cervical spondylosis of the type caused by liver and kidney deficiency combined with phlegm and dampness obstruction. This invention also provides a method for preparing the traditional Chinese medicine composition and its uses.

[0008] This invention provides a traditional Chinese medicine composition for treating cervical spondylosis, which is prepared from the following raw materials in the indicated weight ratios:

[0009] Astragalus membranaceus 14.4-21.6 parts, Paeonia lactiflora 14.4-21.6 parts, Spatholobus suberectus 14.4-21.6 parts, Pueraria lobata 14.4-21.6 parts, Morus alba twig 14.4-21.6 parts, Lycium barbarum 7.2-10.8 parts, Gastrodia elata 7.2-10.8 parts, Ligusticum chuanxiong 7.2-10.8 parts, Clematis chinensis 7.2-10.8 parts, Alisma plantago-aquatica 7.2-10.8 parts, Atractylodes macrocephala 7.2-10.8 parts, Panax notoginseng 2.4-3.6 parts.

[0010] Preferably, it is prepared from the following raw medicinal materials with the following weight ratio:

[0011] Radix Astragali 18 parts, Radix Paeoniae Alba 18 parts, Lycium barbarum 9 parts, Gastrodia 9 parts, Chuanxiong 9 parts, Radix Tricifuerae 9 parts, Alisma 9 parts, Rhizoma Atractylodis Macrocephalae 9 parts, Panax Notoginseng 3 parts.

[0012] The traditional Chinese medicine composition in the application is prepared from the raw medicinal material powder, water or organic solvent extract as the active ingredient, and the pharmaceutically acceptable adjuvant or auxiliary ingredient.

[0013] The preparation is a tablet, a capsule, a granule, a pill or an oral liquid.

[0014] The application further provides a preparation method of the traditional Chinese medicine composition for treating cervical spondylosis.

[0015] a. Weigh the raw medicinal materials with the following weight ratio;

[0016] b. Powdering, or extracting with water or organic solvent, concentrating the extract, and then adding the pharmaceutically acceptable adjuvant or auxiliary ingredient to prepare a commonly used pharmaceutical preparation.

[0017] The application further provides the use of the traditional Chinese medicine composition in the preparation of a medicine for treating cervical spondylosis.

[0018] The medicine is a medicine for treating cervical spondylosis of the type of liver and kidney deficiency combined with phlegm dampness blocking the collaterals.

[0019] The medicine is a medicine for treating cervical spondylosis of the type of nerve root, vertebral artery and mixed type.

[0020] The medicine is a medicine with the effects of benefiting qi and nourishing blood, relaxing sinews and dredging collaterals.

[0021] The raw materials of the traditional Chinese medicine composition in the application are matched based on the theory system of traditional Chinese medicine, and it is considered that cervical spondylosis is caused by overwork and internal injury, unfavorable meridian transmission, blood stasis, liver and kidney deficiency, marrow deficiency, and muscle and bone atrophy, leading to cervical spondylopathy. The composition is composed of twelve kinds of traditional Chinese medicines, including Huangqi, Baishao, Jixueteng, Chuanxiong, Lingshenteng, Gegen, Gouqi, Tianma, Zexie, Baizhu, Sanqi and Sangzhi, for treating liver and kidney deficiency and phlegm and blood stasis. In the composition, Huangqi can raise yang and benefit qi, and qi can produce blood; Baishao can nourish blood and soften tendon, and relieve pain; the two medicines can benefit qi and nourish blood, and are the monarch medicines. Jixueteng can nourish blood and activate meridian, Chuanxiong can activate blood and promote flow of qi, Lingshenteng can resolve phlegm and dredge collaterals, Gegen can soothe the channels and relieve convulsions, the four medicines can resolve phlegm and remove blood stasis, dredge collaterals and relieve pain, and are the minister medicines. Tianma can soothe liver and dredge collaterals, Gouqi can nourish liver and kidney, the two medicines can regulate liver and kidney, nourish heart and brain, Zexie can drain water and reduce turbidity, Baizhu can invigorate spleen and dredge yang, the two medicines can clear away heat and remove dampness to stop dizziness, and are the assistant medicines. Sanqi can activate blood and dredge collaterals to relieve pain, and Sangzhi can dispel wind, relax tendon and activate collaterals, and are the ministerial medicines. The combination of the medicines can benefit qi and nourish blood, relax tendon and dredge collaterals, thereby relieving the pressure on nerve root and vertebral artery caused by cervical spondylopathy, improving cerebral ischemia, restoring the physiological function of cervical vertebra, and relieving symptoms such as headache, dizziness, cervical and shoulder pain, upper limb numbness and weakness.

[0022] The application has the following beneficial effects:

[0023] The application is aimed at the complex syndrome of liver and kidney deficiency combined with phlegm and dampness blocking collaterals, and introduces Zexie and Baizhu to promote water and remove dampness, invigorate the spleen and dry dampness, and is specially used for treating dizziness caused by phlegm and dampness. When combined with Tianma, the effect of resolving phlegm and calming wind to stop dizziness is significantly enhanced. Meanwhile, Chuanxiong is introduced to activate blood and promote flow of qi, and is upward to the head and eyes to relieve pain, and is synergistically combined with Jixueteng, Lingshenteng and Gegen. The application is aimed at the complex syndrome of liver and kidney deficiency combined with phlegm and dampness blocking collaterals, and at the same time, Huangqi, Baishao and Gouqi are used to protect the liver and kidney, and the medicinal properties are mild, the curative effect is remarkable, the side effect risk is low, and it is very suitable for long-term treatment of chronic cervical spondylosis. DETAILED DESCRIPTION

[0024] Example 1 Preparation of the traditional Chinese medicine composition (hereinafter referred to as “Jingfushu granules”) in the application

[0025] Prescription: Huangqi 18g, Baishao 18g, Jixueteng 18g, Gegen 18g, Sangzhi 18g, Gouqi 9g, Tianma 9g, Chuanxiong 9g, Lingshenteng 9g, Zexie 9g, Baizhu 9g, Sanqi 3g.

[0026] Function and indication: It has the effects of benefiting qi and nourishing blood, relaxing tendon and dredging collaterals, and is used for treating cervical spondylosis, and symptoms such as headache, dizziness, cervical and shoulder pain, upper limb numbness and weakness.

[0027] Usage and dosage: 1 dose is taken 2 days, 3 times a day, and water decoction is taken, and Sanqi is powdered and taken.

[0028] Preparation process:

[0029] The above twelve ingredients, except for the Sanchi powder, are decocted three times with water, each time for 1.0 hour, the decoction is combined, filtered, the filtrate is concentrated to a clear extract with a relative density of 1.10-1.15 (55-60°C), the Sanchi powder and an appropriate amount of dextrin are added, mixed, granulated, and dried to obtain the granules.

[0030] Example 2 Preparation of the tablet of the traditional Chinese medicine composition of the present application

[0031] The prescription is taken: 14.4g of Huangqi, 14.4g of Baishao, 14.4g of Jixueteng, 14.4g of Gegen, 14.4g of Sangzhi, 7.2g of Gouqi, 7.2g of Tianma, 7.2g of Chuanqiong, 7.2g of Lingshenteng, 7.2g of Zexie, 7.2g of Baizhu, and 2.4g of Sanchi.

[0032] The granules are prepared according to the preparation process of Example 1, and the tablets are pressed to obtain the tablets.

[0033] Example 3 Preparation of the oral liquid of the traditional Chinese medicine composition of the present application

[0034] The prescription is taken: 21.6g of Huangqi, 21.6g of Baishao, 21.6g of Jixueteng, 21.6g of Gegen, 21.6g of Sangzhi, 10.8g of Gouqi, 10.8g of Tianma, 10.8g of Chuanqiong, 10.8g of Lingshenteng, 10.8g of Zexie, 10.8g of Baizhu, and 3.6g of Sanchi.

[0035] The oral liquid is prepared according to the preparation process of Example 1.

[0036] The beneficial effects of the present application are proved by the following clinical tests.

[0037] Example 1 Clinical test of the traditional Chinese medicine composition of the present application

[0038] The clinical test of the granules for treating cervical spondylosis is jointly undertaken by the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Suining Hospital of Traditional Chinese Medicine, and Mianyang Hospital of Traditional Chinese Medicine.

[0039] The clinical test is a single-blind prospective study method using the commercially available Chinese patent medicine "Jingfukang granules" with the drug permit Z13022204 as the control medicine. 120 patients with cervical spondylosis of the nerve root type, vertebral artery type, and mixed type are observed, including 60 patients in the treatment group and 60 patients in the control group. The "Jingfukang granules" are differentiated into the syndrome type of wind-dampness and blood stasis, i.e., the combination of external wind-dampness and internal blood stasis, the mutual combination of the two evils of "wind-dampness" and "blood stasis", and the blockage of meridians. The "Jingfukang granules" of the present application are differentiated into the syndrome type of deficiency of liver and kidney combined with blockage of collaterals by phlegm-dampness, i.e., the deficiency of liver and kidney, the deficiency of qi and blood, the malnutrition of tendons and bones, the mutual combination of phlegm-dampness and blood stasis, and the blockage of collaterals.

[0040] The observation results are reported as follows:

[0041] I. General information

[0042] 1. Case source: see Table 1

[0043] Table 1: Comparison of outpatient and inpatient cases in two groups

[0044]

[0045] After statistical processing, X2=1.875, P>0.05, not statistically significant.

[0046] It shows that the outpatient and inpatient cases in the two groups are comparable.

[0047] 2. Gender composition: see Table 2

[0048] Table 2: Comparison of gender composition of patients in two groups

[0049]

[0050] After statistical processing, X2=0.833, P>0.05, not statistically significant. The male and female distribution in the two groups is comparable.

[0051] 3. Age distribution: see Table 3

[0052] Table 3: Comparison of age distribution and average age of patients in two groups (years)

[0053]

[0054] After statistical processing, t=0.561, P>0.05, not statistically significant.

[0055] The age distribution in the two groups is comparable.

[0056] 4. Disease duration: see Table 4

[0057] Table 4: Comparison of disease duration of patients in two groups (months)

[0058]

[0059] After statistical processing, t=0.4712, P>0.05, not statistically significant.

[0060] The disease duration distribution in the two groups is comparable.

[0061] 5. Syndrome distribution: see Table 5

[0062] Table 5: Comparison of syndrome distribution in two groups

[0063]

[0064] Statistical processing, X2=1.573, P>0.05, no statistical significance. The distribution of the two groups is comparable.

[0065] The clinical classification of cervical spondylosis is mainly based on the classification of modern medicine, including cervical type, nerve root type, spinal cord type, vertebral artery type, sympathetic nerve type, and mixed type (commonly nerve root type combined with other types).

[0066] The TCM classification of cervical spondylosis is mainly wind-cold-dampness type, qi stagnation and blood stasis type, phlegm-dampness blocking collaterals type, liver and kidney deficiency type, and qi and blood deficiency type. Among them, the phlegm-dampness blocking collaterals type is characterized by dizziness, headache, nausea and vomiting, numbness of limbs, poor appetite, and thick and greasy tongue coating. The pathogenesis is that the spleen is weak in transportation, and the "phlegm" and "stasis" are intertwined, blocking the collaterals. The liver and kidney deficiency type is characterized by dizziness, tinnitus, deafness, headache, soreness of waist and knees, and atrophy of limbs. The pathogenesis is that the liver blood is deficient, and the kidney essence is insufficient, which cannot nourish the tendons and bones and clear the orifices.

[0067] "Liver and kidney deficiency combined with phlegm-dampness blocking collaterals" belongs to the complex type, which corresponds to the symptoms of dizziness, headache (vertebral artery type), upper limb numbness (nerve root type), and their combination in western medicine classification.

[0068] 6. Disease severity analysis: see Table 6

[0069] Table 6: Comparison of disease severity between the two groups

[0070]

[0071] Statistical processing, u=1.27, P>0.05, no statistical significance.

[0072] The disease severity of the two groups is comparable.

[0073] II. Case selection

[0074] 1. Diagnostic criteria

[0075] Refer to the relevant diagnostic content of "Chinese Orthopedics and Traumatology" edited by Jan Hongsheng and Leng Xiangyang in April 2015 as the diagnostic classification standard of this disease.

[0076] (1) Symptoms: such as headache, dizziness, neck pain, shoulder and arm pain, scapular pain, arm numbness, nausea and vomiting, etc. The main symptoms meet the clinical manifestations of cervical spondylosis, and the symptoms of neck strain and cold are aggravated. Except for other diseases. The syndrome types are: whiplash type (or cervical type); arthromyodynia type (or nerve root type); flaccid syndrome type (or spinal cord type); dizziness and syncope type (or vertebral artery type); five types (or sympathetic nerve type) and mixed type.

[0077] (2) Signs: There is neck stiffness, limited activity. There is one or more pressure points in the transverse process of the cervical spine, or spinous process, or posterior muscle group of the neck, or the upper angle of the scapula, or there are cord-like indurations on both sides of the spinous process. The brachial plexus traction test is positive, the intervertebral foramen compression test is positive, the vertebral artery tortuosity test is positive, and the lateral bending test is positive.

[0078] (3) X-ray film:

[0079] There is a change in the physiological curvature of the cervical spine, vertebral body hyperplasia, lateral and oblique position, and the structure of the intervertebral joint is disordered. Or there is a significant narrowing of the intervertebral space, or there is a change in the intervertebral foramen (such as intervertebral foramen narrowing, facet joint hyperplasia, hook bone spur, vertebral body anterior and posterior displacement), or spinous process deviation and nuchal ligament calcification.

[0080] Spinal cord type: CT confirms that the cervical disc is protruding and pressing the spinal cord.

[0081] 2. Inclusion criteria

[0082] Any patient who meets the following diagnostic criteria for cervical spondylosis of nerve root type, vertebral artery type and mixed type, aged 18-65 years old, as the inclusion criteria. "Liver and kidney deficiency combined with phlegm blocking the collaterals" belongs to the complex syndrome type, which is often manifested as dizziness, headache (vertebral artery type), upper limb numbness (nerve root type) and mixed cases in western medicine classification.

[0083] Cervical spondylosis of nerve root type:

[0084] Patients with head and neck, shoulder and arm pain, upper limb and finger numbness, their pain can be dull, sore, burning or dull pain, and individual acute pain, restlessness. Head and neck movement or cough, sneezing, etc. can aggravate the symptoms, and there is obvious radiating pain and numbness.

[0085] Examination: Neck stiffness, limited activity, spinous process and shoulder pain, intervertebral foramen compression test and brachial plexus traction test positive, hand function decreased.

[0086] X-ray film shows: There is a change in the physiological curvature of the cervical spine, the intervertebral space is narrowed, the intervertebral foramen is smaller, the vertebral body forms bone spurs on the anterior and posterior edges, or the supraspinous ligament is calcified.

[0087] Cervical spondylosis of vertebral artery type:

[0088] The main symptoms of patients with this type are dizziness, which can be induced or aggravated by head and neck flexion, extension, rotation, or body position change. When it occurs, the head is heavy and the feet are light, and standing is unstable. It is also accompanied by headache, tinnitus, nausea, vomiting, blurred vision and syncope.

[0089] Signs: Neck discomfort, stiffness and pain, limited activity, flexion, lateral bending and arterial tortuosity test are positive.

[0090] X-ray film shows: intervertebral foramen shape change, push gap narrow, hook vertebra joint or intervertebral joint hyperosteogeny, or nuchal ligament calcification.

[0091] Mixed type of cervical spondylosis:

[0092] Patients with the above two types of symptoms and signs are classified as this type.

[0093] 3. Exclusion criteria

[0094] (1) Patients under the age of 18 and over the age of 65.

[0095] (2) Do not meet the inclusion criteria, do not take the drug as required.

[0096] Three, treatment method

[0097] 1. Grouping method: single blind control method, 60 cases in treatment group, 60 cases in control group.

[0098] 2. Drug method;

[0099] (1) Treatment group: oral administration of Jifushu granules, 1 bag (24.5g of crude drug) each time, 3 times a day, 1 hour after meal, without other drugs and treatment methods.

[0100] (2) Control group: oral administration of Jifukang granules, 2 bags each time (marketed, according to the instructions, 1-2 bags a day, according to the maximum dose), twice a day, 1 hour after meal, without other drugs and treatment methods.

[0101] 3. Observation time

[0102] The observation time of the two groups is 1 week, 1 course of treatment, 3 courses of continuous observation for 21 days. Those who have reached the clinical cure standard can stop taking medicine.

[0103] 4. Recording method:

[0104] The physician responsible for clinical observation is responsible for recording every 2 days in the first 1-9 days of treatment, and recording once every 3 days in the last 9-21 days. Detailed records of symptoms, signs, side effects and adverse reactions of drugs, and the contents required by the clinical observation table are filled in one by one.

[0105] 5. The degree of the above symptoms and signs is indicated by mild "+", moderate "++", severe "+++". The disappearance of symptoms and signs is indicated by "-".

[0106] Four, treatment effect

[0107] 1. Evaluation criteria

[0108] According to the course of treatment and efficacy evaluation criteria of Jingfushu Granule Clinical Verification Implementation Scheme. Its efficacy evaluation criteria are divided into four levels: clinical cure, significant effect, effective and ineffective.

[0109] Clinical cure: disappearance of main symptoms and positive signs, recovery of daily workers;

[0110] Significant effect: main symptoms improved significantly and most of the positive signs disappeared, and the workers could insist on working;

[0111] Effective: main symptoms improved and positive signs relieved;

[0112] Ineffective: no improvement in symptoms and signs.

[0113] 2 Treatment results

[0114] (1) Comparison of overall efficacy of the two groups: see Table 7

[0115] Table 7: Comparison of overall efficacy of the two groups

[0116]

[0117] After statistical processing, the overall efficacy u=3.828, the cure rate t=2.195, the significant efficiency t=2.856, the effective rate t=2.355, P<0.05, with statistical significance.

[0118] The efficacy of the treatment group is better than that of the control group.

[0119] (2) Comparison of efficacy of the two groups

[0120] a Comparison of efficacy of the two groups of nerve root type: see Table 8

[0121] Table 8: Comparison of efficacy of nerve root type

[0122]

[0123] After statistical processing, u=2.09, P<0.05, with statistical significance. The efficacy of the treatment group is better than that of the control group.

[0124] b Comparison of efficacy of the two groups of vertebral artery type: see Table 9

[0125] Table 9: Comparison of efficacy of vertebral artery type

[0126]

[0127] After statistical processing, u=2.24, P<0.05, with statistical significance. The efficacy of the treatment group is better than that of the control group.

[0128] c Comparison of efficacy of the two groups of mixed type: see Table 10

[0129] Table 10 Comparison of mixed type therapeutic effect

[0130]

[0131] After statistical processing, u = 2.41, P < 0.05, it is statistically significant. The therapeutic effect of the treatment group is better than that of the control group.

[0132] (3) Drug onset time analysis: see Table 11

[0133] Table 11 Comparison of drug onset time of two groups

[0134]

[0135] After statistical processing, t = 4.52, P < 0.05, it is statistically significant.

[0136] The average onset time of the treatment group is shorter than that of the control group.

[0137] V. Safety

[0138] Only 2 patients in the treatment group had mild stomach discomfort, which did not require special treatment and drug withdrawal, and disappeared later.

[0139] VII. Discussion

[0140] 1. The trial adopts a random single-blind prospective research method, and a total of 120 patients are observed, including 60 patients in the treatment group and 60 patients in the control group. The total effective rate of the treatment group is 96.67%, and the total cure and significant efficiency is 60%. The total effective rate of the control group is 85%, and the total cure and significant efficiency is 25%. After statistical processing, the total therapeutic effect of the two groups has significant difference (P < 0.05), and the therapeutic effect of the "Jingfushu Granules" is better than that of the control group.

[0141] 2. The "Jingfushu Granules" has the functions of relaxing tendons and activating collaterals, relieving pain, tonifying qi and blood, and tonifying kidney and strengthening bones. It has obvious effect on meridian obstruction caused by strain and rheumatism, and its curative effect on patients with cervical spondylosis accompanied by liver and kidney deficiency and qi and blood deficiency is particularly positive.

[0142] 3. Only 2 patients in the treatment group have mild stomach discomfort, which does not require special treatment and drug withdrawal, and can be relieved by themselves.

[0143] 4. The "Jingfushu Granules" is convenient and safe to use, and has no special contraindications.

[0144] VIII. Conclusion

[0145] According to the verification results of 60 cases of cervical spondylosis (nerve root type, vertebral artery type, mixed type) of the "Jingfushu Granules", the summary is as follows:

[0146] 1, "Jingfushu particles" curative effect is affirmative, total effective rate is 96.67%, total cure efficiency is 60%. After statistical processing, the total curative effect of two groups has significant difference (P<0.05). Therefore, the total curative effect of "Jingfushu particles" is better than that of "Jingfukang particles".

[0147] 2, "Jingfushu particles" curative effect is remarkable. The average onset time is shorter than that of "Jingfukang particles" (P≤0.05).

[0148] 3, "Jingfushu particles" is pure traditional Chinese medicine preparation, convenient to use, no toxic side effects, provides a wider selection range for clinical doctors.

Claims

1. A traditional Chinese medicine composition for treating cervical spondylosis of liver-kidney deficiency combined with phlegm-dampness blocking collaterals, characterized in that: It is prepared from the following raw medicinal materials in the following weight ratio: ​ Radix Astragali 14.4-21.6 parts, Radix Paeoniae Alba 14.4-21.6 parts, Caulis Lonicerae 14.4-21.6 parts, Radix Puerariae 14.4-21.6 parts, Ramulus Mori 14.4-21.6 parts, Fructus Lycii 7.2-10.8 parts, Gastrodia 7.2-10.8 parts, Rhizoma Chuanxiong 7.2-10.8 parts, Radix Aristolochiae 7.2-10.8 parts, Rhizoma Alismatis 7.2-10.8 parts, Rhizoma Atractylodis Macrocephalae 7.2-10.8 parts, Radix Notoginseng 2.4-3.6 parts.

2. The traditional Chinese medicine composition for treating cervical spondylosis of liver-kidney deficiency and phlegm-dampness blocking collaterals type according to claim 1, characterized in that: It is prepared from the following raw medicinal materials in the following weight ratio: Radix Astragali 18 parts, Radix Paeoniae Alba 18 parts, Caulis Lonicerae 18 parts, Radix Puerariae 18 parts, Ramulus Mori 18 parts, Fructus Lycii 9 parts, Gastrodia 9 parts, Rhizoma Chuanxiong 9 parts, Radix Aristolochiae 9 parts, Rhizoma Alismatis 9 parts, Rhizoma Atractylodis Macrocephalae 9 parts, Radix Notoginseng 3 parts.

3. The traditional Chinese medicine composition for treating cervical spondylosis of liver-kidney deficiency and phlegm-dampness blocking collaterals type according to claim 1 or 2, characterized in that: It is prepared from the raw medicinal material in the form of crude powder, water or organic solvent extract as active ingredient, and pharmaceutically acceptable adjuvants.

4. The traditional Chinese medicine composition for treating cervical spondylosis of liver-kidney deficiency and phlegm-dampness blocking collaterals type according to claim 3, characterized in that: The preparation is tablet, capsule, granule, pill, oral liquid.

5. A method for preparing the Chinese medicinal composition for treating cervical spondylosis of liver-kidney deficiency and phlegm-dampness blocking collaterals according to any one of claims 1-4, characterized in that: It comprises the following steps: a. weighing each raw medicinal material in the following weight ratio; b. powdering, or extracting with water or organic solvent, concentrating the extract, and adding pharmaceutically acceptable adjuvants to prepare a commonly used pharmaceutical preparation.

6. Use of the traditional Chinese medicine composition of any one of claims 1-4 in the preparation of a medicament for treating cervical spondylosis of liver-kidney deficiency and phlegm-dampness blocking the collaterals type.

7. Use according to claim 6, characterized in that: The cervical spondylosis is nerve root type cervical spondylosis, vertebral artery type cervical spondylosis, and mixed type cervical spondylosis.

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