A medicine and instrument combination system for treating bromhidrosis by combining a sclerosing agent and a multi-needle injection needle and its use

Abstract

The application belongs to the technical field of medicine, and relates to a medicine and instrument combination system for treating bromhidrosis by using a sclerosing agent and a multi-needle injection needle and application thereof. The medicine and instrument combination system is a medicine and instrument composition comprising a sclerosing agent and a disposable sterile injection needle. The sclerosing agent comprises one or more of polidocanol, lauromacrogol, sodium myristyl sulfate and sodium morrhuate. The disposable sterile injection needle is a nine-needle injection needle or a five-needle injection needle. The nine-needle injection needle or the five-needle injection needle has uniformly distributed needle heads and equal lengths of the needle heads. The medicine and instrument combination system can standardize injection of the sclerosing agent in the process of treating bromhidrosis, accurately control the dosage, control the curative effect, reduce adverse reactions and improve safety.

Description

Technical Field

[0001] This invention belongs to the field of medical technology and relates to a combination system of sclerosing agent and multi-needle injection needle for treating axillary osmidrosis and its application. Background Technology

[0002] Axillary osmidrosis (body odor) is a common skin condition, primarily characterized by an unpleasant odor emanating from the armpits. Due to its abnormal smell, it often causes discomfort to others. Therefore, axillary osmidrosis can affect a patient's normal social interactions, causing psychological distress and even impacting their daily life, work, studies, and employment.

[0003] Body odor is related to the secretion of apocrine glands in the armpits. At the same time, body odor also has a certain degree of heritability. Its cause is mostly due to the development of apocrine glands in the armpits during puberty. The sweat and secretions secreted by the apocrine glands interact with bacteria, fungi and other microorganisms to produce short-chain fatty acids and ammonia, which produce odor.

[0004] Currently, common treatments for underarm odor include surgery, botulinum toxin type A, laser therapy, radiofrequency microneedling, and microwave therapy.

[0005] Surgical treatment is a common treatment for patients with bromhidrosis. By surgically removing the apocrine glands, the patient's symptoms can be fundamentally improved. However, the surgery is quite invasive, requiring incisions in the skin of both armpits. After the surgery, scars will remain, and the patient's recovery period is about 2 weeks. During this period, both armpits need to be bandaged with pressure, which affects the patient's normal life. There is a risk of skin necrosis in the armpits after surgery, and the scars are obvious after healing, which can lead to traction on the upper limbs.

[0006] Botulinum toxin type A injections show significant short-term effects in treating underarm odor, but the treatment effect only lasts for an average of 4-6 months. After 6 months, the effect of botulinum toxin type A usually wears off, and underarm odor usually recurs. Therefore, in order to achieve long-term treatment results, patients need to have repeated injections.

[0007] The depth and extent of physical damage caused by electro-optical treatments such as laser, radiofrequency microneedling, and microwave are difficult to control. In addition, apocrine sweat glands are numerous, widely distributed, and randomly distributed. Therefore, electro-optical treatment carries the risk of missing any glands and has a high recurrence rate. It also requires the highest level of skill from the operator. If the operation is not performed properly, it is easy to leave extensive dot-like scars and obvious local adhesions after the operation. Furthermore, if the axillary odor recurs in the future, the difficulty of surgical treatment is high.

[0008] Currently, there are existing literature reports on sclerotherapy for treating axillary osmidrosis. For example, CN119925318A discloses the use of polidocanol in the preparation of a drug for treating axillary osmidrosis through diffuse, grid-like, multi-point continuous subcutaneous injection. This method utilizes polidocanol's mechanism of action as a sclerosing agent. Policocanol is injected into the axillary skin, where it comes into contact with the soft tissue containing the subcutaneous apocrine glands, producing a sclerosing effect and inducing chemical aseptic inflammation, thereby destroying the subcutaneous apocrine glands in the armpit and achieving a therapeutic effect on axillary osmidrosis.

[0009] CN119925318A describes a sclerotherapy procedure involving the following steps: using a disposable sterile syringe (single needle), the needle is inserted into the lower corner of a grid marked under the patient's armpit, remaining embedded in the skin. Multiple, fan-shaped, continuous subcutaneous injections of polidocanol are then performed within the grid, requiring punctures in multiple directions within the same grid. While this therapy avoids surgical incisions, is minimally invasive, has a long duration of therapeutic effect, and exhibits good clinical efficacy, it also presents several challenges. These include uneven drug delivery within each grid, high physician workload, difficulty in standardizing injection dosage, challenges in mastering the injection pattern, the risk of local tissue necrosis due to excessive local administration, inconsistent injection depth, and the potential for subcutaneous hematoma due to multiple punctures at different levels within the same grid. Summary of the Invention

[0010] The problem the invention aims to solve

[0011] To address the aforementioned problems in the existing technology, the present invention aims to provide a drug-device combination system for treating axillary osmidrosis using a sclerosing agent and a multi-needle injection needle, and its application. The drug-device combination system can solve the problems of uneven drug delivery and inconsistent injection depth of traditional disposable syringes, and avoid the problems of local tissue necrosis caused by excessive or superficial local drug delivery, as well as subcutaneous hematoma caused by multi-directional punctures at different levels.

[0012] Solution for solving the problem

[0013] To address the above problems, the present invention provides the following technical solution:

[0014] First, the present invention provides a pharmaceutical and medical device composition for treating axillary osmidrosis using a combination of a sclerosing agent and a multi-needle injection needle, comprising a sclerosing agent and a disposable sterile injection needle; wherein, the sclerosing agent comprises one or more of polidocanol, polidocanol, sodium tetradecyl sulfate, and sodium morrhuate, and the disposable sterile injection needle is a nine-needle injection needle or a five-needle injection needle; the nine-needle injection needle comprises nine needles arranged in a 3×3 square array with equal needle lengths; the five-needle injection needle comprises five needles, four of which are arranged in a 2×2 square array, with the remaining needle located at the center of the 2×2 square array, and all five needles are of equal lengths.

[0015] Preferably, the length of the needle tip of the nine-needle injection needle or five-needle injection needle is such that its tip reaches the deep dermis and superficial fat layer, preferably 1.5-3.7 mm, more preferably 1.5-2.0 mm, and even more preferably 1.5 mm or 2.0 mm.

[0016] Preferably, the side length of the 3×3 square array or the 2×2 square array is 0.8-1.2 cm, more preferably 1 cm.

[0017] Preferably, the medical device composition further includes a disposable sterile syringe, and the hardening agent is filled inside the syringe.

[0018] Preferably, the nine-needle injection needle or the five-needle injection needle further includes a needle body, a needle hub, and a needle handle; one end of the needle body is embedded in the needle hub, and the other end is connected to the needle tip; the needle hub is connected to the needle handle; the needle handle has a cavity that matches the needle hub of the syringe; and there is a through channel between the needle body, the needle hub, and the needle handle.

[0019] Preferably, the needle hub of the disposable sterile syringe is optionally pre-connected to the needle handle.

[0020] Preferably, the medical device composition further includes a protective sleeve located outside the needle and the needle hub.

[0021] Preferably, the hardener includes one or more of podocalcitonin injection, polidocanol injection, sodium tetradecyl sulfate injection, and sodium morrhuate injection, with podocalcitonin injection being preferred, and 0.5%-5% podocalcitonin injection being more preferred.

[0022] Preferably, the polidocanol injection comprises water for injection and ethanol; preferably, the polidocanol injection further comprises pharmaceutically acceptable excipients.

[0023] Secondly, the present invention also provides the use of the above-mentioned pharmaceutical and medical device composition in the preparation of a pharmaceutical and medical device combination product for treating axillary osmidrosis.

[0024] Preferably, the drug-device combination product is a drug-device combination product for subcutaneous injection to treat axillary osmidrosis.

[0025] The effects of the invention

[0026] The drug-device combination system provided by this invention is a drug-device combination including a sclerosing agent and a disposable sterile injection needle (multi-needle head). It enables the sclerosing agent to be injected in a standardized manner during the treatment of axillary osmidrosis, with precise dosage, controllable efficacy, fewer adverse reactions, and better safety.

[0027] Specifically, the pharmaceutical composition provided by this invention enables the drug to be evenly delivered into the subcutaneous or superficial fat layer of the armpit, allowing for precise targeting of the apocrine glands and resulting in a more controllable and effective treatment of bromhidrosis.

[0028] The pharmaceutical-medical device composition provided by this invention solves the problems of uneven drug delivery and inconsistent injection depth of traditional disposable syringes (single needle), avoids the problems of local tissue necrosis caused by excessive or superficial local drug delivery, and subcutaneous hematoma caused by repeated punctures in multiple directions and at different levels.

[0029] Meanwhile, the pharmaceutical and medical device composition provided by this invention can realize a standardized injection treatment mode for axillary osmidrosis, which is simple to operate, reduces the difficulty and intensity of doctors' operation, significantly shortens the treatment time, is more acceptable to patients, and is easier to promote. Attached Figure Description

[0030] Figure 1 The disposable sterile injection needle (nine-needle head) used in Example 1 is shown below; where 1 is the needle head, 2 is the needle body, 3 is the needle hub, and 4 is the needle handle.

[0031] Figure 2 This diagram illustrates the connection between a disposable sterile injection needle (nine-needle tip) and a syringe.

[0032] Figure 3 This is a schematic diagram of a disposable sterile injection needle (nine-needle head) with a protective sheath.

[0033] Figure 4 The changes in the appearance of the axillary skin of patient 1 in Example 2; wherein, Figure 4 In the image, 'a' represents a photograph of the armpit where the skin of the patient's armpit sweat gland distribution area is marked with a grid. Figure 4 In the image, b is a photograph of the armpit skin after disinfection; Figure 4 The 'c' in the image is a photograph taken during the injection treatment process; Figure 4 In this context, d represents the appearance of the axillary skin immediately after the injection treatment; Figure 4 In the figure, 'e' represents the appearance of the axillary skin one week after the injection treatment; Figure 4In the figure, f represents the appearance of the axillary skin two weeks after the injection treatment.

[0034] Figure 5 The changes in the appearance of the axillary skin of patient 2 in Example 3; wherein, Figure 5 In the image, 'a' represents a photograph of the armpit after the skin in the area where the sweat glands are distributed has been marked using a grid. Figure 5 b in the image is a photograph taken during the injection treatment process; Figure 5 In the figure, 'c' represents the appearance of the axillary skin immediately after the injection treatment. Figure 5 In this context, d represents the appearance of the axillary skin one day after the injection treatment; Figure 5 In the figure, 'e' represents the appearance of the axillary skin one week after the injection treatment; Figure 5 In the figure, f represents the appearance of the axillary skin two weeks after the injection treatment.

[0035] Figure 6 The changes in the appearance of the axillary skin of patient 3 in Example 4; wherein, Figure 6 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 6 b in the image is a photograph taken during the injection treatment process; Figure 6 In the figure, 'c' represents the appearance of the axillary skin immediately after the injection treatment. Figure 6 In the figure, d represents the appearance of the axillary skin one day after the injection treatment.

[0036] Figure 7 The changes in the appearance of the axillary skin of patient 4 in Example 5; wherein, Figure 7 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 7 b in the image is a photograph taken during the injection treatment process; Figure 7 In the figure, 'c' represents the appearance of the axillary skin immediately after the injection treatment. Figure 7 In this context, d represents the axillary injection area and surrounding skin one day after the injection treatment. Figure 7 In the figure, 'e' represents the appearance of the axillary skin one week after the injection treatment.

[0037] Figure 8 This is a photograph of the disposable sterile injection needle (five needles) and syringe used in Example 6 after connection.

[0038] Figure 9 The changes in the appearance of the axillary skin of patient 5 in Example 6; wherein, Figure 9 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 9 b in the image is a photograph taken during the injection treatment process; Figure 9 In the figure, 'c' represents the appearance of the axillary skin immediately after the injection treatment. Figure 9 In this context, d represents the axillary injection area and surrounding skin two days after the injection treatment. Figure 9In the figure, 'e' represents the appearance of the axillary skin 4 days after the injection treatment.

[0039] Figure 10 The changes in the appearance of the axillary skin of patient 6 in Example 7; wherein, Figure 10 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 10 In the figure, b represents the appearance of the axillary skin immediately after the injection treatment; Figure 10 In the text, 'c' refers to the axillary injection area and surrounding skin the day after the injection treatment. Figure 10 In the figure, d represents the appearance of the axillary skin 5 days after the injection treatment.

[0040] Figure 11 This is a photo taken during the injection treatment process for Comparative Example 1.

[0041] Figure 12 The changes in the appearance of the axillary skin of patient 7 in Comparative Example 1; among them, Figure 12 In the figure, 'a' represents the appearance of the axillary skin immediately after the injection treatment; Figure 12 b in the figure represents the appearance of the axillary skin one day after the injection treatment; Figure 12 In the image, 'c' represents the skin in the armpit and surrounding area two days after the injection treatment. Figure 12 In the figure, d represents the axillary injection area and surrounding skin one week after the injection treatment. Detailed Implementation

[0042] Various exemplary embodiments, features, and aspects of the present invention will be described in detail below. The term "exemplary" as used herein means "serving as an example, embodiment, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as superior to or better than other embodiments.

[0043] Furthermore, to better illustrate the present invention, numerous specific details are set forth in the following detailed embodiments. Those skilled in the art should understand that the present invention can be practiced without certain specific details. In other instances, methods, means, apparatus, and steps well known to those skilled in the art have not been described in detail in order to highlight the spirit of the present invention.

[0044] Unless otherwise stated, all units used in this specification are international standard units, and all numerical values ​​and ranges appearing in this invention should be understood to include systematic errors that are unavoidable in industrial production.

[0045] In this specification, the word "may" has two meanings: to perform a certain process and not to perform a certain process.

[0046] In this specification, references to "some specific / preferred embodiments," "other specific / preferred embodiments," "implementation," etc., refer to specific elements (e.g., features, structures, properties, and / or characteristics) related to that embodiment, which are included in at least one of the embodiments described herein and may or may not be present in other embodiments. Furthermore, it should be understood that these elements may be combined in any suitable manner in various embodiments.

[0047] In this specification, the range of values ​​referred to as "value A to value B" refers to the range including the endpoint values ​​A and B.

[0048] In this instruction manual, the concentration of podocalcitonin injection refers to the volumetric mass concentration, specifically the mass percentage of podocalcitonin in a specific volume of podocalcitonin injection. For example, 1% podocalcitonin injection means that 100 mL of podocalcitonin injection contains 1 g of podocalcitonin.

[0049] <Pharmaceutical and Medical Device Combinations>

[0050] First, the present invention provides a pharmaceutical and medical device composition for treating axillary osmidrosis using a sclerosing agent and a multi-needle injection needle. The pharmaceutical and medical device composition includes a sclerosing agent and a disposable sterile injection needle. The sclerosing agent includes one or more of podocarbamate, polidocanol, sodium tetradecyl sulfate, and sodium morrhuate. The disposable sterile injection needle is a nine-needle injection needle or a five-needle injection needle. The nine-needle injection needle includes nine needles arranged in a 3×3 square array with equal needle lengths. The five-needle injection needle includes five needles, four of which are arranged in a 2×2 square array, with the remaining needle located at the center of the 2×2 square array. All five needles are of equal length.

[0051] In this invention, the needle tip of the nine-needle injection needle or five-needle injection needle refers to the part exposed outside the needle hub that can penetrate the skin, such as... Figure 1 The "1" in the nine-needle injection needle shown.

[0052] In some embodiments, the length of the nine-needle or five-needle injection needle is such that its tip reaches the deep dermis and superficial fat layer. In some specific embodiments, the length of the nine-needle or five-needle injection needle is 1.5-3.7 mm, such as 1.5 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.2 mm, 2.5 mm, 3 mm, etc., preferably 1.5-2.0 mm.

[0053] In some embodiments, the side length of the 3×3 square array or the 2×2 square array can be adjusted according to the area of ​​the injection sites defined during treatment. In some specific embodiments, the side length of the 3×3 square array or the 2×2 square array is 0.8-1.2 cm, for example, 0.9 cm, 1 cm, 1.1 cm, etc.

[0054] In some embodiments, the medical device composition further includes a disposable sterile syringe, with the hardening agent filling the syringe. In some specific embodiments, the syringe includes a needle hub, a needle tube, and a piston, with the hardening agent filling the needle tube, and the needle hub connected to the nine-needle injection needle or the five-needle injection needle.

[0055] In some implementation schemes, such as Figure 1 As shown, the nine-needle injection needle or the five-needle injection needle further includes a needle body, a needle hub, and a needle handle; one end of the needle body is embedded in the needle hub, and the other end is connected to the needle tip; the needle hub has the function of fixing the needle body; the needle hub is connected to the needle handle; the needle handle has a cavity that matches the needle hub of the syringe; the needle body, needle hub, and needle handle have a through channel.

[0056] In some embodiments, the needle hub of the disposable sterile syringe is optionally pre-connected to the handle of the nine-needle or five-needle injection needle. In some specific embodiments, when the pharmaceutical composition is used, the needle hub of the disposable sterile syringe is connected to the handle of the nine-needle or five-needle injection needle, such as... Figure 2 As shown.

[0057] In some embodiments, the medical device composition further includes a protective sleeve located outside the needle and the needle hub. In some specific embodiments, such as Figure 3 As shown, the protective sleeve has a positioning angle design to prevent damage to the needle tip caused by handling or other reasons before use. In some other specific embodiments, when the needle hub of the disposable sterile syringe is not pre-connected to the handle of the nine-needle injection needle or the five-needle injection needle, the needle hub of the disposable sterile syringe also has a protective sleeve.

[0058] In some implementations, the needle and needle body are made of stainless steel.

[0059] In some implementations, the diameter of the needle and needle body is 32 G.

[0060] In some implementations, the needle handle is made of PVC material.

[0061] In some implementations, the needle hub is made of PVC material.

[0062] Regarding sclerosing agents, polidocanol, polidocanol, sodium tetradecyl sulfate, and sodium morrhuate are all common medical sclerosing agents. These sclerosing agents can produce a hardening effect after contacting the soft tissue where the subcutaneous apocrine glands are located, destroying the subcutaneous apocrine glands in the armpit, thereby achieving the therapeutic effect of treating axillary odor.

[0063] In some embodiments, the hardener includes one or more of podocarbamate injection, polidocanol injection, sodium tetradecyl sulfate injection, and sodium morrhuate injection.

[0064] Polycarboxylic acid is a polyol with the chemical structural formula C. 12 H 25 (OCH2CH2) n OH, where n is the average degree of polymerization, preferably 8-10, more preferably 9, and when n=9, the molecular weight is approximately 600. The molecular structure of polydocaol contains multiple hydroxyl groups, which gives it good solubility and adhesion.

[0065] In some preferred embodiments, the hardener is polydocaol injection.

[0066] In some preferred embodiments, the concentration of the podocalcitonin injection can be 0.5%-5%, such as 0.5%, 1%, 1.5%, 2%, 3%, etc., preferably 0.5%-2%. In this invention, the concentration is a volumetric mass concentration, that is, 0.5%-5% podocalcitonin injection means that 100 mL of podocalcitonin injection contains 0.5-5 g of podocalcitonin.

[0067] In some embodiments, the solvent of the polydextrose injection includes water for injection.

[0068] In some embodiments, the solvent of the polydocaol injection also includes ethanol, for example, ethanol with a volume fraction of 96%.

[0069] In some embodiments, the solvent of the polydextrose injection further includes 5% ethanol by volume.

[0070] In some embodiments, the podocalcitonin injection also contains pharmaceutically acceptable excipients.

[0071] In this invention, "pharmaceuticalally acceptable" means a substance that is not biologically or otherwise undesirable; for example, a substance that can be incorporated into a pharmaceutical composition administered to a patient without producing any significant undesirable biological effects or interacting harmfully with any other component contained in the composition. Pharmaceutically acceptable excipients (such as pH adjusters, suspending agents, surfactants, etc.) preferably meet the required standards for toxicological and finished product testing and / or have been included in the inactive ingredient guidelines established by the U.S. Food and Drug Administration.

[0072] In some implementations, the pharmaceutically acceptable excipients include one or more of potassium dihydrogen phosphate and disodium hydrogen phosphate.

[0073] In some embodiments, the polydocaol injection contains less than 68 mg of potassium dihydrogen phosphate per milliliter of solvent, and / or less than 71 mg of disodium hydrogen phosphate per milliliter of solvent.

[0074] <Applications in the preparation of drug-device combination products>

[0075] The present invention also provides the use of the above-described pharmaceutical and medical device composition in the preparation of a pharmaceutical and medical device combination product for treating axillary osmidrosis.

[0076] In some embodiments, the drug-device combination product is a drug-device combination product for subcutaneous injection to treat axillary osmidrosis.

[0077] In some preferred embodiments, the total daily therapeutic dose of the drug-device combination product should generally not exceed 2 mg polidocanol per kilogram of body weight per day. For example, for a patient weighing 60 kg, this is equivalent to 12 mL of 1% polidocanol injection (2 mL of injection contains 20 mg polidocanol) per day, with a total daily dose not exceeding 14 mL.

[0078] Treatment methods

[0079] The present invention also provides a method for treating axillary odor, which includes the following steps:

[0080] (1) After the subject’s armpit area was prepared, the skin in the sweat gland distribution area was marked in a grid pattern, with each grid being a square with a side length of about 1 cm;

[0081] (2) Inject polidocanol into the deep dermis and superficial fat layer corresponding to each square of skin. The specific steps are as follows: First, mark the injection sites. Use a sterile subcutaneous needle (nine or five needles) to cover an area of ​​1 cm². 2Prepare a disposable sterile syringe (containing polidocanol injection solution). Make perpendicular contact with the skin, press firmly downwards, and slowly inject the polidocanol injection solution evenly into the deep dermis and superficial fat layer corresponding to the square grid of skin at the injection site. Ensure that the tip of the nine-needle or five-needle syringe remains within the deep dermis and superficial fat layer throughout the injection process. After injection, slowly lift the syringe. Repeat the injection process sequentially until the entire treatment area is covered.

[0082] To ensure efficacy and safety, the total daily treatment dose should generally not exceed 2 mg polidocanol per kilogram of body weight per day. For example, for a patient weighing 60 kg, this is equivalent to 12 mL of 1% polidocanol injection (2 mL of injection contains 20 mg polidocanol) per day, with a total daily dose not exceeding 14 mL.

[0083] In some implementations, the injection dose at each injection site is 1.5-2.5 mg of polidocanol, which is equivalent to 1 cm of the subject's tissue. 2 The corresponding injection dose for the axillary skin is 1.5-2.5 mg polidocanol, such as 1.8 mg, 2 mg, or 2.2 mg polidocanol.

[0084] Example

[0085] The embodiments of the present invention will be described in detail below with reference to examples. However, those skilled in the art will understand that the following examples are for illustrative purposes only and should not be considered as limiting the scope of the invention. Unless otherwise specified in the examples, conventional conditions or conditions recommended by the manufacturer are followed. Reagents or instruments whose manufacturers are not specified are all commercially available conventional products.

[0086] Example 1

[0087] Patients with axillary osmidrosis were divided into two groups: an experimental group and a control group.

[0088] The experimental group consisted of 30 patients with axillary osmidrosis (bromhidrosis), including 15 males and 15 females, with a mean age of 25.0 ± 4.4 years (range: 16-33 years). The control group consisted of 28 patients with axillary osmidrosis, including 15 males and 13 females, with a mean age of 25.1 ± 4.8 years (range: 19-33 years). There were no significant differences in gender and age between the experimental and control groups (P>0.05). According to the Traumatoid Arthritis Odor Scale (TAOGS), all patients were classified as grade 2 or 3, excluding those at grade 0 or 1. In the experimental group, 13 patients were grade 2 and 17 were grade 3; in the control group, 14 patients were grade 2 and 14 were grade 3. There was no significant difference in the severity of axillary osmidrosis between the experimental and control groups (P>0.05). Baseline data of the patients are shown in Table 1, where P > 0.05 indicates no significant difference, and P < 0.05 indicates a significant difference.

[0089] Table 1: Baseline data of patients with axillary osmidrosis

[0090]

[0091] The treatment plan for the experimental group was as follows:

[0092] The experimental group received 1% polidocanol in combination with a nine-needle injection needle. The 1% polidocanol was marketed as Anshuxi, with the generic name Polidocanol Injection (1%), and a specification of 2 mL: 20 mg (meaning 2 mL of injection solution contains 20 mg of polidocanol). The manufacturer was Siegfried Hameln GmbH. The disposable sterile injection needle (nine-needle head) was described in [link to instructions]. Figure 1 The needle is 1.5 mm long, with 9 needles arranged in a 3×3 square array. The side length of the square array is 1 cm. The needle tip and body are made of stainless steel with a diameter of 32 G. The needle hub and handle are made of PVC material. The brand is Compvo, and the manufacturer is Jiangsu Zhongsheng Medical Technology Co., Ltd.

[0093] The injection treatment process is as follows:

[0094] (1) After preparing the patient's axillary area, mark the skin in the sweat gland distribution area with a marker pen in a grid pattern. Each grid is a square with a side length of about 1 cm, and each grid is an injection site.

[0095] (2) Inject polidocanol into the deep dermis and superficial fat layer corresponding to each square of skin. The specific steps are as follows: Mark the injection sites; make perpendicular contact between a disposable sterile injection needle (nine needles, equipped with a disposable sterile syringe containing 1% polidocanol) and the skin at the injection site, press down firmly, and inject 0.2 mL of polidocanol. Inject the polidocanol evenly into the deep dermis and superficial fat layer corresponding to the square of skin at the injection site. After injection, slowly lift the syringe; mark the injection sites in sequence until the entire treatment area is covered. After injection, cover the injection site with gauze. If the patient's sweat gland distribution area is large, the amount can be increased appropriately, but the total injection amount should not exceed 2 mg of polidocanol per kilogram of body weight per day. For example, if 2 mL of injection contains 20 mg of polidocanol, for a patient weighing 70 kg, the daily treatment dose should not exceed 14 mL.

[0096] The treatment plan for the control group was:

[0097] The control group received non-negative pressure gold microneedling. The microneedles were inserted into the skin of the axillary region, releasing energy to heat the apocrine glands to 60-90℃, causing liquefaction and denaturation, thus achieving the therapeutic effect. The procedure was as follows: During the operation, the left hand was used to flatten the skin in the patient's axillary region, while the right hand held the treatment handle perpendicular to the skin. The non-negative pressure treatment head was pressed firmly downwards, and the pedal was simultaneously pressed down to release radiofrequency energy. After the energy release was complete, the microneedle retracted, the handle was lifted, and the next operation was performed until the entire area requiring treatment was covered. This was repeated twice.

[0098] The treatment effects of the experimental group and the control group are shown in Table 2. P > 0.05 indicates no significant difference, and P < 0.05 indicates a significant difference.

[0099] Table 2: Clinical data on the treatment of axillary osmidrosis with 1% podocarboxylic acid combined with nine-needle tip and gold microneedle.

[0100]

[0101] Note: In the grouping, "Excellent" means that the patient's armpit odor has completely disappeared, "Good" means that the patient's armpit odor has almost disappeared, "Average" means that the patient's armpit odor has been significantly reduced, and "Poor" means that the improvement of the patient's armpit odor is not obvious or ineffective.

[0102] Table 2 shows that, in terms of efficacy, at 7 days post-operation, the effective rates in the experimental group and the control group were 83.33% and 92.86%, respectively (p>0.05), with no significant difference between the two groups. At 1-month and 3-month follow-up, the effective rates in the experimental group and the control group were also 83.33% and 92.86%, respectively (P>0.05), indicating that the long-term efficacy of polidocanol combined with nine-needle acupuncture for treating axillary osmidrosis is comparable to that of gold microneedling, with no significant difference between the two groups. The recurrence rates in the experimental group and the control group were 16.7% and 14.3%, respectively (P>0.05), with the recurrence rate in the experimental group being comparable to that in the control group. These clinical data indicate that polidocanol combined with nine-needle acupuncture for treating axillary osmidrosis is comparable to gold microneedling in terms of efficacy and recurrence rate.

[0103] Regarding adverse reactions, 7 days post-surgery, 20 patients in the experimental group experienced skin pain, and 5 patients experienced mild subcutaneous ecchymosis. In the control group, 4 patients developed necrosis and infection, with significant differences between the two groups (P<0.05). 7 days post-surgery, all patients in the experimental group recovered to normal skin condition, while the 4 patients in the control group experienced necrosis and infection that did not heal, with significant differences between the two groups (P<0.05). Three months post-surgery, 4 patients in the control group developed hypertrophic scars, with significant differences between the two groups (P<0.05).

[0104] All adverse reactions in the experimental group were transient and tolerable, and all were completely relieved within one week after the procedure. In contrast, the control group had residual scars. Therefore, it can be concluded that the experimental group (polidocanol combined with nine needles) was superior to the control group (gold microneedles) in terms of treatment safety, and there was a significant difference between the two groups.

[0105] Example 2

[0106] Patient 1, a 20-year-old male, presented with bilateral axillary sweating and odor after activity for approximately 8 years. He was diagnosed with bilateral axillary osmidrosis and treated with subcutaneous injections of 1% polidocanol in both axillae using disposable sterile syringes (nine-needle heads). Information regarding the 1% polidocanol and the disposable sterile syringes (nine-needle heads) is the same as in Example 1.

[0107] The injection treatment process is as follows:

[0108] After preparing the skin in the axillary area of ​​patient 1 and marking the areas where sweat glands are distributed, a grid was drawn using a marker. Each grid was a square with a side length of approximately 1 cm. Figure 4 As shown in 'a'; then the marked skin was disinfected, and the resulting photograph of the disinfected skin is shown below. Figure 4 As shown in b;

[0109] Following the sequence of each square site, inject 0.2 mL of polidocanol subcutaneously into each square site. The specific procedure is as follows: Place a disposable sterile injection needle (nine-needle head, equipped with a disposable sterile syringe containing 1% polidocanol solution) perpendicularly into the skin at the injection site, press firmly downwards, and inject 0.2 mL of polidocanol solution. The polidocanol solution is evenly injected into the deep dermis and superficial fat layer corresponding to the square skin at the injection site. Photos of the injection process are shown below. Figure 4 As shown in c; after injection, slowly lift the syringe; stamp the injection site in sequence until the entire treatment area is covered, and cover the injection site with gauze after injection.

[0110] Figure 4 In the image, 'd' represents the appearance of the axillary skin immediately after the injection treatment. It can be seen that the skin in the injection area showed acute inflammatory changes after the subcutaneous injection of polidocanol, manifested as redness, swelling, and a slight increase in skin lines. Figure 4 In the figure, 'e' represents the appearance of the axillary skin one week after the injection treatment, showing mild subcutaneous ecchymosis with hemosiderin deposition in the injection area and surrounding skin of the armpit. Figure 4 The image in f shows the appearance of the axillary skin two weeks after the injection treatment. The skin appearance has returned to normal, with only a slight residual hemosiderin to be absorbed.

[0111] Follow-up results: Follow-up visits 3 and 6 months after injection treatment showed that symptoms of underarm sweating and odor were significantly relieved, with no obvious pigmentation and no limitation of activity.

[0112] Example 3

[0113] Patient 2, a 21-year-old female, presented with bilateral axillary sweating and odor after activity for approximately 10 years. She was diagnosed with bilateral axillary osmidrosis and treated with subcutaneous injection of 0.5% polidocanol in both axillae using disposable sterile syringes (nine-needle head). The 0.5% polidocanol is marketed as Anshuxi, with the generic name Polidocanol Injection (0.5%), a specification of 2 mL: 10 mg, and manufactured by Siegfried Hameln GmbH. Information regarding the disposable sterile syringes (nine-needle head) is the same as in Example 1.

[0114] The injection treatment process is the same as in Example 2, except that the volume of polidocanol injection solution injected subcutaneously at each grid site is adjusted to 0.4 mL.

[0115] Figure 5 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 5 b in the image is a photograph taken during the injection treatment process; Figure 5 In the image, 'c' represents the immediate appearance of the axillary skin after the injection treatment, showing mild swelling and slight increase in skin lines in the injection area after the subcutaneous injection of polidocanol. Figure 5In the figure, d represents the appearance of the axillary skin one day after the injection treatment, with mild subcutaneous bruising in the injection area and surrounding skin. Figure 5 The "e" in the image represents the appearance of the armpit skin one week after the injection treatment, which has basically returned to normal. Figure 5 The image shows the appearance of the armpit skin two weeks after the injection treatment, which has completely returned to normal.

[0116] Follow-up results: Follow-up visits 3 and 6 months after injection treatment showed that symptoms of underarm sweating and odor were significantly relieved, with no obvious pigmentation and no limitation of activity.

[0117] Example 4

[0118] Patient 3, female, 18 years old, had experienced bilateral axillary sweating with odor after activity for approximately 10 years. She was diagnosed with bilateral axillary osmidrosis and treated with subcutaneous injection of 1% polidocanol into both axillae using disposable sterile syringes (nine-needle head). Information regarding the 1% polidocanol and the disposable sterile syringes (nine-needle head) is the same as in Example 1.

[0119] The injection treatment process is the same as in Example 2.

[0120] Figure 6 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 6 b in the image is a photograph taken during the injection treatment process; Figure 6 In the image, 'c' shows the immediate appearance of the axillary skin after the injection treatment. It can be seen that the skin in the injection area showed acute inflammatory changes after the subcutaneous injection of polidocanol, manifested as redness, swelling, and a slight increase in skin lines. Figure 6 In the figure, 'd' represents the appearance of the axillary skin one day after the injection treatment, showing mild subcutaneous bruising in the injection area and surrounding skin; the appearance of the axillary skin returned to normal two weeks after the injection treatment.

[0121] Follow-up results: Follow-up visits 3 and 6 months after injection treatment showed that symptoms of underarm sweating and odor were significantly relieved, with no obvious pigmentation and no limitation of activity.

[0122] Example 5

[0123] Patient 4, a 38-year-old female, presented with bilateral axillary sweating and odor after activity for approximately 18 years. She was diagnosed with bilateral axillary osmidrosis and treated with subcutaneous injection of 2% polidocanol in both axillae using disposable sterile syringes (nine-needle head). The 2% polidocanol is marketed as Anshuxi, with the generic name Polidocanol Injection (2%), a specification of 2 mL: 40 mg, and manufactured by Siegfried Hameln GmbH. Information regarding the disposable sterile syringes (nine-needle head) is the same as in Example 1.

[0124] The injection treatment process is the same as in Example 2, except that the volume of polidocanol injection solution injected subcutaneously at each grid site is adjusted to 0.1 mL.

[0125] Figure 7 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 7 b in the image is a photograph taken during the injection treatment process; Figure 7 In the image, 'c' shows the immediate appearance of the axillary skin after the injection treatment. It can be seen that the skin in the injection area showed acute inflammatory changes after the subcutaneous injection of polidocanol, manifested as redness, swelling, and a slight increase in skin lines. Figure 7 In the figure, d represents the axillary injection area and surrounding skin one day after the injection treatment, with no obvious subcutaneous bruising. Figure 7 The "e" in the image represents the appearance of the armpit skin one week after the injection treatment, indicating that it has returned to normal.

[0126] Follow-up results: Follow-up visits 3 and 6 months after injection treatment showed that symptoms of underarm sweating and odor were significantly relieved, with no obvious pigmentation and no limitation of activity.

[0127] Example 6

[0128] Patient 5, a 21-year-old male, presented with a 10-year history of bilateral axillary sweating and odor after activity. He was diagnosed with bilateral axillary osmidrosis and treated with subcutaneous injections of 1% polidocanol in both axillae using disposable sterile syringes (five needles). The 1% polidocanol is marketed as Anshuxi, with the generic name Polidocanol Injection (1%), a strength of 2 mL: 20 mg, and manufactured by Siegfried Hameln GmbH. A photograph of the disposable sterile syringe (five needles) and syringe connected is shown below. Figure 8 The five-needle injection needle has a needle length of 2.0 mm. Four of the five needles are arranged in a 2×2 square array, and the other needle is located at the center of the 2×2 square array. The side length of the square array is 1 cm. The needles and needle bodies are made of stainless steel with a diameter of 32 G. The needle hub and needle handle are made of PVC material. The manufacturer is NOBA MEDI Co., Ltd. of South Korea.

[0129] The injection treatment process is the same as in Example 2.

[0130] Figure 9 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 9 b in the image is a photograph taken during the injection treatment process; Figure 9 In the image, 'c' represents the immediate appearance of the armpit skin after the injection treatment, showing minimal redness and swelling in the injection area. Figure 9 In the figure, d represents the axillary injection area and surrounding skin two days after the injection treatment, with no obvious subcutaneous bruising. Figure 9 The "e" in the image represents the appearance of the armpit skin 4 days after the injection treatment, indicating that it has returned to normal.

[0131] Example 7

[0132] Patient 6, a 25-year-old male, presented with bilateral axillary sweating and odor after activity for approximately 12 years. He was diagnosed with bilateral axillary osmidrosis and treated with subcutaneous injection of 1% polidocanol in both axillae using disposable sterile syringes (five needles). The 1% polidocanol is marketed as Anshuxi, with the generic name Polidocanol Injection (1%), a strength of 2 mL: 20 mg, and manufactured by Siegfried Hameln GmbH. Information regarding the disposable sterile syringes (five needles) is the same as in Example 6.

[0133] The injection treatment process is the same as in Example 2.

[0134] Figure 10 In the image, 'a' represents a photograph of the skin in the axillary sweat gland distribution area after it has been marked with a grid. Figure 10 In the image, b represents the appearance of the axillary skin immediately after the injection treatment. The skin in the injection area is slightly swollen, with no obvious bleeding. Figure 10 In the image, 'c' represents the axillary injection area and surrounding skin the day after the injection treatment, where a small area of ​​mild bruising appeared under the skin. Figure 10 In the image, 'd' represents the appearance of the armpit skin 5 days after the injection treatment, which has basically returned to normal.

[0135] Follow-up results: Follow-up visits 3 and 6 months after injection treatment showed that symptoms of underarm sweating and odor were significantly relieved, with no obvious pigmentation and no limitation of activity.

[0136] Comparative Example 1

[0137] Patient 7, a 25-year-old male, presented with a 15-year history of bilateral axillary sweating and odor after activity. He was diagnosed with bilateral moderate to severe axillary osmidrosis and treated with bilateral axillary subcutaneous injections of 1% polidocanol using a single-needle disposable sterile syringe. The 1% polidocanol is marketed as Anshuxi, with the generic name Polidocanol Injection (1%), a specification of 2 mL: 20 mg, and manufactured by Siegfried Hameln GmbH. The single-needle disposable sterile syringe was a standard 1 mL medical syringe with a single needle.

[0138] The injection treatment process is as follows:

[0139] After preparing the skin in the axillary area of ​​patient 7 and marking the skin in the area where the sweat glands are distributed, a grid was marked with a marker pen, with each grid being a square with a side length of about 1 cm.

[0140] Following the sequence of each grid point, inject 0.2 mL of polidocanol subcutaneously into each grid point. The specific procedure is as follows: Insert a single-needle, sterile syringe (containing 1% polidocanol solution) into the lower corner of the marked grid under the patient's armpit, ensuring the needle remains within the skin. Perform multiple, fan-shaped, continuous subcutaneous injections of polidocanol within the grid. This means performing multiple punctures within the same grid to ensure the needle remains within the deep dermis and superficial fat layer. Inject 0.2 mL of polidocanol solution. Photos of the injection process are shown below. Figure 11 As shown; after injection, slowly lift the syringe; stamp the injection site in sequence until the entire treatment area is covered, and cover the injection site with gauze after injection.

[0141] Depend on Figure 11 It can be seen that during injection, punctures at different levels in multiple directions within the same grid cause bleeding, and the injection time at the same site is significantly longer.

[0142] Immediate appearance of the axillary skin after injection treatment Figure 12 In Figure 'a', we can see that the skin in the injection area after subcutaneous injection of polidocanol showed acute inflammatory changes, manifested as redness, swelling, and a slight increase in skin lines; the appearance of the axillary skin one day after injection treatment is shown... Figure 12 In step b, subcutaneous ecchymosis with hemosiderin deposition began to appear in the axillary injection area and surrounding skin; two days after the injection treatment, extensive ecchymosis and increased hemosiderin deposition were observed in the axillary area and surrounding skin. Figure 12 c; the appearance of the axillary skin one week after injection treatment is shown in Figure 1. Figure 12 In case d, a larger area of ​​skin bruising appeared in the armpit and surrounding skin, and the hemosiderin deposition was more severe.

[0143] Follow-up results: Follow-up visits 3 and 6 months after injection treatment showed improvement in underarm sweating and odor, no obvious pigmentation, no limitation of activity, and no other adverse reactions.

[0144] As can be seen from Examples 2-7 and Comparative Example 1, compared with the traditional single-needle injection needle, the multi-needle injection needle of the present invention combined with polidocanol subcutaneous injection for the treatment of axillary osmidrosis is more standardized, simpler to operate, and greatly shortens the injection time. At the same time, it can reduce bleeding during the injection process and significantly alleviate adverse reactions such as redness, swelling, subcutaneous ecchymosis, and pigmentation after injection.

[0145] It should be noted that although the technical solution of the present invention has been described with specific examples, those skilled in the art will understand that the present invention should not be limited thereto.

[0146] The various embodiments of the present invention have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles, practical application, or technical improvements to the embodiments in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

Claims

1. A pharmaceutical and medical device composition for treating axillary osmidrosis using a sclerosing agent and a multi-needle injection needle, characterized in that, The medical device composition includes a hardening agent and a disposable sterile injection needle; wherein the hardening agent includes one or more of polidocanol, polidocanol, sodium tetradecyl sulfate, and sodium morrhuate, and the disposable sterile injection needle is a nine-needle injection needle or a five-needle injection needle; the nine-needle injection needle includes nine needles arranged in a 3×3 square array with equal needle lengths; the five-needle injection needle includes five needles, four of which are arranged in a 2×2 square array, and the remaining needle is located at the center of the 2×2 square array, and all five needles are of equal lengths.

2. The pharmaceutical-medical device composition according to claim 1, characterized in that, The length of the needle tip of the nine-needle injection needle or five-needle injection needle is such that its tip reaches the deep dermis and superficial fat layer, preferably 1.5-3.7 mm, more preferably 1.5-2.0 mm, and even more preferably 1.5 mm or 2.0 mm.

3. The pharmaceutical-medical device composition according to claim 1 or 2, characterized in that, The side length of the 3×3 square array or the 2×2 square array is 0.8-1.2 cm, preferably 1 cm.

4. The pharmaceutical and medical device composition according to any one of claims 1-3, characterized in that, The medical device composition also includes a disposable sterile syringe, the hardening agent being filled inside the syringe.

5. The pharmaceutical and medical device composition according to any one of claims 1-4, characterized in that, The nine-needle injection needle or five-needle injection needle further includes a needle body, a needle hub, and a needle handle; one end of the needle body is embedded in the needle hub, and the other end is connected to the needle tip; the needle hub is connected to the needle handle; the needle handle has a cavity that matches the needle hub of the syringe; and there is a through channel between the needle body, the needle hub, and the needle handle.

6. The pharmaceutical-medical device composition according to claim 5, characterized in that, The needle hub of the disposable sterile syringe is optionally pre-connected to the needle handle.

7. The pharmaceutical-medical device composition according to claim 5 or 6, characterized in that, The medical device composition also includes a protective sleeve located outside the needle and the needle hub.

8. The pharmaceutical and medical device composition according to any one of claims 1-7, characterized in that, The hardening agent includes one or more of polidocanol injection, polidocanol injection, sodium tetradecyl sulfate injection, and sodium morrhuate injection, preferably polidocanol injection, and more preferably 0.5%-5% polidocanol injection.

9. The pharmaceutical and medical device composition according to any one of claims 1-8, characterized in that, The polidocanol injection contains water for injection and ethanol; preferably, the polidocanol injection also contains pharmaceutically acceptable excipients.

10. Use of the pharmaceutical and medical device composition according to any one of claims 1-9 in the preparation of a pharmaceutical and medical device combination product for treating axillary osmidrosis; preferably, the pharmaceutical and medical device combination product is a pharmaceutical and medical device combination product for subcutaneous injection to treat axillary osmidrosis.

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