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CN109091542A - Chinese and western medicinal composition and its clinical application for treating baby's Intrahepatic Cholestasis - Google Patents

Chinese and western medicinal composition and its clinical application for treating baby's Intrahepatic Cholestasis Download PDF

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Publication number
CN109091542A
CN109091542A CN201811109963.XA CN201811109963A CN109091542A CN 109091542 A CN109091542 A CN 109091542A CN 201811109963 A CN201811109963 A CN 201811109963A CN 109091542 A CN109091542 A CN 109091542A
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vitamin
chinese
western medicine
cholestasis
day
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陈宗波
刘叶丹
宋杰
刘培培
李菲
郭娅
赵娜
胡静飞
辛丹丹
王媛媛
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Affiliated Hospital of University of Qingdao
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Affiliated Hospital of University of Qingdao
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/708Rheum (rhubarb)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07Retinol compounds, e.g. vitamin A
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • A61K31/122Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355Tocopherols, e.g. vitamin E
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/59Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • A61K31/5939,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745Bifidobacteria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747Lactobacilli, e.g. L. acidophilus or L. brevis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics

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Abstract

本发明提出一种治疗婴儿胆汁淤积症的中西药组合物及其临床应用,属于复方制剂领域,能够提高临床疗效、减少不良反应,有效治疗或改善婴儿胆汁淤积症。该中西药组合物由以下组分组成:大黄、维生素A、维生素D3、维生素E、维生素K1和双歧杆菌三联活菌。本发明能够应用于临床婴儿胆汁淤积症的治疗中。The invention provides a traditional Chinese and western medicine composition for treating infantile cholestasis and its clinical application, which belongs to the field of compound preparations, can improve clinical efficacy, reduce adverse reactions, and effectively treat or improve infantile cholestasis. The Chinese and western medicine composition consists of the following components: rhubarb, vitamin A, vitamin D 3 , vitamin E, vitamin K 1 and bifidobacterium triple live bacteria. The invention can be applied to the clinical treatment of infantile cholestasis.

Description

Chinese and western medicinal composition and its clinical application for treating baby's Intrahepatic Cholestasis
Technical field
The invention belongs to compound preparation field more particularly to a kind of Chinese and western medicinal composition for treating baby's Intrahepatic Cholestasis and Its clinical application.
Background technique
Baby's Intrahepatic Cholestasis is more typical one of the disease of cradle (including neonatal period), baby's cholestasis hair Sick rate is in 1/2500-1/5000, hence it is evident that is higher than western countries.Baby's cholestasis is divided due to caused by Different types of etiopathogenises inside and outside liver It secretes or excretion of bile dysfunction, causes bilirubin, bile acid in extrahepatic tissue retention, so that reflux enters clinical condition caused by blood Shape and corresponding sign, as jaundice, liver enlargement, stool colour are abnormal.
It is clinical at present for the disease predominantly protect liver, removing jaundice, the cause of disease and supportive treatment to the ill.Ursodesoxycholic acid is mainly logical It crosses calcium approach and protein kinase C pathway promotes bile discharge, improve the intestines liver circulation of bile acid, regulating lipid metabolism, to drop Low bilirubin level, and improve other and lead to the factor of cholestasis, prevent the pathological change of liver histological.The medicine can improve Skin itching symptom, but minority may occur in which transient serum creatinine and blood glucose rise, oligoleukocythemia etc., and to Biliary atresia and Serious dysfunction of liver infant disabling.Glucocorticoid has non-specific anti-inflammatory, antiallergy and transudation, can make capillary gallbladder Pipe, portal vein portal area inflammation mitigate, and increase bile flow.But the adverse reaction of glucocorticoid and complication are relatively conventional, It especially will appear the more intractable infection of clinical treatment, clinical application is limited.Rifampin choleretic effect mechanism is still unclear, may By inducing hepatocyte microsomal enzyme, improve bile acid biosynthesis, adverse reaction includes hepatocellular damage, kidney function damage, molten Hemolytic hemolytic anemia.Yin Zhi Huang can promote bile secretion, increase the cholic acid in bile and bilirubin discharge, and can improve microcirculation.But The less effective of removing jaundice, jaundice is easily repeatedly.Treatment generally, for this disease there is no satisfied therapeutic agent, clinical treatment compared with For difficulty, curative effect is not satisfied, and prognosis is dangerous and expense is high.Therefore, how a kind of effective, convenient and fast therapeutic agent is provided, It can be improved clinical efficacy, reduce adverse reaction, this will be to improvement baby's Intrahepatic Cholestasis prognosis important in inhibiting.
Summary of the invention
The present invention proposes a kind of Chinese and western medicinal composition for treating baby's Intrahepatic Cholestasis and its clinical application, can be improved and faces Bed curative effect reduces adverse reaction, effectively treatment or improvement baby's Intrahepatic Cholestasis.
In order to achieve the above object, the present invention provides a kind of Chinese and western medicinal composition for treating baby's Intrahepatic Cholestasis, by Following components composition: rheum officinale, vitamin A, vitamin D3, vitamin E, vitamin K1With Bifidobacterium live triple.
Rheum officinale is traditional conventional Chinese medicine in formula provided by above-mentioned technical proposal, has the function of liver protection, can be obvious The ALT value that CCl4 etc. causes liver injury model is reduced, swelling of liver cell, denaturation and necrosis are mitigated, effect link includes: to promote liver Cell RNA synthesis and liver cell regeneration;It stimulates interferon to generate, inhibits the breeding of virus;Promote liver blood circulation, improves micro- Circulation etc..Rheum officinale choleretic effect shows bile capillaries in dredging liver, improves cholestasis in cholangiole, promotes gallbladder contraction, Relaxation Oddis sphincter promotes bile secretion and bilirubin excretion.Liver be internal storage liposoluble vitamin (vitamin A, Vitamin D, vitamin E, vitamin K) main place, and play in the absorption of vitamin, conversion process vital Effect.The absorption of liposoluble vitamin must have the assistance of the cholate in bile, and bile reduction certainly will make fat soluble vitamin absorption Obstacle causes it to reduce and lack.It will lead to hypovitaminosis if hepatosis, so as to cause metabolic disorder or lead to crowd Mostly relevant disease.Therefore the stable state that each family vitamin maintains body is required supplementation with.Probiotics, which has the synthesis of vitamin, to be adjusted Control effect, intestinal bacilli illness when to cholestasis play certain role of correcting, make to be excreted to enteron aisle by hepato-enteric circulation Toxic metabolic substance intestinal degradation increase, alleviate intestinal endotoxemia, cholestasis infant enteron aisle can be helped micro- Ambient environment restores normal, corrects flora imbalance, and intestinal mucosal barrier effect is protected.
Preferably, the dosage of each component are as follows: rheum officinale 3-7mg/kg/d, vitamin A 1500-2000IU/d, vitamin D3 500-700IU/d, vitamin E 10-50mg/d, vitamin K10.5-1mg/kg, Bifidobacterium live triple 360-480mg/ d.Recipe ingredient dosage provided by the technical program is calculated according to children's weight.
Preferably, the usage mode of each component are as follows: decoction is made on behalf of the tea in rheum officinale, 6-8 times daily, vitamin A, dimension life Plain D3It is taken orally 1 time daily with vitamin E, vitamin K1It is only primary in the injection in the 1st day for starting treatment, Bifidobacterium live triple 1 tablet each time, 3 times a day.It should be noted that vitamin K in the technical program1It is that liver synthesis factor is indispensable Substance, effect is that prothrombin precursor is promoted to be changed into factor.It can cause Hypoprothrombinemia when shortage, coagulate Blood obstacle.Due to Intrahepatic Cholestasis, the possible intracorporal factor synthesis of many infants is insufficient, and causing bleeding, (intracranialing hemorrhage can It is fatal).But a possibility that under normal circumstances, occurring is smaller, therefore only uses primary as prophylactic.But if infant is There are the related symptoms of bleeding, then vitamin k1Then it can need to reuse according to infant.
Preferably, the method that decoction is made in the rheum officinale are as follows: the rheum officinale of corresponding amount is cut into uniform diameter 4-6mm's Graininess is added 15-20ml hot-water soak, decoction is made, on behalf of the tea.
Preferably, the dosage form of the Chinese and western medicinal composition is decoction, capsule, granule, mixture or injection.
The present invention also provides a kind of Chinese and western medicinal composition according to the above technical scheme preparation for preventing or Treat infantile liver cellular type cholestasis, baby's bile duct cholestasis, Combination cholestasis or baby's cholestatic hepatic diseases Application in drug.
Compared with prior art, the advantages and positive effects of the present invention are:
Chinese and western medicinal composition provided by the invention is using single rheum officinale as main ingredient, and combination of vitamins medication, and is aided with bifid Bacillus live triple can quickly treat all kinds of baby's cholestatic conditions, and therapeutic effect is good;The Chinese and western medicinal composition side of taking Just, it is easy to patient's receiving, compares other therapies, a large amount of unnecessary medical spendings can be saved, go on smoothly treatment can;This Outside, the treatment of the Chinese and western medicinal composition is particularly suitable for light-duty patient's treat-and-release, has biggish medical value, and can be effective It reduces admission rate, save medical resource and expense, be worth wideling popularize application in clinic.
Specific embodiment
The Chinese and Western medicine group that baby's Intrahepatic Cholestasis is treated provided by the embodiment of the present invention is introduced in detail in order to become apparent from Object and its clinical application are closed, the technical solution in the present invention is clearly and completely described below in conjunction with specific embodiment, Obviously, described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.Based in the present invention Embodiment, every other embodiment obtained by those of ordinary skill in the art without making creative efforts, all Belong to the scope of protection of the invention.
Embodiment 1
Rheum officinale 5mg/kg/d, vitamin A 1500IU/d, vitamin D3500IU/d, vitamin E 10mg/d, vitamin K1 1mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 360mg/d.
Embodiment 2
Rheum officinale 7mg/kg/d, vitamin A 2000IU/d, vitamin D3700IU/d, vitamin E 50mg/d, vitamin K1 1mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 480mg/d.
Embodiment 3
Rheum officinale 5mg/kg/d, vitamin A 1750IU/d, vitamin D3650IU/d, vitamin E 30mg/d, vitamin K1 0.75mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 420mg/d.
Embodiment 4
Rheum officinale 3mg/kg/d, vitamin A 1500IU/d, vitamin D3500IU/d, vitamin E 10mg/d, vitamin K1 0.5mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 360mg/d.
Embodiment 5
Rheum officinale 5mg/kg/d, vitamin A 1500IU/d, vitamin D3500IU/d, vitamin E 50mg/d, vitamin K1 0.5mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 360mg/d.
Embodiment 6
Rheum officinale 5mg/kg/d, vitamin A 1500IU/d, vitamin D3500IU/d, vitamin E 50mg/d, vitamin K1 0.5mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 420mg/d.
Embodiment 7
Rheum officinale 3mg/kg/d, vitamin A 1500IU/d, vitamin D3500IU/d, vitamin E 10mg/d, vitamin K1 1mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 360mg/d.
Embodiment 8
Rheum officinale 7mg/kg/d, vitamin A 1500IU/d, vitamin D3500IU/d, vitamin E 10mg/d, vitamin K1 1mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 420mg/d.
Embodiment 9
Rheum officinale 5mg/kg/d, vitamin A 1500IU/d, vitamin D3500IU/d, vitamin E 10mg/d, vitamin K1 0.5mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 360mg/d.
Embodiment 10
Rheum officinale 5mg/kg/d, vitamin A 1500IU/d, vitamin D3700IU/d, vitamin E 10mg/d, vitamin K1 1mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 360mg/d.
The preparation of 11 rheum officinale decoction of embodiment
It is taken according to any proportion of embodiment 1-10, the rheum officinale of corresponding weight is cut into uniform diameter 4- The graininess of 6mm is added 15-20ml hot-water soak and is taken in small doses at short intervals on behalf of the tea, and 6-8 times/day.The rheum officinale decoction is made.
12 mixed vitamin of embodiment is taken
It is taken according to any proportion of embodiment 1-10, the vitamin A of corresponding unit, D drops and dimension is given birth to Plain E capsule and pill is directly fed.
13 vitamin K of embodiment1Use
It is administered according to any proportion of embodiment 1-10, vitamin K1Dosage is carried out according to the corresponding weight of infant It calculates, it is primary in the intramuscular injection in first day for starting treatment.
14 Bifidobacterium live triple of embodiment is taken
It is taken according to any proportion of embodiment 1-10,4 DEG C of refrigerator fresh-keeping, with warm water or the molten rear clothes of warm milk With.
Clinical Retrospective Study
1, research method
Using Clinical Review Case-control Study Method.
2, technology path and design scheme
1. research object is screened
I case source: affiliated hospital of University Of Qingdao pediatric medicine is hospitalized and outpatient service infant.
Ii diagnostic criteria: infancy cholestatic liver disease (including neonatal period, within especially 3 months) has following spy Sign:
A Clinical symptoms:
A jaundice occurred in neonatal period or infancy;B liver enlargement and (or) Liver on Judge Hardness change;C stool colour changes (yellowish, white);D urine is deep yellow
B blood biochemistry feature:
A serum total bilirubin and bilirubin direct increase, and bilirubin direct/total bilirubin >=20% is cholestasis;b The enzyme of reflection cholestasis increases: gamma glutamyl transpeptidase (γ-GGT), 5'-NT (5 '-NT), alkaline phosphatase etc.; C bile acid increases
C physiologic character: bile flow is reduced or is interrupted.
The consequence of D cholestasis:
A fat soluble vitamin absorption obstacle;B is malnutritive;C infection;D biliary cirrhosis;E portal hypertension, goes out ascites Blood;F liver failure
Iii case is included in standard
A meets the above diagnostic criteria person;Men and women's infant at 0-1 years old B age;The trouble that C is accordingly infected without cytomegalovirus etc. Youngster;D is without obvious renal insufficiency;E can adhere to oral drugs;Bilirubin direct/total bilirubin >=20% before F is treated;G γ-paddy Aminoacyl transpeptidase (γ-GGT) increases
Iv case exclusion criteria
A is associated with the infant of congenital metabolic disease;B merge intentionally, kidney, lung, endocrine, blood (neonatal hemolytic Deng), metabolism and the serious protopathy of gastrointestinal tract infant;C is associated with the infant of the infections relatings such as bacterium, virus;D cannot adhere to taking With the infant of Chinese and Western medicine;E is ultrasonic or MRI image inspection is found has in liver, extrahepatic bile ducts obstructor;Occur in F therapeutic process Hepatic encephalopathy, upper gastrointestinal bleeding, hepatorenal syndrome person
2. research object
All cases are hospitalized from affiliated hospital of University Of Qingdao pediatric medicine and outpatient service infant.It is divided into Chinese medicine group (20 Example), Western medicine group (20), Chinese and western medicinal composition group (20).
3. treatment method
Primary Care: two groups of Primary Cares (intravenous magnesium isoglycyrrhizinate 5mg/kg/d) for being all made of liver protection;
I Chinese medicine group: Yin Zhi Huang 1.5g/ times, 3 times/d, warm water dissolution is taken, and 14d is 1 course for the treatment of, 2 treatments of continuous treatment Journey.
Ii Western medicine group: Ursofalk 10mg/kg/ times, 3 times/d, warm water delivery service, 14d is 1 course for the treatment of, 2 treatments of continuous treatment Journey.
Iii Chinese and western medicinal composition group: embodiment 1 rheum officinale 5mg/kg/d, vitamin A 1500IU/d, vitamin D3 500IU/d, vitamin E 10mg/d, vitamin K11mg/kg (only starts to inject for treatment the 1st day), Bifidobacterium live triple 360mg/d is treated, and 14d is 1 course for the treatment of, continuously treats 2 courses for the treatment of.
4. monitoring index
The improvement of i clinical manifestation, recession degree (complete recession, has no recession at partial remission), the excrement face of Dermal icterus Color changes (continue white, light yellow, yellow), liver size (under rib under < 3cm, rib=3cm, > 3cm under rib) Liver on Judge Hardness (soft, medium, hard), by it is light, in, again, it is 1 point, 2 points, 3 points that each clinical manifestation score respectively.
The change of ii laboratory checking index: monitoring serum total bilirubin (TBIL), serum combination bilirubin (DBIL), blood Clear glutamic-pyruvic transaminase (ALT), serum L-aminobutanedioic acid transferase (AST), alkaline phosphatase (ALP), gamma glutamyl transpeptidase (GGT), the variation of total bile acid (TBA).
5. efficacy assessment standard:
According to clinical manifestation serum total bilirubin, serum direct bilirubin, glutamic-pyruvic transaminase, gamma glutamyl transpeptidase (GGT) etc. liver function indexs are evaluated.
Cure: jaundice subsides completely, and liver function index restores, and clinical symptoms disappear;
Effective: jaundice obviously declines earlier above, serum total bilirubin fall > 50%, other liver function indexs improve, Symptom is substantially reduced;
Improve: jaundice declines earlier above, and between serum total bilirubin fall 30%~50%, other liver function indexs are good Turn, symptom slightly improves;
Invalid: jaundice has no that recession or jaundice are moved back and reappeared, serum total bilirubin fall < 30%, other liver functions Energy index is without improvement, and symptom is without improvement.
6. statistical method
Statistics between different groups is selected the corresponding method of inspection according to data characteristics and is analyzed: qualitative data between different groups Compare using Chi-square Test, the quantitative data comparison among groups of normal distribution make the t inspection for being all made of two independent samples and single factor test Variance analysis (ANOVA), is indicated with average ± standard deviation;It is examined when the quantitative data comparison among groups of Non-Gaussian Distribution using sum of ranks It tests, is indicated with median and quartile (P25-P75);All statistical analysis are all made of BMI SPSS19.0 processing, p < 0.05 prompt difference is statistically significant.
3, result of study
1. Clinical efficacy comparison
aChinese and Western medicine group is compared between Western medicine group curative effect
bChinese and Western medicine group is compared between Chinese medicine group group curative effect
2. symptom scores compare
Western medicine group, Chinese medicine group and the pretherapy and post-treatment xanthochromia of Chinese and Western prescription group, stool color, liver size, Liver on Judge Hardness Symptom score have decline, but Western medicine group is in xanthochromia, stool color and the pretherapy and post-treatment difference of three aspects of Liver on Judge Hardness It is different and not statistically significant.Chinese medicine group compares before and after treatment at two aspects of stool color and liver size, without apparent statistics Learn difference.Chinese and Western medicine group front and back in terms of Liver on Judge Hardness is compared, no significant difference.Symptom score after the treatment of Chinese and Western medicine group Decline compared with Western medicine group and Chinese medicine group, wherein compared with Western medicine group, difference has statistical significance for xanthochromia and stool color;Greatly Just compared with Chinese medicine group, difference has statistical significance for color and Liver on Judge Hardness.
3. clinical examination index compares
Three groups pretherapy and post-treatment, and each group index is declined.Wherein * shows Chinese and Western medicine group compared with Western medicine group, and difference has Statistical significance P < 0.05,#Show Chinese and Western medicine group compared with Chinese medicine group, difference has statistical significance P < 0.05.
Clinic Case research one
Shen, male, 46 days, Qingdao of Shandong province people from Laixi, the first visit date: on October 14th, 2016.Patient is because " it was found that skin Skin xanthochromia 40 days " is medical.Infant started skin and mucosa xanthochromia occur before (6 days after raw) in 40 days, facial more apparent, no fever, Without groan, saliva, without the milk, milk of choking of overflowing, no abdominal distension, stool and urine appearance is shown no obvious abnormalities, and is gone to a doctor and is cured in Qingdao City women and children Institute's row liver power checking shows TBIL 61.4umol/L, DBIL 53.2umol/L, ALT 56U/L.Give oral Ursofalk treatment, skin Skin xanthochromia, which has no, to be clearly better.On November 4th, 2016, infant started white pottery soil sample stool occur, percutaneously surveyed jaundice in local hospital Value is 13.1, does not give special treatment.It looked into liver function November 5 and shows total bilirubin 116.8umol/L, bilirubin direct 98.1umol/L, indirect bilirubin 18.7umol/L, glutamic-pyruvic transaminase 63U/L, glutamic-oxalacetic transaminease 91U/L;Row microspironema pallidum Antibody 38.99s/co, courage type-B ultrasonic show that liver echo is slightly strong, and gall-bladder is full poor after empty stomach.It gives hepatocyte and generates plain liver protection, bear Gallbladder deoxycholic aicd cholagogue, supplement fat-soluble, water soluble vitamin, supplement iron in treatment, skin and mucosa xanthochromia without improvement, go to a doctor in Our hospital's outpatient service.November 14, liver function show TBIL126.39umol/L, DBIL:87.82umol/L, ALT 58U/L, AST 84U/ L;Skin, icteric sclera are shown in physical examination, see 1.0cm × 1.0cm big tag navel week, about 4.0cm under liver rib, matter is hard, under spleen rib about 1.5cm.Urine is yellow, and stool whitens, no liver palms, spider angioma, and for full abdomen without tenderness, shifting dullness is negative.It is diagnosed as 1. baby's gallbladders Juice siltation 2. congenital syphilis of disease, 3. umbilical hernia.It is antiviral to give Vidarabine Monophosphate, piperacillin-sulbactam sodium is anti-infective Treatment becomes a fine day sweet and refreshing liver protection and the treatment of rheum officinale normalizing gallbladder to cure jaundice.Recipe: rheum officinale: 2g 1 day 6-7 times on behalf of the tea;VitaminAD: 1 time 1 Grain, 1 day 1 time, oral vitamin E capsule and pill: one a time, the next day 1 time;Vitamin K1: interim 1 intramuscular injection of 4mg;Bifidobacterium Live triple: one a time, three times a day.Check liver function shows total bilirubin 149.91umol/L after rule takes orally prescription × 15 day, Bilirubin direct 103.37umol/L, glutamic-pyruvic transaminase 53U/L, glutamic-oxalacetic transaminease 87U/L.Continue to take orally prescription × 15 day Afterwards, show total bilirubin 140.10umol/L, bilirubin direct 97.76umol/L in check on December 15th, 2016 liver function, indirectly Bilirubin 42.34umol/L, glutamic-pyruvic transaminase 83U/L, glutamate-oxaloacetate transaminase 25U/L;Infant xanthochromia mitigates.Continue to take orally Liver function is checked after the prescription × January shows total bilirubin 30.68umol/L, bilirubin direct 19.91umol/L, indirect bilirubin 10.77umol/L, glutamic-pyruvic transaminase 39U/L, glutamic-oxalacetic transaminease 54U/L;Continue check liver function after the prescription takes orally × 25 days to show Total bilirubin 10.28umol/L, bilirubin direct 4.76umol/L, indirect bilirubin 5.52umol/L, glutamic-pyruvic transaminase 44.0U/L, glutamic-oxalacetic transaminease 52.0U/L;Continue check liver function after taking orally × 34 days and shows total bilirubin 6.79umol/L, direct gallbladder Red pigment 2.0umol/L, glutamic-pyruvic transaminase 49U/L, glutamic-oxalacetic transaminease 50U/L;Continue to take orally × 23 days, check liver function shows that total gallbladder is red Plain 8.4umol/L, bilirubin direct 1.26umol/L, glutamic-pyruvic transaminase 34U/L, glutamic-oxalacetic transaminease 37U/L;Continue to take orally × 35 Liver function is checked after it shows total bilirubin 6.23umol/L, bilirubin direct 1.83umol/L, glutamic-pyruvic transaminase 39U/L, millet straw Transaminase 32U/L.Infant whitens without xanthochromia, no abnormal color of urine, no stool.Liver function is down to normally.It is discontinued.
Clinic Case research two
Qi female 90 days, Yantai City people from Haiyang City, on March 7 2017 first visit date, infant was because " it was found that skin Xanthochromia more than 2 months " is medical.There is xanthochromia in infant (raw after the 3rd day) before more than 2 months, without drowsiness, irritated, without screaming, faint from fear, Without vomiting, diarrhea, specially treated is not given.Before January is remaining, because xanthochromia is gone to a doctor in women and children hospital of Qingdao City, liver function is looked into Show: total bilirubin: 155umol/L, bilirubin direct 124.3umol/L, indirect bilirubin 30.7umol/L, albumin 39.3g/ L, glutamic-pyruvic transaminase 225U/L, glutamic-oxalacetic transaminease 421U/L, paddy acyl transpeptidase 91U/L, TORCH inspection: it is negative, it is metabolized three: Blood ammonia 2.3umol/L, lactic acid 6.69mmol/L, beta-hydroxybutyric acid 0.04mmol/L, Epstein-Barr virus antibody, human cytomegalovirus DNA, liver Scorching a full set of to check no abnormality seen, Cardiac ultrasound: ventricular septal defect (7mm) is given " Piperacillin Tazobactam Sodium, erythromycin, more Alkene phosphatidyl choline, hepatocyte generation element, ursodesoxycholic acid " etc. treatment 16 days, check liver function is shown on 03 21st, 2017: Bilirubin: 111.5umol/L, bilirubin direct 91.5umol/L, indirect bilirubin 20umol/L, glutamic-pyruvic transaminase 123U/L, Aspartate transaminase 2 41U/L, total bile acid 212.2umo/L, following the service " Polyene Phosphatidylcholine, ursodesoxycholic acid, levocarnitine " Treatment.Check on April 12nd, 2017 liver function is shown: total bilirubin: 35.5umol/L, bilirubin direct 27umol/L, indirect gallbladder Red pigment 8.5umol/L, albumin 38.3g/L, glutamic-pyruvic transaminase 134U/L, glutamate-oxaloacetate transaminase 39U/L, paddy acyl transpeptidase 394U/ L, total bile acid 80.8umol/L, goes to a doctor in our hospital.Row Cardiac ultrasound shows congenital heart disease after being admitted to hospital: membranous part of interventri cular septum Tumor rupture, left, left room slightly expand, and pulmonary hypertension is slight.On April 18th, 2017 looks into liver function and shows total bilirubin 33.89umol/L, bilirubin direct 21.05umol/L, indirect bilirubin 12.84umol/L, glutamic-pyruvic transaminase 109U/L, millet straw Transaminase 120U/L, paddy acyl transpeptidase 296U/L.Infant xanthochromia when being admitted to hospital, sclera have no bright without xanthochromia, stool and urine appearance Aobvious abnormal, full abdomen is without tenderness, 5cm under liver rib, about 4cm under spleen rib, and shifting dullness is negative.It is disease-resistant to give Vidarabine Monophosphate Poison becomes a fine day the treatment such as sweet and refreshing liver protection and removing jaundice cholagogue, recipe: rheum officinale: 2.25g 1 day 6 times on behalf of the tea;VitaminAD: one a time, 1 It 1 time, oral vitamin E capsule and pill 0.1g:1 times 1, the next day 1 time;Vitamin K1: interim 1 intramuscular injection of 4.5mg;Bifid bar Bacterium live triple: one a time, three times a day.After continuously taking prescription × 2 month, check liver function shows total bilirubin 9.97umol/ L, bilirubin direct 1.85umol/L, glutamic-pyruvic transaminase 29U/L, glutamic-oxalacetic transaminease 69U/L, paddy acyl transpeptidase 18U/L.It is continuous oral Liver function is checked after × 34 days shows total bilirubin 6.79umol/L, bilirubin direct 2.0umol/L, glutamic-pyruvic transaminase 49U/L, millet straw Transaminase 50U/L;Continuing to take orally × 23 days, check liver function shows total bilirubin 8.4umol/L, bilirubin direct 1.26umol/L, Glutamic-pyruvic transaminase 34U/L, glutamic-oxalacetic transaminease 37U/L;Continue check liver function after taking orally × 35 days and shows total bilirubin 6.23umol/ L, bilirubin direct 1.83umol/L, glutamic-pyruvic transaminase 39U/L, glutamic-oxalacetic transaminease 32U/L.Infant is without xanthochromia, anuria color Abnormal, no stool whitens.Liver function is down to normally.Infant xanthochromia disappears, and liver function recovery is normal.
Clinic Case research three
Mr. Wang male 151 days, Qingdao Jimo people, first visit time: on November 22nd, 2016.Infant is because " it was found that skin is viscous Film xanthochromia is more than May." medical.There is xanthochromia (2 days after raw) before May in infant, and sclera is without xanthochromia, no Nausea and vomiting, nothing Diarrhea, no clay sample stool, goes to a doctor and gives the treatment of blue light removing jaundice in women and children hospital of Qingdao City, look into liver function on November 22nd, 2016 Show substantially normal.No. 07 infant looks into liver function because " abdominal distension " is in Qingdao City women and children hospital surgery hospitalization within 2 months 2017 Show: glutamic-pyruvic transaminase 238.00U/L, glutamic-oxalacetic transaminease 381.00U/L, total bilirubin 173.4umol/L, bilirubin direct 138.6umol/L gives " Ursofalk and vein liver protection, daily siphon bowel lavage " and treats 8 days, and infant abdominal distension mitigates earlier above, whole body Skin and mucosa still has xanthochromia, and No. 14 check liver functions are shown within 2 months 2017: glutamic-pyruvic transaminase 119.00U/L, glutamic-oxalacetic transaminease 190.00U/L, total bilirubin 199.5umol/L, bilirubin direct 122.4umol/L.On March 8th, 2017, infant was because " bile becomes silted up Product disease " in Qingdao City's women and children's hospital treat, give " hepatocyte generate element, Coenzyme Complex, Potassium Magnesium Aspartate, Yinzhihuang oral liquor, ursodesoxycholic acid benefit " treatment, infant whole skin mucous membrane do not improve, check on March 15th, 2017 liver function Show: glutamic-pyruvic transaminase 212.00U/L, aspartate transaminase 2 55.00U/L, total bilirubin 138umol/L, bilirubin direct 108.9umol/L.03 month 2017 No. 26 infants because " pneumonia " in Qingdao women and children's hospital treat, give it is anti-infective, (specifically unknown) treatment of liver protection 24 days, infant cough is slightly better earlier above, and whole skin mucous membrane xanthochromia aggravates earlier above, icteric sclera, Then it goes to a doctor in our hospital.Infant xanthochromia when being admitted to hospital, no icteric sclera, just, physical examination: hepatic face, umbilical region are visible for no clay sample One size about 3 × 2 × 1.5cm bulging object, the accessible 2*3*2 size mass of left side iliac region.4cm under liver rib, under spleen rib It does not touch.Shifting dullness is negative.Liver function is looked into after being admitted to hospital shows glutamic-pyruvic transaminase 571.00U/L, aspartate transaminase 2 34.00U/L, Total bilirubin 92.19umol/L, bilirubin direct 63.87umol/L, glutamyl transpeptidase 508U/L.Avocin is given to relax Batan sodium anti-infective therapy becomes a fine day the treatment such as sweet and refreshing liver protection and removing jaundice cholagogue.Recipe: rheum officinale: 2.25g 1 day 6 times on behalf of the tea;Dimension Raw element AD:1 times 1,1 day 1 time, oral vitamin E capsule and pill 0.1g:1 times 1, the next day 1 time;Vitamin K1: interim 1 flesh of 4mg Meat injection;Bifidobacterium live triple: one a time, three times a day.Rule takes orally prescription × 8 day, looks into liver function on May 1st, 2017 Show glutamic-pyruvic transaminase 161.0U/L, glutamic-oxalacetic transaminease 94.0U/L, total bilirubin 45.39umol/L, bilirubin direct 30.25umol/L glutamyl transpeptidase 267U/L.After continue to take orally the prescription × January, on June 1st, 2017 look into liver function and show paddy third Transaminase 99U/L, glutamic-oxalacetic transaminease 880U/L, total bilirubin 13.2umol/L, bilirubin direct 4.88umol/L, glutamy turn Peptase 56U/L.Continue to take orally × 2.5 months, No. 15 check liver functions show glutamic-pyruvic transaminase 80U/L, glutamic-oxalacetic transaminease within 08 month 2017 62.0U/L, total bilirubin 5.65umol/L, bilirubin direct 2.19umol/L, glutamyl transpeptidase 16.0U/L.Continue to take orally After × 36 days, show glutamic-pyruvic transaminase 39.0U/L in No. 21 check liver functions of in September, 2017, glutamic-oxalacetic transaminease 41.0U/L, total gallbladder is red Plain 8.08umol/L, bilirubin direct 1.48umol/L, glutamyl transpeptidase 10.0U/L.Continue to take orally prescription × 39 day, it is multiple It looks into liver function and shows glutamic-pyruvic transaminase 41.0U/L, glutamic-oxalacetic transaminease 47.0U/L, total bilirubin 7.52umol/L, bilirubin direct 0.98umol/L, glutamyl transpeptidase 8.0U/L.Continue to take orally × 65 days, shows third turn of ammonia of paddy in check on January 4th, 2018 liver function Enzyme 32.0U/L, glutamic-oxalacetic transaminease 40.0U/L, total bilirubin 5.64umol/L, bilirubin direct 0.91umol/L, glutamy turn Peptase 10.0U/L.Infant whitens without xanthochromia, no abnormal color of urine, no stool.Liver function is down to normally.

Claims (6)

1.治疗婴儿胆汁淤积症的中西药组合物,其特征在于,由以下组分组成:大黄、维生素A、维生素D3、维生素E、维生素K1和双歧杆菌三联活菌。1. The Chinese and Western medicine composition for treating infantile cholestasis, which is characterized in that it consists of the following components: rhubarb, vitamin A, vitamin D3 , vitamin E, vitamin K1 and bifidobacteria triple live bacteria. 2.根据权利要求1所述的中西药组合物,其特征在于,各组分的用量为:大黄3-7mg/kg/d,维生素A 1500-2000IU/d,维生素D3 500-700IU/d,维生素E 10-50mg/d,维生素K1 0.5-1mg/kg,双歧杆菌三联活菌360-480mg/d。2. The Chinese and Western medicine composition according to claim 1, characterized in that the dosage of each component is: rhubarb 3-7mg/kg/d, vitamin A 1500-2000IU/d, vitamin D 3 500-700IU/d , vitamin E 10-50mg/d, vitamin K 1 0.5-1mg/kg, bifidobacteria triple live bacteria 360-480mg/d. 3.根据权利要求2所述的中西药组合物,其特征在于,各组分的使用方式为:大黄制成汤剂代茶饮,每日6-8次,维生素A、维生素D3和维生素E每日口服1次,维生素K1仅在开始治疗的第1天注射一次,双歧杆菌三联活菌每次1粒,每日3次。3. The Chinese and Western medicine composition according to claim 2, characterized in that, the usage of each component is: rhubarb is made into decoction instead of tea, 6-8 times a day, vitamin A, vitamin D 3 and vitamin E was taken orally once a day, vitamin K 1 was only injected once on the first day of treatment, and bifidobacterium triple live bacteria were taken 1 capsule each time, 3 times a day. 4.根据权利要求3所述的中西药组合物,其特征在于,所述大黄制成汤剂的方法为:将相应量的大黄剪成均匀的直径4-6mm的颗粒状,加入15-20ml热水浸泡,制成汤剂,代茶饮。4. The Chinese and Western medicine composition according to claim 3, characterized in that, the method of making decoction from rhubarb is: cutting the corresponding amount of rhubarb into uniform granules with a diameter of 4-6mm, adding 15-20ml Soak it in hot water to make a decoction and replace it with tea. 5.根据权利要求1所述的中西药组合物,其特征在于,所述中西药组合物的剂型为汤剂、胶囊剂、颗粒剂、合剂或针剂。5. The Chinese and Western medicine composition according to claim 1, characterized in that, the dosage form of the Chinese and Western medicine composition is decoction, capsule, granule, mixture or injection. 6.根据权利要求1所述的中西药组合物在制备用于预防或治疗婴儿肝细胞型胆汁淤积、婴儿胆管性胆汁淤积、混合性胆汁淤积或婴儿淤积性肝病的药物中的应用。6. The application of the Chinese and Western medicine composition according to claim 1 in the preparation of medicines for preventing or treating infant hepatocellular cholestasis, infantile bile duct cholestasis, mixed cholestasis or infantile stasis liver disease.
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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1223865A (en) * 1998-01-20 1999-07-28 上海信谊药业有限公司 Live triple bifidobacteria preparation and preparing method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1223865A (en) * 1998-01-20 1999-07-28 上海信谊药业有限公司 Live triple bifidobacteria preparation and preparing method thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
池肇春等: "《消化系统疾病鉴别诊断与治疗学 第2版》", 31 July 2017, 济南:山东科学技术出版社 *
许丽等: "中西医结合治疗婴儿胆汁淤积性肝病临床研究现状", 《中国中西医结合儿科学》 *
黄伟星: ""双歧杆菌三联活菌辅助治疗婴儿胆汁淤积性肝病的临床疗效观察", 《现代诊断与治疗》 *

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