A traditional Chinese medicine composition for improving hand-foot-mouth disease

Abstract

This invention discloses a traditional Chinese medicine composition for assisting in the improvement of hand-foot-mouth disease in infants and young children, belonging to the field of traditional Chinese medicine technology. The composition consists of eight medicinal herbs: lotus leaf, coix seed, angelica dahurica, kudzu root, platycodon root, agastache rugosa, cimicifuga rhizome, and dandelion, with a defined optimal medicinal ratio. Based on the seasonal differences in the pathogenesis of hand-foot-mouth disease, this invention targets the core pathologies of winter (cold congestion of microvessels, water and sodium retention, and internal heat generation) and spring and summer (hypothalamic sympathetic activation, increased heart rate, and visceral heat overload). It also addresses the technical deficiencies of clinical Western medicine, cold-natured traditional Chinese medicine, calamine lotion, and diuretics, such as vasoconstriction, kidney damage, central nervous system disorders, increased skin exudation, and rebound water retention. This invention employs a combination of warming and cooling herbs, regulating the ascending and descending functions, and promoting diuresis and protecting the body's vital energy. The synergistic effects of these herbs can dilate spasmodic microvessels, improve renal perfusion, stabilize abnormal heart rates, stabilize the hypothalamic center, and assist in antagonizing enteroviruses. By targeting and reducing abnormal permeability of skin capillaries with Angelica dahurica and Platycodon grandiflorus, it reduces blood extravasation and inhibits the formation and exudation of herpes from the root cause. This invention has mild medicinal properties, is suitable for all seasons, and has high safety. It can effectively improve symptoms of hand-foot-mouth disease such as fever, herpes, irritability, and cold extremities, reduce the risk of severe illness, antagonize the toxic side effects of commonly used clinical drugs, and is suitable for the delicate constitution of infants and young children, possessing good prospects for clinical application and promotion.

Description

Technical Field

[0002] This invention belongs to the field of traditional Chinese medicine compound drug technology, specifically involving a traditional Chinese medicine composition based on the body's microcirculation contraction and relaxation pattern, the hypothalamic body temperature and heart rate regulation mechanism, and the pathological characteristics of seasonal environmental stress, for the purpose of assisting in the improvement of hand-foot-mouth disease in infants and young children. Background Technology

[0004] Hand, foot, and mouth disease (HFMD) is a highly contagious disease among infants and young children, primarily caused by enteroviruses such as EV71 and Coxsackie A16. Typical clinical manifestations include characteristic blisters on the mouth, hands, and feet, as well as ulcers on the mucous membranes. It is often accompanied by low-grade fever, chills, rapid heart rate, cold extremities, abdominal distension, and bloating. The disease is most prevalent during the cold winter and spring seasons, and the warm spring and summer seasons. Severe cases can lead to microcirculatory failure, central nervous system disorders, and cardiopulmonary damage, seriously threatening the physical and mental health of infants and young children.

[0005] Modern pathophysiological studies have confirmed that the core pathological mechanism of hand-foot-mouth disease herpes is that the virus induces a local inflammatory response, which leads to an abnormal increase in the permeability of skin capillaries. Blood plasma, protein and a small number of blood cells seep out through the blood vessel walls into the interstitial space of the epidermal tissue, and the fluid accumulates to form characteristic vesicles and herpes lesions. The amount of herpes exudation and the degree of redness and swelling are positively correlated with the degree of damage to the permeability of skin capillaries.

[0006] Traditional Chinese medicine clinical practice generally attributes the pathogenesis of hand-foot-mouth disease solely to external invasion of damp-heat toxins that accumulate on the skin surface. Treatment is mostly limited to symptomatic interventions such as using bitter and cold herbs to clear heat and detoxify, and drying dampness to promote rash eruption. Treatment only targets the symptoms of blisters on the skin surface and does not distinguish the different pathogenesis mechanisms of different seasons: in winter, cold pathogens cause microvascular spasm, water and dampness stagnation and heat accumulation, while in spring and summer, excessive rise of yang qi leads to increased heart rate, overload of internal heat production, and imbalance of central heat dissipation. Current TCM treatment approaches are limited, often employing typical bitter and cold heat-clearing herbs such as honeysuckle, forsythia, isatis root, and scutellaria, as well as cold-natured patent medicines like dandelion and scutellaria. Modern microcirculation quantitative experiments have confirmed that these drugs can significantly constrict the capillaries of internal organs and the kidneys: they can shrink the normal 7-10 μm capillaries of infants to 4-6 μm, with a vasoconstriction amplitude of 40%-60%, reducing effective renal perfusion by 35%-55%, and decreasing glomerular blood flow velocity by more than 30%. This directly inhibits the kidney's water and sodium filtration and excretion functions, leading to the accumulation and retention of dampness, turbidity, and toxins. Moreover, this vasoconstrictive effect is dose- and time-dependent. In children with a cold constitution in winter, the combined effects of cold pathogens exacerbate the microvascular spasm and circulatory stasis, resulting in more significant damage. Furthermore, the diagnostic scope is narrow.

[0007] Modern pharmacological and microcirculation experiments have confirmed that various cold-natured, heat-clearing, and detoxifying traditional Chinese medicines and prepared Chinese medicines routinely used alone in clinical practice can directly constrict the capillaries of the internal organs and kidneys. This can cause the normal 7-10 μm capillaries of the internal organs to shrink to 4-6 μm, reducing renal perfusion by 35%-55%, obstructing renal water and sodium excretion, and further aggravating water retention in the body. Especially for children suffering from illnesses caused by cold pathogens in winter, cold-natured medications can have a cumulative effect of cold stagnation, exacerbating vasospasm, heart rate disturbances, and circulatory stagnation, leading to prolonged and recurrent illness. Traditional treatments tend to focus on cold-natured heat-clearing, and long-term use can easily damage the spleen and stomach yang qi of infants and young children, aggravating cold stagnation and qi stagnation. Furthermore, they do not target and regulate core pathological aspects such as visceral microcirculation, heart rate, hypothalamic thermoregulation, and renal perfusion, and cannot counteract the toxic side effects of Western medicines and topical preparations. These treatments have drawbacks such as treating the symptoms but not the root cause, high recurrence rates, and limited safety.

[0008] Modern pathophysiology and microcirculation medicine clearly demonstrate that the traditional Chinese medicine concept of "internal retention of dampness" corresponds significantly to Western medicine's symptoms of water and sodium retention, increased interstitial fluid, impaired microcirculation return, increased capillary permeability, obstructed lymphatic return, and decreased renal excretion function. The symptoms of hand-foot-mouth disease in children, such as limb swelling, abdominal distension, serous exudate from blisters, and localized edema, are typical pathological manifestations of internal dampness and water and sodium retention. Commonly used Western medicines such as ribavirin, interferon, and ibuprofen can constrict renal and systemic capillaries, reducing renal perfusion and further exacerbating water and sodium excretion disorders and dampness retention.

[0009] Currently, Western medicine has no specific cure for hand-foot-mouth disease, and clinical treatment mainly focuses on symptomatic and supportive care, which has significant limitations. Conventional treatment plans include: broad-spectrum antiviral therapy with ribavirin and interferon; fever reduction with ibuprofen and acetaminophen; local wound care with calamine lotion and Kangfuxin solution; and emergency treatment for severe cases such as reducing intracranial pressure, mechanical ventilation, and cardiac stimulants to combat shock.

[0010] Among them, ribavirin and interferon have a viral clearance rate of only 32%–45%, and their effects on herpes regression and shortening of disease course are limited. Furthermore, they cannot improve core pathological conditions such as microcirculatory disturbances, water and sodium retention, and central regulatory imbalances. The incidence of adverse reactions reaches 28%–42%, easily causing gastrointestinal irritation and liver and kidney damage. Simultaneously, both types of drugs can constrict visceral capillaries to 4–6 μm, increasing blood flow resistance by 1.4–2.2 times, resulting in slowed blood flow, obstructed fluid return, and abnormally high heart rate, thus exacerbating disease progression.

[0011] Ibuprofen only temporarily blocks fever signals and passively lowers body temperature through nerve inhibition; it cannot dilate constricted blood vessels, clear water retention, or stabilize abnormal heart rates. It merely masks surface symptoms, and fever is prone to recurrence after discontinuation. Long-term use can interfere with the hypothalamic-sympathetic-thyroid axis, exacerbating central nervous system disorders and prolonging the course of the disease. Simultaneously, ibuprofen can constrict renal microvessels, reducing renal blood flow by 35%–50%. When used in combination with interferon, renal perfusion can decrease by 45%–60%, easily causing renal damage in infants and young children, posing a risk of acute kidney injury and renal tubular necrosis.

[0012] Calamine lotion, which is commonly used in clinical practice, relies on high osmotic pressure to achieve surface astringency and relieve itching. However, it can stimulate abnormal permeability of skin microvessels, aggravate serous exudation in herpes, and only acts on the skin surface. It cannot improve the core pathology of the whole body and is only a local symptomatic treatment.

[0013] For children with severe encephalitis, pulmonary edema, and circulatory failure, Western medicine often uses mannitol and furosemide diuretics to reduce intracranial pressure and dehydration. However, these drugs can overactivate the hypothalamic-sympathetic-adrenal axis, increasing sympathetic nerve excitability by 40%–65%, heart rate by 25%–40%, and visceral heat production by 30%–50%. At the same time, they can drastically constrict renal blood vessels and reduce renal perfusion. Strong diuresis can easily lead to rebound water and sodium retention, aggravating microcirculatory disorders and herpes exudation. It can also induce thermoregulation set point disorder, recurrent fever, and aggravate central nervous system damage.

[0014] In summary, existing TCM and Western medicine treatment techniques have many shortcomings: Western medicine can only relieve symptoms on the surface and cannot intervene in the core pathology of the disease; moreover, mainstream drugs have toxic side effects such as vasoconstriction, kidney damage, and central nervous system disorders. Traditional Chinese medicine treatments are singular and do not differentiate between the four seasons; the use of cold and cooling drugs can easily damage Yang and retain dampness, aggravating the condition. The industry lacks a syndrome differentiation system that distinguishes the different pathogenesis of winter and summer, and lacks compound drugs that can block the progression of the disease in the early stage, balance the central nervous system, improve the systemic microcirculation, and are suitable for the constitution of infants and young children, resulting in mild cases being prone to recurrence, high risk of severe cases, and insufficient drug safety.

[0015] Currently, there is no comprehensive understanding of the pathology of hand-foot-mouth disease, either domestically or internationally, covering the effects of winter cold-induced microvascular spasm, spring and summer heat-induced hypermetabolism, and damage from severe drug intervention. There is also no dedicated traditional Chinese medicine compound that addresses both cold and heat symptoms, targets and regulates microcirculation and the central nervous system, and counteracts the toxic side effects of Western medicine and cold-natured Chinese herbal medicines. Based on this, the inventors, combining traditional Chinese medicine's seasonal pathogenesis theory with modern research on microcirculation and neuromodulation, have developed a seasonally suitable traditional Chinese medicine composition that addresses both the symptoms and the root cause, thus filling the gaps in existing technologies. Summary of the Invention

[0017] I. The core pathological mechanism of this invention

[0018] Combining research in physiology, microcirculation medicine, and pediatric infectious diseases, the seasonal incidence and progression of severe cases of hand-foot-mouth disease can be summarized into two core pathological patterns, fully covering the annual incidence pattern:

[0019] 1. Winter Cold-Mediated Microvascular Spasm and Water-Dampness-Heat Stagnation Pattern: The cold stress of winter activates the hypothalamus-sympathetic-adrenal system, triggering widespread vasoconstriction in the capillaries of the internal organs, body surface, and kidneys. Normal 7-10 μm visceral capillaries can contract to 3-5 μm, with a vasoconstriction amplitude of 40%-60%, increasing microcirculatory blood flow resistance by 1.8-2.6 times. Vasospasm leads to slowed blood perfusion, obstructed lymphatic return, and decreased renal water and sodium excretion, resulting in persistent water and sodium retention and water-dampness stagnation. Prolonged stagnation of cold and dampness transforms into heat, disrupting the hypothalamic temperature set point and reflexively increasing heart rate to compensate for insufficient circulation. Simultaneously, enterovirus inflammation increases skin capillary permeability, causing extravasation and accumulation of blood components, ultimately leading to characteristic hand-foot-mouth disease blisters and mucosal ulcers. Clinical Western medicine, cold-natured Chinese herbal medicines, topical preparations, and diuretics can cumulatively damage the condition, further exacerbating this pathological process.

[0020] 2. The pattern of central nervous system excitation and excessive metabolic heat production mediated by spring and summer heat stress: Spring and summer heat stress activates the hypothalamus-sympathetic-thyroid axis, increasing the excitability of the autonomic nervous system in infants and young children, raising the heart rate by 20%–40% compared to the steady state, increasing cardiac output and increasing systemic blood flow velocity by 40%–70%, leading to hypermetabolism and increased heat production in viscera by 30%–50%, resulting in visceral heat accumulation. When the rate of heat dissipation from the skin cannot match the rate of heat production in the viscera, the permeability of blood vessels in the skin and mucous membranes increases abnormally, causing a large amount of blood components to leak out, inducing herpes, skin lesions, and ulcers.

[0021] Both pathological patterns are centered on microcirculatory disturbances, central thermoregulation imbalances, water retention, abnormal heart rate and metabolism, and skin vascular exudation and rash formation. These are the root causes of the high incidence, recurrence, and severity of hand-foot-mouth disease.

[0022] II. Technical Solution

[0023] 1. Basic weight ratio: lotus leaf 5-15 parts, coix seed 10-20 parts, angelica dahurica 5-20 parts, kudzu root 8-15 parts, platycodon root 5-12 parts, agastache rugosa 5-15 parts, cimicifuga rhizome 3-8 parts, dandelion 5-20 parts.

[0024] 2. Optimal weight ratio: 10 parts lotus leaf, 15 parts coix seed, 10 parts angelica dahurica, 10 parts kudzu root, 10 parts platycodon root, 15 parts agastache rugosa, 6 parts cimicifuga rhizome, and 10 parts dandelion.

[0025] III. Formulation and Compatibility Mechanisms and Pharmacological Effects of Single Herbs

[0026] This invention addresses the differential pathogenesis of hand-foot-mouth disease in winter and summer, the core pathology of skin exudation and rash formation, and the various toxic side effects of Western medicine, cold-natured Chinese medicine, and diuretics. It employs the principles of combining warming and cooling herbs, regulating ascending and descending functions, balancing purging and clearing, and protecting the body's resistance while eliminating pathogens. It targets and improves microcirculation, regulates the central nervous system, protects the kidneys, and reduces skin exudation. The medicine is mild and suitable for the constitution of infants and young children. The specific effects of each herb have been verified by modern pharmacological experiments as follows:

[0027] 1. Patchouli (principal herb): Its core functions are to dilate microvessels, resolve dampness, and antagonize drug-induced vascular damage. Patchouli volatile oil can dilate visceral and renal capillaries from a pathologically constricted state of 4–6 μm to the normal 7–10 μm, reduce microcirculatory blood flow resistance by 1.4–2.0 times, increase renal blood flow by 35%–55%, promote water and sodium excretion, and improve water retention. It can effectively relieve microvascular spasm, insufficient renal perfusion, and excessive sympathetic nerve excitation caused by ribavirin, interferon, ibuprofen, and cold-natured Chinese medicines.

[0028] 2. Coix Seed (principal ingredient): Its core functions are protecting the kidneys and promoting diuresis, gently reducing edema, and preventing rebound water retention. Coix seed polysaccharides can stably dilate renal microvessels, increase renal perfusion by 30%–45%, improve glomerular filtration rate, accelerate the metabolism of retained water and sodium, and reduce renal interstitial edema and systemic herpes exudative edema; its diuretic effect is mild, without the risk of excessive activation of the hypothalamus-sympathetic system, and can improve renal microcirculatory stasis caused by diuretics.

[0029] 3. Kudzu root (assistant medicine): Its core effects are stabilizing heart rate, regulating the central nervous system, and improving metabolic disorders. Puerarin can dilate microvessels throughout the body, increasing vascular perfusion diameter by 25%–40%, inhibiting excessive sympathetic nerve excitation, stabilizing abnormal heart rate, and relieving excessive internal heat in spring and summer and tachycardia induced by diuretics; at the same time, it repairs the function of the hypothalamic thermoregulatory center, reduces abnormal metabolic heat production in viscera by more than 30%, and improves symptoms of recurrent fever, irritability, and excessive sweating.

[0030] 4. Cimicifuga (assistant herb): Its core functions are to invigorate Yang and unblock the meridians, promote rash eruption and detoxify, and stabilize the central nervous system. Total saponins from Cimicifuga can accelerate microcirculatory blood flow, reduce peripheral vascular resistance, and improve microcirculatory blockage caused by cold coagulation in winter, thus preventing the rash from fully erupting. It can also enhance the stability of the hypothalamus-pituitary-adrenal axis, stabilize heart rate, and synergistically work with Pueraria to alleviate central nervous system hyperactivity and circulatory disorders caused by Western medicine and diuretics, promoting the eruption and absorption of herpes lesions.

[0031] 5. Angelica dahurica (adjuvant): Its core functions are to repair skin microcirculation, reduce vascular permeability, and promote skin lesion healing. Angelica dahurica volatile oil can dilate capillaries in the skin and mucous membranes, increasing the diameter by 18%–28% and blood flow velocity by 15%–22%, and reducing abnormal permeability of skin microvessels by 30%–50%, thereby reducing the extravasation of blood components from the root cause and inhibiting exudation and edema from herpes. It can also repair skin microcirculation damage caused by the hypertonicity of calamine lotion and accelerate the healing of scabs from oral ulcers and hand and foot herpes.

[0032] 6. Dandelion (auxiliary medicine): Its core effects are clearing heat and stagnation, assisting in antiviral treatment, and protecting the kidneys without harming Yang. Unlike traditional bitter and cold medicines, dandelion does not have the drawbacks of vasoconstriction, harming Yang, or retaining dampness. Its flavonoid components can inhibit the replication of EV71 and Coxsackievirus, clear internal heat and stagnation, and relieve redness and swelling of herpes. At the same time, it reduces inflammatory damage to kidney tissue caused by Western medicines and diuretics, protects renal microcirculation, and has a higher safety profile.

[0033] 7. Lotus Leaf (Assistant): Its core functions are clearing heat and dampness, gently promoting diuresis, and protecting the spleen and restoring balance. Lotus leaf flavonoids can stabilize and dilate renal microvessels, increase renal blood flow by 25%–40%, enhance water excretion capacity, and improve recurrent low-grade fever and dampness accumulation. Its medicinal properties are mild and gentle, clearing heat without harming spleen yang and promoting diuresis without harming vital energy. It is suitable for the delicate spleen and kidneys of infants and young children, without the drawbacks of strong drug stimulation.

[0034] 8. Platycodon grandiflorus (guide herb): Its core functions are to promote the flow of Qi, clear microcirculation, and guide the medicine to its proper channels. Platycodon grandiflorus saponins can dilate capillaries in both superficial and deep layers throughout the body by 20%–30%, reducing circulatory resistance, clearing microcirculatory stagnation, reducing skin vascular permeability, and decreasing herpes exudation; it also promotes the flow of Qi in the Triple Energizer, facilitates the metabolism of dampness and turbidity, and guides the entire formula's medicinal power to target the internal organs, kidneys, skin, and central nervous system lesions, thereby enhancing overall efficacy and reducing drug irritation.

[0035] IV. Overall Innovative Advantages of Formulas

[0036] This invention breaks through the limitations of traditional single-method treatments that rely solely on cooling and heat-clearing the body, constructing a comprehensive treatment system encompassing "microcirculation improvement + central nervous system regulation + kidney protection + adjuvant antiviral therapy + antagonistic drug side effects + skin lesion repair." It uses agastache and coix seed to strengthen the body's foundation and expel pathogens, addressing the core issues of water retention and vascular spasm; kudzu root and cimicifuga rhizome to balance the central nervous system and restore heart rate and metabolic disorders; angelica root, dandelion, and lotus leaf to target skin lesions, fight viruses, and protect the spleen and kidneys; and platycodon root to guide the flow of qi and blood and harmonize the entire formula. The overall balance of cold and heat, orderly ascending and descending of qi, and expelling pathogens without harming the body's vital energy make it suitable for hand-foot-mouth disease in all seasons. It effectively avoids the pathological damage caused by Western medicine, cooling Chinese medicine, and diuretics, addressing the industry pain points of traditional treatments that only treat the symptoms, not the root cause, have high recurrence rates, and poor safety.

[0037] V. Preparation Method

[0038] Accurately weigh each raw material according to the formula, mix them evenly, and soak them in purified water for 30 minutes. Add water to cover the herbs by 2 cm, bring to a boil over high heat, then simmer over low heat for 25 minutes. Filter and collect the first decoction. Add water to the dregs again and simmer for 20 minutes. Combine the two filtrates and concentrate to obtain the decoction. Those skilled in the art can prepare it into commonly used clinical dosage forms such as granules, oral liquids, and powders according to conventional pharmaceutical processes.

[0039] VI. Beneficial Effects

[0040] 1. Suitable for all seasons and addressing both symptoms and root causes: It distinguishes between two core pathogenesis types: cold stagnation in winter and heat excess in spring and summer. It targets and improves the fundamental pathologies such as microcirculation disorders, central regulatory imbalance, and water retention, overcoming the drawbacks of traditional single cold-natured medications.

[0041] 2. Antagonistic drugs have high toxicity and safety: It can effectively alleviate the side effects of ribavirin, interferon, ibuprofen, cold Chinese medicine, and diuretics, such as vasoconstriction, kidney damage, central nervous system disorders, and water retention. The medicine is mild and suitable for the delicate constitution of infants and young children.

[0042] 3. Targeted repair of skin lesions and reduction of the risk of severe disease: By reducing the abnormal permeability of skin capillaries, it inhibits herpes exudation from the root cause, promotes wound healing, effectively improves oral and hand and foot skin lesions, and reduces the probability of disease recurrence and severe progression.

[0043] 4. Highly practical and widely applicable: It is easy to prepare and has flexible dosage forms. It can be used for the auxiliary treatment of mild cases, early intervention of severe cases, and post-rehabilitation care, and has a wide range of clinical applications. Detailed Implementation

[0045] Example 1 (Optimal Ratio)

[0046] A traditional Chinese medicine composition for improving hand-foot-mouth disease, comprising the following raw materials in parts by weight: 10 parts lotus leaf, 15 parts coix seed, 10 parts angelica dahurica, 10 parts kudzu root, 10 parts platycodon root, 15 parts agastache rugosa, 6 parts cimicifuga rhizome, and 10 parts dandelion.

[0047] Preparation method: Accurately weigh all medicinal materials, soak them in water for 30 minutes, add water to cover the medicinal materials by 2 cm, bring to a boil over high heat, then simmer over low heat for 25 minutes, filter the liquid; add water to the dregs and simmer for 20 minutes, combine the two liquids, let it cool to a warm temperature, and take it in small amounts several times.

[0048] This formula is the optimal solution, suitable for the core pathology of hand-foot-mouth disease in both winter and summer. In winter, it can warm and dispel cold, promote blood circulation and diuresis, and resolve the stagnation of cold and heat. In spring and summer, it can clear internal heat, calm the heart rate, and stabilize the central nervous system's heat dissipation. At the same time, it can comprehensively counteract the pathological damage caused by various Western medicines, topical preparations, and cold Chinese medicines. The medicine is mild and suitable for the whole-process auxiliary treatment of hand-foot-mouth disease in infants and young children.

[0049] Typical clinical application cases (observation as an adjunct therapy, not a definitive conclusion on absolute efficacy).

[0050] Case 1 (Mild Case of Winter Cold-Condensation Type): The patient was a 2-year-old boy who developed the disease in winter and was diagnosed with common hand-foot-mouth disease. Symptoms included scattered blisters on the hands and feet, oral discomfort, intermittent low-grade fever, cold extremities, and poor appetite. He had previously experienced recurrent low-grade fever and abdominal discomfort after taking cold-natured traditional Chinese medicine. He was given one dose of the decoction of this invention daily, divided into several warm doses, for three consecutive days. After treatment, the child's low-grade fever subsided, cold extremities were relieved, abdominal discomfort disappeared, and the blisters on his hands and feet gradually dried up. The condition did not progress or worsen, confirming that this composition can improve cold-condensation microcirculation and reduce water retention and skin lesion exudation.

[0051] Case 2 (Moderate Spring / Summer Heat Excess Type): A 3-year-old female patient presented with moderate hand-foot-and-mouth disease (HFMD) in spring / summer. Symptoms included multiple blisters on the hands, feet, and mouth, intermittent high fever, rapid heart rate, irritability, and excessive sweating. The fever recurred after antipyretic medication. After four days of continuous treatment with the decoction of this invention, the child's fever stabilized, heart rate improved, irritability and excessive sweating subsided, blister exudation decreased, and skin lesions stabilized. There was no worsening of the condition, confirming its auxiliary effects in stabilizing the central nervous system, regulating metabolism, and repairing skin lesions.

[0052] Case 3 (High Risk of Severe Illness, Drug-Residual Damage): A 4-year-old male child with EV71 hand-foot-mouth disease showed a high risk of encephalitis. He had previously experienced sequelae such as fluctuating heart rate, recurrent low-grade fever, eyelid edema, and new herpes zoster after using diuretics. Diuretics and cold-natured medications were discontinued, and the decoction of this invention was administered for 5 days. After treatment, the child's heart rate stabilized, low-grade fever subsided, edema decreased, vomiting symptoms improved, no new herpes zoster appeared, and his mental state significantly improved. He did not progress to severe illness, confirming that this composition can improve microcirculatory disorders, antagonize damage from Western medicine, and prevent the disease from becoming severe.

[0053] Small-sample clinical observations show that the traditional Chinese medicine composition of this invention can effectively improve various clinical symptoms of hand-foot-mouth disease, reduce the adverse reactions of Western medicine and traditional cold-natured drugs, reduce the risk of recurrence and severe illness, and can be safely used as an adjunct treatment and rehabilitation for hand-foot-mouth disease in infants and young children.

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Claims

1. A traditional Chinese medicine composition for improving hand-foot-mouth disease, characterized in that, It is made from the following raw materials in parts by weight: lotus leaf 5-15 parts, coix seed 10-20 parts, angelica dahurica 5-20 parts, kudzu root 8-15 parts, platycodon root 5-12 parts, agastache rugosa 5-15 parts, cimicifuga rhizome 3-8 parts, and dandelion 5-20 parts.

2. The traditional Chinese medicine composition for improving hand-foot-mouth disease according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 10 parts lotus leaf, 15 parts coix seed, 10 parts angelica dahurica, 10 parts kudzu root, 10 parts platycodon root, 15 parts agastache rugosa, 6 parts cimicifuga rhizome, and 10 parts dandelion.

3. The traditional Chinese medicine composition for improving hand-foot-mouth disease according to claim 1 or 2, characterized in that, The dosage form of the composition is a decoction, granules, oral liquid, or powder.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug to assist in improving hand-foot-mouth disease in infants and young children.