Summary of the invention:
The objective of the invention is to: a kind of usefulness preparation that single herbal medicine is made is provided, its good effect, low price is to satisfy the needs of extensive patients.
The present invention is achieved in that it is the preparation made from Radix ceratostigmatis willemottiani list Herba indigoferae Pseudotinctoriae.
Described preparation is a tablet.
Its preparation method is: to produce 1000, get Radix ceratostigmatis willemottiani 300~800g, decoct with water secondary, each 2 hours, collect distillate, cold preservation is more than 48 hours, the collection crystallization is deposited standby in addition, and collecting decoction filters, it is 1.33 that filtrate is concentrated into relative density, puts the crystal that cold back adds above-mentioned collection, stirs evenly, add an amount of adjuvant, mixing, drying, be pressed into 1000, coating promptly.
Radix ceratostigmatis willemottiani is warm in nature, sweet in the mouth.Has promoting blood circulation and stopping pain, the effect of blood stasis dispersing and fresh blood promoting.
Advantages such as the present invention compared with prior art has the alleviating pain longer duration, and price is low, has no side effect, and technology is simple.Can treat diseases such as postoperative pain, traumatic pain.Concrete clinical summary is as follows:
One, research method
(1), case is selected
1. tcm diagnosis standard
Acute periankle injury: different forms of violence causes the damage of ankle muscle, comprise fascia, tendon,
Ligament, and tissue such as subcutaneous tissue, part muscle, arthritis.
Acute trauma history is arranged: ankle soft tissue swelling, pain, ecchymosis, dysfunction; The X ray examination does not have fracture.
2. differential diagnosis in tcm standard
Qi stagnation and blood stasis type: acute trauma history is arranged, ankle swelling, ecchymosis or local pyrexia, pain with tenderness, localized pain, function limitation, pale tongue or dark partially, thin fur is white or yellow, the puckery or summary number of arteries and veins or string.
3. Western medicine diagnose standard
Acute soft tissue injury of ankles: comprise contusion (directly external force is hit or collided the limbs part, causes subcutaneous tissue of ankle, muscle, tendon equivalent damage) and sprain that (indirect violence makes limbs and periarticular fascia, muscle.Ligament hyperflexion, tractive cause the damage of surrounding soft tissue or tear).
4. include the case standard in
(1) the acute soft tissue injury course of disease is no more than 3 days;
(2) meet Western medicine diagnose standard and differential diagnosis in tcm standard person;
(3) age is at 18-65 between year.
5. get rid of case standard (comprising incompatibility or rejecting standard)
(1) above-mentioned symptom person due to the non-acute soft tissue injury of ankles;
(2) took relevant analgesic drug product person after the wound;
(3) age under-18s or over-65s person;
(4) gestation or women breast-feeding their children are to this medicine allergy sufferers;
(5) intentionally, important organ severe dysfunction persons such as liver, kidney;
(6) do not meet the standard of including in, non-curative effect reason, also non-untoward reaction and drug withdrawal person midway, and not medication in accordance with regulations can't judge that curative effect or data are incomplete, affect the treatment or safety judgement person.
(2), the administrated method and the course of treatment
The Radix ceratostigmatis willemottiani sheet, every day three times, each 2.Three days is a course of treatment.
Reach treatment back pain intensity, pain degree, tenderness, swelling and dysfunction respectively before the record treatment.
(3), observation index
1, pain intensity, (PI)
Help to judge by the patient or the doctor, oneself records with 0-10 numeral pain intensity staging.The no pain of 0 expression, 10 represent that patients think serious pain, and 1-3 mild pain, 4-6 are moderate pain, and 7-9 is a severe pain.
2. pain degree classification (WTO three step analgesia therapy pain grade scales)
0 grade of (0 minute) no pain;
I level (1 minute): (mild pain) though pain is arranged but still can stand, and can orthobiosis, sleep is interference-free;
II level (2 minutes): (moderate pain) pain is obvious, is impatient at, and needs to use analgesic, and sleep is disturbed;
III level (3 minutes): (severe pain) sharp ache, sleep seriously is interfered, and needs to use analgesic, can be with autonomic nervous dysfunction or positive position.
3. tenderness
No tenderness 0 minute
Mild pain when pushing, no pain expression 1 minute
Pain is heavier when pushing, and painful expression is arranged, and still can stand 2 fens
Sharp ache during flicking, tenderness 3 minutes
4. swelling
No swelling 0 minute
Mild swelling was lower than bone mark 1 minute
Moderate swelling, flat bone mark, dermatoglyph disappeared 2 fens
Severe swelling exceeds bone mark, and severe patient can have blister 3 minutes
5. joint motion
Can do comings and goings 0 minute
Moderate is limited, can take care of oneself, and can be engaged in 1 minute orthobiosis
Obviously limited, can take care of oneself, but can not be engaged in normal activity 2 minutes
The mobility forfeiture, life can not be from 3 minutes
(4), efficacy assessment standard
1. pain intensity poor (PID)
Be before the patient treatment and the difference of treatment back pain intensity, reaction pain relief degree.
2. total effects
Recovery from illness: pain, tenderness, swelling disappear, and joint motion is normal, and integration is 0 minute.
Produce effects: pain, tenderness, swelling obviously alleviate, and joint motion is normal substantially, and integration reduces more than 2/3.
Effectively: pain, tenderness, swelling alleviate to some extent, and joint motion recovers to some extent, and integration reduces more than 1/3.
Invalid: pain, tenderness, swelling, joint motion do not change, and integration reduces below 1/3.
3. safety is observed
There is the gastrointestinal side effect of case in observation post, whether has the secondary work of poison to understand medicine.
Two, clinical data
This is organized 30 routine cases and is outpatient service or emergency case.Male's 18 examples wherein, women's 12 examples, men and women's ratio is 1.5: 1.Minimum 18 years old of age, maximum 60 years old, average 33.88 ± 13.48 years old
Pain degree distributes
n | I level (%) | II level (%) | III level (%) |
30 | 7(23.33%) | 21(70%) | 2(6.67%) |
Three, therapeutic outcome
(1) total effects
n | Recovery from illness | Produce effects | Effectively | Invalid | Total effective rate |
30 | 2 | 2 | 21 | 5 | 83.33% |
This is organized in the 30 routine cases, 2 examples of fully recovering, produce effects 2 examples, effective 21 examples, invalid 5 examples.Total effective rate 83.33%.
(2), each symptom and sign curative effect
| Pain degree | Tenderness | Swell and ache | Joint motion |
Before the treatment | 1.83±0.53 | 1.87±0.52 | 1.20±0.48 | 1.27±0.45 |
After the treatment | 0.77±0.43 | 1.06±0.45 | 0.73±0.64 | 0.76±0.57 |
Relatively, expression is through the t check before and after the treatment, and there is significant difference p<0.05.Treat the back and control preceding comparison, pain degree, tenderness, swelling, joint motion all have alleviation.
(3) pain intensity compares before and after the treatment
Pain intensity before the treatment | Treatment back pain intensity | Pain intensity is poor before and after the treatment |
4.55±1.11 | 1.43±1.14 | 3.00±1.05 |
Relatively, expression is through the t check before and after patient's statement treatment, and there is significant difference p<0.05.The treatment back is relatively preceding with treatment, and pain intensity alleviates.
(4) relation of pain degree and curative effect
Pain degree | n | Recovery from illness | Produce effects | Effectively | Invalid | Effective percentage |
I | 7 | 1 | 0 | 5 | 1 | 85.71% |
II | 21 | 1 | 2 | 15 | 4 | 85.71% |
III | 2 | 0 | 2 | 0 | 0 | 100% |
Through X
2P>0.05, no difference of science of statistics are compared in check between three groups.Show that pain degrees at different levels and curative effect do not have dependency.
(5) safety is observed
In the 30 routine cases, finding no bad of tangible gastrointestinal tract should.
Four, discuss
The present invention is used for the treatment of acute ankle sprain 30 examples, 2 examples of fully recovering, produce effects 2 examples, effective 21 examples, invalid 5 examples, total effective rate 83.23%.Symptoms such as the pain that acute ankle sprain is caused, swelling, joint function disturbance are analyzed by statistics, and relatively, there is significant difference P<0.05 before treatment back and the treatment, and treatment back symptom alleviates before the treatment.Pain degree and curative effect do not have dependency, and pain at different levels are all had tangible analgesic effect.Find no tangible gastrointestinal side effect in the therapeutic process.