A Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating yang deficiency and stasis type hand-foot syndrome and its preparation method

Abstract

The present invention provides a Chinese medicine composition for warming yang, activating blood circulation and detoxifying for treating yang deficiency and stasis type hand and foot syndrome and a preparation method thereof, belonging to the technical field of Chinese medicine. The raw materials of the Chinese medicine composition of the present invention include astragalus, cinnamon twig, epimedium, herba scutellariae, geranium, lithospermum and phellodendron, and the above Chinese medicine raw materials are decocted into an external liquid medicine, and the hands and feet are soaked and washed to achieve the therapeutic effect of treating yang deficiency and stasis type hand and foot syndrome. The Chinese medicine composition of the present invention can improve the clinical symptoms of hand and foot syndrome and improve the quality of life of patients.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a yang-warming, blood-activating and detoxifying traditional Chinese medicine composition for treating yang deficiency and stasis type hand-foot syndrome and a preparation method thereof. Background Art

[0002] At present, chemotherapy is the main treatment for advanced malignant tumors. While chemotherapy can control tumors, some adverse reactions are inevitable, and hand-foot syndrome (HFS) is one of the common adverse reactions. Severe hand-foot syndrome will affect the patient's quality of life. Some patients need to adjust the drug dose or stop the drug for observation, which affects the efficacy of anti-tumor treatment. Common chemotherapy drugs that cause hand-foot syndrome include capecitabine, liposome doxorubicin, cytarabine and docetaxel. At present, there is no definite and effective treatment method for Western medicine.

[0003] The diagnostic criteria for hand-foot syndrome refer to the NCI grading criteria developed by the National Cancer Institute of the United States. Grade I: mild skin changes or dermatitis, accompanied by abnormal sensation (numbness, tingling, burning sensation), but does not affect daily activities; Grade II: skin changes as above accompanied by pain, slightly affecting daily activities, and the skin surface is intact; Grade III: ulcerative dermatitis or skin changes accompanied by severe pain, seriously affecting daily life, and obvious tissue destruction (such as desquamation, blisters, bleeding, edema).

[0004] With reference to the guiding principles for clinical research of new Chinese medicines and the expert consensus on TCM syndrome differentiation and treatment of hand-foot syndrome, the diagnostic criteria for yang deficiency and blood stasis type are as follows: pigmentation of the skin of the hands and feet, with dull, cyanotic, blackened colors, unclear boundaries, and thickened nails; dark red macules the size of millet grains appear on the fingers and soles of the feet, and in severe cases, they merge into patchy dark red macules with unclear boundaries or accompanied by erosion on the palms, backs of hands and backs of feet; cold limbs and fear of cold extremities; pain and numbness in the hands and feet, which worsens when exposed to cold and gradually develops to affect normal activities such as walking and holding objects; pale tongue or dull tongue with ecchymosis, and stringy or deep and fine pulse.

[0005] The present invention provides a Chinese medicinal composition for warming yang, promoting blood circulation and detoxifying for hand-foot syndrome of yang deficiency and stasis type, and improving the cure rate is a problem to be solved. Summary of the invention

[0006] In view of this, the purpose of the present invention is to provide a Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating yang deficiency and stasis type hand and foot syndrome, which is used to treat yang deficiency and stasis type hand and foot syndrome and improve the cure rate.

[0007] The Chinese medicinal composition for warming yang, promoting blood circulation and detoxifying for treating yang deficiency and stasis type hand-foot syndrome of the present invention comprises the following raw materials in parts by weight:

[0008] 25-30 parts of Astragalus, 12-15 parts of cinnamon twig, 15-18 parts of epimedium, 25-30 parts of scutellaria baicalensis, 20-23 parts of geranium, 15-18 parts of lithospermum, and 12-15 parts of phellodendron.

[0009] Preferably, the Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for hand-foot syndrome of yang deficiency and stasis type comprises the following raw materials in parts by weight:

[0010] 30 parts of Radix Astragali, 15 parts of Ramulus Cinnamomi, 15 parts of Herba Epimedii, 30 parts of Herba Polygoni Multiflori, 20 parts of Herba Geraniae, 15 parts of Radix Lithospermi, 15 parts of Cortex Phellodendri.

[0011] Preferably, the Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating hand-foot syndrome of yang deficiency and toxic stasis type described in the present invention is a liquid medicine for external use.

[0012] Another object of the present invention is to provide a method for preparing a Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating yang deficiency and stasis type hand-foot syndrome, comprising the following steps:

[0013] (1) Weigh the raw materials according to the proportion and soak them in cold water for half an hour;

[0014] (2) decocting the original solution after soaking over high heat, then decocting over low heat for another 20 minutes, and filtering to obtain the residue and juice;

[0015] (3) adding cold water to the residue, repeating step (2), filtering to obtain a medicinal juice, mixing the two medicinal juices, and obtaining the warming yang, promoting blood circulation and detoxifying Chinese medicine composition for treating yang deficiency and stasis type hand and foot syndrome.

[0016] Preferably, the ratio of the raw material to cold water in step (1) is 120-150 g:1200 mL, and the ratio of the slag to cold water in step (3) is 100-150 g:1200 mL.

[0017] Compared with the prior art, the present invention has the following beneficial effects: the present invention provides a Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating yang deficiency and stasis type hand and foot syndrome, wherein the liquid medicine is prepared with astragalus, cinnamon twig, epimedium, herba spatholobi, geranium, lithospermum officinale and phellodendron as raw materials, and the hands and feet are soaked when the temperature drops to 37 to 40°C, each time for half an hour, twice a day, and the Chinese medicine is soaked continuously for 2 weeks, which has a good therapeutic effect on the treatment of yang deficiency and stasis type hand and foot syndrome, can improve the clinical symptoms of the hands and feet of the hand and foot syndrome, and improve the quality of life of patients. DETAILED DESCRIPTION

[0018] The present invention will be further described below in conjunction with the embodiments.

[0019] Example 1

[0020] A Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating yang deficiency and stasis type hand-foot syndrome, comprising the following raw materials:

[0021] Astragalus 30g, cinnamon twig 15g, epimedium 15g, radix polygoni lobata 30g, geranium 20g, lithospermum 15g, phellodendron chinense 15g.

[0022] The preparation method of the Chinese medicine composition comprises the following steps:

[0023] (1) Weigh the raw materials according to the proportion and soak them in 1200 mL of cold water for half an hour;

[0024] (2) After the soaking, the liquid was boiled over high heat, then boiled over low heat for another 20 minutes, and filtered to obtain the residue and 800 mL of the juice;

[0025] (3) Add 1200 mL of water to the residue, repeat step (2), filter to obtain 800 mL of medicinal juice, mix the two medicinal juices to a total of 1600 mL, and obtain the external liquid preparation of the traditional Chinese medicine composition.

[0026] The following tests were performed using the Chinese medicine composition prepared in Example 1 of the present invention:

[0027] A total of 38 patients with hand-foot syndrome were selected from the outpatient and inpatient departments of the School of Clinical Oncology, Fujian Medical University from December 2018 to December 2022. Among them, 20 were males and 18 were females; the age ranged from 25 to 78 years, with an average age of 48±3.5 years; the KPS score was ≥70 points;

[0028] Hand-foot syndrome grading (NCI grading): grade I: 9 cases, grade II: 17 cases, grade III: 12 cases;

[0029] Tumor types: 1 case of nasopharyngeal carcinoma, 5 cases of esophageal squamous cell carcinoma, 5 cases of esophagogastric junction adenocarcinoma, 4 cases of gastric body adenocarcinoma, 2 cases of gastric antral adenocarcinoma, 3 cases of gastric signet ring cell carcinoma, 5 cases of breast cancer, 6 cases of colon cancer, 2 cases of rectal cancer, 3 cases of pancreatic cancer, and 2 cases of pancreatic neuroendocrine tumors;

[0030] The treatment regimens were either single-agent capecitabine or combination therapy containing capecitabine, including 6 cases using capecitabine alone, 8 cases using oxaliplatin, 3 cases using gemcitabine, 5 cases using paclitaxel, 4 cases using docetaxel, 3 cases using bevacizumab, 4 cases using irinotecan, 2 cases using furiquintinib, 1 case using apatinib, and 2 cases using temozolomide.

[0031] Use the external liquid medicine prepared in Example 1 to soak hands and feet when the temperature drops to 37 to 40° C., soak for half an hour each time, twice a day, and soak with Chinese medicine for 2 weeks.

[0032] (1) The symptoms of hand-foot syndrome of yang deficiency and stasis type (pigmentation of the skin of fingers / toes, dark red macules, cold extremities, pain in the hands and feet, numbness, ulcers and edema) were scored according to the severity of the symptoms: no symptoms 0 points, mild 1 point, moderate 2 points, severe 3 points, the lower the score, the milder the symptoms. The changes in the TCM syndrome scores before and after treatment are shown in Table 1.

[0033] The efficacy criteria include obvious improvement, partial improvement and ineffectiveness, among which obvious improvement: the total symptom score after treatment decreased by ≥2 / 3 compared with that before treatment; partial improvement: the total symptom score after treatment decreased by 1 / 3 to 2 / 3 compared with that before treatment; ineffectiveness: the total symptom score before and after treatment decreased by <1 / 3. The improvement of symptoms before and after treatment is shown in Table 2.

[0034] Table 1

[0035]

[0036]

[0037] Note: Compared with the group before treatment, △ P<0.05, ▲ P<0.01.

[0038] Table 2

[0039]

[0040] As can be seen from Tables 1 and 2, after treatment, the patients' skin pigmentation, dark red macules, cold extremities, pain in the hands and feet, numbness, and ulcer edema were alleviated compared with before treatment, and the scores of each symptom were reduced compared with before treatment (P<0.05), among which cold extremities, ulcer edema, and pain were improved more significantly (P<0.01). The total score after treatment was significantly lower than that before treatment. The total effective rate was 81.58%.

[0041] (2) The HF-QOL scale was used for questionnaire survey. The HF-QOL quality of life scale includes 18 items. Each item is divided into five dimensions according to the frequency of daily activities caused by skin reactions: not at all, rarely, sometimes, often, and always, and is scored as 0, 1, 2, 3, and 4 points respectively. The total score is then added up for each item. The lower the score, the lighter the condition; the higher the score, the more severe the condition. Among them, 7 items 1-5, 7, and 10 reflect activity ability, 7 items 12-18 reflect social psychology, and 4 items 6, 8, 9, and 11 reflect daily life. The total scores of activity ability, social psychology, and daily life before and after treatment were calculated respectively. The changes in HF-QOL quality of life scores before and after treatment are shown in Table 3.

[0042] The efficacy criteria include obvious improvement, partial improvement and ineffectiveness, among which obvious improvement: the total symptom score after treatment decreased by ≥2 / 3 compared with that before treatment; partial improvement: the total symptom score after treatment decreased by 1 / 3 to 2 / 3 compared with that before treatment; ineffectiveness: the total symptom score before and after treatment decreased by <1 / 3. The improvement of HF-QOL quality of life before and after treatment is shown in Table 4.

[0043] Table 3

[0044] project Before treatment After treatment Activity 19.7±0.23 <![CDATA[11.8±0.35 △ ]]> Social Psychology 18.6±0.48 <![CDATA[13.5±0.28 ☆ ]]> Daily life 12.5±0.21 <![CDATA[7.2±0.16 △ <!-- 3 -->]]> Total points 50.8±0.92 <![CDATA[32.5±0.79 △ ]]>

[0045] Note: Compared with the group before treatment, △ P<0.05, ☆ P>0.05

[0046] Table 4

[0047]

[0048] As can be seen from Tables 3 and 4, the patients' activity ability, daily life, and social psychology in the HF-QOL scale improved after treatment, with an effective rate of 78.95%. Among them, the improvement in activity ability and daily life was more obvious (P<0.05). Although social psychology improved, there was no statistical difference. It may be that the 2-week observation time was not long enough, and the patient's psychological transformation required longer time to adjust.

[0049] During and after the treatment, the patient did not experience abnormalities in liver, kidney, or heart function due to the use of the drugs.

[0050] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating hand-foot syndrome of yang deficiency and stasis type, characterized in that: Made from the following raw materials in parts by weight: 25-30 parts of Astragalus, 12-15 parts of Cinnamon Twig, 15-18 parts of Epimedium, 25-30 parts of Herba Scutellariae, 20-23 parts of Geranium, 15-18 parts of Lithospermum, 12-15 parts of Cortex Phellodendri; The preparation method of the Chinese medicinal composition for warming yang, promoting blood circulation and detoxifying for treating yang deficiency and stasis type hand and foot syndrome comprises the following steps: (1) Weigh the raw materials according to the proportion and soak them in cold water for half an hour; (2) After the soaking, boil the original liquid over high heat, then reduce the heat and boil for another 20 minutes. Filter to obtain the residue and juice. (3) adding cold water to the residue, repeating step (2), filtering to obtain a medicinal juice, mixing the two medicinal juices, and obtaining the warming yang, promoting blood circulation and detoxifying Chinese medicine composition for treating yang deficiency and stasis type hand-foot syndrome; The ratio of the raw material to cold water in step (1) is 120-150 g: 1200 mL, and the ratio of the slag to cold water in step (3) is 100-150 g: 1200 mL; The Chinese medicine composition is a liquid medicament for external use.

2. The Chinese medicine composition for warming yang, promoting blood circulation and detoxifying for treating hand-foot syndrome of yang deficiency and stasis type according to claim 1, characterized in that: Made from the following raw materials in parts by weight: 30 parts of Radix Astragali, 15 parts of Ramulus Cinnamomi, 15 parts of Herba Epimedii, 30 parts of Herba Polygoni Multiflori, 20 parts of Herba Geraniae, 15 parts of Radix Lithospermi, 15 parts of Cortex Phellodendri.

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