CN110123977A - A kind of external application for curing diabetes merge the Chinese medicine composition of gout - Google Patents

Abstract

The invention discloses the Chinese medicine compositions that a kind of external application for curing diabetes merge gout, are mainly made of the Chinese medicine material of following parts by weight: 5 ~ 30 parts of dandelion, 5 ~ 30 parts of Honeysuckle flower, 5 ~ 30 parts of Fructus Forsythiae, 10 ~ 35 parts of semen coicis, 5 ~ 30 parts of pheretima, 5 ~ 30 parts of trigone, 5 ~ 30 parts of leech, 5 ~ 30 parts of the coptis, 5 ~ 30 parts of viola mandshurica.The present invention have the characteristics that letter, just, it is honest and clean, test, patient compliance is good, and we are used as and are applied with, and non-for oral administration, on hepatic and renal function without influence, safety is controllable.

Description

A kind of external application for curing diabetes merge the Chinese medicine composition of gout

Technical field

The present invention relates to diabetes to merge gout treatment drug technical field, and especially a kind of external application for curing diabetes merge The Chinese medicine composition of gout.

Background technique

Diabetes (Diabetesmellitus) are absolute insulin secretion or relative deficiency and body target tissue or target Organ reduces the caused metabolic disease characterized by blood glucose rise to insulin sensitivity.Gout (gout) is long-term purine Dysbolism, blood uric acid increase one group of different substantiality disease for causing tissue damage.Diabetes and gout are metabolic disease, with People's living standard improve, dietary structure changes, and disease incidence increasing year by year, and 432 2 type glycosurias are investigated in Shanghai within 2002 Patient, wherein merging hyperuricemia person accounts for 25.2%, diabetes B merges hyperuricemia person and occupies considerable proportion.

The influence factor that diabetes merge gout is as follows: 1. inherent cause: the two has Family inherited inclination, and most of Belong to multiple-factor inheritance, is to be fallen ill on the basis of genetic predisposition by diet or such environmental effects.2. dietary factor: Living standard improves, and dietary structure changes, and total amount of heat, protein uptake and drinking amount increase, and activity is reduced.Due to diet knot Structure changes, and its uric acid excretion ability is not increase accordingly, and the incidence for causing diabetes to merge gout increases.3. fat, Hypertension, hyperlipidemia: diabetes and gout are metabolic disease, are often accompanied with obesity, hypertension, hyperlipidemia.These factors Have an impact to uric acid, glycometabolism.Overweight people's Energy intaking is more, and purine synthesis accelerates blood uric acid can be caused to increase;It is fat simultaneously Patient insulin is insensitive, need to secrete more insulin, eventually leads to the failure of β cell function and diabetes occur.Patient is long-term Hypertension can lead to glomerulus artery sclerosis, and renal tubule causes lactic acid generation to increase because of anoxic, and excretion of the lactic acid to uric acid There is competitive inhibitory effect, reduce uric acid discharge, causes uric acid storage to stay, and then cause hyperuricemia.Studies have found that high urine It is significantly raised that acidaemia person more normal than uric acid suffers from hypertension, hyperlipidemia, the recall rate of hyperglycemia.It can be seen that diabetes merge gout with Obesity, hypertension, hyperlipidemia have apparent correlation.4. insulin resistance (IR) refers to the physiology effect of the insulin of normal concentration It should inhibit the ability of liver release glucose lower than insulin normally, is mainly shown as and promote surrounding tissue (mainly in skeletal muscle) Declined using the ability of glucose, in order to adjust blood glucose in normal level, body compensatory hypersecretion insulin, i.e., high pancreas islet Plain mass formed by blood stasis, so as to cause a series of pathological changes of body.There is scholar to merge patient with gout, the 2 types sugar without gout to diabetes B It urinates patient and carries out the measurement such as fasting blood-glucose, insulin, 2h-plasma glucose, insulin, blood uric acid, and calculate insulin sensitivity Index, diabetes B merge diabetic of the patient with gout compared with no gout with apparent hyperinsulinemia, it was confirmed that sugar Urine disease merges gout, and compared with the diabetic of no gout, there are obvious hyperinsulinemia and insulin resistances.It can be seen that sugared Urine disease can lead to hyperuricemia, and hyperuricemia is the important biochemical indicator of gout, gout be diabetes B it is dangerous because Element, can induced Diabetic, two disease simultaneously deposit, can influence each other.

The patient that diabetes merge gout is increasing, and harm mainly causes atherosclerosis, cardiovascular and cerebrovascular disease Sick incidence increases.Money honourably obtains a very important independent hazard factor for also thinking that uric acid is T2DM macroangiopathy.

In traditional Chinese medicine and non-diabetic merges this name of disease of gout, and " bi Zheng " is attributed to for its symptom, " is disappeared Yearningly ", the scopes such as " joint-running ".Diabetes merging gout product mainly greasy due to addiction greasy and surfeit flavour, sweet and refreshing taste, impairing the spleen and stomach, Make the dysfunction of the spleen in transport, gather wet at helping humidogene phlegmization turbid caused by phlegm, be infiltrated on skin and extremities joint, streamer in channels and collaterals and blood vessels it In, to hinder mechanism of qi, hematogenous blockage is caused, forms hemostasis.Phlegm-turbidity and blood stasis blood is mutually fought knot, can be changed turbidity poison, be injured blood vessels muscles and bones, Damage internal organs, the generation of a variety of chronic complicating diseases such as atherosclerotic blood vessel variation.Majority by its it is dialectical be divided into both ends, real person is more For wet hot phlegm it is turbid in accumulate or blood stasis folder it is wet;Empty person is mostly the deficiency of vital energy, spleen kidney or kidney deficiency and liver.Diabetes merge the substantially sick of gout Machine is more complex, and now to think that its basic interpretation of the cause, onset and process of an illness is asthenia in origin and asthenia in superficiality, kidney qi deficiency is unable to regulating fluid apssage and causes spleen renal dysfunction, spleen more Fortune is lost strong, helps humidogene phlegm, and qi and blood stops up knot, qi depression to blood stasis, phlegm-dampness stagnation, cause the phlegm wet stasis of blood it is turbid in accumulate, make real more real, empty more empty, empty Interlock in fact, ultimately forms the card of asthenia in origin and asthenia in superficiality.

Diagnosis and treatment is the basic thought of Chinese medicine, and there are no unified marks for the differentiation of symptoms and signs for classification of syndrome of the gout of diabetes merging at present Standard, Wang Dongyun etc. is dialectical in type 2 diabetic patient's progress by serum uric acid level, is divided into extreme heat due to deficiency of yin, deficiency of both qi and yin and yin-yang two Deficiency, find diabetes B and merge hyperuricemia extreme heat due to deficiency of yin, yin-yang deficiency group be apparently higher than on serum uric acid level Deficiency of both qi and yin group.But doctor mostly carries out according to the clinical experience of oneself dialectical, mostly based on " stasis of blood, phlegm, turbid, malicious ", emphasizes particularly on different fields. Commonly use following therapy: 1. kidney and spleen invigorating, dissolving stasis let out turbid method: once English selected this Out-patient Department and inpatient, and totally 57.By random number Word table method is divided into two groups, wherein Chinese medicine group 32, and control group 25, two groups of case genders, age, the course of disease and blood glucose, blood lipid water There are no significant meaning that adjustment is different, is comparable (P > 0.05).Chinese medicine group gives kidney and spleen invigorating, dissolving stasis lets out turbid Chinese medicine compound prescription (each 15g of Rehmannia glutinosa, Fructus Corni, Radix Salviae Miltiorrhizae, each 20g of Radix Astragali, Radix Codonopsis, it is Rhizoma Atractylodis Macrocephalae, rhizoma alismatis, Poria cocos, the mono- Collettii of ramulus cinnamomi, peach kernel, safflower, ripe Each 10g of rheum officinale), control group gives Allopurinol in Treatment, each 0.1g, 3 times a day.Two groups are controlled 4 weeks.Chinese medicine group cure rate and total Effective percentage is respectively 25.0%, 87.5%, and control group is then 16.0%, 80.0%, is had preferably to diabetes B Patients with Hyperuricemia Curative effect.2. the turbid dispersing blood stasis method of invigorating the spleenization: the selected cases such as Liu Chengqin be diabetes B with hyperuricemia patient, totally 52, It is randomly divided into treatment group's (turbid dispersing blood stasis side's group of invigorating the spleenization) 35 in 2:1 ratio, control group (allopurinol group) 17, invigorating the spleenization is turbid Dispersing blood stasis side's group use compound are as follows: Radix Astragali 10g, rhizoma atractylodis 10g, smilax 15g, Semen Coicis Semen Coicis 10g, Bi Collettii 10g, edible tulip 10g, Herba Lycopi 10g, rhizoma alismatis 10g, semen plantaginis 15g, Radix Salviae Miltiorrhizae 10g, Pollen Typhae 10g, rheum officinale 3g.It takes medicine 4 weeks respectively, hyperuricemia is controlled Treatment effect, treatment group's total effective rate 83.0%, control group total effective rate 82.0%, quite, two groups are compared that there was no significant difference for effect. The total effective rate of FBG, 2HPBG, HbA1C are reduced, treatment group is 80.00%, 85.71%, 74.29% respectively；Control group is respectively 52.94%,58.82%,52.94%；The effect of cholesterol and triacylglycerol is reduced, treatment group's effect is obvious, control group therapeutic effect Unobvious, the turbid dispersing blood stasis side of invigorating the spleenization has a better effect diabetes B Patients with Hyperuricemia.3. clearing damp disperse blood stasis and dredge collateral: beautiful Mountain Jiang Aike wood etc. selects patient totally 60 of diabetes and hyperuricemia, is divided into treatment group and control by table of random number Group 30.Treatment group is on the basis of Gliquidone plus uses clearing damp disperse blood stasis and dredge collateral side, and clearing damp disperse blood stasis and dredge collateral side forms are as follows: semen coicis 30g, Smilax 15g, Caulis Spatholobi 15g, rhizoma alismatis 10g, bark of ash 10g, radix achyranthis bidentatae 10g；Treatment group's total effective rate is 93.3%；Control group always has Efficiency is 23.33%, and it is curative for effect that clearing damp disperse blood stasis and dredge collateral method Treatment for Diabetes Based on Zheng-differentiation merges hyperuricemia.

Single recipe research: 1. two drop soup: merging Patients with Hyperuricemia 30 in the selection diabetes B such as Tsing-Hua University, clothes are certainly Soup, two drop soup compositions: Radix Rehmanniae 20g, rhizoma anemarrhenae 20g, coptis 10g, ginseng 10g, Radix Salviae Miltiorrhizae 10g, fructus lycii drop in quasi- side two 30g, gentianae macrophyllae 10g, smilax 100g, semen plantaginis 10g, Radix Glycyrrhizae 5g；Dialectical plus-minus, total effective rate 93.3%.Two drop soup It is curative for effect that Treatment for Diabetes Based on Zheng-differentiation merges hyperuricemia.2. plus taste Siwu Tang: the selections such as river forever being exhaled to meet diabetes and nothing The patient of symptomatic hyperuricemia diagnostic criteria 76 is randomly divided into control group 38, and treatment group 38, control group gives section's element Sub- 50mg, 1 time a day；Treatment group give plus taste Siwu Tang (composition: Radix Angelicae Sinensis 12g, Rehmannia glutinosa 15g, Radix Paeoniae Alba 10g, Rhizoma Chuanxiong 12g, Dried orange peel 10g, PORIA ALBA 10g, ginseng 6g, Cortex Phellodendri 10g, peach kernel 6g, rhizoma anemarrhenae 4g, Bi Collettii 10g, radix cyathulae 10g, the root of Chinese clematis 10g), 1 time a day, course for the treatment of March.Observe pretherapy and post-treatment blood glucose, insulin, blood pressure, cholesterolemia, triglycerides, body mass index, Blood uric acid (SUA) and serum creatinine, urine uric acid (UUA) and urine creatinine, urine pH value, microdose urine protein (U-mAlb) calculate uric acid Clearance rate, creatinine clearance rate, uric acid remove score etc., and treatment group's total effective rate is 81.58%, and control group 60.53% is poor It is different to have significant (P < 0.01)；Treatment group SUA, urine pH value, UUA, urine volume etc. is better than control group for 24 hours；Control group U- MAlb, diastolic pressure are better than treatment group.Taste Siwu Tang is added to have significant curative effect to diabetes asymptomatic hyperuricemia.3. gout Fixed: 60 patients are randomly divided into treatment group 35 by Guo Yinghui etc., and control group 25, treatment group gives gout capsule.Observation clothes 4 weeks, 8 weeks, 12 weeks uric acid of having a blood test, hepatic and renal function, plasma lipid profile (TC, TG, HDL-C) before medicine and after medication, after two groups of patients treat Blood uric acid and plasma lipid profile variation show the treatment group for adding gout after 12 weeks compared with the control group, gout is surely substantially reduced blood urine Acid, treatment group pretherapy and post-treatment TC, TG decline, and HDL-C rises, it was demonstrated that gout has diabetes B Patients with Hyperuricemia Preferable curative effect.

Diabetes merge its complication of gout not only bring the pain on body to patient, but also return patient home with And society causes very big burden, just seems most important then preventing and treating diabetes and merging gout.Traditional Chinese medicine at present Merging gout to diabetes has had certain understanding, but because without unified diagnosis, card type, criterion of therapeutical effect, in clinical research Lack random, single blind or double blind control, multisample or a large amount of prediction multicenter large sample double blind control researchs, curative effect in design to lack Weary certain credibility and convincingness.Therefore, the foundation that related diabetes merge gout theory of traditional Chinese medical science also needs medical worker Keep punching.Diabetes and gout are metabolic disease, are often accompanied with obesity, hypertension, hyperlipidemia, in the treatment some Depressor can be such that blood glucose, blood lipid increases, and fat regulation medicine can increase blood glucose, and these medicine side effects are very big, can cause the damage of multi viscera Wound.Adverse reaction of tcm is relatively small, so we should utilize the advantage of traditional Chinese medicine, explores traditional Chinese medicine or therapy of combing traditional Chinese and Western medicine Diabetes merge gout, and Chinese medicine organic conception and diagnosis and treatment principle are combined, TCM Treatment of Diabetes is closed And gout obtains bigger progress.

Summary of the invention

The invention discloses the Chinese medicine composition that a kind of external application for curing diabetes merge gout, have letter, just, it is honest and clean, test Feature, patient compliance is good, and we are used as external application, and non-for oral administration, on hepatic and renal function without influence, safety is controllable.

To achieve the above object, the technical solution of the present invention is as follows:

A kind of external application for curing diabetes merge the Chinese medicine composition of gout, are mainly made of the Chinese medicine material of following parts by weight: Pu 5 ~ 30 parts of public English, 5 ~ 30 parts of Honeysuckle flower, 5 ~ 30 parts of Fructus Forsythiae, 10 ~ 35 parts of semen coicis, 5 ~ 30 parts of pheretima, 5 ~ 30 parts of trigone, leech 5 ~ 30 parts, 5 ~ 30 parts of the coptis, 5 ~ 30 parts of viola mandshurica.

Preferably, above-described external application for curing diabetes merge the Chinese medicine composition of gout, mainly by following parts by weight Chinese medicine material composition: 10 parts of dandelion, 10 parts of Honeysuckle flower, 10 parts of Fructus Forsythiae, 20 parts of semen coicis, 10 parts of pheretima, 10 parts of trigone, water 10 parts of leech, 10 parts of the coptis, 10 parts of viola mandshurica.

Invention further provides above-described external application for curing diabetes to merge the preferred of the Chinese medicine composition of gout Preparation method, comprising the following steps:

S1. dandelion, Honeysuckle flower, Fructus Forsythiae, semen coicis, pheretima, trigone, leech, the coptis and viola mandshurica are weighed by weight, are added Enter the water of 8 ~ 15 times of weight, impregnate, decocts 30 ~ 120min, obtain Chinese medicine extract；

S2. applicator material is dipped in Chinese medicine extract, is taken out, medicine for external application preparation is made.

Above-described external application for curing diabetes merge the Chinese medicine composition of gout, including dandelion, Honeysuckle flower, Fructus Forsythiae, Nine kinds of semen coicis, pheretima, trigone, leech, the coptis and viola mandshurica Chinese medicine materials, effect are each are as follows:

Dandelion: nature and flavor are sweet, slight bitter, tremble with fear.Return liver, stomach meridian；There are diuresis, laxative, removing jaundice subcutaneous ulcer, cholagogue and other effects；Control heat toxin, carbuncle Swollen, sore, internal carbuncle, red eye, swell pain, damp and hot, jaundice, the puckery pain of dribbling urination, furuncle swelling toxin, acute mastitis, toothache, hot eyes, pharyngalgia, lung Carbuncle, acute appendicitis, jaundice with damp-heat pathogen, puckery pain of heat gonorrhea.

Honeysuckle flower: clearing heat and detoxicating, dispelling wind and heat from the body.Sore, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, temperature are treated for carbuncle swells Heat morbidity.

Fructus Forsythiae: property is sweet, trembles with fear.It is bitter in taste, it is cool.Heat-clearing, removing toxic substances, dissipating bind, detumescence.Control warm, erysipelas, macula, large carbuncle pyogenic infections, Scrofula, urine leaching closes.Clinically have and is applied to treatment acute nephritis.

Semen coicis: nature and flavor are sweet, light, cool in nature.There are clearing damp and promoting diuresis, invigorating the spleen to arrest diarrhea, eliminating impediment, apocenosis, detoxicating and resolving a mass.

Pheretima: have effects that heat-clearing arresting convulsion, dredging collateral, relieving asthma, diuresis.

Trigone: property is pungent, bitter, puts down.With breaking blood and promoting the circulation of qi, the effect of clearing stagnation and killing pain.For abdominal mass lump in the abdomen, dysmenorrhea, hemostasis warp It closes, chest impediment and cardialgia, dyspepsia distending pain.

Leech: there is treatment apoplexy, hypertension, the clear stasis of blood, amenorrhoea, traumatic injury and other effects.

The coptis: heat-clearing and damp-drying drug, purging fire for removing toxin.For damp and hot feeling of fullness, acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, internal heat are vomitted Kang Sheng, dysphoria and insomnia, blood-head tells nosebleed, hot eyes, toothache are quenched one's thirst, carbuncle swells furunculosis；Eczema, wet sore, purulent ear canal are controlled outside.

Viola mandshurica: taste bitter, acrid, cold.Converge to heart and liver channels.With clearing heat and detoxicating, cool blood detumescence, the effect of clearing heat and promoting diuresis is main Control furunculosis, carbuncle swells, scrofula, jaundice, dysentery, diarrhea, hot eyes, sore throat, venomous snake bite.

The present invention bottom side of for, reuses semen coicis with classical Chinese medicine recipe " wuwei xiaodu drink ", reinforces clearing damp and promoting diuresis, Chubi Pulvis The function of knot adds trigone and leech with activating microcirculation and removing stasis medicinal, adds the coptis and reinforce clearing heat and detoxicating power.Our compatibility is rationally exquisite, benefit With the effect of its clearing heat and detoxicating dissipation furunculosis, achieve the purpose that treat acute gout.

The method for merging acute gout with Chinese medicine preparation treatment diabetes, have the characteristics that it is simple, just, it is honest and clean, test, Huan Zheyi It is good from property, and we are used as external application, non-for oral administration, on hepatic and renal function without influence, safety is controllable.Meanwhile many diseases are in difference Stage have the performance of damp-heat accumulation, popularization is said, and the external application for curing that the illness of all retention of damp-heat in the interior can be of the invention is pacified Entirely, effectively, treatment method without side-effects be worth clinical expansion.

Specific embodiment

Below in conjunction with specific embodiment, the invention will be further described, but protection scope of the present invention is not limited to following reality Apply example.

Embodiment 1

A kind of external application for curing diabetes merge the Chinese medicine composition of gout, composition: dandelion 10g, Honeysuckle flower 10g, Fructus Forsythiae 10g, Semen coicis 20g, pheretima 10g, trigone 10g, leech 10g, coptis 10g, viola mandshurica 10g.

External application for curing diabetes merge the preparation method of the Chinese medicine composition of gout, comprising the following steps:

S1. dandelion, Honeysuckle flower, Fructus Forsythiae, semen coicis, pheretima, trigone, leech, the coptis and viola mandshurica are weighed by weight, are added Enter the water of 1000g, impregnate 30min, decocts 60min, obtain Chinese medicine extract；

S2. gauze is dipped in Chinese medicine extract, is taken out, medicine for external application preparation is made.

Embodiment 2

A kind of external application for curing diabetes merge the Chinese medicine composition of gout, composition: dandelion 15g, Honeysuckle flower 15g, Fructus Forsythiae 15g, Semen coicis 20g, pheretima 5g, trigone 10g, leech 5g, coptis 20g, viola mandshurica 20g.

External application for curing diabetes merge the preparation method of the Chinese medicine composition of gout, comprising the following steps:

S1. dandelion, Honeysuckle flower, Fructus Forsythiae, semen coicis, pheretima, trigone, leech, the coptis and viola mandshurica are weighed by weight, are added Enter the water of 1100g, impregnate 30min, decocts 90min, obtain Chinese medicine extract；

S2. gauze is dipped in Chinese medicine extract, is taken out, medicine for external application preparation is made.

Embodiment 3

A kind of external application for curing diabetes merge the Chinese medicine composition of gout, composition: dandelion 30g, Honeysuckle flower 30g, Fructus Forsythiae 5g, the heart of a lotus seed Seed of jog's tears 35g, pheretima 5g, trigone 5g, leech 5g, coptis 5g, viola mandshurica 5g.

External application for curing diabetes merge the preparation method of the Chinese medicine composition of gout, comprising the following steps:

S1. dandelion, Honeysuckle flower, Fructus Forsythiae, semen coicis, pheretima, trigone, leech, the coptis and viola mandshurica are weighed by weight, are added Enter the water of 1200g, impregnate 30min, decocts 60min, obtain Chinese medicine extract；

S2. gauze is dipped in Chinese medicine extract, is taken out, medicine for external application preparation is made.

Embodiment 4: diabetes merge the clinical therapeutic efficacy observation of gout

1. case selection

Choosing two sections clinical diagnosis in the hospitals of traditional Chinese and western medicine, Guilin City is 60 people's conduct of patient that diabetes merge acute gout Research object, all subjects sign informed consent form, this test of voluntary participation.

2. diagnostic criteria

(1) standard that diabetes diagnostic criterion was worked out referring to WHO expert consulting report in 1999: having the symptom of diabetes, any Venous plasma concentration of glucose >=11.1mmol/L(200mg/dl of time)；Or limosis vein blood slurry concentration of glucose >= 7.0mmol/L(126mg/dl)；Or the 2 hours venous plasma glucose after oral glucose tolerance test (OGTT) takes 75g glucose Concentration >=11.1mmol/L.

(2) standard that gout uses American Rheumatism Association in 1977 to propose: there is special urate crystal in joint fluid Body, or have tophus, chemically (murexide test) or polarized light microscope observing confirmation contain urate crystal.On Stating three and meeting a person can make a definite diagnosis.Have 6 persons in following clinical, laboratory inspection and x-ray sign etc. 12, it can be true It examines as gout；1. 1 time or more acute arthritis is broken out；2. inflammation shows in 1 day and peaks；3. monarthritis is broken out； 4. observing joint redness；5. Metatarsophalangeal joint pain or swelling；6. Metatarsophalangeal joint is involved in unilateral side breaking-out；7. unilateral side hair Work involves midtarsal joints；8. suspicious tophus；9. hyperuricemia；10. x-ray checks intra-articular asymmetry enlargement；⑪ X Ray examination is not with tumour under the cortical bone of sclerotin corrosion；During arthritis breaks out, joint fluid microculture is negative.

(3) Syndrome Differentiation of Traditional Chinese Medicine standard: being the diabetic of retention of damp-heat in the interior through Chinese medical discrimination, with reference to " new Chinese medicine is controlled Treat the guideline of clinical investigations quenched one's thirst " the tcm diagnosis CM syndrome differentiation criterion in relation to diabetes in (tentative 2002).According to Pu Dingfang Prescription combination principle, the patient of Chinese medical discrimination category syndrome of accumulated dampness-heat is classified as observation object.

Primary symptom: arthralgia, swelling, morning stiffness, joint stuffiness, polydipsia, mostly food gluttony, frequent micturition urine are more；

Minor symptom: the fever of local joint touching, color of the leather is rubescent, and whole body generates heat (body temperature≤38.5 DEG C), there is sense of heaviness, thirsty to be not intended to Drink, restlessness with opprssive feeling and worry.Tongue vein: red tongue body, yellow and greasy fur, soft and rapid pulse or sliding number.

The above primary symptom has 2,3 in minor symptom, can make a definite diagnosis referring to tongue vein.

3. case is included in standard

Meet doctor trained in Western medicine diabetes diagnostic criterion, gout diagnostic criteria and TCM syndrome diagnostic criteria person；

1) age between 20-70 years old, male or female；

2) do not receive the acupuncture for the disease, drug therapy in one week；

3) cognitive function is complete, agrees to simultaneously partner treatment.

4. case exclusion criteria

1) 20 years old person of 70 years old person of age > or age <；

2) gestation and breast feeding women；

3) it cannot take medicine as required on time, keeper；Incomplete recording or the automatic stopped treatment person of patient；

4) to drug allergy person used.

5. rejecting and the case standard that falls off

1. not pressing predetermined treatment, curative effect person can not be judged.

2. the infull person of data affects the treatment or safety judgement person.

3. accident occurs in therapeutic process and cannot adhere to curer.

4. patient mismatches curer in therapeutic process.

6. experimental design: this test is divided into test group and right using random, parallel control design scheme, by research object Placebo.

Random device: selection meets case totally 60 of the standard of being included in, and all selected patients are pressed medical serial number, are adopted Randomization distribution is carried out with SPSS software, is sequentially loaded into random mail grouping, and register.Guarantee each group patient year in grouping The harmony of age, gender, the course of disease etc..

Technology path: according to diagnosing, be included in, exclude and tcm diagnosis parting standard, by it is all it is selected after patients be included in sight Examine object.

Random grouping → 1 course for the treatment of of carry out corresponding treatment → observation clinical efficacy and every observation index → evaluation curative effect → Statistical analysis.

Experimental program: two groups of patients carry out health education, low sugar, low purine diet, and give hypoglycemic treatment, with mouth Take antidiabetic drug or subcutaneous insulin injections measure.

A. study subject and grouping:

Test group:

A1 treatment group: the Chinese medicine extract 400mL of embodiment 1 divides the preparation that uses medicine for external application twice sooner or later to spread on affected part, Chinese medicine is mentioned Liquid application is taken to finish.

A2 placebo: sterilized water for injection (specification: 500ml/ bottles, Shuanghe Pharmaceutical Ind Co., Ltd., Anhui's production, National drug standard H20043055) 500ml converts 20ml Iodophor (specification: 100ml/ bottles, Anhui Xinhecheng Wannan Pharmaceutical Co., Ltd is raw Produce), a point morning and evening uses gauze soak affected part twice.

B. the course for the treatment of: one week for a course for the treatment of is observed as a result, evaluation curative effect after 1 course for the treatment of.

C. clinical observation on the therapeutic effect index

Visual analogue scale (VAS) point system (i.e. graduated scale method) that C1 is supervised referring to pain association, Chinese Medical Association: it is with length 10cm scale both ends (0-10, every 1cm represent 1 point, O points be it is painless, 10 points are severe pain), respectively represent best and worst.Suffer from Person faces the one side without scale, and patient is allowed to take at the position that can most represent pain degree at that time；Doctor faces graduated one side Pain degree is recorded, doctor reads score, observes the data obtained.

11 o'clock pain degree Numerical Rating Scales (NRS-11) of C2: 0 minute without pain, 10 points indicate it is envisioned that arriving most Severe pain；1-3 points indicate mild pain, but still can be engaged in normal activity；4-6 points indicate moderate pain, influence work, but energy It takes care of oneself；7-9 points indicate that comparing 7-9 points indicates more serious pain, can't take care of oneself；10 points of expression severe pains, It can not endure.

D. safety observations index

Pretherapy and post-treatment blood is detected, is urinated, just conventional, liver kidney function measures (glutamic-pyruvic transaminase, glutamic-oxalacetic transaminease, urea nitrogen, creatinine), the heart Electrograph.

Number of cases/total case load × 100% occurs for adverse reaction rate=adverse reaction.

E, efficacy assessment standard

Referring to People's Republic of China's traditional Chinese medicine industry standard Standards for Diagnosis and Curative Effect of Chinese Medical Symptom (ZY/T001.1-94) and defend " new Chinese medicine guideline of clinical investigations " (third volume) that life portion develops and publishes for 1997 is evaluated.

Clinical recovery: blood glucose is normal, and clinical symptoms completely disappear, and joint function recovery is normal, and blood uric acid is down to normal pain Pain disappear or mostly disappear, therapeutic index >=95%；

Effective: blood glucose is normal, and clinical symptoms completely disappear, and joint function recovery is normal, and blood uric acid is down to normal pain and is obviously changed It is kind, therapeutic index >=70%；

Effective: blood glucose is normal, and clinical symptoms improve, and joint symptoms are alleviated, 10% or more blood uric acid decline；Pain improves, curative effect Index >=30%；

Invalid: even symptom is not improved exacerbation, blood uric acid is unchanged earlier above, and pain is not improved, therapeutic index < 30%.

Therapeutic index=[(pre-treatment score-post treatment integral)/pre-treatment score] × 100%

Total effective rate=[(recovery from illness case+effective case)/total case load] × 100%

R, statistical method

All data informations are inputted with Excel, are counted by SPSS13.0 software systems.Measurement data uses mean ± standard Difference indicates that enumeration data is indicated with rate.Comparison among groups use independence if meeting normal distribution and homogeneity of variance in measurement data Sample t-test, group are interior before and after treatment relatively using matched-pair design t inspection；It is used if not meeting normal distribution and homogeneity of variance Non-parametric test is compared.The comparison of measurement data is examined using row × list data X2.

7. result

7.1 pain improve situation

Pain improves situation and is shown in Table 1:

1 treatment group of table and placebo pain improve situation comparison sheet

Group	Sample size	Before treatment	After treatment
				Treatment group	30	9.20±0.66	1.67±0.92
Placebo	30	9.13±0.73	6.20±1.03

Note: comparing before two groups of treatments, * P > 0.05；Compare after two groups of treatments,^△P < 0.01

7.2 treatment overall situations

Total effective rate situation is shown in Table 4:

4 treatment group of table and placebo treat overall situation comparison sheet

Group	Sample size	Clinical recovery	It is effective	Effectively	In vain	Total effective rate
							Treatment group	30	3	23	4	0	86.67%
Placebo	30	0	1	19	10	3.33%

Note: two groups of total effective rates compare,^△P < 0.01

7.3 typical case

Case 1: Zhang is treated, male, 84 years old, Guilin City oriole rock people suffered from more than 10 years of goat, and biped is carried on the back red and swollen heat pain 2 days, 40 degree of body temperature, it is diagnosed as gout acute attack, anti-inflammatory, analgesic etc. is given and controls, be applied in treatment gout acute attack of the invention Medicine, twice a day, continuous treatment 1 week, symptom disappears substantially, and blood uric acid is down to normally.

Treat case 2: Tang so-and-so, male, 73 years old, Guilin City people from Quanzhou County suffered from more than 10 years of goat, right elbow joint swelling and pain 1 Week it is diagnosed as gout acute attack, gives anti-inflammatory, analgesic etc. and control, be applied with the Chinese medicine for the treatment of gout acute attack of the invention, one day Twice, continuous treatment 1 week, symptom disappears substantially, and blood uric acid is down to normally.

Claims (3)

1. the Chinese medicine composition that a kind of external application for curing diabetes merge gout, which is characterized in that mainly by following parts by weight Medicine raw material composition: 5 ~ 30 parts of dandelion, 5 ~ 30 parts of Honeysuckle flower, 5 ~ 30 parts of Fructus Forsythiae, 10 ~ 35 parts of semen coicis, 5 ~ 30 parts of pheretima, trigone 5 ~ 30 parts, 5 ~ 30 parts of leech, 5 ~ 30 parts of the coptis, 5 ~ 30 parts of viola mandshurica.

2. the Chinese medicine composition that external application for curing diabetes according to claim 1 merge gout, which is characterized in that mainly by The Chinese medicine materials of following parts by weight forms: 10 parts of dandelion, 10 parts of Honeysuckle flower, 10 parts of Fructus Forsythiae, 20 parts of semen coicis, 10 parts of pheretima, 10 parts of trigone, 10 parts of leech, 10 parts of the coptis, 10 parts of viola mandshurica.

3. external application for curing diabetes as claimed in claim 1 or 2 merge the preparation method of the Chinese medicine composition of gout, feature Be the following steps are included:

S1. dandelion, Honeysuckle flower, Fructus Forsythiae, semen coicis, pheretima, trigone, leech, the coptis and viola mandshurica are weighed by weight, are added Enter the water of 8 ~ 15 times of weight, impregnate, decocts 30 ~ 120min, obtain Chinese medicine extract；

S2. applicator material is dipped in Chinese medicine extract, is taken out, medicine for external application preparation is made.