Traditional Chinese medicine externally-applied ointment for treating postoperative complications of mixed hemorrhoids as well as preparation method and application of traditional Chinese medicine externally-applied ointment

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine externally-applied ointment for treating postoperative complications of mixed hemorrhoids as well as a preparation method and application of the traditional Chinese medicine externally-applied ointment. The externally-applied traditional Chinese medicine ointment for treating postoperative complications of mixed hemorrhoids comprises the following raw materials in parts by weight: 150-250 parts of calcined gypsum, 27-45 parts of bryozoatum, 9-15 parts of indigo naturalis, 36-60 parts of borneol, 30-60 parts of sesame oil and 500-850 parts of vaseline, has the effects of clearing heat and promoting diuresis, relieving swelling and pain, and healing sores and stopping bleeding, can treat main symptoms after the mixed hemorrhoids, and has no toxic or side effects. Complications such as postoperative pain, wound edema, anal pendant expansion, bleeding and the like are effectively relieved, and wound healing is accelerated.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine external coating ointment for treating complications after mixed hemorrhoid surgery, and a preparation method and application thereof. Background Art

[0002] Mixed hemorrhoids are common anorectal diseases in clinical practice. A survey shows that the incidence of anorectal diseases is 59.1%, and hemorrhoids account for 87.25% of all rectal diseases, accounting for about 52.19% of anorectal diseases. The clinical manifestations of this disease are mainly blood in the stool, prolapse, pain, perianal moisture and itching, constipation, etc., which are prone to recurrence, with varying lengths of course, gradually worsening, and seriously affecting the patient's quality of life. For patients with mixed hemorrhoids with obvious symptoms and repeated symptoms, conservative treatment is not ideal and surgical treatment is often required. The biggest challenge for many patients and surgeons is postoperative complications, including postoperative edema, bleeding, pain, and swelling; due to the particularity of its location, daily bowel movements are required after surgery, the anatomical structure is rich in blood vessels and nerves, and mechanical damage from surgery, such complications are inevitable.

[0003] As one of the traditional Chinese medicine external treatment methods, Chinese medicine external ointment has the advantages of definite efficacy, fast effect time, small toxic side effects, and low cost in various clinical diseases. At present, the ointments commonly used in the treatment of hemorrhoids in clinical practice often contain precious medicinal materials, such as musk in Mayinglong Musk Hemorrhoid Ointment, and blood clotting and pangolin in Jingwanhong Hemorrhoid Ointment. These precious or scarce Chinese medicinal materials will not only lead to an imbalance in market supply but also high prices. In addition, although mixed hemorrhoids may cause clinical manifestations such as pain, bleeding and edema in the anal area after surgery, the pathophysiological mechanisms of these symptoms are significantly different from the pathophysiological mechanisms of pain, blood in the stool and swelling of mixed hemorrhoids themselves. Therefore, the local ointments conventionally used to treat hemorrhoids often fail to achieve the expected therapeutic effect when treating complications after mixed hemorrhoid surgery. It is of great clinical significance to develop an external ointment with a more definite efficacy for complications after mixed hemorrhoid surgery, thereby minimizing postoperative complications in patients. Summary of the invention

[0004] In order to overcome the problems existing in the prior art, the object of the present invention is to provide a traditional Chinese medicine external application ointment for treating postoperative complications of mixed hemorrhoids and a preparation method and use thereof.

[0005] In order to achieve the above-mentioned purpose and other related purposes, the present invention adopts the following technical solutions:

[0006] The first aspect of the present invention provides a traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids, comprising the following component raw materials in the following weight proportions: 150-250 parts of calcined gypsum, 27-45 parts of pumice, 9-15 parts of indigo, 36-60 parts of borneol, 30-60 parts of sesame oil, and 500-850 parts of vaseline.

[0007] In some embodiments of the present invention, the traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids comprises the following component raw materials in the following weight proportions: 180-230 parts of calcined gypsum, 30-40 parts of pumice, 10-14 parts of indigo, 40-50 parts of borneol, 35-55 parts of sesame oil, and 600-800 parts of vaseline.

[0008] In some embodiments of the present invention, the Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids comprises the following component raw materials in the following weight proportions: 200 parts of calcined gypsum, 36 parts of pumice, 12 parts of indigo, 48 parts of borneol, 45 parts of sesame oil, and 700 parts of vaseline.

[0009] The second aspect of the present invention provides a method for preparing the above-mentioned Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids, comprising the following steps:

[0010] (1) mixing and grinding calcined gypsum, pumice and indigo to obtain a powder, adding the obtained powder to melted vaseline and stirring evenly to obtain a mixed material 1;

[0011] (2) adding sesame oil to the mixed material 1 and stirring evenly to obtain a mixed material 2;

[0012] (3) Add borneol powder to the mixture 2 and stir evenly to obtain the product.

[0013] In some embodiments of the present invention, in step (1), the mixed and ground materials are passed through a 100-mesh sieve to obtain a powder.

[0014] In some embodiments of the present invention, in step (1), adding the obtained powder to the melted vaseline specifically comprises: gradually adding the obtained powder to the melted vaseline in batches. In some specific embodiments of the present invention, the gradually adding in batches specifically comprises dividing the obtained powder into 2 to 4 batches, stirring while adding each time, and adding the next batch after stirring evenly. In some specific embodiments of the present invention, the melted vaseline is prepared by melting solid vaseline by heating it to 60 to 80°C.

[0015] In some embodiments of the present invention, in step (2), the temperature of the sesame oil is 60-70°C, can be 60-65°C, or can be 65-70°C.

[0016] In some embodiments of the present invention, in step (3), the borneol fine powder is obtained by grinding borneol.

[0017] In some embodiments of the present invention, in step (3), when adding borneol powder, the ambient temperature is controlled at 50-60°C, can be 50-55°C, or can be 55-60°C.

[0018] The third aspect of the present invention provides use of the above-mentioned traditional Chinese medicine external ointment for treating complications after mixed hemorrhoid surgery in the preparation of a medicament for treating complications after mixed hemorrhoid surgery.

[0019] In some embodiments of the present invention, the drug for preparing the treatment of complications after mixed hemorrhoid surgery has at least one of the following functions: 1) reducing perianal edema after mixed hemorrhoid surgery; 2) reducing wound pain after mixed hemorrhoid surgery; 3) reducing bleeding after mixed hemorrhoid surgery; 4) reducing anal swelling after mixed hemorrhoid surgery.

[0020] In the present invention, the postoperative perianal edema after mixed hemorrhoid surgery refers to the swelling of soft tissues near the anal margin incision after mixed hemorrhoid surgery, and the reduction of postoperative perianal edema after mixed hemorrhoid surgery refers to reducing the swelling degree and shortening the swelling time of the soft tissues near the anal margin incision after mixed hemorrhoid surgery.

[0021] In the present invention, the postoperative wound pain of mixed hemorrhoids refers to the pain of the postoperative wound of mixed hemorrhoids and the pathological pain caused by wound infection, false healing, etc., and the relief of postoperative wound pain of mixed hemorrhoids refers to reducing the level of postoperative wound pain of the target mixed hemorrhoids and reducing the duration of pain, as well as the level of pathological pain caused by wound infection, false healing, etc. and reducing the duration of pain.

[0022] In the present invention, the postoperative bleeding after mixed hemorrhoid surgery refers to secondary bleeding after mixed hemorrhoid surgery, that is, bleeding occurring 24 hours after surgery, including postoperative wound infection bleeding and bleeding during the hemorrhoid shedding period. The mitigation of postoperative bleeding after mixed hemorrhoid surgery refers to reducing the number and amount of bleeding caused by wound infection after mixed hemorrhoid surgery and the number and amount of bleeding caused by the shedding of unstable vascular thrombus during the shedding period of hemorrhoids.

[0023] In the present invention, the anal swelling after mixed hemorrhoid surgery refers to the swelling caused by damage to the anus and surrounding tissues, poor local blood circulation, tissue edema, or spasm of the sphincter around the anus after mixed hemorrhoid surgery, as well as mucosal congestion and swelling caused by wound infection, and the relief of anal swelling after mixed hemorrhoid surgery refers to reducing the degree of anal swelling after mixed hemorrhoid surgery and shortening the duration of the swelling.

[0024] The Chinese medicinal materials used in the embodiments of the present invention are all Chinese medicinal materials included in the 2020 edition of the Chinese Pharmacopoeia and meet the quality requirements of the Pharmacopoeia.

[0025] The main drug in the prescription of the present invention: calcined gypsum

[0026] Calcined gypsum: as the main medicine. Gypsum is very cold, sweet and spicy, and enters the lung and stomach meridians. Traditional Chinese medicine believes that after anorectal surgery, the meridians are damaged, resulting in poor circulation of qi, blood and body fluids, water retention, swelling and pain; reusing gypsum after surgery can play a role in clearing heat and purging fire, reducing swelling and relieving pain. "Compendium of Materia Medica" mentions that "gypsum is heavy, purging fire, light, and relaxing muscles; sweet and spicy and light, heavy and descending. ... It is also used in the three burners (medicines for the qi of various meridians)". It can be seen that the heat-clearing and fire-purging effect of gypsum is very effective in relieving local redness, swelling, pain and other symptoms caused by heat toxins. In addition, after calcining, gypsum can be used externally, which has the effects of absorbing moisture, astringing sores, promoting tissue regeneration and stopping bleeding. It is especially suitable for wounds with slough and difficult to grow new flesh. The Medical Records of Chinese and Western Medicine mentions: "The Classic of Medicine says that gypsum can cure wounds caused by wounds, and it is used externally to stop bleeding. I have tried to apply calcined gypsum powder to bleeding wounds, which is very effective." The Shennong Herbal Classics mentions: "Gypsum powder can also heal wounds caused by wounds." These all indicate that the external application of calcined gypsum can promote wound healing and reduce postoperative bleeding. Modern studies have shown that calcined gypsum can promote the formation of fibroblasts and capillaries in rat wounds, accelerate the proliferation of granulation tissue, and thus accelerate the healing of skin wounds.

[0027] Assistant medicine: pumice

[0028] Pumice: cold in nature, salty in taste. It enters the lung meridian and kidney meridian. It has the functions of clearing the lungs and resolving phlegm, softening and dispersing lumps. "The lungs and the large intestine are exterior and interior to each other." The lung is responsible for the dissemination and descending of qi, which is closely related to the conduction function of the large intestine. The dissemination and descending of lung qi helps the conduction of the large intestine. Conversely, the normal conduction function of the large intestine also helps the descending of lung qi. The use of pumice in the prescription plays the role of lifting the pot and opening the lid, improving dry stool caused by lung heat. "Compendium of Materia Medica" mentions that pumice can "cure old phlegm accumulation, and salt can soften hard masses", so it can relieve postoperative anal lumps and edema, thereby relieving pain and promoting wound healing. Modern research has found that pumice can effectively inhibit the growth of a variety of pathogenic bacteria, such as Escherichia coli and Staphylococcus aureus, which is of great significance for the prevention and treatment of postoperative wound infection. While reducing the local inflammatory reaction around the anus, it also relieves the patient's postoperative anal pain and discomfort. At the same time, due to its excellent adsorption properties, pumice can help maintain a moist environment around the anus, which also helps wound healing. In addition, pumice, as a ministerial drug, can also enhance the efficacy of the main drug in clearing away heat and dispersing nodules.

[0029] Adjuvant: Indigo

[0030] Indigo is cold in nature, salty in taste, and belongs to the liver and lung meridians. It has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding. "Huangdi Neijing Taisu" says: "The liver governs the tendons and is also born from blood. The liver is already injured, and because of fullness, the grain qi is strong and forced, the tendons and veins are torn, and the wide intestine leaks pus and blood, which is called hemorrhoids." It can be seen that hemorrhoids are closely related to the liver. Damp heat in the liver meridian flows down to the gate of the soul, and stagnation in the local area causes edema of the anus. Indigo has the effect of clearing the liver and purging fire. "Bencao Mengquan" mentioned that Indigo can "drain the liver, stop violent injection, and eliminate phlegm and fire on the upper diaphragm", so it can improve the local blood circulation around the anus and reduce the feeling of anal swelling after surgery. In addition, Indigo has the effects of clearing heat and detoxifying, reducing swelling and dispersing nodules. When used with pumice, it can enhance the effects of clearing heat and detoxifying and softening nodules, and jointly improve the symptoms of local edema, pain, and bleeding on the wound surface after hemorrhoid surgery.

[0031] Drugs: Borneol, sesame oil

[0032] Borneol: As a guiding drug, it tastes pungent and bitter, and enters the heart, spleen, and lung meridians. It has the effects of refreshing the mind, clearing away heat and relieving pain. "Simple Prescriptions" mentions: "To treat internal and external hemorrhoids: one or two fen of borneol, dissolve it in onion juice and apply it." Apply an appropriate amount externally, grind it into powder and apply it to the affected area. Modern research has found that borneol can reduce the harmful stimulation signals transmitted to the spinal cord by nociceptors at the damaged tissue, and inhibit the acute pain caused by trauma. As a guiding drug, its effects of refreshing the mind, clearing away heat and relieving pain help relieve pain and discomfort after hemorrhoid surgery. The pungent and fragrant characteristics of borneol can guide other drugs directly to the lesion and enhance the overall efficacy of the prescription.

[0033] Sesame oil: cool in nature, sweet in taste, and enters the large intestine and lung meridians. As a guiding drug in the prescription, its main functions are to moisten the intestines and relieve constipation, detoxify and promote tissue regeneration. It helps to promote the effects of gypsum in absorbing moisture, consolidating sores, promoting tissue regeneration and stopping bleeding; it can enhance the effects of indigo in clearing away heat, detoxifying, reducing swelling and dispersing nodules, and jointly improve the symptoms of local edema, pain, bleeding and other symptoms of postoperative wounds. As a guiding drug, sesame oil can reconcile the effects of other drugs in the prescription, making it milder, reducing irritation to the wound, and enhancing the overall efficacy of the prescription.

[0034] In summary, the compatibility characteristics of this prescription reflect the compatibility principle of monarch, minister, assistant and envoy in traditional Chinese medicine prescriptions. Calcined gypsum is the monarch drug, and its effects of clearing heat and purging fire, astringing sores and promoting tissue regeneration, and collecting dampness and stopping bleeding are the main therapeutic effects of this prescription; pumice stone is the minister drug, which assists calcined gypsum in strengthening the effect of clearing heat and dispersing nodules; indigo is the adjuvant drug, which enhances the effects of clearing heat and detoxifying and cooling blood and stopping bleeding; borneol and sesame oil are the envoy drugs, which not only have the effects of clearing heat and relieving pain, but also promote the absorption and distribution of other drugs, making the whole prescription milder and better protecting the wound surface. This compatibility is aimed at treating the main symptoms after mixed hemorrhoid surgery, and at the same time, considering the harmonizing effect of the drugs, it has the functions of clearing heat and dampness, reducing swelling and relieving pain, astringing sores and stopping bleeding.

[0035] Compared with the prior art, the present invention has the following beneficial effects:

[0036] 1. The Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids provided by the present invention has a scientific formula, and the whole formula has synergistic effects, which can play the functions of clearing away heat and dampness, relieving swelling and relieving pain, and stopping bleeding. It can effectively alleviate postoperative pain, anal edema, anal swelling, reduce bleeding and other complications, and accelerate wound healing.

[0037] 2. The traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids provided by the present invention has less medicinal taste, abundant drug sources, simple preparation process, low price, good effect, high safety, and good clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 This is a comparison chart of the therapeutic effects between the treatment group and the control group. DETAILED DESCRIPTION

[0039] Before further describing the specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the examples of the present invention are intended to describe specific embodiments, rather than to limit the scope of protection of the present invention. The test methods in the following examples without specifying specific conditions are generally carried out under conventional conditions or under conditions recommended by the manufacturers.

[0040] When the embodiments give numerical ranges, it should be understood that, unless otherwise specified in the present invention, both endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by those skilled in the art. In addition to the specific methods, equipment, and materials used in the embodiments, according to the grasp of the prior art by those skilled in the art and the record of the present invention, any methods, equipment, and materials of the prior art similar or equivalent to the methods, equipment, and materials described in the embodiments of the present invention can also be used to realize the present invention.

[0041] Unless otherwise stated, the experimental methods, detection methods, and preparation methods disclosed in the present invention all adopt conventional techniques in the technical field.

[0042] Example 1

[0043] A traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids comprises the following component raw materials in the following weight proportions: 150 parts of calcined gypsum, 27 parts of pumice, 9 parts of indigo, 36 parts of borneol, 30 parts of sesame oil and 500 parts of vaseline.

[0044] A method for preparing a traditional Chinese medicine external ointment for treating complications after mixed hemorrhoid surgery comprises the following steps:

[0045] (1) taking the above-mentioned raw materials by weight;

[0046] (2) Grind borneol into fine powder and place in a dry mortar for later use;

[0047] (3) mixing and grinding calcined gypsum, pumice and indigo, and passing through a 100-mesh sieve to obtain a powder;

[0048] (4) heating vaseline to a molten state, adding the obtained powder to the molten vaseline and stirring evenly to obtain a mixed material 1;

[0049] (5) adding sesame oil to the mixed material 1 and stirring evenly to obtain a mixed material 2;

[0050] (6) Add the borneol powder obtained in step (2) to the mixed material 2 and stir evenly to obtain the product.

[0051] Example 2

[0052] A traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids comprises the following component raw materials in the following weight proportions: 180 parts of calcined gypsum, 30 parts of pumice, 10 parts of indigo, 40 parts of borneol, 35 parts of sesame oil and 600 parts of vaseline.

[0053] The preparation method of the above-mentioned traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids is the same as that of Example 1.

[0054] Example 3

[0055] A traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids comprises the following component raw materials in the following weight proportions: 200 parts of calcined gypsum, 36 parts of pumice, 12 parts of indigo, 48 parts of borneol, 45 parts of sesame oil and 700 parts of vaseline.

[0056] The preparation method of the above-mentioned traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids is the same as that of Example 1.

[0057] Example 4

[0058] A traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids comprises the following component raw materials in the following weight proportions: 250 parts of calcined gypsum, 45 parts of pumice, 15 parts of indigo, 60 parts of borneol, 60 parts of sesame oil and 850 parts of vaseline.

[0059] The preparation method of the above-mentioned traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids is the same as that of Example 1.

[0060] Example 5

[0061] A traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids comprises the following component raw materials in the following weight proportions: 230 parts of calcined gypsum, 40 parts of pumice, 14 parts of indigo, 50 parts of borneol, 55 parts of sesame oil and 800 parts of vaseline.

[0062] The preparation method of the above-mentioned traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids is the same as that of Example 1.

[0063] Clinical Data

[0064] Referring to the "Guidelines for the Diagnosis and Treatment of Hemorrhoids in China (2020)" revised by the Colorectal and Anal Diseases Professional Committee of the Chinese Association of Integrated Traditional Chinese and Western Medicine, 200 patients with mixed hemorrhoids and surgical indications from January 2022 to December 2023 were selected and randomly divided into two groups, 100 in each group. Eight cases dropped out during the period, and 98 cases finally entered the treatment group and 94 cases in the control group. There was no significant difference in gender, age, and course of disease between the two groups after statistical analysis, P>0.05, and they were comparable.

[0065] The inclusion criteria were in accordance with the diagnostic criteria for mixed hemorrhoids. The internal hemorrhoids were staged as III and IV, and the external hemorrhoids were mainly connective tissue hemorrhoids. The age range was 18 to 65 years old, regardless of gender. After admission, all preoperative examinations were within the normal range, and no contraindications to surgery were found; patients who agreed to participate in the trial and signed relevant documents.

[0066] Exclusion criteria Patients who do not meet the diagnostic criteria and inclusion criteria. Colonoscopy excludes malignant lesions. Previous anal surgery or trauma history. Severe liver and kidney dysfunction, serious cardiovascular and cerebrovascular diseases, etc. Pregnant patients, allergic constitution or abnormal liver function. Patients who have entered other drugs or clinical trials in clinical trials. Patients who refuse to participate in this study observation, voluntarily withdraw from the trial during the trial, or are unable to participate in follow-up.

[0067] Treatment options

[0068] (1) All patients received routine anti-inflammatory and hemostatic treatment after surgery.

[0069] (2) Treatment group: conventional anti-inflammatory and hemostatic treatment + the Chinese medicine external application ointment provided in Example 3 of the present invention. After cleaning the local wound every day, apply the Chinese medicine external application ointment provided in Example 3 of the present invention evenly to the affected area twice a day.

[0070] (3) Control group: conventional anti-inflammatory and hemostatic treatment + Mayinglong Musk Hemorrhoid Ointment. After cleaning the local wound, apply Mayinglong Musk Hemorrhoid Ointment evenly to the affected area twice a day.

[0071] (4) To observe the overall efficacy, postoperative edema, pain, bleeding, anal swelling, recovery time and hospitalization costs of the two groups.

[0072] Efficacy evaluation standards (refer to the "Traditional Chinese Medicine Industry Standards of the People's Republic of China·Efficacy Standards for Diagnosis of TCM Anorectal Diseases" promulgated by the State Administration of Traditional Chinese Medicine in 2017)

[0073] Calculation formula (nimodipine method): Efficacy index (n) = [(pre-treatment score - post-treatment score) / pre-treatment score] × 100%

[0074] Comprehensive efficacy evaluation criteria:

[0075] Cured: After treatment, symptoms basically disappear, n≥95%

[0076] Significantly effective: After treatment, symptoms are significantly improved, 70%≤n<95%

[0077] Effective: After treatment, symptoms improved, 30%≤n<70%

[0078] Ineffective: After treatment, there is no significant change in symptoms, n < 30%

[0079] Total effective rate = [(number of cured cases + number of markedly effective cases + number of effective cases) / total number of samples] × 100%

[0080] Observation indicators

[0081] ① Symptom observation: observe and record the patient's postoperative edema score, pain score, bleeding score, and swelling score on the 1st, 3rd, 7th, and 14th days after surgery.

[0082] Edema score:

[0083] 0 points, none;

[0084] 1 point: the swelling is mild, but the skin wrinkles still exist;

[0085] 2 points: the swelling is more obvious, and there is no skin wrinkle;

[0086] 3 points: severe swelling and blisters are present.

[0087] Pain score:

[0088] 0 points, VAS score 0 to 2 points;

[0089] 1 point, VAS score 3-5 points;

[0090] 2 points, VAS score 6-8 points;

[0091] 3 points, VAS score>8 points.

[0092] Bleeding score:

[0093] 0 points, none;

[0094] 1 point, a small amount, not soaking a piece of 70 mm × 70 mm gauze (8 layers);

[0095] 2 points, medium amount, soak a piece of 70mm×70mm gauze (8 layers);

[0096] 3 points, large amount, soak two pieces of 70mm×70mm gauze or more (16 layers).

[0097] Swelling score: Note: Postoperative anal swelling score = anal swelling duration score + anal swelling degree score.

[0098] Swell duration points:

[0099] 0 points, no swelling;

[0100] 1 point: total anal swelling time ≤ 1h;

[0101] 2 points: total anal swelling time > 1-3 hours;

[0102] 3 points: total anal swelling time > 3 hours.

[0103] Swelling degree score:

[0104] 0 points, none;

[0105] 1 point, slight swelling;

[0106] 2 points: obvious heaviness and swelling, relieved after rest;

[0107] 3 points: The heaviness and swelling are severe and continuous, affecting sitting or lying down and resting.

[0108] ② Healing time: the number of days from surgery to complete recovery of the wound surface.

[0109] ③ Cure rate: the proportion of cured patients to all treated patients in the treatment group or control group.

[0110] Safety evaluation

[0111] The patients' fine bowel control was observed before and after treatment, and Wexner anal function and quality of life were evaluated.

[0112] Results and Analysis

[0113] 1. Comparison of efficacy

[0114] Figure 1 The comparison chart of the efficacy between the treatment group and the control group is shown in Figure 2. Figure 1 It can be seen that the total effective rate of the treatment group is 94%, and the total effective rate of the control group is 89%. The total effective rate of the traditional Chinese medicine external application ointment provided by the present invention is higher than that of the control group.

[0115] 2. Comparison of reducing edema after mixed hemorrhoid surgery

[0116] The edema score results of the two groups of patients are shown in Table 1.

[0117] Table 1 Comparison of edema scores between the two groups of patients

[0118]

[0119] As can be seen from Table 1, compared with the control group, the edema scores of the treatment group on the 1st day, 3rd day, 7th day and 14th day after surgery were respectively measured by the Wilcoxon rank sum test, and it can be seen that the P values ​​were all less than 0.05, which was statistically significant, proving that the Chinese medicine external ointment provided by the present invention is superior to the control group in reducing postoperative edema complications.

[0120] 3. Comparison of pain relief after mixed hemorrhoid surgery

[0121] The pain score results of the two groups of patients are shown in Table 2.

[0122] Table 2 Comparison of pain scores between the two groups

[0123]

[0124] As can be seen from Table 2, compared with the control group, the postoperative pain scores of the treatment group on the 1st day, 3rd day, 7th day and 14th day after surgery were all less than 0.05 by the Wilcoxon rank sum test, which showed statistically significant differences, proving that the present invention is superior to the control group in alleviating postoperative pain.

[0125] 4. Comparison of postoperative bleeding scores in reducing mixed hemorrhoids

[0126] Table 3 Comparison of postoperative bleeding scores between the two groups

[0127]

[0128] As shown in Table 3, compared with the control group, the postoperative bleeding scores of the treatment group on the 1st day, 3rd day, 7th day and 14th day after surgery were all less than 0.05 by the Wilcoxon rank sum test, which showed statistically significant differences, proving that the present invention is superior to the control group in reducing postoperative bleeding.

[0129] 5. Comparison of reducing swelling after mixed hemorrhoid surgery

[0130] The swelling scores of the two groups of patients are shown in Table 4.

[0131] Table 4 Comparison of swelling scores between the two groups of patients

[0132]

[0133]

[0134] As can be seen from Table 4, compared with the control group, the postoperative swelling scores of the treatment group on the 1st day, 3rd day, 7th day and 14th day after surgery were respectively measured by the Wilcoxon rank sum test, and it can be seen that the P values ​​were all less than 0.05, which was statistically significant, proving that the present invention is superior to the control group in reducing postoperative swelling complications.

[0135] 6. Healing time and hospitalization costs

[0136] Comparison of healing time and hospitalization costs between the two groups of patients are shown in Tables 5 and 6, respectively.

[0137] Table 5 Comparison of healing time between the two groups of patients

[0138]

[0139] As can be seen from Table 5, in terms of healing time, the average healing time of patients in the treatment group was 24.95±3.063 days, and the average healing time of patients in the control group was 26.93±2.422 days. The T test showed that P=0.002<0.05, and there was a statistically significant difference between the two groups of data, indicating that the treatment group was superior to the control group in terms of healing days.

[0140] Table 6 Comparison of hospitalization expenses between the two groups

[0141]

[0142] As can be seen from Table 6, the average hospitalization cost of the treatment group was 14641.53±2206.75 yuan, and the average hospitalization cost of the control group was 18729.58±2794.18 yuan. The T-test showed that P=0.00<0.05, which was statistically significant. Since these products are common and inexpensive medicines, and have advantages in healing time and hospitalization time, the treatment group has a clear advantage in hospitalization costs.

[0143] in conclusion

[0144] Clinical observation experiments show that the Chinese medicine external ointment of the present invention can significantly relieve postoperative perianal edema, alleviate postoperative pain, reduce postoperative bleeding, improve postoperative anal swelling, and promote wound healing. It has a definite therapeutic effect and no obvious adverse reactions or side effects.

[0145] Typical Cases

[0146] Patient Qin, 67 years old, male, was admitted to our outpatient department for "mixed hemorrhoids" due to "swelling and prolapse of the anus, pain and blood in the stool for 1 week"; specialist examination upon admission (bladder lithotomy position) visual examination: obvious hyperplasia of skin tags at the anal margin at 1-3, 5-6, and 7-9 points; obvious prolapse of the anal mucosa at 3 points with congestion; palpation: the texture of the hyperplasia is soft and slightly tender; anal finger: the mucosa near the tooth line at 3, 7, and 11 points is obviously raised and soft, and there are no other obvious abnormalities in the anal finger. Auxiliary examination: 2022.10.28 blood routine: HB89 copies / L; 2022.10.29 painless colonoscopy in our department: no obvious abnormality was found in the colon. Later, mixed hemorrhoids were externally stripped and internally ligated under spinal anesthesia + automatic elastic line internal hemorrhoids band ligation. Due to premature defecation and too many times after the operation, the anal margin edema was obvious, accompanied by bleeding during defecation, and the anus was swollen; conventional anti-inflammatory hemostatic treatment was given after the operation; after cleaning the local wound every day, the Chinese medicine plaster of the present invention was evenly applied on the gauze and applied on the wound, and the symptoms were significantly improved. This method was implemented twice a day. After 7 days of use, the patient's edema was significantly subsided and the amount of bleeding was reduced, but there was still a feeling of anal swelling; continued use, until the 10th day after the operation, the edema was basically subsided, there was no obvious bleeding, and the feeling of anal swelling was significantly improved than before. On the 14th day after the operation, the anal swelling basically disappeared.

[0147] The above is only a preferred embodiment of the present invention, and is not any formal or substantial limitation of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession, without departing from the spirit and scope of the present invention, can make some changes, modifications and evolutions of the technical content disclosed above, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. A Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids, characterized in that: The invention comprises the following raw materials in proportion by weight: 150-250 parts of calcined gypsum, 27-45 parts of pumice, 9-15 parts of indigo, 36-60 parts of borneol, 30-60 parts of sesame oil and 500-850 parts of vaseline.

2. The Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids as claimed in claim 1, characterized in that: The invention comprises the following raw materials in proportion by weight: 180-230 parts of calcined gypsum, 30-40 parts of pumice, 10-14 parts of indigo, 40-50 parts of borneol, 35-55 parts of sesame oil and 600-800 parts of vaseline.

3. The Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids as claimed in claim 1, characterized in that: The invention comprises the following raw materials in proportion by weight: 200 parts of calcined gypsum, 36 parts of pumice, 12 parts of indigo, 48 parts of borneol, 45 parts of sesame oil and 700 parts of vaseline.

4. A method for preparing a traditional Chinese medicine external ointment for treating postoperative complications of mixed hemorrhoids according to any one of claims 1 to 3, characterized in that: The steps include: (1) mixing and grinding calcined gypsum, pumice and indigo to obtain a powder, adding the obtained powder to melted vaseline and stirring evenly to obtain a mixed material 1; (2) adding sesame oil to the mixed material 1 and stirring evenly to obtain a mixed material 2; (3) Add borneol powder to the mixture 2 and stir evenly to obtain the product.

5. The preparation method according to claim 4, characterized in that: Also includes one or more of the following features: (a) In step (1), the mixed and ground materials are passed through a 100-mesh sieve to obtain a powder; (b) in step (1), adding the obtained powder to the melted vaseline specifically comprises: gradually adding the obtained powder to the melted vaseline in batches; (c) In step (2), the temperature of the sesame oil is 60-70° C.; (d) In step (3), the borneol fine powder is obtained by grinding borneol; (e) In step (3), the ambient temperature is controlled at 50-60° C. when the borneol powder is added.

6. The preparation method according to claim 5, characterized in that: Also includes one or more of the following features: (b1) the step of gradually adding in batches specifically comprises dividing the obtained powder into 2 to 4 batches, stirring each time while adding, and adding the next batch after stirring evenly; (b2) The melted vaseline is prepared by heating solid vaseline to 60-80°C and melting it.

7. Use of the traditional Chinese medicine external coating ointment for treating postoperative complications of mixed hemorrhoids as claimed in any one of claims 1 to 3 or the traditional Chinese medicine external coating ointment for treating postoperative complications of mixed hemorrhoids prepared by the preparation method of any one of claims 4 to 6 in the preparation of a medicament for treating postoperative complications of mixed hemorrhoids.

8. The use according to claim 7, characterized in that The drug for treating complications after mixed hemorrhoid surgery has at least one of the following functions: 1) alleviating perianal edema after mixed hemorrhoid surgery; 2) alleviating wound pain after mixed hemorrhoid surgery; 3) alleviating bleeding after mixed hemorrhoid surgery; 4) alleviating anal swelling after mixed hemorrhoid surgery.

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