Summary of the invention
The purpose of this invention is to provide a kind of treatment asthenic cold type chronic gastroenteritis, rheumatic arthritis rubber-emplastrum and preparation method thereof, overcome the shortcoming of said medicine, have advantage easy to use, evident in efficacy, that have no side effect.
The objective of the invention is to be achieved through the following technical solutions:
A kind of treatment asthenic cold type chronic gastroenteritis, rheumatic arthritis rubber-emplastrum are by the unguentum that comprises that following weight portion raw material is made: Fructus Capsici 3.8-5.4, Rhizoma Zingiberis Recens or Rhizoma Zingiberis 2-5, Oleum Cinnamomi 0.1-0.3; And rubber-emplastrum substrate pharmaceutically commonly used.
Described raw material is following weight portion raw material: Fructus Capsici 4.6, Rhizoma Zingiberis Recens or Rhizoma Zingiberis 3.5, Oleum Cinnamomi 0.2.
Rubber-emplastrum matrix optimization of the present invention is rubber, zinc oxide, Colophonium, a lanoline ratio matrix prepared routinely.
The proportioning ratio of described matrix components rubber, zinc oxide, Colophonium, lanoline is preferably (0.5-2.5): (0.5-2.5): (0.4 :-2.5): (0.1-0.55).The proportioning ratio of described matrix components rubber, zinc oxide, Colophonium, lanoline is well 0.5: 0.5: 0.4: 0.1,1: 1: 1: 0.22 or 1.5: 1.5: 1.5: 0.33.
Described treatment asthenic cold type chronic gastroenteritis, rheumatic arthritis rubber-emplastrum also comprise following weight portion raw material: Cortex Cinnamomi 0.75-1.35 is preferably following weight portion: Cortex Cinnamomi 1.05.
The present invention also provides above-mentioned a kind of preparation method for the treatment of asthenic cold type chronic gastroenteritis, rheumatic arthritis rubber-emplastrum, may further comprise the steps: Rhizoma Zingiberis is broken into coarse powder or Rhizoma Zingiberis Recens drying, is broken into coarse powder; Pepper drying is broken into coarse powder; Mix, the mixture alcohol dipping, impregnation liquid filters, and filtrate recycling ethanol is condensed into clear paste, adds rubber-emplastrum substrate pharmaceutically commonly used, adds the Oleum Cinnamomi mixing again, makes coating, is coated with cream, cutting, the lid lining is cut into pieces, promptly.
In the preparation method of the present invention, preferred mixture alcohol dipping three times, 24 hours for the first time, 72 hours for the second time, 48 hours for the third time, impregnation liquid filtered, merging filtrate reclaims ethanol, and being condensed into relative density is the clear paste of 1.3-1.35 (70 ℃), the substrate that adding is made by rubber, zinc oxide, Colophonium, lanoline, add the Oleum Cinnamomi mixing again, make coating, be coated with cream, cutting, the lid lining.
Above-mentioned preparation method also comprises: the Cortex Cinnamomi drying is broken into coarse powder, adds said mixture, use alcohol dipping.
Function of the present invention cures mainly: promoting the flow of QI-blood by warming the meridian, jiao dispelling cold and analgesia.Be used for back due to the wind-cold channel blocking network, extremities joint cold type of pain; And the coldness and pain in the epigastrium that stops causing in the wind and cold, deficiency and coldness is had loose bowels; Chronic asthenic cold type gastroenteritis, chronic rheumatic arthritis are seen above-mentioned patient.
Using method: external, according to disease, paste one by the acupuncture point.
Medicine of the present invention is based on following mechanism: we be " this thing difficulty is known ", " Li Yue Pianwen, Rhymed Discourse for Topical Remedies " for moxibustion on the basis of proved recipe, verify repeatedly, study and form through clinical.The side is monarch with the Fructus Capsici, and this thing Da Xin, big heat have temperature by cold-evil, the merit that restores menstrual flow and invigorates blood circulation, " property of medicine is examined " calls it " warming spleen and stomach for dispelling cold removes the wind diaphoresis, goes cold addiction ", " food compatibility and incompatibility of drugs " speech " warming the middle warmer and descending qi; dispelling cold and removing dampness ", and " medicine inspection " then claims its " promoting the circulation of blood of dispeling the wind, cold expelling resolving depression ".Right this product external studies show that it can make local skin vasoreflex expansion, promotes the vigorous of local blood circulation, and the intense stimulus sensory nerve ending, causes warming sense.This shows, execute this product in body surface on the cave, the not only desirable warming sense that it causes and for moxibustion, and its hot property go into the cave follow through and cold expelling, can unobstructed QI and blood and pain relieving, so with thinking monarch.The Cortex Cinnamomi that Fang Yixin is sweet, hot is a minister, and both principal drug assistance stimulated the menstrual flow by cold, and himself is complement sun, warming the spleen and stomach, removing accumulated cold again, and promoting blood circulation is longer than and is exempted from the numbness pain relieving, " property of medicine class is bright " cloud: " yang-energy can be guided in osmanthus, and a surname's promoting blood circulation makes the QI and blood colleague.So ", Fructus Capsici and Cortex Cinnamomi match, and by the merit multiplication of cold inducing menstruation to relieve menalgia, the merit that hot a surname that looses leads is more violent.Be assistant again with the Rhizoma Zingiberis Recens, strengthen on the one hand the dispel effect of cold expelling heresy of monarch, ministerial drug, strengthen monarch, ministerial drug on the other hand, make QI of channels and collaterals speed logical hot stimulation through the cave.All medicines are harmonious, make the rubber plaster, effect is collaborative, and hot to restore menstrual flow and invigorate blood circulation, heat is with dispersing cold for relieving pain, so cold-evil visitor is cut down card due to the body, subsides in through the cave, make the property of medicine penetrate the acupuncture point, follow through and cloth reach the whole body, thereby reach the cold-evil loose, through ruton, QI and blood and, the pain purpose of ending, play the good result that substitutes moxibustion.
The rubber-emplastrum of treatment chronic asthenic cold type gastroenteritis of the present invention, chronic rheumatic arthritis has the following advantages: rubber-emplastrum of the present invention is a kind of plaster preparation that replaces warm moxibustion therapy, be that one of Chinese medicine compound preparation improves greatly, filled up the blank of moxibustion therapy.The medical material that will have unique curative effect, compatibility in proportion makes that plaster is easy to use, steady quality, determined curative effect.
The present invention treats the advantage of the rubber-emplastrum of chronic asthenic cold type gastroenteritis, chronic rheumatic arthritis for proof, carried out following examples 1 rubber-emplastrum (to call in the following text: clinical trial Dai wen moxibustion plaster) and pharmacological testing:
1. test method
Adopt random packet, the positive drug parallel control, double blinding is observed, the multi-center clinical trial design
1.1 experimenter source and sample content
The experimenter derives from the outpatient service or the inpatient of each clinic test center.With reference to the regulation of " medicine registration management way " (try) the relevant relevant sample content of III clinical trial phase, intend including in observation and meet the scheme case and be no less than 400 examples.Treatment is organized in 300 examples, cold dampness accumulation pattern rheumatic arthritis (chronic phase) 120 examples, asthenic cold type chronic gastritis, each 90 example of asthenic cold type chronic nonspecific colitis: in matched group 100 examples, cold-damp resistance network rheumatic arthritis (chronic phase) 40 examples, asthenic cold type chronic gastritis, each 30 example of asthenic cold type chronic nonspecific colitis.Group comes off the case number average must not be above 20%.
1.2 group technology and blind method are implemented
Adopt statistical software establishment random coded table (blind table) and medicine coding schedule.The test drug peace is required unitizing according to blind method, number according to the medicine coding schedule then.In the process of the test, researcher is included serial number in according to case, takes the medicine in the corresponding numbering packing.All clinical trial finishes, and data management work is finished, open-blind after the data interlock.
2. curative effect observation: disease is levied the scalar quantization table
2.1 syndrome of cold-dampness blocking collaterals and rheumatic arthritis (chronic phase):
(1) related symptoms and sign: arthralgia, arthroncus, articular pain, the joint joint stuffiness, the joint is done cold, aversion to wind and cold, limbs are heavy, and the tongue pulse condition changes.The tongue pulse condition is put down in writing strictly according to the facts.Disease is levied grade scale and is seen " syndrome of cold-dampness blocking collaterals and rheumatic arthritis (chronic phase) disease is levied the scalar quantization table ", arthralgia wherein, arthroncus, articular pain, the joint joint stuffiness, the cold primary symptom that is is made in the joint, light, in, weigh three grades and remember 2,4,6 fens respectively; Aversion to wind and cold, limbs are heavy to be time disease, light, in, weigh three grades and remember 1,2,3 fen respectively.
(2) physico-chemical examination: anti-" O ", erythrocyte sedimentation rate, c reactive protein.
Syndrome of cold-dampness blocking collaterals and rheumatic arthritis (chronic phase) disease is levied the scalar quantization table
| Gently | In | Heavy |
Arthralgia | Pain is light, still can stand, or only send out when fatigue or Changes in weather. | Pain is heavier, and work and rest are affected | Pain is serious, is difficult to stand, and has a strong impact on work and rest |
Articular pain | Light tenderness, the patient claims to have pain | The moderate tenderness still can be stood | The severe tenderness, pain can not be touched. |
The joint joint stuffiness | Joint motion is slightly limited, and range of motion reduces<1/3 | Joint motion is obviously limited, and range of motion reduces 〉=1/3 | Joint motion is seriously limited, and range of activity reduces 〉=2/3 |
Arthroncus | Slight swollen, skin texture shoals, and the bone sign is still obvious | Swelling is more obvious, and skin texture disappears substantially, and the bone sign is not obvious | Swelling is serious, and skin is tight, the bone marks obliterated |
The joint is done cold | Joint aversion to wind and cold only, that touches is not cool | The joint aversion to wind and cold, the cold of touching, happiness temperature | The joint aversion to wind and cold is obvious, and that touches is cold, the Chang Jiayi protection |
Aversion to wind and cold | Idol has | Often have, but need not add clothing | Continue to exist, need add clothing |
Limbs are heavy | It is heavy to feel slightly | Limbs are heavy, movable feel effort | Heavy difficult act the during limbs are heavy |
2.2 deficiency-cold syndrome and chronic gastritis, chronic non-specific ulcerative colitis:
(1) related symptoms and sign: mainly observe coldness and pain in the epigastrium, loose stool and diarrhea or rare half congealed, indigestion and loss of appetite lack of appetite, coldness of the body with chills, spiritlessness and weakness, abdominal distention after meal, the tongue pulse condition changes.The tongue pulse condition is put down in writing strictly according to the facts.Disease is levied grade scale and is seen " deficiency-cold syndrome and chronic gastritis, chronic non-specific ulcerative colitis disease are levied the scalar quantization table ", coldness and pain in the epigastrium wherein, loose stool or have loose bowels, indigestion and loss of appetite lack of appetite is a primary symptom, light, in, weigh three grades and remember 2,4,6 fens respectively; Coldness of the body with chills, spiritlessness and weakness, abdominal distention after meal are time disease, light, in, weigh three grades and remember 1,2,3 fen respectively
Asthenic cold type chronic gastritis, chronic non-specific ulcerative colitis disease are levied the scalar quantization table
| Gently | In | Heavy |
Coldness and pain in the epigastrium | Slightly, dull pain, accidental | Dull pain or distending pain, outbreak every day for several times | Severe pain or angor, outbreak repeatedly |
Loose stool and diarrhea | Be less than every day 3 times | Every day 3-6 time | Every day is more than 7 times |
Loose stool | It is shapeless to defecate | Every day 2-3 time, the loose stool | Every day is more than 4 times, and is just rare half congealed |
Indigestion and loss of appetite lack of appetite | Loss of appetite, appetite subtracts slightly | Inappetence, appetite reduces | Anorexia all day, appetite obviously reduces |
Coldness of the body with chills | Body temperature Chang Buneng reaches normal level, no matter winter summer-heat hands and feet coolness. | Regular be afraid of cold or winter brothers ice-coldly owe warm, need put on more clothes more | Conscious being afraid of cold worn clothes obviously many than ordinary person |
Spiritlessness and weakness | Lassitude is felt asthenia slightly, can adhere to light physical labor | Spirit is tired, drowsy, and asthenia is supported daily routines more reluctantly | Spirit is extremely tired, and myasthenia of limbs can not be adhered to daily routines, |
Abdominal distention after meal | Feel abdominal distention after the food slightly | Abdominal distention after meal is heavier, continues more than 2 hours | The food back is abdominal distention obviously, continues more than 4 hours |
(2) physico-chemical examination: 1. chronic gastritis: fibergastroscopy and gastric mucosa histology biopsy; 2. chronic nonspecific ulcer colonitis: fibercolonscopy and enteroscopy and intestinal mucosa histology biopsy, stool routine examination inspection.
3. Therapeutic Method
3.1 test drug
(1) is subjected to reagent: Dai wen moxibustion plaster
(2) contrast medicine: 1. cold dampness accumulation pattern rheumatic arthritis (chronic phase): Moschus Analgesic Unguentum, promulgated by the ministries or commissions of the Central Government 8 208 pages are recorded.Prescription is made up of Semen daturae fluid extract, Radix Illicii Lanceolati, Fructus Capsici, Moschus, Radix Aconiti, methyl salicylate, Camphora.The function cold expelling is invigorated blood circulation, analgesia.Be used for rheumatic arthralgia, articular sprain is produced authentication code: the accurate word Z43020486 of traditional Chinese medicines by Hengyang Sanitary Material Factory, Hunan Prov..2. asthenic cold type chronic gastritis, chronic non-specific ulcerative colitis: SHUFU TIEGAO, promulgated by the ministries or commissions of the Central Government 14 177 pages are recorded, and prescription is made up of Mentholum, Rhizoma Zingiberis Recens cream, Camphora cream.The function warming spleen and stomach for dispelling cold, promoting the circulation of QI to relieve pain.Be used for gastric abscess, abdominal pain and distension is felt sick, vomiting, inappetence, borborygmus diarrhea, infantile diarrhea.Produce authentication code: the accurate word Z37021126 of traditional Chinese medicines by Jinan Sanitary Materials Factory.
The contrast medicine is selected foundation: Dai wen moxibustion plaster is an external rubber paste formulation, requires should adopt same drug form in principle from comparability, and blind method is observed has feasibility.By retrieval, do not find the lamellar rubber paste formulation identical with the Dai wen moxibustion plaster main disease to be treated.Select the contrast medicine so divide sick the kind.Last art Moschus Analgesic Unguentum, SHUFU TIEGAO are with consistent for warm moxa-preparation type, and function is basic identical.Cold dampness accumulation pattern chronic rheumatic arthritis, asthenic cold type chronic gastroenteritis that the main syndrome of two medicines divides other and Dai wen moxibustion plaster to be cured mainly are approximate.And be the national standard medicine, therefore be chosen as the contrast medicine.
3.2 usage and dosage:
(1) treatment group: use Dai wen moxibustion plaster.External, according to disease, except that affected part (Ashi point), and by specification selects the cave, pastes one in each cave, exchanges cards containing all personal details and become sworn brothers 1 time in 24 hours.
(2) matched group: cold dampness accumulation pattern rheumatic arthritis (chronic phase) patient uses Moschus Analgesic Unguentum; Asthenic cold type chronic gastritis, chronic nonspecific ulcer colonitis patient use SHUFU TIEGAO.External, according to disease, except that affected part (Ashi point), and by specification selects the cave, pastes one at each acupuncture point, exchanges cards containing all personal details and become sworn brothers 1 time in 24 hours.
3.3 journey:
Test group, matched group were 1 course of treatment with 45 days all.
3.4 and medication
In the clinical observation process, tried case all must not take or adopt with the observed disease of this clinical trial serve as adapt to disease in, western drug or other treatment method.
4. curative effect judging standard
With reference to " the clinical research guideline of new Chinese medicine treatment numbness disease .-curative effect determinate standard ", " the clinical research guideline-curative effect of disease criterion of new Chinese medicine treatment rheumatoid arthritis; therapeutic effect of syndrome criterion ", " the clinical research guideline curative effect of disease criterion of new Chinese medicine treatment epigastric fullness; therapeutic effect of syndrome criterion; cardinal symptom curative effect determinate standard ", " the clinical research guideline-comprehensive therapeutic effect criterion of new Chinese medicine treatment chronic non-specific ulcerative colitis; therapeutic effect of syndrome criterion; cardinal symptom curative effect determinate standard " is worked out.
4.1 syndrome of cold-dampness blocking collaterals and deficiency-cold syndrome therapeutic effect of syndrome criterion:
Subtracting the branch rate by treatment back syndrome integration judges.
Integration subtracts branch rate=[integration before (integration before the treatment-treatment back integration)/treatment] * 100%.
(1) clinical recovery: the syndrome integration subtracts branch rate 〉=95%.
(2) produce effects: the syndrome integration subtracts branch rate 〉=70%.
(3) effective: the syndrome integration subtracts branch rate 〉=30%.
(4) invalid: the syndrome integration subtracts branch rate<30%.
4.2 the efficacy assessment standard of cardinal symptom or sign:
(1) clinic control: after finishing the course of treatment, Sx disappears.
(2) produce effects: after finishing the course of treatment, the symptom and sign classification reduces 2 grades.
(3) effective: after finishing the course of treatment, the symptom and sign classification reduces 1 grade.
(4) invalid: as not reach the following standard of effectively stating.
4.3 disease comprehensive therapeutic effect criterion:
(1) rheumatic arthritis (chronic phase) comprehensive therapeutic effect criterion:
1. clinic control: symptom, sign all disappear, and integration reduces 〉=95%, and it is normal that the function of joint activity recovers, and main doctor trained in Western medicine physico-chemical examination index is normal.
2. produce effects: cardinal symptom, sign are obviously improved, and integration reduces 〉=75%, and function of joint is recovered substantially, can participate in operate as normal and work, and main doctor trained in Western medicine physico-chemical examination index is obviously improved or near normal.
3. effective: cardinal symptom, body prove to show and improve that integration reduces 〉=35%, and function of joint is recovered substantially or had clear improvement, and live to have can not take care of oneself to transfer to can take care of oneself, or the work ability to work of mistake cloud are recovered to some extent.Main doctor trained in Western medicine physico-chemical examination index makes moderate progress.
4. invalid: as not reach above-mentioned effective standard.
(2) chronic gastritis comprehensive therapeutic effect criterion:
1. clinic control: symptom, sign all disappear, and integration reduces 〉=95%.Gastroscope check mucosa chronic inflammatory disease is clearly better and reaches slightly, and histopathologic examination's body of gland atrophy, intestinal epithelial metaplasia and dysplasia recover normal or disappear.
2. produce effects: cardinal symptom, sign are obviously improved, and integration reduces 〉=75%.Gastroscope check mucosa chronic inflammatory disease takes a turn for the better, and histopathologic examination's body of gland atrophy, intestinal epithelial metaplasia and dysplasia recover normal or alleviate 2 level degree.
3. effective: cardinal symptom, sign are obviously improved, and integration reduces 〉=35%, and gastroscope check mucosa chronic inflammatory disease extent of disease dwindles more than 1/2, and histopathologic examination's body of gland atrophy, intestinal epithelial metaplasia and dysplasia alleviate.
4. invalid: as not reach the effective standard of art.
(3) chronic non-specific ulcerative colitis comprehensive therapeutic effect criterion:
1. produce effects (or fully alleviate): clinical symptom disappearance, colonoscope check mucosa is normal.Drug withdrawal or only use the maintenance dose medicine is observed and was not had recurrence in 6 months.
2. effective: clinical symptoms disappears substantially, and mild inflammation reaction of colonoscope check mucosa and part pseudopolyp form.
3. invalid: clinical symptoms, scope and pathologic finding do not have improvement.
4.4 statistical method
Measurement data adopts pairing or t check in groups, and enumeration data adopts X
2Check, ranked data adopt rank test.Data statistic analysis adopts the SPSS10.0 statistical package.
Clinical test results
1. baseline analysis
1.1 case source and performance: see Table 1.
Table 1 case performance
Test unit | Add up to 1234 | Test group 1234 | Matched group 1234 |
The 3rd Hunan Inst of Traditional Chinese Medicine Affiliated Hospital of Affiliated Hospital of second Hunan College of Traditional Chinese Medicine of Affiliated Hospital of Hunan College of Traditional Chinese Medicine | ?120???120???0????0 ?123???120???3????0 ?160???160???0????0 | ?90????90????0????0 ?92????90????2????0 ?120???120???0????0 | ?30???30???0???0 ?31???30???1???0 ?40???40???0???0 |
Add up to | ?403???400???3????0 | ?302???300???2????0 | ?101??100??1???0 |
Annotate: 1: go into to organize case: 2: finish case: 3 cases that come off: 4 reject cases.The above case reason that comes off is and lose visits.
1.2 subject age: see Table 2.
The analysis of table 2 Dai wen moxibustion plaster clinical trial subject age (year)
| The example number | ?X±SD | ????T | ????P |
Treatment group matched group | ????300 ????100 | ?41.06±16.25 ?39.81±15.47 | ????0.67 | ????0.5007 |
1.3 experimenter's sex: see Table 3.
Table 3 Dai wen moxibustion plaster clinical trial experimenter sex is analyzed (example)
| The example number | The male | The women | ????X
2 | ????P |
The treatment group | ????300 | ????111 | ????189 | ????0.51 | ????0.4751 |
Matched group | ????100 | ????41 | ????59 |
1.4 experimenter's course of disease: see Table 4
Table 4 Dai wen moxibustion plaster clinical trial experimenter's course of disease situation (moon)
| The example number | ????X±SD | ????T | ????P |
The treatment group | ????300 | ????16.61±14.51 | ????0.66 | ????0.4751 |
Matched group | ????100 | ????15.53±13.27 |
1.5 sick kind of experimenter distributes: see Table 5:
Sick plant distribute (example) of table 5 experimenter
| The example number | Rheumatic arthritis | Chronic gastritis | Chronic colitis | ??X
2 | ????P |
The treatment group | ??300 | ????122 | ????91 | ????87 | ??0.17 | ????0.9162 |
Matched group | ??100 | ????41 | ????32 | ????27 |
1.6 cold-damp resistance network or deficiency-cold syndrome card Hou Jifen: see Table 6:
Table 6 Dai wen moxibustion plaster clinical trial experimenter treats preceding Syndrome in TCM marquis integration
| The example number | ????X±SD | ????T | ????P |
The treatment group | ????300 | ????15.87±5.77 | ????0.99 | ????0.3205 |
Matched group | ????100 | ????15.20±6.02 |
By last baseline analysis result as can be known, test between two groups treat before at main demography data and the equal not statistically significant of state of an illness data comparable group differences (P>0.05), point out two groups of experimenter's distributing equilibriums, have comparability preferably.
2. efficiency evaluation result
2.1 card marquis and symptom curative effect thereof
2.1.1 curative effect overall merit: see Table 7:
Table 7 Dai wen moxibustion plaster clinical trial experimenter cold-damp resistance network or deficiency-cold syndrome marquis curative effect comprehensive evaluation result (routine %)
| The example number | Control | Produce effects | Effectively | Invalid | Obvious effective rate | Effective percentage |
The treatment group | 300 | ??67 | ?112 | ????93 | ????28 | ??59.67 | ????90.67 |
Matched group | 100 | ??14 | ?34 | ????35 | ????17 | ??48.00 | ????83.00 |
Treatment group and matched group be (rank test): Z=2.35 relatively, P0.0134.
2.1.2 observed result before and after cold-damp resistance network or deficiency and coldness symptom rank scores and the card Hou Jifen treatment: see Table 8-9.
Rank scores result before and after table 8 Dai wen moxibustion plaster clinical trial experimenter cold-damp resistance network or the deficiency-cold syndrome symptom treatment (X ± SD)
| | The example number | Before the treatment | After the treatment | Difference | ??T | ??P |
The joint | The treatment group | ????122 | ????4.09±1.62 | ????1.84±1.19 | ????2.55±1.43 | ??1.60 | ??0.1116 |
Pain | Matched group | ????41 | ????4.00±1.44 | ????2.15±1.33 | ????1.85±1.24 |
The joint | The treatment group | ????118 | ????3.78±1.4 | ????1.51±1.26 | ????2.27±1.39 | ??0.86 | ??0.3984 |
Tenderness | Matched group | ????40 | ????3.57±1.29 | ????1.75±1.37 | ????1.82±1.29 |
Bend and stretch | The treatment group | ????104 | ????3.64±3.03 | ????1.62±1.87 | ????2.02±1.50 | ??0.76 | ??0.4517 |
Unfavorable | Matched group | ????36 | ????3.58±2.95 | ????1.98±2.11 | ????1.60±1.19 |
The joint | The treatment group | ????99 | ????3.05±1.31 | ????0.69±1.08 | ????2.29±1.23 | ??1.59 | ??0.1211 |
Swelling | Matched group | ????32 | ????2.91±1.63 | ????1.38±1.54 | ????1.53±1.28 |
The joint | The treatment group | ????93 | ????3.32±1.16 | ????0.84±1.02 | ????2.49±0.82 | ??3.47 | ??0.0015 |
Do cold | Matched group | ????29 | ????3.14±1.23 | ????1.22±1.33 | ????1.44±0.67 |
Aversion to wind | The treatment group | ????57 | ????0.97±0.66 | ????0.35±1.14 | ????0.78±0.35 | ??3.59 | ??0.0010 |
Cold | Matched group | ????24 | ????0.99±1.30 | ????0.48±1.23 | ????0.33±0.23 |
Limbs | The treatment group | ????80 | ????1.32±0.54 | ????0.40±0.79 | ????0.91±0.69 | ??1.43 | ??0.1617 |
Heavy | Matched group | ????29 | ????1.27±0.59 | ????0.70±0.57 | ????0.54±0.61 |
The gastral cavity abdomen | The treatment group | ????164 | ????2.97±0.94 | ????0.52±0.8 | ????2.45±1.20 | ??0.33 | ??0.7428 |
Cold type of pain | Matched group | ????49 | ????2.97±1.07 | ????0.63±0.8 | ????2.34±1.46 |
Stool | The treatment group | ????86 | ????1.71±1.29 | ????0.27±0.75 | ????1.44±1.12 | ??0.81 | ??0.4231 |
Have loose bowels | Matched group | ????24 | ????1.44±1.07 | ????0.25±0.54 | ????1.20±1.16 | | |
Stool | The treatment group | ????110 | ????1.84±1.36 | ????0.46±0.81 | ????1.39±1.24 | ??0.13 | ??0.9006 |
Rare half congealed | Matched group | ????41 | ????1.69±1.21 | ????0.33±0.62 | ????1.35±1.11 |
Indigestion and loss of appetite | The treatment group | ????130 | ????2.13±1.08 | ????0.63±1.03 | ????1.50±1.08 | ??0.04 | ??0.9709 |
Lack of appetite | Matched group | ????43 | ????2.12±1.09 | ????0.61±0.95 | ????1.51±0.87 |
Cold physique | The treatment group | ????136 | ????0.87±0.65 | ????0.31±0.49 | ????0.56±0.52 | ??0.36 | ??0.7227 |
Cold extremities | Matched group | ????37 | ????0.85±0.60 | ????0.34±0.43 | ????0.51±0.57 |
Mental fatigue | The treatment group | ????114 | ????0.89±0.37 | ????0.29±0.45 | ????0.61±0.46 | ??0.88 | ??0.3801 |
Weak | Matched group | ????37 | ????0.72±0.55 | ????0.22±0.42 | ????0.50±0.51 |
After the food | The treatment group | ????108 | ????1.01±0.58 | ????0.21±0.39 | ????0.80±0.49 | ??1.71 | ??0.0913 |
Abdominal distention | Matched group | ????32 | ????0.87±0.44 | ????0.29±0.37 | ????0.58±0.48 |
Observed result before and after table 9 Dai wen moxibustion plaster clinical trial person cold-damp resistance network or the treatment of deficiency-cold syndrome marquis integration (X ± SD)
| The example number | Before the treatment | After the treatment | Difference |
The treatment group | ??300 | ????15.48±5.53 | ????4.49±6.28 | ??6.22±4.62 |
Matched group | ??100 | ????14.67±5.49 | ????6.33±6.72 | ??5.03±3.69 |
Compare in the group: treatment group T=23.16 P=0.0000, matched group T=13.49 P=0.0000
Compare between group: T=1.26 before treating, P=0.2088 treats back T=2.47, P=0.0139, difference T=2.32 P=0.0211
2.1.3 cold-damp resistance network or deficiency-cold syndrome symptom therapeutic evaluation result: see Table 10.
Table 10 cold-damp resistance network or deficiency and coldness symptom therapeutic evaluation result (example)
| | Symptom example number appears | Clinic control | Produce effects | Enabledisable | | Obvious effective rate % | Effective percentage % | ????Z | ????P |
The joint | The treatment group | ????122 | ????46 | ????27 | ????40 | ????9 | ??59.84 | ??92.62 | ??1.01 | ?0.3125 |
Pain | Matched group | ????41 | ????13 | ????10 | ????10 | ????8 | ??56.10 | ??80.49 |
The joint | The treatment group | ????116 | ????42 | ????16 | ????45 | ????13 | ??50.00 | ??88.79 | ??1.18 | ?0.2381 |
Tenderness | Matched group | ????38 | ????11 | ????5 | ????14 | ????8 | ??42.11 | ??78.95 |
Bend and stretch | The treatment group | ????104 | ????38 | ????14 | ????37 | ????15 | ??50.00 | ??85.58 | ??1.96 | ?0.0501 |
Unfavorable | Matched group | ????34 | ????8 | ????5 | ????9 | ????12 | ??38.23 | ??64.71 |
The joint | The treatment group | ????99 | ????60 | ????11 | ????11 | ????17 | ??71.72 | ??82.83 | ??1.62 | ?0.1065 |
Swelling | Matched group | ????32 | ????13 | ????5 | ????7 | ????7 | ??56.25 | ??78.13 |
The joint | The treatment group | ????93 | ????54 | ????13 | ????14 | ????12 | ??72.04 | ??87.10 | ??2.99 | ?0.0012 |
Do cold | Matched group | ????29 | ????8 | ????3 | ????9 | ????9 | ??37.93 | ??68.97 |
Aversion to wind | The treatment group | ????57 | ????35 | ????8 | ????9 | ????5 | ??75.44 | ??91.23 | ??3.23 | ?0.0005 |
Cold | Matched group | ????24 | ????5 | ????5 | ????7 | ????7 | ??41.67 | ??70.83 |
Limbs | The treatment group | ????80 | ????36 | ????7 | ????26 | ????11 | ??53.75 | ??86.25 | ??1.64 | ?0.0817 |
Heavy | Matched group | ????29 | ????8 | ????3 | ????11 | ????7 | ??37.93 | ??75.86 |
The gastral cavity abdomen | The treatment group | ????164 | ????87 | ????33 | ????29 | ????15 | ??73.17 | ??90.85 | ??1.02 | ?0.2693 |
Cold type of pain | Matched group | ????49 | ????23 | ????8 | ????11 | ????7 | ??63.27 | ??85.71 |
Stool | The treatment group | ????86 | ????50 | ????12 | ????12 | ????12 | ??72.09 | ??86.05 | ??0.409 | ?0.6446 |
Have loose bowels | Matched group | ????24 | ????15 | ????2 | ????6 | ????1 | ??70.83 | ??65.83 |
Stool | The treatment group | ????110 | ????59 | ????13 | ????26 | ????12 | ??65.45 | ??89.09 | ??0.03 | ?0.9780 |
Rare half congealed | Matched group | ????41 | ????22 | ????5 | ????9 | ????5 | ??65.85 | ??87.80 |
Indigestion and loss of appetite | The treatment group | ????130 | ????64 | ????16 | ????31 | ????19 | ??61.54 | ??85.38 | ??0.29 | ?0.7563 |
Lack of appetite | Matched group | ????43 | ????21 | ????3 | ????12 | ????7 | ??55.81 | ??83.72 |
Cold physique | The treatment group | ????136 | ????66 | ????11 | ????35 | ????24 | ??56.62 | ??82.35 | ??1.37 | ?0.1426 |
Cold extremities | Matched group | ????37 | ????13 | ????2 | ????14 | ????8 | ??40.54 | ??78.38 |
Mental fatigue | The treatment group | ????114 | ????51 | ????8 | ????30 | ????25 | ??51.75 | ??78.07 | ??1.22 | ?0.1964 |
Weak | Matched group | ????37 | ????13 | ????1 | ????12 | ????11 | ??37.84 | ??70.27 |
After the food | The treatment group | ????108 | ????70 | ????4 | ????13 | ????21 | ??68.52 | ??80.56 | ??1.17 | ?0.1764 |
Abdominal distention | Matched group | ????32 | ????17 | ????1 | ????4 | ????10 | ??56.25 | ??68.75 |
2.1.4 tongue arteries and veins observed result before and after cold-damp resistance network or the deficiency-cold syndrome treatment: see Table 11.
Observed result (example) before and after table 11 Dai wen moxibustion plaster clinical trial experimenter cold-damp resistance network or deficiency-cold syndrome tongue, the arteries and veins treatment
| | | The example number | Occur | Do not occur | ?X
2 | P |
Pale tongue or light fat | The treatment group | Before the treatment | 296 | ?241 | ?55 | ?62.38 | <0.0001 |
After the treatment | 296 | ?150 | ?146 |
Matched group | Before the treatment | 98 | ?82 | ?16 | ?26.41 | <0.0001 |
After the treatment | 98 | ?48 | ?50 |
X before the treatment
2=0.25, P=0.6171; Treatment back X
2=0.08,P=0.7773
|
Tongue is white or white and moist | The treatment group | Before the treatment | 296 | ?257 | ?39 | ?92.87 | <0.0001 |
After the treatment | 296 | ?148 | ?148 |
Matched group | Before the treatment | 98 | ?87 | ?11 | ?31.73 | <0.0001 |
After the treatment | 98 | ?51 | ?47 |
X before the treatment
2=0.25, P=0.6171; Treatment back X
2=0.12,P=0.7291
|
Stringy and tense pulse or heavy thin | The treatment group | Before the treatment | 296 | ?198 | ?98 | ?38.28 | <0.0001 |
After the treatment | 296 | ?123 | ?173 |
Matched group | Before the treatment | 98 | ?64 | ?34 | ?4.70 | ?0.0301 |
After the treatment | 98 | ?49 | ?49 |
X before the treatment
2=0.08, P=0.7773; Treatment back X
2=2.14,P=0.435
|
By table 8-11 analysis result as can be known, observation interpretation of result explanation before and after cold-damp resistance network or deficiency and coldness symptom rank scores and the card Hou Jifen treatment, card marquis cardinal symptom all has clear improvement after two groups of patient's medications, and the Dai wen moxibustion plaster group improvement situations such as cylindrarthrosis cold type of pain, aversion to wind and cold of suiting the medicine to the illness are better than matched group, and relatively reaching two groups of differences of curative effect comparison with the score fall has statistical significance.
2.2 curative effect of disease and main lab index thereof are treated forward and backward testing result
2.2.1 rheumatic arthritis
(1) curative effect overall merit: see Table 12.
Table 12 Dai wen moxibustion plaster clinical trial experimenter rheumatic arthritis curative effect comprehensive evaluation result (example, %)
| The example number | Control | Produce effects | Effectively | Invalid | Obvious effective rate | Effective percentage |
The treatment group | ????122 | ????25 | ????45 | ????38 | ????14 | ??54.38 | ??88.52 |
Matched group | ????41 | ????8 | ????9 | ????13 | ????11 | ??41.46 | ??73.17 |
Curative effect compares (rank test): Z=1.78, P=0.0742 between group.
(2) anti-" O " treats forward and backward testing result with erythrocyte sedimentation rate: see Table 13, table 14.
Testing result before and after table 13 Dai wen moxibustion plaster clinical trial rheumatic arthritis experimenter anti-" O " the treatment treatment
| The example number | Before the treatment | After the treatment |
| | ??≤500U | ??>500U | ??≤500U | ??>500U |
The treatment group | ????122 | ????57 | ????65 | ????113 | ????9 |
Matched group | ????41 | ????18 | ????23 | ????32 | ????9 |
Compare in the group: treatment group X
2=60.82, P<0.0001; Matched group X
2=10.05, P=0.0001.
Compare between group: before the treatment: X
2=0.10, P=0.7542 treats back X
2=6.63, P=0.01.
Testing result before and after the treatment of table 14 Dai wen moxibustion plaster clinical trial rheumatic arthritis experimenter erythrocyte sedimentation rate
| The example number | Before the treatment | After the treatment |
| | Normally | Speed | Normally | Speed |
The treatment group | ????122 | ????48 | ????74 | ????103 | ????19 |
Matched group | ????41 | ????15 | ????26 | ????32 | ????9 |
Compare in the group: treatment group X
2=52.56, P<0.0001; Matched group X
2=14.41, P<0.0001.
Compare between group: before the treatment: X
2=0.10, P=0.7542 treats back X
2=0.88, P=0.3482.
2.2.2 chronic gastritis: the curative effect comprehensive evaluation result sees Table 15.
Table 15 Dai wen moxibustion plaster clinical trial experimenter chronic gastritis curative effect comprehensive evaluation result (example, %)
| The example number | Control | Produce effects | Effectively | Invalid | Obvious effective rate | Effective percentage |
The treatment group | ????91 | ????9 | ????15 | ????38 | ????29 | ????26.37 | ????68.13 |
Matched group | ????32 | ????3 | ????5 | ????13 | ????11 | ????25.00 | ????65.63 |
Curative effect compares (rank test): Z=0.22, P=0.8243 between group
2.2.3 chronic enteritis
(1) curative effect overall merit: see Table 16.
Table 16 Dai wen moxibustion plaster clinical trial experimenter chronic enteritis curative effect comprehensive evaluation result (example, %)
| The example number | Produce effects | Effectively | Invalid | Obvious effective rate | Effective percentage |
The treatment group | ????87 | ????13 | ????38 | ????36 | ????15.12 | ????58.14 |
Matched group | ????27 | ????3 | ????14 | ????10 | ????11.54 | ????61.58 |
Curative effect compares (rank test): Z=0.12, P=0.9043 between group.
(2) testing result before and after the stool routine examination treatment: see Table 17.
Testing result before and after the treatment of table 17 Dai wen moxibustion plaster clinical trial chronic enteritis experimenter stool routine examination
| The example number | Before the treatment | After the treatment |
| | Normally | Bloody purulent stool | Normally | Bloody purulent stool |
The treatment group | ????87 | ????55 | ????32 | ????83 | ????4 |
Matched group | ????27 | ????16 | ????11 | ????25 | ????2 |
Compare in the group: treatment group X
2=27.46, P<0.0001; Matched group X
2=8.21.P=0.0042。
Compare between group: before the treatment: X
2=0.14, P=0.7113 treats back X
2=0.33, P=0.568.
By above table 12-17 analysis result as seen, two groups are detected with main lab index curative effect of disease and not to be seen notable difference.
(3) safety evaluatio result
3. adverse events: in process of the test, have 3 examples to be the treatment group, 2 examples occur outside the anaphylaxis of slight cuticle rash phenomenon for the case of the matched group local skin of applying ointment or plaster, and do not observe other obvious adverse reaction.
4. conclusion
Dai wen moxibustion plaster is made up of Fructus Capsici, Cortex Cinnamomi, Rhizoma Zingiberis Recens, Oleum Cinnamomi, the side in all medical instruments have warming middle-JIAO to promote blood circulation, cold expelling dispel the pain function.Suit with common syndrome of cold-dampness blocking collaterals and the gastric abscess (chronic gastritis) of numbness disease (rheumatic arthritis), the etiology and pathogenesis of (chronic non-specific ulcerative colitis) deficiency-cold in middle-JIAO card of having loose bowels.This product is not only easy to use, and effect is comparatively lasting, especially follows through pasting the cave in conjunction with theory of Chinese medical science is dialectical, and promoting the flow of QI-blood by warming the meridian is arranged, the merit of QI and blood regulating, thus play the promoting the circulation of blood disperse blood stasis and dredge collateral, the effect of dispersing cold for relieving pain is for its clinical efficacy is laid a good foundation.
Clinical test results shows, Dai wen moxibustion plaster is better to cold-damp resistance network or deficiency-cold syndrome marquis curative effect, main feature is for obviously improving spinal column extremities joint cold type of pain due to the rheumatic arthritis wind-cold damp pathogen resistance network, tenderness, swelling, movable unfavorable etc., coldness and pain in the epigastrium due to chronic gastroenteritis patient's deficiency-cold in middle-JIAO, the clear symptom such as rare of loose stool or diarrhea.Curative effect of disease overall merit, this product also have certain curative effect, simultaneously rheumatic arthritis patient anti-" O " are had certain restitution unusually with erythrocyte sedimentation rate and the inspection of chronic non-specific ulcerative colitis patient stool routine examination.From different curative effect of disease angle analysis, this product is better for cold dampness accumulation pattern rheumatic arthritis curative effect, is preferably kind patient's disease clinical symptoms and asthenic cold type chronic gastritis, chronic non-specific ulcerative colitis mainly acted on.Except that being subjected to reagent group 3 examples untoward reaction to occur all not finding the erythra phenomenon, safety indexes does not also go out normally to transfer to unusual in treatment or exceptional value obviously raises, reduces in this test.
The specific embodiment
Embodiment 1
A kind of rubber-emplastrum for the treatment of chronic asthenic cold type gastroenteritis, chronic rheumatic arthritis, make by following raw material that (weight: g): Fructus Capsici 4.6, Rhizoma Zingiberis Recens 3.5, Oleum Cinnamomi 0.2, Cortex Cinnamomi 1.05 and base rubber, zinc oxide, Colophonium, lanoline, proportioning ratio are 1: 1: 1: 0.22.
Preparation method:, be broken into coarse powder with the Rhizoma Zingiberis Recens drying; Pepper drying is broken into coarse powder; The Cortex Cinnamomi drying is broken into coarse powder, mixes mixture alcohol dipping three times, 24 hours for the first time, 72 hours for the second time, 48 hours for the third time, impregnation liquid filters, and merging filtrate reclaims ethanol, being condensed into relative density is the clear paste of 1.3-1.35 (70 ℃), adds the substrate of being made by rubber, zinc oxide, Colophonium, lanoline, adds the Oleum Cinnamomi mixing again, make coating, be coated with cream, cutting, the lid lining is cut into pieces, makes 360cm
2Promptly.
[character] this product is saffron lamellar rubber cream; Gas fragrance.
[discriminating] draws above-mentioned each 2ul of two solution according to the thin layer chromatography test, put respectively on same silica gel g thin-layer plate, and be developing solvent with petroleum ether (60-90 ℃)-ethyl acetate (17: 3), launch, take out, to dry, spray is with the dinitrophenylhydrazine test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get the capsaicin reference substance, add ethanol and make the solution that every 1ml contains 4mg, in contrast product solution.According to thin layer chromatography (appendix VIB) test, draw need testing solution and each 10ul of above-mentioned reference substance solution under the item of [discriminating] (1), put in same silica gel G F respectively
254On the lamellae, be developing solvent, launch that taking-up is dried, and puts under the ultra-violet lamp (254nm) and inspects with petroleum ether (30-60 ℃)-dehydrated alcohol (9: 1).In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
[inspection] paste containing amount: measure according to rubber-emplastrum paste containing amount algoscopy, make solvent with ether, every 100cm
2Should be no less than 1.7g.
[usage and consumption] external according to disease, is pasted one by the acupuncture point.
Embodiment 2
A kind of rubber-emplastrum for the treatment of chronic asthenic cold type gastroenteritis, chronic rheumatic arthritis is by following raw material (weight: g) make: Fructus Capsici 3.8, Rhizoma Zingiberis 2, Oleum Cinnamomi 0.1; And base rubber, zinc oxide, Colophonium, lanoline, the proportioning ratio is 0.5: 0.5: 0.4: 0.1.
Preparation method: Rhizoma Zingiberis is broken into coarse powder; Pepper drying is broken into coarse powder; Mix mixture alcohol dipping three times, 24 hours for the first time, 72 hours for the second time, 48 hours for the third time, impregnation liquid filtered, merging filtrate reclaims ethanol, and being condensed into relative density is the clear paste of 1.3-1.35 (80 ℃), the substrate that adding is made according to the above ratio by rubber, zinc oxide, Colophonium, lanoline adds the Oleum Cinnamomi mixing again, makes coating, be coated with cream, cutting, lid lining, section, promptly.
Embodiment 3
A kind of treatment asthenic cold type chronic gastroenteritis, rheumatic arthritis rubber-emplastrum are by comprising following raw material (weight: the unguentum of g) making: Fructus Capsici 5.4, Rhizoma Zingiberis 5, Oleum Cinnamomi 0.3, Cortex Cinnamomi 1; And matrix components rubber, zinc oxide, Colophonium, lanoline, the proportioning ratio is 1.5: 1.5: 1.2: 0.2.
Preparation method: Rhizoma Zingiberis is broken into coarse powder; Pepper drying is broken into coarse powder; With the Cortex Cinnamomi drying, be broken into coarse powder, add said mixture, mixture is with 85% ethanol extraction secondary, each 2 hours, extracting liquid filtering, filtrate recycling ethanol is condensed into the clear paste of 1.2-1.3 (70 ℃) to there not being the alcohol flavor, adds the substrate that above-mentioned rubber, zinc oxide, Colophonium, lanoline are made, add the Oleum Cinnamomi mixing again, make coating, be coated with cream, cutting, the lid lining is cut into pieces, promptly.
Embodiment 4
A kind of treatment asthenic cold type chronic gastroenteritis, rheumatic arthritis rubber-emplastrum are by comprising following raw material (weight: the unguentum of g) making: Fructus Capsici 3.8, Rhizoma Zingiberis Recens 2, Oleum Cinnamomi 0.1, Cortex Cinnamomi 1.35; And base rubber, zinc oxide, Colophonium, lanoline, the proportioning ratio is 2.5: 2.5: 2.5: 0.55.
Preparation method: with embodiment 3.
Embodiment 5
A kind of treatment asthenic cold type chronic gastroenteritis, rheumatic arthritis rubber-emplastrum are by comprising following raw material (weight: the unguentum of g) making: Fructus Capsici 5.4, Rhizoma Zingiberis Recens 5, Oleum Cinnamomi 0.3; And base rubber, zinc oxide, Colophonium, lanoline, the proportioning ratio is 0.5: 0.5: 0.4: 0.1.
Preparation method: with embodiment 1, difference is the Cortex Cinnamomi drying is broken into coarse powder, adds said mixture, uses alcohol dipping.