CN102579803B - Medicine for treating post-chemotherapy leucopenia and preparation method thereof - Google Patents
Medicine for treating post-chemotherapy leucopenia and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a medicine for treating post-chemotherapy leucopenia and a preparation method thereof. The medicine consists of the following raw materials in part by weight: 2 to 20 parts of ginseng, 5 to 50 parts of astragalus, 5 to 50 parts of gensing, 5 to 50 parts of largehead atractylodes rhizome, 5 to 30 parts of epimedium, 5 to 20 parts of malaytea scurfpea fruit, 5 to 30 parts of Chinese angelica, 5 to 50 parts of suberect spatholobus stem, 5 to 50 parts of medlar, 5 to 30 parts of dwarf lilyturf tuber, 3 to 25 parts of bupleurum, 3 to 35 parts of largetrifoliolious bugbane rhizome and 1 to 15 parts of pangolin scales. According to the preparation method, the Chinese medicinal composition is prepared according to a method for the conventional preparation of Chinese medicines, wherein the conventional preparation comprises a water decoction, an oral liquid, granules, capsules or powder and the like. According to the medicine, a prescription for treating post-chemotherapy leucopenia is created on the basis of clinical experiences of multiple years, and a curative effect is obvious.
Description
Technical field
The present invention relates to a kind of medicine and preparation method thereof, specifically a kind of is the medicine and preparation method thereof of raw material treatment malignant tumor patient leukopenia after chemotherapy with the Chinese herbal medicine.
Background technology
Chemotherapy is one of main method for the treatment of malignant tumor, cancerous cell there are inhibition and lethal effect, but simultaneously normal cell also there is extremely strong lethal effect with organizing, especially the destruction of myeloid element, bone marrow normal hematopoiesis function can not be recovered, cause leucocytes reduction, multiple infection occurs, patient's resistivity descends, and can not tolerate chemotherapy.Therefore, the protection hemopoietic function of bone marrow, the leukocyte increasing number, reduction chemotherapy and carcinous toxin seem particularly important to the damage of hemopoietic system.Treat the leukopenia that is caused by chemotherapeutics in recent years adopts colony stimulating factor to carry out auxiliary treatment more, this type of curative effect of medication significantly but the price comparison costliness, action time is short, curative effect is unstable, side effect is also bigger, as colony stimulating factor except can causing osteodynia, outside the side effect such as leukopenia, also might stimulate the growth of some malignant cell after influenza-like symptom, heating, the drug withdrawal, making has certain limitation in the clinical practice.Other therapies such as hormonotherapy are still arranged in addition, and shortcoming is that curative effect is unreliable and easily bring out infection; Oral vitamin, batilol, leucogen, curative effect is not good enough; A small amount of repeatedly leukocyte is carried or the whole blood conveying, and shortcoming is the expense height, complicated operation, and blood transfusion itself has certain risk again, time-to-live weak point in institute's leucocyte transfusion body, and present blood source scarcity.Doctor trained in Western medicine lacks effect specific medicament preferably for leukopenia after chemotherapy at present.
Summary of the invention
The objective of the invention is for overcoming above-mentioned the deficiencies in the prior art, a kind of abundant raw materials, the medicine of simple, the eutherapeutic treatment leukopenia after chemotherapy of preparation and the preparation method of this medicine are provided.
For achieving the above object, the present invention adopts following technical proposals:
A kind of medicine for the treatment of leukopenia after chemotherapy, it is made up of following raw materials in portion by weight: Radix Ginseng 2-20 part, Radix Astragali 5-50 part, Radix Codonopsis 5-50 part, Rhizoma Atractylodis Macrocephalae 5-50 part, Herba Epimedii 5-30 part, Fructus Psoraleae 5-20 part, Radix Angelicae Sinensis 5-30 part, Caulis Spatholobi 5-50 part, Fructus Lycii 5-50 part, Radix Ophiopogonis 5-30 part, Radix Bupleuri 3-25 part, Rhizoma Cimicifugae 3-35 part, Squama Manis 1-15 part.
The use amount of above-mentioned raw materials increases and decreases in above-mentioned scope according to the difference of patient's concrete condition, and effect is better.
Preferably, it is made up of following raw materials in portion by weight: 3 parts of Radix Ginsengs, 25 parts of the Radixs Astragali, 15 parts of Radix Codonopsis, 20 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Herba Epimedii, 15 parts of Fructus Psoraleaes, 12 parts of Radix Angelicae Sinensis, 25 parts of Caulis Spatholobis, 25 parts of Fructus Lycii, 10 parts of Radix Ophiopogonis, 6 parts of Radix Bupleuri, 6 parts of Rhizoma Cimicifugaes, 3 parts of Squama Maniss.
Preferably, it is made up of following raw materials in portion by weight: 8 parts of Radix Ginsengs, 40 parts of the Radixs Astragali, 30 parts of Radix Codonopsis, 30 parts of the Rhizoma Atractylodis Macrocephalaes, 30 parts of Herba Epimedii, 20 parts of Fructus Psoraleaes, 20 parts of Radix Angelicae Sinensis, 40 parts of Caulis Spatholobis, 35 parts of Fructus Lycii, 20 parts of Radix Ophiopogonis, 20 parts of Radix Bupleuri, 15 parts of Rhizoma Cimicifugaes, 9 parts of Squama Maniss.
Use through reality, the embodiment of effect optimum is:
It is made up of following raw materials in portion by weight: 5 parts of Radix Ginsengs, 30 parts of the Radixs Astragali, 20 parts of Radix Codonopsis, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Herba Epimedii, 15 parts of Fructus Psoraleaes, 15 parts of Radix Angelicae Sinensis, 30 parts of Caulis Spatholobis, 30 parts of Fructus Lycii, 15 parts of Radix Ophiopogonis, 12 parts of Radix Bupleuri, 10 parts of Rhizoma Cimicifugaes, 5 parts of Squama Maniss.
Manufacture method: used Chinese medicine composition is according to the preparation of Chinese medicine conventional formulation method, comprising: water decoction, oral liquid, granule, capsule or powder etc.
Wherein water decoction is that each raw material is mixed in proportion by described weight, adds the water about 1000 weight portions, soaks after 1 hour, fries in shallow oil to water with automatic boiling-machine and remains 1/3 of the former water yield, obtains water decoction.
Powder is that the prepared slices of Chinese crude drugs rinsing of each raw material is clean, and is dry then, disinfection by ultraviolet light, and pulverizer is pulverized.
Capsule is that the clean back of the prepared slices of Chinese crude drugs rinsing of each raw material is dry, and the reuse ultraviolet radiation disinfection with incapsulating after the pulverizing of 300 order pulverizers, carries out capsule ultraviolet radiation again and sterilizes after 30 minutes, obtains capsule preparations (every 0.5g).
Usage and dosage: be example with the capsule, warm water takes when taking, each 6-8 grain, every day 3-5 time.
Function cures mainly: QI invigorating, spleen invigorating, YIN nourishing, the kidney invigorating, invigorate blood circulation, loose long-pending, health invigorating, improve immunity, and be used for the treatment of leukopenia after the chemotherapy.
The present invention is on the basis of clinical experience for many years, and the prescription that leukocyte lowers after effective treatment chemotherapy of foundation is evident in efficacy.
Chinese medicine thinks that chemotherapy belongs to " poison of drug ", and namely patient is after accepting chemotherapy, and pyretic toxicity is crossed Sheng in the body, causes body fluid impaired, disharmony between QI and blood; Poison accumulates in the heresy, injures the vital organs of the human body, causes taste imbalance and deficiency of both the liver and kidney, thus indigestion, whole body loses supports, and resembling of existing deficient depletion then is so the internal organs that all show clinically behind the malignant tumor chemotherapy in various degree lose empty not enough, deficient the resembling of yang blood and qi.Concrete manifestation is as dizzy, weak, shallow complexion, sweating, Mental fatigue, deficient pulse, easy catching a cold etc.The present invention be according to " damage person's benefit, diseases caused by over-strain should be treated by warming " and " the weakened configuration person, warming with drugs of thick nature, the insufficiency of essence person, benefit with blood " etc. the principles of formulating prescriptions draft Therapeutic Method, with benefiting QI and nourishing blood, Yin Yang balancing, strengthening vital QI to eliminate pathogenic factors, alleviate or eliminate chemotherapy to the infringement of body.
Adopting Radix Ginseng in the side is monarch drug, and the Radix Ginseng mildly bitter flavor is warm in nature, goes into spleen, lung two warps, but strongly invigorating primordial QI, supplementing QI for promoting the production of body fluid; Modern pharmacological research confirms that Radix Ginseng has the effect of regulating body's immunity, promotes hemopoietic function of bone marrow, alleviates chemotherapy adverse effect, promotes leukocyte to generate, and prevents the leukopenia that multiple reason causes; Its mechanism of action can stimulate the effect of bone marrow hematogenesis stem/progenitor cells proliferation and differentiation relevant with the ginsenoside.
The Radix Astragali, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Epimedii, Fructus Psoraleae are ministerial drug.The sweet temperature of the Radix Astragali is returned spleen, lung two warps, can mend all empty deficiencies, beneficial vigour, strong taste, and the prosperous then soil of temper can be given birth to gold, and it is real that the lung qi foot is then shown Gu Wei.In Radix Codonopsis invigorating the spleen and replenishing QI, the accent harmonization of the stomach.Modern pharmacological research confirms that the Radix Astragali and Radix Codonopsis have invigorating the spleen and replenishing QI, and the effect of promoting the production of body fluid and nourishing blood can promote the normal body growth, antioxidation, the effect of enhance immunity and inhibition antibacterial.Active polysaccharide in the Chinese medicine ingredients has bigger effect as biological immunomodulator to body's immunity, astragalus polysaccharides and Radix Codonopsis polysaccharide be find at present aspect the immunity of organism adjusting and the representative of anti-tumor aspect with important function, can activating macrophage, breed lymphocyte, promote protein synthesis, bring out interferon or interleukin generation etc.Rhizoma Atractylodis Macrocephalae sweetness and bitterness and temperature, replenishing QI to invigorate the spleen.Modern pharmacological research confirms that the Rhizoma Atractylodis Macrocephalae promotes cellular immune function by improving lymhocyte transformation rate and natural rosette forming rate.Herba Epimedii acrid in the mouth warm in nature, sweet is returned liver, kidney channel, kidney invigorating and YANG supporting; The big temperature acrid in the mouth of Fructus Psoraleae, hardship, tonifying the kidney to consolidate the essence, warming spleen and stopping diarrha, the two share and plays the power that kidney invigorating and YANG supporting, kidney tonifying are filled out marrow altogether.Modern pharmacological research shows, the Herba Epimedii main component comprises Herba Epimedii total flavones, icariine and epimedium brevicornum polysaccharide, Herba Epimedii total flavones can suppress the growth of tumor cell, icariine has transfer and the tumor vascular nucleus formation that suppresses tumor cell, and epimedium brevicornum polysaccharide has tumor growth, the immune cell activated of inhibition, improve effect such as body's immunity.Fructus Psoraleae be used for the treatment of because of put, leukopenia due to the chemotherapy, have to rise white preferably and improve immunization.Four medicines share, and spleen reinforcing kidney, QI invigorating are given birth to marrow, help the principal agent training to mend the congenital and day after tomorrow, kidney essense fills then that function biochemistry does not stop, and QI and blood is vigorous, mends bone and gives birth to marrow, the strong then precise and tiny conversion QI and blood of transporting and transforming nutrients from foodstuff of taste, gastrointestinal reaction can appear in the chemotherapeutics major part, causes not desire feed of patient, declination of stomach-QI, " getting gastric qi then gives birth to; it is then dead to lose gastric qi ", the gas of strengthening the spleen and stomach is the basis that patient can continue to treat, so the agent of invigorating spleen and reinforcing stomach is indispensable in the square medicine.
Radix Angelicae Sinensis, Caulis Spatholobi, Fructus Lycii, Radix Ophiopogonis are adjuvant drug.Radix Angelicae Sinensis is done, suffering, warm, returns liver, the heart, spleen channel, is longer than and enriches blood, and arrogates to oneself blood circulation promoting competent silt again; Caulis Spatholobi property hardship, little doing are returned liver, kidney channel, are the good merchantable brand of promoting the circulation of blood dissipating blood stasis, have the merit of enriching blood concurrently; Two medicines all have the power of the promoting the circulation of blood of enriching blood, and can prevent that the monarch-minister drug tonification too becomes the stasis of blood, avoid blood stasis and cause pain.Modern pharmacological research confirms that Radix Angelicae Sinensis polysaccharide can promote stromal cell synthetic and secrete GM-CSF or the GM-CSF sample material in lymphocyte and the hematopoieticmicroenviron-ment, and then promotes the generation of grain monosystem hemocyte.The suberone that Caulis Spatholobi is contained and alcohols thereof have anticancer, antibacterial and anti-radiation, improve the bone marrow microcirculation, promote proliferation of pluripotent stem cells and differentiation, significantly leukocyte increasing.Then are Fructus Lycii, Radix Ophiopogonis the product of YIN nourishing.Fructus Lycii is sweet, flat, returns liver, kidney channel, and the moon of nourish liver and kidney is the product of the smart liver blood of flat the kidney invigorating, and Radix Ophiopogonis is sweet and slightly bitter taste then, cold nature, and GUIXIN, lung, kidney channel, the energy lung moistening clears away heart-fire and promotes the production of body fluid, and two medicines share the property that can alleviate the monarch-minister drug warm-dryness syndrome, reach YIN and YANG balancing.Modern pharmacological research confirms that Fructus Lycii has hemopoietic, promotes leukocyte to recover and the raise immunity effect.
Radix Bupleuri, Rhizoma Cimicifugae, Squama Manis are messenger drug.Three medicines share as guiding drug, and priming is to whole body.The Radix Bupleuri bitter in the mouth, be slightly cold, return liver, gallbladder meridian, be longer than the gas of the clear sun of elevate a turnable ladder, kindly control diseases such as Mental fatigue heating due to the deficiency of vital energy, anorexia and loose stool, the compatibility Radix Ginseng is invigorating spleen and reinforcing stomach then, and compatibility Rhizoma Cimicifugae then elevate a turnable ladder is positive clearly, and priming is up.Modern pharmacological research confirms that the main active of Radix Bupleuri is saikoside, can bring out the drift that macrophage is assembled, increased macrophage, activation is engulfed, and can be by stimulating the immunomodulating of T lymphocyte and bone-marrow-derived lymphocyte participation body, the non-specific and specific immunoreation of enhancing body.Rhizoma Cimicifugae another name week fiber crops can be spreaded all over whole body.Its salty in the mouth of Squama Manis, cold nature is gone into liver, stomach two warps.Li Shizhen (1518-1593 A.D.) is said: " the Squama Manis bright warp of yin, yang of going into to faint.The ancient prescription using fresh herb, modern times malaria caused by wind pathogen, skin ulcer section, stimulate the menstrual flow, stimulating milk secretion, with being key medicine.Cover this mountain, thing cave and occupy, residence water and eating the moon and goes into sun, can scurry meridians, reaches in sick and dies also." Zhang Xichun " Records of Tradition Chinese and Western Medicine in Combination " cloud: " and the lightly seasoned property of Squama Manis is flat, gas raw meat and scurrying, and the property that it walks to scurry, very careful, so can declare logical internal organs, implement meridians, reach the pass key thoroughly, blood clotting blood is poly-to be disease, all can open it, to control the furuncle carbuncle, uses it boldly and with confidence, produces immediate results." Squama Manis not only has the stimulating milk secretion of stimulating the menstrual flow, eliminating stasis and resolving masses, eliminating carbuncle evacuation of pus, except the effect of anemofrigid-damp arthralgia, the property that traditional Chinese medical science Chang Yiqi walks to scurry is penetrated everywhere, blood circulation and channel invigorating, priming is to whole body.In addition, bibliographical information Squama Manis in many places has the effect of leukocyte increasing concurrently.
The specific embodiment
The present invention will be further elaborated below by instantiation, should be noted that following explanation only is in order to explain the present invention, its content not to be limited.
Embodiment 1
A kind of medicine for the treatment of leukopenia after chemotherapy, it is made up of following raw materials in portion by weight: 3 parts of Radix Ginsengs, 25 parts of the Radixs Astragali, 15 parts of Radix Codonopsis, 20 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Herba Epimedii, 15 parts of Fructus Psoraleaes, 12 parts of Radix Angelicae Sinensis, 25 parts of Caulis Spatholobis, 25 parts of Fructus Lycii, 10 parts of Radix Ophiopogonis, 6 parts of Radix Bupleuri, 6 parts of Rhizoma Cimicifugaes, 3 parts of Squama Maniss.
Preparation method: the prepared slices of Chinese crude drugs rinsing of each raw material is clean, dry then, disinfection by ultraviolet light, pulverizer is pulverized, and makes powder.
Embodiment 2
A kind of medicine for the treatment of leukopenia after chemotherapy, it is made up of following raw materials in portion by weight: 8 parts of Radix Ginsengs, 40 parts of the Radixs Astragali, 30 parts of Radix Codonopsis, 30 parts of the Rhizoma Atractylodis Macrocephalaes, 30 parts of Herba Epimedii, 20 parts of Fructus Psoraleaes, 20 parts of Radix Angelicae Sinensis, 40 parts of Caulis Spatholobis, 35 parts of Fructus Lycii, 20 parts of Radix Ophiopogonis, 20 parts of Radix Bupleuri, 15 parts of Rhizoma Cimicifugaes, 9 parts of Squama Maniss.
Preparation method: each raw material is mixed in proportion by described weight, adds the water about 1000 weight portions, soaks after 1 hour, fries in shallow oil to water with automatic boiling-machine and remains 1/3 of the former water yield, obtains water decoction.
Embodiment 3 (most preferred embodiment)
A kind of medicine for the treatment of leukopenia after chemotherapy, it is made up of following raw materials in portion by weight: 5 parts of Radix Ginsengs, 30 parts of the Radixs Astragali, 20 parts of Radix Codonopsis, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Herba Epimedii, 15 parts of Fructus Psoraleaes, 15 parts of Radix Angelicae Sinensis, 30 parts of Caulis Spatholobis, 30 parts of Fructus Lycii, 15 parts of Radix Ophiopogonis, 12 parts of Radix Bupleuri, 10 parts of Rhizoma Cimicifugaes, 5 parts of Squama Maniss.
Preparation method: with the totally dry and mixing in back of prepared slices of Chinese crude drugs rinsing of each raw material, the reuse ultraviolet radiation disinfection with incapsulating after the pulverizing of 300 order pulverizers, carries out capsule ultraviolet radiation again and sterilizes after 30 minutes, obtains capsule preparations (every 0.5g).
Embodiment 4
A kind of medicine for the treatment of leukopenia after chemotherapy, it is made up of following raw materials in portion by weight: 15 parts of Radix Ginsengs, 15 parts of the Radixs Astragali, 5 parts of Radix Codonopsis, 50 parts of the Rhizoma Atractylodis Macrocephalaes, 5 parts of Herba Epimedii, 10 parts of Fructus Psoraleaes, 30 parts of Radix Angelicae Sinensis, 5 parts of Caulis Spatholobis, 45 parts of Fructus Lycii, 5 parts of Radix Ophiopogonis, 25 parts of Radix Bupleuri, 20 parts of Rhizoma Cimicifugaes, 15 parts of Squama Maniss.
Preparation method: oral liquid be water decoction water boiling and extraction liquid after filtration, remove slag, precipitate, supernatant is added an amount of antiseptic packing makes.
Embodiment 5
A kind of medicine for the treatment of leukopenia after chemotherapy, it is made up of following raw materials in portion by weight: 20 parts of Radix Ginsengs, 10 parts of the Radixs Astragali, 45 parts of Radix Codonopsis, 10 parts of the Rhizoma Atractylodis Macrocephalaes, 10 parts of Herba Epimedii, 5 parts of Fructus Psoraleaes, 5 parts of Radix Angelicae Sinensis, 50 parts of Caulis Spatholobis, 8 parts of Fructus Lycii, 30 parts of Radix Ophiopogonis, 30 parts of Radix Bupleuri, 30 parts of Rhizoma Cimicifugaes, 12 parts of Squama Maniss.
Preparation method: with the totally dry and mixing in back of prepared slices of Chinese crude drugs rinsing of each raw material, the reuse ultraviolet radiation disinfection with incapsulating after the pulverizing of 300 order pulverizers, carries out capsule ultraviolet radiation again and sterilizes after 30 minutes, obtains capsule preparations (every 0.5g).
Usage and dosage: be example with the capsule, warm water takes when taking, each 6-8 grain, every day 3-5 time.
The present invention has significant therapeutic effect for leukopenia after the chemotherapy through clinical and zoopery checking.Carry out following clinical and experimentation with the preferred embodiment capsule below.
One. clinical research
1. clinical data
1.1 physical data is selected to accept to cause leukopenia to 4.0 * 10 after the chemotherapy
9The tumour patient that/L is following, and Kamofsky marked 〉=60 fens.Be divided into each 90 example for the treatment of group and matched group at random.90 examples are organized in treatment, male's 63 examples wherein, women's 27 examples; Age 42-74 year, year mean age (49.43 ± 2.45); Gastric cancer 49 examples, hepatocarcinoma 12 examples, the esophageal carcinoma 7 examples, pulmonary carcinoma 8 examples, mammary cancer 12 examples, colon cancer 2 examples.Matched group 90 examples, male's 65 examples wherein, women's 25 examples; Age 43-72 year, year mean age (47.67 ± 3.27); Gastric cancer 47 examples, hepatocarcinoma 14 examples, the esophageal carcinoma 9 examples, pulmonary carcinoma 6 examples, mammary cancer 10 example, colon cancer 4 examples.Two groups of patient ages, sex, sick kinds are learned processing by statistics, and there was no significant difference (P＞0.05) has comparability.
1.2 the standard of including in is through pathology and the cytology makes a definite diagnosis and accept the tumor patient of chemotherapy in hospital; Peripheral blood leucocyte counting＞2.0 * 10
9/ L, neutrophilic granulocyte counting＞1.0 * 10
9The I degree of/L, II degree patient; The scoring of card labor Paderewski (Karnofsky) behavioral aspect is more than 〉=60 minutes, estimates life cycle＞3 month; The heart, liver, renal function are normal substantially; The clinical trial of experimenter's voluntary participation and informed consent.
1.3 meeting, the case exclusion standard do not include standard person in; The leukopenia person who causes because of other reasonses such as infection, immunity; Peripheral blood leucocyte counting＜2.0 * 10
9/ L, neutrophilic granulocyte counting＜1.0 * 10
9The III degree of/L, IV degree patient; Merge cardiovascular, cerebrovascular, liver, kidney and hemopoietic system and other serious primary diseases; The psychotic; Allergic constitution or to this medicine allergy sufferers; The consenter does not know the inside story.
2. oral medicine of the present invention is organized in the research method treatment, and prescription is formed: 5 parts of Radix Ginsengs, 30 parts of the Radixs Astragali, 20 parts of Radix Codonopsis, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Herba Epimedii, 15 parts of Fructus Psoraleaes, 15 parts of Radix Angelicae Sinensis, 30 parts of Caulis Spatholobis, 30 parts of Fructus Lycii, 15 parts of Radix Ophiopogonis, 12 parts of Radix Bupleuri, 10 parts of Rhizoma Cimicifugaes, 5 parts of Squama Maniss.After making capsule according to preceding method, each 6, every day 3 times; The oral batilol 100mg of matched group, 3 times/d, leucogen 20mg 3 times/d, in addition, treats the medicine of all treatment primary disease of stopping using in preceding 1 week.2 groups is 1 course for the treatment of with 4 weeks all.
3. reach treatment back 2 all peripheral blood leucocyte situations of change before the observation index treatment; Quality of life is estimated before and after the treatment; The T lymphocyte immunologic function changes before and after the treatment; The safety observation index.
4. criterion of therapeutical effect
4.1 the variation evaluation of quantity of leucocyte.The leukopenia degree is pressed the WHO classification.0 degree: leukocyte 〉=4.0 * 10
9I degree: leukocyte＜4.0 * 10
9, 〉=3.0 * 10
9II degree: leukocyte＜3.0 * 10
9, 〉=2.0 * 10
9III degree: leukocyte＜2.0 * 10
9, 〉=1.0 * 10
9IV degree: leukocyte＜1.0 * 10
9Produce effects: continuous 2 numeration of leukocyte 〉=4.0 * 10, treatment back
9/ L, and keep more than 2 weeks; Effectively: treatment back total white blood cells＜4.0 * 10
9/ L, but than (0.5-1.0) * 10 of rising before the treatment
9/ L also keeps more than 2 weeks; Invalid: leukocyte count does not have obvious raising after treating.
4.2 quality of life is estimated.Scoring is drafted with reference to Karnofsky.The muscle power situation: all are normal, do not have uncomfortable disease, 100 minutes; Can carry out normal activity, slight disease is arranged, 90 minutes; Can carry out normal activity reluctantly, some Sxs are arranged, 80 minutes; Life can be taken care of oneself, but can not keep normal activity or heavy work, 70 minutes; Life can most ofly be taken care of oneself, but needs others to help once in a while, 60 minutes; Need others more to help, and often need medical treatment and nursing, 50 minutes; Lose viability, need special treatment and help 40 fens; Seriously lose viability, need to be in hospital, but do not have death threats temporarily, 30 minutes; Seriously ill, need to be in hospital and positive Supporting Therapy 20 fens; Critically ill, 10 minutes; Death, 0 minute.Improve: the treatment back increases 〉=10 fens before the treatment; Descend: the treatment back is reduced 〉=10 fens before the treatment; Stable: as to change＜10 fens before and after the treatment.Treatment is estimated respectively before and after organizing 90 routine patient.
4.3 the variation evaluation of amynologic index.Reach the level that 1 week is respectively monitored 1 T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+/CD8+) in the treatment back before two groups of treatments.
4.4. safety observation index.1. conventional sense index: urine is conventional, stool routine examination, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr).Respectively detect 1 time before and after the treatment.2. adverse events.
5. statistical analysis method.Adopt the SPSS13.0 software kit to handle, enumeration data adopts chi-square criterion, measurement data with
The t check is adopted in expression, is that difference has statistical significance with P＜0.05.
5 results
5.1 two groups of curative effects relatively by table 1 as seen, two groups of total effective rate comparing differences have statistical significance (P＜0.05), and the treatment group is better than matched group.
Table 1 liang group curative effect is (example) relatively
Annotate: compare with matched group,
*P＜0.05
Relatively treatment divides for (54.78 ± 8.46) before organizing 90 routine patient 5.2 treatment group Karnofsky marks, and the treatment back is that (79.96 ± 9.42) are divided, and difference has highly significant meaning (P＜0.01), wherein improves 46 examples, stablizes 41 examples, and 3 examples descend.
5.3 amynologic index relatively by table 2 as seen, contrast CD3+, CD4+, CD4+/CD8+ all raise (P＜0.01) before and after the treatment for the treatment of group, CD8+ descend (P＜0.01); Compare CD3+, CD4+, CD8+, CD4+/CD8+ have no significant change (P＞0.05) after the treatment of control group with before the treatment.The treatment group is better than matched group. results suggest: improve CD3+, CD4+ content, reducing CD8+ expresses, thereby improve CD4+/CD8+ ratio, and CD3+, CD4+, CD8+ are the important indicators of T cell subsets, prompting the present invention can obviously improve body's immunological function, promotion is played therapeutical effect thereby kill and wound oncocyte to tumor to the cellular immunization of tumor.
Table 2 liang group T Cells in Peripheral Blood from Patients subgroup variation (%,
)
Annotate: compare before and after the treatment for the treatment of group:
*P＜0.01; Compare before and after the treatment of control group: #P＞0.05; Compare 2 groups for the treatment of backs: △ P＜0.05
5.4 the ANOMALOUS VARIATIONS relevant with trial drug all do not take place safety evaluatio 1. two groups for the treatment of back urine, stool routine examination, electrocardiogram, liver, renal functioies, (P＞0.05) is analysed in credit by statistics.2. accept in the case of Drug therapy at all, adverse events and serious adverse events take place in none example.
Two, zoopery
1 materials and methods
1.1 60 of animal and grouping cleaning level kunming mices, male and female half and half, body weight 18-22g is divided into 4 groups at random, 15 every group.Be respectively blank group, model group, low dosage medicine group of the present invention, high dose medicine group of the present invention.
1.2 medicine and instrument cyclophosphamide (the permanent auspicious medical company limited production in Jiangsu).The leukocyte diluent, preparation according to a conventional method, (with reference to Li Yikui. herbal pharmacology experimental methodology [M]. Shanghai: Science and Technology of Shanghai publishing house, 1991:251-253).Olympus biological microscope (Japanese Olympus company).Blood cell counting plate.
1.3 it is standby that modeling and medication are diluted to the variable concentrations suspension with medicine of the present invention with normal saline.Totally 18 days this experimental period.Preceding 3 days except matched group, all the other animal lumbar injection 1% cyclophosphamide solution (120mg/kg), matched group lumbar injection equivalent normal saline.4-15 days, matched group and model group were irritated stomach with normal saline 0.4ml/10g, and low dose group is irritated stomach with 5mg crude drug/ml according to 0.4ml/10g, and high dose group is irritated stomach with 10mg crude drug/ml according to 0.4ml/10g, every day 1 time.
1.4 peripheral blood leucocyte (WBC) counting respectively organize mice respectively eye socket get blood 20ul, inject the 4mlWBC diluent, behind the mixing, add in the blood cell counting plate, microscopically is observed in the counting chamber WBC quantity in 4 big grids, and calculates the WBC sum according to following formula.
Computing formula: WBC (10
9/ l)=4 WBC number/4 * extension rate * 10 in the big grid
7
1.5 the statistical procedures data are so that (x ± s) form is represented, two groups of data relatively adopt the t check.
2 as a result in the experimentation model group 1, low-dose drugs group and each 1 dead mouse of high dose medicament group are arranged.The results are shown in Table 3, compare with the normal control group, model control group WBC quantity significantly reduces (P＜0.01); Compare high dose group and low dose group WBC digital display work rising (P＜0.05) with model control group; Compare difference no statistical significance (P＞0.05) between 2 treatment groups.
Table 3 is respectively organized the comparison of mice peripheral hemogram
Annotate: compare with model control group
*P＜0.05,
*P＜0.01.
With the different embodiment of Chinese medicinal capsule of the present invention, in conjunction with following case, the present invention is further described below.
Case 1
The patient finishes certain, man, 68 years old, workman.Cause " pulmonary carcinoma postoperative " is in May, 2008 row " gemcitabine+cisplatin " scheme chemotherapy, and it is white to occur face color Koushi after 2 weeks, and dizziness is weak, soreness of the waist and knees, and cardiopalmus, spontaneous perspiration, it is poor to sleep, and appetite is poor.Blood test routine: leukocyte 3.0 * 10
9/ l.Give the Chinese medicinal capsule agent that the embodiment of the invention 1 is made, each 6, serve on for 2 weeks every day 3 times, the blood test routine: leukocyte rises to 4.2 * 10
9/ l, dizzy, weak, cardiopalmus, spontaneous perspiration, all diseases of dormancy difference are all lost.
Case 2
Patient Zhang, woman, 48 years old, ovarian cancer patients, teacher.Came my section's first visit on August 12nd, 2010.From the cause " the discovery ovarial lump is surplus January " row operative treatment, Pathological diagnoses ovarian serous papillary cystadenocarcinoma, postoperative give docetaxel+carboplatin chemotherapy scheme, carry out for 3 cycles, leukopenia occurs after the 3rd chemotherapy of patient, leukocyte fluctuates in 2.0-3.0 * 10
9/ l, the bone marrow examination no abnormality seen, intramuscular injection recombinant human granulocyte colony stimulating factor 100ug every day 1 time once, be used in conjunction 3 days after leukocyte rise to 3.1 * 10
9/ l.Because of leukopenia, can not continue chemotherapy.Patient's private prosecution breathes hard, uncomfortable in chest, poor appetite, weak, dizzy, cold limbs and aversion to cold.Disease is seen patient's lethargy, shallow complexion, and light red tongue, tongue is greasy in vain, deep-thready pulse.Give the Chinese medicinal capsule agent that the embodiment of the invention 2 is made, each 8, serve on for 2 weeks every day 3 times, in the back 2 week check routine blood test of taking medicine, treat that leukocyte rises to 4.0 * 10
9Continue the row chemotherapy when/l is above, and add we simultaneously in chemotherapy.JIUYUE in 2010 further consultation on the 2nd, check routine blood test leukocyte rises to 4.2 * 10
9/ l prepares to proceed chemotherapy.December was examined on the 12nd again in 2010, told and finished chemotherapy smoothly the 6th time.Advise the patient to obey said medicine in every month again 14 days, and the periodic review routine blood test.
Case 3
Cai, man, 38 years old, rectal cancer patient, peasant.First visit on June 26 in 2010.Medical history: the patient moves in my institute because of " March of having blood in stool, become thin is surplus ", the row sigmoidoscopy is diagnosed as carcinomaofsigmoid, in capable carcinomaofsigmoid radical correction on January 2nd, 2010, postoperative pathology shows: sigmoid colon adenocarcinoma (middle differentiation adenocarcinoma), postoperative is made merry calmly husky+ftorafur+5 cycles of CF scheme chemotherapy, the bone marrow depression of I degree appears in chemotherapeutic period, and leukocyte fluctuates in 3.0-4.0 * 10
9/ l.Examine and see: Mental fatigue is sleepy, limbs fatigue, and tastelessness is dull, and it is shapeless to defecate, shallow complexion, spirit is poor, the tongue dimness, channels stasis of blood purple, yellow and thin fur at the bottom of the tongue are a little less than the stringy pulse.Routine blood test: WBC 3.1 * 10
9/ L; Liver, renal function are normal.Mistake that dialectical genus is insufficiency of the spleen fortune, deficiency of qi and blood, phlegm stagnation in collateral.Give the present invention optimum embodiment (embodiment 3) Chinese medicinal capsule agent, each 6, serve on for 2 weeks every day 3 times, in the back 2 week check routine blood test of taking medicine, further consultation on July 20 in 2010, check routine blood test leukocyte rises to 4.8 * 10
9/ l, no significant discomfort symptom.
Claims (2)
1. medicine for the treatment of leukopenia after chemotherapy, it is characterized in that: it is made up of following raw materials in portion by weight: 5 parts of Radix Ginsengs, 30 parts of the Radixs Astragali, 20 parts of Radix Codonopsis, 25 parts of the Rhizoma Atractylodis Macrocephalaes, 20 parts of Herba Epimedii, 15 parts of Fructus Psoraleaes, 15 parts of Radix Angelicae Sinensis, 30 parts of Caulis Spatholobis, 30 parts of Fructus Lycii, 15 parts of Radix Ophiopogonis, 12 parts of Radix Bupleuri, 10 parts of Rhizoma Cimicifugaes, 5 parts of Squama Maniss; Dosage form is capsule.
2. the preparation method of the medicine of the described treatment leukopenia after chemotherapy of claim 1, method is: with the dry and mixing in the clean back of the prepared slices of Chinese crude drugs rinsing of each raw material, the reuse ultraviolet radiation disinfection, with incapsulating after the pulverizing of 300 order pulverizers, again capsule is carried out ultraviolet radiation and sterilize after 30 minutes, obtain capsule preparations.
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| CN103301211B (en) * | 2013-06-14 | 2015-05-13 | 袁军清 | Traditional Chinese medicine for treating leukopenia |
| CN104623265A (en) * | 2013-11-14 | 2015-05-20 | 王秀杰 | Medicament for treating radiation syndromes and preparation method thereof |
| CN104069396A (en) * | 2014-06-26 | 2014-10-01 | 王在峰 | Traditional Chinese medicine for treating chemoradiotherapy-induced leukopenia |
| CN105853724A (en) * | 2016-06-06 | 2016-08-17 | 孙喜艳 | Chinese herbal preparation for treating leucopenia caused by chemoradiotherapy |
| CN113599425A (en) * | 2021-09-22 | 2021-11-05 | 何彦生 | Traditional Chinese medicine formula for treating leukopenia after chemotherapy |
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Non-Patent Citations (4)
| Title |
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| 《中医药治疗放化疗后白细胞减少症研究进展》;韩旭;《国医论坛》;20080331;第23卷(第2期);50-53 * |
| 中医药治疗恶性肿瘤化疗后白细胞减少的研究述评;钱丹萍;《中医学报》;20110401;第26卷(第4期);391-393 * |
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