The specific embodiment
According to the prescription that the technical program provided, adopt existing Chinese medicine preparation method to make capsule or tablet, electuary, carry out following clinical trial, the prescription of embodiment sees Table one.
The type ii diabetes diagnostic criteria: with reference to the diabetes etiology typing standard of publishing on the Diabetes Care magazine in July, 1997, all diagnosis of diabetes standards that meets, the insulin release test result meets one of following condition person and promptly is diagnosed as type 2 diabetes mellitus.1. with the insulin resistant the relative insufficient insulin of main companion.2. insulin obviously lacks companion's insulin resistant.3. not making a definite diagnosis the person 1. can not do, 2..
Chinese medical discrimination diagnostic criteria: deficiency of both QI and YIN or double heat syndrome: (1) primary symptom: fatigue and weakness, thirst and liking drink, easy hungry polyphagia, frequent micturition.(2) inferior disease: dysphoria with feverish sensation in the chest palms and soles, spontaneous perspiration or night sweat, breathe hard lazy speech, cardiopalmus, constipation.(3) tongue arteries and veins: red tongue with a little fluid or corpulent tongue are big, thready pulse or count accurately.Indispensable 1 of above primary symptom adds 2 of time diseases, and is promptly diagnosable with reference to the tongue arteries and veins.
Embodiment 1
In Xiyuan Hospital, Chinese Medicine Academy of China's clinical trial, observe patient's 50 examples of type ii diabetes altogether, adopt prescription as the embodiment in the table one 1, its clinical test results is as follows:
Experimenter group: meet the heat syndrome diagnosis of holding concurrently of type 2 diabetes mellitus diagnosis and traditional Chinese medical science deficiency of both QI and YIN.
Therapeutic scheme:
Test group: the present invention,, every day 3 times, obey, around the course of treatment before the meal half an hour by each 6.
Matched group: JIANGTANGNING JIAONANG, each 6, every day 3 times, obey half an hour before the meal, around the course of treatment.
Duration of test forbids merging other blood sugar lowering Western medicine of application, and it is as follows to merge the unified regulation of Western medicine:
Moderate state of an illness experimenter: enlightening sand (glipizide) 2.5mg 3 times/day obeys before the meal half an hour.
Severe state of an illness experimenter: enlightening sand (glipizide) 5mg 2 times/day (sooner or later respectively once) obeys before the meal half an hour.
Main curative effect index: symptom, sign, fasting glucose, post-prandial glycemia, glycolated hemoglobin, saccharifying serum albumin.
Secondary efficacy index: blood fat, hemorheology.
Safety indexes: routine blood test, routine urinalysis, just routine, electrocardiogram, liver function, renal function
Statistics: the efficacy analysis employing meets the scheme collection to be analyzed, and safety analysis adopts the intentional analysis collection to analyze.
Case 50 examples are observed in this test altogether.
Test group curative effect: fasting glucose curative effect obvious effective rate 36.00%, post-prandial glycemia obvious effective rate 36.00%, tcm symptom obvious effective rate 32.00%;
Matched group curative effect: fasting glucose curative effect obvious effective rate 28.00%, post-prandial glycemia obvious effective rate 32.00%, tcm symptom obvious effective rate 32.00%;
Do not see toxic and side effects and untoward reaction in the process of the test to hepatic and renal function and blood system.
Embodiment 2
In No.1 Hospital of Guiyang Traditional Chinese Medicine College, observe patient's 84 examples of type ii diabetes altogether, adopt prescription as the embodiment in the table one 2, its clinical test results is as follows:
Test group medicine: Chinese medicine of the present invention, each 6, every day 3 times, the course of treatment: 6 weeks
Matched group medicine: JIANGTANGNING JIAONANG, each 6, every day 3 times, the course of treatment: 6 weeks
This clinical trial is observed altogether and is met scheme case 84 examples, and according to above statistical analysis, main result is as follows.
Test group 63 examples: fasting glucose curative effect obvious effective rate 41.3%, post-prandial glycemia obvious effective rate 52.4%, tcm symptom obvious effective rate 57.2%;
Matched group 21 examples: fasting glucose curative effect obvious effective rate 23.8%, post-prandial glycemia obvious effective rate 33.3%, tcm symptom obvious effective rate 61.9%.
Group 84 examples are gone in this test altogether, and test group is included 63 examples altogether in, do not find untoward reaction in the test and to electrocardiogram, liver, renal function, blood system toxic side effect.
Embodiment 3
In Xiyuan Hospital, Chinese Medicine Academy of China's clinical trial, observe patient's 200 examples of type ii diabetes altogether, adopt prescription as the embodiment in the table one 3, its clinical test results is as follows:
Experimenter group: meet the heat syndrome diagnosis of holding concurrently of type 2 diabetes mellitus diagnosis and traditional Chinese medical science deficiency of both QI and YIN.
Therapeutic scheme:
Test group: Chinese medicine of the present invention, each 6, every day 3 times, obey half an hour before the meal, around the course of treatment.
Matched group: JIANGTANGNING JIAONANG, each 6, every day 3 times, obey half an hour before the meal, around the course of treatment.
Duration of test forbids merging other blood sugar lowering Western medicine of application, and it is as follows to merge the unified regulation of Western medicine:
Moderate state of an illness experimenter: enlightening sand (glipizide) 2.5mg 3 times/day obeys before the meal half an hour.
Severe state of an illness experimenter: enlightening sand (glipizide) 5mg 2 times/day (sooner or later respectively once) obeys before the meal half an hour.
Main curative effect index: symptom, sign, fasting glucose, post-prandial glycemia, glycolated hemoglobin, saccharifying serum albumin.
Secondary efficacy index: blood fat, hemorheology.
Safety indexes: routine blood test, routine urinalysis, just routine, electrocardiogram, liver function, renal function
Statistics: the efficacy analysis employing meets the scheme collection to be analyzed, and safety analysis adopts the intentional analysis collection to analyze.
Test group 100 examples: fasting glucose curative effect obvious effective rate 41%, post-prandial glycemia obvious effective rate 43%, tcm symptom obvious effective rate 39%;
Matched group 100 examples: fasting glucose curative effect obvious effective rate 32%, post-prandial glycemia obvious effective rate 30%, tcm symptom obvious effective rate 31%;
Test group is better than matched group to the curative effect of 2 hours blood glucose after the meal, and significant difference is arranged.Tired slow-witted weak doing well,improving is better than matched group.To improving significantly before and after cholesterol, the low density lipoprotein, LDL treatment.
After the test group treatment after the meal islets of langerhans have obvious rising, significant difference is arranged.The treatment of control group front and back are to the change there was no significant difference of insulin.
The improvement of glycolated hemoglobin has significant difference before and after the test group treatment, and glycolated hemoglobin improves no difference of science of statistics before and after the treatment of control group
Safety results: test group is gone into group 109 examples, and not observing has anomalous effects and other untoward reaction to the heart, liver, renal function, blood system.
Conclusion: treatment by Chinese herbs type 2 diabetes mellitus of the present invention (deficiency of both QI and YIN hold concurrently heat syndrome) is safe and effective.
Test group treatment back saccharifying serum albumin has obvious decline, and significant difference is arranged.
Embodiment 4
In Hospital Attached to Shandong Chinese Medical Univ., patient's case 80 examples of type ii diabetes are observed in clinical trial altogether, adopt the prescription as the embodiment in the table one 4, administration such as embodiment 1.According to statistical analysis, main result is as follows.
Test group 60 examples: fasting glucose curative effect obvious effective rate 50.0%, post-prandial glycemia obvious effective rate 53.3%, tcm symptom obvious effective rate 25.0%;
Matched group 20 examples: fasting glucose curative effect obvious effective rate 30.0%, post-prandial glycemia obvious effective rate 35.0%, tcm symptom obvious effective rate 25.0%;
Group 80 examples are gone in this test altogether, do not find untoward reaction in the test and to electrocardiogram, liver, renal function, blood system toxic side effect.
Embodiment 5
No.1 Hospital Attached to Hunan College of Traditional Chinese Medicine, clinical trial are observed patient's case 77 examples of type ii diabetes altogether, adopt the prescription as the embodiment in the table one 5, administration such as embodiment 2.According to statistical analysis, main result is as follows.
Test group 59 examples: fasting glucose curative effect obvious effective rate 49.2%, post-prandial glycemia obvious effective rate 55.9%, tcm symptom obvious effective rate 23.7%;
Matched group 18 examples: fasting glucose curative effect obvious effective rate 33.3%, post-prandial glycemia obvious effective rate 38.9%, tcm symptom obvious effective rate 27.8%;
Group 77 examples are gone in this test altogether, do not find untoward reaction in the test and to electrocardiogram, liver, renal function, blood system toxic side effect.
Embodiment 6
The hospital of traditional Chinese hospital, Xi'an, patient's case 84 examples of type ii diabetes are observed in clinical trial altogether, adopt the prescription as the embodiment in the table one 6, administration such as embodiment 1.Its clinical test results is as follows:
Test group 62 examples: fasting glucose curative effect obvious effective rate 30.6%, post-prandial glycemia obvious effective rate 61.3%, tcm symptom obvious effective rate 32.3%;
Matched group 22 examples: fasting glucose curative effect obvious effective rate 13.6%, post-prandial glycemia obvious effective rate 31.8%, tcm symptom obvious effective rate 18.2%;
Group 84 examples are gone in this test altogether, find with trial drug clearly relevant untoward reaction is arranged in the test and to electrocardiogram, liver, renal function, blood system toxic side effect.
Embodiment 7
In the pharmacodynamic study of Xian Medical Univ's clinical pharmacology institute, adopt and test as the prescription of the embodiment in the table one 7 and the prescription of embodiment 1-6, the result is as follows:
Adopt required standard, gastric infusion has obvious reduction effect to normal mouse blood sugar level; Alloxan model hyperglycemic rat, rabbit blood sugar level, mice epinephrine hyperglycemia there is obvious reduction effect; Rabbit alloxan model hyperglycemia rabbit glucose tolerance curve is obviously moved down, can obviously improve the rabbit carbohydrate tolerance; Also can promote rabbit insulin secretion under the high sugared state; The pancreatic tissue damage that alloxan is caused has certain repair.
Up to now, this is that other similar Chinese patent medicine is unexistent, and this conclusion has been checked and approved by State Food and Drug Administration and write the medicine operation instructions.
Table one: embodiment and prescription correspondence table
Embodiment |
Prescription |
1 |
1 part of Radix Panacis Quinquefolii, 2 parts of the Rhizoma Anemarrhenaes, 1 part in Gypsum Fibrosum, 3 parts in Fructus Momordicae charantiae, 2 parts of Bombyx bombycis, 1 part of the Radix Astragali, 1 part of Rhizoma Dioscoreae, 1 part in the Radix Rehmanniae, 1 part of Radix Scrophulariae, 1 part of Radix Glehniae, 1 part of Radix Ophiopogonis, 1 part of Rhizoma Polygonati Odorati, 1 part of Rhizoma Polygonati, 1 part of Radix Trichosanthis, 1 part of Endothelium Corneum Gigeriae Galli, 1 part of Rhizoma Coptidis, 1 part of Fructus Corni, 2 parts of Fructus Lycii, 2 parts of Fructus Ligustri Lucidi, 1 part of Herba Epimedii. |
Embodiment |
Prescription |
??2 |
4 parts of Radix Panacis Quinquefoliis, 5 parts of the Rhizoma Anemarrhenaes, 5 parts in Gypsum Fibrosum, 8 parts in Fructus Momordicae charantiae, 6 parts of Bombyx bombycis, 5 parts of the Radixs Astragali, 5 parts of Rhizoma Dioscoreaes, 5 parts in the Radix Rehmanniae, 5 parts of Radix Scrophulariaes, 5 parts of Radix Glehniaes, 5 parts of Radix Ophiopogonis, 5 parts of Rhizoma Polygonati Odorati, 5 parts of Rhizoma Polygonatis, 5 parts of Radix Trichosanthis, 5 parts of Endothelium Corneum Gigeriae Galli, 5 parts of Rhizoma Coptidis, 5 parts of Fructus Corni, 5 parts of Fructus Lycii, 6 parts of Fructus Ligustri Lucidi, 5 parts of Herba Epimedii |
??3 |
3 parts of Radix Panacis Quinquefoliis, 4 parts of the Rhizoma Anemarrhenaes, 3 parts in Gypsum Fibrosum, 5 parts in Fructus Momordicae charantiae, 4 parts of Bombyx bombycis, 3 parts of the Radixs Astragali, 3 parts of Rhizoma Dioscoreaes, 3 parts in the Radix Rehmanniae, 3 parts of Radix Scrophulariaes, 3 parts of Radix Glehniaes, 3 parts of Radix Ophiopogonis, 3 parts of Rhizoma Polygonati Odorati, 3 parts of Rhizoma Polygonatis, 3 parts of Radix Trichosanthis, 3 parts of Endothelium Corneum Gigeriae Galli, 3 parts of Rhizoma Coptidis, 3 parts of Fructus Corni, 4 parts of Fructus Lycii, 4 parts of Fructus Ligustri Lucidi, 3 parts of Herba Epimedii |
??4 |
2 parts of Radix Panacis Quinquefoliis, 3 parts of the Rhizoma Anemarrhenaes, 4 parts in Gypsum Fibrosum, 7 parts in Fructus Momordicae charantiae, 5 parts of Bombyx bombycis, 4 parts of the Radixs Astragali, 4 parts of Rhizoma Dioscoreaes, 4 parts in the Radix Rehmanniae, 4 parts of Radix Scrophulariaes, 4 parts of Radix Glehniaes, 4 parts of Radix Ophiopogonis, 4 parts of Rhizoma Polygonati Odorati, 4 parts of Rhizoma Polygonatis, 4 parts of Radix Trichosanthis, 4 parts of Endothelium Corneum Gigeriae Galli, 4 parts of Rhizoma Coptidis, 4 parts of Fructus Corni, 6 parts of Fructus Lycii, 6 parts of Fructus Ligustri Lucidi, 4 parts of Herba Epimedii |
??5 |
4 parts of Radix Panacis Quinquefoliis, 5 parts of the Rhizoma Anemarrhenaes, 2 parts in Gypsum Fibrosum, 4 parts in Fructus Momordicae charantiae, 3 parts of Bombyx bombycis, 2 parts of the Radixs Astragali, 2 parts of Rhizoma Dioscoreaes, 2 parts in the Radix Rehmanniae, 2 parts of Radix Scrophulariaes, 2 parts of Radix Glehniaes, 2 parts of Radix Ophiopogonis, 2 parts of Rhizoma Polygonati Odorati, 2 parts of Rhizoma Polygonatis, 2 parts of Radix Trichosanthis, 2 parts of Endothelium Corneum Gigeriae Galli, 2 parts of Rhizoma Coptidis, 2 parts of Fructus Corni, 5 parts of Fructus Lycii, 3 parts of Fructus Ligustri Lucidi, 2 parts of Herba Epimedii |
??6 |
4 parts of Radix Panacis Quinquefoliis, 5 parts of the Rhizoma Anemarrhenaes, 2 parts in Gypsum Fibrosum, 4 parts in Fructus Momordicae charantiae, 3 parts of Bombyx bombycis, 2 parts of the Radixs Astragali, 2 parts of Rhizoma Dioscoreaes, 2 parts in the Radix Rehmanniae, 2 parts of Radix Scrophulariaes, 2 parts of Radix Glehniaes, 2 parts of Radix Ophiopogonis, 2 parts of Rhizoma Polygonati Odorati, 2 parts of Rhizoma Polygonatis, 2 parts of Radix Trichosanthis, 2 parts of Endothelium Corneum Gigeriae Galli, 2 parts of Rhizoma Coptidis, 2 parts of Fructus Corni, 3 parts of Fructus Lycii, 5 parts of Fructus Ligustri Lucidi, 2 parts of Herba Epimedii |
??7 |
5 parts of Radix Panacis Quinquefoliis, 6 parts of the Rhizoma Anemarrhenaes, 5 parts in Gypsum Fibrosum, 8 parts in Fructus Momordicae charantiae, 6 parts of Bombyx bombycis, 5 parts of the Radixs Astragali, 5 parts of Rhizoma Dioscoreaes, 5 parts in the Radix Rehmanniae, 5 parts of Radix Scrophulariaes, 5 parts of Radix Glehniaes, 5 parts of Radix Ophiopogonis, 5 parts of Rhizoma Polygonati Odorati, 5 parts of Rhizoma Polygonatis, 5 parts of Radix Trichosanthis, 5 parts of Endothelium Corneum Gigeriae Galli, 5 parts of Rhizoma Coptidis, 5 parts of Fructus Corni, 7 parts of Fructus Lycii, 7 parts of Fructus Ligustri Lucidi, 5 parts of Herba Epimedii |