CN104189846A - Traditional Chinese medicine composition used as radiotherapy and chemotherapy sensitizing agent and preparation method thereof - Google Patents
Traditional Chinese medicine composition used as radiotherapy and chemotherapy sensitizing agent and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicines and relates to a traditional Chinese medicine composition used as a radiotherapy and chemotherapy sensitizing agent and a preparation method thereof. In order to overcome the technical defects of great toxic or side effects and non-ideal treatment effect in the tumor treatment process in the prior art, the invention provides the traditional Chinese medicine composition which can obviously reduce toxic or side effects on radiotherapy and can also be used as the radiotherapy sensitizing agent. The traditional Chinese medicine composition is prepared by various traditional Chinese medicinal materials, and a pharmacological experiment and a clinical experiment prove that when the traditional Chinese medicine composition is used as the radiotherapy and chemotherapy sensitizing agent, the toxic or side effects on the radiotherapy can be reduced, and the sensitivity of tumor cells can be enhanced. Therefore, the medical popularization value is wide.
Description
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of for Chinese medicine composition as chemicotherapy sensitizer and preparation method thereof.
Background technology
Malignant tumor is one of major disease of harm humans health.For the treatment of malignant tumor, mainly take the Comprehensive Treatment mode combining with operative treatment, radiotherapy, chemotherapy etc. at present.Although cytotoxic drug benefits many tumor patients, due to constitutional and the acquired drug-resistance of tumor cell, that antitumor drug toxicity causes working concentration is lower, reduces the factors such as killing activity, chemotherapeutical curative effect is still difficult to satisfactory now.Chemotherapy sensitizing or Reversal of multidrug resistance refer to and adopt this kind of material of microdosage and radiotherapy or chemotherapeutics to share can to make the chemotherapy effect main side reaction of radiotherapy that is significantly increased to have: (1) nasopharynx part, oral mucosa and skin injury; (2) heart radiation injury; (3) radiation pneumonia; (4) radioactivity bone marrow injury; (5) other: Brain Radiation Injury, radiation rectitis, injury of bladder etc.Wherein the damage meeting of mouth and nose mucosa and skin occurs at radiation period, patient there will be the diseases such as dry mouth and throat, oral ulcer, skin pigment precipitation, and some damage there will be after radiotherapy several weeks and even several months, for example induced lung injury is divided in early days, mid-term, late period.Mostly occur in early days and in several weeks, occur after radiotherapy, clinical manifestation is acute radiation pneumonia; May appear at late period and irradiate latter 6 months or the longer time.Most of antineoplastic chemotherapy medicine has immunosuppressive action, and chemotherapeutics can damage patient's immune system, causes immunodeficiency or decline.Immune function is as the test of E-rosette, CH50, C3 complement, T cell subsets, and NK cytoactive, interleukin I I etc., all can be to some extent compared with declining before chemotherapy after chemotherapy, and the chemicotherapy patient Chang Hui respiratory symptom that occurs together, as cough, pneumonia etc.Therefore, how to improve the importance that the curative effect of chemicotherapy the large to the greatest extent toxic and side effects that alleviates possibly chemicotherapy have become oncotherapy.
Chinese medicine is as one of conventional Therapeutic Method of malignant tumor, coordinated radiotherapy, not only can alleviate the toxicity of body, can also strengthen the curative effect of radiotherapy, improve patient's tolerance and quality of life, thereby strengthen patient's immunologic function, reduce the chance of tumor recurrence and transfer, to extend patient's life-span.The traditional Chinese medical science thinks that lonizing radiation belong to the heresy of fire-toxin, and lonizing radiation are in killing tumor cell, also cloudy as " pyretic toxicity " damage people bromhidrosis.The clinical product of supplementing QI and nourishing YIN, removing pathogenic heat from blood and toxic substance from the body of often selecting are alleviated caused by radiation yin asthenia generating intrinsic heat symptom, and common drug is as Radix Adenophorae (Radix Glehniae), Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Arnebiae (Radix Lithospermi), Cortex Moutan, the Radix Rehmanniae etc.In addition, blood-activating and stasis-removing can be prevented and treated pulmonary fibrosis, myocardial damage, radioactivity esophagitis and radiation pneumonia.Chinese medicine external can also be alleviated radiotherapy and the skin and the mucosa injury that cause.Blood-activating and stasis-removing can change alleviating vascular spasm, kind microcirculation, and the oxygen content of increase diseased region cancerous cell, anticoagulant, regulates connective tissue metabolism, makes weary oxygen cancer carefully responsive to lonizing radiation, thereby strengthens radiotherapeutic effect.Clinical Cortex Magnoliae Officinalis, Flos Carthami, Rhizoma Sparganii, Rhizoma Curcumae, the Radix Notoginseng powder etc. often selected.
In prior art, radiotherapy and chemotherapy process are larger to the side effect of tumor patient, and can not be satisfactory for killing of tumor cell, lack clinically at present corresponding chemicotherapy sensitizer.In order to overcome above-mentioned the deficiencies in the prior art, the object of this invention is to provide a kind of Chinese medicine composition that can be used as chemicotherapy sensitizer, it can significantly alleviate the toxic and side effects in radiotherapy and chemotherapy, and can strengthen tumor cell to radiocurable sensitivity, significantly improve tumor killing effect.
The object of the invention is to be achieved through the following technical solutions:
As a Chinese medicine composition for chemicotherapy sensitizer, its raw material by following weight portion proportioning is made:
Radix Scutellariae 8-20 part, Radix Notoginseng 5-15 part, Rhizoma Coptidis 5-15 part, Herba Menthae 3-10 part, Radix Ginseng 10-25 part, Poria 5-15 part, Semen Ziziphi Spinosae 10-20 part, Radix Tripterygii Wilfordii 3-10 part, Cortex Magnoliae Officinalis 10-20 part, Fructus Forsythiae 8-20 part, Herba Menthae 5-12 part, Radix Puerariae 10-20 part, Rhizoma Zingiberis 3-10 part, Rhizoma Alismatis 5-15 part, Semen Cuscutae 3-10 part, Radix Gentianae 3-10 part, Semen Plantaginis 5-12 part, Fructus Lycii 10-15 part, Cortex Eucommiae 10-20 part, Rhizoma Pinelliae 3-10 part, Herba Hedyotidis Diffusae 5-15 part, Folium Nelumbinis 5-15 part, Bulbus Lilii 5-25 part, Radix Glycyrrhizae 10-20 part,
The above-mentioned Chinese medicine of the present invention is clinical conventional Chinese medicine, and its medicinal part is well known to the skilled person, described Chinese medicine composition remarkable toxic and side effects in ameliorate tumor therapeutic process after reasonable compatibility, and heighten the effect of a treatment.The reinforced effects of tumor cell in tumour medicine or radiation therapy process being killed according to Chinese medicine composition and for the difference that alleviates effect of toxic and side effects in therapeutic process, inventor is preferably as follows on above-mentioned Chinese medicine composition basis:
(1) 15 parts of Radix Scutellariaes, 10 parts of Radix Notoginseng, 10 parts of Rhizoma Coptidis, 7 parts of Herba Menthaes, 18 parts of Radix Ginsengs, 10 parts, Poria, 15 parts of Semen Ziziphi Spinosaes, 7 parts of Radix Tripterygii Wilfordiis, 15 parts of Cortex Magnoliae Officinalis, 14 parts of Fructus Forsythiaes, 9 parts of Herba Menthaes, 15 parts of Radix Puerariaes, 7 parts of Rhizoma Zingiberiss, 10 parts of Rhizoma Alismatis, 7 parts of Semen Cuscutae, 6 parts of Radix Gentianaes, 8 parts of Semen Plantaginiss, 13 parts of Fructus Lycii, 15 parts of the Cortexs Eucommiae, 7 parts of the Rhizoma Pinelliaes, 10 parts of Herba Hedyotidis Diffusaes, 10 parts, Folium Nelumbinis, 20 parts of Bulbus Liliies, 15 parts, Radix Glycyrrhizae.
(2) 8 parts of Radix Scutellariaes, 5 parts of Radix Notoginseng, 5 parts of Rhizoma Coptidis, 3 parts of Herba Menthaes, 10 parts of Radix Ginsengs, 5 parts, Poria, 10 parts of Semen Ziziphi Spinosaes, 3 parts of Radix Tripterygii Wilfordiis, 10 parts of Cortex Magnoliae Officinalis, 8 parts of Fructus Forsythiaes, 5 parts of Herba Menthaes, 10 parts of Radix Puerariaes, 3 parts of Rhizoma Zingiberiss, 5 parts of Rhizoma Alismatis, 3 parts of Semen Cuscutae, 3 parts of Radix Gentianaes, 5 parts of Semen Plantaginiss, 10 parts of Fructus Lycii, 10 parts of the Cortexs Eucommiae, 3 parts of the Rhizoma Pinelliaes, 5 parts of Herba Hedyotidis Diffusaes, 5 parts, Folium Nelumbinis, 5 parts of Bulbus Liliies, 10 parts, Radix Glycyrrhizae.
(3) 20 parts of Radix Scutellariaes, 15 parts of Radix Notoginseng, 15 parts of Rhizoma Coptidis, 10 parts of Herba Menthaes, 25 parts of Radix Ginsengs, 15 parts, Poria, 20 parts of Semen Ziziphi Spinosaes, 10 parts of Radix Tripterygii Wilfordiis, 20 parts of Cortex Magnoliae Officinalis, 20 parts of Fructus Forsythiaes, 12 parts of Herba Menthaes, 20 parts of Radix Puerariaes, 10 parts of Rhizoma Zingiberiss, 15 parts of Rhizoma Alismatis, 10 parts of Semen Cuscutae, 10 parts of Radix Gentianaes, 12 parts of Semen Plantaginiss, 15 parts of Fructus Lycii, 20 parts of the Cortexs Eucommiae, 10 parts of the Rhizoma Pinelliaes, 15 parts of Herba Hedyotidis Diffusaes, 15 parts, Folium Nelumbinis, 25 parts of Bulbus Liliies, 20 parts, Radix Glycyrrhizae.
(4) 12 parts of Radix Scutellariaes, 12 parts of Radix Notoginseng, 10 parts of Rhizoma Coptidis, 5 parts of Herba Menthaes, 16 parts of Radix Ginsengs, 18 parts, Poria, 13 parts of Semen Ziziphi Spinosaes, 6 parts of Radix Tripterygii Wilfordiis, 20 parts of Cortex Magnoliae Officinalis, 10 parts of Fructus Forsythiaes, 8 parts of Herba Menthaes, 16 parts of Radix Puerariaes, 6 parts of Rhizoma Zingiberiss, 10 parts of Rhizoma Alismatis, 5 parts of Semen Cuscutae, 8 parts of Radix Gentianaes, 7 parts of Semen Plantaginiss, 8 parts of Fructus Lycii, 14 parts of the Cortexs Eucommiae, 10 parts of the Rhizoma Pinelliaes, 5 parts of Herba Hedyotidis Diffusaes, 15 parts, Folium Nelumbinis, 15 parts of Bulbus Liliies, 17 parts, Radix Glycyrrhizae.
Chinese medicine composition of the present invention can be prepared into conventional clinically dosage form.Preferably, Chinese medicine composition of the present invention is prepared into powder, mixture, tablet or capsule according to conventional preparation technology.The present invention also provides a kind of preparation method of above-mentioned Chinese medicine composition, it comprises the steps: to get recipe quantity Chinese crude drug and is broken into coarse powder, according to 4～9 times of coarse powder gross weight, adding volumetric concentration is 40%～95% alcoholic solution, reflux, extract, three times, return time is 2～5h, filters, after merging, filtrate reclaims ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Those skilled in the art can be at the technical conventional Chinese medicine pharmaceutical dosage form clinically for preparing of this preparation method, as tablet, capsule etc.
The present invention also asks for protection above-mentioned Chinese medicine composition and is used as the purposes in the medicine of chemicotherapy sensitizer in preparation.In purposes described above, the embodiment of the present invention 8 shows, experimental result shows, two dosage groups of Chinese medicine composition height of the present invention all have significant tumor killing effect, and wherein the tumor killing effect of high dose group is close to positive control medicine fluorouracil.When Drug therapy is combined use with radiotherapy, Chinese medicine composition of the present invention and radiotherapy have shown remarkable synergism, and tumor control rate significantly rises.Its synergistic therapeutic effect is significantly due to radiotherapy and fluorouracil therapeutic alliance.This shows that the be significantly improved effect Chinese medicine composition 30mgmg/kg especially of the present invention of radiotherapy cancerous cell sensitivity of Chinese medicine composition tool of the present invention compares the independent X-ray therapy that does not give Chinese medicine composition and improved 36% tumour inhibiting rate, and this further shows that Chinese medicine composition of the present invention can be used as the clinical meaning that radiotherapeutic sensitizer is used.
The embodiment of the present invention 7 result of the tests show:
1) treatment group patient incidence of radioactive pneumonia is starkly lower than matched group (P < 0.01), difference has statistical significance, results suggest Chinese medicine compound of the present invention can obviously reduce the incidence rate of radiation pneumonia after chest radiotherapy, has the effect of prevention radiation pneumonia.
2) the front two groups of patient Ka Shi scoring for the treatment of no difference of science of statistics (P > 0.05), have comparability, after radiotherapy, after treatment, physical function slightly declines treatment group 1～March, treat the front improvement of physical function state in latter 6 months, be even better than before radiotherapy; And matched group patient is in 6 carrying out property of physical function situation declines in the middle of the month of following up a case by regular visits to, two groups of each monitoring points result difference is obvious, illustrates that Chinese medicine compound side of the present invention can obviously improve patient body function, improves patients ' life quality.
3) the tcm symptom no significant differences (P > 0.05) such as before treatment, two groups of patients cough, breathe hard, weak, have comparability.Treatment group cough symptom after radiotherapy 1st month the most obvious, symptom is progressively alleviated subsequently, after 6 months, patient's cough shape alleviates before compared with radiotherapy; The symptom of breathing hard is obviously alleviated before treatment for 1st month after radiotherapy, and 2 slightly increased the weight of to 3 months, alleviated subsequently, before treating, breathed hard and obviously improved after 6 months; Weak symptom is fluctuation downward trend in 6 middle of the month of following up a case by regular visits to, treat after 6 months weak treatment before make moderate progress.Matched group is between follow-up period, and carrying out property of every tcm symptom increases the weight of, without improvement trend, and symptom increase the weight of with radiotherapy after the time be proportionate, treatment group is starkly lower than matched group in each monitoring point tcm symptom order of severity, difference has statistical significance,
In a word, Chinese medicine composition of the present invention, aspect chemicotherapy sensitizer, compared with prior art has following advantage:
1) compare with current radiocurable adjuvant therapy medicaments, Chinese medicine composition of the present invention is natural pure Chinese medicinal preparation, untoward reaction and side effect significantly reduce, and Chinese medicine composition effect of the present invention is comprehensive, medication effect is better, significantly improved the compliance of tumor patient, and improved patient's quality of life.
2) in Chinese medicine composition of the present invention, contain multi-medicament component, action target spot is numerous, pharmacological evaluation shows that it has the effect of toxic and side effects in remarkable reduction radiation therapy process, not only the incidence rate of radiation pneumonia significantly reduces, and patient obtains physical function state and also significantly improve, symptoms such as coughing, breathe hard, be weak is also significantly improved.
3) when Chinese medicine composition of the present invention and radiotherapy share, can significantly strengthen the sensitivity of tumor cell, thereby greatly improve its tumor suppression effect.Experimental result shows, has significant synergism after Chinese medicine composition of the present invention and radiotherapy coupling aspect tumor killing effect.
Summary of the invention
The specific embodiment
By specific embodiment, further describe the present invention below, but those skilled in the art should know, described embodiment does not also limit the present invention in any way.
(1) FORMULATION EXAMPLE part
Embodiment 1 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: Radix Scutellariae 80g, Radix Notoginseng 50g, Rhizoma Coptidis 50g, Herba Menthae 30g, Radix Ginseng 100g, Poria 50g, Semen Ziziphi Spinosae 100g, Radix Tripterygii Wilfordii 30g, Cortex Magnoliae Officinalis 100g, Fructus Forsythiae 80g, Herba Menthae 50g, Radix Puerariae 100g, Rhizoma Zingiberis 30g, Rhizoma Alismatis 50g, Semen Cuscutae 30g, Radix Gentianae 30g, Semen Plantaginis 50g, Fructus Lycii 100g, Cortex Eucommiae 100g, Rhizoma Pinelliae 30g, Herba Hedyotidis Diffusae 50g, Folium Nelumbinis 50g, Bulbus Lilii 50g, Radix Glycyrrhizae 100g;
Preparation method: get recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 4 times of coarse powder gross weight is 40% alcoholic solution, reflux, extract, three times, return time is 5h, filters, and after filtrate merges, reclaims ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into tablet or capsule.
Embodiment 2 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: Radix Scutellariae 200g, Radix Notoginseng 150g, Rhizoma Coptidis 150g, Herba Menthae 100g, Radix Ginseng 250g, Poria 150g, Semen Ziziphi Spinosae 200g, Radix Tripterygii Wilfordii 100g, Cortex Magnoliae Officinalis 200g, Fructus Forsythiae 200g, Herba Menthae 120g, Radix Puerariae 200g, Rhizoma Zingiberis 100g, Rhizoma Alismatis 150g, Semen Cuscutae 100g, Radix Gentianae 100g, Semen Plantaginis 120g, Fructus Lycii 150g, Cortex Eucommiae 200g, Rhizoma Pinelliae 100g, Herba Hedyotidis Diffusae 150g, Folium Nelumbinis 150g, Bulbus Lilii 250g, Radix Glycyrrhizae 200g;
Preparation method: get recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 90% alcoholic solution, reflux, extract, three times, return time is 3h, filters, and after filtrate merges, reclaims ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into tablet or capsule.
Embodiment 3 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: Radix Scutellariae 150g, Radix Notoginseng 100g, Rhizoma Coptidis 100g, Herba Menthae 70g, Radix Ginseng 180g, Poria 100g, Semen Ziziphi Spinosae 150g, Radix Tripterygii Wilfordii 70g, Cortex Magnoliae Officinalis 150g, Fructus Forsythiae 140g, Herba Menthae 90g, Radix Puerariae 150g, Rhizoma Zingiberis 70g, Rhizoma Alismatis 100g, Semen Cuscutae 70g, Radix Gentianae 60g, Semen Plantaginis 80g, Fructus Lycii 130g, Cortex Eucommiae 150g, Rhizoma Pinelliae 70g, Herba Hedyotidis Diffusae 100g, Folium Nelumbinis 100g, Bulbus Lilii 200g, Radix Glycyrrhizae 150g;
Preparation method: get recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 70% alcoholic solution, reflux, extract, three times, return time is 4h, filters, and after filtrate merges, reclaims ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Chinese medical concrete is pulverized and added the conventional adjuvant of preparation to be prepared into tablet or capsule.
Embodiment 4 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: Radix Scutellariae 80g, Radix Notoginseng 150g, Rhizoma Coptidis 150g, Herba Menthae 30g, Radix Ginseng 250g, Poria 150g, Semen Ziziphi Spinosae 100g, Radix Tripterygii Wilfordii 100g, Cortex Magnoliae Officinalis 100g, Fructus Forsythiae 160g, Herba Menthae 120g, Radix Puerariae 100g, Rhizoma Zingiberis 30g, Rhizoma Alismatis 50g, Semen Cuscutae 100g, Radix Gentianae 100g, Semen Plantaginis 70g, Fructus Lycii 100g, Cortex Eucommiae 150g, Rhizoma Pinelliae 30g, Herba Hedyotidis Diffusae 100g, Folium Nelumbinis 100g, Bulbus Lilii 100g, Radix Glycyrrhizae 100g;
Preparation method: get recipe quantity Chinese crude drug and be broken into coarse powder, adding volumetric concentration according to 5 times of coarse powder gross weight is 70% alcoholic solution, reflux, extract, three times, return time is 4h, filters, and after filtrate merges, reclaims ethanol, cold filtration, washes with water, after being dried, obtains Chinese medical concrete; Adding ethanol is 75% (v/v) to containing alcohol amount, standing 24 hours, get supernatant, and reclaim ethanol concentrated, add water to 1000ml, stir evenly, subpackage, flowing steam sterilization 35min, obtains mixture.
Embodiment 5 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: Radix Scutellariae 120g, Radix Notoginseng 120g, Rhizoma Coptidis 100g, Herba Menthae 50g, Radix Ginseng 160g, Poria 180g, Semen Ziziphi Spinosae 130g, Radix Tripterygii Wilfordii 60g, Cortex Magnoliae Officinalis 200g, Fructus Forsythiae 100g, Herba Menthae 80g, Radix Puerariae 160g, Rhizoma Zingiberis 60g, Rhizoma Alismatis 100g, Semen Cuscutae 50g, Radix Gentianae 80g, Semen Plantaginis 70g, Fructus Lycii 80g, Cortex Eucommiae 140g, Rhizoma Pinelliae 100g, Herba Hedyotidis Diffusae 50g, Folium Nelumbinis 150g, Bulbus Lilii 150g, Radix Glycyrrhizae 170g;
Preparation method is with embodiment 4.
Embodiment 6 Chinese medicine composition of the present invention and preparation technology
Write out a prescription composed as follows: Radix Scutellariae 140g, Radix Notoginseng 100g, Rhizoma Coptidis 130g, Herba Menthae 60g, Radix Ginseng 200g, Poria 150g, Semen Ziziphi Spinosae 200g, Radix Tripterygii Wilfordii 30g, Cortex Magnoliae Officinalis 160g, Fructus Forsythiae 110g, Herba Menthae 70g, Radix Puerariae 160g, Rhizoma Zingiberis 70g, Rhizoma Alismatis 110g, Semen Cuscutae 50g, Radix Gentianae 100g, Semen Plantaginis 120g, Fructus Lycii 150g, Cortex Eucommiae 160g, Rhizoma Pinelliae 100g, Herba Hedyotidis Diffusae 150g, Folium Nelumbinis 120g, Bulbus Lilii 180g, Radix Glycyrrhizae 170g;
Preparation technology is with embodiment 4.
(2) drug effect embodiment part
Embodiment 7: Chinese medicine composition of the present invention alleviates radiotherapy side effect clinical research
1 clinical data
1.1 case source and physical data
Selected 99 routine breast tumors are all carried out the patient of comfortable Sanmenxia City tumour hospital treatment, choose and meet the case of inclusive criteria and get rid of simultaneously treatment with chemotherapy person and fasting or the opposition person that takes Chinese medicine, are divided at random treatment group 47 examples, matched group 52 examples.Wherein:
Treatment group 47 examples, male 25 examples, female's 22 examples, 56～79 years old age, average (67.30 ± 7.36) year.Histological type: pulmonary carcinoma 20 examples, the esophageal carcinoma 27 examples.Average (59.33 ± 6.99) Gy of radiological dose.Matched group 52 examples, male 30 examples, female's 22 examples, 54～86 years old age, average (69.60 ± 10.20) year.Histological type: pulmonary carcinoma 24 examples, the esophageal carcinoma 28 examples.Average (58.69 ± 7.49) Gy of radiological dose.Two groups of Genders, sick kind, age, exposure dose statistical analysis, it is approximate that two groups of patient clinical datas distribute, and has comparability.
1.2 inclusion criteria
Inclusive criteria: (1) is clinical clarifies a diagnosis as breast tumor, and determine the patient who carries out radiotherapy; (2) physical function condition grading (KPs) is more than 60 minutes; (3) expect >6 month life cycle.
Exclusion standard: (1) is treatment with chemotherapy medicine person simultaneously; (2) fasting or the opposition person that takes Chinese medicine.
Rejecting standard: (1) is due to irrelevant former of test of cure thereby interrupt radiotherapy or cut out Chinese medicine person; (2) due to other diseases occurring in the course for the treatment of, may cause result bias person.
2 methods
2.1 Therapeutic Method
Treatment group and matched group all give radiotherapy (radioactive source high energy x line: 23EX high energy two-photon accelerator, produced by U.S. VARIAN company) treatment primary tumo(u)r.According to conditions of patients, therapeutic modality is defined as to radical radiation therapy, radical radiation therapy dose,tumor reaches TD40Gy/20 time/4w.In therapeutic process according to the state of an illness need to give oxygen uptake, eliminate the phlegm, bronchodilator etc., concurrent infection and need preventive use antibiotic person to give antibiotic medicine, do if desired Sputum bacterial culture and drug sensitive test to adjust antibiotic, and itemized record patient other medicines treatment information, comprise medicine name, method and dosage.
Treatment group adds with Herbal compound capsule agent of the present invention (embodiment 1) at radiotherapy simultaneously, and taking dose is 30mg/kg.Medical material is provided by Chinese medicine pharmacy of Sanmenxia City tumour hospital, and it is fried that Bing You Chinese medicine pharmacy application Korea S produces DHJ mono-Dl type boiling machine, vacuum packaging, and 4 ℃ of refrigerator storages, the storage life is no more than 7 days.By researcher, provided to patient.Instructions of taking: 1 times/day, 6 doses/week, serveing on 4 weeks was 1 course for the treatment of, took altogether 2 courses for the treatment of, carried out therapeutic evaluation 1 time in every 4 weeks.
Put and observation index 2.2 observing times
The follow-up observation phase is 6 months, respectively before treatment, treatment carries out 1st month, 2 months, 3 months, 6 months time after starting, observe patient's lung radiation injury infringement overall state, patient body functional status, cardinal symptom etc., patient checks at any time if any change of illness state, and review time and result are carried out to record in time.
2.2.1 incidence of radioactive pneumonia
Radiation pneumonia diagnostic criteria: the < < acute radiation pneumonia diagnostic criteria > > (GBZll0-2002) in the national occupational health standard that the diagnostic criteria of radiation pneumonia is issued according to Ministry of Public Health:
(1) pulmonary's radioactive dose is 8Gy above (containing 8Gy);
(2) there are the clinical symptoms such as cough, uncomfortable in chest, chest pain, dyspnea and low grade fever;
(3) sign: the lighter can Non Apparent Abnormality, severe one respiratory murmur reduces, and occurs dry, moist rales.
(4) X-ray examination finds that netted, the irregular fuzzy shape shade in edge appears in exposure pulmonary, or CT scan occurs that ground-glass-like changes and patch shape high density shadow.
2.2.2 evaluate scale
It is index that physical function state evaluation be take the scoring of KPS muscle power situation, and after treatment finishes, KPS scoring increases >=20 and is divided into effectively before treatment, increase by 10 and be divided into improvement, without increase or reduce >=10 be divided into invalid; Tcm symptom is observed the method improvement design that scale provides with reference to Xu Di China < < traditional Chinese medical science Quantitative Diagnosis > >, and cardinal symptom scoring comprises cough, breathes hard, weak classification is scored.
3 results
3.1 incidence of radioactive pneumonia
After chest radiation treatment, there is radiation pneumonia in the routine patient for the treatment of group 8, incidence of radioactive pneumonia is 39.39%, there is radiation pneumonia in the routine patient of matched group 38, incidence of radioactive pneumonia is 53.80%, treatment group patient's incidence of radioactive pneumonia is starkly lower than matched group (P < 0.01), difference has statistical significance, results suggest Chinese medicine compound of the present invention can obviously reduce the incidence rate of radiation pneumonia after chest radiotherapy, has the effect of prevention radiation pneumonia.
The impact of table 1 Chinese medicine composition of the present invention on incidence of radioactive pneumonia in radiotherapy
| Group | Case load | Radiation pneumonia number of cases | Incidence of radioactive pneumonia (%) |
| Treatment group | 47 | 7 | 14.89## |
| Matched group | 52 | 30 | 57.69 |
With matched group comparison, #
#p < 0.01
3.2 liang of group patients ' life qualities improve situation
Treat front two groups of patient Ka Shi scoring no difference of science of statistics (P > 0.05), have comparability, after radiotherapy, after treatment, physical function slightly declines treatment group 1～March, treat the front improvement of physical function state in latter 6 months, be even better than before radiotherapy; And matched group patient is in 6 carrying out property of physical function situation declines in the middle of the month of following up a case by regular visits to, two groups of each monitoring points result difference is obvious, illustrates that Chinese medicine compound side of the present invention can obviously improve patient body function, improves patients ' life quality.
The impact of table 2 Chinese medicine composition of the present invention on radiotherapy Patients Before And After quality of life improvement situation
| Group | Before treatment | January after treatment | February after treatment | March after treatment | June after treatment |
| Treatment group | 82.41±7.54 | 82.15±7.35 | 80.61±5.96 | 80.19±6.31 | 84.59±9.51 |
| Matched group | 81.93±6.85 | 75.64±6.52 # | 73.29±7.24 ## | 71.58±4.29 ## | 70.68±7.58 ## |
With matched group comparison,
#p < 0.05,
##p < 0.01
3.3 traditional Chinese medical science cardinal symptom scorings
Before treatment, two groups of patients cough, breathe hard, the tcm symptom no significant difference (P > 0.05) such as weak, have comparability.Treatment group cough symptom after radiotherapy 1st month the most obvious, symptom is progressively alleviated subsequently, after 6 months, patient's cough shape alleviates before compared with radiotherapy; The symptom of breathing hard is obviously alleviated before treatment for 1st month after radiotherapy, and 2 slightly increased the weight of to 3 months, alleviated subsequently, before treating, breathed hard and obviously improved after 6 months; Weak symptom is fluctuation downward trend in 6 middle of the month of following up a case by regular visits to, treat after 6 months weak treatment before make moderate progress.Matched group is between follow-up period, and carrying out property of every tcm symptom increases the weight of, without improvement trend, and symptom increase the weight of with radiotherapy after the time be proportionate, treatment group is starkly lower than matched group in each monitoring point tcm symptom order of severity, difference has statistical significance.
The improvement of table 3 Chinese medicine composition of the present invention to tcm symptom in radiotherapy
With matched group comparison,
#p < 0.05,
##p < 0.01
Embodiment 8 Chinese medicine composition of the present invention is at the applied research as radiotherapeutic sensitizer
1, test method:
Mice lung cancer Lewis tumor strain cell culture is in RPMI-1640, and 37 ℃, cellar culture under 5%CO2, on average goes down to posterity once for every two days, and during to exponential phase, with normal saline, being prepared into density is 3.0 * 10
7individual/ml single cell suspension, at aseptic condition hemostasis in mouse peritoneal, inoculate latter 7 days and see the obvious enlargement of mouse peritoneal, now, de-neck is put to death, and puts into the beaker that fills 75% ethanol and soaks 2～3 minutes, and the mice after sterilization is put into superclean bench, expose abdominal part, by asepsis injector extraction ascites, put into aseptic reagent bottle standby.Above-mentioned ascites is counted with trypan blue, with normal saline dilution, adjusted cell number to 1.0 * 10
7individual/ml, is inoculated in the right oxter of mice, every 0.2ml.After animal inoculation tumor, after the 4th day, divide into groups: (1) radiotherapy group; (2) radiotherapy+administration Chinese medicine composition group of the present invention, (3) Chinese medicine composition group of the present invention arranges fluorouracil positive controls simultaneously.It is as shown in table 4 that each organizes dosage, and each organizes gastric infusion 1 time (every morning administration), and administration volume is 10mlkg-1; The normal saline of model group gavage equivalent.Successive administration 10 days.
2, experimental result:
This experimental result shows, two dosage groups of Chinese medicine composition height of the present invention all have significant tumor killing effect, and wherein the tumor killing effect of high dose group is close to positive control medicine fluorouracil.When Drug therapy is combined use with radiotherapy, Chinese medicine composition of the present invention and radiotherapy have shown remarkable synergism, and tumor control rate significantly rises.Its synergistic therapeutic effect is significantly due to radiotherapy and fluorouracil therapeutic alliance.This shows the be significantly improved effect of radiotherapy cancerous cell sensitivity of Chinese medicine composition tool of the present invention, is significantly greater than fluorouracil as the curative effect of radiation ancillary drug; Especially Chinese medicine composition 30mgmg/kg of the present invention compares the independent X-ray therapy that does not give Chinese medicine composition and has improved 36% tumour inhibiting rate, and this further shows that Chinese medicine composition of the present invention can be used as the clinical meaning that radiotherapeutic sensitizer is used.
Table 4 Chinese medicine composition of the present invention and radiotherapy share rear tumour inhibiting rate
| Group | Dosage | Tumor heavy (g) | Tumour inhibiting rate (%) |
| Model group | — | 4.52±0.98 | — |
| Radiotherapy group | — | 3.04±0.75 | 32.7 |
| Low group of the present composition | 5mg/kg | 2.86±0.61 | 36.7 |
| High group of the present composition | 30mg/kg | 2.67±0.32 | 40.9 |
| Fluorouracil group | 10mg/m 3 | 2.62±0.36 | 42.0 |
| Low group of radiotherapy+Chinese medicine composition | 5mg/kg | 1.41±0.26 | 68.1 ##** |
| Radiotherapy+Chinese medicine composition object height group | 30mg/kg | 1.06±0.19 | 76.5 ##** |
| Radiotherapy+fluorouracil | 10mg/m 3 | 2.08±0.28 | 54.8 # |
Compare with radiotherapy group,
#p < 0.05,
##p < 0.01;
Compare with compositions use group separately,
*p < 0.05,
*p < 0.01.
Claims (8)
1. the Chinese medicine composition as chemicotherapy sensitizer, it is characterized in that, described Chinese medicine composition is mainly made by the raw material of following weight portion: Radix Scutellariae 8-20 part, Radix Notoginseng 5-15 part, Rhizoma Coptidis 5-15 part, Herba Menthae 3-10 part, Radix Ginseng 10-25 part, Poria 5-15 part, Semen Ziziphi Spinosae 10-20 part, Radix Tripterygii Wilfordii 3-10 part, Cortex Magnoliae Officinalis 10-20 part, Fructus Forsythiae 8-20 part, Herba Menthae 5-12 part, Radix Puerariae 10-20 part, Rhizoma Zingiberis 3-10 part, Rhizoma Alismatis 5-15 part, Semen Cuscutae 3-10 part, Radix Gentianae 3-10 part, Semen Plantaginis 5-12 part, Fructus Lycii 10-15 part, Cortex Eucommiae 10-20 part, Rhizoma Pinelliae 3-10 part, Herba Hedyotidis Diffusae 5-15 part, Folium Nelumbinis 5-15 part, Bulbus Lilii 5-25 part, Radix Glycyrrhizae 10-20 part.
2. Chinese medicine composition as claimed in claim 1, it is characterized in that, described Chinese medicine composition is mainly made by the raw material of following weight portion: 15 parts of Radix Scutellariaes, 10 parts of Radix Notoginseng, 10 parts of Rhizoma Coptidis, 7 parts of Herba Menthaes, 18 parts of Radix Ginsengs, 10 parts, Poria, 15 parts of Semen Ziziphi Spinosaes, 7 parts of Radix Tripterygii Wilfordiis, 15 parts of Cortex Magnoliae Officinalis, 14 parts of Fructus Forsythiaes, 9 parts of Herba Menthaes, 15 parts of Radix Puerariaes, 7 parts of Rhizoma Zingiberiss, 10 parts of Rhizoma Alismatis, 7 parts of Semen Cuscutae, 6 parts of Radix Gentianaes, 8 parts of Semen Plantaginiss, 13 parts of Fructus Lycii, 15 parts of the Cortexs Eucommiae, 7 parts of the Rhizoma Pinelliaes, 10 parts of Herba Hedyotidis Diffusaes, 10 parts, Folium Nelumbinis, 20 parts of Bulbus Liliies, 15 parts, Radix Glycyrrhizae.
3. Chinese medicine composition as claimed in claim 1, it is characterized in that, described Chinese medicine composition is mainly made by the raw material of following weight portion: 8 parts of Radix Scutellariaes, 5 parts of Radix Notoginseng, 5 parts of Rhizoma Coptidis, 3 parts of Herba Menthaes, 10 parts of Radix Ginsengs, 5 parts, Poria, 10 parts of Semen Ziziphi Spinosaes, 3 parts of Radix Tripterygii Wilfordiis, 10 parts of Cortex Magnoliae Officinalis, 8 parts of Fructus Forsythiaes, 5 parts of Herba Menthaes, 10 parts of Radix Puerariaes, 3 parts of Rhizoma Zingiberiss, 5 parts of Rhizoma Alismatis, 3 parts of Semen Cuscutae, 3 parts of Radix Gentianaes, 5 parts of Semen Plantaginiss, 10 parts of Fructus Lycii, 10 parts of the Cortexs Eucommiae, 3 parts of the Rhizoma Pinelliaes, 5 parts of Herba Hedyotidis Diffusaes, 5 parts, Folium Nelumbinis, 5 parts of Bulbus Liliies, 10 parts, Radix Glycyrrhizae.
4. Chinese medicine composition as claimed in claim 1, it is characterized in that, described Chinese medicine composition is mainly made by the raw material of following weight portion: 20 parts of Radix Scutellariaes, 15 parts of Radix Notoginseng, 15 parts of Rhizoma Coptidis, 10 parts of Herba Menthaes, 25 parts of Radix Ginsengs, 15 parts, Poria, 20 parts of Semen Ziziphi Spinosaes, 10 parts of Radix Tripterygii Wilfordiis, 20 parts of Cortex Magnoliae Officinalis, 20 parts of Fructus Forsythiaes, 12 parts of Herba Menthaes, 20 parts of Radix Puerariaes, 10 parts of Rhizoma Zingiberiss, 15 parts of Rhizoma Alismatis, 10 parts of Semen Cuscutae, 10 parts of Radix Gentianaes, 12 parts of Semen Plantaginiss, 15 parts of Fructus Lycii, 20 parts of the Cortexs Eucommiae, 10 parts of the Rhizoma Pinelliaes, 15 parts of Herba Hedyotidis Diffusaes, 15 parts, Folium Nelumbinis, 25 parts of Bulbus Liliies, 20 parts, Radix Glycyrrhizae.
5. Chinese medicine composition as claimed in claim 1, it is characterized in that, described Chinese medicine composition is mainly made by the raw material of following weight portion: 12 parts of Radix Scutellariaes, 12 parts of Radix Notoginseng, 10 parts of Rhizoma Coptidis, 5 parts of Herba Menthaes, 16 parts of Radix Ginsengs, 18 parts, Poria, 13 parts of Semen Ziziphi Spinosaes, 6 parts of Radix Tripterygii Wilfordiis, 20 parts of Cortex Magnoliae Officinalis, 10 parts of Fructus Forsythiaes, 8 parts of Herba Menthaes, 16 parts of Radix Puerariaes, 6 parts of Rhizoma Zingiberiss, 10 parts of Rhizoma Alismatis, 5 parts of Semen Cuscutae, 8 parts of Radix Gentianaes, 7 parts of Semen Plantaginiss, 8 parts of Fructus Lycii, 14 parts of the Cortexs Eucommiae, 10 parts of the Rhizoma Pinelliaes, 5 parts of Herba Hedyotidis Diffusaes, 15 parts, Folium Nelumbinis, 15 parts of Bulbus Liliies, 17 parts, Radix Glycyrrhizae.
6. the Chinese medicine composition as described in as arbitrary in claim 1-5, is characterized in that, described Chinese medicine composition is powder, mixture, tablet or capsule.
7. a method of preparing the arbitrary described Chinese medicine composition of claim 1-5, it is characterized in that, described preparation method comprises the steps: to get recipe quantity Chinese crude drug and is broken into coarse powder, and according to 4～9 times of coarse powder gross weight, adding volumetric concentration is 40%～95% alcoholic solution, reflux, extract, three times, return time is 2～5h, filter, after filtrate merges, reclaim ethanol, cold filtration, wash with water, after being dried, obtain Chinese medical concrete; Those skilled in the art can be at the technical conventional Chinese medicine pharmaceutical dosage form clinically for preparing of this preparation method.
8. the arbitrary described Chinese medicine composition of claim 1-5 is used as the purposes in the medicine of chemicotherapy sensitizer in preparation.
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