CN115337341B

CN115337341B - Traditional Chinese medicine composition for resisting hand-foot syndrome as well as preparation method and application thereof

Info

Publication number: CN115337341B
Application number: CN202110517259.3A
Authority: CN
Inventors: 卞卫和; 倪婷; 孙莉; 张晓清; 薛静娴; 张敏
Original assignee: Jiangsu Provincial Hospital of Chinese Medicine
Current assignee: Jiangsu Provincial Hospital of Chinese Medicine
Priority date: 2021-05-12
Filing date: 2021-05-12
Publication date: 2023-04-07
Anticipated expiration: 2041-05-12
Also published as: CN115337341A

Abstract

The invention discloses a traditional Chinese medicine composition for resisting hand-foot syndrome as well as a preparation method and application thereof, wherein the traditional Chinese medicine composition comprises the following traditional Chinese medicine compositions in parts by weight: 15-25 parts of radix sophorae flavescentis, 15-25 parts of red paeony root, 10-20 parts of cortex moutan, 10-20 parts of salvia miltiorrhiza and 10-20 parts of angelica dahurica. The traditional Chinese medicine composition provided by the invention can effectively prevent hand-foot syndrome, and the effective rate reaches 93.94% which is higher than 80% of clinical reports.

Description

Traditional Chinese medicine composition for resisting hand-foot syndrome as well as preparation method and application thereof

Technical Field

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for resisting hand-foot syndrome, and a preparation method and application thereof.

Background

Hand-foot syndrome (HFS), also known as palmoplantar paregoric erythema syndrome, is a relatively frequent dose-limiting local skin toxicity reaction and can be caused by a plurality of chemotherapeutic drugs such as novel anthracyclines (PLD), capecitabine, fluorouracil, sorafenib, and the like. HFS is probably present at the earliest stage 3-5 days after the initial treatment, and early symptoms of erythema, considerable discomfort, swelling or tingling sensation on the palms and soles, and severe blistering and even ulcer development; patients may be associated with pigmentation and skin thickening. HFS is most likely to occur in the palms and soles of the feet, and other areas such as the underarm, groin, waist, medial knee, posterior elbow, anterior side of the wrist folds, etc. may also be involved.

The hand-foot syndrome is the complication with the highest incidence rate after the chemotherapy of the novel anthracycline (PLD) at present, the novel anthracycline has good curative effect in the treatment of breast cancer, particularly relieves cardiac toxicity, and is widely used clinically at present. HFS is the most prone dose-limiting toxicity of PLD. Meta-analysis showed that HFS occurred in about 45% of patients treated with breast or ovarian cancer. HFS occurs in connection with the distribution characteristics of PLD and the attack of Reactive Oxygen Species (ROS) on skin tissue. PLD accumulated in the stratum corneum slowly releases doxorubicin, which reacts with metal ions in the skin to generate ROS. ROS damage keratinocytes, release chemokines and inflammatory factors such as Interleukin (IL) -1 β, IL-6, and IL-1 α, and induce inflammation, resulting in skin tissue damage.

Generally, the risk factors for chemotherapeutic drug-induced HFS, which occur in the 2-3 cycles after treatment initiation, are primarily the duration and cumulative dose of administration. Practical experience with a large number of clinicians indicates that early identification, patient education, and supportive care are key factors in HFS management. Dose modulation and therapeutic intervention are the primary means of managing HFS. The currently used therapeutic methods for treating this disease mainly include: 1. patient education and prevention: educating patients to recognize symptoms and signs early in HFS and guide patients to report relevant information timely and accurately, helping clinicians to better manage HFS and reduce its incidence and severity. To achieve maximum benefit, the patient should be educated prior to initial administration to learn information about HFS and be instructed to take the following precautions: (1) moisturizing ointments are often applied to the hands and feet; (2) Skin irritation avoidance (e.g., perfumes, alcohols, strong cleansers); (3) Wearing cotton socks or gloves during sleep to enhance the absorption of ointment; (4) Avoiding the tight, irritating or ill-fitting clothes and shoes; (5) Avoiding the use of band-aids or other types of adhesive bandages; (6) avoidance of repetitive activities or long-term maintenance of a single posture; (7) minimizing skin coverage to minimize perspiration; (8) gently patting with a towel to dry the skin (without rubbing); (9) Avoid being subjected to extreme temperature, pressure, friction or strong light irradiation; (10) Avoid engaging in mechanical and stressful physical work, etc. 2. Dose adjustment: HFS is a dose-dependent adverse reaction, the more drug accumulated, the higher its incidence. Therefore, the dose of the chemotherapeutic drug is reducedEffective means of reducing the risk of developing HFS or alleviating HFS symptoms. Studies have shown that, irrespective of the dosing interval, PLD dose strengths were maintained at 10mg/m weekly ² When the medicine is used, the curative effect is better and the adverse reaction can be tolerated; at PLD dose not exceeding 10mg/m per week ² At the time, most HFS are at mild to moderate levels and to some extent avoid potential HFS development. 3. Local ice compress: topical ice application can cause vasoconstriction, thereby limiting the arrival of circulating drugs at the extremities, reducing drug accumulation in the palms, soles, etc., and reducing the incidence and severity of HFS. 4. External use antiperspirant: PLD is easily transported with sweat to densely distributed sweat glands such as palms, soles, and axillas, and thus, the use of antiperspirant can reduce the accumulation of drugs in these parts to some extent, thereby reducing the occurrence of HFS. 5. And (3) infusing amifostine: the amifostine is a selective cell protective agent, and can effectively remove excessive free radicals generated by chemotherapeutic drugs and radiotherapy rays, thereby protecting normal tissue cells. The traditional Chinese medicine composition is mainly used for the adjuvant therapy of various tumors clinically. 6. Hormone therapy: clinicians may instruct patients to pre-treat with oral dexamethasone, however, there is currently insufficient evidence to support regular oral glucocorticoid prophylaxis of HFS. 7. The traditional Chinese medicine comprises the following components: the medicine can be used for treating patients based on syndrome differentiation, and can be used for oral decoction and external lotion, so that the generation and severity of HFS can be effectively managed in the whole course. 8. Other intervention measures: vaseline softens the skin and helps it retain moisture, and is effective in preventing chapping of the skin especially when the skin is dry.

Is a novel ointment for treating HFS developed in Germany, is rich in various antioxidant components such as plant extracts and the like, but the ointment is not sold at present at home. Celecoxib was shown to significantly improve capecitabine-induced HFS, reducing risk of development by 53% (P = 0.003), but there is currently no study on celecoxib to prevent PLD-induced HFS. There is currently controversy as to whether large doses of vitamin B6 can prevent and treat PLD-induced HFS. There were studies showing that 34 breast cancer patients treated with PLD chemotherapy were given vitamin B6 or placebo, vitamin B6 group, respectivelyHFS occurred in 52% of patients and grade 2 or 3 in 35%, but the difference in the incidence of HFS between vitamin B6 and placebo was not statistically significant.

The adjustment of the dose has an influence on the effect of chemotherapy, and other related treatment methods, such as intolerance of cold compress patients, incapability of persisting patients who frequently use ointment, multiple hormone therapy side effects, and more damage to the damaged gastrointestinal tract caused by oral celecoxib.

However, the existing treatment has the defects that according to the statistics of world health organization in 2020, breast cancer becomes the first malignant tumor with incidence in the world, chemotherapy is one of the important means for treating the breast cancer, the effect of the novel anthracycline medicine is clear, but 1, the reduction of the dosage of the chemotherapeutic medicine influences the curative effect of tumor treatment, and particularly, the dose-effect relationship of the anthracycline medicine has an obvious positive correlation. 2. Hormone is not commonly used clinically for treating secondary side reaction. Other treatments are not ideal or inconvenient. 3. The PLD is not unified and still in the empirical treatment stage, and especially the standardized prevention and treatment of traditional Chinese medicines are still blank stages. 4. Oral administration of drugs burdens the gastrointestinal tract of tumor chemotherapy patients and may affect other organ functions. Therefore, the invention provides a novel traditional Chinese medicine composition for resisting hand-foot syndrome as well as a preparation method and application thereof.

Disclosure of Invention

The purpose of the invention is as follows: the invention aims to solve the technical problem of the prior art and provides a traditional Chinese medicine composition for resisting hand-foot syndrome.

The technical problem to be solved by the invention is to provide a preparation method of the traditional Chinese medicine composition.

The invention further aims to solve the technical problem of providing the application of the traditional Chinese medicine composition.

In order to solve the first technical problem, the invention discloses a traditional Chinese medicine composition for resisting hand-foot syndrome, which is characterized by comprising the following traditional Chinese medicine compositions in parts by weight: 15-25 parts of radix sophorae flavescentis, 15-25 parts of red paeony root, 10-20 parts of cortex moutan, 10-20 parts of salvia miltiorrhiza and 10-20 parts of angelica dahurica.

The traditional Chinese medicine composition provided by the invention has the effects of clearing heat and removing blood stasis, eliminating pathogenic factors, relieving swelling and pain, and promoting blood circulation and tissue regeneration. In the formula, the radix sophorae flavescentis is a monarch drug: clearing heat and eliminating dampness, is used for treating skin pruritus, eczema and eczema, and has the effects of tonifying middle-jiao and Qi. Record flavescent sophora root in famous physicians' book: nourishing liver and gallbladder qi, calming the five internal organs, stabilizing mind, replenishing vital essence, benefiting nine orifices, removing latent heat, colon, quenching thirst, sobering up, yellow and red urine, treating lower ulcer of malignant sore, calming stomach qi and being addicted to food by people. The red paeony root is a ministerial drug and has the effects of clearing heat and cooling blood, and eliminating stasis and relieving pain. The combination of the medicines has the effect of treating both principal and secondary aspect of disease. Hand-foot syndrome caused by breast cancer chemotherapy belongs to the 'arthralgia syndrome' of the traditional Chinese medicine. The cortex moutan in the formula is also used as a ministerial drug and has the effects of clearing heat and cooling blood, and activating blood and dissolving stasis. Modern researches show that paeonol and other glycosides contained in cortex moutan have anti-inflammatory effect; the methanol extract of cortex moutan has platelet inhibiting effect; the paeonol has central inhibition effects of tranquilizing, cooling, relieving fever, relieving pain, and relieving spasm, and has good therapeutic effect on inflammation and pain caused by hand-foot syndrome. Salvia miltiorrhiza, as an adjuvant drug, has the effects of tonifying qi, nourishing blood, removing blood stasis, clearing away the heart-fire, relieving restlessness, cooling blood and resolving carbuncle, and can nourish spirit, calm mind, and dredge guan pulse according to records in Rihuazi materia Medica. Treating cold and hot strain, arthralgia, and hemiplegia of limbs; expel pus and alleviate pain, promote tissue regeneration and promote granulation. Modern pharmacology finds that tanshinone contained in the tanshinone is a strong menstrual flow clearing agent and has good effects on arthralgia, anemia, mastitis and sore furuncle pain and swelling. In the formula, the angelica root is a guiding drug, can expel wind and reduce swelling, activate blood and discharge pus, promote granulation and relieve pain, is used for treating skin itch, furuncle and pyogenic infections and other symptoms, enters lung, spleen and stomach and is a channel-guiding drug for yangming meridians. In Ben Cao Jing Shu, it is recorded that Bai Zhi is pungent in flavor, non-toxic in temperature, strong in fragrance, and also fragrant in herb. Entering yang-Ming of hand and foot, taiyin of foot, qi system and blood system, ascending more than descending, yang is also involved. It is good at dispelling wind and removing pus, pungent and fragrant, dissipating nodulation and stopping pain, so it can strengthen the skin.

Preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine compositions in parts by weight: 20 parts of radix sophorae flavescentis, 20 parts of red paeony root, 15 parts of cortex moutan, 15 parts of salvia miltiorrhiza and 15 parts of angelica dahurica.

Further preferably, the traditional Chinese medicine composition comprises the following traditional Chinese medicine compositions in parts by weight: 20g of radix sophorae flavescentis, 20g of red paeony root, 15g of cortex moutan, 15g of salvia miltiorrhiza and 15g of angelica dahurica.

Wherein, the dosage form of the traditional Chinese medicine composition comprises any one of powder, granules, aqua, ointment and cream; wherein, the water agent includes but is not limited to skin lotion.

The invention has no specific requirements on the particle size of the powder; preferably, the particle size of the powder is 5-25 μm; further preferably, the particle size of the powder is 15 μm.

In order to solve the second technical problem, the invention discloses a preparation method of the traditional Chinese medicine composition, which comprises the steps of weighing the traditional Chinese medicine compositions according to the formula ratio, and crushing the traditional Chinese medicine compositions into powder by using a wall breaking machine.

Wherein, the breaking machine is used for breaking cell walls.

The cell wall breaking technology is an ultra-micro powder processing technology, and effective ingredients of medicinal materials can be fully released by the processing technology. After the cell wall is broken, the water and oil in the cell are migrated out, so that the surfaces of the particles are in a semi-moist state, stable particle groups can be formed among the particles, and each particle group contains the traditional Chinese medicine components in the same proportion. The physical structure of the particle group is different along with different combinations and different interactions of HLB (hydrophile-lipophile balance), ductility, fragmentity, specific gravity and the like of all components in the composition. The structure is beneficial to the absorption and utilization of the traditional Chinese medicine by the human body. The traditional Chinese medicine has enhanced lipid solubility, easily penetrates lipid membrane, and can rapidly enter blood concentration of human body to achieve the purpose of healing. Research shows that the method is related to that the superfine grinding technology destroys cell walls of a large number of cells in the medicinal materials, promotes the antioxidant active ingredients in the medicinal materials to be fully dissolved out, and simultaneously retains the active ingredients and the physicochemical properties of the medicinal materials.

In order to solve the third technical problem, the invention discloses application of the traditional Chinese medicine composition in preparing a medicine for resisting hand-foot syndrome.

Wherein the anti-hand-foot syndrome is preventing hand-foot syndrome and treating hand-foot syndrome.

Wherein the hand-foot syndrome is caused by chemotherapy; preferably, the hand-foot syndrome is caused by chemotherapy of any one or more of novel anthracycline (PLD), fluorouracil, capecitabine and pirrolitinib maleate; further preferably, the hand-foot syndrome is caused by novel anthracycline (PLD) chemotherapy.

Wherein the novel anthracycline is Pegylated Liposomal Doxorubicin (PLD).

The hand-foot syndrome caused by chemotherapy of any one or more of the novel anthracycline, fluorouracil, capecitabine and piretanide maleate is different from the conventional hand-foot syndrome, and the occurrence of the hand-foot syndrome is related to the distribution characteristics of the novel anthracycline and the attack of active oxygen on tissues. The novel anthracycline is modified by the outer polyethylene glycol long chain, has enhanced hydrophilicity, and is easily transported to the parts with densely distributed sweat glands, such as palms, soles, armpits and the like along with sweat. The hydrophilic layer of the liposome may promote the process; once on the skin surface, the drug permeates into the stratum corneum of the skin via sweat and accumulates, and permeates from the stratum corneum into deeper parts of the skin. PLD accumulated in the stratum corneum slowly releases doxorubicin, which reacts with metal ions in the skin to generate ROS. ROS damage keratinocytes, release chemokines and inflammatory factors such as Interleukin (IL) -1 β, IL-6, and IL-1 α, and induce inflammation, resulting in skin tissue damage.

The traditional Chinese medicine composition provided by the invention can effectively remove excessive free radicals generated by chemotherapeutic drugs, thereby protecting normal tissue cells.

The application method is Chinese medicine soaking and washing, which is one of the external treatment methods of the traditional Chinese medicine, and the operation method is used for soaking and washing local skin by taking the basic theory of the traditional Chinese medicine as guidance and by means of the self effect of the medicine during soaking and washing, so that the effects of activating blood, reducing swelling, relieving pain, removing blood stasis, promoting tissue regeneration and the like are achieved.

Specifically, 1 dose of the composition is taken each time, added into 3000mL of hot water, and soaked into the liquid medicine for 30min 1 time per day when the temperature is reduced to 22-24 ℃.14 days is a treatment course, and 2 treatment courses are continued.

Wherein, the affected part should be soaked in the liquid medicine.

Wherein, patients with local skin bleeding and infection need to follow the medical advice.

Wherein, the temperature of the soaking is room temperature, and overheating is not suitable.

The traditional Chinese medicine composition has the functions of promoting blood circulation, removing obstruction in channels, relieving swelling and pain, removing stasis and promoting tissue regeneration, and can be used for preventing and treating hand-foot syndrome caused by chemotherapy.

Has the advantages that: compared with the prior art, the invention has the following advantages:

1. the traditional Chinese medicine composition provided by the invention can effectively prevent hand-foot syndrome, and the effective rate reaches 93.94%, which is higher than 80% of clinical reports.

2. The invention treats HFS by soaking and washing the traditional Chinese medicines, leads the medicines to be directly absorbed through skin and directly reach the focus, reduces the burden of the medicines on the digestive tract, is particularly suitable for patients with prominent digestive tract reaction of chemotherapy, and avoids the worry of doctors and patients about whether the chemotherapy curative effect is influenced by oral traditional Chinese medicines.

3. When the traditional Chinese medicine is subjected to cell wall breaking and superfine grinding, worm eggs with the same cell size can be killed, so that the pollution and damage of plant diseases and insect pests to the traditional Chinese medicine are reduced, the superfine traditional Chinese medicine has pure naturalness, and the integrity and safety of traditional Chinese medicine components are ensured.

4. The preparation process of the medicine is advanced, and the proven effective ingredients of the traditional Chinese medicine can enhance the lipid solubility, easily penetrate through lipid membranes, quickly improve the blood concentration in human bodies, be beneficial to keeping the bioactive ingredients of the traditional Chinese medicine, improve the efficacy and achieve the aim of healing.

5. The invention solves the problem which puzzles the development of the traditional Chinese medicine industry for a long time, namely the complex use, the time consumption and the inconvenience, and is widely accepted by patients.

6. The invention reduces the drug residue in the human body, can also improve the drug quality and is beneficial to the health of human beings.

7. The invention is an external preparation, the clinical use proves that the invention is effective, and the preparation method of the invention keeps the active ingredients of the plants, and can achieve the effects of eliminating evil, relieving spasm, reducing swelling and relieving pain; and the patient acceptance is high, the environment is protected, and the price is economic.

Drawings

FIG. 1 is a comparison of the improvement in clinical symptoms of two groups. A: and (4) scoring the VAS. Traditional Chinese medicine syndrome B: and (6) scoring. Compared with the same group before the treatment, ^*** P<0.001. compared with the control group, the compound of the formula, ^### p<0.001.VAS represents a visually simulated scale. The integral of syndrome in traditional Chinese medicine refers to the integral of syndrome in traditional Chinese medicine.

Detailed Description

The experimental methods described in the following examples are all conventional methods unless otherwise specified; the reagents and materials are commercially available, unless otherwise specified.

Example 1

The formula is as follows: 20g of radix sophorae flavescentis, 20g of red paeony root, 15g of cortex moutan, 15g of salvia miltiorrhiza and 15g of angelica dahurica.

Preparation: weighing the traditional Chinese medicine compositions according to the formula ratio. Drying the Chinese medicinal composition in a 50 + -5 deg.C forced air drying oven to constant weight, pulverizing in a high-speed pulverizer to obtain powder, and sieving with 50 mesh sieve (national standard sieve, pore diameter of 355 + -13 μm, sieve III) to obtain common powder of Chinese medicinal composition; putting the common powder into a QLM-80K airflow type superfine pulverizer and adjusting the working pressure: 7kg/m ² And power: deeply pulverizing at 25Hz for 20min, and sieving with 800 mesh sieve (aperture: 15 μm) to obtain superfine powder of Chinese medicinal composition. To obtain powder with the particle size of 15 mu m.

Example 2

1. Test method

A prospective randomized control study of 65 breast cancer patients who developed HFS after novel anthracycline chemotherapy in my hospital during months 3-2020 and 06. The case numbers are as follows:

1096271、1095552、1088788、1095202、1103605、1095378、1089048、1095766、1096359、1096147、1104423、1093207、1102234、1096141、1096336、1095787、1099732、1095201、1091072、1100840、1092944、1101083、1106726、1100078、1109601、1098401、1090511、1105832、1099470、1114039、1121449、1067124、1128102、1128327、1127743、1127430、1127800、1122204、1122575、1123979、1122815、1123597、1127055、1126722、1126720、1126616、1126420、11264601125758、1124718、1122454、1128102、1128327、1127743、1127430、11278001135724、1132894、1132000、1133439、1129850、1137084、1137969、1146737、1146226

patients were randomized into experimental (n = 33) and control (n = 32) groups using a random number table. The control group is given conventional western medicines for treatment (vitamin B6, mecobalamin tablet oral administration, etc.) and nursing, and the experimental group adopts a hand and foot soaking and washing formula for soaking and washing treatment and nursing on the basis, which comprises the following specific steps:

the control group was given conventional western treatments and cares: (1) Keeping warm, coating vaseline ointment on skin ulcer part, and keeping skin moisture with urea cream; (2) neurotrophic: vitamin B6 is orally taken (Jiangxi medicine Co., ltd., china, batch number H36020859) at a dose of 100 mg/per time, 3 times a day; mecobalamin tablets (manufactured by Beijing Xinghao pharmacy Co., ltd., china, batch number H20060865) were orally administered at 0.5 g/time, 3 times per day. The two medicines are taken simultaneously; and (3) wearing loose clothes and shoes. All patients were treated continuously for 4 weeks.

The experimental group adopts the same nursing method as the control group, except that the powder prepared in the example 1 is added for soaking hands and feet without oral medicine treatment, 1 dose of the formula is taken each time, added into 3000mL of hot water, and soaked in the liquid medicine for 30min after the temperature is reduced to 22-24 ℃, and the medicine is soaked for 1 time every day. Treatment lasted 4 weeks.

2. Observation index

2.1 main observation indexes:

(1) The two groups of clinical curative effects are divided into healing, obvious effect, effective and ineffective. And (3) healing: the traditional Chinese medicine syndrome reduction rate is more than or equal to 95%, clinical symptoms (including abnormal hand and foot sensation, swelling and pain, erythema and the like) almost disappear, and the life is not influenced. The effect is shown: the traditional Chinese medicine syndrome reduction rate is more than or equal to 75 percent but less than 95 percent, the clinical symptoms are obviously improved, and the life is slightly influenced. The method has the following advantages: the traditional Chinese medicine syndrome reduction rate is more than or equal to 50 percent but less than 75 percent, the clinical symptoms are improved, and the life is influenced to a certain extent. And (4) invalidation: the reduction rate of the medical symptoms is less than 50%, the clinical symptoms are not obviously improved or aggravated, and the life is greatly influenced. The total effective rate of treatment = (number of healing people + number of significant people + number of effective people)/total number of people x 100%.

(2) The clinical symptom improvement before and 4 weeks of treatment in both groups was evaluated using HFS grading, visual Analog Scale (VAS) scoring, and TCM syndrome score. The HFS grade is evaluated by using a common toxicity standard 5.0 edition of the national cancer institute of America, and is divided into 1 grade to 4 grades, wherein the higher the grade is, the higher the HFS degree is, and the 0 grade represents no adverse reaction. The VAS score is 0-10, and higher VAS score indicates more obvious pain. The Chinese medicine symptom score comprises hand and foot feeling, stabbing pain, skin and nail color and texture, complexion and the like, each item is scored for 0-8 points, the full score is 32 points, and the higher the score is, the heavier the symptom is.

2.2 secondary observation indices:

(1) Completion rates of chemotherapy in both groups: i.e., the percentage of people who complete a given 2 chemotherapy cycles to the total.

(2) Two groups of treatment satisfaction rates: namely the satisfaction degree of the patients on the treatment effect of the hand-foot syndrome, which is divided into very satisfactory, common and unsatisfactory, and the total satisfaction rate = (very satisfactory + satisfied people)/total people is multiplied by 100%.

(3) Adverse skin reactions: including erythema, eschar, edema, etc.

3. Statistical method

Statistical data analysis was performed using SPSS version23.0 (SPSS, inc., chicago, IL, USA) software. The counting data are given as counts (percentages) [ n (%)]Representing, performing parallel chi-square inspection, and selecting alpha =0.05 at two sides according to an inspection level; according to the normal distribution of the measurement data, the average value is + -standard deviation

Representing that independent sample t test is adopted for comparison among groups, paired t test is adopted for comparison in groups, and the test level selects alpha =0.05 on two sides; p<0.05 represents that the difference is statistically significant.

4. Results

4.1 Baseline data for both groups

The experimental groups were statistically insignificant (P > 0.05) for differences in age, ECOG score, HFS course, HFS grade, etc., and were comparable (table 1).

Table 1: comparison of baseline conditions in two groups of patients

Note that ECOG American society for tumor; HFS is indicative of hand-foot syndrome.

4.2 comparison of clinical efficacy of two groups

The total effective rate of the experimental group is 93.94% (9 cases are cured, 16 cases are obviously effective, 6 cases are effective), the total effective rate of the control group is 75.00% (3 cases are cured, 9 cases are obviously effective, 12 cases are effective), and the comparison difference of the two groups has statistical significance (P < 0.05) (Table 2).

Table 2: clinical efficacy comparison of two groups of patients [ n (%) ]

4.3 comparison of the improvement in clinical symptoms of the two groups

During the study, two sets of no 4-stage HFS occurred. The HFS grade of the two groups of patients before treatment, VAS score and Chinese medicine score are compared, and the difference has no statistical significance (P is more than 0.05). After treatment, the HFS grades of the two groups are reduced (P is less than 0.05), and the VAS and the traditional Chinese medicine syndrome score are also obviously reduced (P is less than 0.001). The HFS rating after treatment was much higher (P < 0.05) than the control group at a ratio of ≦ 1 in the experimental group (table 3), much lower VAS score and the chinese medical score (P < 0.001) (table 3 and fig. 1).

Table 3: HFS grading comparison before and after treatment [ n (%) ]

4.4 comparison of completion rates to treatment satisfaction rates for both groups of chemotherapy

Chemotherapy was completed on schedule in 32 of the 33 experimental cases (96.97%) and 30 of the 32 control cases (93.75%) the completion rate was higher in the experimental group than in the control group (P < 0.01) (table 4). In addition, the overall satisfaction of the experimental group was much higher than that of the control group (table 4) (P < 0.01).

TABLE 4 comparison of completion and satisfaction of chemotherapy in two groups

4.5 safety

The experimental group has no adverse reactions such as skin irritation and skin allergy related to the soaking washing treatment in the treatment process.

Through the traditional Chinese medicine soaking and washing treatment, the experimental group obtains 93.94% of total treatment effective rate which is obviously higher than 75.00% of that of the control group (P is less than 0.05). The experimental group had significantly lower HFS grading, visual analog pain scale (VAS) and chinese medical syndrome score (P < 0.05) after treatment compared to the control group, and significantly higher treatment satisfaction (P < 0.05) compared to the control group. Adverse reactions such as skin irritation, skin allergy and the like related to Chinese medicine soaking and washing are not observed in the treatment process of the experimental group. The conclusion shows that: the hand and foot soaking and washing formula has obvious clinical curative effect on HFS (high frequency Structure) caused by anthracycline chemotherapy of breast cancer patients through traditional Chinese medicine external treatment, can further improve the total effective rate, improve the clinical symptoms and the life quality of the patients, and improve the chemotherapy satisfaction degree, and has high safety.

Example 3

The technical scheme of the experimental group in the embodiment 2 is applied to the prevention of the hand-foot syndrome of the patient after 100 cases of novel anthracyclines are chemotherapy in 8 months in 2020; wherein, the case number is as follows:

1146056、1145882、1145398、1145090、1144499、1145139、1144588、1144335、1144699、1144499、1145139、1145316、1145037、1144379、1142891、1143392、1143367、1148753、1148157、1155394、1158846、1159428、1156647、1156500、1157203、1155374、1156500、1156967、1155353、1156711、1157539、1157535、1157114、1155892、1156531、1155892、1156513、1155978、1155892、1156513、1155101、1153825、1153020、1153746、1153559、1153370、1153746、1153095、1152943、1153329、1151893、1152753、1151639、1151903、1151893、1152753、1159253、1159998、1159428、1159289、1160670、1160987、1159978、1161400、1161683、1161698、1161377、1161698、1162175、1162085、1162303、1162175、1164683、1164060、1162901、1165193、1166919、1165938、1167234、1167666、1167763、1166919、1165938、1160670、1173255、1173559、1173206、1168711、1170033、1166647、1167099、1166919、1167666、1167234、1180723、1179668、1179714、1178030、1177574、1182038

the incidence of hand-foot syndrome in months 8 to 12 in 2020 is only 34.4%, which is far below 45% of clinical reports.

Example 4

In view of the good clinical effects, 4 breast cancer patients who developed HFS were treated by the department taking capecitabine in combination with piretanide maleate, and were not treated with the oral drug of the control group in example 2, and were subjected to the soaking and the nursing with powder according to the method of the experimental group in example 2. Among them, the case numbers are 1179418, 1173230, 1167763 and 1152943.

Adding 1 agent of the formula into 3000mL of hot water each time, cooling to 22-24 deg.C, soaking the affected part in the medicinal liquid for 30min, 1 time per day. The 4 patients complained of intermittent immersion and washing, but the pain and pigmentation were improved. This is further confirmed by a number of clinical trials.

The invention provides a traditional Chinese medicine composition for resisting hand-foot syndrome, a preparation method and an application thought and method, and a plurality of methods and ways for realizing the technical scheme are provided. All the components not specified in the present embodiment can be realized by the prior art.

Claims

1. The traditional Chinese medicine composition for resisting hand-foot syndrome is characterized by being prepared from the following traditional Chinese medicine components in parts by weight: 15-25 parts of radix sophorae flavescentis, 15-25 parts of red paeony root, 10-20 parts of cortex moutan, 10-20 parts of salvia miltiorrhiza and 10-20 parts of angelica dahurica.

2. The traditional Chinese medicine composition as claimed in claim 1, which is prepared from the following traditional Chinese medicine components in parts by weight: 20 parts of radix sophorae flavescentis, 20 parts of red paeony root, 15 parts of cortex moutan, 15 parts of salvia miltiorrhiza and 15 parts of angelica dahurica.

3. The traditional Chinese medicine composition according to claim 1, which is prepared from the following traditional Chinese medicine components in parts by weight: 20g of radix sophorae flavescentis, 20g of red paeony root, 15g of cortex moutan, 15g of salvia miltiorrhiza and 15g of angelica dahurica.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, wherein the dosage form of the traditional Chinese medicine composition is any one of powder, granules, aqua, ointment and cream.

5. The preparation method of the traditional Chinese medicine composition as claimed in any one of claims 1 to 3, characterized in that the traditional Chinese medicine composition is weighed according to the formula ratio and is crushed into powder by a wall breaking machine to obtain the traditional Chinese medicine composition.

6. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of an anti-hand-foot syndrome medicament.

7. The use according to claim 6, wherein the antipodal hand-foot syndrome is a prophylactic hand-foot syndrome.

8. The use according to claim 6, characterized in that said antipodal hand-foot syndrome is the treatment of hand-foot syndrome.

9. The use according to claim 6, wherein the hand-foot syndrome is chemotherapy-induced hand-foot syndrome.

10. The use of claim 9, wherein the hand-foot syndrome is caused by chemotherapy with any one or more of novel anthracyclines, fluorouracil, capecitabine and pirrolitinib maleate.