CN102078352B - Composition for treating cancers - Google Patents
Composition for treating cancers Download PDFInfo
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- CN102078352B CN102078352B CN2011100202781A CN201110020278A CN102078352B CN 102078352 B CN102078352 B CN 102078352B CN 2011100202781 A CN2011100202781 A CN 2011100202781A CN 201110020278 A CN201110020278 A CN 201110020278A CN 102078352 B CN102078352 B CN 102078352B
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Abstract
The invention relates to a traditional Chinese medicine composition which takes toad-cortex, acanthopanax senticosus extract and paecilomyces hepiali mycelia as active components and is used for treating various cancers, such as solid tumor, preferably liver cancer, lung cancer, breast cancer, esophagus cancer, gastric cancer, nasopharyngeal cancer, ovarian cancer, bladder cancer, rectal cancer, cervical cancer, skin cancer, brain cancer, bone cancer, lymph cancer and the like, further preferably liver cancer, lung cancer, breast cancer, esophagus cancer, gastric cancer, rectal cancer, cervical cancer and lymph cancer, more further preferably liver cancer, lung cancer, esophagus cancer and lymph cancer, and especially liver cancer with the symptoms of liver cirrhosis and ascites and lung cancer with the symptom of pleural effusion. In the invention, the preparation which is prepared from the toad-cortex, the acanthopanax senticosus extract and the paecilomyces hepiali mycelia not only has a marvelous effect on treating intractable diseases (tumors) but also only takes the toad-cortex obtained by the natural molting phenomenon of toads, thereby effectively utilizing the resources and protecting the ecological environment.
Description
Technical field
The present invention relates to use a kind of compositions of treating cancer; Cutin clothing film under Bufo siccus sloughs off naturally specifically is that toad clothing associating Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia are treated cancer, and wherein said composition can be processed dosage forms such as capsule, electuary, tablet, drop and oral liquid as required.
Background technology
Cordyceps Cordyceps sinensis (Berk) Sacc is Stroma and the larva cadaveric complex of Clavicipitaceae fungi autoeciousness on Vespertilio moth insecticide Cordyceps Vespertilio moth larvae; It is the rare Chinese medicine of China's tradition strengthening by means of tonics, in Chinese herbal medicine and health product, uses in a large number.Along with the increasingly extensive and unordered madness that natural cs is used on market is excavated, the resource of natural cs is exhausted just rapidly.China has begun the research work of artificial culture Paecilomyces hepiali Chen et Dai Mycelia in early 1980s, and has obtained remarkable progress.The fungus composition that extraction separation obtains in the artificial fermentation Cordyceps mycelium main source natural cordyceps.So far, microorganism scholar report kind surplus the fungus bacterium pearl of extraction separation and evaluation reaches ten from natural cs, wherein the evaluation again of some strains postmenstruation is same strain in fact.State approval application peacilomyce hepiahi bacterium (Paecilanyces hepiali) and Hirsutlla sinensis bacterium (Hirsutella sinensis) tunning use in Chinese herbal medicine and health product as the Cordyceps mycelium of artificial fermentation at present.Wherein peacilomyce hepiahi bacterium (Paecilanyces hepiali) is by the extensive use in treatment cancer and health product of a plurality of countries such as the U.S., Japan, Korea S.
Because isolated different bacterium pearls on different types of Cordyceps even the same Cordyceps, or the different places of production of same Cordyceps, effective ingredient is often different, and its drug effect or function are also inequality.
In CN101653466A, disclosed the compositions of the treatment cancer that contains toad clothing, Radix Et Caulis Acanthopanacis Senticosi and Cordyceps mycelium, Cordyceps mycelium wherein is natural prodcuts.Receive raw-material restriction; Peacilomyce hepiahi bacterium (Paecilanyces hepiali) that the inventor attempts to use with present state approval and Hirsutlla sinensis bacterium (Hirsutella sinensis) tunning are as the substitute products of Cordyceps mycelium; Its therapeutic effect is wondrous, has accomplished the present invention then.
Summary of the invention
One of main purpose of the present invention provides a kind of compositions evident in efficacy; Be used to treat cancer; The said preparation compositions comprises toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and three kinds of active component of Paecilomyces hepiali Chen et Dai Mycelia; The ratio of the weight of three kinds of active component in compositions is the toad clothing: Radix Et Caulis Acanthopanacis Senticosi extract: Paecilomyces hepiali Chen et Dai Mycelia is 1-5: 3-15: 1-5, the ratio of further preferred weight is: 1: 3.75: 1.25.
Two of main purpose of the present invention is above-mentioned compositions that contain toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia of preparation taking convenience, and said preparation is prepared into common formulations: the form like capsule, tablet, electuary, drop or oral liquid can make things convenient for patient to take.Certainly these preparations can be used as drug administration and also can be used as health food and take.
The specific embodiment
The present composition with containing toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia is treated cancer; Wherein said cancer is a solid tumor; Multiple cancers such as preferred hepatocarcinoma, pulmonary carcinoma, breast carcinoma, esophageal carcinoma, gastric cancer, nasopharyngeal carcinoma, ovarian cancer, bladder cancer, rectal cancer, cervical cancer, skin carcinoma, the brain cancer, osteocarcinoma and lymphatic cancer; Further preferred hepatocarcinoma, pulmonary carcinoma, breast carcinoma, esophageal carcinoma, gastric cancer, rectal cancer, cervical cancer, lymphatic cancer; Further preferred hepatocarcinoma, pulmonary carcinoma, esophageal carcinoma, lymphatic cancer, the pulmonary carcinoma effect of hepatocarcinoma and pleural effusion that liver cirrhosis and ascites have particularly occurred is especially obvious.
The compositions that contains toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia of the present invention can the cost of manufacture those skilled in the art being seen various dosage forms usually; Like capsule, electuary, tablet, drop and oral liquid etc.; Be that particle diameter is at 1200 order to 5000 order superfine powder with toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia pulverizing usually wherein in order to be easy to the body absorption; This superfine powder can obtain through following manner; The mode of certain this acquisition only plays illustrational effect in the present invention, the present invention is not constituted any technical restriction:
The toad clothing is the cutin clothing film under Bufo siccus sloughs off naturally, and owing to different regions, different time, different storage methods, the different methods of gathering and processing, the effective ingredient in the toad clothing that is obtained also has very big difference, and its drug effect is also inequality.The used toad clothing of the present invention must not be placed on rinsing in the water, can farthest keep the benefit materials on toad clothing surface, in CN1331480C, has disclosed the method for gathering and processing of toad clothing.Through detect confirming that per 5 kilograms of toad clothing without rinsing can extract effective total extract of 100 grams, and areal, the toad clothing that the same time gathers and processes, per 5 kilograms are placed in the water rinsing and are processed into complete toad clothing, can extract effective total extract of 60 grams.
Be used for toad clothing acquisition method of the present invention and see that the toad clothing that CN1331480C discloses gathers and processes method.Concrete steps are to become one toad clothing to be placed on a carrier surface wrinkle that collects; Must not be placed on rinsing in the water; Carrier is put into 30 to 70 degrees centigrade of drying baker continuous dryings together with the toad clothing of carrier surface; Make water content≤2.0%, divide in the plastic bag of packing into, promptly get required Chinese crude drug or functional food.The method can farthest keep the benefit materials on Cutis Bufonis surface, and improves collecting efficiency.
Radix Et Caulis Acanthopanacis Senticosi is the dry root and rhizome of Araliaceae Radix Et Caulis Acanthopanacis Senticosi.Radix Et Caulis Acanthopanacis Senticosi and Radix Ginseng belong to Araliaceae together, are sibling species not, have the effect of activating blood circulation to dissipate blood stasis, dredge the meridian passage, can blood vessel dilating, improve the blood flow of parenchymal visceras such as the heart, brain, kidney, increase tissue to anoxybiotic toleration etc.Be used for Radix Et Caulis Acanthopanacis Senticosi extract of the present invention and be water extract or alcohol extract that conventional method is extracted, specifically can referring to (Liang Li's heavily fortified point etc., " experimentation of Radix Et Caulis Acanthopanacis Senticosi extract antitumor action ", the time precious traditional Chinese medical science traditional Chinese medicines, 2006 the 17th the 7th phases of volume).
Collect natural toad clothing, remove impurity, be placed on continuous drying in 60 degrees centigrade of drying baker without rinsing, when water content less than 10%, preferably less than 5%, be more preferably less than at 2% o'clock and pulverize, cross 50 order to 100 mesh sieves, toad clothing coarse powder; Take by weighing " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia " and 50 order to 100 purpose toad clothing coarse powder mixing stirrings; With mix stirring continuous drying in the drying baker that back medicated powder is placed on 60 degrees centigrade; Make water content less than 2%, dried medicated powder is further pulverized again, get 1200 order to 5000 order toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder; Preferred 1200 order to 2000 order toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder; The plastic bag of packing into, sealing, subsequent use.
Or it is subsequent use that the mixture of toad clothing and " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia " is prepared as superfine powder respectively:
The preparation of toad clothing superfine powder: get the natural toad clothing that collects without rinsing, remove impurity, be placed on continuous drying in 60 degrees centigrade of drying baker; When water content less than 10%, preferably less than 5%, be more preferably less than at 2% o'clock and pulverize; Cross 50 order to 100 mesh sieves, get toad clothing coarse powder; Toad clothing coarse powder is further pulverized again, got 1200 order to 5000 order toad clothing superfine powder, preferred 1200 order to 2000 order toad clothing superfine powder, the plastic bag of packing into, sealing, subsequent use;
The preparation of the superfine powder of " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia " mixture: take by weighing " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia " mixes stirring; With mix stirring continuous drying in the drying baker that back medicated powder is placed on 60 degrees centigrade; Make water content less than 2%, further pulverize again, get 1200 order to 5000 orders " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia " superfine powder; Preferred 1200 order to 2000 orders " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia superfine powder "; The plastic bag of packing into, sealing, subsequent use.
Paecilomyces hepiali Chen et Dai Mycelia is to adopt from Qinghai cajaput area to produce separating obtained Clavicipitaceae fungus peacilomyce hepiahi strain Cs-4 bacterial strain the fresh peacilomyce hepiahi bacterium, through the mycelial dried powder of liquid submerged fermentation gained.
Embodiment
Embodiment 1: capsule finished product (containing toad clothing, " Radix Et Caulis Acanthopanacis Senticosi water extract " and " Paecilomyces hepiali Chen et Dai Mycelia ")
Take by weighing toad clothing 10000 grams, remove impurity, be placed on 60 degrees centigrade the interior continuous drying of drying baker, water content was pulverized less than 5% o'clock, cross 50 order to 100 mesh sieves, get toad clothing coarse powder without rinsing; Take by weighing " sting five water and add extract " 3750 grams and mix stirring with 50 order to 100 purpose toad clothing coarse powder, 1000 grams with " Paecilomyces hepiali Chen et Dai Mycelia " 1250 grams; With mix stirring continuous drying in the drying baker that back medicated powder is placed on 60 degrees centigrade; Make water content less than 2%, further pulverize again 1200 order to 5000 order toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder, the plastic bag of packing into; Sealing, subsequent use.Take by weighing 1200 order to 5000 purpose toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia superfine powder 1000 grams, be distributed into 5000 Capsuleses, every contains crude drug 0.2 gram; With above-mentioned capsulation, sealing, irradiation sterilization is capsule finished product.
Embodiment 2: capsule finished product (being the capsule of toad clothing capsule and " Radix Et Caulis Acanthopanacis Senticosi water extract " and " Paecilomyces hepiali Chen et Dai Mycelia " mixture)
Toad clothing capsule: take by weighing toad clothing 5000 grams, remove impurity, be placed on 60 degrees centigrade the interior continuous drying of drying baker, water content was pulverized less than 5% o'clock, cross 50 order to 100 mesh sieves, get toad clothing coarse powder without rinsing; Toad clothing coarse powder is placed on continuous drying in 60 degrees centigrade the drying baker, makes water content less than 2%, further pulverize again 1200 order to 5000 order toad clothing superfine powder, take by weighing toad clothing superfine powder 1000 grams, be distributed into 5000 Capsuleses, every contains crude drug 0.2 gram; With above-mentioned capsulation, sealing, irradiation sterilization is toad clothing capsule finished product.
The capsule of " Radix Et Caulis Acanthopanacis Senticosi water extract " and " Paecilomyces hepiali Chen et Dai Mycelia " mixture: take by weighing " Radix Et Caulis Acanthopanacis Senticosi water extract " 3750 grams and mix stirring with " Paecilomyces hepiali Chen et Dai Mycelia " 1250 grams; With mix stirring continuous drying in the drying baker that back medicated powder is placed on 60 degrees centigrade; Make water content less than 2%, further pulverize again 1200 order to 5000 orders " Radix Et Caulis Acanthopanacis Senticosi water extract " with " Paecilomyces hepiali Chen et Dai Mycelia " superfine powder, the plastic bag of packing into; Sealing, subsequent use.Take by weighing 1200 order to 5000 orders " Radix Et Caulis Acanthopanacis Senticosi water extract " and " Paecilomyces hepiali Chen et Dai Mycelia " superfine powder 1000 grams, be distributed into 5000 Capsuleses, every contains crude drug 0.2 gram; With above-mentioned capsulation, sealing, irradiation sterilization is capsule finished product.
Embodiment 3: the electuary finished product
Take by weighing 1200 order to 5000 order toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder 1000 grams of embodiment 1 gained, added the cane sugar powder 2000 gram mixing and stirring of 80 mesh sieves; An amount of with disintegrating agent, mixing is processed soft material, pushes 8 order to 12 mesh sieves and processes granule, is placed on 60 degrees centigrade the interior continuous drying of drying baker; Make water content less than 2%,, get the granule that sieves after 6 order to 10 mesh sieves; Reuse 60 mesh sieves sieve goes segmentation with material all in one piece, divides the aluminium plastic composite material packing of packing into, and every bag contains crude drug 1.5 grams; The sealing, irradiation sterilization, the electuary finished product.
Embodiment 4, the present invention contain the anti-tumor experiment of the Chinese medicine composition of toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia
1. test objective:
Observe: " toad clothing, Radix Et Caulis Acanthopanacis Senticosi, Cordyceps mycelium " prescription is pressed the CN101653466A preparation hereinafter to be referred as " experiment A group "; " toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia " of the present invention prescription is hereinafter to be referred as " experiment B group "; " toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Hirsutlla sinensis mycelium " prescription is hereinafter to be referred as " experiment C group "; " Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia " prescription is hereinafter to be referred as " experiment D group "; Its compound method is with experiment B group ", and " toad clothing ", " Radix Et Caulis Acanthopanacis Senticosi water extract ", " Paecilomyces hepiali Chen et Dai Mycelia " and " Hirsutlla sinensis mycelium " compare curative effect of Mice Bearing Lewis Lung Cancer, S180 sarcoma and H22 hepatocarcinoma separately.
2. receive the reagent thing:
Title: " experiment A group ", " experiment B group " ", " experiment C group " ", " experiment D group ", " toad clothing ", " Radix Et Caulis Acanthopanacis Senticosi water extract ", " Paecilomyces hepiali Chen et Dai Mycelia " and " Hirsutlla sinensis mycelium ".
The unit of providing: Chanbao Organism Science and Technology Co., Ltd., Shanghai
Sample preparation: get the respective amount sample, add a small amount of Tween 80 hydrotropy, add 0.5%CMC-Na solution to aequum (each dosage 0.5ml/ Mus) more gradually.
3. laboratory animal:
3.1 source kind strain: Kunming mouse, the quality certification number are: " Shanghai is moving closes the card word No. 201 ".C
57The BL/6 mice is provided by Shanghai Chinese Academy of Sciences animal center, and the quality certification number is: " Shanghai is moving closes the card word No. 85 "
3.2 body weight: 19.5 ± 1.5 grams
3.3 sex: take Kunming mouse, male and female half and half, every batch of test is used with a kind of sex.
3.4 number of animals: every group of 10 Kunming mouses.Each test group and positive controls are 10 for every group, and negative control group is 20.
4. tumor source: Mice Bearing Lewis Lung Cancer, S180 sarcoma, H22 liver cancer model, go down to posterity by Chanbao Organism Science and Technology Co., Ltd., Shanghai and to keep.
5. dosage setting:
Clinical trial: respectively establish a dose groups, be 4g/kg dosage, the therapeutic scheme of ig * 10qd.Positive controls cyclophosphamide (CTX) 15mg/kg, negative control group is given corresponding solvent.
6. dosage regimen: test group and matched group are gastric infusion, once a day, and continuous ten days.
7. experimental control:
Negative control is given coordinative solvent.
Positive control is cyclophosphamide (CTX), and the injectable powder that Hua Lian, Shanghai pharmacy group company produces is prepared with normal saline.
8. test key step:
8.1 the subcutaneous vaccination of Mice Bearing Lewis Lung Cancer toes is tested: get eugonic solid tumor mice, aseptic condition takes out tumor down, is prepared into 1-2 * 10 with the homogenate method
7/ ml cell suspension, with the right toes subcutaneous vaccination of the every Mus of corresponding host 0.05ml/ only, about ten day put to death each treated animal by the administration of EXPERIMENTAL DESIGN scheme next day, cuts open to get lotus tumor toes and weigh, and calculates tumor control rate by following formula:
Tumor control rate=(the average tumor of the average tumor weight/matched group of the average tumor weight-administration of matched group group is heavy] * 100
8.2 the clinical trial to S180 sarcoma and H22 hepatocarcinoma axil subcutaneous vaccination solid tumor: get eugonic solid tumor mice, aseptic condition takes out tumor down, is prepared into 1-2 * 10 with the homogenate method
7/ ml cell suspension, with the right axil subcutaneous vaccination of the every Mus of corresponding host 0.2ml/ only, about ten day put to death each treated animal by the administration of EXPERIMENTAL DESIGN scheme next day, cuts open to get tumor and weigh, and calculates tumor control rate by following formula:
Tumor control rate=(the average tumor of the average tumor weight/matched group of the average tumor weight-administration of matched group group is heavy] * 100
Table 1. sample is to one of inhibition test of Mice Bearing Lewis Lung Cancer (toes subcutaneous vaccination)
Compare * * * P＜0.01 with negative control group
Table 2 sample is to two of the inhibition test of Mice Bearing Lewis Lung Cancer (toes subcutaneous vaccination)
Compare * * * P＜0.01 with negative control group
Table 3. sample is to one of inhibition test of mice S180 sarcoma
Compare * * * P＜0.01 with negative control group
Table 4. sample is to two of the inhibition test of mice S180 sarcoma
Compare * * * P＜0.01 with negative control group
Table 5. sample is to one of inhibition test of mice H22 hepatocarcinoma
Compare P＜0.01 with negative control group
Table 6. sample is to two of the inhibition test of mice H22 hepatocarcinoma
Compare P＜0.01 with negative control group
9. result of the test:
Experiment A group, experiment B group, experiment C group, experiment D group, toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia and Hirsutlla sinensis mycelium sample are irritated stomach single-dose one day to kunming mice and with the therapeutic scheme of 4g/kg dosage ig * qd twice of Mice Bearing Lewis Lung Cancer toes subcutaneous vaccination are tried the experimental result tumour inhibiting rate and see table 1,2 and figure one for details;
Experiment A group, experiment B group, experiment C group, experiment D group, toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia and Hirsutlla sinensis mycelium sample see table 3,4 and figure two for details to S180 sarcoma experimental result tumour inhibiting rate;
Experiment A group, experiment B group, experiment C group, experiment D group, toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia and Hirsutlla sinensis mycelium sample to the anti-tumor experiment of H22 hepatocarcinoma as a result tumour inhibiting rate see table 5,6 and figure three for details.
10. test brief summary:
10.1. it is similar with negative control group that experiment A group, experiment B group, experiment C group, experiment D group, toad clothing, Radix Et Caulis Acanthopanacis Senticosi water extract, Paecilomyces hepiali Chen et Dai Mycelia and Hirsutlla sinensis mycelium sample the weight of animals when clinical trial changes, and has certain safety so sample is respectively organized in prompting.
10.2. " experiment A group " antitumor test reaches about 70% Mice Bearing Lewis Lung Cancer, S180 sarcoma and H22 liver-cancer solid tumor antitumous effect;
" experiment B group " experiment antitumor test reaches about 80% Mice Bearing Lewis Lung Cancer, S180 sarcoma and H22 liver-cancer solid tumor antitumous effect;
" experiment C group " experiment antitumor test reaches about 60% Mice Bearing Lewis Lung Cancer, S180 sarcoma and H22 liver-cancer solid tumor antitumous effect;
" experiment D group " antitumor test reaches about 50% Mice Bearing Lewis Lung Cancer, S180 sarcoma and H22 liver-cancer solid tumor antitumous effect;
The toad clothing ", the test of " Radix Et Caulis Acanthopanacis Senticosi water extract ", " Paecilomyces hepiali Chen et Dai Mycelia " and " Hirsutlla sinensis mycelium " experiment antitumor reaches about 30%-35% Mice Bearing Lewis Lung Cancer, S180 sarcoma and H22 liver-cancer solid tumor antitumous effect.
Experimental result shows that " experiment B group " sample truly has stronger antitumor action, has the prospect of replacement " experiment A group " and " experiment D group ".And experiment all has repeatability.
Implement 5. experiment E, two groups of treatments of F late malignant tumour, 1300 examples
Tentatively add up from a year August in May, 2007 to 2010; Adopt toad clothing associating Radix Et Caulis Acanthopanacis Senticosi water extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder capsule and Radix Et Caulis Acanthopanacis Senticosi water extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder capsule for treating late malignant tumour 1300 examples; And with merely with doctor trained in Western medicine put, 650 examples of chemotherapeutic treatment contrast; Observe its lump size, pain relief degree and leukocyte and have or not variations such as up-down; The result tests that two groups of treatments of E, F late malignant tumour all is superior to putting merely, chemotherapy group, and toad clothing associating Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder capsule effect are especially obvious.The existing statistics as follows:
1, physical data
This is organized 1300 examples and is the hospitalization patient, is diagnosed as late malignant tumour through histopathology or CT examination.Gastric cancer 270 examples wherein, pulmonary carcinoma 248 examples, hepatocarcinoma 243 examples, esophageal carcinoma 213 examples, rectal cancer 192 examples, malignant lymphoma 180 examples, cervical cancer 124 examples, mammary cancer 1 25 examples, nasopharyngeal carcinoma 113 examples, ovarian cancer 94 examples, bladder cancer 79 examples, skin carcinoma 69 examples.Be divided into experiment E group, F group and each 650 example of matched group at random.Experiment E group, F organize in 1300 examples male's 708 examples, women's 596 examples; The oldest 79 years old, minimum 20 years old, average 59 years old; The course of disease is the longest 550 days, and is the shortest 22 days, and average 76 days, in matched group 650 examples, male's 359 examples, women's 291 examples, the oldest 79 years old, minimum 21 years old, average 57 years old, the course of disease was the longest 528 days, and was the shortest 26 days, average 72 days.
2, Therapeutic Method
Toad clothing associating Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder capsule, hereinafter to be referred as: experiment E group;
Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder capsule, hereinafter to be referred as: experiment F group.
Matched group adopts doctor trained in Western medicine conventional radiotheraphy, chemotherapeutic treatment, and carries out anti symptom treatment.Experiment E group: on the basis of matched group conventional therapy, add with toad clothing associating Radix Et Caulis Acanthopanacis Senticosi water extract and the treatment of Paecilomyces hepiali Chen et Dai Mycelia superfine powder capsule oral.Every day 3-4 time.The composition capsule of 1 toad clothing superfine powder capsule of each clothes and 5 Radix Et Caulis Acanthopanacis Senticosi water extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder, every is respectively 0.2g; Experiment F group: on the basis of matched group conventional therapy, add with Radix Et Caulis Acanthopanacis Senticosi water extract and the treatment of Paecilomyces hepiali Chen et Dai Mycelia superfine powder capsule oral.Every day 3-4 time.The composition capsule of 5 Radix Et Caulis Acanthopanacis Senticosi water extract of each clothes and Paecilomyces hepiali Chen et Dai Mycelia superfine powder, every 0.2g; Two groups are all treated 60 days was 1 course of treatment.
3, therapeutic outcome
(1) variation of cancerous protuberance: lump dwindles or is temporary transient controlled for effective, and lump does not dwindle or continues and increases to invalid.The result: experiment E group 350 examples are effective, and 300 examples are invalid, total effective rate 53.85%; Experiment F group 311 examples are effective, and 339 examples are invalid, total effective rate 47.85%; Matched group 128 examples are effective, and 522 examples are invalid, total effective rate 19.69%.(seeing accompanying drawing four)
(2) analgesic effect: pain relief or part are alleviated to effective, and pain is not controlled to be invalid.The result: experiment E organizes 297 examples effectively, and 353 examples are invalid, total effective rate 45.69%, and experiment F organizes 279 examples effectively, and 371 examples are invalid, total effective rate 42.92%, matched group 196 examples are effective, and 454 examples are invalid, total effective rate 30.15%.(seeing accompanying drawing five)
(3) numeration of leukocyte changes: WFC counts 4.0 * 10
9/ L～10 * 10
9/ L is that effectively WFC counts less than 4.0 * 10
9/ L is invalid, the result: experiment E group 348 examples are effective, and 302 examples are invalid, total effective rate 53.54%; Experiment F group 313 examples are effective, and 337 examples are invalid, total effective rate 48.15%; Matched group 23 examples are effective, and 627 examples are invalid, total effective rate 3.54%.(seeing accompanying drawing six)
Experiment E group and F group are at the clinical effectiveness of treatment late malignant tumour 1300 examples
4. typical medical record
4.1 patients with lung cancer: Huang man Tongzhou diformazan people from town of 63 years old Jiangsu Province
The patient sputum mixed with blood phenomenon occurs in August, 2007, and cough is serious, comes the inspection of Nantong City tumour hospital on JIUYUE 3rd, 2007, is diagnosed as pulmonary carcinoma late period, and there are a plurality of tumors such as 6.2 * 4.8cm, 3.2 * 2.2cm in pulmonary.Because it is later that the state of an illness is made a definite diagnosis, and tangible transfer phenomena is arranged, lost the chance of operation, begin chemotherapy after the week, but chemotherapy is only two days later, serious toxic and side effects has appearred in the patient, and vomiting is severe, and leukocyte index decreased to 3800 stops chemotherapy.Begin to take " experiment E group " of the present invention compositions, every day 3 times, 6, every 0.2 gram; Obeyed back 30 days, patient's appetite is clearly better, and the cough frequency also obviously reduces, beginning dosage examination clothes after month; Every day 4 times, each 6, after 60 days; Patient oneself goes tumour hospital's check, and the big tumor of pulmonary is reduced into 2.2 * 1.1cm, leukocyte index 6200.On January 20th, 08, last check was shown: lung tumors is 1.3 * 0.8cm, leukocyte index 7300, and existing patient takes care of oneself.
4.2 patients with lung cancer: Liu so-and-so woman 51 years old Shanghai City people from Baoshan District
The patient is in December, 08, and often cough is more than.In February, 09, the state of an illness still is degradating trend, cough companion hemoptysis, chest pain, hypopnea.In on March 21st, 09 at Shanghai Chest Hospital's CT examination: the lung right lower lobe has an obvious lump, and companion's hydrothorax is diagnosed as advanced lung cancer.Received treatment in hospital March 26.March 30, the patient carries out the lung tumor resection operation, and postoperative is accepted chemotherapy twice.Because the intensive toxic and side effects of chemotherapy, leukopenia to 3500 can not continue chemotherapy, uses treatment by Chinese herbs instead.June 18 required down the patient, every day 4 times, and 6 of each examination clothes the present invention " experiment E group " composition capsules, every 0.2 gram was obeyed back 60 days, and conditions of patients begins stable gradually, and the hemoptysis phenomenon alleviates gradually, and appetite is clearly better.Serve on 120 days, chest pain, cough phenomenon disappear, and hydrothorax disappears, and breathes unimpeded.Through following up a case by regular visits to 1 year, it is normal that patient body recovers more.
4.3 liver cancer patient: Tang so-and-so man 45 years old Jiangsu people from Haimen City
The patient feels liver's pain in February, 2008.March layman on the 1st accompanying under come Haimen City institute of traditional Chinese medicine inspection, CT shows liver's malignant tumor, the lump 10.6 * 9.8CM of liver, the multiple huge property tumor of 7.6 * 4.8CM, AFP is greater than 2500, the interventional therapy scheme is carried out in hospital's suggestion.Because patient's family economical condition is poor, can't carry out interventional therapy.March 6, the patient began every day 4 times, 6 of each examination clothes the present invention " experiment E group " compositionss, every 0.2 gram; Serve on back 90 days, go the check of Haimen City institute of traditional Chinese medicine, CT shows: liver's tumor is reduced into 6.8 * 5.6CM, 3.2 * 2.5CM; Albumen recovers normal value; AFP is less than 500, and pain disappears, and liver does not have ascites; Took continuously 120 days, and went the check of Haimen City institute of traditional Chinese medicine, CT shows: liver's tumor is reduced into 3.0 * 2.5CM, 2.1 * 1.1CM; Albumen recovers normal value, and AFP is less than 20, and other each item indexs are all normal; Hospital doctor is surprisingly asked the patient, and you do not do interventional therapy, and it is so fast that tumor is dwindled; Eaten what medicine, the patient also as tell the truth: " what I ate is not medicine, is to have eaten a kind of health product to add the toad clothing ".
4.4 esophageal carcinoma Chen woman 43 years old Jiangsu Haimen, Haimen City people from town
After patient 2006 suffered from " esophageal carcinoma " operative treatment, in May, 2008 was through Shanghai Changhai Hospital inspection diagnosis: " esophageal carcinoma recurrence, hepatic metastases ", in December, the 2008 stream juice of can only taking food, hepatalgia, the about 5.7 * 3.3cm of liver's tumor.December in 2008 beginning on the 12nd examination every day clothes the present invention " experiment E group " compositions, every day 3 times, each 6, every 0.2 gram serve on about 30 days, and hepatalgia alleviates gradually, and sleep takes a turn for the better.Back escalated dose, every day 4 times, each 6, followed up a case by regular visits to that the patient is in high spirits on July 1st, 2009, hepatalgia disappears, liver's lump has the sensation of dwindling.Conditions of patients is stable now, and the cervical region lymph tumor disappears, and lives the same life of healthy subjects.
4.5 so-and-so jiangsu wuxi people from city of gastric cancer Jiang
The patient is in June, 2007, the indistinct pain of stomach, and anorexia, the People's Hospital is diagnosed as by Wuxi City: early gastric cancer.Carried out full stomach operation on June 25, it is more successful to perform the operation.After 1 year, carry out the CT check in July, 2008 at Shanghai Changhai Hospital, the report prompting: right lung is seen a plurality of lesser tubercle, mediastinal lymph node enlargement.Diagnosis: the postoperative gastric cancer lung shifts.On July 10th, 2008 was lived in Shanghai Changhai Hospital, carried out chemotherapy, through 4 chemotherapy, did not see to be clearly better that body weight obviously reduces.The patient begins to take the present invention's " experiment E group " compositions every day at the beginning of 2009 1 month, and every day 4 times, each 6, every 0.2 gram serve on about 30 days, and weight in patients obviously increases.Continued serve on 60 days, and the side effect of sensation chemotherapy obviously alleviates, and feels sick, phenomenons such as vomiting, alopecia disappear.Check on May 6, the CT finding: lung tumor and anter (contrast) obviously dwindle.On December 12nd, 2009, and CT reports demonstration: multiple nodules disappears in the former lung, and conditions of patients is effectively controlled.The patient is in after treatment now.
4.6 the esophageal carcinoma lung shifts so-and-so 43 years old Tongzhou District people of male Nantong City of Pan
The patient is in June, 08, and having a meal often has the sense of obstruction, and number of times is more and more frequent after one month, and feeling has pain.July 12, to make a definite diagnosis be that esophageal carcinoma shifts pulmonary carcinoma to tumour hospital's detailed inspection through the Nantong City, and hospital's suggestion is not performed an operation; Do not do chemotherapy; The suggestion treatment by Chinese herbs of can only going home to adopt has been eaten the Nantong Chinese medicine and has been opened Chinese medicine several times, each 21 days; Yet Chinese medicine does not let the patient feel to take a turn for the better, and uncomfortable in chest on the contrary, cough increases the weight of gradually.The patient produces desperate thought at the beginning of 08, refuses a treatment in month.On February 12nd, 08, advice following every day of examination clothes the present invention " experiment E group " compositions of patient layman, every day 4 times, each 6, every 0.2 gram serve on about 60 days, and patient's appetite increases, whole people's spiritedness, uncomfortable in chest, cough alleviates.Serve on 90 days, weight ratio had increased by 8 jin in the past.Through following up a case by regular visits to 1 year, the patient does not a bit see it being a cancer patient more.
4.7 gastric cancer money so-and-so woman 48 years old Jiangsu people from Yangzhou
The patient is in January, 2008, because of epigastrium glutted, pain 45 days.February 19 in 2008, Nikkei Yangzhou institute of traditional Chinese medicine CT scan was diagnosed as gastric cancer, found that there is the focus about 4.5cm in lesser gastric curvature portion, a plurality of positions such as neoplasm metastasis liver, abdominal cavity.Hospital carries out chemotherapy for the patient, and through 2 chemotherapy, chemotherapy produces very big side effect, after abandon chemotherapy.On May 25th, 08, the household sees that the patient can't bear the side effect of chemotherapy, examination every day clothes the present invention " experiment E group " compositions, and every day 4 times, each 6, every 0.2 gram serve on about 60 days, and the patient has rosy cheeks, and body weight obviously increases.Through check, about lesser gastric curvature tumor 2.5cm, the tumor at a plurality of positions such as lymph, head of pancreas, abdominal cavity disappears.Follow up a case by regular visits to more than a year, the patient can take part in the work.
4.8 40 years old Qidong City people of Jiangsu Province of so-and-so man of lymphatic cancer beam
The patient finds that at the beginning of 08 the left side cervical region is hard with the no tenderness of hands touch, matter; After Qidong City People's Hospital is diagnosed as " malignant lymphoma "; Cervical region has 3.8 * 3.2cm and 2.8 * 2.5cm multiple tumor, and hospital's suggestion chemotherapy is because household economy is not rich; The patient abandons chemotherapy, takes the Chinese medicine expectant treatment.Began examination clothes the present invention " experiment E group " compositions on March 26, every day 4 times, each 6, every 0.2 gram serve on about 60 days, and hands is touched left side cervical region and left abdomen thigh to be had obviously and dwindle.After taking 120 days, go Qidong City People's Hospital check, the left neck tumor is contracted to 1.5 * 1.5cm, JIUYUE 20 the daily inspection result: left neck lump size: 0.5 * 0.5cm, and do not have any transfer sign.
4.9 pulmonary carcinoma companion bone marrow extensively shifts 62 years old retired cadre of Haidian District Beijing people office of so-and-so man of Wu
The patient begins to feel chest pain in January, 2008, can be As time goes on, and the state of an illness is more and more serious, loses weight more than 8 jin; The household realizes in bad order, goes to hospital to be PET-CT, and check pathological section, is diagnosed as many places such as lung cancer metastasis bone; Lose the surgical engine meeting, chemotherapy is carried out in hospital suggestion since the age higherly add that the side effect of chemotherapy is too big, just chemotherapy 1 time; Just occur to feel sick, vomiting, appetite be very poor, leukocyte reduces to 3500, have to go home to take good care of, lie on a bed all day.Began to take the compositions of the present invention's " experiment E group " on March 2nd, 08, every day 3 times, each 6, every 0.2 gram serve on about 60 days, and miracle has occurred after two months, felt sick, vomiting, pain phenomenon alleviate gradually.The own escalated dose of patient, 4 times on the one, each 6, glowing with health now, spirit is good, and body weight obviously increases, and through following up a case by regular visits to 1 year, the patient is the same with the normal person, does not also do inspection more.
4.10 cancer of pancreas shifts so-and-so woman 46 years old Jiangsu Haimen people of liver, stomach Shen
The patient is in March, 2008, and in upper left one week of abdomen severe pain, the liver and gall hospital diagnosis is through east, Shanghai: cancer of pancreas shifts the liver stomach function regulating.The patient loses the surgical engine meeting, only carries out chemotherapy, and chemotherapy just begins for the 2nd time, and leukocyte just will arrive 3200, abandon chemotherapy, and the doctor says and goes home to have additional nutrients, takes a good rest.Began to take the compositions of the present invention's " experiment E group " on May 2, every day 3 times, each 6, every 0.2 gram serve on more than 60 day; The people feels spiritedness, and it is also many day by day to have a meal, the own escalated dose of patient on July 18,4 times on the one; Each 6, December went the check of east, Shanghai liver and gall hospital on the 11st, and the tumor at pancreas, the original position of liver stomach function regulating is dwindled, and the doctor tells the patient that miracle has occurred; Leukocyte rises to 6800, and AFP is less than 20, weight increase 12 jin, everyway is fine now.
4.11 rectal cancer turns round and look at 52 years old Haining City people of Zhejiang Province of so-and-so woman
The patient feels dyschesia in March, 2008; Zhejiang Prov. Tumor Hospital is diagnosed as rectal cancer and shifts hepatocarcinoma; It is that repeatedly metastatic tumour has been arranged that family numbers of patients is considered, the refusal operative treatment goes home to lean on some Chinese patent medicines to carry out expectant treatment; Beginning to occur stool band blood evening May 25 has mucus, and having an intense pain at the beginning of 7 months is difficult to fall asleep.Same month 18 began to take the compositions of the present invention's " experiment E group ", every day 4 times, each 6, every 0.2 gram; Serve on more than 30 day, pain alleviates gradually, and the hemorrhage recovery gradually of defecating is normal, 6 jin of weight increase; Oneself can hold up implantation to walk about, through 120 days treatment, patient's pain disappeared, and body weight obviously increases by 5 kilograms; Spirit appetite also is clearly better, and it is normal that stool recovers fully, can do housework.
4.12 ovarian cancer turns round and look at so-and-so the woman Nanjing people national public servants of 32 years old Jiangsu Province
The patient feels lower abdomen pain in March, 08, and stomachache, and inappetence is weak, after Jiangsu Prov. Tumour Hospital's CT examination shows; There are 6.5 * 6.3cm and two tumors of 6.6 * 4.5cm in the ovary position, is diagnosed as ovarian cancer, through 3 chemotherapy, leukocyte index decreased to 3600, the state of an illness increases the weight of, and feels sick, exerts one's utmost effort, what does not all feel like eating, body weight obviously reduces, after have to abandon chemotherapy.At the beginning of 8 months the same years, have the psychology of trying in arms, examination clothes the present invention's " experiment E group " compositions, every day 3 times; Each 6, every 0.2 gram serve on more than 30 day, and weight in patients obviously increases; Through Jiangsu Prov. Tumour Hospital's inspection, ovary position tumor is reduced into 3.1 * 2.2cm and 3.4 * 1.8cm respectively, back escalated dose, 4 times on the one; Each 6, continued to take 90 days, go Jiangsu Prov. Tumour Hospital's check in February, 2009; Ovary position tumor disappears basically, and all other indexs are all normal, and body weight has also increased more than 10 jin.Through following up a case by regular visits to, the patient gets back to original work unit, and the leader of unit considers that the patient is bit strip tumor existence patient, has arranged the less work of a operating pressure to her.
4.13 45 years old Shanghai City Jiading District people of breast carcinoma Lin woman
The patient is in JIUYUE, 2007, and patient oneself finds that breast is red and swollen, has pain; The examination in hospital through area, Jiading finds that left breast has a plurality of low echo lumps, maximum about 3.3 * 2.4cm; Obscurity boundary, form is irregular, and internal echo is uneven; Come the inspection of Shanghai chest hospital on JIUYUE 14 and be diagnosed as malignant breast carcinomas, left subaxillary lymphadenectasis.Examination clothes the present invention's by the end of September " experiment E group " compositions, every day 3 times, each 6; Every 0.2 gram serve on more than 30 day, the red and swollen disappearance of patient left side breast; Maximum on inspection tumor is reduced into 1.5 * 1.1cm, and continued is taken the compositions of the present invention's " experiment E group ", every day 4 times; Each 6, every 0.2 gram, the complete obiteration of 6 months rear udder attachment tumors.
4.14 cancer of pancreas Chen woman people from Nantong City of 70 years old Jiangsu Province
The patient begins to occur phenomenons such as stomachache, inappetence, weight loss in March, 08, and institute of traditional Chinese medicine's inspection is diagnosed as cancer of pancreas through the Nantong City, and tumor is about 4.4 * 3.1cm, and the doctor advises chemotherapy, and chemotherapy does not finish for the first time, and the patient refuses to continue chemotherapy.Examination on April 5th, 2008 clothes the present invention's " experiment E group " compositions, every day 4 times, each 6, every 0.2 gram; Serve on more than 30 day, patient's mental status takes a turn for the better, and appetite increases; Pain disappears basically, serve on 3 months, weight increase 12 jin; Institute of traditional Chinese medicine's check knot through Nantong: tumor is reduced into 1.8 * 1.3cm, and physical recovery is good, and each item index is all normal.Hospital's suggestion continues to take the compositions of invention " experiment E group ", and through following up a case by regular visits to, the patient can take part in the work.
Sum up
Through a large amount of zooperies with to treating the clinical observation of late malignant tumour, the inventor sums up following some cognition:
1, toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract, Paecilomyces hepiali Chen et Dai Mycelia compositions reach about 80% at the antitumous effect to kunming mice Lewis lung cancer, S180 sarcoma, H22 hepatocarcinoma; And do not find a routine animal dead, and when clinical trial, the weight of animals increases obviously, the hair color light, convenient to both normal, do not find toxic side effect.
2, toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract, Paecilomyces hepiali Chen et Dai Mycelia compositions are in the clinical observation of treatment 1300 routine late malignant tumours; Find that it dwindles lump or temporary transient controlled percentage rate is 53.85%; The percentage rate that pain relief or part are alleviated is 45.69%, and the percentage rate that numeration of leukocyte changes reaches 53.54%.And the total effective rate of matched group difference 19.69%, 30.15% and 3.54%.Prompting toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract, Paecilomyces hepiali Chen et Dai Mycelia compositions have the good antitumor effect; Suitable cooperation is put, chemotherapy is carried out comprehensive diagnosis and treatment; Said composition can play the effect of efficacy enhancing and toxicity reducing, and the part patient tumors is dwindled obviously, the most of patients weight increase; The existence of band tumor, the complete obiteration of individual patient tumor.But also some is that the patient with advanced cancer tumor continues to increase, and is uncontrollable.
3, toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract, Paecilomyces hepiali Chen et Dai Mycelia compositions are in the clinical observation of treatment late malignant tumour; The clinical onset of action time of finding said composition and the length of Time of Administration and to take dosage closely related; Usually taking 1 toad clothing superfine powder capsule and 5 Radix Et Caulis Acanthopanacis Senticosi extracts, Paecilomyces hepiali Chen et Dai Mycelia superfine powder composition capsule at every turn; Every day 3-4 time, clinical efficacy is comparatively obvious when taking 45-60 days, and it is more obvious to continue to strengthen the treatment curative effect.
4, toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract, Paecilomyces hepiali Chen et Dai Mycelia compositions find that analgesic effect is not so good as domestic existing Western medicine in the said composition short time, but the Western medicine life-time service have dependency in the clinical observation of treatment late malignant tumour.And the onset time of said composition analgesic effect is longer, but no dependence, and lasting analgesic effect is arranged after the drug withdrawal.
Significant curative effect has bigger DEVELOPMENT PROSPECT to the compositions that contains toad clothing, " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia " of the present invention having shown unique aspect the treatment cancer.
Claims (5)
1. compositions that is used to treat cancer; It contains toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and three kinds of active component of Paecilomyces hepiali Chen et Dai Mycelia; Wherein the ratio of toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and the Paecilomyces hepiali Chen et Dai Mycelia weight in compositions is 1: 3.75: 1.25, and described Radix Et Caulis Acanthopanacis Senticosi extract is the Radix Et Caulis Acanthopanacis Senticosi water extract.
2. compositions as claimed in claim 1, the cancer of wherein being treated is a solid tumor.
3. compositions as claimed in claim 1, wherein said toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia are that 1200 orders-5000 purpose superfine powder form exists with particle diameter.
4. compositions as claimed in claim 1 is to take in order or unite and take when needed patient takes.
5. preparation of compositions method as claimed in claim 1; It is characterized in that it being to be prepared from: the toad clothing that takes by weighing respective amount with following method; Remove impurity, be placed on 60 degrees centigrade the interior continuous drying of drying baker, water content was pulverized less than 10% o'clock; Cross 50 order to 100 mesh sieves, get toad clothing coarse powder; Take by weighing " Radix Et Caulis Acanthopanacis Senticosi extract " and " Paecilomyces hepiali Chen et Dai Mycelia " coarse powder and 50 order to 100 purpose toad clothing coarse powder mixing stirrings of respective amount; To mix and stir the further pulverizing again of back medicated powder; Get 1200 order to 5000 order toad clothing, Radix Et Caulis Acanthopanacis Senticosi extract and Paecilomyces hepiali Chen et Dai Mycelia superfine powder; Be placed on 60 degrees centigrade the interior continuous drying of drying baker, make water content, get product less than 2%.
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