CN108578603B - Traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on shaoyang bone governing theory and application thereof - Google Patents
Traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on shaoyang bone governing theory and application thereof Download PDFInfo
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8994—Coix (Job's tears)
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- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/233—Bupleurum
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/285—Aucklandia
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
The invention discloses a traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on a shaoyang bone governing theory, which comprises the following components in parts by weight: 15-20 parts of vinegar-processed radix bupleuri, 10-12 parts of fried radix scutellariae, 10-12 parts of fried white peony root, 10-12 parts of radix codonopsis, 5-10 parts of radix cyathulae, 5-10 parts of salted eucommia ulmoides, 10-12 parts of fried semen coicis, 10-12 parts of white poria, 5-10 parts of costus root, 5-10 parts of ligusticum wallichii and 10-12 parts of honey-fried licorice root. The traditional Chinese medicine compound for treating kidney deficiency and marrow deficiency type knee osteoarthritis follows the formula principle of 'monarch, minister, assistant and guide' in the traditional Chinese medicine under the theory of 'shaoyang leading bones', and each medicine component has the synergistic effect and has the effects of harmonizing shaoyang, harmonizing qi and blood, and relieving swelling and pain; the traditional Chinese medicine has the advantages of obvious curative effect, no toxic or side effect, convenient use and low price.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese pharmacology, and relates to a traditional Chinese medicine compound taking Chinese herbal medicines as raw materials, in particular to a traditional Chinese medicine compound for treating kidney deficiency and marrow deficiency type knee osteoarthritis based on the theory of 'shaoyang governing bones' and application thereof.
Background
Knee osteoarthritis is a degenerative osteoarticular disease, a common and frequent arthropathy in the elderly, and is characterized typically by articular cartilage destruction, subchondral bone sclerosis, osteophyte formation, and the like. According to statistics, about 3% of people in China have osteoarthritis, knee osteoarthritis accounts for most of the proportion, and the long-term disability rate of osteoarthritis patients over 50 years old is second to cardiovascular diseases, which is named as the second. With the increasing aging of the population in China, the harmfulness of knee osteoarthritis is gradually increased. At present, western medicine treatment is mainly divided into knee joint replacement and conservative treatment, the surgical treatment has the problems of high cost, high pain, secondary revision and the like, and the conservative treatment represented by oral non-steroidal anti-inflammatory drugs and hyaluronic acid knee injection also has the defects of a plurality of gastrointestinal adverse reactions and easy complicated infection. Compared with the limitations of western medicine treatment, the traditional Chinese medicine has a long history of treating knee osteoarthritis, is rich in experience, and has natural advantages of obvious curative effect, good safety and the like. Knee osteoarthritis belongs to the category of bone rheumatism in traditional Chinese medicine, most modern doctors consider that the bone rheumatism disease mechanism is mainly based on liver and kidney deficiency and qi and blood disorder, and is marked by external pathogenic factors such as wind, cold and dampness, but the disease mechanism is usually treated by prescriptions of tonifying liver and kidney, dispelling wind and removing rheumatism and the like only by taking the theory of kidney governing bones as guidance, and the disease is lack of overall understanding.
Knee osteoarthritis (bone rheumatism) is classified into kidney and marrow deficiency type, yang deficiency and congealing cold type and blood stasis type in traditional Chinese medicine, and the most common type is the kidney and marrow deficiency type clinically because most patients are old people. The Maryong professor of Nanjing university of traditional Chinese medicine serves as a fifth generation of inheritance of Shi's traumatology, and the teacher studys professor of the Chinese medicine, namely the Shang Dynasty, applies the professor of the Chinese wolfberry from famous families of the Chinese medicinal and orthopedic department in China, and through years of clinical practice, on the basis of the clinical experience of the aged, the theory that the Shaoyang governing bones are adopted to be compared with the theory that the kidney governs bones is found to have limitation, and the innovative proposal is made for treating the kidney deficiency and marrow deficiency type knee osteoarthritis from the aspect of ' use degree '. When treating kidney-deficiency and marrow-deficiency type knee osteoarthritis, the kidney-tonifying medicine is used only, the disease mechanism is summarized from the angle of 'degree of use', the disease mechanism is further summarized into 'the lack of shaoyang pivot mechanism, the loss of nourishment of qi, blood, muscles and bones', and a shaoyang knee arthralgia prescription for treating the major disease by harmonizing shaoyang, regulating qi and blood, and relieving swelling and pain is created, and the good effect can be achieved in clinical application.
Disclosure of Invention
The technical problem to be solved is as follows: in order to overcome the defects of the prior art, solve the defects existing in the treatment by only using the prescription of tonifying liver and kidney, dispelling wind and removing arthralgia and the like, and obtain the traditional Chinese medicine composition which has the effects of harmonizing shaoyang, harmonizing qi and blood, reducing swelling and relieving pain and the like, is safe and has no side effect.
The technical scheme is as follows: the traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on the theory of 'shaoyang governing bones', comprises the following components in parts by weight: 15-20 parts of vinegar-processed radix bupleuri, 10-12 parts of fried radix scutellariae, 10-12 parts of fried white peony root, 10-12 parts of radix codonopsis, 5-10 parts of radix cyathulae, 5-10 parts of salted eucommia ulmoides, 10-12 parts of fried semen coicis, 10-12 parts of white poria, 5-10 parts of costus root, 5-10 parts of ligusticum wallichii and 10-12 parts of honey-fried licorice root.
Preferably, the vinegar processed radix bupleuri and the fried radix scutellariae are monarch drugs; the fried white paeony root, the codonopsis pilosula in the root of Lu, the medicinal cyathula root and the salted eucommia bark are used as ministerial drugs; parched Coicis semen, Poria, radix aucklandiae, rhizoma Ligustici Chuanxiong, and radix Glycyrrhizae Preparata as adjuvant and guiding drugs.
Preferably, the Chinese herbal compound preparation is decoction, granules or capsules.
The application of any one of the traditional Chinese medicine compounds in preparing the medicine for treating kidney deficiency and marrow depletion type knee osteoarthritis.
The invention relates to a traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on the theory of 'shaoyang governing bones', which comprises the following components in part by weight:
bupleurum root, radix bupleuri, being bitter, pungent and slightly cold in nature, enters liver and gallbladder meridians. Relieving exterior syndrome, relieving fever, dispersing stagnated liver qi, relieving qi stagnation, and lifting yang qi. Can be used for treating fever due to exogenous pathogens, alternating chills and fever, malaria, hypochondriac pain and distention, headache, blurred vision, menoxenia, prolapse of anus, uterine prolapse, and gastroptosis due to qi deficiency sinking. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, Chinese medicine university, page 2572).
Baikal skullcap root, with bitter and cold properties, enters lung, heart, liver, gallbladder and large intestine meridians. Clear heat and purge fire, dry dampness and remove toxicity, stop bleeding and prevent abortion. Can be used for treating cough due to lung heat, fever, coma, headache due to liver fire, conjunctival congestion, swelling and pain, jaundice due to damp-heat pathogen, dysentery, stranguria due to heat pathogen, hematemesis, metrorrhagia, metrostaxis, threatened abortion, carbuncle, swelling, and furuncle. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing university of traditional Chinese medicine, university of China, page 2808).
Bai Shao is bitter, sour and slightly cold in property, and enters liver and spleen meridians. To invigorate the spleen and tonify the lung, replenish qi and promote the production of body fluid. Can be used for treating spleen and stomach weakness, anorexia, loose stool, extremity debilitation, lung deficiency, cough and asthma, short breath, spontaneous perspiration, and deficiency of both qi and blood. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, Chinese medicine university, page 706).
Dang Shen is sweet and neutral in nature and enters lung and spleen meridians. Pacify liver and alleviate pain, nourish blood and regulate menstruation, astringe yin and check sweating. Can be used for treating headache, vertigo, hypochondriac pain, abdominal pain, limb spasm and pain, blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, and night sweat. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, Chinese medicine university, page 2579).
Niu xi, with bitter, sour and neutral properties, enters liver and kidney meridians. Tonify liver and kidney, strengthen tendons and bones, activate blood and dredge channels, induce fire to descend, induce diuresis and treat stranguria. Can be used for treating soreness of waist and knees, flaccidity and weakness of lower limbs, amenorrhea due to blood stagnation, dysmenorrhea, puerperal blood stasis and abdominal pain, abdominal mass, retention of exocytosis, heat stranguria, stranguria with blood, traumatic injury, carbuncle, swelling, sore, and sore throat. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, university of traditional Chinese medicine, second edition, page 570).
Eucommia bark, cortex Eucommiae, sweet, slightly pungent and warm in nature, enters liver and kidney meridians. Tonify liver and kidney, strengthen tendons and bones, prevent abortion. Can be used for treating soreness of waist and knees, sexual impotence, frequent micturition, dribbling urination, rheumatalgia, threatened abortion, and habitual abortion. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, university of traditional Chinese medicine, page 1514).
Coix seed, sweet, bland and slightly cold in property, enters spleen, stomach and lung meridians. Promoting diuresis, invigorating spleen, relaxing muscles and tendons, relieving arthralgia, clearing away heat, and expelling pus. Can be used for treating edema, loempe, dribbling urination, damp-heat disease, diarrhea, leukorrhagia, rheumatalgia, spasm of tendons and vessels, pulmonary abscess, intestinal abscess, and verruca plana. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, Chinese medicine university, page 3725).
Poria, sweet, bland and neutral in nature, enters heart, spleen, lung and kidney meridians. Induce diuresis and drain dampness, invigorate spleen and stomach, calm heart and induce tranquilization. Can be used for treating dysuria, edema, abdominal distention, phlegm and fluid, cough, emesis, spleen deficiency, anorexia, diarrhea, palpitation, insomnia, amnesia, nocturnal emission, and whitish and turbid urine. (second edition of Shanghai science and technology Press, Nanjing university of traditional Chinese medicine, Chinese medicine dictionary, pp 2154).
Mu Xiang is pungent, bitter and warm in property, and enters spleen, stomach, liver and lung meridians. Move qi and alleviate pain, regulate middle energizer and remove food stagnation. Can be used for treating fullness in chest and hypochondrium, abdominal pain, emesis, diarrhea, and dysentery with tenesmus. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, Chinese medicine university, page 480) is included in the dictionary.
Chuan Xiong is pungent and warm in property, and enters liver, gallbladder and pericardium meridian. Promoting blood circulation, dispelling blood stasis, promoting qi circulation, relieving depression, dispelling pathogenic wind, and relieving pain. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, puerperal abdominal pain due to blood stasis, abdominal mass, pain in chest and hypochondrium, headache, vertigo, arthralgia due to wind-cold-dampness, traumatic injury, carbuncle, cellulitis, and pyocutaneous disease. (second edition of Shanghai science and technology Press, Shanghai university of traditional Chinese medicine, Nanjing, Chinese medicine university, page 292).
Licorice root, radix Glycyrrhizae, sweet and neutral, enters spleen, stomach, heart and lung meridians. Harmonize the middle energizer and relieve urgency, moisten lung, read and harmonize the recipe. It is used to treat weakness of spleen and stomach, lassitude, poor appetite, abdominal pain, loose stool, spasm and pain of limbs, palpitation, irritability, consumptive lung disease and cough. (second edition of Shanghai science and technology Press, second edition of Nanjing university of traditional Chinese medicine, page 792 in Chinese medicine dictionary).
Has the advantages that: (1) the traditional Chinese medicine compound for treating kidney deficiency and marrow deficiency type knee osteoarthritis follows the formula principle of 'monarch, minister, assistant and guide' in the traditional Chinese medicine under the theory of 'shaoyang leading bones', and each medicine component has the synergistic effect and has the effects of harmonizing shaoyang, harmonizing qi and blood, and relieving swelling and pain; (2) the traditional Chinese medicine contains saponin, protein, glucose, volatile oil, fructose, organic acid, lecithin, vitamins, amino acids, phytosterol and various trace elements, is beneficial to absorption of a human body, and improves the physique; (3) the traditional Chinese medicine has the advantages of obvious curative effect, no toxic or side effect, convenient use and low price.
Detailed Description
The following examples further illustrate the present invention but are not to be construed as limiting the invention. Modifications and substitutions to methods, procedures, or conditions of the invention may be made without departing from the spirit and substance of the invention. Unless otherwise specified, the technical means used in the examples are conventional means well known to those skilled in the art.
Example 1
The traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on the theory of 'shaoyang governing bones', comprises the following components in parts by weight: 20 parts of vinegar radix bupleuri, 12 parts of fried radix scutellariae, 12 parts of fried white peony root, 10 parts of radix codonopsis, 9 parts of radix cyathulae, 9 parts of salted eucommia bark, 10 parts of fried semen coicis, 12 parts of white poria, 10 parts of costus root, 10 parts of ligusticum wallichii and 10 parts of honey-fried licorice root.
The radix bupleuri and the radix scutellariae are monarch drugs; radix Paeoniae alba, radix Codonopsis, Achyranthis radix, and Eucommiae cortex as ministerial drugs; coix seed, tuckahoe, costus root, Szechuan lovage rhizome and honey-fried licorice root are assistant and guiding drugs.
The Chinese herbal compound preparation is decoction.
The decoction is prepared by the following method: cleaning the raw materials, removing impurities, air drying, pulverizing into granules, soaking in water, boiling with strong fire, and decocting with slow fire for 40 min for 2 times per dose.
Example 2
The traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on the theory of 'shaoyang governing bones', comprises the following components in parts by weight: 15 parts of vinegar radix bupleuri, 12 parts of fried radix scutellariae, 12 parts of fried white peony root, 10 parts of radix codonopsis, 9 parts of radix cyathulae, 9 parts of salted eucommia bark, 10 parts of fried semen coicis, 12 parts of white poria, 10 parts of costus root, 10 parts of ligusticum wallichii and 10 parts of honey-fried licorice root.
The vinegar radix bupleuri and the fried radix scutellariae are monarch drugs; the fried white paeony root, the codonopsis pilosula in the root of Lu, the medicinal cyathula root and the salted eucommia bark are used as ministerial drugs; parched Coicis semen, Poria, radix aucklandiae, rhizoma Ligustici Chuanxiong, and radix Glycyrrhizae Preparata as adjuvant and guiding drugs.
The Chinese herbal compound preparation is granules.
The granules are prepared by the following method: decocting with 6 times of clear water for 40 min for 2 times, mixing water extractive solutions, concentrating at 60 deg.C under reduced pressure to obtain extract, adding appropriate amount of sugar powder and stabilizer, sieving with 40 mesh sieve to obtain granule, and packaging.
Example 3
The traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on the theory of 'shaoyang governing bones', comprises the following components in parts by weight: 20 parts of vinegar radix bupleuri, 12 parts of fried radix scutellariae, 12 parts of fried white peony root, 10 parts of radix codonopsis, 9 parts of radix cyathulae, 9 parts of salted eucommia bark, 10 parts of fried semen coicis, 12 parts of white poria, 10 parts of costus root, 10 parts of ligusticum wallichii and 10 parts of honey-fried licorice root.
The vinegar radix bupleuri and the fried radix scutellariae are monarch drugs; the fried white paeony root, the codonopsis pilosula in the root of Lu, the medicinal cyathula root and the salted eucommia bark are used as ministerial drugs; parched Coicis semen, Poria, radix aucklandiae, rhizoma Ligustici Chuanxiong, and radix Glycyrrhizae Preparata as adjuvant and guiding drugs.
The Chinese herbal compound preparation is a capsule.
The capsule is prepared by the following method: decocting the raw materials in 8 times of clear water for 30min for 2 times, mixing water extractive solutions, concentrating under reduced pressure at 60 deg.C to obtain compound Chinese medicinal extract, pulverizing, sieving with 60 mesh sieve, and making into capsule.
Example 4 clinical Observation study for treating deficiency of the kidney and marrow type Knee osteoarthritis
1 case selection
1.1 sources of cases
Knee osteoarthritis patients are treated at orthopedics clinic of an affiliated hospital of Nanjing Chinese medicine university from 5 months to 12 months in 2017.
1.2 Chinese medicine diagnostic Standard
The diagnosis standard of kidney deficiency and marrow deficiency type knee osteoarthritis (bone bi-syndrome) is formulated by referring to the Chinese medicine industry standard of the people's republic of China, namely Chinese medicine diagnosis and treatment effect standard (1994 edition), as follows:
(1) at the beginning, the knee joint is hidden and painful, the flexion and extension are not good, the slight movement is slightly relieved, the climatic change is aggravated, the patient is not healed after repeatedly winding, and the waist and the knees are limp. Accompanied by dizziness, tinnitus, deafness, blurred vision. A pale-red tongue with thin and white coating and a thready pulse.
(2) The disease is insidious and slow, and is often seen in the middle-aged and the elderly.
(3) The knee joint may be slightly swollen, and there is often a clicking or rubbing sound of the joint during movement. Muscular atrophy and joint deformity can be seen in severe cases.
(4) X-ray inspection: osteoporosis, irregular articular surfaces, narrowing of the articular space, subchondral bone sclerosis, as well as changes in the limbic lip and osteophyte formation.
1.3 Western diagnostic standards
The Western diagnostic standard refers to osteoarthritis diagnosis and treatment guidelines (2007 edition) formulated by the bone science division of the Chinese medical society. Firstly, knee joint pain is repeated in nearly 1 month; the X-ray film shows that the joint clearance is narrowed, subchondral bone sclerosis and/or bursa change are/is caused, and joint edge osteophyte is formed; thirdly, the joint fluid is transparent and viscous, and the number of leucocytes is checked to be less than 2000/mL; fourthly, the age is more than or equal to 40 years old; fifthly, morning stiffness time is less than or equal to 30 min; sixthly, bone rubbing sound is felt when the patient moves. The diagnosis can be carried out by the fifth step or the fifth step.
1.4X-ray grading Standard
Referring to osteoarthritis Kellgren-Lawrance grading standard in 'Standard of curative Effect for diagnosis of disease in traditional Chinese medicine', grade 0: normal; stage I: mild osteophytes; and II, stage: obvious osteophytes, suspicious narrowing of the joint space; grade III: the joint space becomes narrower, and subchondral bone is hardened; IV stage: massive osteophytes, marked narrowing of the joint space, severe subchondral bone sclerosis and marked deformity.
1.5 inclusion criteria
(1) The traditional Chinese medicine diagnosis standard of knee osteoarthritis is met;
(2) the knee osteoarthritis western medicine diagnosis standard is met;
(3) the nature is not limited, and the age is 40-80 years old;
(4) the patient, if already receiving other surgical treatment, will go through an elution period of 7 days;
(5) the protocol was fully known and informed consent was signed.
All the above five items can be combined.
1.6 exclusion criteria
(1) Acute synovitis, infection, tuberculosis, rheumatic arthritis, rheumatoid arthritis, etc. of knee joint;
(2) patients who have had a history of peptic ulcer and who have undergone a gastrointestinal operation;
(3) serious internal basic diseases of heart, brain, liver, kidney, respiratory system and the like, serious mental disorder, hereditary diseases, serious systemic diseases of tumor and the like are combined;
(4) analgesic such as non-steroidal anti-inflammatory drugs and opioids is orally taken in nearly 1 month, the patient is treated by systemic or intra-articular hormone, and the patient is subjected to intra-articular injection or arthroscopy in 3 months;
(5) those with allergic constitution;
(6) patients who are participating in other drug clinical trials;
(7) poor compliance, difficulty in visiting follow-up patients on time;
(8) a woman who is nursing, pregnant, or is ready for pregnancy.
One of the above is excluded.
1.7 criteria for shedding
The compliance of the testee is poor, and the testee cannot participate in the therapist according to the amount on time.
② serious adverse reaction and complication occur, and people should not be retested.
And thirdly, the lost visitors due to other various reasons.
The subjects satisfied any of the above, and were exfoliative cases.
1.8 rejection Standard
Subjects who met the inclusion criteria but were somehow not assigned randomly by the investigator.
② repeated subjects are grouped.
And thirdly, the testee is unwilling to continue the clinical test for various reasons, fails to complete the treatment course and is actively withdrawn.
Fourthly, the subject uses the Chinese and western medicines or the treatment method which are not in the range specified by the study in the treatment course.
Fifthly, the patients who are not prescribed and cannot judge the curative effect or the data are incomplete and the like and influence the curative effect and the safety judgment.
Subjects satisfied any of the above, and the study was rejected.
1.9 case exit procedure
The researchers fill out the case exit table including the patient number, name, age, group, reason for exit, etc.
Determining the reason and avoiding measures for case exit and filling in the case exit list.
Subjects who meet any of the above criteria may be withdrawn from the study.
2 random grouping and masking
The 28 subjects of the subject are from orthopedic department outpatients of the affiliated hospital of Nanjing Chinese medicine university, after the basic data of the subject is collected and signed with an informed consent, researchers use numbering software to number each patient, a random number table is adopted to be distributed to an observation group and a comparison group according to the subject number, grouping information is stored in a notebook computer in an encrypted EXCEL form, the form is not opened from the time of storing the grouping information to the time of completing the test, the first half part of an opening password is set by a subject third responsible person, the second half part of the opening password is set by a sixth responsible person, after the test is finished, the two responsible persons combine the passwords to open the EXCEL, the work of randomly grouping and shielding the grouping information is completed by the two researchers together, and the two researchers do not participate in the collection of the patient information and the data analysis after the test is finished. Because the intervention of this trial was not of the same natural form, we were unable to achieve double blindness between the clinician and the patient, and so selected for single blindness, i.e., all researchers responsible for data statistics and assessment were not involved and were unaware of patient inclusion and grouping.
3 methods of treatment
Control group: the meloxicam tablets (Hongqiang) (Yangziang pharmaceutical industry group limited company, national standard H20010207) are prepared with specification of 7.5mg × 10 tablets/box. The use method comprises the following steps: it is administered orally 1 tablet at a time, 1 time daily, after meal. 4 weeks is a treatment course, and 2 treatment courses are continuously taken. The main component of the product is meloxicam, and is suitable for treating symptoms of rheumatoid arthritis and painful osteoarthritis (arthropathy and degenerative osteoarthropathy).
Treatment groups: the prescription for treating the lesser yang knee arthralgia comprises the following medicaments: 15g of vinegar-processed radix bupleuri, 12g of fried radix scutellariae, 10g of fried white peony root, 10g of radix codonopsis pilosulae, 9g of medicinal cyathula root, 9g of salted eucommia bark, 10g of fried semen coicis, 10g of white poria, 6g of costus root, 9g of rhizoma ligustici wallichii and 10g of honey-fried licorice root, which can be modified according to the symptoms. The traditional Chinese medicine is produced by the department of traditional Chinese medicine preparation of subsidiary hospitals of Nanjing university of traditional Chinese medicine according to the standard flow of the pharmaceutical preparation. Decocting the above materials with 500ml water twice, collecting 300ml juice, 1 dose per day, and administering separately in the morning and evening for 8 weeks.
4 observation index
(1) General item
Including name, gender, age, height, weight, medical history, etc.
(2) Index of effectiveness observation
(ii) West Tachy lake and McMaster Osteoarthritis score (The Western Ontario and McMasteruniversity Osteoarthritis Index, WOMAC)
This scoring scale assesses knee joint structure and function in terms of pain, stiffness, and joint function, for a total of 24 items, including the basic symptoms and signs of osteoarthritis as a whole. There are 5 items for the painful part, 2 items for the stiff part, and 17 items for the joint functional part. The score may be recorded using the vas (visual analogue) scale. The details are shown in quantitative evaluation standards of symptoms and signs in an annex case observation table.
② short form of health survey (the MOS item short from health survey, SF-36)
The scale evaluates 8 aspects of Health-related quality of life, which fall into two broad categories, physiological and Mental Health, namely physiological Function (Physical Function), physiological Function (Role Physical), somatic pain (bodiypain), General Health (General Health), Vitality (Vitality), Social Function (Social Function), Emotional Function (Role), Mental Health (Mental Health). The scores of the patients in each option are evaluated one by one, and finally score recording is carried out.
(3) Security observation
The indexes of the patients such as blood, urine, feces routine, liver and kidney functions and the like are monitored. The time and degree of any adverse reactions and adverse events after administration, including systemic reactions and digestive tract reactions, were recorded, whether the administration was stopped or not, and the treatment measures were taken.
(4) Observation time point
The above indices were observed and recorded before and 8 weeks after treatment, respectively.
5 statistical methods
Data are input and analyzed by SPSS 19.0 statistical software, and missing data of a part related to the curative effect are supplemented by a method of data transmission of last observation before. The measurement data is expressed by +/-s, the measurement data which accords with normal distribution and has uniform variance adopts t test, the measurement data which has nonuniform variance adopts t' test, and the measurement data which does not accord with normal distribution adopts nonparametric test. The data of the counting is as follows2And (4) testing, wherein Ridit analysis or rank sum test is adopted for the grade data. The test standard α is 0.05.
6 therapeutic results
6.1 WOMAC score
Comparison between groups: the difference of WOMAC scores of the two groups before treatment is not statistically significant (P is more than 0.05), the stiffness score, the joint function score and the total score of the treatment group are all significantly lower than those of a control group (P is less than 0.05), and the difference of pain scores of the two groups is relatively insignificant (P is more than 0.05); comparison in group: both groups scored significantly higher for WOMAC than their respective pre-treatment scores (P <0.05) 8 weeks post-treatment. See table 1.
6.2 SF-36 score
Comparison between groups: the difference in SF-36 scores between the two groups before treatment was not statistically significant (P > 0.05). The physiological function (P & ltSUB & gt 0.046), somatic pain (P & ltSUB & gt 0.036) and overall health (P & ltSUB & gt 0.020) scores in the treatment group were all significantly higher than those in the control group 8 weeks after treatment; differences between emotional function groups are close to statistical significance (P ═ 0.052); no statistical difference in physiological function, vitality, social function and mental health (P > 0.05); comparison in group: the SF-36 score after treatment was higher than before treatment for both groups, and the difference was statistically significant (P < 0.05). See Table 1
Table 1 comparison of treatment group (n-13) with control group (n-12) before and 8 weeks after treatment
Clinical observation results show that the traditional Chinese medicine compound guided by the theory of 'shaoyang governing bones' has obvious improvement effect on symptoms and physical signs of patients with kidney deficiency and marrow deficiency type knee osteoarthritis, has definite clinical curative effect, and prompts that the traditional Chinese medicine compound has a good regulation effect on relieving and improving the kidney deficiency and marrow deficiency type knee osteoarthritis, has no adverse reaction after long-term administration, and is worthy of being further developed into a new generation of medicine for treating the kidney deficiency and marrow deficiency type knee osteoarthritis.
Claims (3)
1. The traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on the theory of 'shaoyang governing bones' is characterized by comprising the following components in parts by weight: 15-20 parts of vinegar radix bupleuri, 10-12 parts of fried radix scutellariae, 10-12 parts of fried white peony root, 10-12 parts of radix codonopsis, 5-10 parts of radix cyathulae, 5-10 parts of salted eucommia ulmoides, 10-12 parts of fried semen coicis, 10-12 parts of white poria, 5-10 parts of costus root, 5-10 parts of ligusticum wallichii and 10-12 parts of honey-fried licorice root; the vinegar radix bupleuri and the fried radix scutellariae are monarch drugs; the fried white paeony root, the codonopsis pilosula in the root of Lu, the medicinal cyathula root and the salted eucommia bark are used as ministerial drugs; parched Coicis semen, Poria, radix aucklandiae, rhizoma Ligustici Chuanxiong, and radix Glycyrrhizae Preparata as adjuvant and guiding drugs.
2. The traditional Chinese medicine compound for treating kidney deficiency and marrow depletion type knee osteoarthritis based on the shaoyang bone governing theory as claimed in claim 1, wherein the dosage form of the traditional Chinese medicine compound is decoction, granules or capsules.
3. The application of the traditional Chinese medicine compound of any one of claims 1-2 in preparing a medicine for treating kidney deficiency and marrow depletion type knee osteoarthritis.
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| 施杞另辟蹊径论治膝骨关节炎—"少阳主骨"辨析;马勇等;《中国中医基础医学杂志》;20171130;第23卷(第11期);第1536-1538页 * |
| 论"少阳主骨"理论研究进展及其与胆源性骨病的关系;司誉豪等;《上海中医药杂志》;20161231;第50卷(第10期);第35-38页 * |
| 马勇辨治少阳失和型骨关节炎经验撷英;司誉豪等;《辽宁中医杂志》;20171231;第44卷(第5期);第926-928页，尤其是第926页正文及第927页左栏第1-2段、病案举例 * |
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