A traditional Chinese medicine composition for treating chemotherapy-induced phlebitis, and its preparation method and application

Abstract

The present invention relates to the technical field of traditional Chinese medicine preparation, and specifically discloses a traditional Chinese medicine composition for treating chemotherapy phlebitis, a preparation method, and an application thereof. 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. The traditional Chinese medicine composition provided by the present invention is used to treat chemotherapy phlebitis, softens blood vessels in the affected area, restores vascular elasticity, and alleviates tenderness and redness and swelling symptoms of the affected limb and affected area.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparation, and in particular to a traditional 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 damage the vascular endothelium, increase vascular permeability, and cause drug extravasation. It is also accompanied by vasospasm and reduced blood supply to local tissues, leading to tissue ischemia and hypoxia. Its main clinical manifestations are redness, swelling and pain along the punctured vein, the appearance of red lines or ecchymosis under the skin, and in severe cases, cord-like changes and nodules in the affected veins, and even venous thrombosis and skin ulceration. 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 financial burden of patients, but also makes nursing work more difficult. In severe cases, it affects the progress of chemotherapy and the prognosis of the disease.

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

[0004] To develop a drug for preventing and treating chemotherapy-induced phlebitis, the present invention provides a traditional Chinese medicine composition for preventing and treating chemotherapy-induced phlebitis, as well as a preparation method and application thereof. The traditional Chinese medicine composition provided herein is used to treat chemotherapy-induced phlebitis, softening and restoring vascular elasticity in the affected area and alleviating tenderness, redness, and swelling in the affected limb and 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 monarch drugs to enhance the effects of clearing away heat and toxic substances, reducing swelling and dispersing granules; yellow wax as a ministerial drug and the monarch drug to coordinately enhance the effects of clearing away heat and toxic substances, astringing sores and promoting tissue regeneration, and reducing swelling and dispersing granules; lithospermum officinale is used as a ministerial drug in combination with yellow wax to enhance the effects of detoxification and analgesia, and can simultaneously enhance the power of the monarch drug of clearing away heat and toxic substances, dispersing toxins and eliminating spots; frankincense and myrrh are used as adjuvant drugs to coordinate the monarch drug to enhance the effects of clearing away heat and toxic substances, reducing swelling and dispersing granules, and coordinate the ministerial drug to enhance the effects of detoxification, astringing sores, reducing swelling and promoting tissue regeneration; borneol as an adjuvant passes through multiple physiological barriers such as the blood-brain barrier, mucous membranes and skin, while helping other drug components enter tissues, improving drug delivery and therapeutic effect, and can enhance the therapeutic effects of the monarch and ministerial drugs. The Chinese medicine composition of the present invention can be used to treat chemotherapy phlebitis, so that the affected part blood vessels soften, the vascular elasticity is restored, and the affected limb and affected part tenderness and redness and swelling symptoms are alleviated.

[0007] Furthermore, the traditional 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 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.

[0009] Furthermore, 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.

[0010] Furthermore, 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.

[0011] The present invention provides a method for preparing the traditional Chinese medicine composition for treating chemotherapy-induced 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 10 to 12 hours, then heat to 150 to 160 degrees Celsius and keep warm for 0.5 to 1.0 hours, then filter to remove the residue, add yellow wax to melt; when the oil temperature cools to below 80 degrees Celsius, add borneol powder, and immediately package after it is completely dissolved, seal and set aside.

[0013] Furthermore, 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 relief of the symptoms of chemotherapy-induced phlebitis is manifested as: relief of redness, swelling, pain and nodules at the puncture site of the vein; the relief refers to softening the blood vessels in 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 present invention provides a traditional 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, and has the effects of clearing away heat and detoxifying, and dispersing wind-heat. It can be clinically used to treat carbuncle, furuncle, erysipelas, dysentery caused by heat toxins, wind-heat cold, and fever caused by febrile diseases. Forsythia is bitter and cool in nature, enters the heart, liver, and gallbladder meridians, and has the effects of clearing away heat and detoxifying, reducing swelling and dispersing stagnation, and dispersing wind-heat. It can be used to treat wind-heat cold, mastitis, scrofula, swelling and pain, and the like. The combination of honeysuckle and forsythia as monarch drugs can enhance the effects of clearing heat and detoxifying, reducing swelling and dispersing stagnation.

[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 primarily used in beehive construction and is typically yellow, tan, or dark yellow in color. It contains water, lipids, free fatty alcohols, free fatty acids, carbohydrates, carotenoids, vitamin A, and aromatic substances. It has detoxifying, sore-healing, tissue-stimulating, and analgesic properties. It is commonly used for persistent ulcers, erosive ecthyma, ruptured wounds, and burns. Yellow wax, when used in combination with the main herbs honeysuckle and forsythia, enhances its heat-clearing and detoxifying, sore-healing, tissue-stimulating, and swelling-reducing properties.

[0023] As an adjuvant herb, Lithospermum officinale has the effects of clearing heat and cooling blood, promoting blood circulation and detoxifying, and clearing rashes and removing freckles. It is used to treat ailments such as excessive blood heat and toxicity, purple-black rashes, measles that do not clear up, sores, eczema, and burns caused by water or fire. Lithospermum officinale also has anti-tumor, anti-inflammatory, anti-pathogenic microbial, analgesic, and sedative effects. Combining it with yellow wax can enhance the detoxification and analgesic effects, while also strengthening the heat-clearing, detoxifying, and freckle-dispelling power of the adjuvant herb.

[0024] Frankincense and myrrh, as adjuvants, both promote blood circulation, dissipate blood stasis, and relieve swelling and pain. Frankincense is warm in nature, pungent and bitter in flavor, and enters the heart, liver, and spleen meridians, promoting blood circulation and qi circulation, relieving pain and promoting tissue regeneration. Myrrh is pungent, bitter, and neutral in nature, and enters the heart, liver, and spleen meridians, promoting blood stasis, relieving pain, and promoting tissue regeneration. The two herbs complement each other, working together to promote qi and blood circulation, promoting blood circulation, relieving swelling and pain, and promoting tissue regeneration. Frankincense and myrrh, when used in combination with the main herb, enhance their effectiveness in clearing heat and detoxifying, dissipating swelling and dispersing stagnation, while when used in combination with the auxiliary herb, they enhance their effectiveness in detoxification, sore regeneration, and promoting tissue regeneration.

[0025] Borneol is a causative agent, with a pungent and bitter taste and a slightly cold nature. It enters the heart, lung, and spleen meridians and has the effects of invigorating the mind, clearing away heat and relieving pain, and promoting tissue regeneration. Borneol, as a causative agent, can pass through multiple physiological barriers such as the blood-brain barrier, mucous membranes, and skin, while helping other drug components enter tissues, improving drug delivery and therapeutic effects, and enhancing the therapeutic effects of the monarch and ministerial 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. 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 any creative work.

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

[0028] In the figure, A shows the appearance of the affected area of ​​a patient with chemotherapy-induced phlebitis before using the ointment prepared in Example 1 of the present invention;

[0029] B shows the recovery of a patient with chemotherapy-induced 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 scope of protection of the present invention is not limited by the specific embodiments. Based on the embodiments in the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative work are within 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 sources unless otherwise specified.

[0031] Example 1: A Chinese medicine composition, 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: Soak honeysuckle, forsythia, lithospermum, frankincense, and myrrh in sesame oil for 12 hours. Heat to 150°C and hold for 0.5 hours. Filter through four layers of gauze to remove the residue. Add yellow wax and dissolve. Once the oil cools to below 80°C, slowly add borneol powder. Stir until completely dissolved. Immediately aliquot, seal, and set aside.

[0034] Example 2: A Chinese medicine composition, 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: Soak honeysuckle, forsythia, lithospermum, frankincense, and myrrh in sesame oil for 12 hours. Heat to 150°C and hold for 0.5 hours. Filter through four layers of gauze to remove the residue. Add yellow wax and dissolve. Once the oil cools to below 80°C, slowly add borneol powder. Stir until completely dissolved. Immediately aliquot, seal, and set aside.

[0037] Example 3: A Chinese medicine composition, 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: Soak honeysuckle, forsythia, lithospermum, frankincense, and myrrh in sesame oil for 12 hours. Heat to 150°C and hold for 0.5 hours. Filter through four layers of gauze to remove the residue. Add yellow wax and dissolve. Once the oil cools to below 80°C, slowly add borneol powder. Stir until completely dissolved. Immediately aliquot, seal, and set aside.

[0040] Take Example 1 as an example to prepare 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 were diagnosed as post-chemotherapy phlebitis, they were randomly divided into a control group and a test group, the control group was given 50% magnesium sulfate solution wet compress, and the patient's skin was cleaned with alcohol or iodine before the wet compress, and then three layers of gauze were covered on the phlebitis part, 50% magnesium sulfate solution was soaked in gauze, so as not to drip, and gauze was fixed with plastic wrap at the same time to avoid the evaporation of magnesium sulfate solution, 2 times a day, each wet compress for 5 hours. The test group was given Chinese herbal ointment to rub, and the specific operation was as follows: according to the size of phlebitis, the Chinese herbal ointment prepared was taken in appropriate amount and evenly smeared on the patient's phlebitis part with a sterile cotton swab, and the smearing area was slightly larger than the phlebitis skin area, twice a day, each time for 5 hours, and the patient's phlebitis recovery situation was observed every day, and detailed records were made. Among the 120 patients, 90 were grade II I and 30 were grade III-IV. The ointment was applied evenly to the affected area, with a recommended dosage of 0.5g-1g per square centimeter. The ointment was administered for seven consecutive days. On the seventh day, the number of patients with different levels of post-chemotherapy phlebitis was 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: asymptomatic;

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

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

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

[0048] Grade IV: local pain, erythema or edema, venous cord-like changes, 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 diagnosed with post-chemotherapy phlebitis who were hospitalized in the Department of Medical Oncology at the First Affiliated Hospital of Xi'an Jiaotong University between July 2023 and October 2024 were selected. The patients ranged in age from 18 to 80 years (mean, 55 ± 8.5 years). Cancers included breast, colorectal, gastric, pancreatic, gallbladder, lung, cervical, and prostate cancers. Medications used included chemotherapy drugs such as cyclophosphamide, paclitaxel, oxaliplatin, and leucovorin; antibiotics such as moxifloxacin and cefoperazone-sulbactam sodium; and stomach 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; ④ Expected survival time ≥ 3 months; ⑤ Good compliance.

[0053] 4. Exclusion criteria

[0054] ① Pregnant or lactating women; ② Patients with skin infections or large-area skin lesions; ③ Patients with serious primary diseases such as cardiovascular, liver, and kidney diseases; ④ Patients who are allergic to the drugs used in this study; ⑤ Patients with mental illness; ⑥ Patients with other serious diseases such as uncontrolled active infections and severe electrolyte imbalances.

[0055] 5. Random Grouping

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

[0057] 6. Treatment methods

[0058] Control group: Apply 50% magnesium sulfate solution wet compress. Clean the patient's skin with alcohol or iodine before applying wet compress. Then cover the phlebitis area with three layers of gauze. Soak the gauze with 50% magnesium sulfate solution until there is no dripping. Fix the gauze with plastic wrap to prevent the magnesium sulfate solution from evaporating. Apply wet compress 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. Apply twice a day for 5 hours each time.

[0060] 7. Evaluation indicators

[0061] VAS scoring standard:

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

[0063] Instructions: Hold the ruler with the graduated side facing away from the patient and have the patient mark the area on the ruler that represents their pain level. The physician will then assign a score based on the patient's markings. "0-2" is "Excellent," "3-5" is "Good," "6-8" is "Acceptable," and "8" or higher is "Poor." Observe the patient's phlebitis recovery daily and keep detailed records.

[0064] (2) Average pain resolution 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 to complete disappearance of redness and swelling.

[0068] (4) Efficacy evaluation criteria

[0069] Recovery: Clinical symptoms disappear, the veins in the affected area become softer and their elasticity is restored after treatment, and there is no tenderness, redness or swelling in the affected limb or 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 are slightly softer than before treatment, and the redness, swelling and pain are slightly reduced or remain unchanged. The blood vessels are still cord-like.

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

[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] SPSS 25.0 statistical software was used for data processing. The counts between groups were described as 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 resolution time, and average redness and swelling resolution time between the two groups

[0078] Compared with the control group, the average pain level, average calf pain duration, and average redness and swelling resolution time in the test group were significantly lower than those in the control group (P < 0.001) (see Table 1 for details). This indicates that the use of the Chinese herbal ointment of the present invention to treat post-chemotherapy phlebitis significantly alleviated the patient's pain level, and significantly shortened the average pain resolution time and average redness and swelling resolution time. The patient experienced a good experience after use, with significant pain relief, cleanliness, and ease of use, and no adverse reactions.

[0079] Table 1 Average pain intensity, 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 a sample of 120 patients, and photographs were taken to record changes in the affected area before and after medication. The patient was a 63-year-old female diagnosed with rectal malignancy, ovarian malignancy, and peritoneal metastasis. Her chief complaint was rectal cancer diagnosed over six months prior, and ovarian cancer peritoneal metastasis over four months prior. Current medical history: At the end of February 2024, the patient developed abdominal distension and decreased appetite. A chest and whole-abdominal CT scan at a local hospital revealed a soft tissue opacity (3.2 x 24 cm) in the left adnexa, multiple nodules in the greater and lesser omentum, and a large abdominal and pelvic effusion, suggesting the possibility of malignancy with omental metastasis. A pelvic MRI with plain, contrast-enhanced, and diffusion-weighted imaging revealed soft tissue opacities in the bilateral adnexa and multiple omental nodules, suggesting ovarian cancer with omental metastasis, with a soft tissue mass involving the mid-rectum and mesorectum. Considerations included rectal cancer, stromal tumor, and a large pelvic and abdominal effusion. On March 6, 2024, a colonoscopy revealed a large, raised rectal adenoma. Pathology (B202411985) indicated moderately differentiated adenocarcinoma in the rectum. Morphology and immunohistochemistry suggested a primary intestinal origin. An ultrasound-guided biopsy of a solid, hypoechoic mass in the left adnexal region was subsequently performed. Pathology (B202417473) revealed a left ovarian biopsy with poorly differentiated carcinoma infiltrating within fibrous tissue, combined with high-grade serous tissue staining. Immunohistochemistry revealed CK7 (+), CK20 (-), CDX2 (-), PAX8 (+), WT-1 (+), P53 (+80%), P16 (+), ER (+), PR (-), and Ki67 (+60%). On April 12, 2024, an ultrasound-guided biopsy of a hypoechoic nodule within the focal omental thickening in the right upper quadrant was performed. Pathology revealed moderately to poorly differentiated adenocarcinoma infiltrating fibrofatty tissue within the nodule. Immunocytochemical staining was consistent with high-grade serous carcinoma. Immunocytochemical staining revealed PAX8 (+), WT-1 (+), P16 (+), P53 (strong, +90%), Ki67 (+40%), CDX2 (-), SATB2 (-), CK5 / 6 (+), D2-40 (-), and DES (-). On April 19, 2024, ascites cytology (CT202411310) revealed immunocytochemical staining of CK7 (+), BerEp4 (+), PAX8 (+), weakly WT-1 (+), CK20 (-), CEA (-), CDX2 (+), CR (-), DES (-), and SATB2 (-). Our hospital's pathology department was consulted 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 ovary puncture", indicating high-grade serous carcinoma. Comparing the two pathological examination sections, the morphology and immunolabeling showed that there were differences between the two, suggesting 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 indurations. The patient was diagnosed with chemotherapy-related phlebitis, which was classified as Grade III. Six hours after the use of 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 indurations were smaller than before (eg Figure 1 After that, the patient successfully completed the entire chemotherapy cycle.

[0083] (2) Clinical efficacy evaluation 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, with a statistically significant difference (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%, with significant therapeutic effect.

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

[0086] Group Recovered (case) Significantly effective (example) Valid (example) Invalid (example) control group 2 8 15 35 experimental group 18 20 22 0

[0087] (3) Safety comparison between the two groups

[0088] No serious adverse reactions occurred in either group (see Table 3 for details), indicating that the Chinese herbal ointment application 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 the item does not exist.

[0092] In summary, the traditional Chinese medicine composition prepared by the present invention can effectively prevent the occurrence of chemotherapy-induced phlebitis; alleviate the symptoms of chemotherapy-induced phlebitis, including redness, swelling, pain, and nodules at the puncture site; and soften and restore elasticity of the affected blood vessels. The traditional Chinese medicine composition prepared by the present invention has a total efficacy of 100% for chemotherapy-induced phlebitis, with no serious adverse reactions, and is safe and reliable.

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

[0094] Obviously, those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, if such modifications and variations fall within the scope of the claims and their equivalents, the present invention is intended to include such 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: 90-120 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.

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 traditional 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 10 to 12 hours, then heat to 150 to 160 degrees Celsius and keep warm for 0.5 to 1.0 hours, then filter to remove the residue, add yellow wax to melt; when the oil temperature cools to below 80 degrees Celsius, add borneol powder, and immediately package after it is completely dissolved, seal 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 traditional 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 relief of the symptoms of chemotherapy-induced phlebitis is manifested as: relief of redness, swelling, pain and nodules at the puncture site of the vein; the relief refers to softening the blood vessels in the affected area and restoring the elasticity of the blood vessels.

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