Summary of the invention
Purpose of the present invention is exactly the problem that exists at above-mentioned prior art, and a kind of elimination clinical symptoms is provided, promotes ulcer healing, prevention of recurrence and avoids complication, the Chinese medicine preparation that cure rate is high.
This preparation be famous pharmacologist professor ZhaoDongKe based on motherland's medical science to the pathogenetic understanding of chronic gastritis stomach function regulating, duodenal ulcer and reflux esophagitis, excavate the traditional Chinese medical science and enrich clinical experience, in conjunction with modern pharmacological research, test drawing in a large number, each amounts of components all has better curative effect in the following weight parts scope.
Endoconcha Sepiae 28-36 part, Herb Gynostemmae Pentaphylli total glycosides 0.5-1.5 part, Fructus Hippophae 20-30 part, Fructus Aurantii Immaturus 50-65 part, Rhizoma Atractylodis Macrocephalae 70-85 part, Cortex Phellodendri 15-25 part, Rhizoma Corydalis 15-25 part, Radix Glycyrrhizae 50-65 part.
Be preferably: 32 parts of Endoconcha Sepiaes, 1 part of Herb Gynostemmae Pentaphylli total glycosides, 25 parts of Fructus Hippophaes, 57 parts of Fructus Aurantii Immaturuss, 76 parts of the Rhizoma Atractylodis Macrocephalaes, 19 parts of Cortex Phellodendris, 20 parts of Rhizoma Corydalis, 57 parts in Radix Glycyrrhizae.
Wherein Endoconcha Sepiae is salty, puckery, temperature.Return spleen, kidney channel.Have astringing to arrest bleeding, hold back effects such as skin ulcer antacid, cure mainly Peptic Ulcers, hyperchlorhydria, stomachache acid regurgitation, hematemesis hematochezia; Herb Gynostemmae Pentaphylli total glycosides has the spleen invigorating of nourishing heart, QI invigorating and blood regulating, expectorant blood stasis dispelling effect; Fructus Hippophae is rich in vitamin C and several amino acids, regains one's strength, allaying tiredness, digestion and ShengJing, nourishing stomach and spleen, strong intensive culture is refreshing and promote cellular metabolism, promotes epithelial tissue regeneration, the effect of antibacterial anti-inflammatory; Fructus Aurantii Immaturus hardship, suffering are slightly cold.Return spleen, stomach large intestine channel, be suitable for that gastrointestinal retention abdominal distention, excess-heat knot stagnates, stomachache distension, food stagnation do not disappear, stagnation of phlegm-damp in middle-JIAO, the dispelling the stagnated QI intestinal stasis relieving is arranged, the painful abdominal mass effect that disappears of reducing phlegm; Rhizoma Atractylodis Macrocephalae bitter in the mouth, sweet, temperature.Return spleen, stomach warp.Be used for that insufficiency of the spleen lack of appetite, abdominal distention are had loose bowels, the phlegm retention vertigo and palpitation, invigorating the spleen and benefiting QI, dampness diuretic arranged, the effect of hidroschesis stomach function regulating; Cortex Phellodendri is cold in nature, and bitter in the mouth is used for damp-heat dysentery, sore swollen toxin, has heat clearing and damp drying, pathogenic fire purging to remove and steams, detoxifies and treat the effect of skin ulcer; Rhizoma Corydalis suffering, hardship, temperature.GUIXIN bag, liver, spleen, lung meridian.Promoting flow of QI and blood, pain relieving blood stasis dispelling, the intestinal stasis relieving painful abdominal mass effect that disappears is arranged; The Radix Glycyrrhizae invigorating the spleen and replenishing QI, the collateral dredging arteries and veins has the effect of warming middle-JIAO emergency and coordinating the actions of various ingredients in a prescription.
Endoconcha Sepiae, Herb Gynostemmae Pentaphylli total glycosides, Fructus Hippophae, Fructus Aurantii Immaturus, the Rhizoma Atractylodis Macrocephalae, Cortex Phellodendri, Rhizoma Corydalis, Radix Glycyrrhizae, all medicines share to have astringing to arrest bleeding, holds back skin ulcer antacid, QI invigorating and blood regulating, expectorant blood stasis dispelling, digestion and ShengJing, invigorating the spleen and regulating the stomach, strong intensive culture god, dispelling the stagnated QI intestinal stasis relieving, painful abdominal mass, dampness diuretic, convergence pain relieving, detoxifcation treatment skin ulcer, the promoting flow of QI and blood effect of disappearing of reducing phlegm, modern pharmacological research shows that sweet extra large Weikang capsule for curing gastric disease has the promotion cellular metabolism, prevent that inflammatory from invading profit, promote epithelial tissue regeneration, improve not tip blood circulation and capillary permeability, promote the effect of ulcer healing.
Another object of the present invention provides manufacturing method for above mentioned medicine.
Preparation method: Endoconcha Sepiae is ground into fine powder and Herb Gynostemmae Pentaphylli total glycosides mix homogeneously, standby, Fructus Hippophae, Fructus Aurantii Immaturus, the Rhizoma Atractylodis Macrocephalae, Cortex Phellodendri, Rhizoma Corydalis, Radix Glycyrrhizae decocts with water three times, add for the first time 10-14 times of water gaging and soaked 25-35 minute, decocted 1.5-2.5 hour, add 6-10 times of water gaging for the second time, decocted 1-2 hour, add 6-10 times of water gaging for the third time and decocted 0.5-1.5 hour, merge three times decoction liquor, filter, filtrate is concentrated into the thick paste that relative density is 1.35-1.40 (60 ℃ of heat is surveyed), add Endoconcha Sepiae fine powder and Herb Gynostemmae Pentaphylli total glycosides and stir, vacuum drying is ground into fine powder, granulate, drying is sub-packed in the capsule, sterilization back packing.
This composition of medicine also can be made pill, powder, electuary, unguentum, oral liquid.
In order to verify the present invention; drug nomenclature of the present invention is ' a sweet extra large Weikang capsule for curing gastric disease '; the inventor has carried out pharmacodynamic study in the Xi'an Communications University institute of pharmacology; protection mechanism research and safety research to anti-fluidity esophagitis esophageal mucosa membrane injury comprise acute toxicity test and long term toxicity test; and select the part model case, particulars is seen appendix.
In addition, carried out following clinical trial in No.1 affiliated Hospital, Xian Medical Univ..
Test example 1
Clinical trial
Sweet extra large Weikang capsule for curing gastric disease treatment peptic ulcer clinical trial 130 examples are summed up
No.1 affiliated Hospital, Xian Medical Univ.
My institute has carried out clinical trial to the sweet extra large Weikang capsule for curing gastric disease of Chinese medicine for the treatment of chronic gastritis and gastric and duodenal ulcers, observe case 175 examples altogether, test group (sweet extra large Weikang capsule for curing gastric disease) 130 examples wherein, matched group (WEINAI AN JIAONANG) 45 examples are existing as follows with the clinical trial situation report:
One, physical data
1, case source: select outpatient service and inpatient totally 175 examples, whole cases all meet includes the case choice criteria in.
2, sex: two groups of patient's sex situation comparabilities detect, and see Table 1.
table 1 patient sex distribution situation
Group | The example number | Man N (%) | Woman N (%) |
The test group matched group | 130 45 | 70(53.8) 23(51.1) | 60(46.2) 22(48.9) |
X
2(2×2)=0.1004 P>0.05
As can be seen from the above table, test group and matched group sex distribution there was no significant difference, P>0.05 illustrates that two groups have comparability.
3, the age: two groups of age comparabilities detect, maximum 59 years old age of test group, minimal ages 18 years old; At maximum 56 years old age of matched group, minimal ages 18 years old is commented to see Table 2.
Table 2 liang group age distribution situation comparison (year)
Group | The example number | N (%) below 30 years old | 30-50 year N (%) | 50~ N(%) |
The test group matched group | 130 45 | 39(30.0) 11(24.4) | 65(50.0) 25(55.6) | 26(20.0) 9(20.0) |
X
2(R×C)=0.5617 P>0.05
as can be seen from the above table, test group and matched group age distribution there was no significant difference, P>0.05 illustrates that two groups have comparability.
4, occupation: two groups of patient's occupation distribution situation comparabilities detect, and see table 3 for details.
The professional distribution situation of table 3
Group | The example number | Workman N (%) | Cadre N (%) | Peasant N (%) | Other N (%) |
The test group matched group | 130 45 | 35(26.9) 15(33.3) | 39(30.0) 11(24.4) | 29(22.3) 10(22.2) | 27(20.8) 9(20.0) |
X
2(R×C)=0.8516 P>0.05
As can be seen from the above table, test group and matched group occupation distribution there was no significant difference, P>0.05 illustrates that two groups have comparability.
5, differential diagnosis in tcm: two groups of patient's tcm syndrome differentiation and typing situations can see Table 4 through the property detection.
Table 4 liang group patient tcm syndrome differentiation and typing situation
Group | The example number | Stagnation of QI pattern of syndrome N (%) | Insufficiency of the spleen pattern of syndrome N (%) |
The test group matched group | 130 45 | 55(42.3) 22(48.9) | 75(57.7) 23(51.1) |
X
2(2×2)=0.0.5876 P>0.05
As can be seen from the above table, test group and two pattern of syndrome distribution situations of matched group there was no significant difference, P>0.05 illustrates that two groups have comparability.
Two, case is selected
1, Western medicine diagnose standard
Draft diagnostic criteria with reference to " the clinical research guideline of new Chinese medicine treatment peptic ulcer ";
The periodicity of prolonged and repeated generation, the chronic epigastrium pain of rhythmicity, the using basic medicine can be alleviated; Epigastrium has limitation deeply in tenderness; Splanchnoscopy can be seen active stage ulcer.
2, differential diagnosis in tcm standard
Syndrome of spleen-deficiency: it is indistinct that primary symptom shows as 1. stomachache, the happiness pain relieved by pressing; 2. cold whenever or tired easy outbreak or increase the weight of; 3. pain of empty stomach is heavy, must eat alleviation of pain, abdominal distention after meal; 4. pale and tender tongue, there is indentation on the limit, white and thin fur; 5. deep-thready pulse or late.Inferior disease performance: 1. fatigue and weakness, spiritlessness and sparing of words; 2. aversion to cold and cold limbs; 3. big loose stool is thin.
Above-mentioned primary symptom is 1. indispensable, and should having in all the other primary symptoms 1 concurrently, to add time 2 of diseases promptly diagnosable.
Syndrome of stagnation of QI: primary symptom shows as 1. gastral cavilty distending pain, two side of body feeling of distension and oppression; 2. meet that feelings will is unsuccessful then to be increased the weight of; 3. belch or arrow gas then relax; 4. susceptible to get angry; Sighing frequently.Inferior disease shows as lack of appetite 1. uncomfortable in chest; 2. pantothenic acid guttation; 3. thin white fur of tongue; 4. stringy pulse.□
1. above-mentioned primary symptom must possess, and should having in all the other primary symptoms 1 concurrently, to add time 2 of diseases promptly diagnosable.
3, case is included standard in: meet primary disease diagnosis and differential diagnosis in tcm standard and through the fibergastroscope person that confirms to suffer from the peptic ulcer, can include the test case in.
4, exclusion standard: 1. in preceding 30 days of test, complication takes place and the person of undergoing surgery; Stomach or 12 gallbladder intestinal ulcer that 2. cause specific is arranged are as gastrinoma etc.; 3. the age is at under-18s, person more than 60 years old; 4. be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, the psychotic; 5. gestation or women breast-feeding their children; 6. the observation that can affect the treatment of other complication is arranged; 7. all standards of including in that do not meet, medication person in accordance with regulations not can't judge that curative effect or data are not congruent to affect the treatment or safety judgement person.
Three, test method
1, case source: the outpatient service of clinical trial unit and inpatient, out-patient's strict control variable factor and drug combination voluntarily are with the comparability of guarantee test.
2, blind method is selected and implemented: adopt single blind observation plan, 175 routine cases adopt the completely random method of dividision into groups.
3, administrated method: the sweet extra large Weikang capsule for curing gastric disease of test group is provided by research institute, every day 3 times, each 6; Matched group medicine WEINAI AN JIAONANG, every day 3 times, each 6.
Four, efficacy determination
1, Syndrome in TCM marquis curative effect determinate standard
Clinical cure: primary symptom all disappears with time disease;
Produce effects: primary symptom all has clear improvement with time disease; Or primary symptoms are slightly improved individually, but inferior disease all disappears;
Effectively: primary symptom all has improvement with time disease; Or primary symptom do not have improvement, but inferior disease all disappears;
Invalid: primary symptom, inferior disease all do not have improvement.
2, gastroscopy effect criterion
Clinical cure: the ulcer complete obiteration, local mild hyperaemia does not have obvious edema;
Produce effects: ulcer disappears substantially, still has obvious inflammation;
Effectively: ulcer surface dwindles more than 50%;
Invalid: ulcer surface dwindles not as good as 50%.
Five, therapeutic effect
1, two groups of tcm syndrome efficacy determination contrasts see table 5 for details.
Table 5 liang group tcm syndrome curative effect situation
Group | The example number | Clinical cure N (%) | Produce effects N (%) | Invalid N (%) | Effective N (%) | Total effectively N (%) |
The test group matched group | 130 45 | 44(33.8) 7(15.6) | 21(16.2) 4(8.9) | 13(10.0) 12(26.7) | 52(40.0) 22(48.9) | 117(90.0) 33(73.3) |
Ridit analyzes: R
Examination=0.4429, R
Right=0.3410, u=2.0415, P<0.05.
As can be seen from the above table, the test group curative effect obviously is better than matched group, and significant difference P<0.05 is arranged between both curative effects.
2, test group differential diagnosis in tcm curative effect situation relatively sees table 6 for details.
The contrast of table 6 test group differential diagnosis in tcm curative effect situation
Group | The example number | Clinical cure N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effectively N (%) |
The test group matched group | 75 55 | 24(32.0) 20(36.4) | 13(17.3) 8(14.5) | 30(40.0) 22(40.0) | 8(10.7) 5(9.1) | 67(89.3) 50(90.9) |
Ridit analyzes: R
Insufficiency of the spleen=0.3697, R
The stagnation of QI=0.3855, u=0.2174, P>0.05.
As can be seen from the above table, curative effect no significant difference between two pattern of syndrome of test group, P>0.05.
3, the relation of test group age and curative effect sees table 7 for details.
Table 7 test group age and tcm syndrome therapeutic effect relationship
Age | The example number | Clinical cure N (%) | Produce effects N (%) | Effective N (% | Invalid N (%) | Total effectively N (%) |
~30 30~50 50~ | 39 65 26 | 12(30.8) 25(38.5) 7(26.9) | 7(17.9) 11(16.9) 3(11.5) | 16(41.0) 23(35.4) 13(50.0) | 4(10.3) 6(9.2) 3(11.5) | 35(89.7) 59(90.8) 23(88.5) |
Ridit analyzes: R
~30=0.4991, R30=0.5237, R50=0.4420, x2=1.4887, P>0.05.
As can be seen from the above table, test group age grading and curative effect there was no significant difference, P>0.05.
4, the test group sex distributes and the curative effect situation, sees table 8 for details.
Table 8 test group sex distributes and the curative effect situation
Group | The example number | Clinical cure N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effectively N (%) |
The men and women | 70 60 | 24(34.3) 20(33.3) | 12(17.1) 9(15.0) | 27(38.6) 25(41.7) | 7(10.0) 6(10.0) | 63(90.0) 54(90.0) |
Ridit analyzes: R
The man=0.3983, R
The woman=0.0346, u=0.2706, P>0.05.
As can be seen from the above table, test group sex and curative effect no significant difference, P>0.05.
5, the comparison of two groups of patient's gastroscopy effects sees table 9 for details.
Table 9 liang group patient gastroscopy effect relatively
Group | The example number | Clinical cure N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effectively N (%) |
The test group matched group | 130 45 | 39(30.0) 9(20.0) | 19(14.6) 3(6.7) | 59(45.4) 21(46.7) | 13(10.0) 12(26.7) | 117(90.0) 33(73.3) |
Ridit analyzes: R
Examination=0.4455, R
Right=0.3434, u=2.0451, P<0.05.
As can be seen from the above table, two groups of patient's gastroscopy effects compare, and test group obviously is better than matched group, P<0.05.
Six, test group is estimated with ulcer healing quality (QUH) and ultrasonic endoscope (EUS)
A, ulcer healing quality (QUH) are estimated
1, QUH evaluation criterion
(1) regenerated mucosa Maturity under the scope
1. R phase (regeneration period): have white fur to exist
R
0Phase: the ulcer edge does not have regeneration floss hair; R
1Phase: the ulcer edge fine hair of can regenerating on a small quantity.
2. S phase (cicatrix phase): white fur disappears
The Sa phase: ulcer cicatrix central part depression;
The Sb phase: ulcer cicatrix central part depression disappears, and regeneration fine hair is big particle;
The Sc phase: ulcer cicatrix concavity disappears, and regeneration fine hair is fine particle, and cicatrix portion mucosa is smooth, near the normal mucosa form.
(2) regenerated mucosa histology Maturity
1. epithelial cell: the thickness of regenerated mucosa, epithelial cell group,
2. granulation tissue: with the regeneration situation of fibroblast quantity, new vessels number and distribution structure phase, collagen fiber and muscular layer of mucosa.
(3) regenerated mucosa function assessment Maturity: biopsy comprises
1. microcirculation situation (mucosal blood flow mensuration);
2. glycoprotein assay and sugared component analysis;
3. prostaglandin (PGS), epidermal growth factor (EGF) level determination;
4. regenerated mucosa produces the mucus function;
5. expression of receptor situation such as EGF-R ELISA, heat shock protein (HSPS) are expressed and the mensuration of immunologic function etc.
2, evaluation result
(1) mucosa Maturity under the scope: the Sc phase heals;
(2) regenerated mucosa histology Maturity: newborn mucosa is basic identical with normal mucosa thickness.There is a large amount of granulation tissuies to form;
(3) regenerated mucosa function assessment Maturity: blood flow speeds, prostaglandin (PGS), and epidermal growth factor (EGF) is than different the raising all arranged before the medication.
3, conclusion: sweet extra large Weikang capsule for curing gastric disease treatment peptic ulcer reaches the healing of I level.
B, ultrasonic endoscope evaluation
1, ultrasonic endoscope evaluation criterion
Chronic ulcer generally was divided into for three phases from acute stage healing extremely fully:
(1) acute stage (A phase) claims the thick fur phase again: the ulcer initial phase, there are tangible inflammation, edema in the ulcer edge, and tissue repair does not begin.
The A1 phase: ulcer thick fur and filth, mucosa swelling on every side, no duplicature is concentrated;
The A2 phase: the formed blush of epithelium regeneration occurs around the ulcer thick fur and cleaning, ulcer, mucosa swelling on every side fades away, and begins to occur the duplicature of concentrating to ulcer.
(2) healing stage (H phase) ulcer tongue attenuation, ulcer is dwindled, the blush that has epithelium regeneration to form all around, and have duplicature to concentrate to ulcer.The difference of H1 phase and H2 phase is latter's ulcer near healing fully, but it is residual to have a little thin and whitish fur.
(3) this phase ulcer of cicatricial phase (S phase) complete obiteration healing is repaired and is finished.
The S1 phase: the ulcer tongue disappears, and central authorities are congested, the cicatrix red cicatricial phase that takes on a red color-claim again;
The S2 phase: the white cicatricial phase of red complete obiteration-claim again.
2, criterion
Clinical cure: the high echo of white fur disappears, and does not show the low echo of ulcer;
Produce effects: the high echo of white fur disappears substantially, the low echo of the ulcer that display list is shallow;
Effectively: the high echo of white fur does not disappear, the low echo of the ulcer that display list is shallow;
Invalid: the high echo of white fur exists, and shows the low echo of ulcer.
3, evaluation result
(1) active stage and healing stage all the low echo of visible ulcer shoal;
(2) the high echo of the white fur of cicatricial phase disappears, and the low echo of ulcer also can not show sometimes.
4, conclusion: sweet extra large Weikang capsule for curing gastric disease can obviously improve the ulcer healing quality.
Seven, safety analysis
Sweet extra large Weikang capsule for curing gastric disease of test group and matched group WEINAI AN JIAONANG are not found obvious toxic-side effects and untoward reaction in the experimental observation process, two group of 80% patient all done blood, urine, stool routine regulating liver-QI, kidney function test and Electrocardioscopy before and after the treatment, check result is all no abnormal, show and use said preparation safety, and have no side effect.
Eight, conclusion
1, by the clinical comparison test, said preparation has significant curative effect to the peptic ulcer patient as can be seen.Its tcm syndrome total effective rate is 90.0%.
2, said preparation gastroscopy effect total effective rate is 90.0%.
3, said preparation is to analyzing through Ridit between the segmentation of peptic ulcer patient's age, sex and the tcm syndrome curative effect, there was no significant difference, and P>0.05 shows that said preparation is not subjected to the influence of above-mentioned factor, curative effect is approaching.
4, it is basic identical with normal mucosa thickness to estimate newborn as can be seen mucosa with ulcer healing quality (QUH), there is a large amount of meat dental tissues to form, blood flow speeds and can promote its energy metabolism, guarantee that mucous epithelium and ulcer bottom and edge body of gland are regenerated rapidly and the acid-base balance of maintenance mucosa microenvironment, prostaglandin simultaneously, epidermal growth factor all have different the raising before than medication.Thereby improve the gastric mucosal barrier function, strengthen the mucosa repair ability, improve QUH.
5, with ultrasonic endoscope (EUS) estimate as can be seen active stage and healing stage all the low echo of visible ulcer shoal; The high echo of the white fur of cicatricial phase disappears, and the low echo of ulcer also can not show sometimes, shows that sweet extra large Weikang capsule for curing gastric disease can obviously improve the ulcer healing quality.
6, in the said preparation clinical trial process, do not find obvious toxic-side effects and untoward reaction, the inspection by to routine blood test, routine urinalysis, stool routine, liver, renal function and electrocardiogram etc. before and after the treatment shows the said preparation application safety.
Observe by 175 examples (sweet extra large Weikang capsule for curing gastric disease 130 examples of test group, matched group WEINAI AN JIAONANG 45 examples) clinical trial, show that sweet extra large Weikang capsule for curing gastric disease treatment peptic ulcer has significant curative effect, and do not find toxic and side effects and untoward reaction, illustrate that said preparation is safe and effective.
Test example 2
Sweet extra large Weikang capsule for curing gastric disease treatment chronic gastritis and gastroduodenal ulcer clinical observation are summed up
First Affiliated Hospital of Xi'an Communications University
Traditional Chinese Medicine Research Institute, Shanxi Province Affiliated Hospital
We are with sweet extra large Weikang capsule for curing gastric disease treatment chronic gastritis and gastric and duodenal ulcers 250 examples, simultaneously with WEINAI AN JIAONANG treatment chronic gastritis and duodenal ulcer 95 examples as matched group, carried out comparatively detailed observation, now be summarized as follows.
Clinical data
One, physical data
Sweet extra large Weikang capsule for curing gastric disease is organized as treatment, totally 250 examples, wherein male 134 examples, women 116 examples, the oldest 59 years old minimum 18 years old.WEINAI AN JIAONANG group 95 examples, wherein male 44 examples, women 41 examples, maximum 59 years old age, 18 years old off year, 39 years old mean age.Belong to insufficiency of the spleen pattern of syndrome 142 examples, stagnation of QI pattern of syndrome 108 examples in the treatment group.Belong to insufficiency of the spleen pattern of syndrome 44 examples, stagnation of QI pattern of syndrome 41 examples in the matched group.
Two, diagnostic criteria: undertaken by " sweet extra large Weikang capsule for curing gastric disease clinical research scheme ".
Three, Therapeutic Method: undertaken by " sweet extra large Weikang capsule for curing gastric disease clinical research scheme ".
Four, curative effect judging standard: undertaken by " sweet extra large Weikang capsule for curing gastric disease clinical research scheme ".
Therapeutic outcome
One, treatment group and matched group observation of curative effect result see Table 1
Table 1 treatment group and matched group tcm syndrome observation of curative effect table
Group | Cure N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate N (%) | The P value |
Treatment group (250) matched group (95) | 85(34.0) 13(15.3) | 40(16.0) 7(8.2) | 101(40.4) 43(50.7) | 24(9.6) 22(25.9) | 226(90.4) 63(74.2) | P<0.05 |
Table 1 explanation, the total effective rate of treatment group is 90.4%, 74.2%, two group of comparing difference of the total effective rate of matched group has apparent Millefolium meaning (P<0.05), show sweet extra large Weikang capsule for curing gastric disease to chronic gastritis, gastric and duodenal ulcers curative effect apparently higher than matched group.
Two, treatment group and matched group see Table 2 to traditional Chinese medical science different syndrome type observation of curative effect result
Table 2 treatment group is to traditional Chinese medical science different syndrome type observation of curative effect table
Typing | Treatment group (250) | The P value |
Total routine number | Effective routine number | Effective percentage (%) |
Insufficiency of the spleen pattern of syndrome syndrome of stagnation of QI type | 142 108 | 128 99 | 90.2 91.7 | P>0.05 |
Table 2 explanation, the treatment group shows that to the curative effect no significant difference between two pattern of syndrome (P>0.05) sweet extra large Weikang capsule for curing gastric disease all has curative effect preferably to insufficiency of the spleen pattern of syndrome, stagnation of QI pattern of syndrome.
Three, treatment group age and therapeutic effect relationship see Table 3
Table 3 treatment group age and observation of curative effect table
Age | The example number | Cure N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate N (%) | The P value |
~30 30~50 50~ | 77 130 43 | 24(31.2) 49(37.6) 12(28.5) | 14(18.2) 21(6.2) 5(11.65) | 31(40.2) 48(37.0) 22(51.15) | 8(10.4) 12(9.2) 4(8.7) | 69(89.6) 118(90.8) 39(91.3) | P>0.05 |
Table 3 explanation, the treatment group age, influence had little significance (P>0.05) to clinical efficacy, showed that sweet extra large Weikang capsule for curing gastric disease is applicable to all age group to treatment chronic gastritis, gastric and duodenal ulcers.
Four, treatment group and matched group gastroscopy effect are observed, and see Table 4
Table 4 treatment group and matched group gastroscopy effect are observed table
Group | The example number | Clinical cure N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate N (%) | The P value |
The test group matched group | 250 95 | 78(31.25) 17(20.0) | 36(14.4) 5(5.85) | 111(44.35) 41(48.3) | 25(10.0) 22(25.85) | 225(90.0) 63(74.15) | P< 0.05 |
Table 4 explanation: treatment group gastroscopy effect total effective rate 90.0%, 74.15%, two group of obvious difference of the gastroscopy effect total effective rate of matched group (P<0.05) shows that sweet extra large Weikang capsule for curing gastric disease gastroscopy effect is apparently higher than matched group.
Five, to test group ulcer healing quality (QUH) and ultrasonic endoscope (EUS) evaluation result
1, ulcer healing quality (QUH) evaluation result
(1) mucosa Maturity under the scope: the Sc phase heals;
(2) regenerated mucosa histology Maturity: newborn mucosa is basic identical with normal mucosa thickness.There is a large amount of granulation tissuies to form;
(3) regenerated mucosa function assessment Maturity: blood flow speeds, prostaglandin (PGS), epidermal growth factor (EGF) be than different the raising all arranged before the medication.
Conclusion: sweet extra large Weikang capsule for curing gastric disease treatment peptic ulcer reaches the healing of I level
2, ultrasonic endoscope evaluation result
(1) active stage and healing stage all the low echo of visible ulcer shoal;
(2) the high echo of the white fur of cicatricial phase disappears, and the low echo of ulcer also can not show sometimes.
Conclusion: sweet extra large Weikang capsule for curing gastric disease can obviously improve the ulcer healing quality.
Conclusion
1, sweet extra large Weikang capsule for curing gastric disease is to peptic ulcer, and chronic gastritis patient has significant curative effect.Its Syndrome in TCM marquis total effective rate is 90.4%, and matched group is 74.2%, two group of difference significance (P<0.05), illustrates that said preparation is higher than matched group to the curative effect of peptic ulcer, chronic gastritis.
2, sweet extra large Weikang capsule for curing gastric disease is all effective in cure to the gentle stagnant pattern of syndrome of insufficiency of the spleen pattern of syndrome, and effective percentage is respectively 90.2% and 91.7%, amphitypy comparing difference nonsignificance (P>0.05).
3, sweet extra large Weikang capsule for curing gastric disease gastroscopy effect total effective rate is 90.0%, and it is 74.15% that the matched group gastroscope is imitated total effective rate, P<0.05, and curative effect is apparently higher than matched group.
4, sweet extra large Weikang capsule for curing gastric disease is to analyzing with Ridit between the segmentation of peptic ulcer patient's age, sex and the Syndrome in TCM marquis curative effect, there was no significant difference, and P>0.05 shows that said preparation is not subjected to the influence of above-mentioned factor, curative effect is approaching.
5, it is basic identical with normal mucosa thickness to estimate newborn as can be seen mucosa with ulcer healing quality (QUH), there is a large amount of meat dental tissues to form, blood flow speeds and can promote its energy metabolism, guarantee that mucous epithelium and ulcer bottom and edge body of gland are regenerated rapidly and the acid-base balance of maintenance mucosa microenvironment, prostaglandin simultaneously, epidermal growth factor all have different the raising before than medication.Thereby improve the gastric mucosal barrier function, strengthen the mucosa repair ability, improve QUH.
6, with ultrasonic endoscope (EUS) estimate as can be seen active stage and healing stage all the low echo of visible ulcer shoal; The high echo of the white fur of cicatricial phase disappears, and the low echo of ulcer also can not show sometimes, shows that sweet extra large Weikang capsule for curing gastric disease can obviously improve the ulcer healing quality.
7, in the sweet extra large Weikang capsule for curing gastric disease clinical trial process, do not find obvious toxic-side effects and untoward reaction, the inspection by to routine blood test, routine urinalysis, stool routine, liver, renal function and electrocardiogram etc. before and after the treatment shows that said preparation is safe in utilization.
In sum, by 345 examples (sweet extra large Weikang capsule for curing gastric disease 250 examples of test group, matched group WEINAI AN JIAONANG 95 examples) clinical trial is observed, show that sweet extra large Weikang capsule for curing gastric disease treatment peptic ulcer, chronic gastritis have significant curative effect, and there are not obvious toxic-side effects and untoward reaction, illustrate that said preparation is safe and effective, be worthy of popularization.
Test example 3
Sweet extra large Weikang capsule for curing gastric disease is treated anti-fluidity esophagitis 66 routine final reports
First Affiliated Hospital of Xi'an Communications University
My institute has carried out clinical trial to the sweet extra large Weikang capsule for curing gastric disease of new Chinese medicine for the treatment of chronic gastritis, peptic ulcer and anti-fluidity esophagitis, has observed 116 examples altogether, treatment group (sweet extra large Weikang capsule for curing gastric disease) 66 examples, matched group (ranitidine) 50 examples.Now that clinical experiment report is as follows.
One, physical data
1, case source: select outpatient service and inpatient 116 examples, whole cases meet includes the case choice criteria in.
2, sex: two groups of patient's sex situation comparabilities detect, and see Table 1.
Table 1 patient sex distribution situation
Group | The example number | Man N (%) | Woman N (%) |
The test group matched group | 66 50 | 34(51.5) 22(44) | 32(48.5) 28(56) |
X
2(2×2)=0.1002 P>0.05
As can be seen from the above table, test group and matched group sex distribution there was no significant difference, P>0.05 illustrates that two groups have comparability.
3, the age: two groups of age comparabilities detect, maximum 64 years old age of test group, minimal ages 18 years old; At maximum 61 years old age of matched group, minimal ages 19 years old auspiciously sees Table 2.
Table 2 liang group age distribution situation comparison (year)
Group | The example number | N (%) below 30 years old | 30~50 N(%) | 50~ N(%) |
The test group matched group | 66 50 | 16(24.2) 11(22) | 31(47) 23(46) | 19(28.8) 16(32) |
X
2(R×C)=0.5421 P>0.05
As can be seen from the above table, test group and matched group age distribution there was no significant difference, P>0.05 illustrates that two groups have comparability.
4, occupation: two groups of patients occupation distribution situation comparabilities detect, and auspiciously see Table 3.
The professional distribution situation comparison of table 3 liang group (year)
Group | The example number | Workman N (%) | Cadre N (%) | Peasant N (%) | Other N (%) |
The test group matched group | 66 50 | 14(21.2) 11(22) | 16(24.2) 13(26) | 17(25.6) 14(28) | 19(28.9) 12(24) |
X
2(R×C)=0.7421 P>0.05
As can be seen from the above table, test group and matched group occupation distribution there was no significant difference, P>0.05 illustrates that two groups have comparability.
Two, case is selected
1, case is included standard in
Work out diagnostic criteria with reference to " new Chinese medicine is treated the clinical research guideline of anti-fluidity esophagitis ";
Burn feeling or pain, acid regurgitation, acataposis behind the breastbone, in addition hemorrhage, establish diagnosis person in conjunction with acid perfusion test, stomach esophagus scintigraphy or fiber boroscopy and tissue pathology checking, can include the test case in.
2, exclusion standard
1. the age is at under-18s, person more than 70 years old; 2. be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, the psychotic; 3. gestation and women breast-feeding their children; 4. other complication observer that can affect the treatment; 5. allly be not inconsistent and include standard in, medication person in accordance with regulations not can't judge that curative effect or data are not congruent to affect the treatment or safety judgement person.
Three, test method
1, case source: the outpatient service of clinical trial unit and inpatient, out-patient's strict control variable factor and drug combination voluntarily are to protect the comparability of testing;
2, blind method is selected and implemented: adopt single blind method observation plan, 116 routine cases adopt the completely random method of dividision into groups;
3, administrated method: the oral sweet extra large Weikang capsule for curing gastric disease of test group, one time 6,3 times/day, 1 month is a course of treatment; Matched group: oral ranitidine, each 150mg, 3 times/day, 1 month is a course of treatment.
Four, curative effect determinate standard
1, recovery from illness: clinical symptom disappearance, diet is normal, and the gastroscope finding does not have gastric juice and backflows into esophagus, and it is normal that mucous membrane of esophagus Histological change recovers;
2, produce effects: symptom disappears substantially, and diet is normal substantially, and the gastroscope finding does not have gastric juice and backflows into esophagus, and mucous membrane of esophagus Histological change is clearly better or recovers normal substantially;
3, effective: sx, gastroscope finding gastric juice still backflows into esophagus, and the mucous membrane of esophagus inflammation takes a turn for the better or scope is dwindled;
4, invalid: clinical symptoms and gastroscope finding do not have improvement.
Five, therapeutic outcome
1, two groups of patient's curative effects relatively auspiciously see Table 4
Table 4 liang group patient curative effect relatively
Group | The example number | Clinical recovery N (%) | Produce effects N (%) | Effective N (%) | Invalid N (%) | Total effective rate N (%) |
The test group matched group | 66 50 | 29(43.9) 12(24) | 17(25.8) 15(30) | 16(24.2) 8(16) | 4(6.1) 15(30) | 62(93.94) 35(70) |
Ridit analyzes: R
Examination=0.435, R
Right=0.4134, P<0.05.
From as can be seen above, two groups of patient's therapeutic evaluatioies, test group is apparently higher than matched group, p<0.05.Illustrate that there were significant differences between two groups, the test group curative effect obviously is better than matched group.
Six, safety analysis
Sweet extra large Weikang capsule for curing gastric disease of test group and matched group clothes ranitidine are not found obvious toxic-side effects and untoward reaction in the experimental observation process, two group of 80% patient all done blood, urine, stool routine and inspection of Liver and kidney merit and Electrocardioscopy before and after the treatment, check result is all no abnormal, show and use said preparation safety, and have no side effect.
Seven, conclusion
1, by the clinical comparison test, said preparation has significant curative effect to anti-fluidity esophagitis as can be seen.And total effective rate reaches 93.94%;
2, said preparation is to analyzing with Ridit between the segmentation of anti-fluidity esophagitis patient's age, sex and the occupation, no significant difference, and P>0.05 shows that said preparation is not subjected to the influence of above-mentioned factor, curative effect is approaching;
3, in the said preparation clinical trial process, do not find obvious toxic-side effects and untoward reaction, check and Electrocardioscopy that by blood, urine, stool routine and Liver and kidney merit check result is all no abnormal, show and use the said preparation application safety.
By 116 examples (sweet extra large Weikang capsule for curing gastric disease 66 examples of test group, matched group ranitidine 50 examples) clinical trial is observed, and shows that sweet extra large Weikang capsule for curing gastric disease treats anti-fluidity esophagitis significant curative effect is arranged, and total effective rate reaches 93.94%, and do not find toxic and side effects, illustrate that transformation of the way agent is safe and effective.
The present invention is described in further detail below in conjunction with instantiation that the inventor provides.