Summary of the invention
The technical problem to be solved in the present invention is for overcoming above-mentioned doctor trained in Western medicine fractures time length, needing operation and bed, bring defectives such as misery to patient, developing motherland's Chinese medicine is the fine tradition that cures the wound, and has proposed the eldeline that a kind of oral Chinese medicine secret recipe treatment effective, that the recovery from illness cycle is short is fractured.
The technical scheme of wound synthetism electuary of the present invention is a historical elite of concentrating doctor's treatment by Chinese herbs to fracture several thousand, and is progressively perfect through clinical checking repeatedly, proposed the prescription and the preparation method of one group of treatment trauma fracture.It is not had, Rhizoma Drynariae, Cornu Cervi Degelatinatum, Sanguis Draxonis, Eupolyphaga Seu Steleophaga, Pyritum, Flos Carthami, is processed Os Canitis, Radix Dipsaci, the Radix Angelicae Dahuricae, Cortex Cinnamomi, Cortex tripterygii hypoglauci radicis, Radix Angelicae Sinensis, synthetic musk etc. 15 flavor and form by Os Draconis, system breast.Its prescription does not have 30-50 gram, Rhizoma Drynariae 110---160 gram, Cornu Cervi Degelatinatum 250-350 gram, Sanguis Draxonis 95-105 gram, Eupolyphaga Seu Steleophaga 120---150 gram, Pyritum 180-220 gram, Flos Carthami 180-220 gram, processs Os Canitis 100--120 gram, Radix Dipsaci 380-400 gram, Radix Angelicae Dahuricae 180--220 gram, Cortex Cinnamomi 180----230 gram, Cortex tripterygii hypoglauci radicis 380--450 gram, Radix Angelicae Sinensis 390--410 gram, synthetic musk 3.5--6 gram for Os Draconis 80---120 gram, system breast.
Use in the wound synthetism electuary prescription of the present invention that Radix Angelicae Sinensis, Sanguis Draxonis etc. can nourish blood, invigorate blood circulation, collateral dredging; Energy such as Rhizoma Drynariae tonifying liver is supported kidney; Tools such as Pyritum continue the function of muscle, synthetism, and full side has the effect of activating blood circulation to dissipate blood stasis, reducing swelling and alleviating pain, benefit lid Liver and kidney, reunion of bone.
Wound synthetism electuary preparation method of the present invention is: Pyritum is broken into the coarse granule shape, adds decocting in water twice, boiled 3 hours at every turn, get filtered solution and clarify back standby; To except that the synthetic musk medicine, decoct with water twice by other medicines, boil 1 hour at every turn, collecting decoction, the stand for standby use of sieving; With being condensed into clear paste after above-mentioned two kinds of standby filtrates mixing, restrain into granule with sucrose, dextrin, ethanol and synthetic musk 3.5--6, be drying to obtain, with every bag 12 gram packing.10 bags are a box.
Wound synthetism electuary of the present invention has carried out tight scientific research and design, taken into full account at random, fundamental such as contrast, double blinding, according to national Gw standard, listing medicine " ocean board " bone setting tablet of Dalian pharmaceutical factory of traditional Chinese medicine production has one by one all been used in all control experiments.Mainly carried out rigorous, complete scientific appraisal from experimentation and clinical research two broad aspect.
Experimentation is carried out in Ministry of Public Health pharmacology base China Medicine University and Institutes Of Technology Of Nanjing.Experiment mainly comprises three parts: acute toxicity test, pharmacodynamics test and biomechanics test.
By test, prove that wound synthetism electuary has good antiinflammatory and analgesic activity, and do not have anxious, slow toxic action.
Learn inspection and electron microscope scanning observation by blood biochemical.The callus of direct observation gained healing Sui condition under the lifting variation of the serum alkaline phosphatase that causes from wound synthetism electuary, blood calcium, serium inorganic phosphorus and the electron microscope scanning has proved absolutely that wound synthetism electuary is for the remarkable effect that promotes union of fracture.
Aspect the biomechanics test,, proved the significantly big sub non-treatment group of fracture resistence force through the fracture of wound synthetism electuary treatment mainly by the test of stretch-proof, counter-bending, three indexs of shock resistance.
Research has proved that wound synthetism electuary does not have obvious toxic and side effects to experimental rabbit by experiment, and functions such as invigorating blood circulation, change silt, calmness, antiinflammatory is arranged significantly, and the synthetism effect is remarkable.It is to be noted that especially all test control group medications are the ocean board bone setting tablet that the Dalian pharmaceutical factory of traditional Chinese medicine produces, thereby provide comparability and enough experiment and theoretical foundations preferably for this medicine of clinical use.Utilize wound synthetism electuary of the present invention treatment fracture, adopt that oral curative effect is fast, not painful, safety, cost is low, easy to make.
The specific embodiment
Embodiment 1:
One assembly side of wound synthetism electuary of the present invention is: Os Draconis 110 gram, system breast do not have each 45 gram, Rhizoma Drynariae 160 grams, Cornu Cervi Degelatinatum 280 grams, Sanguis Draxonis 105 grams, Eupolyphaga Seu Steleophaga 140 grams, Pyritum 220 grams, Flos Carthami 190 grams, process Os Canitis 110 grams, Radix Dipsaci 380 grams, the Radix Angelicae Dahuricae 210 grams, Cortex Cinnamomi 190 grams, Cortex tripterygii hypoglauci radicis 420 grams, Radix Angelicae Sinensis 390 grams, synthetic musk 5 grams.
Earlier Pyritum is broken into the coarse granule shape, adds decocting in water twice, each 3 hours, get filtered solution and clarify back standby; Other medicines (removing synthetic musk) are decocted with water twice, each 1 hour, collecting decoction, the stand for standby use of sieving; With being condensed into clear paste after above-mentioned two kinds of standby filtrates mixing, restrain into granule and dry with sucrose, dextrin, ethanol and synthetic musk 5, be a bag packing with 12 grams.10 bags are a box.
Embodiment 2:
One assembly side of wound synthetism electuary eldeline of the present invention is: Os Draconis 90 grams, system breast do not have each 48 gram, Rhizoma Drynariae 120 grams, Cornu Cervi Degelatinatum 340 grams, Sanguis Draxonis 95 grams, Eupolyphaga Seu Steleophaga 130 grams, Pyritum 180 grams.Flos Carthami 220 gram, process Os Canitis 105 grams, Radix Dipsaci 390 grams, the Radix Angelicae Dahuricae 180 grams, Cortex Cinnamomi 220 grams, Cortex tripterygii hypoglauci radicis 380 grams, Radix Angelicae Sinensis 410 grams, synthetic musk 3.5 grams.
Earlier Pyritum is broken into the coarse granule shape, adds decocting in water twice, each 3 hours, get filtered solution and clarify back standby; Other medicines (removing synthetic musk) are decocted with water twice, each 1 hour, collecting decoction, the stand for standby use of sieving; With being condensed into clear paste after above-mentioned two kinds of standby filtrates mixing, restrain into granule and dry with sucrose, dextrin, ethanol and synthetic musk 3.5, be a bag packing with 12 grams.10 bags are a box.
Embodiment 3:
One assembly side of wound synthetism electuary eldeline of the present invention is: Os Draconis 80 grams, system breast do not have each 45 gram, Rhizoma Drynariae 140 grams, Cornu Cervi Degelatinatum 320 grams, Sanguis Draxonis 105 grams, Eupolyphaga Seu Steleophaga 120 grams, Pyritum 210 grams, Flos Carthami 210 grams, process Os Canitis 120 grams, Radix Dipsaci 400 grams, the Radix Angelicae Dahuricae 220 grams, Cortex Cinnamomi 210 grams, Cortex tripterygii hypoglauci radicis 440 grams, Radix Angelicae Sinensis 400 grams, synthetic musk 6 grams.
Earlier Pyritum is broken into the coarse granule shape, adds decocting in water twice, each 3 hours, get filtered solution and clarify back standby; Other medicines (removing synthetic musk) are decocted with water twice, each 1 hour, collecting decoction, the stand for standby use of sieving; With being condensed into clear paste after above-mentioned two kinds of standby filtrates mixing, restrain into granule and dry with sucrose, dextrin, ethanol and synthetic musk 6.0, be a bag packing with 12 grams.10 bags are a box.
Usage: oral, every day 3 times, each 12 grams; Anemia of pregnant woman and woman month are withdrawn menstrual period, and the child follows the doctor's advice.Be about 24-28 days a general course of treatment, needs the 6-8 box altogether.
Aspect clinical research: carry out back 118 routine inpatients, 100 routine outpatients' uses through continuous application and subject study that many decades is clinical, respond well.
Fracture to 118 routine inpatient's all ages and classes, position, type has been carried out clinical observation.Through conscientious collection, arrangement, analysis, statistical procedures, show that " wound synthetism electuary " group curative effect obviously is better than matched group, especially show the fracture heals in early days aspect, have good invigorate blood circulation, the function of dissipating blood stasis, synthetism, continuous muscle.
1, case grouping and physical data
Selecting 118 examples altogether, all is the inpatient of the court, wherein male 68 examples, women 50 examples; Age is 18-65 year, average 40.6 years old.Be the fresh closed fracture of extremity, humeral fracture 11 examples wherein, forearm fracture 34 examples, fracture of metacarpal bone and phalanges of fingers 15 examples, Fracture of femur 17 examples, fracture of tibia and fibula 26 examples, metatarsophalangeal fracture 15 examples.All patients are divided into two groups in proper order by prescription on individual diagnosis, and odd number is the treatment group, and even number is a matched group, and each organizes 59 examples.
Table 1 liang group patient distribution situation
Age | Treatment group example (%) | Matched group example (%) | Add up to example (%) |
18-30 | 16(27.12) | 17(28.81) | 33(27.97) |
31-40 | 8(13.56) | 8(13.56) | 16(13.56) |
41-50 | 11(18.64) | 13(22.03) | 24(20.34) |
51-60 | 10(16.95) | 9(15.25) | 19(16.10) |
61-65 | 14(23.13) | 12(20.03) | 26(22.03) |
Table 2 liang group patient distribution situation
Sex | Treatment group example (%) | Matched group example (%) | Add up to example (%) |
The man | 36(61.02) | 32(54.24) | 68(57.63) |
The woman | 23(38.98) | 27(45.76) | 50(42.73 |
Table 3 liang group patient fracture site distribution situation
The position | Treatment group example (%) | Matched group example (%) | Add up to example (%) |
Humerus | 5(8.47) | 6(10.17) | 11(9.32) |
The chi radius | 18(30.51) | 16(27.12) | 34(28.81 |
Metacarpal-phalangeal | 8(13.56) | 7(11.86) | 15(12.71) |
Femur | 9(15.25) | 8(13.56) | 17(14.41) |
Tibiofibula | 12(20.03) | 14(23.73) | 26(22.03) |
Sole of the foot phalanx | 7(11.86) | 8(13.56) | 15(12.71) |
Two groups of patients' age, sex, fracture site roughly the same (P>0.05) have comparability.
2. Therapeutic Method:
Two groups of patients are all conventional adopt traditional reset, fixing, the treatment of functional exercise method, oral wound synthetism electuary is organized in treatment on this basis, each 6 grams, every day three times, 15 days is a course of treatment, needs 1-3 course of treatment or longer of logotype but look the state of an illness.The ocean board bone setting tablet that the oral Dalian of the matched group pharmaceutical factory of traditional Chinese medicine produces, each 4, every day three times, 15 days is a course of treatment.
3, observation index: (1), safety observation: A), general health check-up project.B), hematuria, just, routine test.C), the heart, liver, kidney function test.D), chest X-ray.(2), health giving quality observation: A), the position of fracture, type, displacement situation, para-position degree, broken ends of fractured bone state and fracture site swelling, bitterly, active situation.B), General Symptoms, picture of the tongue, pulse condition.C), the inside and outside callus formation time, the speed of growth is measured, density measurement D), prudent mensuration.E), carry out the tracking observation of late result.4, curative effect determinate standard: fracture generally can normal healing, and various endogenouss and ectogenic factor can influence the healing of fracture.Therefore, allly can shorten the union of fracture medicine of (clinical healing and bony union) time, all think effective.
(1), healing standard:
A), Gu Zhe clinical healing standard:
A-1), local no tenderness, do not have vertical percussion pain.
A-2), local no abnormal activity.
A-3), the X line shows that according to levying fracture line is fuzzy, has the seriality callus to pass through fracture line.
A-4), functional examination: removing under the external fixation situation, upper limb can be put down act 1Kg weight and be reached the continuous free-hand walking of 1 minute lower limb energy 3 minutes, and is no less than for 30 steps.
A-5), continuously observed for two weeks, indeformable the 1st day of then observing of fracture is the clinical healing date.
A-2) and A-4) mensuration of two functions must be prudent, not deform or refracture is a principle.
B), the bony union standard of fracture:
B-1), possess the clinical union of bone standard conditions.
B-2), the X line shows that according to levying the little fine strain of millet of bone passes through fracture line.
(2), the common clinical union of bone time reference value of adult:
Clavicular fracture 4-6 week; Collum chirurgicum humeri orthopaedics 4--6 week; Humeral shaft fracture 4--8 week; Supracondylar fracture of the humerus 3--6 week; Chi, fracture of radial shaft 6--8 week; Distal radius 3--6 week; Palm or phalanx bone fracture 3--4 week; Fracture of femoral neck 12--24 week; Intertrochanteric fracture 7--12 week; Fracture of shaft of femur 8--12 week; Patella fracture 4-6 week.
(3) criterion of therapeutical effect:
A), estimate curative effect according to healing time:
Cure: than similar clinical union of bone time in advance more than 1/3.
Produce effects: shift to an earlier date 1/4-1/3 than the similar clinical union of bone time.
Effectively: shift to an earlier date 1/5--1/4 than the similar clinical union of bone time.
Invalid: identical with the similar clinical union of bone standard time.
B), functional rehabilitation situation evaluation criteria:
Excellent: union of fracture, range of motion is normal or approaching normal, resumes work
Very: union of fracture, joint motion are limited in more than 30 degree, and life can be taken care of oneself.
Difference: union of fracture, the obvious obstacle of joint motion, upper limb forearm rotation is limited or can not prudent thing, the walking of maybe can not bearing a heavy burden of joint of the lower extremity pain.
Can: union of fracture, joint motion has mild pain less than 30 degree during joint motion.
5, therapeutic outcome:
Two groups of cases are accepted 1--3 the course of treatment, and healing time relatively sees Table 4, and the functional rehabilitation situation sees Table 5.Learn by statistics and handle X ' check, total effective rate compares (P<0.05) significant difference between two groups.The effect that wound synthetism electuary auxiliary treatment fracture is described is remarkable, not only promotes union of fracture, accelerating bone healing speed, and curative effect obviously is better than matched group.
Table 4 liang group patient healing time relatively
Group | Therapeutic effect | Effective percentage (%) |
Treatment | Produce effects | Effectively | Invalid |
Treatment | 30 | 16 | 9 | 4 | 93.22 |
Matched group | 6 | 12 | 10 | 31 | 47.46 |
Table 5 liang group patient functional rehabilitation situation relatively
Group | Therapeutic effect | Effective percentage (%) |
Excellent | Very | Can | Difference |
Treatment | 51 | 7 | 1 | 0 | 98.30 |
Matched group | 43 | 9 | 5 | 2 | 88.14 |
As can be seen from the above table, take wound synthetism electuary treatment fracture, patient's functional rehabilitation situation acceptance rate reaches 98.30%, analyzes treatment group and matched group significant difference (P<0.05) by statistics.
Clinical research proves: no matter be the patient of operation and non-operative treatment, can both promote the growth and the healing of bone after taking, shorten the time of knitting, can carry out functional exercise in advance, slow down joint stiffness, promote functional rehabilitation, effectively prevent and reduce the generation of delayed healing and bone does not connect.Clinical practice fully proves: " wound synthetism electuary " curative effect is obvious, uses easy to carryly, and easily what is applied.