Traditional Chinese medicine composition for treating chemotherapeutic phlebitis as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation, and particularly discloses a traditional Chinese medicine composition for treating chemotherapeutic phlebitis and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from, by weight, 90-120 parts of honeysuckle flowers, 90-120 parts of fructus forsythiae, 60-90 parts of beeswax, 30-60 parts of radix arnebiae seu lithospermi, 30-60 parts of frankincense, 30-60 parts of myrrh, 10-20 parts of borneol and 500-1000 parts of sesame oil. The traditional Chinese medicine composition provided by the invention is used for treating chemotherapeutic phlebitis, so that blood vessels at an affected part are softened, the elasticity of the blood vessels is recovered, and the pressing pain and red and swollen symptoms of an affected limb and the affected part are relieved.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine preparation, and in particular to a Chinese medicine composition for treating chemotherapy phlebitis, and a preparation method and application thereof. Background Art

[0002] Phlebitis caused by chemotherapy drugs refers to aseptic inflammation caused by irritating and corrosive chemotherapy drugs during intravenous infusion, which damages the vascular endothelium, increases vascular permeability, and causes drug extravasation, accompanied by vasospasm, reduced blood supply to local tissues, and leads to tissue ischemia and hypoxia. Its main clinical manifestations are redness, swelling and pain along the punctured vein, red lines or ecchymoses under the skin, and in severe cases, cord-like changes and nodules in the affected veins, and even venous thrombosis, skin ulcers, etc. Some may be accompanied by systemic symptoms such as fever and chills. Chemotherapy phlebitis is a common complication of chemotherapy and one of the common nursing problems. It not only increases the pain and economic burden of patients, but also increases the difficulty of nursing work. In severe cases, it affects the chemotherapy process and disease prognosis.

[0003] There is an urgent need to provide a drug for preventing and treating chemotherapy-induced phlebitis. Summary of the invention

[0004] In order to develop a drug for preventing and treating chemotherapy phlebitis, the present invention provides a Chinese medicine composition for preventing and treating chemotherapy phlebitis, as well as a preparation method and application. The Chinese medicine composition provided by the present invention is used to treat chemotherapy phlebitis, softening blood vessels in the affected area, restoring blood vessel elasticity, and alleviating tenderness and redness and swelling symptoms of the affected limb and the affected area.

[0005] The invention provides a traditional Chinese medicine composition for treating chemotherapy phlebitis. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 90-120 parts of honeysuckle, 90-120 parts of forsythia, 60-90 parts of yellow wax, 30-60 parts of lithospermum, 30-60 parts of frankincense, 30-60 parts of myrrh, 10-20 parts of borneol and 500-1000 parts of sesame oil.

[0006] The Chinese medicine composition provided by the present invention uses honeysuckle and forsythia as the main medicine to enhance the heat-clearing and detoxicating, swelling and dispersing the merit of the knot; yellow wax as the ministerial medicine and the main medicine to coordinate and enhance the effect of heat-clearing and detoxicating, sore astringing and promoting tissue regeneration, and swelling and dispersing the effect of knot; lithospermum as the ministerial medicine cooperates with yellow wax to enhance the effect of detoxification and analgesia, and can enhance the power of the main medicine of heat-clearing and detoxification, dispersing toxins and eliminating spots; frankincense and myrrh as adjuvants coordinate the main medicine to enhance the effect of heat-clearing and detoxicating, swelling and dispersing the effect of knot, coordinate the ministerial medicine to enhance the detoxification, sore astringing, swelling and promoting tissue regeneration; borneol as an adjuvant passes through multiple physiological barriers such as blood-brain barrier, mucosa and skin, and helps other drug components to enter tissues at the same time, improves drug delivery and therapeutic effect, and can enhance the therapeutic effect of the main and ministerial medicines. The Chinese medicine composition of the present invention can be used to treat chemotherapy phlebitis, so that the blood vessels of the affected part become soft, the elasticity of the blood vessels is restored, and the tenderness and redness and swelling symptoms of the affected limb and the affected part are alleviated.

[0007] Furthermore, the Chinese medicine composition is made of the following raw materials in parts by weight: 90 to 100 parts of honeysuckle, 90 to 100 parts of forsythia, 60 to 70 parts of yellow wax, 30 to 40 parts of lithospermum, 30 to 40 parts of frankincense, 30 to 40 parts of myrrh, 10 to 12 parts of borneol, and 500 to 600 parts of sesame oil.

[0008] Furthermore, the Chinese medicine composition is made of the following raw materials in parts by weight: 90 parts of honeysuckle, 90 parts of forsythia, 60 parts of yellow wax, 30 parts of lithospermum, 30 parts of frankincense, 30 parts of myrrh, 10 parts of borneol, and 500 parts of sesame oil.

[0009] Furthermore, the Chinese medicine composition is made of the following raw materials in parts by weight: 100 parts of honeysuckle, 100 parts of forsythia, 70 parts of yellow wax, 40 parts of lithospermum, 40 parts of frankincense, 40 parts of myrrh, 15 parts of borneol, and 800 parts of sesame oil.

[0010] Furthermore, the Chinese medicine composition is made of the following raw materials in parts by weight: 120 parts of honeysuckle, 120 parts of forsythia, 90 parts of yellow wax, 60 parts of lithospermum, 60 parts of frankincense, 60 parts of myrrh, 20 parts of borneol, and 1000 parts of sesame oil.

[0011] The present invention provides a method for preparing the traditional Chinese medicine composition for treating chemotherapy phlebitis, comprising the following steps:

[0012] Weigh the raw materials by weight, add honeysuckle, forsythia, lithospermum, frankincense and myrrh into sesame oil and soak for 10h to 12h, then heat to 150℃ to 160℃ and keep warm for 0.5h to 1.0h, then filter to remove the residue, add yellow wax to melt; when the oil temperature cools to below 80℃, add borneol powder, and package it immediately after it is completely dissolved, seal it and set aside.

[0013] Furthermore, the borneol powder is added while stirring.

[0014] The present invention provides an application of the traditional Chinese medicine composition in preparing a medicine for preventing or treating chemotherapy-induced phlebitis.

[0015] Furthermore, the medicine is an ointment.

[0016] Furthermore, the ointment also includes an auxiliary material, and the auxiliary material is vaseline or olive oil.

[0017] Furthermore, the drug has at least one of the following effects:

[0018] Prevent the occurrence of chemotherapy-induced phlebitis;

[0019] Relieve the symptoms of chemotherapy-induced phlebitis; wherein, the symptoms of chemotherapy-induced phlebitis are manifested as: relieving the redness, swelling, pain and nodules at the puncture site of the vein; the relief refers to softening the blood vessels at the affected area and restoring the elasticity of the blood vessels.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The invention provides a Chinese medicine composition for treating chemotherapy phlebitis, wherein honeysuckle and forsythia are used as monarch drugs, honeysuckle is sweet and cold in nature, enters the lung and stomach meridians, has the effects of clearing away heat and detoxifying, and dispersing wind-heat, and can be used clinically to treat carbuncle, furuncle, erysipelas, dysentery caused by heat toxins, wind-heat cold, fever caused by febrile diseases, etc.; forsythia is bitter and cool in nature, enters the heart, liver, and gallbladder meridians, has the effects of clearing away heat and detoxifying, reducing swelling and dispersing knots, and dispersing wind-heat, and can be used to treat wind-heat cold, mastitis, scrofula, swelling and pain, etc. Honeysuckle and forsythia are combined as monarch drugs to enhance the effects of clearing away heat and detoxifying, reducing swelling and dispersing knots.

[0022] Yellow wax, also known as beeswax, is an organic mixture secreted by the wax glands of 8-12-day-old worker bees. It is mainly used for the construction of honeycombs. It is usually yellow, brown or dark yellow and contains water, lipids, free fatty alcohols, free fatty acids, carbohydrates, carotenoids, vitamin A and aromatic substances. It has the effects of detoxification, sore astringence, tissue regeneration and analgesia. It is often used for ulcers that do not heal, ecthyma erosion, trauma rupture, and burns. Yellow wax combined with the main medicines honeysuckle and forsythia can enhance the effects of clearing heat and detoxification, sore astringence and tissue regeneration, and swelling and stagnation.

[0023] As a ministerial drug, Lithospermum officinale has the effects of clearing heat and cooling blood, promoting blood circulation and detoxifying, and clearing rashes and removing spots. It is used for diseases such as excessive blood heat and toxicity, purple and black rashes, measles that do not clear, sores, eczema, and burns caused by water or fire. Lithospermum officinale also has anti-tumor, anti-inflammatory, anti-pathogenic microorganism, analgesic, and sedative effects. It can be used with yellow wax to enhance the detoxification and analgesic effects, and at the same time enhance the power of the monarch drug to clear heat and detoxify, dissipate toxins and remove spots.

[0024] Frankincense and myrrh are used as adjuvants, and both are products that promote blood circulation, dissipate blood stasis, relieve swelling and relieve pain. Frankincense is warm in nature, pungent and bitter in taste, and enters the heart, liver, and spleen meridians, and has the effects of promoting blood circulation, promoting qi, relieving pain, and promoting tissue regeneration; myrrh is pungent, bitter, and flat in nature, and enters the heart, liver, and spleen meridians, and has the effects of dissipating blood stasis, relieving pain, and promoting tissue regeneration. The two are used together, and the qi and blood are treated together, and the merits of promoting the meridians, promoting blood circulation, dissipating blood stasis, relieving swelling and relieving pain, and astringing sores and promoting tissue regeneration are played together. Frankincense and myrrh can enhance the effects of clearing away heat and detoxification, reducing swelling and dispersing nodules when used in combination with the main medicine, and can enhance the merits of detoxification, astringing sores, reducing swelling and promoting tissue regeneration when used in combination with the ministerial medicine.

[0025] Borneol is a drug that is spicy and bitter, slightly cold in nature, and enters the heart, lung, and spleen meridians. It has the effects of refreshing the mind, clearing away heat and relieving pain, and promoting tissue regeneration. Borneol as a drug that can pass through multiple physiological barriers such as the blood-brain barrier, mucous membranes, and skin, while helping other drug components enter the tissue, improving drug delivery and therapeutic effects, and can enhance the therapeutic effects of the monarch and minister drugs. In summary, the Chinese medicine composition of the present invention can play a role in clearing away heat and detoxicating, reducing swelling and relieving pain. It can be used to alleviate the symptoms of patients with post-chemotherapy phlebitis and is a good medicine for post-chemotherapy phlebitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 This is a comparison chart of the effects of chemotherapy-induced phlebitis patients before and after using the ointment prepared in Example 1 of the present invention;

[0028] In the figure, A is the appearance of the affected part of a patient with chemotherapy phlebitis before using the ointment prepared in Example 1 of the present invention;

[0029] B shows the recovery status of a patient with chemotherapy phlebitis after using the ointment prepared in Example 1 of the present invention. DETAILED DESCRIPTION

[0030] The specific embodiments of the present invention are described in detail below, but it should be understood that the protection scope of the present invention is not limited by the specific embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without creative work belong to the scope of protection of the present invention. The experimental methods described in the embodiments of the present invention are conventional methods unless otherwise specified, and the materials, reagents, etc. used in the following embodiments can be obtained from commercial channels unless otherwise specified.

[0031] Example 1: A Chinese medicine composition and its preparation method and application.

[0032] The following Chinese medicinal components were weighed by mass: 90 g honeysuckle, 90 g forsythia, 60 g yellow wax, 30 g lithospermum, 30 g frankincense, 30 g myrrh, 10 g borneol, and 500 g sesame oil.

[0033] Preparation steps: Soak honeysuckle, forsythia, lithospermum, frankincense, and myrrh in sesame oil for 12 hours, then heat to 150℃ and keep warm for 0.5 hours. Filter with four layers of gauze to remove the drug residue, add yellow wax to dissolve; when the oil temperature cools to below 80℃, slowly add borneol powder. Stir while adding until all dissolved, immediately divide into packages, seal, and set aside.

[0034] Example 2: A Chinese medicine composition and its preparation method and application.

[0035] The following Chinese medicinal components were weighed by mass: 100 g honeysuckle, 100 g forsythia, 70 g yellow wax, 40 g lithospermum, 40 g frankincense, 40 g myrrh, 15 g borneol, and 800 g sesame oil.

[0036] Preparation steps: Soak honeysuckle, forsythia, lithospermum, frankincense, and myrrh in sesame oil for 12 hours, then heat to 150℃ and keep warm for 0.5 hours. Filter with four layers of gauze to remove the drug residue, add yellow wax to dissolve; when the oil temperature cools to below 80℃, slowly add borneol powder. Stir while adding until all dissolved, immediately divide into packages, seal, and set aside.

[0037] Example 3: A Chinese medicine composition and its preparation method and application.

[0038] The following Chinese medicinal components were weighed by mass: 120 g honeysuckle, 120 g forsythia, 90 g yellow wax, 60 g lithospermum, 60 g frankincense, 60 g myrrh, 20 g borneol, and 1000 g sesame oil.

[0039] Preparation steps: Soak honeysuckle, forsythia, lithospermum, frankincense, and myrrh in sesame oil for 12 hours, then heat to 150℃ and keep warm for 0.5 hours. Filter with four layers of gauze to remove the drug residue, add yellow wax to dissolve; when the oil temperature cools to below 80℃, slowly add borneol powder. Stir while adding until all dissolved, immediately divide into packages, seal, and set aside.

[0040] Take Example 1 as an example to prepare a Chinese medicine composition, select 120 patients who were hospitalized in the Department of Oncology of the First Affiliated Hospital of Xi'an Jiaotong University from July 2023 to October 2024 and diagnosed with post-chemotherapy phlebitis, and randomly divide them into a control group and a test group. The control group is given a 50% magnesium sulfate solution wet compress, and the patient's skin is cleaned with alcohol or iodine before the wet compress, and then three layers of gauze are covered on the phlebitis, and the 50% magnesium sulfate solution is soaked in gauze, preferably without dripping, and the gauze is fixed with plastic wrap to avoid the evaporation of magnesium sulfate solution, 2 times a day, and each wet compress is 5 hours. The test group is rubbed with Chinese herbal ointment, and the specific operation is as follows: according to the size of phlebitis, the prepared Chinese herbal ointment is taken in an appropriate amount and evenly applied to the patient's phlebitis with a sterile cotton swab, and the application area is slightly larger than the phlebitis skin area, twice a day, 5 hours each time, and the patient's phlebitis recovery is observed daily, and recorded in detail. Among the 120 patients, 90 were grade II I and 30 were grade II I-IV. The medication method is to take the ointment and apply it evenly to the lesion. The reference dosage is: 0.5g-1g per square centimeter. The medication is used continuously for 7 days. On the seventh day, the number of patients with different levels of post-chemotherapy phlebitis is counted.

[0041] The specific methods and results are as follows:

[0042] 1. Classification of severity of chemotherapy-induced phlebitis

[0043] According to the 2021 Infusion Therapy Practice Standards (Gorski LA. A Look at 2021 Infusion Therapy Standards of Practice. Home Health Now. 2021; 39(2): 62-71.), the severity of chemotherapy-induced phlebitis is divided into 5 levels:

[0044] Grade 0: no symptoms;

[0045] Grade I: local pain, erythema or edema, no cord-like changes in the veins, and no induration;

[0046] Grade II: local pain, erythema or edema, venous cord-like changes, and no palpable nodules;

[0047] Grade III: local pain, erythema or edema, venous cord-like changes, and palpable nodules;

[0048] Grade IV: local pain, erythema or edema, cord-like changes in the veins, palpable nodules greater than 2.5 cm in length, and may be accompanied by pus.

[0049] 2. Clinical patient data

[0050] A total of 120 patients who were hospitalized in the Department of Oncology of the First Affiliated Hospital of Xi'an Jiaotong University from July 2023 to October 2024 and diagnosed with post-chemotherapy phlebitis were selected. The patients were aged 18 to 80 years old, with an average age of (55±8.5) years old. The diseases involved included breast cancer, colorectal cancer, gastric cancer, pancreatic cancer, gallbladder cancer, lung cancer, cervical cancer, and prostate cancer. The drugs used included chemotherapy drugs such as cyclophosphamide, paclitaxel, oxaliplatin, and folinic acid, antibiotics such as moxifloxacin, cefoperazone sulbactam sodium, and stomach protection and antiemetic treatments such as omeprazole and ondansetron.

[0051] 3. Inclusion criteria

[0052] ① Patients diagnosed with tumors by pathological or histological diagnosis; ② Meet the diagnostic criteria for chemotherapy-induced phlebitis in the "Guidelines for the Diagnosis and Treatment of Chronic Venous Diseases in China"; ③ Age 18 to 80 years old; ④ Expected survival period ≥ 3 months; ⑤ Good compliance.

[0053] 4. Exclusion criteria

[0054] ① Women who are pregnant or breastfeeding; ② Those with skin infection or large skin lesions; ③ Those with serious primary diseases such as cardiovascular, liver, and kidney diseases; ④ Those who are allergic to the drugs used in this study; ⑤ Those with mental illness; ⑥ Those with other serious diseases such as uncontrolled active infection and severe electrolyte imbalance.

[0055] 5. Random Grouping

[0056] The patients were randomly divided into an experimental group (n=60) and a control group (n=60) using the random number table method.

[0057] 6. Treatment methods

[0058] Control group: 50% magnesium sulfate solution was applied for wet compress. The patient's skin was cleaned with alcohol or iodine before wet compress. Then three layers of gauze were covered on the phlebitis area. The gauze was soaked with 50% magnesium sulfate solution until there was no dripping. At the same time, the gauze was fixed with plastic wrap to prevent the magnesium sulfate solution from evaporating. The wet compress was applied twice a day for 5 hours each time.

[0059] The experimental group was given Chinese herbal ointment. The specific operation was as follows: according to the size of the phlebitis, take an appropriate amount of the prepared Chinese herbal ointment and apply it evenly to the phlebitis area of ​​the patient with a sterile cotton swab. The application area should be slightly larger than the phlebitis skin area, twice a day, 5 hours each time.

[0060] 7. Evaluation indicators

[0061] VAS scoring criteria:

[0062] (1) The Visual Analog Scale (VAS) is a method for pain assessment. Its basic principle is to use a 10-cm long floating ruler with a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain that is unbearable.

[0063] How to use: Place the scaled side of the ruler facing away from the patient, and ask the patient to mark the corresponding position on the ruler that represents the degree of pain. The doctor will score the patient based on the position marked by the patient. "0-2" is "excellent", "3-5" is "good", "6-8" is "acceptable", and greater than "8" is "poor". Observe the patient's recovery from phlebitis every day and record it in detail.

[0064] (2) Average pain relief time

[0065] The average time from application to complete disappearance of pain.

[0066] (3) Average time for redness and swelling to subside

[0067] The average time from topical application until redness and swelling completely disappear.

[0068] (4) Efficacy evaluation criteria

[0069] Recovery: Clinical symptoms disappear, the veins in the affected area become softer and the elasticity of the blood vessels is restored after treatment, and there is no tenderness, redness or swelling in the affected limb and the affected area;

[0070] Markedly effective: After treatment, the blood vessels in the affected area become soft, with slight tenderness and redness and swelling;

[0071] Effective: After treatment, the blood vessels in the affected area become slightly softer than before treatment, and the redness, swelling and pain are slightly reduced or unchanged, while the blood vessels are still in cord-like shape;

[0072] Ineffective: After treatment, the blood vessels in the affected area did not change or worsen, and the pain level did not change or worsen.

[0073] Total effective rate = (number of cured cases + number of effective cases + number of markedly effective cases) / total number of cases × 100%.

[0074] 8. Statistical methods

[0075] SPSS25.0 statistical software was used for data processing. The counts between groups were described by rate (%). The rank sum test was used for comparison between groups. The difference was considered statistically significant when P < 0.05.

[0076] 9. Results

[0077] (1) Comparison of average pain intensity, average pain relief time, and average redness and swelling relief time between the two groups

[0078] Compared with the control group, the average pain level, average calf pain time and average swelling and redness disappearance time of the test group were significantly lower than those of the control group (P < 0.001) (see Table 1 for details). This shows that after using the Chinese herbal ointment of the present invention to treat post-chemotherapy phlebitis, the patient's pain level is significantly reduced, and the average pain disappearance time and average swelling and redness disappearance time are significantly shortened. After using it, the patient has a good experience, the pain is significantly reduced, it is clean, easy to operate, and has no adverse reactions.

[0079] Table 1 Average pain level, average pain relief time and average redness and swelling relief time in the two groups

[0080]

[0081] like Figure 1As shown, one patient was randomly selected from 120 patients, and photos were taken to record the changes in the affected area before and after the medication. The patient was a 63-year-old female with a diagnosis of rectal malignancy, ovarian malignancy, and peritoneal metastasis. Chief complaint: Diagnosis of rectal cancer for more than 6 months, and peritoneal metastasis of ovarian cancer for more than 4 months. Current medical history: The patient felt abdominal distension and decreased appetite at the end of February 2024. She went to a local hospital for chest + whole abdominal CT, which showed: soft tissue shadows in the left adnexa (3.2x24cm), multiple nodules in the greater and lesser omentum, and a large amount of fluid in the abdomen and pelvis. The possibility of malignant tumor with omental metastasis was considered. Pelvic MRI plain scan + enhanced + diffusion-weighted imaging showed: soft tissue shadows in the bilateral adnexa, multiple nodules in the omentum, and ovarian Ca metastasis was considered, involving the soft tissue mass shadow in the middle part of the mesorectum and rectum, and considered: rectal cancer? Stromal tumor?; A large amount of fluid in the pelvic and abdominal cavity. Colonoscopy on March 6, 2024 showed: huge raised lesion adenoma in the rectum? Pathology (B202411985): "Rectal" moderately differentiated adenocarcinoma, combined with morphology and immunohistochemistry results, suggested that it was intestinal primary. Later, "ultrasound-guided puncture biopsy of a solid hypoechoic mass in the left adnexa" was performed, and pathology (B202417473) showed: "Left ovarian puncture biopsy" poorly differentiated carcinoma infiltration in fibrous tissue combined with group staining suggested high-grade serous. Immunohistochemistry: CK7 (+), CK20 (-), CDX2 (-), PAX8 (+), WT-1 (+), P53 (+80%), P16 (+), ER (+), PR (-), Ki67 (+60%). On April 12, 2024, an ultrasound-guided biopsy of a hypoechoic nodule in the right upper abdomen with local omental thickening was performed. The pathology showed that the infiltration of moderately to poorly differentiated adenocarcinoma in the fibrofatty tissue of the "local omental nodule biopsy in the right upper abdomen" combined with immunohistochemical staining results indicated that it was consistent with high-grade serous carcinoma. Immunohistochemical staining: PAX8 (+), WT-1 (+), P16 (+), P53 (strong, +90%), Ki67 (+40%), CDX2 (-), SATB2 (-), CK5 / 6 (+), D2-40 (-), DES (-). On April 19, 2024, ascites exfoliated cytology pathology (CT202411310): Immunocytochemical staining: CK7 (+), BerEp4 (+), PAX8 (+), WT-1 weak (+), CK20 (-), CEA (-), CDX2 (), CR (-), DES (-), SATB2 (-). We asked our hospital's pathology department for consultation to evaluate whether the ovarian lesions and rectal lesions were homologous. The consultation opinion showed that: section B202411985 showed moderately differentiated adenocarcinoma in the "rectum", and section B202417473 showed poorly differentiated carcinoma infiltration in a small piece of fibrous tissue in the "left ovarian puncture", suggesting high-grade serous carcinoma. Comparing the two pathological examination sections, the morphology and immune markers showed that there were differences between the two, indicating the possibility of dual primary tumors.After excluding contraindications, 1-6 cycles of chemotherapy combined with targeted therapy were performed on April 12, 2024, May 11, 2024, May 31, 2024, June 21, 2024, July 11, 2024, and August 1, 2024, respectively. Specifically: paclitaxel liposome 180 mg iv.dr ip, d1+ oxaliplatin mannitol 150 ml iv.dr ip.d l+ capecitabine 1.50 g po bid, d1-d14+ bevacizumab 500 mg, ivd ip, d l.q3w.

[0082] After the sixth cycle of chemotherapy, the patient developed pain and erythema at the venous puncture site, and palpable venous cords and nodules were found. The patient was diagnosed with chemotherapy-related phlebitis, which was classified as grade III. Six hours after using the Chinese medicine composition prepared in Example 1 of the present invention, the patient showed no obvious pain at the venous puncture site. After 24 hours, the erythema disappeared, and the palpable venous cords and nodules were smaller than before (eg Figure 1 After that, the patient successfully completed the whole chemotherapy cycle.

[0083] (2) Evaluation of clinical efficacy of the two groups

[0084] Compared with the control group, the total effective rate of the test group was 100%, significantly higher than that of the control group, and the difference was statistically significant (P < 0.001) (see Table 2 for details), indicating that the effective rate of the Chinese medicine composition of the present invention was as high as 100%, and the therapeutic effect was significant.

[0085] Table 2 Comparison of clinical efficacy between the two groups

[0086] Group Recovered (Example) Significantly effective (example) Valid (Example) Invalid (Example) Control group 2 8 15 35 Experimental Group 18 20 22 0

[0087] (3) Comparison of safety between the two groups

[0088] No serious adverse reactions occurred in both groups (see Table 3 for details), indicating that the Chinese herbal ointment treatment has no adverse reactions and is safe and reliable.

[0089] Table 3 Comparison of adverse reactions between the two groups

[0090]

[0091] Note: “-” in the table means that there is no such item.

[0092] In summary, the Chinese medicine composition prepared by the present invention can effectively prevent the occurrence of chemotherapy-induced phlebitis; relieve the symptoms of phlebitis caused by chemotherapy: relieve the redness, swelling, pain and nodules at the puncture site of the vein; soften the blood vessels at the affected area and restore the elasticity of the blood vessels. The total effective rate of the Chinese medicine composition prepared by the present invention on chemotherapy-induced phlebitis is 100%, no serious adverse reactions occur, and it is safe and reliable.

[0093] Although preferred embodiments of the present invention have been described, additional changes and modifications may occur to these embodiments once those skilled in the art are aware of the basic inventive concepts.

[0094] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicine composition for treating chemotherapy-induced phlebitis, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 90 to 120 parts of honeysuckle, 90 to 120 parts of forsythia, 60 to 90 parts of yellow wax, 30 to 60 parts of lithospermum, 30 to 60 parts of frankincense, 30 to 60 parts of myrrh, 10 to 20 parts of borneol and 500 to 1000 parts of sesame oil.

2. The Chinese medicine composition for treating chemotherapy-induced phlebitis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 90-100 parts of honeysuckle, 90-100 parts of forsythia, 60-70 parts of yellow wax, 30-40 parts of lithospermum, 30-40 parts of frankincense, 30-40 parts of myrrh, 10-12 parts of borneol and 500-600 parts of sesame oil.

3. The Chinese medicine composition for treating chemotherapy-induced phlebitis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 90 parts of honeysuckle, 90 parts of forsythia, 60 parts of yellow wax, 30 parts of lithospermum, 30 parts of frankincense, 30 parts of myrrh, 10 parts of borneol and 500 parts of sesame oil.

4. The Chinese medicine composition for treating chemotherapy-induced phlebitis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 100 parts of honeysuckle, 100 parts of forsythia, 70 parts of yellow wax, 40 parts of lithospermum, 40 parts of frankincense, 40 parts of myrrh, 15 parts of borneol and 800 parts of sesame oil.

5. The Chinese medicine composition for treating chemotherapy-induced phlebitis according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 120 parts of honeysuckle, 120 parts of forsythia, 90 parts of yellow wax, 60 parts of lithospermum, 60 parts of frankincense, 60 parts of myrrh, 20 parts of borneol and 1000 parts of sesame oil.

6. A method for preparing the Chinese medicine composition for treating chemotherapy-induced phlebitis according to any one of claims 1 to 5, characterized in that: The steps include: Weigh the raw materials by weight, add honeysuckle, forsythia, lithospermum, frankincense and myrrh into sesame oil and soak for 10h-12h, then heat to 150℃-160℃ on fire and keep warm for 0.5h-1.0h, then filter to remove the residue, add yellow wax to melt; when the oil temperature cools to below 80℃, add borneol powder, and package it immediately after it is completely dissolved, seal it and set aside.

7. The method for preparing the Chinese medicine composition for treating chemotherapy-induced phlebitis according to claim 6, characterized in that: Add borneol powder while stirring.

8. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a drug for preventing or treating chemotherapy-induced phlebitis.

9. The use according to claim 8, characterized in that: The medicine is an ointment.

10. The use according to claim 8, characterized in that: The drug has at least one of the following effects: Prevent the occurrence of chemotherapy-induced phlebitis; Relieve the symptoms of chemotherapy-induced phlebitis; wherein, the symptoms of chemotherapy-induced phlebitis are manifested as: relieving the redness, swelling, pain and nodules at the puncture site of the vein; the relief refers to softening the blood vessels at the affected area and restoring the elasticity of the blood vessels.

Images