CN102727570A - External pharmaceutical composition for treating diabetic foot as well as preparation method and application of external pharmaceutical composition - Google Patents
External pharmaceutical composition for treating diabetic foot as well as preparation method and application of external pharmaceutical composition Download PDFInfo
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Abstract
The invention discloses an external medicine composition for treating diabetic foot. The composition is a medicament prepared from raw material medicaments in parts by weight: 30 to 90 parts of astragalus mongholicus, 10 to 30 parts of angelica sinensis, 7.5 to 22.5 parts of ligusticum wallichii, 15 to 45 parts of caulis lonicerae, 15 to 45 parts of caulis spatholobi, 7.5 to 22.5 parts of myrrh and 7.5 to 22.5 parts of frankincense. The invention also discloses the preparation method and application of the pharmaceutical composition. According to the external pharmaceutical composition, the raw material medicaments are compatible and have the functions of reinforcing qi and nourishing blood and activating meridians to stop pain, and are not greasy in nourishing, and are mild and out of hot and dry, and can treat both principal and secondary aspect of disease, thus the qi is reinforced, the blood flows smoothly, the stagnate is removed, and the gain is released. The composition has obvious effect of treating diabetic foot, in particular diabetic foot at high risk; and the composition is a new choice for clinic.
Description
Technical field
The present invention relates to a kind of externally-applied medicinal composition of treating diabetic foot.Belong to drug world.
Background technology
(diabetic foot is diabetic neuropathy, vascular lesion and the coefficient result of infection DF) to diabetic foot, is called diabetic acromelic gangrene again.WHO was defined as it in 1999: diabetics owing to merge neuropathy and the various pathological changes of peripheral vessel in various degree cause lower limb infection, ulcer and (or) deep tissue destroys (ApelqvistJ; BakkerK; VanHoutum WH, et al.International consensus andpractical guidelines on the management and the prevention of the diabetic foot.International Working Group on the Diabetic Foot.Diabetes Metab Res Rev2000; 16Suppl:S842-892.).DF is that diabetics is disabled and lethal main cause, and its sickness rate is the trend that rises year by year in recent years.Calendar year 2001, Chinese Medical Association's diabetology branch showed the retrospective analysis report of diabetics complication; The diabetics of being in hospital above 5% has diabetic foot (diabetology branch of Chinese Medical Association; Chronic complicating diseases of diabetes investigation team. the whole nation is diabetics chronic complicating diseases and 10 years Retrospective Analysis [J] of hazard factor thereof in hospital. Chinese diabetes magazine; 2003,11 (4): 232～237.).There are some researches show; The amputation rate of diabetics is 15 times of ND; 85% amputation is to cause (Pecoraro RE by diabetic foot ulcer; Reiber GE, Burgess EM.Pathways to diabetic limb amputation.Basis for prevention.Diabetes Care, 1990; 13:513-521.), the generation of primary disease and develop the serious health that is threatening diabetics.Just propose as far back as Oakley in 1956, the two big pathologic basis that diabetic foot takes place are vascular lesion and neuropathy.Because diabetics is in the state of proteinic nonenzymatic glycosylation and hyperglycemia for a long time, causes disorders of lipid metabolism, blood is in Gao Ning, high viscosity and high coagulant state; Cause artery of lower extremity blood vessel generation pathological changes, tube wall thickens, luminal stenosis; Blood capillary, microcirculation disturbance cause that the lower limb blood supply reduces simultaneously; And diabetic neuropathy can cause terminal protectiveness decreased sensation of patient's lower limb or forfeiture and foot biomechanics to change, and makes the foot protective measure lack, thereby causes the damage of mechanicalness and temperature property; Cause diabetics to infect easily; And be difficult to control, cause foot ulcers generation (Yuan Qun, Wu Shibai. the diagnosis and treatment of diabetic foot [J]. PLA's sanipratics magazine; 2004,6 (4): 203-206.).
High-risk sufficient definition does not still have unified standard for diabetes at present; Most scholars thinks that the high-risk foot of diabetes is diabetes foot of 0-grade; Refer to that the diabetics foot is outstanding etc. with peripheral neuropathy or peripheral blood vessel pathological changes or dermatosis or foot deformity, bone property; But do not have breakage, have serious foot ulcers risk.Edmonds; M.E. reach Foster; A.V.M proposes in its monograph " A Practical Manual of Diabetic Foot Care "; When the patient is in the high-risk sufficient stage of diabetes, promptly should carry out multidisciplinary monitoring, concrete measure comprises: the enforcement of machinery control, the processing of blood vessel, metabolic treatment, education.
Do not have " diabetic foot " in the TCM Document and reach the record of " the high-risk foot of diabetes " name of disease, but combine its clinical symptoms, can be with the category of the high-risk foot ownership of diabetes for " arthralgia due to stagnation of blood ", " BI-syndrome involved the blood vessels ".Doctor trained in Western medicine does not have special treatment measure to high-risk sufficient intervention at present, and the high-risk foot of utilization Chinese medicine diabetes has special advantages.Research in the past shows that according to the high-risk sufficient clinical manifestation of diabetes, in conjunction with four diagnostic methods data, oral medicinal herb, washout intervention are selected in determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs for use, and its curative effect is affirmed, and had no side effect.Therefore how to use Chinese medicine to intervene the high-risk foot of diabetes, block it and further develop, reduce the probability that it develops into foot ulcers, alleviate the financial burden of family and society, improve patient's quality of life, have crucial meaning.
Summary of the invention
Technical scheme of the present invention has provided a kind of externally-applied medicinal composition of treating diabetic foot, and another technical scheme of the present invention has provided the method for preparing and the purposes of this externally-applied medicinal composition.
The invention provides a kind of externally-applied medicinal composition of treating diabetic foot, it is the medicament that is prepared from following raw materials by weight proportions:
Radix Astragali 30-90 part, Radix Angelicae Sinensis 10-30 part, Rhizoma Chuanxiong 7.5-22.5 part, Caulis Lonicerae 15-45 part, Caulis Spatholobi 15-45 part, Myrrha 7.5-22.5 part, Olibanum 7.5-22.5 part, wherein, the consumption of the Radix Astragali is greater than the consumption of other Six-element crude drug.
Further preferably, it is the medicament that is prepared from following raw materials by weight proportions:
60 parts of the Radixs Astragali, 20 parts of Radix Angelicae Sinensis, 15 parts of Rhizoma Chuanxiongs, 30 parts of Caulis Lonicerae, 30 parts of Caulis Spatholobis, 15 parts of Myrrhas, 15 parts of Olibanums.
Wherein, described Myrrha, Olibanum are Myrrha, Olibanum or Myrrha (processed), Olibanum (processed).Described system MEIXIANG, Olibanum (processed) are parch or Myrrha (processed with vinegar), Olibanum.
Pharmaceutical composition of the present invention is to be active component by the protogenic medicinal powder of the Radix Astragali, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Caulis Lonicerae, Caulis Spatholobi, Myrrha, Olibanum, water or organic solvent; Add acceptable accessories or complementary composition, be prepared into external preparation pharmaceutically commonly used.
Wherein, described external preparation is powder, foot-bath agent, foot subsides.
The present invention also provides a kind of method for preparing the externally-applied medicinal composition of described treatment diabetic foot, and it comprises the steps:
A, weighting raw materials;
B, crude drug are directly beaten powder, or add water or organic solvent extraction, add acceptable accessories or complementary composition, are prepared into external preparation pharmaceutically commonly used.
The present invention also provides the purposes of described pharmaceutical composition in the medicine of preparation treatment diabetic foot.
Wherein, described medicine is the high-risk sufficient medicines of treatment diabetes.
To the high-risk sufficient Chinese medicine prevention of diabetes, the inventor combines clinical experience for many years, according to the traditional Chinese medical science " prolonged illness must be empty ", " pathogen usually intruding into collateral in protracted disease " theory, has formed effective Therapeutic Method of medicated bath foot of the present invention.And this method has been introduced the thought of the traditional Chinese medical science " preventive treatment of disease ", is to the high-risk sufficient early intervention of diabetes.Be intended to use the method for benefiting QI for activating blood circulation collateral dredging; By the dual function of heat, medicine, medicine under the effect of heat energy, is directly absorbed entering blood network through skin hole, acupuncture points on the human body etc.; Fail the cloth whole body and bring into play drug action; Have blood circulation promoting, improve surrounding tissue nutrition, effects such as excitating organism self regulatory function.Finally reach and improve patient's clinical symptoms, the purpose of the generation of prevention foot ulcers.
Reuse the Radix Astragali in the medicine material medicine prescription of the present invention, to reach the merit of inrigorating qi and promoting blood circulation blood stasis dispelling, make that arrogant then blood is capable, blood circulation promoting and blood stasis dispelling and just not hindering is to be monarch drug.Fang Zhongchen to reach the merit of promoting blood circulation and stopping pain, plays benefiting QI for activating blood circulation with Radix Astragali compatibility, the effect of blood-activating analgetic with Radix Angelicae Sinensis altogether.The Rhizoma Chuanxiong and the Radix Astragali match, the QI invigorating circulation of qi promoting, and tonify without causing stagnation matches with Radix Angelicae Sinensis, plays the effect of promoting blood circulation, removing blood stasis and relieving pain altogether.Assistant is with Caulis Lonicerae, Caulis Spatholobi, Olibanum, Myrrha, the Caulis Lonicerae sweet in the mouth, and heat clearing away and non-impairment of YIN, bitter cold and do not consume gas, but both heat-clearing and toxic substances removing, also promoting blood circulation to remove obstruction in the collateral matches with above-mentioned three medicines, strengthens the merit of its promoting blood circulation to remove obstruction in the collateral.The Caulis Spatholobi sweet in the mouth, sweet can the benefit is equipped with Radix Angelicae Sinensis, and two medicines strengthen enriching blood active merit with going into blood system.Olibanum, Myrrha two medicines are shared, and the merit of its promoting blood circulation and stopping pain is more remarkable.In sum, medicine material prescription compatibility characteristics of the present invention: 1, reuse the gas of the big spleen reinforcing lung of the Radix Astragali,, the prosperous blood of bringing about the desired sensation is given birth to, be equipped with an amount of Radix Angelicae Sinensis as a means of the change source, nourshing blood and promoting blood circulation, blood stasis dispersing and fresh blood promoting, row stagnation pain makes that the side invigorates blood circulation and do not feel frustrated qi and blood tonifying entirely; 2, the hot temperature of loosing of Olibanum is logical, can reach meridians outward, and the pain relieving of loosing of interior logical internal organs, blood circulation promoting and blood stasis dispelling then, row with Myrrha and usefulness, amounts to the merit of promoting blood circulation, dredging meridian and relieving pain; 3, in a large amount of hot using warming therapy article, be equipped with cold and cool Caulis Lonicerae in right amount, make full side warm and not dry.Full side's compatibility is played benefiting QI and nourishing blood altogether, and the merit of removing obstruction in the collateral to relieve pain is mended and oiliness, and temperature is not and dry, and treating both the principal and secondary aspects of a disease makes the prosperous blood of bringing about the desired sensation capable, the stagnation resolvation ruton.Medicine of the present invention is used to treat diabetic foot, the high-risk foot of diabetes especially, and drug effect is clear and definite, for clinical a kind of new selection is provided.
Description of drawings
Fig. 1 clinical trial step of the present invention
Fig. 2 total effects distributes
The specific embodiment
The preparation of embodiment 1 external used medicine of the present invention
Get Radix Astragali 60g, Radix Angelicae Sinensis 20g, Rhizoma Chuanxiong 15g, Caulis Lonicerae 30g, Caulis Spatholobi 30g, Myrrha 15g, Olibanum 15g, decocte with water is concentrated into 300ml, gets medicine external foot bathing lotion of the present invention.
The preparation of embodiment 2 external used medicines of the present invention
Get Radix Astragali 30g, Radix Angelicae Sinensis 10g, Rhizoma Chuanxiong 7.5g, Caulis Lonicerae 15g, Caulis Spatholobi 15g, Myrrha (processed with vinegar) 7.5g, Olibanum (processed with vinegar) 7.5g, directly beat powder, sieve, get powder.
The preparation of embodiment 3 external used medicines of the present invention
Get Radix Astragali 90g, Radix Angelicae Sinensis 30g, Rhizoma Chuanxiong 22.5g, Caulis Lonicerae 45g, Caulis Spatholobi 45g, Myrrha 22.5g, Olibanum 22.5g, extract the active component spray drying separately and process single herbal concentrate-granule, use according to this ratio compatibility again, packing.
Below prove effective effect of the present invention through concrete clinical trial.
Test Example 1 the present invention treats the high-risk sufficient clinical trial of diabetes
1 clinical data
1.1 case source
This research case all comes from is in hospital and the out-patient in Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ department of endocrinology in January, 2011～2012 year January, totally 64 examples, and matched group 32 examples, 32 examples are organized in treatment.
1.2 diagnostic criteria
1.2.1 diabetes diagnosis standard
With reference to WHO diagnostic criteria (Yang Wenying in 1999; Lu Juming; Weng Jianping; Et al.Prevalence of diabetes among men and women in China [J] .The New England Journal of Medicine; 2010,362 (12): 1090-1101.): 1, diabetic symptom (classical symptom comprises the weight loss of polydipsia, polyphagia, polyuria and unknown cause) adds random blood sugar (random time in a day is not considered meal time last time) >=11.1mmol/L (200mg/dl); Or fasting glucose (at least 8 hours heats of not taking food) >=7.0mmol/L (126mg/dl); Or clothes sugar blood glucose >=11.1mmol/L (200mg/dl) after back 2 hours in the carbohydrate tolerance test (OGTT).2, non-diabetic symptom needs other day to resurvey blood glucose to clarify a diagnosis.
Annotate: 1. above blood glucose value is the venous plasma measured value.2. the diabetic symptom person of not being true to type, clinical diagnosis must confirm through the repeated trials of another day.
1.2.2 the high-risk sufficient diagnostic criteria of diabetes
With reference to " 2007 diabetic foots dispose and prevention practical guide " (the international diabetic foot working group/.2007 of IDF advisor group diabetic foot is disposed and prevention practical guide [J]. Chinese diabetes magazine; 2007; 15 (11): appendix I-III .) and " A Practical Manual of Diabetic Foot Care " (Yu Demin; Wang Penghua. colored diagram [M] is put into practice in the diabetic foot diagnosis and treatment. Tianjin Scientific English Translation publishing company, 2006:45-73.) and pertinent literature comprehensively formulate:
Diabetics and occur below any one or an above person all can include in.
Neuropathy: the symptom of neuropathy is arranged, like the pain at numbness, twinge or pain, the especially night of lower limb; Neural electromyogram has lower extremity movement conduction or sensation conduction abnormalities.
Vascular lesion: intermittent claudication; Pain during rest; Dorsal artery of foot is beaten and is obviously weakened or disappear; The skin relevant with position is kermesinus; ABI＜0.9.
Dermatosis: color is kermesinus, blue; Temperature obviously reduces; Edema; Xerosis cutis.
1.2.3 the high-risk sufficient symptom score table of diabetes
With reference to the refined hospital in the Hunan strange symptom score of combination of Chinese and Western medicine institute Chen Ze and combine clinical formulation (Chen Zeqi. add the clinical observation [S] of flavor tonifying liver soup treatment diabetic neuropathy. the 6th the academic meeting of national combination of Chinese and Western medicine diabetes. Mount Huang, 200:339-340.):
The table 1 disease table of integrals
1.3 case is included standard in
(1) meets the patient of diabetes diagnosis standard.
(2) meet the high-risk sufficient patient of diabetes.
(3) reach the patient of diabetes control criterion.
(4) informed consent, aspiration is tried, and the signing Informed Consent Form.
1.4 exclusion standard
(1) complication with diabetes ketosis person;
(2) other ischemic disease of limb persons such as thromboangiitis obliterans, Takayasu arteritis, Raynaud disease are arranged;
(3) person of can't take care of oneself or noncooperationist (refer to can not partner treatment or not according to the regulation medication person of affecting the treatment).
(4) this is tested used drug allergy person;
(5) gestation or preparation gestation and women breast-feeding their children;
(6) complication such as severe cardiac, liver, kidney are arranged, or be associated with other serious primary diseases, psychiatric patient.
1.5 rejecting standard
(1) do not meet the standard of including in and by the case included in of mistake, or the person that meets the exclusion standard;
(2) it is poor to include case experimenter compliance in, does not use overtesting medicine person
(3) make and serious adverse reaction, complication or special physiological take place after the medicament change and should not continue reception test, and bolter etc. voluntarily, be the case that comes off;
1.6 test case end condition
(1) state of an illness increases the weight of in the therapeutic process, or other have occurred and influence the disease of experimental observation in the test, stop clinical trial person according to judging, does invalid case processing;
(2) experimenter is unwilling to proceed clinical trial in the clinical trial process, proposes the claimer who withdraws from clinical trial to physician.
2 research steps and method
2.1 technology path figure sees Fig. 1.
2.2 test packet design
This research is included in altogether and is observed case 64 examples, adopts the method for contrast at random, is pressed into group sequencing numbering, and each patient all distributes a random number, and even number is included the treatment group in, and odd number is included matched group in.Wherein 32 examples are organized in treatment; Matched group 32 examples.
2.3 therapeutic scheme
2.3.1 the introduction period
2 weeks of introduction period.According to " Chinese type 2 diabetes mellitus guideline of prevention and treatment " (version in 2010; Exposure draft) works out unified diabetes education, diet, motion, Drug therapy principle; Adopt corresponding diabetes education, diet, motion, Drug therapy; Concrete condition to the patient is worked out the individualized treatment scheme, carries out the Drug therapy of diabetes education, diet, motion and standard, makes blood glucose, blood pressure, blood fat reach ideal range (index up to standard is seen table 2).
Table 2 blood glucose, blood pressure, blood fat controlled target
| Desired value | |
| Blood glucose (mmol/L) * on an empty stomach | 3.9–7.2mmol/l |
| Non-empty stomach | ≤10.0mmol/l |
| HbA 1c（%） | <7.0 |
| Blood pressure (mmHg) | <130/80 |
| HDL-C (mmol/l) male | >;1.0 |
| The women | >;1.3 |
| TG（mmol/l） | <1.7 |
| LDL-C (mmol/l) does not merge coronary heart disease | <2.6 |
| Merge coronary heart disease | <1.8 |
| Initiatively aerobic activity (minute/week) | ≥150 |
2.3.2 Primary Care
Treating diabetes: medicine, diet, motion and education, blood sugar control, blood pressure and blood fat.
(1) blood pressure: first-selected ACEI class, can unite in case of necessity and use CCB or diuretic, it is up to standard to make every effort to blood pressure.
(2) blood fat: according to the difference of dyslipidemia, raising with T-CHOL (comprising low-density lipoprotein cholesterol) is main person, selects Statins; With the triglyceride rising is that main person selects fibrate.
(3) blood glucose: the treatment procedure with reference in " Chinese type 2 diabetes mellitus guideline of prevention and treatment " (version in 2010, exposure draft) carries out medicament selection.
(4) other complication treatment: carry out necessary treatment according to the situation of complication.
2.3.3 the high-risk foot therapy of diabetes
Two groups of patients all give above-mentioned Primary Care, add usefulness simultaneously:
(1) treatment group: add with medicine 300ml of the present invention (embodiment 1 preparation)+eliminating cold for resuscitation water 4000ml, temperature is once-a-day bathed foot, each 30 minutes at 37-40 ° of C.
(2) matched group: eliminating cold for resuscitation water 4000ml, temperature is once-a-day bathed foot, each 30 minutes at 37-40 ° of C.
The course of treatment: 4 weeks were a course of treatment, totally 3 courses of treatment.
2.4 observation index
2.4.1 safety indexes
General reaction and blood, stool, urine routine test, liver, kidney function test, Electrocardioscopy (above except that general reaction is write down at any time, other indexs detect before treatment and after the treatment end).
2.4.2 diagnostic index
(1) fasting glucose, 2 hours after the meal blood glucose
(2) ankle upper arm index (ABI)
(3) two lower limb electromyograms
ABI, two lower limb electromyogram are checked before treatment and after 12 weeks of treatment.
2.4.3 diabetes controlling index
(above blood glucose, blood pressure detect before going into group, before the treatment and during treating in per 4 weeks for blood glucose, blood pressure, blood fat, glycolated hemoglobin; HbAlc, blood fat detect before treatment, after treating for 12 weeks).
2.4.4 parameters for observation on effect
Symptom integral, ABI (above index detects before treatment and after 12 weeks of treatment).
2.5 curative effect determinate standard
With reference to therapeutic evaluation standard in the strange symptom score of the combination of Chinese and Western medicine institute Chen Ze of the refined hospital in Hunan (Chen Zeqi. add the clinical observation [S] of flavor tonifying liver soup treatment diabetic neuropathy. the 6th the academic meeting of national combination of Chinese and Western medicine diabetes. Mount Huang; 200:339-340.) and the relevant index of diabetes pedopathy diagnosis and treatment and curative effect judging standard (Li Shiming. the diagnosis and treatment of diabetic foot and related complication [M]. Beijing: People's Health Publisher, 2002:168.) the comprehensive formulation:
Produce effects: clinical symptoms and sign are obviously improved, and symptom integral reduces >=70%; The ankle upper arm is than (ABI) more preceding rising more than 0.1;
Effectively: clinical symptoms and sign all have improvement, and symptom integral reduces 30%～70%; The ankle upper arm than (ABI) more preceding rising O.05～0.1;
Invalid: clinical symptoms and sign do not have obvious improvement, even increase the weight of, symptom integral reduces≤30%; The ankle upper arm is than (ABI) more preceding rising＜0.05.
Annotate: computing formula is (a nimodipine method): [integration before (integration before the treatment-treatment back integration)/treatment] * 100%.
2.6 statistical analysis
This research adopts the SPSS13.0 statistical software to analyze, and each item observation index is carried out contrast between contrast and group before and after self; Measurement data is represented with mean ± standard deviation
; Accord with normal distribution adopts the t check, and the abnormal data adopts rank test; Enumeration data adopts the Pearson chi-square criterion in the two sample data, and ranked data adopt the nonparametric rank test.Inspection level is α=0.05.
3 results
3.1 physical data analysis
Data such as patient's sex, age, the course of disease, cardinal symptom distribution, symptom integral and ABI are relatively seen table 3～table 8 before the treatment.
3.1.1 two groups of sexes distribute relatively
The preceding two groups of patient's sex ratios of table 3 treatment
Can find out that from table 3 two groups of patient's sexes distribute, through X
2Check, P＞0.05, no difference of science of statistics has comparability.
3.1.2 two groups of age distribution relatively
The preceding two groups of patient age of table 4 treatment (year) relatively
Can find out that from table 4 two groups of patient age distribute, through X
2Check, P＞0.05, no difference of science of statistics has comparability.
3.1.3 two groups of courses of disease distribute relatively
The table 5 preceding two groups of patient's courses of disease of treatment (year) distribute relatively
Can find out that from table 5 two groups of patient's courses of disease distribute, through X
2Check, P＞0.05, no difference of science of statistics has comparability.
3.1.4 treating preceding two groups of patient's cardinal symptoms distributes relatively
The preceding two groups of patient's cardinal symptoms of table 6 treatment relatively
Can find out that from table 6 two groups of patient's each item symptoms distribute, through rank test, P＞0.05, all no difference of science of statistics has comparability.
3.1.5 treat preceding two groups of patient symptom total marks relatively
The preceding two groups of patient symptom total marks of table 7 treatment are
relatively
Can find out that from table 7 two groups of patient symptom total marks are relatively checked through t, bilateral P＞0.05, not statistically significant has comparability.
3.1.6 treat preceding two groups of patient ABI relatively
The preceding two groups of patient ABI of table 8 treatment are
relatively
Can find out that from table 8 two groups of patient ABI relatively check through t, bilateral P＞0.05, not statistically significant has comparability.
To sum up, case 64 examples are accomplished in this research, before the medication baseline data (comprising sex, age, the course of disease, cardinal symptom distributions, symptom total mark, ABI) are carried out statistical analysis, and the P value is equal＞and 0.05, not statistically significant explains that this research has comparability.
3.2 therapeutic effect
3.2.1 two groups of treatment back total effective rates relatively
Table 9 total effective rate is (example) relatively
Can find out from table 9, through rank test, Z=-4.854, P=0.000 (P＜0.05) has statistical significance.Treatment group curative effect is superior to the matched group (see figure 2).
3.2.2 two groups of treatment back cardinal symptoms relatively
Table 10 cardinal symptom is (example) relatively
Can find out from table 10, through rank test, in the group before and after relatively, treatment group limb adynamia, knee jerk, intermittent timpang not statistically significant (P＞0.05) improve not obviously, surplus doing well,improving has statistical significance (P＜0.05); Matched group local cold, vein contracture have statistical significance (P＜0.05) to improve obviously, and surplus doing well,improving is not obvious; Relatively, treatment group each item doing well,improving situation is superior to matched group between the group of treatment back.
Compare 3.2.3 treat in the two groups of patient's symptom total mark groups in back and between group
Table 11 is treated in the two groups of patient's symptom total mark groups in back and between group and is compared
Can find out from table 11, relatively, check before and after the treatment of treatment group through t, t=8.214, there is statistical significance bilateral P＜0.05, explains that the symptom total mark is improved variant after treatment; Compare before and after the treatment of control group, t=2.004, bilateral P＞0.05, the difference not statistically significant explains that the symptom total mark is improved not obvious after treatment; The improvement of to sum up treatment group symptom total mark is superior to matched group.
3.2.4 ankle before and after two groups of patient treatments/upper arm ratio (ABI) relatively
Two groups of interior reaching between group of patient ABI group are compared after table 12 treatment
Can find out that from table 12 ABI relatively checks through t before and after the treatment of treatment group, t=2.324, there is statistical significance bilateral P＜0.05, explains that ABI improves variant after treatment; Compare before and after the treatment of control group, t=1.920, bilateral P＞0.05, the difference not statistically significant explains that ABI improves not obvious after treatment.
3.3 safety evaluatio
Case 64 examples are accomplished in this research altogether, and in the observation process, untoward reaction does not all appear in two groups of patients, blood, urine, stool routine examination, and the equal Non Apparent Abnormality of inspection such as liver, renal function, electrocardiogram, overall security is good.
Total effective rate compares: treatment group total effective rate is 84.37%, and the matched group total effective rate is 21.88%; Symptom integral compares: treatment group limb adynamia, knee jerk, intermittent timpang improve not obvious, not statistically significant (P＞0.05), and surplus doing well,improving is obvious; Local cold, vein contracture improve obviously in the matched group, and statistical significance (P＜0.05) is arranged, and surplus doing well,improving is not obvious; The symptom total mark compares: before and after the treatment of treatment group statistical significance (P＜0.05) is arranged, not statistically significant (P＞0.05) before and after the treatment of control group; ABI compares: before and after the treatment of treatment group statistical significance (P＜0.05) is arranged, not statistically significant (P＞0.05) before and after the treatment of control group
4 conclusions
(1) treatment group numb limbs and tense tendons, limbs pain, locally scorching hotly, local send out cold, skin colour, vein contracture, feel to go down, dorsal artery of foot, posterior tibial artery and sagging cyanosis doing well,improving afterwards be obvious; Limb adynamia, knee jerk, intermittent timpang improve not obvious; Matched group is local sends out cold, vein contracture improvement obviously, and surplus doing well,improving is not obvious; After the treatment, treatment group each item doing well,improving situation is superior to matched group.
(2) ABI relatively: treatment group ABI improves obviously; Control group A BI improves not obvious.The treatment group is superior to matched group.
(3) total effects relatively: the treatment group obviously is superior to matched group.
In sum, the high-risk foot of medicine external curing diabetic foot, especially diabetes of the present invention, drug effect is clear and definite, for clinical a kind of new selection is provided.
Claims (8)
1. externally-applied medicinal composition of treating diabetic foot, it is characterized in that: it is the medicament that is prepared from following raw materials by weight proportions:
Radix Astragali 30-90 part, Radix Angelicae Sinensis 10-30 part, Rhizoma Chuanxiong 7.5-22.5 part, Caulis Lonicerae 15-45 part, Caulis Spatholobi 15-45 part, Myrrha 7.5-22.5 part, Olibanum 7.5-22.5 part, wherein, the consumption of the Radix Astragali is greater than the consumption of other Six-element crude drug.
2. the externally-applied medicinal composition of treatment diabetic foot according to claim 1 is characterized in that: it is the medicament that is prepared from following raw materials by weight proportions:
60 parts of the Radixs Astragali, 20 parts of Radix Angelicae Sinensis, 15 parts of Rhizoma Chuanxiongs, 30 parts of Caulis Lonicerae, 30 parts of Caulis Spatholobis, 15 parts of Myrrhas, 15 parts of Olibanums.
3. the externally-applied medicinal composition of treatment diabetic foot according to claim 1 and 2 is characterized in that: described Myrrha, Olibanum are Myrrha, Olibanum or Myrrha (processed), Olibanum (processed).
4. according to the externally-applied medicinal composition of any described treatment diabetic foot of claim 1-3; It is characterized in that: it is to be active component by the protogenic medicinal powder of the Radix Astragali, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Caulis Lonicerae, Caulis Spatholobi, Myrrha, Olibanum, water or extractive with organic solvent; Add acceptable accessories or complementary composition, be prepared into external preparation pharmaceutically commonly used.
5. the externally-applied medicinal composition of treatment diabetic foot according to claim 4 is characterized in that: described external preparation is powder, foot-bath agent, foot subsides.
6. method for preparing the externally-applied medicinal composition of any described treatment diabetic foot of claim 1-5, it comprises the steps:
A, weighting raw materials;
B, crude drug are directly beaten powder, or add water or organic solvent extraction, add acceptable accessories or complementary composition, are prepared into external preparation pharmaceutically commonly used.
7. the purposes of any described pharmaceutical composition of claim 1-5 in the external used medicine of the treatment diabetic foot of preparation foot administration.
8. purposes according to claim 7 is characterized in that: described medicine is the high-risk sufficient medicines of treatment diabetes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN109550005A (en) * | 2018-12-29 | 2019-04-02 | 中国人民解放军总医院 | Exterior-applied plant composition for the moist ulcer of diabetes |
| CN116898941A (en) * | 2023-07-21 | 2023-10-20 | 首都医科大学附属北京中医医院 | Traditional Chinese medicine composition and application thereof, traditional Chinese medicine preparation and preparation method and application thereof |
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| CN102106932A (en) * | 2011-02-24 | 2011-06-29 | 薛红云 | Medicament for treating diabetic foot |
| CN102188626A (en) * | 2011-04-14 | 2011-09-21 | 刘灿珍 | Traditional Chinese medicine composition capable of treating diabetic peripheral neuropathy |
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| CN109550005A (en) * | 2018-12-29 | 2019-04-02 | 中国人民解放军总医院 | Exterior-applied plant composition for the moist ulcer of diabetes |
| CN116898941A (en) * | 2023-07-21 | 2023-10-20 | 首都医科大学附属北京中医医院 | Traditional Chinese medicine composition and application thereof, traditional Chinese medicine preparation and preparation method and application thereof |
| CN116898941B (en) * | 2023-07-21 | 2024-04-30 | 首都医科大学附属北京中医医院 | Traditional Chinese medicine composition and application thereof, traditional Chinese medicine preparation and preparation method and application thereof |
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