Summary of the invention
Present invention aims at the Chinese medicine compositions for disclosing a kind of replenishing kidney and strengthening bone to lead in preparation treatment arimedex
Application in the drug of the bone joint pain of cause.
Object of the present invention is to what is be achieved through the following technical solutions: the bulk pharmaceutical chemicals composition and parts by weight of the pharmaceutical composition
Are as follows: 150-250 parts of radix rehmanniae preparata, 100-200 parts of pulp of dogwood fruit, Semen Cuscutae 60-150g, 100-200 parts of radix cyathulae, 70-160 parts of rhizoma cyperi,
It is 70-150 parts of Radix Angelicae Sinensis, 100-200 parts of Poria cocos, 100-200 parts of Radix Paeoniae Alba, 60-150 parts of Rhizoma Chuanxiong, 100-200 parts of rhizoma corydalis, deep
It is 100-200 parts careless, 150-250 parts of caulis trachelospermi.
Chinese medicine composition of the present invention can be with are as follows:
180-220 parts of radix rehmanniae preparata, 120-180 parts of pulp of dogwood fruit, Semen Cuscutae 80-120g, 120-180 parts of radix cyathulae, rhizoma cyperi 80-
150 parts, 80-130 parts of Radix Angelicae Sinensis, 120-180 parts of Poria cocos, 120-180 parts of Radix Paeoniae Alba, 80-130 parts of Rhizoma Chuanxiong, 120-180 parts of rhizoma corydalis,
120-180 parts of lopseed, 160-220 parts of caulis trachelospermi.
Chinese medicine composition of the present invention is preferred are as follows:
The bulk pharmaceutical chemicals of the pharmaceutical composition are as follows: 200 parts of radix rehmanniae preparata, 150 parts of pulp of dogwood fruit, 100 parts of Semen Cuscutae, radix cyathulae 150
Part, 100 parts of rhizoma cyperi, 100 parts of Radix Angelicae Sinensis, 150 parts of Poria cocos, 150 parts of Radix Paeoniae Alba, 100 parts of Rhizoma Chuanxiong, 150 parts of rhizoma corydalis, lopseed 150
Part, 200 parts of caulis trachelospermi.
Chinese medicine composition of the present invention can also be preferred are as follows: and 190 parts of radix rehmanniae preparata, 170 parts of pulp of dogwood fruit, Semen Cuscutae 110g,
120 parts of radix cyathulae, 130 parts of rhizoma cyperi, 120 parts of Radix Angelicae Sinensis, 170 parts of Poria cocos, 130 parts of Radix Paeoniae Alba, 120 parts of Rhizoma Chuanxiong, 130 parts of rhizoma corydalis, thoroughly
160 parts, 190 parts of caulis trachelospermi of bone grass.
Chinese medicine composition of the present invention can also be preferred are as follows: and 180 parts of radix rehmanniae preparata, 120 parts of pulp of dogwood fruit, Semen Cuscutae 80g,
It is 180 parts of radix cyathulae, 140 parts of rhizoma cyperi, 90 parts of Radix Angelicae Sinensis, 130 parts of Poria cocos, 170 parts of Radix Paeoniae Alba, 90 parts of Rhizoma Chuanxiong, 170 parts of rhizoma corydalis, deep
130 parts, 170 parts of caulis trachelospermi of grass.
Various dosage forms are made using techniques known in the Chinese medicine composition, dosage form be capsule,
The pharmaceutically acceptable dosage form such as granula, tablet, pill, powder.
It is preferred that granule, capsule, pill or tablet.
The preparation method of the Chinese medicine composition, this method can be with are as follows: flavour of a drug add water to cook, and filter, and concentration adds auxiliary
Material is appropriate, mixes, dry, granulation to get.
The preparation method of the Chinese medicine composition, it is characterised in that this method is preferred are as follows: flavour of a drug add water to cook 2 times, the
60min, the 2nd 30min are filtered, and concentration adds right amount of auxiliary materials, mixes, dry, granulation to get.
The present invention is the prescription that inventor is had found by many years clinical practice, reinforces the kidney to strengthen the bone, adjusts liver dredging collateral.Our radix rehmanniae preparata
Yellow enriching yin and nourishing kidney, life essence-filling, marrow-benefitting;Rhizoma cyperi soothing liver-qi stagnation, regulating the flow of QI to ease the stomach are altogether monarch drug in a prescription.Fructus Corni, Semen Cuscutae, radix cyathulae tonifying liver
The benefits of kidney, strong waist and knee, hard muscles and bones, three medicines and radix rehmanniae preparata compatibility play replenishing kidney, strengthening waist strong bone altogether;Radix Angelicae Sinensis is sweet bitter and warm, blood-nourishing and blood, white
Yin is held back in Chinese herbaceous peony blood-nourishing, soft liver emergency, is returned, Chinese herbaceous peony and rhizoma cyperi are with using, tonifying liver body and help liver to use, make blood and then to fill then liver soft for liver and, blood,
It is ministerial drug.Wood is strongly fragrant not up to spleen insufficiency is caused, and Gu Zuo is with Poria cocos strengthening the spleen and replenishing qi, and real soil is with imperial wood insult.Radix rehmanniae preparata, returning Chinese herbaceous peony etc., yin is soft
The product enriched blood are equipped with the Rhizoma Chuanxiong promoting flow of qi and blood circulation, and sound is suitable, mend without stagnant.Rhizoma corydalis work hard it is warm-natured enter Liver Channel, in promoting circulation of blood the stagnation of the circulation of vital energy with
Up to the function of promoting flow of qi and blood circulation analgesic.Lopseed, caulis trachelospermi return liver kidney channel, remove obstruction in channels to relieve pain, and are all adjutant.
Chinese medicine composition of the present invention has the function for the treatment of arimedex related bone joint symptoms, effect
Fruit is significant.Related bone joint symptoms refer to pain, osteoarthritis, hand rheumatoid arthritis.Chinese traditional medicine composition of the present invention
Object can reduce pain, improve arthralgia, stiff and function, improve hand joint pain, stiff and function.
Specific embodiment
Following experimental examples and embodiment are for further illustrating but being not limited to the present invention.
Experimental example 1: effect of the replenishing kidney and strengthening bone particle to breast cancer arimedex related bone joint symptoms
1, research method
1.1 researching and designings: multicenter, random, double blind, placebo controlled clinical research.
1.1.1 research center
All cases are in Beijing Chinese Medical Hospital, attached to Capital Medical Univ.'s oncology, Beijing Tumour Hospital's combination of Chinese tradiational and Western medicine
Section, China Academy of Sciences Guanganmen Hospital outpatient service and ward are completed.
1.1.2 random device
This research uses district's groups randomized.
1.1.3 blind designs
This research uses double-dummy design.
1.1.4 control setting
It is compareed between group between Chinese medicine group and control group;Treatment before with treatment after itself cross-reference.Placebo is by 95%
Dextrin and 5% wrinkled giant hyssop composition, to guarantee appearance, smell, the similarity degree of quality and taste.
1.2 research object
1.2.1 it is included in standard
(1) there is I-III primary breast cancer patient of clear pathological diagnosis, complete operation, chemicotherapy, confirm no tumour on inspection
Recurrence or transfer.
(2) Bones and joints symptom is occurred after taking third generation arimedex (Letrozole, Anastrozole, Exemestane)
(muscle skeletons such as arthralgia, myalgia, ostalgia, stiff joint symptoms), symptoms last 1 month, scale score >=3 point BPI-SF.
(3) Chinese medical discrimination meets kidney deficiency and liver, obstruction of the circulation of vital energy network resistance card (evaluation criterion is shown in annex).
(4) estimated life cycle is greater than 6 months.
(5) ECOG scoring is 0-2 points.
(6) informed consent form is signed in this research of voluntary participation.
1.3.2 exclusion criteria
(1) (such as hyperthyroidism, first subtract the chronic disease with endocrine system disease and influence bone metabolism, diabetes, Cushing are comprehensive
Sign, chronic liver disease, nephrosis, primary myeloma, bone tumour, Bone tumour etc.).
(2) taking except calcium remover within nearly 3 months influence bone metabolism drug (such as glucocorticoid, thyroid hormone,
Heparin, anticonvulsive drug, diuretics, bisphosphonates etc.) patient.
(3) there is Calcium and vitamin D to use contraindication person.
(4) specific primary osteoarthropathy patient is diagnosed.
(5) merge other organs primary tumo(u)r patient and intentionally, liver, the serious diseases such as kidney and hemopoietic system.
(6) gestation or history is mentally ill and patient that cognitive disorder can not be cooperated.
1.4 intervening measures:
1.4.1 basic medication regulation
It is all enter a group patient be both needed to take one of third generation arimedex and calcium carbonate D3 piece:
(1) Letrozole (Letrozol) trade name: furlong, 2.5mg/d is oral, Novartis Pharma AG;Or cottonrose hibiscus
Auspicious, 2.5mg/d is oral, Hengrui Medicine Co., Ltd., Jiangsu Prov..
(2) Anastrozole (Anastrozole) trade name: Arimidex, lmg/d is oral, AstraZeneca Co., Ltd.
(3) Exemestane (Exemestane) trade name: A Nuoxin, 25mg/d are oral, Pfizer Ltd..
(4) calcium carbonate D3 piece (Calclium Carbonate and Vitamin D3) trade name: Caltrate D tablet (calcium member
Plain 600mg+VitD3125IU/ piece): 2 tablet per days take orally, Wyeth pharmaceuticals.
1.4.2 Chinese medicine group
Replenishing kidney and strengthening bone particle (sample prepared by the method for using embodiment 1), each 1 time daily morning and evening, 1 bag (about every time
12g), warm boiled water.The course for the treatment of: 12 weeks.
1.4.3 control group
Placebo granulation, each 1 time daily morning and evening, every time 1 bag (about 12g), warm boiled water.The course for the treatment of: 12 weeks.
1.5 observations and index of assessment of curative effect
1.5.1 demographic data
1.5.2 tumour medical history
1.5.3 arimedex related bone joint symptoms
Patient's bone joint pain position, time of occurrence, severity, if there are morning stiffness, swelling, carpal tunnel syndrome and
Stuck-finger.
1.5.4 the regulation of time point is observed
1.5.5 index of assessment of curative effect
1.5.5.1 curative effect evaluation index
Brief Pain scale simplified version (Brief Pain Inventory-Short Form, BPI-SF): Brief Pain amount
Table (BPI) is developed by pain research group of neurology department of University of Wisconsin, is suitable for the Clinical Pain assessment of various people.?
It is deleted on the basis of this scale, obtains Brief Pain scale simplified version (BPI-SF), reliability and validity are by multinomial research
It is confirmed.BPI-SF is divided to for two main evaluation areas: pain degree (including the most slight journey of pain most severe degree, pain
Degree, the degree of pain average degree and current pain) and pain relative influence (including general activity, mood, walking ability, day
Often work, with his relationship, sleep and life interest).Scale problematic item mainly uses digit score method (NAS, 0-10 points) right
Patient pain's situation is assessed.Score is higher, and symptom is more serious.
1.5.5.2 secondary efficacy evaluation index
(1) western Ontario and Mike's Maas university Osteoarthritis Index (Western Ontario and McMaster
Universities Osteoarthritis Index, WOMAC Index): WOMAC index is taught by Nicholas Bellamy
It awards and its team designs, to assess the symptom and function of knee, hip joint.Scale shares 24 entries, is divided into three assessment necks
Domain: pain, stiff and function.It can need to select different appraisal procedures according to clinical or research: digit score method (NAS,
0-10), five point-score of visual analogue scales (VAS, 0-100mm) and Li Kete (5-point Likert, 1-5).
(2) hand rheumatoid arthritis assessment correction score (Modified Score for the Assessment and
Quantification of Chronic Rheumatoid Affections of the Hands, M-SACRAH): M-
SACRAH is the scale for assessing hand rheumatoid arthritis shape and function, is the simple version of SACRAH.The scale is divided into pain
Bitterly, stiff and three evaluation areas of function, share 12 problems, and each problem uses VAS methods of marking (0-100mm).
2. result of study
There is the patient with breast cancer of AIMSS to recruiting 146 altogether between in October, 2014 in August, 2013, by being included in, arranging
Screening and informed consent process except standard share 73 research objects and enter group.Wherein Chinese medicine group 38, control group 35.
Arthralgia is more universal (100%) in Bones and joints symptom, is secondly myalgia (48.05%), ostalgia is minimum
(27.27%), for 92.21% patient there are morning stiffness, there is stuck-finger in 27.27% patient, and only 9.09% patient suffers from
Carpal tunnel syndrome.Arthralgia predilection site is knee joint (90.91%), interphalangeal joint (72.73%) and metacarpophalangeal joints
(61.04%);Myalgia focuses mostly in thigh (40.54%), lumbosacral region (37.84%) and arm (35.14%);Ostalgia
Then it is more common in hipbone (57.14%);Severity is mostly light moderate.The rush hour that AIMSS occurs is to take 7.16 after AIs
A month.
2.2 each index of assessment of curative effect compare (PPS)
2.2.1 Brief Pain scale (BPI-SF)
Through two sample t-tests, pain most severe degree: when baseline, Chinese medicine group and control group scoring are 6.18 ± 1.61 Hes
5.97 ± 1.40 (P=0.550), after treatment 12 weeks, Chinese medicine group declines 3.05 points, and control group declines 1.60 points (P=0.002).
Pain degree: when baseline, Chinese medicine group and control group scoring are 4.55 ± 1.25 and 4.25 ± 1.03 (P=0.264), treatment 12
Zhou Hou, Chinese medicine group decline 2.43 points, and control group declines 1.19 points (P=0.007).Pain relative influence: when baseline, Chinese medicine group
With control group average out to 4.51 ± 2.23 and 4.29 ± 1.79 (P=0.655), after treatment 12 weeks, Chinese medicine group declines 2.65 points,
Control group declines 1.24 points (P=0.001).
Each field scoring baseline is comparable (P > 0.05).After treating 12 weeks, either pain degree or pain
In terms of correlation function, Chinese medicine group improves obvious (P < 0.05) compared with control group.After follow-up 12 weeks, two groups of differences equally have statistics
It learns meaning (P < 0.05) (table 1, Fig. 1-3).
(PPS) is compared in 1 two groups of BPI-SF scorings of table
2.2.2 western Ontario and Mike's Maas university Osteoarthritis Index (WOMAC Index)
Through two sample t-tests, pain field: when baseline, 146.66 ± 86.87 He of Chinese medicine group and control group average out to
163.26 ± 72.05 (P=0.380), after treatment 12 weeks, Chinese medicine group decline 83.55, control group declines 35.03 (P=
0.002).Stiff field: when baseline, Chinese medicine group and the (P=of control group average out to 72.05 ± 43.99 and 82.60 ± 35.07
0.264) after, treating 12 weeks, Chinese medicine group decline 38.29, control group declines 19.69 (P=0.003).Functional area: when baseline,
Chinese medicine group and control group average out to 527.08 ± 289.82 and 594.34 ± 254.80 (P=0.298), after treatment 12 weeks, Chinese medicine
Group decline 317.19, control group declines 146.88 (P=0.000) (table 2, Fig. 4-6).
Two groups of baseline scores are comparable (P > 0.05).After treating 12 weeks, Chinese medicine group and control group arthralgia,
There is improvement in terms of stiff and function, Chinese medicine group improves obviously compared with control group, and difference has statistical significance (P < 0.05).With
After visiting 12 weeks, two groups of differences equally have statistical significance (P < 0.05).
(PPS) is compared in 2 two groups of WOMAC scorings of table
2.2.3 hand rheumatoid arthritis assessment correction score (M-SACRAH)
Through two sample t-tests, pain field: when baseline, 68.61 ± 42.13 He of Chinese medicine group and control group average out to
64.91 ± 43.97 (P=0.715), after treatment 12 weeks, Chinese medicine group decline 45.58, control group declines 16.42 (P=0.003).
Stiff field: when baseline, Chinese medicine group and control group average out to 87.71 ± 39.69 and 91.03 ± 39.50 (P=0.722) are controlled
After treating 12 weeks, Chinese medicine group decline 47.95, control group decline 27.06 (P=0.009) functional areas: when baseline, Chinese medicine group and
Control group average out to 97.95 ± 89.14 and 122.97 ± 140.80 (P=0.373), after treatment 12 weeks, the decline of Chinese medicine group
76.95, control group declines 46.57 (P=0.006) (table 3, Fig. 7-9).
Equal no difference of science of statistics (P > 0.05), is comparable when each field scoring baseline.After treating 12 weeks, two groups
There is improvement in terms of hand joint pain, stiff and function, Chinese medicine group improves obvious (P < 0.05) compared with control group.Follow-up 12 weeks
Afterwards, the statistical difference (P < 0.05) equally between three fields observed two groups.
(PPS) is compared in 3 two groups of M-SACRAH scorings of table