CN102106992A - Chinese medicinal granules for treating non-alcoholic steatohepatitis - Google Patents

Chinese medicinal granules for treating non-alcoholic steatohepatitis Download PDF

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CN102106992A
CN102106992A CN 201110032518 CN201110032518A CN102106992A CN 102106992 A CN102106992 A CN 102106992A CN 201110032518 CN201110032518 CN 201110032518 CN 201110032518 A CN201110032518 A CN 201110032518A CN 102106992 A CN102106992 A CN 102106992A
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radix
sargassum
salviae miltiorrhizae
fructus crataegi
rhizoma alismatis
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CN102106992B (en
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赵文霞
段荣章
马素平
刘全忠
陈天朝
李艳敏
刘君颖
孟祥林
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Henan University of Traditional Chinese Medicine HUTCM
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Henan University of Traditional Chinese Medicine HUTCM
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Abstract

The invention relates to Chinese medicinal granules for treating non-alcoholic steatohepatitis, which can solve the problems of high cost, deficiency of pertinent treatment and poor curative effect. The invention adopts a technical scheme that the Chinese medicinal granules are prepared from 27 to 33 grams of alisma orientale, 13 to 17 grams of seaweed, 9 to 11 grams of cassia seed, 13 to 17 grams of curcuma aromatica, 13 to 17 grams of root of red-rooted salvia, 13 to 17 grams of hawthorn fruit, 13 to 17 grams of silymarin and 5 to 7 grams of bupleurum and by the following steps of: distilling curcuma aromatica and bupleurum in water to extract essential oil; after the essential oil is extracted, mixing dregs of decoction and alisma orientale, seaweed, cassia seed, root of red-rooted salvia, hawthorn fruit and silymarin, decocting for three times, adding the water in an amount which is 8, 6 and 6 times the total weight of curcuma aromatica, bupleurum, alisma orientale, seaweed, cassia seed, root of red-rooted salvia, hawthorn fruit and silymarin respectively every time, and decocting respectively for 1 hour; and merging decoction obtained at three times, filtering, concentrating filter liquor under reduced pressure to form extract, drying under the reduced pressure, crushing to prepare granules, adding the essential oil, and mixing uniformly. The Chinese medicinal granules for treating the non-alcoholic steatohepatitis have reliable curative effect and low cost, and do not have toxic or side effects.

Description

A kind of Chinese medicinal granule for the treatment of non-alcoholic stellato-hepatitis
One, technical field
The present invention relates to the field of Chinese medicines, particularly a kind of Chinese medicinal granule for the treatment of non-alcoholic stellato-hepatitis.
Two, background technology
Non-alcohol fatty liver (nonalcoholic fatty liver disease, NAFLD) be meant except clinical pathology syndrome due to ethanol and other clear and definite damage liver factors, become principal character with diffusivity hepatocyte bulla fat.The NAFLD spectrum of disease differs with the performance of course of disease progress, mainly comprises simple fatty liver, fat hepatitis (NASH) and fatty liver fibrosis and liver cirrhosis.And NASH is the important step that causes fatty cirrhosis, liver failure and related complication thereof, therefore, selects the Therapeutic Method that have capable to NASH, and the research of carrying out its treatment NASH mechanism of action is significant.
The NAFLD sickness rate increases year by year at present, average out to 20% among the general crowd, and wherein NASH accounts for 30%-50%.Obesity, diabetes, insulin resistant etc. are closely related with its morbidity, and NAFLD has now become one of common chronic hepatopathy of the world and even China, the serious harm people ' s health.At present, it is main that western medical treatment NASH mainly adopts oral drugs, selects polyene phosphatidylcholine, ursodesoxycholic acid, silymarin or FENOBRATE top grade medicine for use, used drug price costliness, and the evaluation of clinical curative effect of shortage multicenter large sample.In recent years, Chinese medicine has become one of main means of state internal therapy NASH.But the cause of disease and residing pathology stage of fatty liver that the many ignorance of the Chinese medicine of treatment fatty liver or Chinese patent medicine cause fatty liver, no matter ethanol or non-alcoholic, simple fatty liver no matter, still fat hepatitis, liver cirrhosis are all used with a kind of Drug therapy, the medicine that shortage raises at treatment non-alcoholic stellato-hepatitis transaminase, weak curative effect, thus improve and innovate imperative.
Three, summary of the invention
At above-mentioned situation, for overcoming the prior art defective, the present invention's purpose just provides a kind of Chinese medicinal granule for the treatment of non-alcoholic stellato-hepatitis, and effective workout cost height lacks the problem of specific aim treatment and weak curative effect.
The technical scheme that the present invention solves is, this Chinese medicinal granule is by Rhizoma Alismatis 27-33g, Sargassum 13-17g, Semen Cassiae 9-11g, Radix Curcumae 13-17g, Radix Salviae Miltiorrhizae 13-17g, Fructus Crataegi 13-17g, Herba Silybi mariani 13-17g, Radix Bupleuri 5-7g makes, wherein, get Radix Curcumae, volatile oil was extracted in the distillation of Radix Bupleuri water in 2.5-3.5 hour, Radix Curcumae, medicinal residues after the radix bupleuri extract volatile oil and Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani mix, decoct three times, add Radix Curcumae respectively at every turn, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of amounts, 6 times of amounts, the water of 6 times of amounts, each decocted 1 hour, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, drying under reduced pressure, pulverize, make granule, add above-mentioned volatile oil again, mixing, promptly.
It is reliable that the present invention treats the non-alcoholic stellato-hepatitis curative effect, low price, and have no side effect.
Four, the specific embodiment
Below in conjunction with embodiment the specific embodiment of the present invention is elaborated.
Embodiment 1:
This Chinese medicinal granule is made by Rhizoma Alismatis 27g, Sargassum 13g, Semen Cassiae 9g, Radix Curcumae 13g, Radix Salviae Miltiorrhizae 13g, Fructus Crataegi 13g, Herba Silybi mariani 13g, Radix Bupleuri 5g, wherein, gets Radix Curcumae, Radix Bupleuri water distillation and extraction 2.5 hours, gets volatile oil, and is standby; Medicinal residues behind the extraction volatile oil mix with Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani, decoct three times, add for the first time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the second time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the third time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, get decocting liquid, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, granule is made in drying under reduced pressure, pulverizing, adds above-mentioned volatile oil again, mixing, promptly.
Embodiment 2:
This Chinese medicinal granule also can be made by Rhizoma Alismatis 30g, Sargassum 15g, Semen Cassiae 10g, Radix Curcumae 15g, Radix Salviae Miltiorrhizae 15g, Fructus Crataegi 15g, Herba Silybi mariani 15g, Radix Bupleuri 6g, wherein, gets Radix Curcumae, Radix Bupleuri water distillation and extraction 3 hours, gets volatile oil, and is standby; Medicinal residues behind the extraction volatile oil mix with Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani, decoct three times, add for the first time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the second time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the third time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, get decocting liquid, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, granule is made in drying under reduced pressure, pulverizing, adds above-mentioned volatile oil again, mixing, promptly.
Embodiment 3:
This Chinese medicinal granule is made by Rhizoma Alismatis 33g, Sargassum 17g, Semen Cassiae 11g, Radix Curcumae 17g, Radix Salviae Miltiorrhizae 17g, Fructus Crataegi 17g, Herba Silybi mariani 17g, Radix Bupleuri 7g, wherein, gets Radix Curcumae, Radix Bupleuri water distillation and extraction 3.5 hours, gets volatile oil, and is standby; Medicinal residues behind the extraction volatile oil mix with Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani, decoct three times, add for the first time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the second time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the third time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, get decocting liquid, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, granule is made in drying under reduced pressure, pulverizing, adds above-mentioned volatile oil again, mixing, promptly.
Above medicine, wherein:
Rhizoma Alismatis: remove rice shoot, dry, hit crust and fibrous root, clean, soak, vexed, cut into slices, dry, promoting diuresis to eliminate damp pathogen is arranged, expel the heat-evil, eliminating phlegm and softening indurated mass, the effect of inducing diuresis to remove edema;
Sargassum: choose decontamination, water slightly floats, and dries in the air slightly, and cutting is dried, and the effect of softening the hard mass, expectorant, diuretic, detumescent is arranged;
Semen Cassiae: clean, dry in the shade, liver heat removing and eyesight improving is arranged, the effect of loosening bowel to relieve constipation;
Radix Curcumae: hit fibrous root and dry, the blood-activating and qi-promoting pain relieving is arranged, resolving depression clears away heart-fire, promoting the function of the gallbladder to alleviate jaundice, the effect of removing heat from blood;
Radix Salviae Miltiorrhizae: remove fibrous root and earth, dry, promoting blood flow to regulate menstruation is arranged, removing heat from blood eliminating carbuncle, the effect of calming the nerves;
Fructus Crataegi: clean, section is dried, and promoting digestion and removing stagnation is arranged, the effect of circulation of qi promoting dissipating blood stasis;
Herba Silybi mariani: seed is used as medicine, and cleans, and dries, and heat-clearing and toxic substances removing is arranged, the effect of hepatic cholagogic;
Radix Bupleuri: remove clean earth, dry, have to evacuate and bring down a fever dispersing the stagnated live-QI to relieve the stagnation of QI, the effect of ascending up spleen-Qi and Yang.
By above medicine as can be known, through the science compatibility, preparation is supported to each other mutually, has the dispelling phlegm and eliminating dampness stasis of blood alive, is effective to treat non-alcoholic stellato-hepatitis, and through clinical practice, has obtained good effect, and concrete interrelated data is as follows:
One, selects the standard of case
Non-alcoholic stellato-hepatitis (non-alcoholic NASH) is that excessive history of drinking history (or ethanol intake<20 gram/skies) and hepatic cell fattydegeneration, balloon sample do not become to have, dispersivity lobules of liver mild inflammation and (or) collagen deposition etc. is the chronic hepatitis disease of Clinical symptoms around the central veins of liver, sinus hepaticus.Its cause of disease such as can be divided into after trophism (the too fast and long-term total parenteral nutrition of weight loss), metabolic (beta Lipoprotein deficiency disease), endocrine regulation, medicine and the sky-ileum by-pass operation at paathogenic factor.Wherein modal paathogenic factor is: obesity, type ii diabetes, hyperlipemia.The phase clinical symptoms can have nonspecific symptom and signs such as weak, dyspepsia, dull pain in liver, hepatosplenomegaly except that the primary disease clinical manifestation is arranged, therefore, all have an above symptom, all as the standard of selecting case.
Two, diagnostic criteria
1, Western medicine diagnose standard (with reference to " non-alcohol fatty liver practice guidelines ", Chinese Medical Association's hepatology branch fatty liver and alcoholic liver disease group were formulated in 2006)
All possess following person and can be diagnosed as NASH.
1. do not have history of drinking history or drink amount to the amount of alcohol male weekly<140g, the women weekly<70g.
2. viral hepatitis, drug-induced liver disease, total parenteral nutrition, hepatolenticular degeneration etc. can cause the specified disease of fatty liver except.
3. except that the primary disease clinical manifestation, nonspecific symptom and signs such as weak, dyspepsia, dull pain in liver, hepatosplenomegaly can be arranged.
4. can have overweight and (or) metabolism syndrome related components such as internal organs obesity, fasting glucose increase, blood fat disorder, hypertension.
5. serum transaminase and gamma glutamyl transpeptidase level can have slightly to moderate and increase (less than 5 times of upper limits of normal), increase based on alanine aminotransferase (ALT) usually, continue more than 4 weeks.
6. the liver Radiologic imaging meets the imaging diagnosis standard of diffusivity fat hepatitis.
2, imaging diagnosis
2.1B it is super as screening criteria
1. near field, hepatic region echo diffusivity strengthens (being better than kidney and spleen), and far field echo is decayed gradually.
2. the liver flexible innerduct structure shows unclear.
3. the mild to moderate enlargement of liver, the edge angle circle is blunt.
4. color Doppler flow signals reduces or difficult the demonstration in the color doppler flow imaging prompting liver, but the blood vessel trend is normal in the liver.
5. right lobe of liver peplos and diaphragm echo show unclear or imperfect.
Possess in above-mentioned the 1st and the 2nd~4 a person and be slight fatty liver; Possess in above-mentioned the 1st and the 2nd~4 two persons and be the moderate fatty liver; Possess in above-mentioned the 1st and the 2nd~4 two and the 5th person and be severe fatty liver.
2.2CT diagnostic criteria
Diffusivity liver density reduces, ratio≤1 of liver and the CT value of spleen.Diffusivity liver density reduces, liver/spleen CT value≤1.0 but>0.7 be slight; Liver/spleen CT value<0.7 but>0.5 be moderate; Liver/spleen CT value≤0.5 are severe.(the Hepatic CT pH-value determination pH: select four measuring points of liver, at left siphonal lobe, left internal lobe (quadrate lope), right front leaf, right back leaf, avoid blood vessel and walk line position respectively, diameter is not less than 0.75cm, gets the minimum CT value point of four points.The condition of scanning: 130KV, 110mAs; The condition of taking pictures: window width W190Hu, window position C50Hu.)
3, tcm syndrome diagnostic criteria
The dialectical standard of formulating " new Chinese medicine clinical guidance principle ", regular higher education Eleventh Five-Year Plan National planning teaching material Tian Delu chief editor " Chinese Internal Medicine " with reference to " tcm clinical practice diagnosis and treatment term " and the National Drug Administration of State Bureau of Technical Supervision issue is a foundation, is divided into basic card and doublely sees symptom according to the basic pathogenesis of non-alcoholic fatty liver disease clinical manifestation and symptom variation.
Basic card
Phlegm-damp stasis of blood resistance card
Primary symptom: right side of body discomfort/dull pain/distending pain.
Inferior disease: the vexed abdominal distention of weak, gastral cavity, dark tongue quality or petechia or ecchymosis, tongue fur is white, and sublingual vein appears, stringy and thready pulse or heavy.2 of wherein possessing in primary symptom and the double disease are promptly diagnosable.
All have above-mentioned feature and symptom all can be diagnosed as non-alcoholic stellato-hepatitis.
Three, therapeutic scheme
The oral granule of the present invention of patient, every day 3 times, each 1 bag, weight per package is 6g, 1 month was 1 course of treatment, added up effect three courses of treatment.
Four, efficacy assessment standard
With reference to National Drug Administration's " new Chinese medicine clinical guidance principle " and Chinese Medical Association's hepatology branch fatty liver and alcoholic liver disease group " non-alcohol fatty liver practice guidelines " (in February, 2006 revision).Formulate general curative effect evaluation and each index therapeutic evaluation, and the mutual relation between the various criterions of therapeutical effect of observation analysis.
(1) NASH general curative effect evaluation criterion
Cure: primary symptom disappears with time disease, and the relevant detection index is normal substantially;
Produce effects: primary symptom is obviously improved with time disease, and the relevant detection index takes a turn for the better;
Effectively: primary symptom all has improvement with time disease, and the relevant detection index changes little;
Invalid: primary symptom and time disease no change, the corresponding main index that detects does not have change.
(2) NASH therapeutic effect of syndrome evaluation criteria
Cure: symptom, sign disappear or basic the disappearance, and the syndrome integration reduces 〉=95%;
Produce effects: symptom, sign are obviously improved, syndrome integration minimizing 〉=70%-94%;
Effectively: symptom, sign all have improvement, syndrome integration minimizing 〉=36%-69%;
Invalid: do not increase the weight of even symptom, sign have to improve, the syndrome integration reduces≤35%.
Annotate: syndrome integration slip calculates the nimodipine method that adopts, computing formula:
Syndrome integration * 100% before syndrome integration slip=(syndrome integration when syndrome integration before the treatment-treatment finishes)/treatment.
(3) liver function and blood fat therapeutic evaluation standard
Clinic control (whether being modified as healing): liver function recovery is normal, and blood fat is normal substantially;
Produce effects: the every index of liver function is approaching normal, rate and blood-lipid decreased 2 μ mol/L;
Effectively: the every index of liver function is obviously improved, rate and blood-lipid decreased 1 μ mol/L;
Invalid: the every index no change of liver function, blood fat no change.
(4) NASH B ultrasonic therapeutic evaluation standard
Clinic control: ultrasonic echo recovers normal;
Produce effects: ultrasonicly return to slight fatty liver by severe fatty liver;
Effectively: 1 grade of degree decline of fatty liver;
Invalid: ultrasonic no change.
(5) NASH CT therapeutic evaluation standard
Clinic control: ratio>1 of liver and the CT value of spleen;
Produce effects: liver recovers 2 grades with the ratio of the CT value of spleen;
Effectively: liver recovers 1 grade with the ratio of the CT value of spleen;
Invalid: the ratio no change of liver and the CT value of spleen.
(6) safety evaluatio
1 grade: safety, there is not any untoward reaction;
2 grades: compare safety,, do not need to do any processing and can continue administration if any untoward reaction;
3 grades: safety issue is arranged, moderate untoward reaction is arranged, can continue administration after processing;
4 grades: because of test is ended in untoward reaction.
Five, statistical disposition
Be divided into treatment at random and organize 95 examples, wherein male 76 examples, women 19 examples, year at flat an ancient unit of weight age (41.58+9.96); Matched group 97 examples, wherein male 84 examples, women 13 examples, year mean age (38.65+10.77).Non-alcoholic stellato-hepatitis treatment group is light, in, severe is respectively 57 examples, 23 examples, 15 examples; Matched group is respectively 52 examples, 19 examples, 26 examples, and two groups of patients of treatment group and matched group are aspect sex, age, fatty liver degree, liver function (ALT), blood fat (TG) coherence check, and two groups are compared not statistically significant.
The oral polyene phosphatidylcholine of matched group (Essentiale N/Essentiale Forte N) capsule (Sanofi-Aventis<Beijing〉pharmaceutical Co. Ltd's production), every day 3 times, each 456mg, oral; Oral granule of the present invention is organized in treatment, every day 3 times, and each 1 bag, weight per package is 6g, be 3 months the course of treatment of two groups of treatments, followed up a case by regular visits to 3 months.Two groups of patients all take to eat fresh vegetables, fruit, appropriate exercise, treatment measures such as controlling body weight more during treating.
Detect index: two groups of patients all observe symptom variation situations such as weak before and after the treatment, abdominal distention, uncomfortable liver area or dull pain, and indexs such as TG, ALT before and after the monitor therapy.
Statistical method: The data SPSS13.0 for windows statistical analysis software is handled, and data are with mean ± standard deviation
Figure BSA00000429835900071
Expression, whether test samples meets normal distribution, and carries out homogeneity test of variance.Belong to the overall person of normal distribution and adopt paired t-test or t check in groups; The overall person of nonnormal distribution adopts rank test.
The result:
Two groups of patient's clinical efficacies see Table 1, treatment back treatment group fully recover 21 examples, produce effects 47 examples, effective 25 examples, invalid 2 examples, total effective rate 97.89%; Matched group is respectively recovery from illness 8 examples, produce effects 32 examples, effective 44 examples, invalid 13 examples, total effective rate 86.59%.Through χ 2Check, two groups of clinical efficacies have significant difference (P<0.05).
Amount to before and after two groups of patient treatments to divide and relatively the results are shown in Table 2, primary symptom before treatment group and the matched group patient treatment, inferior disease, the total difference not statistically significant (P>0.05) of scoring.Treatment back treatment group and matched group primary symptom, inferior disease, total score reduction all have remarkable meaning (P<0.01).Primary symptom is than matched group decline no significant difference (P>0.05) behind the treatment group patient treatment.Time disease, total score descend obviously than matched group behind the treatment group patient treatment, significant difference (P<0.05), and curative effect is better than matched group.
The results are shown in Table 3, liver spleen CT ratio difference not statistically significant (P>0.05) before treatment group and the matched group patient treatment before and after two groups of patient liver spleen CT ratio treatments.Treatment back treatment group and matched group patient liver spleen CT ratio all obviously raise before the treatment, and significance meaning (P<0.01) is arranged.Treatment back treatment group patient liver spleen CT ratio raises obviously than matched group, and significance meaning (P<0.01) is arranged.
The results are shown in Table 4 before and after two groups of patient ALT, AST treatments, ALT, AST difference not statistically significant (P>0.05) before treatment group and the matched group patient treatment.Treatment back treatment group and matched group patient ALT, AST all obviously descend before the treatment, and significance meaning (P<0.01) is arranged.Treatment back treatment group ALT, AST descend obviously than matched group, and significance meaning (P<0.05, P<0.01) is arranged.
The results are shown in Table 5 before and after two groups of patient TG, CHO treatments, TG, CHO difference not statistically significant (P>0.05) before treatment group and the matched group patient treatment.Treatment back treatment group TG, CHO obviously descend before the treatment, and significance meaning (P<0.01, P<0.05) is arranged.Treatment back matched group TG, CHO be the preceding no significance meaning (P>0.05) that descends of treatment.Treatment back treatment group TG, obvious than matched group decline has significance meaning (P<0.01).Treatment back treatment group CHO is than matched group decline no significance meaning (P>0.05).
Body Mass Index, waist-to-hipratio the results are shown in Table 6 before and after two groups of patient treatments, Body Mass Index, waist-to-hipratio difference not statistically significant (P>0.05) before treatment group and the matched group patient treatment.Treatment back treatment group and matched group weight in patients index, waist-to-hipratio all obviously descend before the treatment, and significance meaning (P<0.01) is arranged.Body Mass Index, waist-to-hipratio are than matched group not statistically significant (P>0.05) behind the treatment group patient treatment.
Table 1 liang group patient clinical efficacy relatively
Figure BSA00000429835900081
Annotate: compare P<0.05 for two groups
Amount to before and after the table 2 liang group patient treatment and divide relatively
Figure BSA00000429835900082
Figure BSA00000429835900083
Figure BSA00000429835900091
Annotate: with preceding relatively ※ P>0.05 of treatment group treatment; ★ P<0.05, ★ ★ P<0.01 are compared in the treatment back between group
Forward and backward relatively △ P<0.05 of group internal therapy, △ △ P<0.01
Liver spleen CT odds ratio before and after the table 3 liang group patient treatment
Figure BSA00000429835900093
Annotate: with preceding relatively ※ P>0.05 of treatment group treatment; ★ P<0.05, ★ ★ P<0.01 are compared in the treatment back between group
Forward and backward relatively △ P<0.05 of group internal therapy, △ △ P<0.01
ALT, AST are relatively before and after the table 4 liang group patient treatment
Figure BSA00000429835900094
Figure BSA00000429835900095
Annotate: with preceding relatively ※ P>0.05 of treatment group treatment; ★ P<0.05, ★ ★ P<0.01 are compared in the treatment back between group
Forward and backward relatively △ P<0.05 of group internal therapy, △ △ P<0.01
TG, CHO are relatively before and after the table 5 liang group patient treatment
Figure BSA00000429835900096
Figure BSA00000429835900097
Annotate: with preceding relatively ※ P>0.05 of treatment group treatment; ★ P<0.05, ★ ★ P<0.01 are compared in the treatment back between group
Forward and backward relatively △ P<0.05 of group internal therapy, △ △ P<0.01
Body Mass Index, waist-to-hipratio are relatively before and after the table 6 liang group treatment
Figure BSA00000429835900098
Figure BSA00000429835900099
Figure BSA00000429835900101
Annotate: with preceding relatively ※ P>0.05 of treatment group treatment; ★ P<0.05, ★ ★ P<0.01 are compared in the treatment back between group
Forward and backward relatively △ P<0.05 of group internal therapy, △ △ P<0.01
Untoward reaction: all patients all do not have any untoward reaction in the treatment group.
Six, conclusion
NASH is the modern medicine notion, can belong to disease categories such as " liver addiction " for the traditional Chinese medical science, " hypochondriac pain " by its clinical manifestation.According to theories of Chinese materia medica, its cause of disease mostly is eating and drinking without temperance, daily life impermanence, disorder of emotion, weakness due to chronic disease etc.Eating and drinking without temperance, the surfeit delicious food, impairing the spleen and stomach, transformation failure of spleen is given birth in water is wet, the wet expectorant that gathers into, mental disorder is handed over knot; The damp-stagnancy heat-transformation, retention of damp-heat in the interior, the hot turbid damp of expectorant occupy in the body, and sending out next in the side of body is " liver addiction "; The pent-up of feelings will, or depressed rage impairing the liver, or worry impairing spleen, the liver failing to maintain the normal flow of QI, mechanism of qi retardance, perverse and unreasonable manner gram spleen; Or worry impairing spleen, the burnt fortune of losing in causing, turbid damp is not changed, expectorant turbid with the QI and blood knot of fighting; Or pathogenic fire derived from stagnation of liver-QI, bright Tianjin is an expectorant, the turbid liver of keeping of damp and hot expectorant forms primary disease.Imbalance after being ill, the kidney usually involved in chronic disease, a little less than causing the moon and feeling frustrated, hematogenous blockage, stagnation of QI and blood are sent out and are primary disease.Excessive idleness, few moving not labor, flaccidity of the extremities, the qi-blood-body fluid heap soil or fertilizer over and around the roots is held back not all right, and the stasis of blood hinders in interior; Or the greasy and surfeit flavour impairing the spleen and stomach, transformation failure of spleen, food turbid damp gas is stopped up to amass and is not changed, and keeping is to suffer from.Primary disease with stop in the phlegm-damp, stasis of blood choke stagnates is main pathogenesis, belong to factor reciprocal actions such as phlegm-damp, the stagnation of QI, blood stasis, food are turbid and form.Sick position is mainly liver, relates to spleen, kidney two is dirty, and pathology character belongs to deficiency in origin and excess in superficiality.Deficiency in origin is relevant with dysfunction of the spleen in transportation, mark is real in wet, heat, expectorant, the stasis of blood is tied mutually in liver and is caused, so determine that the phlegm-damp blood stasis blocking type of NASH is more, granule of the present invention mainly is therapeutic scheme with the dispelling phlegm and eliminating dampness, show by above-mentioned, granule of the present invention is the active drug of the Chinese medicinal granule of treatment non-alcoholic stellato-hepatitis, and nearly 10 years have been used clinically, as in Zhengzhou City institute of traditional Chinese medicine, Kaifeng infectious hospital, the 5th Affiliated Hospital of Guangzhou Zhongshan University, Hubei Province Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine of institute of traditional Chinese medicine etc., be applied to non-alcoholic stellato-hepatitis (phlegm-damp blood stasis blocking type) patient, all obtained better clinical efficacy, treatment non-alcoholic stellato-hepatitis curative effect is reliable, low price, and have no side effect.

Claims (4)

1. Chinese medicinal granule for the treatment of non-alcoholic stellato-hepatitis, it is characterized in that, by Rhizoma Alismatis 27-33g, Sargassum 13-17g, Semen Cassiae 9-11g, Radix Curcumae 13-17g, Radix Salviae Miltiorrhizae 13-17g, Fructus Crataegi 13-17g, Herba Silybi mariani 13-17g, Radix Bupleuri 5-7g makes, wherein, get Radix Curcumae, volatile oil was extracted in the distillation of Radix Bupleuri water in 2.5-3.5 hour, Radix Curcumae, medicinal residues after the radix bupleuri extract volatile oil and Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani mix, decoct three times, add Radix Curcumae respectively at every turn, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of amounts, 6 times of amounts, the water of 6 times of amounts, each decocted 1 hour, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, drying under reduced pressure, pulverize, make granule, add above-mentioned volatile oil again, mixing.
2. the Chinese medicinal granule of treatment non-alcoholic stellato-hepatitis according to claim 1, it is characterized in that, make by Rhizoma Alismatis 27g, Sargassum 13g, Semen Cassiae 9g, Radix Curcumae 13g, Radix Salviae Miltiorrhizae 13g, Fructus Crataegi 13g, Herba Silybi mariani 13g, Radix Bupleuri 5g, wherein, got Radix Curcumae, Radix Bupleuri water distillation and extraction 2.5 hours, get volatile oil, standby; Medicinal residues behind the extraction volatile oil mix with Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani, decoct three times, add for the first time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the second time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the third time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, get decocting liquid, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, drying under reduced pressure, pulverizing, make granule, add above-mentioned volatile oil again, mixing.
3. the Chinese medicinal granule of treatment non-alcoholic stellato-hepatitis according to claim 1, it is characterized in that, make by Rhizoma Alismatis 30g, Sargassum 15g, Semen Cassiae 10g, Radix Curcumae 15g, Radix Salviae Miltiorrhizae 15g, Fructus Crataegi 15g, Herba Silybi mariani 15g, Radix Bupleuri 6g, wherein, got Radix Curcumae, Radix Bupleuri water distillation and extraction 3 hours, get volatile oil, standby; Medicinal residues behind the extraction volatile oil mix with Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani, decoct three times, add for the first time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the second time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the third time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, get decocting liquid, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, drying under reduced pressure, pulverizing, make granule, add above-mentioned volatile oil again, mixing.
4. the Chinese medicinal granule of treatment non-alcoholic stellato-hepatitis according to claim 1, it is characterized in that, make by Rhizoma Alismatis 33g, Sargassum 17g, Semen Cassiae 11g, Radix Curcumae 17g, Radix Salviae Miltiorrhizae 17g, Fructus Crataegi 17g, Herba Silybi mariani 17g, Radix Bupleuri 7g, wherein, got Radix Curcumae, Radix Bupleuri water distillation and extraction 3.5 hours, get volatile oil, standby; Medicinal residues behind the extraction volatile oil mix with Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani, decoct three times, add for the first time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 8 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the second time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, decocting liquid is standby; Add for the third time Radix Curcumae, Radix Bupleuri, Rhizoma Alismatis, Sargassum, Semen Cassiae, Radix Salviae Miltiorrhizae, Fructus Crataegi and Herba Silybi mariani gross weight and 6 times of water gagings, decocted 1 hour, get decocting liquid, merge three times decocting liquid, filter, filtrate decompression is concentrated into 80 °, and to survey relative densities be 1.20 extractum, drying under reduced pressure, pulverizing, make granule, add above-mentioned volatile oil again, mixing.
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CN105833179A (en) * 2016-04-19 2016-08-10 魏侠 Traditional Chinese medicine for treating nonalcoholic steatohepatitis
CN110946969A (en) * 2019-12-23 2020-04-03 河南中医药大学第一附属医院 Traditional Chinese medicine preparation for enhancing CHB and NAFLD entecavir antiviral curative effect, preparation method thereof and combined treatment medicine

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