CN114652674A - Blood circulation promoting and pain relieving ointment and preparation method thereof - Google Patents
Blood circulation promoting and pain relieving ointment and preparation method thereof Download PDFInfo
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- CN114652674A CN114652674A CN202210284393.8A CN202210284393A CN114652674A CN 114652674 A CN114652674 A CN 114652674A CN 202210284393 A CN202210284393 A CN 202210284393A CN 114652674 A CN114652674 A CN 114652674A
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Abstract
The invention belongs to the technical field of orthopedic plasters, and particularly relates to a blood circulation promoting and pain relieving plaster and a preparation method thereof. Step 1: weighing 1.524 parts of winged euonymus twig, 1.524 parts of angelica, 0.914 part of frankincense, 0.914 part of myrrh, 0.914 part of ground beetle, 0.914 part of cassia twig, 0.914 part of lycopodium clavatum, 0.914 part of garden balsam stem, 0.914 part of rhizoma drynariae, 0.914 part of glabrous greenbrier rhizome, 0.914 part of divaricate saposhnikovia root, 0.914 part of rhubarb, 0.914 part of lithospermum, 0.914 part of angelica dahurica, 3.049 parts of safflower, 0.152 part of borneol, 72.256 parts of medical vaseline and 10.666 parts of honey; and 2, step: grinding and crushing the traditional Chinese medicines weighed in the step 1 respectively; and step 3: heating and dissolving the vaseline weighed in the step 1, adding the crushed traditional Chinese medicine in the step 2, decocting the mixture for 10 minutes by slow fire, adding the honey weighed in the step 1, and uniformly stirring the mixture into paste for later use. Has good therapeutic effect on arthralgia, traumatic injury, postherpetic neuralgia, and cancer and swelling.
Description
Technical Field
The invention belongs to the technical field of orthopedic plasters, and particularly relates to a blood circulation promoting and pain relieving plaster and a preparation method thereof.
Background
Pain with swelling is one of the common clinical symptoms, and is difficult to tolerate by patients regardless of traumatic injury, acute and chronic arthritis, and pain caused by diseases such as postherpetic neuralgia, gout, cancer and the like. Pain is one of the common symptoms, and is caused by qi stagnation, blood stasis and obstruction; or the channels and collaterals failing to warm due to the deficiency of qi, blood and body fluids, resulting in the spasm and pain of the tendons and collaterals. However, the swelling caused by various diseases is the main symptom, the cause is not external internal cause, external cause, internal and external cause, the self-regulation, dissolving and resolving capability is low, and the invasion of external pathogen disturbs the metabolism of the organism. The mutual obstruction of pathogenic qi and exogenous pathogenic factors in the body can lead to disorder of qi activity, stagnation of qi and blood stasis, and pain due to obstruction.
At present, Chinese and western medicines have a plurality of medicines and methods for relieving swelling and pain, and have certain effects, but have defects. For example, the swelling and pain relieving method in western medicine is usually to take anti-inflammatory analgesic drugs, which have good effects but are highly dependent, and many side effects of the drugs often appear. The curative effect of the external plaster is not satisfactory. In addition, physical methods such as ice compress, acupuncture and moxibustion physiotherapy and the like have poor effects. Traditional Chinese medicine is usually used for treatment, has certain effects of relieving swelling and pain in application, and has the defects of slow effect, inadaptability of patients and the like.
Disclosure of Invention
Aiming at the technical problems, the invention provides the blood circulation promoting pain relieving plaster and the preparation method thereof, and the plaster for relieving swelling and pain has good treatment effect on pains such as joint swelling and pain, traumatic injury, postherpetic neuralgia and the like caused by various reasons.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a blood circulation promoting analgesic plaster comprises, by weight, 1.524 parts of winged euonymus twig, 1.524 parts of angelica, 0.914 part of frankincense, 0.914 part of myrrh, 0.914 part of ground beetle, 0.914 part of cassia twig, 0.914 part of lycopodium clavatum, 0.914 part of garden balsam stem, 0.914 part of rhizoma drynariae, 0.914 part of divaricate saposhnikovia root, 0.194 part of glabrous greenbrier rhizome, 0.914 part of rhubarb, 0.914 part of lithospermum, 0.914 part of angelica dahurica, 3.049 parts of safflower and 0.152 part of borneol.
A preparation method of a blood circulation promoting pain relieving plaster comprises the following steps: step 1: weighing 1.524 parts of winged euonymus twig, 1.524 parts of angelica, 0.914 part of frankincense, 0.914 part of myrrh, 0.914 part of ground beetle, 0.914 part of cassia twig, 0.914 part of lycopodium clavatum, 0.914 part of garden balsam stem, 0.914 part of rhizoma drynariae, 0.914 part of divaricate saposhnikovia root, 0.914 part of glabrous greenbrier rhizome, 0.914 part of rhubarb, 0.914 part of lithospermum, 0.914 part of angelica dahurica, 3.049 parts of safflower, 0.152 part of borneol, 72.256 parts of medical vaseline and 10.666 parts of honey;
step 2: grinding and crushing the traditional Chinese medicines weighed in the step 1 respectively;
and step 3: heating and dissolving the vaseline weighed in the step 1, adding the crushed traditional Chinese medicine in the step 2, decocting for 10 minutes by slow fire, adding the honey weighed in the step 1, and uniformly stirring to form paste for later use.
Compared with the prior art, the invention has the beneficial effects that:
the plaster has excellent effects of promoting blood circulation to remove blood stasis and relieving swelling and pain, has good treatment effect on pains such as joint swelling and pain, traumatic injury, postherpetic neuralgia and the like caused by various reasons, is high-quality and low-price after being prepared into the plaster, does not need to be orally taken, does not increase the burden of body metabolism medicaments, has small toxic and side effects, and has no adverse reactions such as allergy and the like in the using process of all patients.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention.
In the drawings:
FIG. 1 is a flow chart of the preparation method of the blood-activating pain-relieving plaster of the present invention;
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The plaster for promoting blood circulation and relieving pain comprises, by weight, 1.524 parts of winged euonymus twig, 1.524 parts of angelica, 0.914 parts of frankincense, 0.914 parts of myrrh, 0.914 parts of ground beetle, 0.914 parts of cassia twig, 0.914 parts of lycopodium clavatum, 0.914 parts of garden balsam stem, 0.914 parts of rhizoma drynariae, 0.914 parts of divaricate saposhnikovia root, 0.914 parts of glabrous greenbrier rhizome, 0.914 parts of rhubarb, 0.914 parts of lithospermum, 0.914 parts of angelica dahurica, 3.049 parts of safflower and 0.152 parts of borneol.
A preparation method of a blood circulation promoting pain relieving plaster comprises the following steps:
step 1: weighing 1.524 parts of winged euonymus twig, 1.524 parts of Chinese angelica, 0.914 part of frankincense, 0.914 part of myrrh, 0.914 part of ground beetle, 0.914 part of cassia twig, 0.914 part of lycopodium clavatum, 0.914 part of garden balsam stem, 0.914 part of rhizoma drynariae, 0.914 part of divaricate saposhnikovia root, 0.914 part of glabrous greenbrier rhizome, 0.914 part of rhubarb, 0.914 part of lithospermum, 0.914 part of angelica dahurica, 3.049 parts of safflower, 0.152 part of borneol, 72.256 parts of medical vaseline and 10.666 parts of honey;
step 2: grinding and crushing the traditional Chinese medicines weighed in the step 1 respectively;
and step 3: heating and dissolving the vaseline weighed in the step 1, adding the crushed traditional Chinese medicine in the step 2, decocting the mixture for 10 minutes by slow fire, adding the honey weighed in the step 1, and uniformly stirring the mixture into paste for later use.
The traditional Chinese medicine has the following pharmacological effects:
winged euonymus twig: cold and cool in nature, pungent and bitter in flavor, purgative, entering liver and spleen channels, and having the functions of breaking blood and stimulating menstrual flow, detoxifying and relieving swelling, and dispelling wind and relieving pain.
Chinese angelica: sweet and pungent in flavor and warm in nature; the functions are as follows: pungent and warm in nature, tonify blood and activate blood, regulate menstruation and alleviate pain. The main indications are as follows: it is indicated for abdominal pain due to deficiency-cold, arthralgia due to wind-dampness, traumatic injury, abscess, deep-rooted carbuncle, sore and ulcer. Can be used for treating amenorrhea, dysmenorrhea, rheumatalgia, and traumatic injury.
Frankincense: pungent, bitter and slightly warm in taste; has the functions of promoting blood circulation, promoting qi circulation, relieving pain, eliminating swelling and promoting granulation. The main treatment is as follows: promoting blood circulation and activating qi-flowing, inducing menstruation to relieve pain, subsiding swelling and promoting granulation, rheumatalgia, amenorrhea and dysmenorrhea, traumatic injury and blood stasis and pain, superficial infection and pyogenic infections, and unhealed sore and ulcer.
Myrrh: bitter and flat; has the functions of promoting blood circulation, relieving pain, eliminating swelling and promoting granulation. It can be used for treating chest and abdominal pain due to blood stasis, dysmenorrhea, amenorrhea, abdominal mass, traumatic injury, carbuncle, swelling, and pyocutaneous disease.
And (3) ground beetles: salty taste and cold nature; the functional indications are as follows: can be used for treating traumatic injury, injury of tendons and bones, amenorrhea due to blood stasis, puerperal abdominal pain due to blood stasis, and abdominal mass due to addiction.
Cassia twig: pungent and sweet in flavor and warm in nature; the functional indications are as follows: warming channel and dredging collaterals, and can be used for treating blood stagnation due to cold accumulation.
B, common clubmoss herb: bitter, pungent and warm, efficacy: dispel wind and dampness, relax tendons and activate collaterals. Can be used for treating rheumatalgia, soreness of joints of limbs, difficulty in flexion and extension, and skin weakness.
Garden balsam stem: pungent taste and warm nature; the functional indications are as follows: dispel wind and remove dampness, relax the channels and promote blood circulation, dredge collaterals and relieve pain. Can be used for treating rheumatic arthralgia, contracture of muscles and bones, and waist sprain.
Rhizoma drynariae: bitter taste and warm nature; the functional indications are as follows: tonify liver and kidney, strengthen tendons and bones, heal wound and relieve pain.
Wind prevention: pungent and sweet in flavor and slightly warm in nature; it is the essential herb for dispersing wind and alleviating pain, and has the actions of dispelling wind-cold to release exterior syndrome and expelling wind-damp to alleviate pain.
Glabrous greenbrier rhizome: sweet, bland and neutral in nature, entering liver and stomach meridians, with the functions of removing toxicity and removing dampness, and easing joint movement, it is indicated for spasm of limbs, arthralgia and myalgia, carbuncle and swelling, scrofula.
Rhubarb: bitter taste and cold nature; the functional indications are as follows: purging heat-toxin, breaking stagnation and removing blood stasis. Amenorrhea due to stasis, abscess, sore, and fire injury due to decoction.
Lithospermum: sweet, salty, and cold; the functional indications are as follows: clearing away heat, eliminating stagnation and relieving pain. Can be used for treating blood heat and toxic materials, pyocutaneous disease, eczema, scald due to hot water and fire.
Radix angelicae: pungent taste and warm nature; the functional indications are as follows: warming and dredging the pungent herbs, dispelling wind and removing dampness, dredging orifices and relieving pain, and relieving swelling and discharging pus, and can be used for treating red swelling and pain in the early stage of pyocutaneous disease.
Safflower: pungent taste and warm nature; the functional indications are as follows: can be used for treating dysmenorrhea, abdominal mass, thoracic obstruction, cardialgia, abdominal pain due to blood stasis, pricking pain in chest and hypochondrium, traumatic injury, and pyocutaneous disease with swelling and pain.
Borneol: pungent, bitter and slightly cold; the functions are mainly to dredge orifices, dispel stagnation fire, reduce swelling and alleviate pain.
The combination of ramulus Euonymi, Olibanum and Myrrha has effects of promoting blood circulation, removing blood stasis, relieving swelling and pain, promoting granulation, and healing sore, and is the essential drug for dredging viscera and meridians. The ground beetle enhances the effects of the frankincense and the myrrh on promoting blood circulation, dissipating blood stasis, reducing swelling and relieving pain, and is the essential drug for stasis and pain. The two herbs of buck grass and speranskia tuberculata are mutually reinforced to enhance the functions of dispelling wind and removing dampness, and relaxing tendons and activating collaterals. The combination of the glabrous greenbrier rhizome, the rhubarb and the sinkiang arnebia root has the effects of clearing heat and detoxicating, cooling blood and activating blood circulation, and dissolving stasis and relieving pain. The cassia twig is combined with the medicines, can warm and dredge channels and collaterals, and promote the medicine absorption.
Clinical report
Clinical research 1
1.1 case origin:
209 outpatients and inpatients in a central hospital of Shanlo city in 1 month-2021 month in 2018 meet the requirements of patients with chronic scapulohumeral periarthritis in case screening standards.
1.2 diagnostic criteria for disease:
the standard refers to the guideline of clinical research of new Chinese medicine.
1.2.1 case inclusion criteria:
(1) the good onset age is about 50 years old, and the course of disease is longer.
(2) Has history of chronic strain, wind-cold or trauma.
(3) The pain in the shoulder becomes progressively worse, with the pain radiating into the neck, ears, shoulder blades, forearms and hands.
(4) The limited movement of the shoulder joints is especially marked by the upward movement, outward rotation and backward extension.
(5) The shoulder and arm muscles of the patient suffering from extensive tenderness and severe shoulder and arm atrophy.
(6) X-ray examination generally revealed no specific findings, with some patients showing osteoporosis and a shade of subcapillary calcification.
(7) Signing the informed consent.
1.2.2 case exclusion criteria:
(1) allergic constitution under the age of 45 years or over 65 years.
(2) Complicated with serious primary diseases or mental diseases such as shoulder fracture, cardiovascular diseases, cerebrovascular diseases, liver and kidney diseases, hemopoietic system diseases and the like.
(3) Without signing an informed consent, they are not willing to accept the treatment of the present protocol.
(4) Sensitive skin or local skin ulceration, which is not suitable for topical application.
1.2.3 case shedding criteria:
(1) patient compliance was poor and treatment was discontinued for more than 2 days.
(2) The doctor in traditional Chinese medicine judges that the patient is not suitable for treating the plaster any more in the treatment process.
(3) Serious adverse events, complications and special physiological changes occur during the treatment, and the clinical trial is terminated when the clinical trial is stopped according to the judgment of a doctor.
(4) The patient is automatically quitted and does not insist on the treatment.
(5) Those who are not treated as prescribed.
(6) The patient data do not completely affect the efficacy and safety evaluation.
1.3 test grouping:
in 209 patients, a random comparison test method is adopted, wherein 209 patients select any line of a random number table according to the admission sequence, 200 numbers are transversely and continuously taken from the leftmost end, the number is 1-200, the number of the appearing repeated numbers is taken as the first appearance, odd numbers are coded into a treatment group (ointment group), even numbers are coded into a comparison group (piroxicam patch) (produced by Korea SK chemical Co., Ltd.). Results 106 patients in the treatment group (ointment group) and 103 patients in the control group (radiotherapy group).
1.4 methods of treatment:
(1) control group: the piroxicam patch is applied to the affected part for 2 days per 1 patch for 14 days.
(2) Treatment groups: the self-made plaster is used, and the medicine is changed for 1 time in 3 days, and the treatment lasts for 14 days.
1.5 evaluation of therapeutic effect:
refer to the standard of curative effect in the guideline of clinical research of new Chinese medicine.
(1) Curing, namely the shoulder pain disappears and the shoulder joint movement range is recovered to be normal;
(2) the effect is obvious, the shoulder pain is obviously relieved, and the shoulder joint moving range is obviously improved;
(3) the shoulder pain is basically relieved, and the shoulder joint moving range is partially improved;
(4) the symptoms and signs are not obviously improved.
The total effective rate is (cure + significant effect + effective)/nx100%.
1.6 evaluation of safety:
(1) liver and kidney functions (ALT, AST, BUN, Cr) of two groups of patients before and after treatment were compared among groups to evaluate the safety of treatment.
(2) The patients were closely observed for the presence of allergic or toxic side effects after taking the drug.
1.7 data processing:
statistical analysis is carried out by adopting SPSS17.0 statistical software, the measured data are described by mean plus or minus standard deviation according to normal distribution, t test is carried out, and the counted data adopt x2Checking, grading between data setsAnd the comparison adopts rank sum test, and judges whether the difference has statistical significance by taking P less than or equal to 0.05 as a standard.
Results of the study
2.1 case outcome:
the study was performed on 209 patients, and the study was divided into 106 patients in the treatment group (ointment group), 103 patients in the control group (piroxicam), 3 patients who fell off in the treatment group due to 2 days of discontinuation of the ointment treatment, 1 patient who fell off due to incomplete evaluation data, and 4 patients who fell off, so that 102 patients in the treatment group were subjected to statistical treatment. In the treatment of the control group, since the evaluation data are not totally dropped from 1 patient, 102 patients in the control group were subjected to the statistical treatment, and 204 patients in the two groups were subjected to the statistical treatment.
2.2 age comparison (Table-1)
TABLE-1 age comparison of two groups of patients
Note: two groups of patients were age-matched using two independent sample t-tests.
As can be seen from Table-1, the patients in the treatment group had an age range of 45-64 years, with a mean age of 55.44. + -. 9.91. The age range of the patients in the control group is 48-65 years, the average age is 55.28 +/-8.77, and the ages of the patients in the two groups are tested by two independent sample averages t to obtain that P is 0.947 and P is more than 0.05, which indicates that the ages of the patients in the two groups are not obviously different and are comparable.
2.3 sex comparison (Table-2)
TABLE-2 gender comparison of two groups of patients
Note: sex comparison of two groups of patients adopts four-table data X2And (6) checking.
As can be seen from Table-2, two groups of patientsData X of gender formation through four-table2The test shows that P is more than 0.05, which indicates that the sex constitution of the two groups of patients has no significant difference and is comparable.
2.4 comparison of treatment results (Table-3)
TABLE-3 comparison of the two groups of therapeutic effects
As can be seen from Table-3, the therapeutic effect of the treatment group was significantly higher than that of the control group, as indicated by X2The test shows that P is less than 0.01, which shows that the difference between the two groups of curative effects is significant.
2.5 evaluation of safety measures (tables 4-5)
TABLE-4 comparison of liver and kidney function before and after treatment in the treatment groups
Note: the liver and kidney functions before and after treatment in the treatment group are compared by adopting a paired t test.
As shown in Table-4, there was no significant difference in ALT, AST, BUN and Cr before and after treatment in the treatment groups, and the P values were all greater than 0.05, indicating that the plaster had no damage to liver and kidney functions when applied externally.
TABLE-5 comparison of liver and kidney function before and after treatment in control group
Note: the comparison of liver and kidney functions before and after treatment in the control group adopts a paired t test.
As can be seen from Table-5, there was no significant difference in ALT, AST, BUN, Cr before and after treatment in the control group, and the P values were all greater than 0.05, indicating that the piroxicam patch was harmless to liver and kidney functions.
2.6 adverse reactions
No obvious drug allergy or toxic and side effects are seen in the treatment period of the patients in the two groups.
Clinical research 2
1.1 case origin:
127 outpatients and inpatients in a central hospital of Shanlo city in 1 month in 2018 to 3 months in 2021 meet the acute soft tissue injury patient of the case screening standard.
1.2 diagnostic criteria for disease:
the standard refers to the guideline of clinical research of new Chinese medicine.
1.2.1 case inclusion criteria:
(1) meets the Western medicine diagnosis standard of acute soft tissue injury in the guideline of clinical research of new Chinese medicine.
(2) The course of the disease does not exceed three days.
(3) The age is 18-70 years.
(5) In the test process, other external medicines are not used.
(6) Signing the informed consent.
1.2.2 case exclusion criteria:
(1) patients with fracture, dislocation, tendon, ligament, nerve and blood vessel injury need operation.
(2) Severe allergic constitution and allergic to certain components in the ointment.
(3) Pregnant and lactating patients.
(4) Skin ulceration, erythema and skin disorders in the affected area.
(5) Complicated with serious primary diseases or mental diseases such as shoulder fracture, cardiovascular diseases, cerebrovascular diseases, liver and kidney diseases, hemopoietic system diseases and the like.
(6) Without signing an informed consent, they are not willing to accept the treatment of the present protocol.
(7) Critical illness patients.
1.2.3 case shedding criteria:
(1) patient compliance was poor and treatment was discontinued for more than 2 days.
(2) The doctor in traditional Chinese medicine department judges that the patient is not suitable to use the plaster for treatment any more in the treatment process.
(3) Serious adverse events, complications and special physiological changes occur during the treatment, and the clinical trial of the case is terminated according to the judgment of a doctor that the clinical trial participants should be stopped.
(4) The patient is automatically quitted and does not insist on the treatment.
(5) Those who are not treated as prescribed.
(6) The patient data do not completely affect the efficacy and safety evaluation.
1.3 test grouping:
in total, 127 patients meet the inclusion standard and the exclusion standard, a random comparison test method is adopted, 127 patients select any line of a random number table according to the admission sequence, 127 numbers are transversely and continuously taken from the leftmost end, the number is 1-127, the number of the repeated numbers is the first to appear, odd numbers are coded into a treatment group (ointment group), even numbers are coded into a comparison group (piroxicam patch) (produced by Korea SK chemical Co., Ltd.). Results 64 patients in the treatment group (ointment group) and 63 patients in the control group (radiotherapy group).
1.4 methods of treatment:
(1) control group: the piroxicam patch is applied to the affected part for 2 days per 1 patch for 14 days.
(2) Treatment groups: the self-made plaster is used, and the medicine is changed for 1 time in 3 days, and the treatment lasts for 14 days.
1.5 evaluation of therapeutic effect:
refer to the standard of curative effect in the guideline of clinical research of new Chinese medicine.
(5) The recovery is that the symptoms of pain, swelling, ecchymosis and the like are reduced by more than or equal to 95 percent, the joint movement is normal
(6) Has obvious effects of reducing the signs of pain, swelling, ecchymosis and the like by more than or equal to 70 percent and less than 95 percent, and unlimited joint movement (3) has the effects of reducing the signs of pain, swelling, ecchymosis and the like by more than or equal to 30 percent and improving the joint movement by less than 70 percent
(4) And (4) invalidation: pain, swelling, ecchymosis, etc., the integral of physical signs is reduced by less than 30%, and the joint movement is unchanged
The total effective rate is (cure + significant effect + effective)/nx100%.
Note: the calculation formula (nimodipine method) is: [ (before treatment integration-after treatment integration) ÷ before treatment integration ] × 100%
1.6 evaluation of safety:
(1) liver and kidney functions (ALT, AST, BUN and Cr) of two groups of patients before and after treatment are compared between groups, and treatment safety is evaluated.
(2) The patients were closely observed for the presence of allergic or toxic side effects after taking the drug.
1.7 data processing:
statistical analysis is carried out by adopting SPSS17.0 statistical software, the measured data are described by mean plus or minus standard deviation according to normal distribution, t test is carried out, and the counted data adopt x2And (4) testing, wherein the comparison among the grade data groups adopts rank sum test, and whether the difference has statistical significance is judged by taking P less than or equal to 0.05 as a standard.
Results of the study
2.1 case outcome:
the study was performed on 127 patients, 64 patients in the treatment group (ointment group) and 63 patients in the control group (piroxicam) by using a random number table, 2 patients who fell off in the treatment group after 2 days of the interrupted ointment treatment, 2 patients who fell off due to incomplete evaluation data, and 4 patients who fell off, so 60 patients in the treatment group were subjected to statistical treatment. In the control group, 3 patients dropped out of the treatment for 2 days, and 1 patient dropped out of the evaluation data, so that 60 patients in the control group were subjected to statistical treatment, and 120 patients in the two groups were subjected to statistical treatment.
2.2 age comparison (Table-1)
TABLE-1 age comparison of two groups of patients
Note: two groups of patients were age-matched using two independent sample t-tests.
As can be seen from Table-1, the patients in the treatment group ranged in age from 18 to 70 years, with a mean age of 35.82. + -. 10.56. The age range of the patients in the control group is 19-70 years, the average age is 36.1 +/-10.18, and the ages of the patients in the two groups are tested by the mean number t of two independent samples to obtain P > 0.05, which indicates that the ages of the patients in the two groups are not obviously different and are comparable.
2.3 gender comparison (Table-2)
TABLE-2 gender comparison of two groups of patients
Note: two groups of patients are compared by sex using four-table data X2And (6) checking.
As can be seen from Table-2, the gender of two groups of patients is represented by the four-table data X2The test shows that P is more than 0.05, which indicates that the sex constitution of the two groups of patients has no significant difference and is comparable.
2.4 comparison of treatment results (Table-3)
TABLE-3 comparison of the two groups of therapeutic effects
As can be seen from Table-3, the therapeutic effect of the treatment group was significantly higher than that of the control group, as indicated by X2The test shows that P is less than 0.01, which shows that the difference between the two groups of curative effects is significant.
2.5 evaluation of safety measures (tables 4-5)
TABLE-4 comparison of liver and kidney function before and after treatment in the treatment group
Note: the liver and kidney functions before and after treatment in the treatment group are compared by adopting a paired t test.
As shown in Table-4, there was no significant difference in ALT, AST, BUN and Cr before and after treatment in the treatment groups, and the P values were all greater than 0.05, indicating that the plaster had no damage to liver and kidney functions when applied externally.
TABLE-5 comparison of liver and kidney function before and after treatment in control group
Note: the liver and kidney functions before and after treatment in the control group are compared by adopting a paired t test.
As can be seen from Table-5, there was no significant difference between ALT, AST, BUN, and Cr before and after treatment in the control group, and the P values were all greater than 0.05, indicating that the piroxicam patch was harmless to liver and kidney functions.
2.6 adverse reactions
No obvious drug allergy or toxic and side effects are seen in the treatment period of the two groups of patients.
Clinical research (III)
1.1 case origin:
207 outpatients and inpatients in a central hospital of Shanluo city in 1 month-2021 month in 2018, and knee osteoarthritis patients meeting the case screening standard.
1.2 diagnostic criteria for disease:
the standard refers to the guideline of clinical research of new Chinese medicine.
1.2.1 case inclusion criteria:
(1) meets the Western medicine diagnosis standard of knee osteoarthritis in the guideline of clinical research of new Chinese medicine.
(2) No other drugs or other therapies were used for nearly 1 week.
(3) The age is 18-70 years.
(4) Signing the informed consent.
1.2.2 case exclusion criteria:
(8) the knee joint may be affected by the complication, such as psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease, acute wound, etc.
(9) Severe allergic constitution and allergic to certain component in the ointment.
(10) Pregnant and lactating patients.
(11) Skin ulceration, erythema and skin disorders in the knee joint.
(12) Can be used for treating serious primary diseases or psychosis such as cardiovascular diseases, cerebrovascular diseases, liver and kidney diseases, and hemopoietic system diseases.
(13) Without signing an informed consent, they are not willing to accept the treatment of the present protocol.
(14) Critical illness patients.
1.2.3 case shedding criteria:
(1) patient compliance was poor and treatment was discontinued for more than 2 days.
(2) The doctor in traditional Chinese medicine judges that the patient is not suitable for treating the plaster any more in the treatment process.
(3) Serious adverse events, complications and special physiological changes occur during the treatment, and the clinical trial of the case is terminated according to the judgment of a doctor that the clinical trial participants should be stopped.
(4) The patient is automatically quitted and does not insist on the treatment.
(5) Those who are not treated as prescribed.
(6) The patient data do not completely affect the efficacy and safety evaluation.
1.3 test grouping:
in total 207 patients meet inclusion standards and exclusion standards, a random comparison test method is adopted, 207 patients select any line of a random number table according to the admission sequence, 207 numbers are transversely and continuously taken from the leftmost end, the number is 1-207, the number of the repeated numbers is taken to appear for the first time, odd numbers are coded into a treatment group (ointment group), even numbers are coded into a comparison group (piroxicam patch) (produced by Korea SK chemical Co., Ltd.). 104 patients in the treatment group (ointment group) and 103 patients in the control group (radiotherapy group) were treated.
1.4 methods of treatment:
(1) control group: the piroxicam patch is applied to the affected part for 2 days per 1 patch for 14 days.
(2) Treatment groups: the self-made plaster is used, and the medicine is changed for 1 time in 3 days, and the treatment lasts for 14 days.
1.5 evaluation of therapeutic effect:
refer to the standard of curative effect in the guideline of clinical research of new Chinese medicine.
(7) Clinical control, pain and other symptoms disappear, joint movement is normal, integral is reduced by more than or equal to 95 percent, and X-rays show that the joint movement is normal
(8) Has obvious effects of eliminating pain and other symptoms, limiting joint motion, reducing integral by more than or equal to 70 percent and less than 95 percent, and obviously improving X-ray display
(9) Has the advantages of disappearance of symptoms such as pain, mild limitation of joint movement, reduction of integral by more than or equal to 30 percent, improvement of joint movement by less than 70 percent, and improvement of X-ray display
(10) And (4) invalidation: the symptoms such as pain and the like and joint movement are not obviously improved, the integral is reduced by less than 30 percent, and the X-ray is not improved
The total effective rate is (cure + significant effect + effective)/nx100%.
Note: the calculation formula (nimodipine method) is: [ (before treatment integration-after treatment integration) ÷ before treatment integration ] × 100%
1.6 evaluation of safety:
(1) liver and kidney functions (ALT, AST, BUN, Cr) of two groups of patients before and after treatment were compared among groups to evaluate the safety of treatment.
(2) The patients were closely observed for the presence of allergic or toxic side effects after taking the drug.
1.7 data processing:
statistical analysis is carried out by adopting SPSS17.0 statistical software, the measured data are described by mean plus or minus standard deviation according to normal distribution, t test is carried out, and the counted data adopt x2And (4) testing, wherein the rank sum test is adopted for comparison among the level data groups, and whether the difference has statistical significance is judged by taking P less than or equal to 0.05 as a standard.
Results of the study
2.1 case outcome:
the study was performed on 207 patients, and the study was divided into 104 patients in the treatment group (ointment group), 103 patients in the control group (piroxicam), 3 patients who fell off in the treatment group due to 2 days of discontinuation of the ointment treatment, 1 patient who fell off due to incomplete evaluation data, and 4 patients who fell off, so that 100 patients in the treatment group were subjected to statistical treatment. The treatment of the control group was discontinued for 2 days and 1 patient was dropped, and the evaluation data was not completely dropped for 2 patients and 3 patients were dropped, so that 100 patients in the control group were subjected to statistical treatment and 200 patients in two groups were subjected to statistical treatment.
2.2 age comparison (Table-1)
TABLE-1 age comparison of two groups of patients
Note: two groups of patients were age-matched using two independent sample t-tests.
As can be seen from Table-1, the patients in the treatment group had an age range of 41-75 years, with a mean age of 58.64. + -. 6.21. The age range of the patients in the control group is 42-73 years, the average age is 59.02 +/-6.52, and the ages of the patients in the two groups are tested by the mean number t of two independent samples to obtain P > 0.05, which indicates that the ages of the patients in the two groups are not obviously different and are comparable.
2.3 gender comparison (Table-2)
TABLE-2 gender comparison of two groups of patients
Note: two groups of patients are compared by sex using four-table data X2And (6) checking.
As can be seen from Table-2, the gender of two groups of patients is represented by the four-table data X2The test shows that P is more than 0.05, which indicates that the sex constitution of the two groups of patients has no significant difference and is comparable.
2.4 comparison of treatment results (Table-3)
TABLE-3 comparison of the two groups of therapeutic effects
As can be seen from Table-3, the therapeutic effect of the treatment group was significantly higher than that of the control group, as indicated by X2The test shows that the P is less than 0.01, which shows that the difference of the two groups of curative effects is obvious.
2.5 evaluation of safety measures (tables 4-5)
TABLE-4 comparison of liver and kidney function before and after treatment in the treatment groups
Note: the liver and kidney functions before and after treatment in the treatment group are compared by adopting a paired t test.
As shown in Table-4, there was no significant difference in ALT, AST, BUN and Cr before and after treatment in the treatment groups, and the P values were all greater than 0.05, indicating that the plaster had no damage to liver and kidney functions when applied externally.
TABLE-5 comparison of liver and kidney function before and after treatment in control group
Note: the liver and kidney functions before and after treatment in the control group are compared by adopting a paired t test.
As can be seen from Table-5, there was no significant difference between ALT, AST, BUN, and Cr before and after treatment in the control group, and the P values were all greater than 0.05, indicating that the piroxicam patch was harmless to liver and kidney functions.
2.6 adverse reactions
No obvious drug allergy or toxic and side effects are seen in the treatment period of the patients in the two groups.
Typical cases are:
typical case 1
On a certain course, the woman, age 64, has left pain in the shoulder and back for more than 1 year. The left hand of a patient can not be lifted up due to left shoulder and back pain, daily life is seriously affected, the patient can not turn over at night, axilla canker, the patient is diagnosed and treated in local hospitals, shoulder joint CT and magnetic resonance examination are carried out, chronic scapulohumeral periarthritis is diagnosed, four times of closed therapy is successively carried out in orthopedics department and pain department of central hospitals in Shangluo city, acupuncture physical therapy and traditional Chinese medicine oral administration and external washing are carried out, the pain is relieved at that time, and the disease recurs again after 1 week. The plaster disclosed by the invention is applied on 2019, 4 and 7 days, the pain is obviously relieved after three days, the lifting height of the left arm is increased, the pain basically disappears after 1 week, the left arm can lift the face, comb the hair and the like, the plaster is completely cured after being continuously used for 12 days, and the disease does not relapse after being visited for 2 years.
Typical case 2
Tian Yi, woman, age 63, pain in the right shoulder and back for more than 30 years. The patients do work for growing bean sprouts 30 years ago, the right shoulder and back pain is caused by long-term work, the right hand cannot be lifted, the chronic scapulohumeral periarthritis is detected and diagnosed in multiple hospitals, and no obvious effect is achieved when acupuncture physiotherapy, oral medicaments and external plaster treatment are given. In the process of hospitalization of diabetes mellitus for a patient in 4 months in 2020, the plaster is applied, the pain is obviously relieved after three days, the lifting height of the right arm is increased, the pain basically disappears after 1 week, the right hand can lift the face and comb the hair, and the like, the pain is basically relieved after half a month of continuous use, no pain appears, and the disease does not relapse after 2 years of follow-up visit.
Typical case 3
Wangzhi, female, 50 years old, with swelling and pain of knee joint on left side after exercise for 5 days. The patient had red, swollen and painful knee joints on the left side after playing the badminton 5 days ago, the activity was limited, the left foot could not land on the ground, and could not walk on the ground. The patient in 2019 in 4 months checks left knee joint magnetic resonance in a hospital, and prompts the knee joint ligament to be torn and joint cavity effusion to be diagnosed as knee osteoarthritis, soft tissue injury and joint cavity effusion. When the plaster is applied, the pain is obviously relieved in the next day, the pain disappears after 3 days, but the plaster still feels pain when walking under the ground, the pain basically disappears after the plaster is continuously applied for 1 week, the joint appearance is normal, and the plaster can walk on a flat road. The disease does not relapse after 2 years of follow-up.
Typical case 4
Luo somewhere, male, 65 years old, and pain in the right shoulder and back for 3 years. The patient starts to feel pain on the right shoulder and back 3 years ago, the right hand cannot be lifted, the patient is examined and diagnosed as the chronic scapulohumeral periarthritis in multi-family hospitals in Xian, and no obvious effect is achieved when the patient is treated by operation, acupuncture and moxibustion physiotherapy, oral medicines and external plaster. After a patient visits a hospital in 2019 for 5 months, the plaster starts to be applied, the pain is obviously relieved after three days, the lifting height of the right arm is increased, the pain basically disappears after 1 week, the right hand can lift, wash the face, comb the hair and the like, the patient basically heals after 10 days of continuous use, the pain does not appear any more, and the patient does not relapse after 2 years of follow-up visit.
Typical case 5
Somebody high, male, age 58, left-side head pain, herpes for 11 days. The patient had no obvious induction of left-side headache and facial pain and herpes on the scalp 11 days ago. A patient in 8 months in 2019 is diagnosed as herpes zoster in a hospital and is hospitalized, and medicines such as antiviral medicines, oral pregabalin medicines, fenbide medicines and the like are given, so that symptoms cannot be relieved, the plaster starts to be applied, the feeling of swelling and pain is slightly relieved in the next day, the swelling and pain disappears after 1 week, and the patient is healed and discharged after 13 days. The disease does not relapse after 2 years of follow-up.
Typical case 6
Some ginger, female, 60 years old, left foot swelling and pain for 3 months. The patient has diabetes, equinus, red swelling and pain of left foot joint before 3 months, limited activity, and inability of walking on the ground. A patient in 2019 in 5 months checks left foot photos in a hospital, the left foot is prompted to be deformed, the plaster is coated, the feeling of swelling and pain is obviously relieved in 3 days, the swelling and pain basically disappear after 5 days, and the patient can walk out of the bed after 8 days. No recurrence occurred in 2 years of follow-up.
The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (2)
1. A blood circulation promoting pain relieving plaster is characterized in that: according to the weight portion, the traditional Chinese medicine composition comprises 1.524 portions of winged euonymus twig, 1.524 portions of angelica, 0.914 portion of frankincense, 0.914 portion of myrrh, 0.914 portion of ground beetle, 0.914 portion of cassia twig, 0.914 portion of lycopodium clavatum, 0.914 portion of speranskia herb, 0.914 portion of drynaria rhizome, 0.914 portion of glabrous greenbrier rhizome, 0.914 portion of divaricate saposhnikovia root, 0.914 portion of rhubarb, 0.914 portion of lithospermum, 0.914 portion of angelica root, 3.049 portions of safflower and 0.152 portion of borneol.
2. The method for preparing a blood circulation promoting pain relieving plaster as claimed in claim 1, wherein: the method comprises the following steps:
step 1: weighing 1.524 parts of winged euonymus twig, 1.524 parts of Chinese angelica, 0.914 part of frankincense, 0.914 part of myrrh, 0.914 part of ground beetle, 0.914 part of cassia twig, 0.914 part of lycopodium clavatum, 0.914 part of garden balsam stem, 0.914 part of rhizoma drynariae, 0.914 part of glabrous greenbrier rhizome, 0.914 part of divaricate saposhnikovia root, 0.914 part of rhubarb, 0.914 part of lithospermum, 0.914 part of angelica dahurica, 3.049 parts of safflower, 0.152 part of borneol, 72.256 parts of medical vaseline and 10.666 parts of honey;
and 2, step: grinding and crushing the traditional Chinese medicines weighed in the step 1 respectively;
and step 3: heating and dissolving the vaseline weighed in the step 1, adding the crushed traditional Chinese medicine in the step 2, decocting for 10 minutes by slow fire, adding the honey weighed in the step 1, and uniformly stirring to form paste for later use.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115624581A (en) * | 2022-07-27 | 2023-01-20 | 孙晓辉 | Formula of externally-applied pain-relieving paste prepared by compounding traditional Chinese medicines and preparation method thereof |
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2022
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| CN100998799A (en) * | 2006-12-27 | 2007-07-18 | 陈玉龙 | Chinese medicinal preparation for treating fracture, traumatic injury |
| CN104815017A (en) * | 2015-04-23 | 2015-08-05 | 孙刚 | Traditional Chinese medicine ointment for treating osteoproliferation and preparation method of ointment |
| CN107213347A (en) * | 2017-07-01 | 2017-09-29 | 河南中医药大学 | It is a kind of to treat orthopaedics bone-set plaster of fracture and preparation method thereof |
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