Medicinal thread for treating chloasma and preparation method and application thereof
By burying the medicinal lines soaked in tranexamic acid into the acupoints and combining acupoint stimulation, the problem of the existing acupoint burial therapy being poorly effective for melasma treatment is solved, and effective melasma treatment is achieved with continuous Effectiveness and good safety.
Patent Information
- Application Number
- CN202410692323.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-31
- Publication Date
- 2025-01-17
AI Technical Summary
The existing acupuncture treatment has poor effect on melasma, and the traditional methods have problems such as slow onset, easy recurrence, obvious side effects or poor efficacy.
Using a drug line including tranexamic acid, the drug line is soaked in a tranexamic acid solution and then implanted into the acupuncture point of the patient, and the melanocyte proliferation and blackening of tranexamic acid are used to inhibit melanocyte proliferation and blackening. The synthesis function of the synthesis of the acupuncture points combines the stimulating effect of the acupuncture points to achieve the slow release and penetration of the drug and enhance the therapeutic effect.
This method effectively inhibits the generation of chloasma, improves the function of damaged skin barrier, reduces the number of blood vessels and mast cells, significantly improves the treatment effect, and is simple to operate, safer, and has continuous efficacy.
Smart Images
Figure CN119318601A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical supplies, and in particular to a medicated thread for treating chloasma, and a preparation method and use thereof. Background Art
[0002] Melasma is a common facial hyperpigmentation skin disease, characterized by the appearance of yellow-brown or dark-brown patches on the sun-exposed areas of the facial skin, mainly the cheeks, forehead, upper lip, nose and chin, which has a significant impact on the patient's appearance. Studies have shown that compared with other disfiguring diseases such as acne, surgical and traumatic scars, melasma lasts longer, is more likely to reduce the patient's quality of life, and lead to psychological disorders such as depression and anxiety symptoms.
[0003] At present, the main treatments for melasma include topical drug therapy, systemic drug therapy, chemical peeling, photoelectric therapy, and traditional Chinese medicine treatment. Topical drug therapy has the disadvantages of slow onset and easy recurrence; some drugs may further damage the skin; systemic drug therapy or oral treatment of traditional Chinese medicine has good effects, but has obvious side effects after long-term use; photoelectric therapy is easy to irritate pigment cells and turn black, thereby aggravating pigmentation, which cannot meet clinical needs. Therefore, it is necessary to explore safer, more effective, simple and inexpensive treatment methods.
[0004] Developed on the basis of acupuncture meridian theory, acupoint catgut embedding therapy is a technique of embedding catgut into acupoints, which has the advantages of simple operation and long-term effect. It integrates acupuncture, bloodletting, embedding needles, acupoint injection and other treatment methods into one, and can stimulate acupoints for a long time and safely, effectively regulating the whole body's qi and blood, adjusting endocrine function, and improving blood circulation.
[0005] However, traditional acupoint catgut embedding therapy is limited to the single stimulation of catgut and has poor therapeutic effect. Summary of the invention
[0006] In view of this, the present invention provides a medicated thread for treating chloasma, and a preparation method and use thereof, so as to solve the problem that the existing acupoint catgut embedding therapy has a poor therapeutic effect on chloasma.
[0007] In a first aspect, the present invention provides a drug thread for treating chloasma, the drug thread comprising a thread body and tranexamic acid infiltrated in the thread body.
[0008] Modern pharmacological studies have found that tranexamic acid can inhibit tyrosinase activity and affect multiple pathways of chloasma formation: inhibiting melanocyte proliferation and melanin synthesis in melanocytes, accelerating the recovery of damaged skin barrier function, and reducing the number of blood vessels and mast cells in the dermis. It has good efficacy and biosafety. There are many ways to administer tranexamic acid: oral, injection, and topical. However, the total absorption rate of oral tranexamic acid after metabolism is 30-50%, and long-term use may cause gastrointestinal discomfort, reduced menstruation, and increased risk of thrombosis. Although topical application has fewer adverse reactions, its bioavailability is low. When conducting a meta-analysis on the efficacy and safety of intradermal injection of tranexamic acid in the treatment of chloasma, some scholars believe that transdermal administration can directly distribute tranexamic acid to the site of action, reduce the dosage of the drug, and give a sufficient amount of the drug at the main target, so intradermal injection is desirable.
[0009] In an optional embodiment, the thread body includes at least one of medical absorbable sutures, protein sutures, and chemical synthetic sutures.
[0010] In an optional embodiment, the cross-sectional diameter of the wire body is 0.2-0.3 mm, and the length is 2-6 cm.
[0011] In a second aspect, the present invention provides a method for preparing the above-mentioned drug thread, comprising the following steps: Place the thread body in the tranexamic acid solution and seal and soak it.
[0012] In an optional embodiment, the concentration of tranexamic acid in the tranexamic acid solution is 1 to 30 mg / mL.
[0013] In an optional embodiment, the sealing soaking conditions include: The temperature is 10-30℃ and the time is 7-28 days.
[0014] In an optional embodiment, the solvent of the tranexamic acid solution includes physiological saline.
[0015] In a third aspect, the present invention provides use of the above-mentioned medicinal thread in preparing whitening products.
[0016] In an optional embodiment, the use is use in preparing a product for treating chloasma.
[0017] Through the above technical solution, the present invention has the following beneficial effects: The drug thread for treating chloasma provided by the present invention comprises a thread body and tranexamic acid infiltrated in the thread body. The drug thread can play a drug treatment role while continuously stimulating acupoints, integrates the thread body, drug and acupoint treatment, and can effectively improve the treatment effect on patients with chloasma.
[0018] Specifically, tranexamic acid has the function of inhibiting melanocyte proliferation and melanin synthesis, accelerating the recovery of damaged skin barrier function, and reducing the number of blood vessels and mast cells in the dermis. After the medicine thread soaked in tranexamic acid solution is implanted into the corresponding acupuncture points of the patient's body, tranexamic acid can be slowly released and penetrated at the acupuncture points, synergizing and enhancing the therapeutic effect of simple thread embedding on meridians and acupuncture points, which can effectively improve the various clinical symptoms of this type of patients, and the efficacy is sustained, the operation is simple, and the safety and patient compliance are good. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.
[0020] Figure 1 This is a MASI score change trend chart for the three groups of patients at each observation time point in the experimental example of the present invention. DETAILED DESCRIPTION
[0021] The following examples are provided for a better understanding of the present invention, but are not intended to limit the best mode of implementation, nor to limit the content and protection scope of the present invention. Any product identical or similar to the present invention obtained by anyone under the inspiration of the present invention or by combining the features of the present invention with other prior arts shall fall within the protection scope of the present invention.
[0022] If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in the field can be used. If no manufacturer is specified for the reagents or instruments used, they are all conventional reagent products that can be obtained commercially.
[0023] The present invention is further described in detail below in conjunction with specific embodiments. These embodiments should not be construed as limiting the scope of protection claimed by the present invention. Example 1
[0024] The medicated thread for treating chloasma is prepared as follows: (1) Preparation of tranexamic acid solution: dissolve tranexamic acid in normal saline to prepare a tranexamic acid solution with a tranexamic acid concentration of 1 mg / mL; (2) Using sterile surgical scissors, cut the 2 / 0-4 / 0 absorbable medical suture into segments of 2 to 6 cm in length, and place the cut segments in the tranexamic acid solution obtained in step (1), and soak them in a sealed container at 10-30° C. for 7 days to obtain a medicated suture for treating chloasma. Example 2
[0025] The medicated thread for treating chloasma is prepared as follows: (1) Preparation of tranexamic acid solution: dissolve tranexamic acid in normal saline to prepare a tranexamic acid solution with a tranexamic acid concentration of 4 mg / mL; (2) Using sterile surgical scissors, cut the 2 / 0-4 / 0 absorbable medical suture into segments of 2 to 6 cm in length, and place the cut segments in the tranexamic acid solution obtained in step (1), and soak them in a sealed container at 10-30° C. for 7 days to obtain a medicated suture for treating chloasma. Example 3
[0026] The medicated thread for treating chloasma is prepared as follows: (1) Preparation of tranexamic acid solution: dissolve tranexamic acid in normal saline to prepare a tranexamic acid solution with a tranexamic acid concentration of 10 mg / mL; (2) Using sterile surgical scissors, cut the 2 / 0-4 / 0 absorbable medical suture into segments of 2 to 6 cm in length, and place the cut segments in the tranexamic acid solution obtained in step (1), and soak them in a sealed container at 10-30° C. for 7 days to obtain a medicated suture for treating chloasma. Example 4
[0027] The medicated thread for treating chloasma is prepared as follows: (1) Preparation of tranexamic acid solution: dissolve tranexamic acid in normal saline to prepare a tranexamic acid solution with a tranexamic acid concentration of 15 mg / mL; (2) Using sterile surgical scissors, cut the 2 / 0-4 / 0 absorbable medical suture into segments of 2 to 6 cm in length, and place the cut segments in the tranexamic acid solution obtained in step (1), and soak them in a sealed container at 10-30° C. for 7 days to obtain a medicated suture for treating chloasma. Example 5
[0028] The medicated thread for treating chloasma is prepared as follows: (1) Preparation of tranexamic acid solution: dissolve tranexamic acid in normal saline to prepare a tranexamic acid solution with a tranexamic acid concentration of 20 mg / mL; (2) Using sterile surgical scissors, cut the 2 / 0-4 / 0 absorbable medical suture into segments of 2 to 6 cm in length, and place the cut segments in the tranexamic acid solution obtained in step (1), and soak them in a sealed container at 10-30° C. for 7 days to obtain a medicated suture for treating chloasma. Example 6
[0029] The medicated thread for treating chloasma is prepared as follows: (1) Preparation of tranexamic acid solution: dissolve tranexamic acid in normal saline to prepare a tranexamic acid solution with a tranexamic acid concentration of 30 mg / mL; (2) Using sterile surgical scissors, cut the 2 / 0-4 / 0 absorbable medical suture into segments of 2 to 6 cm in length, and place the cut segments in the tranexamic acid solution obtained in step (1), and soak them in a sealed container at 10-30° C. for 7 days to obtain a medicated suture for treating chloasma.
[0030] Experimental example This experimental example is used to verify the therapeutic effect of the medicated thread of the present invention on chloasma: Through a randomized, blinded, controlled (tranexamic acid acupoint injection, medical absorbable suture embedding, and acupoint implantation of tranexamic acid infiltration thread) research approach, the area and severity score of melasma were used as the main observation indicators, and the patient satisfaction score was used as the secondary observation indicator to objectively evaluate the efficacy and safety of tranexamic acid infiltration thread in the treatment of melasma.
[0031] 1. Research subjects (1) Source of research subjects: All cases were patients with melasma who visited the Department of Dermatology at Guang'anmen Hospital, Chinese Academy of Medical Sciences.
[0032] (2) Diagnostic criteria: Refer to the Diagnostic and Treatment Criteria for Chloasma and Vitiligo (2010 Edition): Skin lesions appear as light brown to dark brown patches on the face, usually symmetrically distributed, without inflammation or scaling; more common in women, mainly after puberty; the condition may be seasonal, with severity in summer and mild in winter; skin diseases such as post-inflammatory pigmentation, malar nevus, Riehl's melanosis, and pigmented lichen planus should be excluded.
[0033] (3) TCM classification standard: refer to the diagnostic basis and symptoms of "dark spots" and "facial dust" in the "Diagnosis and Efficacy Standards of TCM Diseases and Syndromes" of the State Administration of Traditional Chinese Medicine, and classify it as liver depression and qi stagnation type. Facial patches, yellow-brown in color, light or dark, of varying sizes, with irregular edges, butterfly-shaped, symmetrically distributed, may be accompanied by chest and flank distension, irritability, irregular menstruation, and menstrual pain; the tongue is red or dark, the tongue coating is thin, and the pulse is stringy.
[0034] (4) Clinical staging standards: Refer to the clinical staging of melasma in the "Chinese Expert Consensus on the Diagnosis and Treatment of Chloasma (2021 Edition)": Stable stage: The area of the skin lesions has not expanded in the near future, the color has not deepened, the skin lesions have not turned red, the skin lesions do not turn red after scratching, and most of the lesions do not fade when pressed on the slide.
[0035] (5) Inclusion criteria: female, aged 18 to 60 years; no previous acupuncture thread embedding therapy; meeting the diagnostic criteria for chloasma; meeting the syndrome differentiation criteria for liver depression and qi stagnation; clinical stage is stable; each patient understood the purpose and methods of the study before the trial, voluntarily participated, and signed the informed consent form for the trial.
[0036] (6) Exclusion criteria: pregnant or breastfeeding women; patients allergic to the drugs used in this study; patients with inflammatory or infectious skin diseases at the treatment site; patients with severe endocrine, gynecological, cardiovascular and cerebrovascular diseases, coagulation disorders, liver and kidney dysfunction, and tumors; patients who have received laser treatment, oral or topical freckle removal drugs within the past month; and patients who cannot protect themselves from the sun as required during treatment.
[0037] (7) Case exclusion criteria: cases that were found not to meet the inclusion criteria after inclusion; patients who were used concurrently during the trial and whose results may be affected; cases with incomplete data collection.
[0038] (8) Case dropout criteria: severe adverse reactions occur, the doctor determines that the clinical researcher should be stopped; request to withdraw for any reason; withdrawal from the clinical researcher; patient loss to follow-up.
[0039] 2. Sample size calculation: The sample size of each group is 30 cases, for a total of 90 cases.
[0040] 3. Randomization and blinding: The included cases were divided into three groups, A, B, and C, with 30 cases in each group, using the random envelope method. With the help of the PROCPLAN procedure statement of the SAS statistical software, the seed number was given and the segment length was determined. The random arrangement of the treatments received by the 90 subjects was generated, that is, the treatment allocations corresponding to the serial numbers 01-90 were listed (i.e., the random coding table).
[0041] 4. Grouping and treatment (1) Grouping: The enrolled patients were randomly divided into the experimental group (tranexamic acid suture implantation group, referred to as the suture group), control group 1 (tranexamic acid acupoint injection group, referred to as the drug group), and control group 2 (medical absorbable suture embedding group, referred to as the embedding group), with 30 cases in each group. The baseline comparison results of the general data of the patients in each group are shown in Table 1.
[0042] Table 1 Baseline comparison of general information of patients in each group
[0043] Note: a One-way ANOVA analysis was used, and the statistical value was F; b Kruskal Wallis test was used, and the statistical value was 2; c Pearson chi-square test was used, and the statistical value was 2; d Fisher's exact test was used, and the statistical value was Freeman-Halton 2. P values were all greater than 0.05, indicating that there was no difference in the baseline of the three groups of patients.
[0044] (2) Drugs and materials: the drug thread prepared in Example 2; 0.5 g / 5 mL tranexamic acid injection (Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., national medicine standard H20056986); medical absorbable sutures (absorbable surgical sutures, Zhuhai Daotian Medical Technology Co., Ltd., national medical device standard: 20183020382).
[0045] (3) Treatment: Advise the patient to keep the local operation area clean and dry for 24 hours after treatment, and avoid spicy food and alcohol. The treatment cycle is once every 4 weeks, for a total of 12 weeks. During treatment, advise the patient to use sunscreen correctly and avoid using other drugs and cosmetics for the treatment of melasma. If the patient feels unwell during treatment, immediately suspend the treatment and observe closely. With reference to the general higher education textbook, Acupuncture and Moxibustion edited by Shi Xuemin (Beijing: China Traditional Chinese Medicine Press, 2007), five local facial acupoints (Tai Yang, Xia Guan, Quan Liao, Si Bai, and A Shi) were selected.
[0046] Treatment methods for the medicated thread group: ① Preparation: Select five pairs of local facial acupoints (Tai Yang, Xia Guan, Quan Liao, Si Bai, and A Shi points), take ten medicated threads (each 2 cm long), put the medicated threads into the front end of the needle, and keep the length of the medicated threads inside and outside the needle hole basically the same; ② Treatment steps: Ask the patient to lie in a supine position, routinely disinfect the skin of the acupoints, and when the needle is inserted into the acupoints, the thread is pressed at the needle tip to form a fold, and the needle tip quickly pierces the acupoints; after ensuring that the thread outside the needle hole enters the skin and obtains the needle sensation, withdraw the needle, and the thread will remain at the acupoint, that is, a drug-infiltrated thread embedding is completed at the same time.
[0047] Treatment method for the drug group: select the same acupoints as the medication line group, use the above-mentioned tranexamic acid injection, use the same dosage as the medication line group, and inject into the facial acupoints.
[0048] Treatment method for the thread embedding group: the acupoints selected were the same as those for the medicated thread group, absorbable surgical sutures were used, the acupoints, layers, and methods of implantation were the same as those for the medicated thread group, only the thread was injected, no drugs were used.
[0049] The treatment status of patients in each group is shown in Table 2.
[0050] Table 2 Treatment status of patients in each group
[0051] 5. Observation indicators Melasma area severity index (MASI): The total score includes four parts: forehead, right zygomatic region, left zygomatic region, and chin. The higher the score, the more severe the chloasma. The specific scoring criteria are shown in Table 3. Before and after the initial treatment, VISIA skin image analyzer was used to take gross photos of the patient's face in the same location and light source at a 45-degree angle, and the photos were stored and archived. Two experienced dermatologists independently scored the photos taken before and after treatment of each patient. If there was any dispute, a third dermatologist evaluated and the consistent result was selected. The detection nodes were: 0 weeks, 4 weeks, 8 weeks, and 12 weeks after enrollment.
[0052] Table 3 Chloasma area and severity scoring standard
[0053] Note: Forehead score = 0.3 (D + H) × A; right zygomatic score = 0.3 (D + H) × A; left zygomatic score = 0.3 (D + H) × A; chin score = 0.1 (D + H) × A; MASI total score = the sum of the above scores.
[0054] 6. Safety evaluation: observe whether symptoms such as nausea, dizziness, abdominal pain, diarrhea, and redness, swelling, itching, fever, and other reactions occur after treatment, and record the symptoms, time of occurrence, duration, disappearance time, severity, and whether special treatment is required for adverse reactions in detail at each visit.
[0055] 7. Follow-up: Follow-up will be conducted 1 month after the end of treatment (i.e. 16 weeks after enrollment) to determine whether there is recurrence.
[0056] 8. Statistical methods: SPSS 24.0 statistical software was used for statistical data processing and analysis. The mean ± standard deviation was used for statistical description of measurement data. Two independent sample t test was used for those that met the normal distribution; Wilcoxon rank sum test was used for inter-group comparison of those that did not meet the normal distribution, and Friedman rank sum test was used for intra-group comparison. The frequency (constituent ratio) was used for statistical description of count data, and the changes before and after treatment between the two groups were tested by chi-square test or non-parametric test. P < 0.05 was considered statistically significant.
[0057] 9. Results: All 90 patients completed the experiment. For intra-group comparison, non-parametric test was used when the difference between the two groups did not conform to normal distribution, and paired sample t test was used when it conformed to normal distribution. Non-parametric test was used for inter-group comparison.
[0058] (1) The results of intra-group comparison are shown in Table 4.
[0059] Table 4 Comparison of MASI scores within each group at each testing time point
[0060] Note: e was performed using the Wilcoxon signed-rank test; f was performed using the paired sample t-test; ▲ indicates P < 0.05.
[0061] As can be seen from Table 4, the corresponding P values of the three groups at the 4th week were all less than 0.05, indicating that the three groups of patients began to take effect from the 4th week.
[0062] There were statistically significant differences in MASI scores between the medicated thread group, catgut embedding group, and medication group at the 4th, 8th, 12th week of treatment, and the 16th week of follow-up compared with before treatment (W0) (R < 0.05), indicating that the three groups of patients had significant therapeutic effects after each treatment compared with before treatment.
[0063] There were statistically significant differences in MASI scores between the 8th and 12th weeks of treatment and the last treatment (i.e., 4 weeks ago) among the three groups of patients (R < 0.05), indicating that the three groups of patients had significant therapeutic effects after the second and third treatments compared with the first treatment.
[0064] There was no significant difference in MASI scores between the 16th week of follow-up and the last treatment (i.e., 4 weeks ago) (R>0.05), indicating that the efficacy of the three groups of patients was still well maintained one month after the end of treatment compared with the third treatment.
[0065] (2) The results of inter-group comparison are as follows Figure 1 As shown. Figure 1 It can be seen that the downward trend of MASI score in the catgut embedding group was slightly inferior to that in the medication group in the first 4 weeks, and was better than that in the medication group from 4 to 12 weeks; the downward trend of MASI score in the medication catgut group was significantly better than that in the medication group and the catgut embedding group, indicating that the medication catgut group had better efficacy.
[0066] (3) Safety evaluation results: None of the 90 patients experienced symptoms such as nausea, dizziness, abdominal pain, and diarrhea after treatment. There was a normal soreness and swelling at the acupoints for 4-7 days. No patients in the two groups had obvious redness, swelling, itching, fever, etc. This shows that the implanted threads are safe to use and the efficacy is stable and reliable.
[0067] After treatment, a satisfaction survey was conducted on the three groups of patients, and the survey results are shown in Table 5. As shown in Table 5, all three groups of patients were satisfied with the treatment effect.
[0068] Table 5 Survey results of patient satisfaction in the three groups
[0069] 10. Conclusion (1) Thread embedding therapy has a significant effect on the treatment of melasma.
[0070] (2) As the number of catgut implantation times increased, the therapeutic effect of the medicated thread group was better than that of the simple catgut implantation group and the simple medication group, and the therapeutic effect was maintained better after stopping treatment.
[0071] The above test data show that the present invention combines acupoint catgut embedding with tranexamic acid to treat chloasma, soaks the catgut in tranexamic acid injection and implants it into facial acupoints, utilizes the dual effects of continuous stimulation of the acupoints by the catgut and tranexamic acid drug treatment, can reduce the risk of long-term oral tranexamic acid, and can solve the problem of low transdermal absorption of topical tranexamic acid. The present invention is a new type of therapy for treating chloasma by combining needle and medicine, has innovative clinical treatment methods, reliable efficacy, simple operation, good safety and patient compliance, and huge economic and social benefits.
[0072] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.
Claims
1. A medicinal thread for treating chloasma, characterized in that: The drug thread comprises a thread body and tranexamic acid impregnated in the thread body.
2. The medical thread according to claim 1, characterized in that The thread body includes at least one of medical absorbable suture, protein thread, and chemical synthetic thread.
3. The medical thread according to claim 1, characterized in that: The cross-sectional diameter of the wire body is 0.2-0.3 mm, and the length is 2-6 cm.
4. The method for preparing the medical thread according to any one of claims 1 to 3, characterized in that: The steps include: Place the thread body in the tranexamic acid solution and seal and soak it.
5. The preparation method according to claim 4, characterized in that: In the tranexamic acid solution, the concentration of tranexamic acid is 1 to 30 mg / mL.
6. The preparation method according to claim 4, characterized in that: The sealing soaking conditions include: The temperature is 10-30℃ and the time is 7-28 days.
7. The preparation method according to any one of claims 4 to 6, characterized in that: The solvent of the tranexamic acid solution includes physiological saline.
8. Use of the medicated thread according to any one of claims 1 to 3 in the preparation of whitening products.
9. The use according to claim 8, characterized in that The use is for preparing products for treating chloasma.