Traditional Chinese medicine composition for treating children nephrotic syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating children nephrotic syndrome. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 16 to 24 parts of astragalus membranaceus, 12 to 18 parts of radix rehmanniae recen, 7.2 to 10.8 parts of dogwood, 9.6 to 14.4 parts of Chinese yam, 16 to 24 parts of radix pseudostellariae, 7.2 to 10.8 parts of poria cocos, 4.8 to 7.2 parts of bighead atractylodes rhizome, 4.8 to 7.2 parts of rhizoma atractylodis, 9.6 to 14.4 parts of moutan bark, 4 to 6 parts of pseudo-ginseng, 4.8 to 7.2 parts of divaricate saposhnikovia root and 12 to 18 parts of oldenlandia diffusa. The invention further provides a preparation method and application of the traditional Chinese medicine composition. The medicine disclosed by the invention is used for treating children nephrotic syndrome, treating both symptoms and root causes, tonifying kidney without nourishing greasy feeling, inducing diuresis without hurting yin, activating blood without bleeding, and dispersing blood stasis without hurting vital qi, and has the effects of tonifying spleen and promoting diuresis, tonifying kidney qi, nourishing and reinforcing kidney yin, and dispersing blood stasis and inducing diuresis; the serum albumin level of a child patient can be improved, the 24-hour urine protein quantification and the serum total cholesterol level can be reduced, the remission rate can be improved clinically, the recurrence rate can be reduced, and the adverse reactions of hormones and immunosuppressants can be reduced.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating childhood nephrotic syndrome, belonging to the field of traditional Chinese medicines. Background Art

[0002] Nephrotic syndrome (NS) in children is a clinical syndrome characterized by massive proteinuria, hypoproteinemia, edema and hyperlipidemia. It is the most common primary glomerular disease in children. The annual incidence of NS in children worldwide is about 2-7 / 100,000, and the prevalence is about 16 / 100,000. Nephrotic syndrome is divided into hormone-sensitive nephrotic syndrome (SSNS), hormone-dependent nephrotic syndrome (SDNS) and hormone-resistant nephrotic syndrome (SRNS) according to its response to hormones. About 80% to 90% of children with nephrotic syndrome are SSNS, and most of these children are cured before adulthood; while 10% to 20% are SRNS, of which about 50% of children progress to end-stage renal disease (ESRD) 5 years after diagnosis.

[0003] At present, the treatment of NS at home and abroad is still mainly based on prednisone, and the method of increasing the dosage of hormones and prolonging the course of hormone treatment, or using immunosuppressants is often adopted. Although it can relieve some cases and reduce the recurrence rate, the incidence of serious toxic and side effects of hormones and immunosuppressants also increases and worsens. Cui Shixiong and Qian Tongsun in China found from a large number of literature analyses that children with FRNS and SDNS are at risk of serious hormone toxic and side effects, and about 5% of children die from hormone complications. Ma Lu et al. observed that children with NS who used hormones for a long time may have endocrine metabolic changes, mainly manifested as a significant decrease in GH, PRL, ACTH and cortisol levels. Therefore, how to improve the remission rate of pediatric RNS, reduce its recurrence rate, and reduce drug side effects has become an important topic for pediatric nephrologists to explore for a long time.

[0004] In traditional Chinese medicine, pediatric nephrotic syndrome belongs to the category of "edema". Its dialectical treatment is mainly based on traditional Chinese medicine theory, taking into account the physical characteristics and pathological changes of the children. The main pathogenesis of pediatric nephrotic syndrome in traditional Chinese medicine is the deficiency of the lung, spleen and kidney, accompanied by wind, dampness and blood stasis. The treatment should strengthen the body and eliminate evil, take into account both the symptoms and the root cause, and focus on strengthening the lung and spleen, tonifying the kidney and consolidating the body to control proteinuria and prevent respiratory tract infections (Zhu Yueling, Yang Binbin, Dong Ao, et al. TCM pathogenesis and dialectical treatment of idiopathic nephrotic syndrome in children [J]. Journal of Zhejiang University of Traditional Chinese Medicine, 2022, 46(10):11 33-1135,1140.) The currently reported TCM syndrome differentiation type is: Spleen and kidney yang deficiency syndrome: The treatment method is to warm the yang and invigorate qi, resolve blood stasis and promote diuresis, and the recommended prescription is Kidney Disease Sequence No. Ⅰ (raw astragalus 40g, Pseudostellaria 12g, Cuscuta 10g, Viscum album 10g, Cibotium bark 10g, Poria 12g, Zedoaria 10g, Poria 15g, Angelica 12g, Salvia miltiorrhiza 10g, Cinnamon twig 6g, Licorice root 10g).

[0005] CN201510002003.3, invention name: A Chinese medicine composition for treating nephrotic syndrome in children and its application, relates to a Chinese medicine composition for treating nephrotic syndrome in children and its application, the Chinese medicine composition comprises the following raw materials in parts by weight: 10-20 parts of raw rehmannia, 10-20 parts of yam, 9-15 parts of cornus, 9-15 parts of peony, 10-20 parts of astragalus, 9-15 parts of angelica, 9-15 parts of umbellate, 9-15 parts of poria, 9-15 parts of poria, 25-35 parts of codonopsis, 25-35 parts of salvia, 25-35 parts of corn silk, 10-20 parts of pyrrosia, 10-20 parts of motherwort, 9-15 parts of tortoise shell, 9-15 parts of atractylodes, 9-15 parts of atractylodes, and 20-40 parts of oyster. It has the effects of invigorating qi and strengthening spleen, nourishing yin and kidney, promoting blood circulation and removing dampness, and can treat repeated rebound and recurrence of proteinuria in children with nephrotic syndrome during hormone reduction, and can reduce hormone side effects and help withdraw hormones. Due to the complex etiology of nephrotic syndrome in children and the special use of pediatric drugs, current drugs cannot meet clinical needs. Summary of the invention

[0006] The present invention provides a Chinese medicine composition for treating pediatric nephrotic syndrome, and also provides a preparation method and application of the Chinese medicine composition.

[0007] The present invention provides a Chinese medicine composition for treating childhood nephrotic syndrome, which is prepared from the following raw materials in weight proportion:

[0008] 16-24 parts of Astragalus, 12-18 parts of Rehmannia, 7.2-10.8 parts of Cornus, 9.6-14.4 parts of Dioscorea, 16-24 parts of Pseudostellaria, 7.2-10.8 parts of Poria, 4.8-7.2 parts of Atractylodes, 4.8-7.2 parts of Atractylodes, 9.6-14.4 parts of Paeonia, 4-6 parts of Panax notoginseng, 4.8-7.2 parts of Saposhnikovia, and 12-18 parts of Hedyotis diffusa.

[0009] More preferably, it is prepared from the following bulk drugs in the following weight ratio:

[0010] 20 parts of Astragalus, 15 parts of Radix Rehmanniae, 9 parts of Fructus Corni, 12 parts of Dioscorea Rhizoma, 20 parts of Radix Pseudostellariae, 9 parts of Poria, 6 parts of Atractylodes, 6 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Cortex Moutan, 5 parts of Radix Notoginseng, 6 parts of Saposhnikoviae, and 15 parts of Hedyotis diffusa.

[0011] The Chinese medicine composition of the present invention is prepared into a commonly used pharmaceutical preparation by adding pharmaceutically acceptable excipients or auxiliary ingredients into the raw medicine powder, water or organic solvent extract of the raw medicine as active ingredients.

[0012] Wherein, the preparation is tablet, capsule, pill, oral liquid, granule.

[0013] The present invention also provides a method for preparing the Chinese medicine composition for treating childhood nephrotic syndrome, which comprises the following steps:

[0014] a. Weigh the raw materials of each weight ratio;

[0015] b. The raw powder, water or organic solvent extract of the raw material drug is used as the active ingredient, and pharmaceutically acceptable excipients or auxiliary ingredients are added to prepare the commonly used pharmaceutical preparations.

[0016] The present invention also provides use of the traditional Chinese medicine composition in preparing medicine for treating pediatric nephrotic syndrome.

[0017] The present invention also provides the use of the traditional Chinese medicine composition in preparing medicines for treating renal allergic purpura, lupus nephritis, hormone induction period, hormone reduction period and hormone withdrawal period of chronic kidney disease.

[0018] The present invention also provides the use of the Chinese medicine composition in combination with auxiliary hormones and immunosuppressants in the preparation of medicines for treating nephrotic syndrome in children.

[0019] The key pathogenesis of PNS (i.e. primary nephrotic syndrome) in children is kidney deficiency and blood stasis. The onset of PNS in children is mostly due to deficiency of the lung, spleen and kidney, and dysfunction of the internal organs. Long-term illness affects the kidney, kidney qi and kidney essence are both deficient, the lung and spleen lose their mutual support and regulation, and the three organs affect each other, resulting in imbalance of body fluid metabolism, among which the kidney is the fundamental. The kidney is responsible for storing essence, and the internal essence transforms into internal qi. If the kidney essence is deficient, the kidney qi will be weakened, unable to promote blood circulation, blood circulation will be slow, and stagnation will form blood stasis; in addition, the spleen, lung and kidney yang qi deficiency, long-term cold coagulation blood stagnation, or yang deficiency and yin, yin deficiency and fire, poor blood circulation, or weak defense and invasion of external evil can all cause blood stasis. After blood stasis is formed, it will stagnate and not dissipate, resulting in abnormal blood circulation throughout the body, obstruction of vitality, lack of new blood, and lack of nourishment of internal organs, further aggravating the symptoms of kidney deficiency, leading to repeated migration of the disease. Edema and blood stasis are mutually transformed and mutually causal. Water overflows on the skin surface, and the disease can damage the blood vessels if it lasts for a long time. Because blood and water have the same origin, the disease enters the collaterals for a long time, and the collaterals are blocked. Qi and blood deficiency will make the blood flow weak, and the blood and water flow rate will slow down, which can easily lead to blood stasis. Blood stasis can reversely restrict the qi mechanism, aggravate qi stagnation, and cause qi transformation to be unfavorable. Water and moisture stagnate, overflow the skin and cause edema; edema consumes qi over time, and qi deficiency is unable to absorb blood, and blood overflowing outside the veins can also cause stasis. The two complement each other and cause each other, making children's PNS show the characteristics of complexity and migration and difficulty in healing. Kidney deficiency and blood stasis, deficiency and stasis are combined, and they are mutually causal. Therefore, the pathogenesis of children's PNS can be attributed to kidney deficiency and blood stasis. Kidney deficiency and blood stasis not only run through the whole process of the disease, but also are the key factors affecting its pathological mechanism. Children are born with inadequate endowments, and long-term illness affects the kidneys. In addition, long-term use of hormones or immunosuppressants will also damage kidney qi and kidney yin. Therefore, treatment should focus on tonifying the kidney and strengthening the body. Blood stasis is a pathological product in the development of PNS and also a pathogenic factor. It runs through the whole process of the disease. Therefore, promoting blood circulation and removing blood stasis is very important for the treatment of pediatric PNS. By promoting blood circulation, the visible or invisible blood stasis in the body can be removed, so that the stagnant and rigid meridians can be unblocked, the stagnant qi and blood can be unblocked, and the water of the lungs, spleen, and kidneys can be transported and transformed, and the edema will subside. Modern research has also confirmed that the pathological changes such as hypercoagulable state, lipid metabolism disorder, platelet aggregation in capillaries, venous thrombosis, and fibrin deposition in glomeruli that occur in the development of kidney disease are similar to the "blood stasis" syndrome in traditional Chinese medicine. The kidney and blood are mutually nourishing and interdependent in physiology and pathology. Based on the theory of kidney deficiency and blood stasis, the "kidney-benefiting and blood-activating method" is proposed to treat primary nephrotic syndrome in children. The method of replenishing the kidney and activating blood circulation is an organic combination of the method of replenishing the kidney and the method of activating blood circulation. The method of replenishing the kidney and activating blood circulation is not just a simple addition of "activating blood circulation" and "reinforcing the kidney", but a method of promoting "reinforcing the kidney" by "activating blood circulation", and strengthening "activating blood circulation" by "reinforcing the kidney". The two work together to improve the pathological changes of "blood stasis and kidney deficiency", so that the body's yin and yang tend to balance, and the evil is eliminated while the yang is preserved. The two work together and promote each other, which can significantly improve the pathological state of "kidney deficiency and blood stasis", so that the body's evil is eliminated while the yang is preserved, the yin is smooth and the yang is retained. Therefore, the method of replenishing the kidney and activating blood circulation can be used throughout the treatment of nephrotic syndrome.

[0020] The astragalus in the prescription is sweet and warm in nature. It belongs to the lung, spleen, liver and kidney meridians. It has the effects of replenishing qi and promoting blood circulation, replenishing qi and strengthening the exterior, and promoting diuresis and reducing swelling. "Compendium of Materia Medica" says that "astragalus replenishes the middle qi, harmonizes the spleen and stomach, eliminates thirst, and is used to regulate and replenish the qi in the middle qi, which is very safe." It is an important medicine for treating qi deficiency edema. Rehmannia root is sweet and cold in nature. It belongs to the kidney meridian. It can clear away heat and cool blood, nourish yin and produce body fluid, and nourish the true water in the kidney to replenish its yin. "Zhenzhu Nang" says: "Cooling blood, generating blood, and replenishing kidney water true yin." Astragalus and Rehmannia root are combined as the monarch, replenishing both qi and yin, and jointly play the role of replenishing kidney qi, nourishing kidney yin, promoting diuresis and reducing swelling. Chinese yam is sweet and warm in nature. It belongs to the spleen, lung and kidney meridians. It has the effects of nourishing the spleen and lungs, strengthening the essence and consolidating the kidneys. It can not only nourish the qi of the spleen, lung and kidneys, but also nourish the yin of the spleen, lung and kidneys. "Honglu Dianxue" says "Chinese yam is an essential product for nourishing the spleen. With its spleen qi, it can transport the essence of water and grain, transfer it to the kidneys and replenish the essence and qi, so it has the function of nourishing the earth and benefiting water." It has the wonderful effect of mutual generation of gold and water, and can also cultivate the soil and produce fluid. Cornus officinalis is sour, sweet and slightly warm in nature. It belongs to the liver and kidney meridians. It is warm but not dry, and it is nourishing but not harsh. It has the effects of nourishing kidney qi, benefiting kidney essence, consolidating essence and reducing urine. It can nourish the kidney and benefit essence, warm the kidney and assist yang; it can nourish yin and yang. Sour and astringent can protect kidney qi and reduce the loss of fine substances from urine. Chinese yam and cornus officinalis are both ministers of this prescription, which can nourish yin, strengthen the spleen and benefit qi, warm yang and consolidate kidney essence. It is supplemented with Radix Pseudostellariae, Poria, Atractylodes macrocephala, and Atractylodes lancea to invigorate the spleen and eliminate dampness, Cortex Moutan and Panax notoginseng to cool blood, promote blood circulation and remove blood stasis, and Herba Hedyotis diffusae to clear away heat and detoxify. Radix Pseudostellariae is sweet, slightly bitter and flat, and has the effects of invigorating qi and invigorating the spleen, promoting body fluid and moistening the lungs. Poria is sweet, light and flat in nature, and belongs to the spleen, kidney and heart meridians. Sweetness can invigorate the spleen, and lightness can penetrate dampness. It can both dispel evil and strengthen the body, and promote diuresis without hurting the body. It is actually a key medicine for promoting diuresis and reducing swelling. It is combined with Astragalus to strengthen the effects of invigorating the spleen and kidney, promoting diuresis and reducing swelling. Poria promotes diuresis to support yang, invigorates the spleen by penetrating dampness, and uses strengthening the spleen to benefit the kidney, so as to achieve the effect of "strengthening the master of water and calming the sun". Atractylodes macrocephala is sweet, bitter and warm, and can invigorate the spleen and invigorate qi, dry dampness and promote diuresis. The predecessors praised it as "the first key medicine for invigorating qi and strengthening the spleen". Fangfeng is pungent, sweet and slightly warm, and can dispel wind and relieve the symptoms. It can be used in combination with kidney disease combined with exogenous wind-cold, rheumatism or wind-heat symptoms. For some chronic kidney disease patients who often feel wind evil due to low immune function, it can be used in combination with Baizhu, Huangqi and other drugs to dispel evil without hurting the body, consolidate the surface without leaving evil, and play the role of dispelling evil and strengthening the body, such as Yupingfeng Powder in Danxi's Heart Method. Atractylodes is pungent, pungent and warm, and is an important medicine for drying dampness and strengthening the spleen. It can not only dispel rheumatism externally, but also transform dampness and turbidity internally. Danpi is pungent, pungent and slightly cold, and it belongs to the heart, liver and kidney meridians. It is pungent to disperse aggregation, and bitter and cold to remove blood heat. It has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis. It can not only clear away heat evil from the blood, but also remove blood stasis. It has the characteristics of stopping bleeding without leaving stasis and activating blood circulation without causing blood stasis. It can treat various kidney diseases with blood stasis and heat syndrome. It can be used together with raw Rehmannia root. The two can work together to cool the blood and disperse blood stasis, so that the blood is cooled without leaving stasis. It can also clear away heat, nourish yin and calm the collaterals. It is used to clear away the deficiency fire in the kidney and remove blood stasis in the kidney collaterals. "Southern Yunnan Materia Medica" says: "It can break up blood, eliminate diseases of masses and remove heat from the blood."Panax notoginseng tastes sweet, slightly bitter and warm in nature. It enters the liver and stomach meridians and has the great ability to promote blood circulation and remove blood stasis, stop bleeding, reduce swelling and relieve pain, and replenish deficiency. The "New Compendium of Materia Medica" says that "Panax notoginseng can stop bleeding and replenish deficiency". It can dredge the meridians and promote blood circulation, remove blood stasis and promote new blood circulation, and harmonize the circulation and stop bleeding. Peony bark and Panax notoginseng can cool blood and promote blood circulation, dredge the meridians and remove blood stasis, and work together with Radix Rehmanniae to strengthen the effect of clearing heat and cooling blood. Hedyotis diffusa is slightly bitter and sweet, and cold, and has the effect of clearing heat and detoxifying, promoting dampness and relieving stranguria.

[0021] Looking at the whole prescription, it treats both the symptoms and the root cause, tonifies the kidney without being greasy, promotes diuresis without damaging the yin, activates blood circulation without running rampantly, and resolves blood stasis without running rampantly. It has the effects of strengthening the spleen and eliminating dampness, tonifying kidney qi, nourishing kidney yin, resolving blood stasis and promoting diuresis.

[0022] The drug of the present invention can improve the serum albumin level of NS children, reduce the 24-hour urine protein quantity and serum total cholesterol level, and can clinically improve the remission rate, reduce the relapse rate, and reduce the adverse reactions of hormones and immunosuppressants. DETAILED DESCRIPTION

[0023] Example 1 Preparation of the medicinal decoction of the present invention

[0024] Astragalus 20g, Rehmannia root 15g, Cornus officinalis 9g, Chinese yam 12g, Pseudostellaria pseudoginseng 20g, Poria 9g, Atractylodes macrocephala 6g, Atractylodes lancea 6g, Paeonia suffruticosa 12g, Panax notoginseng 5g, Saposhnikovia diffusa 6g, Hedyotis diffusa 15g;

[0025] Add water, boil and concentrate to get the product.

[0026]

dose

[0027] This dosage is for daily use, based on children aged 10-14 years old. For children aged 2-5 years old, reduce the dosage by 1 / 2, and for children aged 6-9 years old, reduce the dosage by 1 / 3.

[0028] The beneficial effects of the present invention are demonstrated by clinical trials as follows.

[0029] Test Example 1 Clinical trial of the drug of the present invention

[0030] 1. Clinical Data

[0031] 1. Case selection

[0032] Cases were selected from 200 children with primary nephrotic syndrome (simple type) and kidney deficiency and blood stasis type TCM syndrome diagnosis points in the outpatient department and ward of Fujian Provincial People's Hospital. From January 2002 to December 2012, they were treated as the control group (Group A), and from January 2013 to December 2023, they were treated with the drug of the present invention (Group B). The chi-square test showed no significant difference in age / disease course distribution between the two groups (P>0.05), and they were comparable.

[0033] 2. Diagnostic criteria:

[0034] (1) Diagnostic criteria for primary nephrotic syndrome (simple type): 2016 evidence-based guidelines for the diagnosis and treatment of common kidney diseases in children [Nephrology Group, Pediatric Branch, Chinese Medical Association. Evidence-based guidelines for the diagnosis and treatment of common kidney diseases in children (I) [J]. Chinese Journal of Pediatrics, 2016, 47(3):167-168];

[0035] ① Heavy proteinuria: qualitative urine protein (+++) to (++++) three times within one week, or random or morning urine protein / creatinine (mg / mg) ≥ 2.0; 24h urine protein ≥ 50mg / kg;

[0036] ②Hypoproteinemia: plasma albumin is lower than 25g / L;

[0037] ③ Hyperlipidemia: plasma cholesterol higher than 5.7mmol / L;

[0038] ④Edema of varying degrees.

[0039] Among the above 4 items, ① and ② are necessary conditions for diagnosis.

[0040] (2) Key points of TCM syndrome diagnosis: refer to [State Administration of Technical Supervision. National Standard for TCM Clinical Diagnosis and Treatment Terminology GB / T16751.1-3-1997 [M]. Beijing: China Standards Press, 2004: 1-258]

[0041] Key points of TCM syndrome diagnosis: Weakness in waist and knees, stabbing pain in the waist and spine, resistance to pressure, tinnitus, pale purple tongue, and thin and wiry pulse are common symptoms.

[0042] 3. Inclusion criteria

[0043] (1) The first visit to the hospital meets the diagnostic criteria for pediatric PNS (simple type);

[0044] (2) Conform to the diagnostic criteria of kidney deficiency and blood stasis syndrome in traditional Chinese medicine;

[0045] (3) Age 2-14 years old;

[0046] (4) Children whose parents or guardians agreed to be included in the study.

[0047] 4. Exclusion criteria

[0048] (1) Children who are allergic to the drugs used in this study;

[0049] (2) Children with hereditary nephrotic syndrome;

[0050] (3) Children with congenital nephrotic syndrome;

[0051] (4) Children with secondary nephrotic syndrome secondary to systemic lupus erythematosus, Henoch-Schonlein purpura, hepatitis B or hepatitis C;

[0052] (5) Children with serious primary diseases such as cardiovascular, liver and hematopoietic system diseases, and mental illness.

[0053] 5. Shedding and rejection criteria

[0054] (1) Those who fail to take medications as prescribed, or who secretly add other medications, and whose efficacy cannot be judged;

[0055] (2) Those who cannot tolerate drug treatment or have serious adverse reactions that affect the judgment of efficacy and safety;

[0056] (3) Those who are unable to cooperate with clinical observation and follow-up and whose efficacy data are incomplete.

[0057] 6. Efficacy evaluation criteria: refer to [Chinese Medical Association Pediatrics Branch Nephrology Group. Evidence-based guidelines for the diagnosis and treatment of common kidney diseases in children (I) [J]. Chinese Journal of Pediatrics, 2016, 47(3): 167-168]

[0058] (1) No remission: morning urine protein ≥ (+++);

[0059] (2) Partial remission: positive morning urine protein [≤(++)], serum albumin >25 g / L, and / or disappearance of edema;

[0060] (3) Complete remission: blood biochemical tests and urine tests are completely normal;

[0061] (4) Clinical cure: complete cure, no recurrence for more than 3 years after stopping treatment.

[0062] 2. Research Methods

[0063] 1. Treatment Methods

[0064] (1) Control group: Group A (Study on the optimization of treatment regimen for children with relapsing nephrotic syndrome by combining traditional Chinese and Western medicine, Liu Yunjun, Traditional Chinese Medicine Pediatrics, Master's thesis of Fujian University of Traditional Chinese Medicine, 2015)

[0065] Drug composition: Astragalus 20g, Rehmannia glutinosa 15g, Cornus officinalis 9g, Dioscorea batatas 12g, Poria cocos 9g, Paeonia suffruticosa 12g, Embroidery needle 15g, Litchi chinensis 15g.

[0066] (2) The drug of the present invention: Group B.

[0067] Drug composition: Astragalus 20g, Rehmannia glutinosa 15g, Cornus officinalis 9g, Dioscorea opposita 12g, Pseudostellaria 20g, Poria 9g, Atractylodes macrocephala 6g, Atractylodes lancea 6g, Paeonia suffruticosa 12g, Panax notoginseng 5g, Saposhnikovia diffusa 6g, Hedyotis diffusa 15g.

[0068] This dosage is based on children aged 10-14 years old. For children aged 2-5 years old, reduce the dosage by 1 / 2, and for children aged 6-9 years old, reduce the dosage by 1 / 3). Chinese herbal medicine pieces were provided by the Pharmacy Department of the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine. Chinese herbal medicine decoction: soak the Chinese herbal medicine pieces for 30 minutes, use enough water to cover the surface of the medicine, boil over high heat, then turn to low heat and decoct for 30 minutes. Decoction twice. The amount of water added for the second time is 1 / 3-1 / 2 of the first time. Remove the residue from the two decoctions and keep about 300 ml. Decoction in water, one dose per day, divided into morning and evening, until 2 months after stopping prednisone.

[0069] (3) Western medicine treatment

[0070] Use 1.5-2.0mg / (kg·d) of prednisone. Two weeks after the urine protein turns negative, change to taking it every other day, that is, 2mg / kg of prednisone. After 4 weeks of use, start to gradually reduce the dosage, reducing 2.5-5.0mg every 2-4 weeks. The total course of treatment is about 1 year. For patients with no effect or partial effect after 4 weeks of prednisone treatment, cyclophosphamide pulse therapy can be added, 8-12 mg / (kg·d), plus an appropriate amount of normal saline intravenous drip, once a day, for 2 consecutive days as a course of treatment, with a total course of 3-9 months (the cumulative total dose should be ≤168 mg / kg); or cyclosporine A 5 mg / (kg·d) can be used. If the condition is stable after 3-6 months, the dose can be reduced by 0.5 mg / (kg·d) every 4 weeks, and maintained when it is reduced to 1 mg / (kg·d), with a total course of 1-2 years; or mycophenolate mofetil 20-30 mg / (kg·d) can be added, taken orally in two doses, with an induction period of 4-6 months. After the induction period, the dose can be reduced by 10 mg / (kg·d) every 3-6 months for maintenance treatment, with a total course of 1-2 years.

[0071] 2. Observation indicators:

[0072] The changes of serum albumin, total cholesterol levels and 24-hour urine protein in groups A and B were detected before treatment and 3 and 6 months after treatment.

[0073] 3. Detection Methods

[0074] Serum albumin and total cholesterol detection: 3 ml of fasting venous blood was collected from children in groups A and B, and centrifuged at 3000 r / min for 15 min within 30 min to separate the supernatant, which was then detected using Becman-CX5delate automatic biochemical analyzer.

[0075] Quantitative determination of urine protein: The urine of children in groups A and B was collected for a whole day, and the sulfosalicylic acid method was used to determine the quantitative urine protein.

[0076] 4. Statistical methods

[0077] The collected data were analyzed and processed using the statistical software package SPSS26.0. The measurement data that conformed to the normal distribution were expressed as the mean ± standard deviation (). The measurement data that did not conform to the normal distribution were expressed as the interquartile range, that is, the median (P25, P75). The specific statistical methods were selected as follows: the Pearson χ2 test was used for gender comparison, and the two-sample Wilcoxon rank sum test was used for age comparison; the two-independent sample t test was used for inter-group comparison that conformed to the normal distribution, and the two-sample Wilcoxon rank sum test was used for non-normal distribution; the paired sample t test was used for intra-group comparison that conformed to the normal distribution, and the paired sample rank sum test was used for non-normal distribution. P < 0.05 was considered to be statistically significant, P < 0.01 was considered to be extremely significant, and P > 0.05 was considered to be statistically insignificant.

[0078] 3. Research Results

[0079] 1. Comparison of gender and age distribution of enrolled children (Table 1-1)

[0080] Table 1-1 Comparison of gender distribution of enrolled patients

[0081]

[0082] The results showed that there was no significant difference in gender distribution between group A and group B (P>0.05), with more males than females.

[0083] 2. Comparison of age distribution of enrolled patients (Table 1-2)

[0084] Table 1-2 Comparison of age distribution of enrolled patients (median (P25, P75))

[0085]

[0086]

[0087] The results showed that there was no significant difference in age distribution between group A and group B (P>0.05), and PNS was more common in school-age children.

[0088] 3. Observe the changes in serum albumin levels in groups A and B before and after treatment (Table 1-3)

[0089] Table 1-3 Comparison of serum albumin (g / L) levels between groups A and B before and after treatment

[0090]

[0091] The results showed that compared with before treatment, the serum albumin levels of groups A and B increased significantly 3, 6 and 12 months after treatment and returned to normal levels, with significant differences compared with before treatment (P < 0.01 and P < 0.05). There was no significant difference between groups A and B (P > 0.05).

[0092] 4. Observe the changes in serum total cholesterol levels in groups A and B before and after treatment (Table 1-4)

[0093] Table 1-4 Comparison of serum total cholesterol (mmol / L) levels between groups A and B before and after treatment

[0094]

[0095] The results showed that compared with before treatment, the serum total cholesterol levels of groups A and B were significantly reduced and returned to normal levels 3, 6 and 12 months after treatment, with significant differences compared with before treatment (P < 0.01 and P < 0.05). There was no significant difference between groups A and B (P > 0.05).

[0096] 5. Observe the changes in 24-hour urine protein in groups A and B before and after treatment (Table 1-5)

[0097] Table 1-5 Comparison of 24-hour urine protein quantity (g / 24h) before and after treatment of A and B

[0098]

[0099] The results showed that compared with before treatment, the 24-hour urine protein quantification of groups A and B at 3, 6 and 12 months after treatment was significantly reduced and returned to normal levels, with significant differences compared with before treatment (P < 0.01 and P < 0.05). There was no significant difference between groups A and B (P > 0.05).

[0100] 6. Comparison of clinical efficacy

[0101] Table 1-6 Comparison of clinical efficacy between groups A and B (Table 1-6)

[0102]

[0103]

[0104] 7. Comparison of clinical relapse frequency

[0105] Group Number of cases 0.5 years 1 year 1.5 years A 100 19(23.45％) 22(27.16％) 23(28.39％) B 100 16(17.39％) 19(20.65) 20(21.74％)

[0106] IV. Research Conclusion

[0107] Clinical studies have shown that both the control group A and the drug of the present invention (group B) can increase serum albumin levels, reduce 24-hour urine protein quantification and serum total cholesterol levels, increase clinical remission rate, and reduce relapse rate. However, the complete remission rate of group B is higher than that of group A, and the relapse rate of group B is lower than that of group A. It can be seen that the clinical efficacy and relapse rate of the drug of the present invention (group B) are better than those of the control group (group A).

Claims

1. A Chinese medicine composition for treating nephrotic syndrome in children, characterized in that: It is prepared from the following raw materials in the following weight ratio: 16-24 parts of Astragalus, 12-18 parts of Rehmannia, 7.2-10.8 parts of Cornus, 9.6-14.4 parts of Dioscorea, 16-24 parts of Pseudostellaria, 7.2-10.8 parts of Poria, 4.8-7.2 parts of Atractylodes, 4.8-7.2 parts of Atractylodes, 9.6-14.4 parts of Paeonia, 4-6 parts of Panax notoginseng, 4.8-7.2 parts of Saposhnikovia, and 12-18 parts of Hedyotis diffusa.

2. The Chinese medicine composition for treating nephrotic syndrome in children according to claim 1, characterized in that: It is prepared from the following raw materials in the following weight ratio: 20 parts of Astragalus, 15 parts of Radix Rehmanniae, 9 parts of Fructus Corni, 12 parts of Dioscorea Rhizoma, 20 parts of Radix Pseudostellariae, 9 parts of Poria, 6 parts of Atractylodes, 6 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Cortex Moutan, 5 parts of Radix Notoginseng, 6 parts of Saposhnikoviae, and 15 parts of Hedyotis diffusa.

3. The Chinese medicine composition for treating nephrotic syndrome in children according to claim 1 or 2, characterized in that: The raw drug powder, water or organic solvent extract of the raw drug are used as active ingredients, and pharmaceutically acceptable auxiliary materials or auxiliary ingredients are added to prepare a commonly used pharmaceutical preparation.

4. The Chinese medicine composition for treating nephrotic syndrome in children according to claim 3, characterized in that: The preparations are tablets, capsules, pills, oral liquids and granules.

5. A method for preparing a Chinese medicine composition for treating childhood nephrotic syndrome according to any one of claims 1 to 4, characterized in that: It includes the following steps: a. Weigh the raw materials of each weight ratio; b. The raw powder, water or organic solvent extract of the raw material drug is used as the active ingredient, and pharmaceutically acceptable excipients or auxiliary ingredients are added to prepare the commonly used pharmaceutical preparations.

6. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating nephrotic syndrome in children.

7. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of drugs for treating renal allergic purpura, lupus nephritis, hormone induction phase, hormone reduction phase and hormone withdrawal phase of chronic kidney disease.

8. Use of the Chinese medicine composition according to any one of claims 1 to 4 in combination with an auxiliary hormone and an immunosuppressant in the preparation of a medicament for treating nephrotic syndrome in children.

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