CN103446261A - Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment - Google Patents
Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment and a preparation method thereof. The Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment is prepared from the following raw materials in parts by mass: 1-3 parts of moutan bark, 0-3 parts of szechwan lovage rhizome and 0-3 parts of safflower as well as the following medicinal materials in parts by mass: 0-2 parts of golden cypress and/or 0-3 parts of geranium wilfordii, wherein the sum of parts by mass of szechwan lovage rhizome and safflower is 1-3. The preparation method of the Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment comprises the following steps of: mixing Chinese herbal medicine decoction pieces in a prescription and decocting for 20-50 minutes, and taking soup for external use; or taking a mixed solvent of major ingredient extracts of single drugs for the external use; or directly mixing and dissolving Chinese medicinal granules in water for the external use. The Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment has the efficacies of clearing heat and detoxifying, activating blood and dissolving stasis as well as dispelling wind and eliminating dampness. Pharmacodynamic tests show that external use of the Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment can prevent and treat the related skin lesion in the tumour treatment, and the Chinese medicinal composition used for preventing and/or treating related skin lesion in tumour treatment is definite in curative effect, simple and easy to use and economical and has no obvious toxic or side effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition that prevents and/or treats the relevant skin lesion of oncotherapy.
Background technology
Some treatment related complications often appear in clinical therapy of tumor at present, reduced patient's quality of life, even affect the continuation of the associated treatment of tumor, wherein skin lesion is one of common complication, as radiodermatitis, the skin lesion that chemotherapeutic is exosmosed and tumor-targeting drug causes etc., specific as follows:
(1), the relevant Skin toxicity of tumor-targeting drug
Targeted drug becomes increasingly conspicuous in the therapeutic field of tumor status, and it is treated relevant untoward reaction and also draws attention gradually.Skin toxicity is the modal untoward reaction of such medicine, has affected the enforcement of patients ' life quality and optimal dose.The incidence rate of Skin toxicity is greater than 50%, and severe patient accounts for 10%.The medicine that causes Skin toxicity mainly contains at present epidermal growth factor receptor inhibitor (EGFRIs) and comprises monoclonal antibody and micromolecule TKI, and many inhibitors of kinases, common performance comprises axersis (xerosis cutis), pruritus, desquamation, fingernail/first week changes (being generally paronychia), trichosis (is usually expressed as alopecia, the thick length of eyelashes or Facial hair) and telangiectasis (being usually expressed as expansion and the pigmentation of little blood vessel), and papulopustular type pathological changes (being acne or acneform eruptions) is modal Skin toxicity, this reaction is dose dependent, incidence rate is 60%-80%.Other untoward reaction occur many in 10% left and right, are no more than 40%.Although relatively rare, but observed the fingernail change in the patient of 10%-29%.The normal generation of these reactions is more late, more than 4-8 week appearance after first treatment.Nail groove (particularly big toe and thumb) inflammation, severe patient can cause purulent granuloma.The patient even can not wear footwear maybe can only wear sandals.Many inhibitors of kinases also easily cause hand-foot skin reaction (HFSR), and incidence rate is 60-70%, clinical manifestation be numb hand and foot sense, numb thorn, burning sensation, erythema swelling, skin send out bleb, dry, chap, desquamation, its symptom is dose dependent.
By the biopsy to the patient skin tissue, find, targeted drug dependency erythra shows that near corium upper strata (especially folliculus), follicular rupture layer and epithelium acantholysis layer present a kind of Combination inflammatory reaction.Find that in the skin histology specimen of biopsy lichen sample tissue reaction, neutrophilic granulocyte folliculitis, keratin bolt and funnel enlarge, microbe deposition.Some enzyme that neutrophilic granulocyte discharges causes the horn cell apoptosis, the cells accumulation of apoptosis causes skin further to damage under corium, and for the excessive multiplication of antibacterial provides condition, thereby increased the weight of inflammatory reaction, finally form tenderness, papulopustule and paronychia.
The cause of disease of the relevant Skin toxicity of targeted drug and mechanism are not yet fully clear and definite at present, but it has been generally acknowledged that the interference to folliculus and interfollicular cells epidermal growth signal transduction pathway is key reason.Targeted drug is combined into dimer by blocking-up EGF and EGFR extracellular region; or the combination of competitive inhibition ATP and receptor cytoplasmic domain; thereby stop EGFR phosphorylation and kinase activation; having destroyed it regulates epidermal growth, suppresses its differentiation; Cell protection opposing ultraviolet associated injury; inflammation-inhibiting also accelerates the effects such as wound healing; can cause that growth inhibited and apoptosis, cell migration minimizing, cell adhesion and differentiation increase, inflammatory reaction activate; and then affect keratinocyte, cause specific cutaneous manifestations.In vitro study shows, the relevant skin lesion of targeted drug is with the release of inflammatory cell chemical inducer, thereby induces leukocyte to gather, and discharges protease and causes the keratinocyte apoptosis.A large amount of apoptotic cells are accumulated under skin corium, further cause skin injury.Think that at present this is the main cause of the symptoms such as tenderness, perionychia and pimple sample pustule.
Up to now, the medicine of clearly treating the relevant Skin toxicity of targeted drug is not yet arranged, and now general doctor trained in Western medicine processing scheme for lacking " best practices " that follows the card foundation: comprise that preventive measure is as avoided Exposure to Sunlight, keep personal cleanliness and dry position skin moistening, wear the clothes of loose zoarium to reduce the friction focus.After skin lesion occurs, according to the order of severity, the lighter gives overview or topical application hormone drugs; Moderate toxicity person is except local application, but oral antihistamines; Heavy toxicity person, except in addition, can give the methylprednisolone of aggressive dosage; If concurrent infection, select antibiotics to be treated; Pruritus can be applied the Drug therapys such as Calamina lotion, zinc oxide; To changes such as fingernail decolouring and folds, can not do special handling.Once paronychia occur, antibiotic is coated with outward, but the severe patient surgery pulls out the first treatment.Generally do not need to change EGFRI dosage because of slight toxicity, and III degree Skin toxicity treatment 2-4 untoward reaction fully alleviation yet after week is considered to reduce targeted drug dosage, is suspended medication or end and treat.Approximately 10% patient is because of serious Skin toxicity decrement, and 1%-3% is forced to drug withdrawal.
At present, the relevant Skin toxicity prevention of targeted drug and treatment measure lack specificity, effective percentage less than 20%, and curative effect is unsatisfactory, therefore needs multidisciplinary participation, carries out combination of Chinese and Western medicine research.There is the scholar to attempt, with the treatment of Chinese medicine for oral administration method, also having obtained certain curative effect, but it is reported that erythra is the signal that treatment benefits, curative effect is relevant to the erythra order of severity, so adopt oral medicinal herb to reduce the relevant erythra of targeted drug, the suspicion of influential curative effect, should not be accepted.The relevant Skin toxicity of minority medical record report external washout with traditional Chinese herbs treatment targeted drug is arranged, obtained good curative effect, but still there is no generally acknowledged fixed prescription or medicine.
(2), radiodermatitis
Radiotherapy is as one of Main Means of current treatment tumor, and clinical practice is very extensive, and approximately the tumor patient of 60%-70% is accepted radiotherapy at course of disease different times because of different purposes so far.Lonizing radiation also produce damage effect to normal skin tissue when tumor cell is produced to therapeutical effect, cause radiodermatitis, and approximately 87% radiotherapy patient there will be the radioactive skin reaction, shows as erythema, edema, pruritus, causalgia; Pathological changes is more obvious, except erythema, edema, vesicle, erosion or shallow table ulcer also can occur, the generally just healing voluntarily in 1～3 month, can leave pigmentation, depigmentation, telangiectasis, atrophoderma, permanent hair de-mistake, cicatrization and sweat gland dysfunction etc. after healing; Serious pathological changes can form dark ulcer, and pathological changes extends to subcutaneous tissue, bone and internal organs.
Radiodermatitis is different from general burn and ulcer, ray directly acts on skin and deep tissue cell thereof, the radical damage basal layer cell of its generation, thereby make the local woanded surface tissue that gradual regression and necrosis occur, necrosis is carrying out property, and the delay time is long, finally form extensive fibrosis.Once ulcer is difficult to the new life of the formation of unsoundness granulation tissue and vasoganglion, and then causes the Long-term Infection of wound surface and deepens the damage of local organization, increase the weight of patient body and psychological misery, affect proceeding of radiotherapy.
The doctor trained in Western medicine clinical treatment of radiodermatitis be take local application as main, the Western medicine for the treatment of radiation dermatitis has than inferior fragrant (Trolamine cream) at present, gold is because of peptide (recombinant human epidermal growth factor externally used solution), Hirudoid (hirudiod), superoxide dismutase spray etc., above-mentioned Therapeutic Method or curative effect are limited, or expensive, still have radioactivity skin lesion obstinate or form deep ulcer, need to take surgical debridement, the measures such as skin flap transplantation, and radiodermatitis often causes last necrosis because substrate nutrition supply deficiency makes skin flap be difficult hair growth promoting.Therefore, the limitation of radiodermatitis western medical treatment method becomes affects one of reason that radiotherapy carries out smoothly, and Chinese medicine is demonstrating unique curative effect aspect the treatment acute radiodermatitis, becomes the potential Therapeutic Method of clinical radiodermatitis tool.Relevant Chinese medicine preparation commonly used includes Aloe juice, Oleum Radix Arnebiae (Oleum Radix Lithospermi), black Jiang Dan (being comprised of Crinis Carbonisatus, Ovum Gallus domesticus Flavus), Sanguis Draxonis powder (mixture of resin ester and dracoresinotannol) etc. at present, at present often because effect is limited, or the cream pasty state should not be cleared up, the reason such as affect partly sterilised, change dressings, not yet clinical being widely used of gaining public acceptance, what the clinician the most often used at present is burn cream, though certain effect is arranged, but serious radiodermatitis is helped little, still demanding party just, effective Chinese medicine preparation treating radioactive skin injury.
(3), the chemotherapeutic skin injury that exosmoses
Tumor patient is when carrying out chemotherapy, once the generation chemotherapeutic is exosmosed and will cause even ulcer of tissue degeneratiaon, necrosis in the intravasation surrounding tissue to blood vessel, clinical manifestation is injection site hyperemia, pain, even diabrosis of swelling, necrosis, forms comparatively serious complication.Although have through ways such as subclavian vein or central vein catheters and improve the chemotherapeutic route of administration, the minimizing chemotherapeutic is exosmosed and is produced the phenomenon of skin lesion, but easily produce phlebothrombosis or strengthen infection risk owing to putting pipe, need that specialty is changed dressings, tube sealing is not easy to the problems such as out-patient's use, give chemotherapeutic through peripheral blood vessel unavoidable, so the exosmose skin lesion that causes of chemotherapeutic is also of common occurrence.
The treating method of exosmosing for chemotherapeutic at present is as follows: stop immediately injection 1.; 2. local procaine+normal saline subcutaneous injection, the chemotherapeutics that can slow down absorbs and analgesia; 3. local ice bag cold compress is limited to affected area; 4. local obvious tumefaction person can be with magnesium sulfate dressing to eliminate swelling; 5. should carry out Surgery Treatment as ulcer or vesicle occurred, invalid through above-mentioned processing, seepage place transfers pitchy to by kermesinus, while forming ulcer, add tetracaine by the cord blood plasma of preparing and be coated with the ulcer part outward, and coordinate dressing change in surgical department, generally need 1-3 month ability to recover fully.For infiltrating subcutaneous scope greatly or the concurrent infection person, also to add and use antibiotic therapy.But inflammation acute stage also physical therapy promotion recovery later, can fit feelings and use ultrashort wave, infrared ray, ultraviolet illuminating instrument etc., to reach the effects such as pain relieving, antiinflammatory, promotion local absorption.The pain caused after seepage occurs also often makes the patient dare not the activity suffering limb, and the time one is long, also can cause ankylosis, amyotrophy.In a word, the chemotherapeutic skin lesion that causes or the most key with acute stages treated of exosmosing, because of the magnesium sulfate dressing curative effect limited, someone attempts with potato chips or Chinese medicine LIUSHEN WAN, JINHUANG SAN soak, but clinical efficacy is not yet extensively approved still do not have at present the relevant Chinese medicine preparation of generally acknowledging to be applied to clinical.
Summary of the invention
The purpose of this invention is to provide a kind of external medicine composition that prevents and/or treats the relevant skin lesion of oncotherapy.
Chinese medicine composition provided by the present invention, the raw material of making it comprises the Chinese crude drug of following mass parts: Cortex Moutan 1-3 part, Rhizoma Chuanxiong 0-3 part Flos Carthami 0-3 part, and the mass parts sum of Rhizoma Chuanxiong, Flos Carthami is 1-3 part.
The raw material of making above-mentioned Chinese medicine composition also can further comprise the Chinese crude drug of following mass parts: Cortex Phellodendri 0-2 part and/or Herba Erodii 0-3 part.
Certainly, Chinese medicine composition of the present invention also can only be made by the Chinese crude drug of following mass parts: Cortex Moutan 1-3 part, Rhizoma Chuanxiong 0-3 part, Flos Carthami 0-3 part, Cortex Phellodendri 0-2 part and Herba Erodii 0-3 part; The mass parts sum of above-mentioned Rhizoma Chuanxiong, Flos Carthami is 1-3 part.
Chinese medicine composition of the present invention is preferably made by the Chinese medicine of the five flavours material of following mass parts: 2 parts of 2 parts of Cortex Moutans, 2 parts of Rhizoma Chuanxiongs, 1 part, Flos Carthami, 2 parts of Cortex Phellodendris and Herba Erodiis.
During drug composition is write out a prescription in the present invention, monarch drug Cortex Moutan clearing away heat and cooling blood, ministerial drug Rhizoma Chuanxiong blood circulation promoting and blood stasis dispelling, assistant helps blood circulation promoting and blood stasis dispelling with Flos Carthami, and assistant, with Cortex Phellodendri heat clearing and damp drying removing heat from blood, makes medicine Herba Erodii dispeiling pathogenic wind and removing dampness, promoting blood circulation to remove obstruction in the collateral, full side's heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, dispeiling pathogenic wind and removing dampness.
Chinese medicine composition provided by the present invention can be prepared into according to conventional method of Chinese medicinal any external preparation.
As: after the Chinese crude drug of respectively distinguishing the flavor of of Chinese medicine composition as described in making can being mixed, decoct with water, decoct after finishing and filter, collect filtrate, obtain described Chinese medicine composition water decoction.
Wherein, the mass ratio of the gross mass of described Chinese crude drug and water can be (1-2): (10-40).Concrete amount of water can be determined according to the quality of medical material.
The time of described decoction can be 20-50 minute.
For the step of conveniently adjusting and removing decoction from, the Chinese crude drug (as the prepared slices of Chinese crude drugs) of each can being distinguished the flavor of replaces to the commercially available Chinese medicinal granule of correspondent equal crude drug amount, and the Chinese medicinal granule of each flavor medicine is directly mixed and gets final product.During use, that it is soluble in water, the wiring solution-forming external.
" Chinese medicinal granule " means that the single medicinal material decoction pieces, according to the Chinese medicine preparation extraction, selects suitable solvent and program, the solubility effective ingredient leached to the powder of making through concentrate drying or granule.Carry out the single quantitative package, follow the doctor's advice with the card prescription for the pharmaceutical personnel, dosage adjustment is directly taken to patient in accordance with regulations.Chinese medicinal granule is traditional decoction pieces whole part extract, and clinical efficacy and decoction pieces are suitable, and the standard of corresponding preparation requirement and Quality Control is arranged, and mixing decoction liquor at aspects such as stability, controllabilitys than the prepared slices of Chinese crude drugs has obvious advantage.
Except above-mentioned two kinds of methods, also each single medicinal material (as the prepared slices of Chinese crude drugs) in above-mentioned Chinese medicine composition can be replaced to the main component extract that the corresponding medicine of respectively distinguishing the flavor of equates the crude drug amount, after each single medicinal material main component extract is mixed, be prepared into the solution external and also can obtain similar curative effect.
Simultaneously, take the external used medicine that prevents and/or treats the relevant skin lesion of oncotherapy that Chinese medicine composition provided by the present invention makes as active component also belongs to protection scope of the present invention.
When needing, can also add one or more pharmaceutically acceptable carriers in said medicine.Described carrier comprises diluent, excipient, filler, binding agent, wetting agent, absorption enhancer, surfactant, absorption carrier and the lubricant etc. of pharmaceutical field routine.
This external used medicine can be made powder, tincture, Emulsion, ointment, emulsifiable paste, lotion, spray, gel etc.The medicine of above-mentioned various dosage forms all can be according to the conventional method preparation of Chinese medicine preparation.
External medicine composition of the present invention is applicable to prevent and/or treat the relevant skin lesion of oncotherapy.
The relevant skin lesion of described oncotherapy specifically comprises: the skin lesion that 1) tumor-targeting drug causes, 2) skin lesion that causes of radiotherapy, 3) the chemotherapeutic skin lesion of exosmosing and causing.
Although the skin lesion mechanism that above oncotherapy is relevant is different, but show clinically similar, all there is common Clinical symptoms red, swollen, hot, pain, principle according to traditional Chinese medical science treating different diseases with the same therapeutic principle, with reference to red, swollen, hot, the dialectical characteristics of pain, take heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling is the rule for the treatment of, the relevant skin lesion of washout treatment oncotherapy that the Chinese medicine compound formed with Cortex Moutan, Rhizoma Chuanxiong, Flos Carthami, Cortex Phellodendri, Herba Erodii and the side's of simplification Cortex Moutan, Rhizoma Chuanxiong or Flos Carthami form, obtained good clinical efficacy.
With reference to herbal pharmacology research in recent years, Rhizoma Chuanxiong, Flos Carthami, Herba Erodii promoting blood circulation to remove obstruction in the collateral, external can improve local blood circulation, Cortex Moutan, Cortex Phellodendri heat-clearing and toxic substances removing, according to antiinflammatory, bacteriostasis are arranged, infer that according to the pharmacological action of these single medicinal materials this compound recipe gets the mechanism of action of effect and be mainly and increase the local skin blood circulation, promoted the removing of local medicine or its metabolite and inflammatory mediator, alleviate the local inflammation reaction, thereby eased the pain, improved skin lesion.
To sum up, the prevention of Chinese medicine compound washout and the relevant skin lesion determined curative effect for the treatment of oncotherapy, use is simple, convenient, and price economy, without obvious toxic-side effects, be worth being developed as patent medicine, carries out clinical expansion.
The specific embodiment
Below by specific embodiment, Chinese medicine composition of the present invention is described, but the present invention is not limited thereto.
Experimental technique described in following embodiment, if no special instructions, be conventional method; Described reagent and material, if no special instructions, all can obtain from commercial channels.
In following embodiment, Cortex Moutan, Rhizoma Chuanxiong, Flos Carthami, Cortex Phellodendri, Herba Erodii used all meets the pertinent regulations under each medical material item of text of Chinese Pharmacopoeia version in 2010.Before feeding intake, be tested and appraised, ingredients is in kind to conform to title, and quality meets standards of pharmacopoeia.
In following embodiment, single medicinal material granule used is all purchased from Shenzhen's three nine-day periods after the winter solstice modern Chinese medicine company limited.
Embodiment 1, preparation prevent and/or treat the Chinese medicine composition decoction 1 of the relevant skin lesion of oncotherapy
1. prescription
Cortex Moutan 2 mass parts, Rhizoma Chuanxiong 2 mass parts, Flos Carthami 1 mass parts, Cortex Phellodendri 2 mass parts, Herba Erodii 2 mass parts
2. method for making
The prepared slices of Chinese crude drugs that measure above-mentioned 5 flavor medicines according to prescription are total to 90g, add the 1500ml decocting after mixing and boil 30 minutes, filter, and collect filtrate, and every milliliter of medicinal liquid is equivalent to crude drug 0.09g, obtains Chinese medicine composition decoction 1.
Embodiment 2, preparation prevent and/or treat the Chinese medicine composition decoction 2 of the relevant skin lesion of oncotherapy
1. prescription
Cortex Moutan 3 mass parts, Rhizoma Chuanxiong 1 mass parts, Flos Carthami 2 mass parts, Cortex Phellodendri 1 mass parts, Herba Erodii 3 mass parts
2. method for making
The prepared slices of Chinese crude drugs that measure above-mentioned 5 flavor medicines according to prescription are total to 100g, add the 1500ml decocting after mixing and boil 30 minutes, filter, and collect filtrate, and every milliliter of medicinal liquid is equivalent to crude drug 0.10g, obtains Chinese medicine composition decoction 2.Embodiment 3, preparation prevent and/or treat the Chinese medicine composition decoction 3 of the relevant skin lesion of oncotherapy
1. prescription
Cortex Moutan 1 mass parts, Rhizoma Chuanxiong 3 mass parts, Cortex Phellodendri 2 mass parts, Herba Erodii 2 mass parts
2. method for making
The prepared slices of Chinese crude drugs that measure above-mentioned 4 flavor medicines according to prescription are total to 80g, add the 1500ml decocting after mixing and boil 30 minutes, filter, and collect filtrate, and every milliliter of medicinal liquid is equivalent to crude drug 0.08g, obtains Chinese medicine composition letter side decoction 3.
Embodiment 4, preparation prevent and/or treat the Chinese medicine composition decoction 4 of the relevant skin lesion of oncotherapy
1. prescription
Cortex Moutan 3 mass parts, Rhizoma Chuanxiong 2 mass parts, 1 part, Flos Carthami, Cortex Phellodendri 2 mass parts
2. method for making
The prepared slices of Chinese crude drugs that measure above-mentioned 4 flavor medicines according to prescription are total to 80g, add the 1500ml decocting after mixing and boil 30 minutes, filter, and collect filtrate, and every milliliter of medicinal liquid is equivalent to crude drug 0.08g, obtains Chinese medicine composition letter side decoction 4.Embodiment 5, preparation prevent and/or treat the Chinese medicine composition decoction 5 of the relevant skin lesion of oncotherapy
1. prescription
1 part of Cortex Moutan 2 mass parts, Rhizoma Chuanxiong 2 mass parts, Flos Carthami
2. method for making
The prepared slices of Chinese crude drugs that measure above-mentioned 3 flavor medicines according to prescription are total to 50g, add the 1500ml decocting after mixing and boil 30 minutes, filter, and collect filtrate, and every milliliter of medicinal liquid is equivalent to crude drug 0.05g, obtains Chinese medicine composition letter side decoction 5.
Embodiment 6, preparation prevent and/or treat the Chinese medicine composition decoction 6 of the relevant skin lesion of oncotherapy
1. prescription
Cortex Moutan 3 mass parts, Rhizoma Chuanxiong 1 mass parts
2. method for making
The prepared slices of Chinese crude drugs that measure above-mentioned 2 flavor medicines according to prescription are total to 40g, add the 1500ml decocting after mixing and boil 30 minutes, filter, and collect filtrate, and every milliliter of medicinal liquid is equivalent to crude drug 0.04g, obtains Chinese medicine composition letter side decoction 6.
Embodiment 7, preparation prevent and/or treat the Chinese medicine composition decoction 7 of the relevant skin lesion of oncotherapy
1. prescription
2 parts of Cortex Moutan 2 mass parts, Flos Carthami 3 mass parts, Cortex Phellodendri
2. method for making
The prepared slices of Chinese crude drugs that measure above-mentioned 3 flavor medicines according to prescription are total to 70g, add the 1500ml decocting after mixing and boil 30 minutes, filter, and collect filtrate, and every milliliter of medicinal liquid is equivalent to crude drug 0.07g, obtains Chinese medicine composition letter side decoction 7.
Embodiment 8, preparation prevent and/or treat the Chinese medicine composition composition powders 1 of the relevant skin lesion of oncotherapy
1. write out a prescription
Cortex Moutan 2 mass parts, Rhizoma Chuanxiong 2 mass parts, Flos Carthami 1 mass parts, Cortex Phellodendri 2 mass parts, Herba Erodii 2 mass parts
2. method for making
Take the Chinese medicinal granule of the ingredients corresponding with above-mentioned ingredients recipe quantity crude drug according to recipe quantity, take off the Chinese medicinal granule of stating quality:
Cortex Moutan 2g, Rhizoma Chuanxiong 2g, Flos Carthami 1g, Cortex Phellodendri 2g, Herba Erodii 2g.
Above-mentioned Chinese medicinal granule is directly mixed, obtain Chinese medicine composition composition powders 1.
Embodiment 9, preparation prevent and/or treat the Chinese medicine composition composition powders 2 of the relevant skin lesion of oncotherapy
1. write out a prescription
Cortex Moutan 2 mass parts, Rhizoma Chuanxiong 2 mass parts, Flos Carthami 1 mass parts
2. method for making
Take the Chinese medicinal granule of the ingredients corresponding with above-mentioned ingredients recipe quantity crude drug according to recipe quantity, take off the Chinese medicinal granule of stating quality:
Cortex Moutan 2g, Rhizoma Chuanxiong 2g, Flos Carthami 1g.
Above-mentioned Chinese medicinal granule is directly mixed, obtain Chinese medicine composition composition powders 2.
Embodiment 10, preparation prevent and/or treat the Chinese medicine composition composition powders 3 of the relevant skin lesion of oncotherapy
1. write out a prescription
Cortex Moutan 3 mass parts, Rhizoma Chuanxiong 2 mass parts, Herba Erodii 2 mass parts
2. method for making
Take the Chinese medicinal granule of the ingredients corresponding with above-mentioned ingredients recipe quantity crude drug according to recipe quantity, take off the Chinese medicinal granule of stating quality:
Cortex Moutan 3g, Rhizoma Chuanxiong 2g, Herba Erodii 2g.
Above-mentioned Chinese medicinal granule is directly mixed, obtain Chinese medicine composition composition powders 3.
Embodiment 11, preparation prevent and/or treat the Chinese medicine composition composition powders 4 of the relevant skin lesion of oncotherapy
1. write out a prescription
Cortex Moutan 2 mass parts, Flos Carthami 3 mass parts
2. method for making
Take the Chinese medicinal granule of the ingredients corresponding with above-mentioned ingredients recipe quantity crude drug according to recipe quantity, take off the Chinese medicinal granule of stating quality: Cortex Moutan 2g, Flos Carthami 3g
Above-mentioned Chinese medicinal granule is directly mixed, obtain Chinese medicine composition composition powders 4.
Embodiment 12, preparation prevent and/or treat the Chinese medicine composition composition powders 5 of the relevant skin lesion of oncotherapy
1. write out a prescription
Cortex Moutan 1 mass parts, Rhizoma Chuanxiong 2 mass parts, Flos Carthami 1 mass parts
2. method for making
Take the Chinese medicinal granule of the ingredients corresponding with above-mentioned ingredients recipe quantity crude drug according to recipe quantity, take off the Chinese medicinal granule of stating quality: Cortex Moutan 1g, Rhizoma Chuanxiong 2g, Flos Carthami 1g
Above-mentioned Chinese medicinal granule is directly mixed, obtain Chinese medicine composition composition powders 5.
Embodiment 13, clinical trial
First: Results
Carried out at present clinical research random, contrast, for the oncotherapy patient who skin lesion occurs, carry out the external washout with traditional Chinese herbs treatment, observational study enters to organize the variation of the relevant skin lesion classification of patient's patients before and after intervention oncotherapy, estimates the clinical efficacy of Chinese medicine compound external preparation; And the treatment of monitoring Chinese medicine compound washout is estimated the safety of Chinese medicine compound washout preparation for treating to the impact of patient's routine blood test, hepatic and renal function.
(1) research approach
1 case enters the group standard
1.1, the case inclusive criteria
1. the malignant tumor patient of making a definite diagnosis through pathology or cytology;
2. through tumor-targeting drug treatment, radiotherapy or chemotherapy, the corresponding skin lesion that drug extravasation causes appears;
3. the PS scoring is≤3 minutes;
4. age >=16 year old ,≤75 years old;
5. without intelligence and mental disorder, the language competence is normal, and self pain and general status are had to judgement, and can cooperation estimate pain and quality of life content etc.;
6. understand and agree to accept this treatment, and the signature Informed Consent Form.
1.2, the case exclusion standard
1. the danger disease patient who there are other position severe pains;
2. the skin lesion that non-oncotherapy occurs;
3. drug dependence or addiction history person were once arranged;
4. skin allergic disease patient;
5. there is hand-foot skin chronic disease person;
1.3, case rejects, termination criteria
1. in research, the patient can not coordinate this therapist of continuation;
2. conditions of patients changes suddenly, affects and disturbs this researcher;
3. in observation process, the skin severe allergy appears in the patient.
2, drugs
The research medicine adopts the Chinese medicine compound powder of embodiment 8 and embodiment 9 preparations, is diluted to 1000ml after dissolving the compounding powder 2 of the compounding powder 1 of 9g embodiment 8 or 5g embodiment 9 with warm water during use.The patient is from entering to organize the 1st day, and affected part (approximately 25～30 ℃ of water temperatures) is washed/soaked in external, and each 30 minutes, every day each 1 time sooner or later, 10 days courses for the treatment of.
Research is observed and to be divided into skin lesion three partial contents that the relevant skin lesion of tumor-targeting drug, radiodermatitis, chemotherapeutic are exosmosed and caused.All adopt to current clinical criteria therapeutic scheme and do contrast: the relevant skin lesion research of tumor-targeting drug selects the placebo of dextrin and food coloring allotment to compare, and while merging local infection, adds with erythromycin or Mupirocin Ointment ointment and is coated with outward; Radiodermatitis is selected than inferior sweet smell+gold and is used as contrast outward because of peptide+MEIBAO SHIRUN SHAOSHANG GAO; The chemotherapeutic skin lesion research caused of exosmosing adopts magnesium sulfate dressing to do contrast.
3, treatment distributes
Double blinding at random,, comparative study: all qualified cases all enter group.The patient presses the 3:1 pro rate to treatment group and matched group.
4, the standard of curative effect evaluation:
The skin lesion classification is according to internationally recognized NCI standard grading, and the standard of curative effect evaluation is as follows: (effectively comprise recovery from illness and take a turn for the better)
Recovery from illness: erythra disappears substantially, without subjective symptom, without infecting sign, orthobiosis, work;
Take a turn for the better: dermal toxicity classification decline one-level and above person.(comprise that erythra obviously reduces or by extensively becoming local distribution, subjective symptom alleviates or disappearance, quality of life obviously improve);
Invalid: erythra unchanged or toxicity grading rising one-level and above person.(comprise the erythra showed increased or by part become whole body extensively distribute, occur subjective symptom or increase the weight of, quality of life obviously worsens.
(2) result
Tumor-targeting drug skin lesion patient 83 examples of being correlated with, treatment group 36 examples of embodiment 9 compounding powders 2, effective percentage 91.67%, cure rate 25%; Treatment group 35 examples of embodiment 8 compounding powders 1, effective percentage 94.29%, cure rate 25.71%; Placebo group 12 examples, effective percentage 16.67%, without the recovery from illness case, two treatment groups all have notable difference than matched group, and compounding powder 2 treatment groups are close with compounding powder 1 treatment group effective percentage, no significant difference between two treatment groups.Treatment group pain relieving onset time is 1-2 days, obviously improve the skin lesions such as pruritus, pain, erythra, vesicle, edema, ulcer in 3-10 days, can effectively avoid the decrement, drug withdrawal and the interruption that cause because of Skin toxicity in the targeted drug treatment, to the untoward reaction of not yet finding at present this external washout with traditional Chinese herbs.
Radiodermatitis patient's 69 examples, embodiment 9 compounding powder 2 treatment group 30 examples, effective percentage 96.67%, cure rate 70%; Treatment group 28 examples of embodiment 8 compounding powders 1, effective percentage 92.86%, cure rate 71.43%; Placebo group 11 examples, effective percentage 36.36%, cure rate 9.1%, two treatment group all has notable difference than matched group, and compounding powder 2 treatment groups are close with compounding powder 1 treatment group effective percentage, no significant difference between two treatment groups.Treatment group pain relieving onset time is 0.5-1 days, and in 2-5 days, the skin lesions such as pruritus, causalgia, erythema, edema, erosion and fester all can be cured, and can effectively avoid radiotherapy decrement or interruption, to the untoward reaction of not yet finding at present this external washout with traditional Chinese herbs.
Skin lesion patient 24 examples that chemotherapeutic is exosmosed and caused, embodiment 9 compounding powder 2 treatment group 8 examples, effective percentage 87.50%, cure rate 12.5%; Treatment group 9 examples of embodiment 8 compounding powders 1, effective percentage 88.89%; Cure rate 22.22%; Placebo group 7 examples, effective percentage 28.57%, without the recovery from illness case.Two treatment groups all have notable difference than matched group, and compounding powder 2 treatment groups are close with compounding powder 1 treatment group effective percentage, no significant difference between two treatment groups.Treatment group pain relieving onset time is 0.5-2 days, in 3-10 days, the skin lesions such as causalgia, erythema, edema, erosion and fester all can be cured, and can effectively avoid the deep tissue necrosis, fester and secondary infection, save function of organization from damage, not yet find the untoward reaction of this external washout with traditional Chinese herbs at present.
Result is specifically in Table 1:
Between table 1 treatment group and matched group, the effective percentage of three types skin lesion relatively
According to the method described above, Chinese medicine compound decoction prepared by the embodiment 1,5 of take is medicine, gets embodiment 1 decoction 1(1000ml) or embodiment 5 decoction 5(1000ml) washout, method is with embodiment 14.
Efficacy result is specifically in Table 2:
Between table 2 treatment group and matched group, the effective percentage of three types skin lesion relatively
From table 1,2 results, the therapeutic equivalence of Chinese native medicine compound prescription pellet mixed solution (embodiment 8,9) and Chinese medicine decoction (embodiment 1,5), there was no significant difference between the two.Curative effect between the full side of Chinese medicine compound simplification side and Chinese medicine compound is also without significant difference simultaneously.
The effect of powder prepared by all the other embodiment or the curative effect of decoction and embodiment 1,5,8,9 is suitable.
Second portion: prevention is intervened
The skin lesion incidence rate that two class tumor-targeting drugs cause is the highest, one class is Cetuximab, the papulopustular type pathological changes that it causes (being acne or acneform eruptions) incidence rate is up to 80%, another kind of is many inhibitors of kinases, as Sorafenib and Sutent, it causes hand-foot skin reaction (HFSR), and incidence rate is 70% left and right, and skin lesion occurred frequently has like this affected the smooth enforcement of patients ' life quality and tumor-targeting drug treatment.Therefore, the inventor obtains on the basis of good efficacy at the relevant Skin toxicity of Chinese medicine compound washout treatment targeted drug, explore the prevention of Chinese medicine compound washout and intervened the patient that targeted drug is treated, estimate the Chinese medicine compound washout and whether can reduce the skin lesion that targeted drug causes, or reduce its extent of damage, and pay close attention to whether therefore it improved targeted drug patient's compliance indirectly.
Concrete research is as follows:
(1) research approach
1 case enters the group standard
1.1, the case inclusive criteria
1. the malignant tumor patient of making a definite diagnosis through pathology or cytology;
2. Cetuximab, Sorafenib or Sutent are treated the patient for the first time;
3. the PS scoring is≤3 minutes;
4. age >=16 year old ,≤75 years old;
5. without intelligence and mental disorder, the language competence is normal, and self pain and general status are had to judgement, and can cooperation estimate pain and quality of life content etc.;
6. understand and agree to accept this treatment, and the signature Informed Consent Form.
1.2, the case exclusion standard
1. the danger disease patient who there are other position severe pains;
2. there is skin chronic disease person;
3. drug dependence or addiction history person were once arranged;
4. skin allergic disease patient;
1.3, case rejects, termination criteria
1. in research, the patient can not coordinate this therapist of continuation;
2. conditions of patients changes suddenly, affects and disturbs this researcher;
3. in observation process, the skin severe allergy appears in the patient.
2, drugs
Drugs adopts the Chinese medicine compound powder 1 of embodiment 8 preparations, is diluted to 1000ml after dissolving 9g powder with warm water during use.The patient starts from starting the targeted drug treatment on the 1st day, face (Cetuximab treatment patient) or brothers' (Sorafenib or Sutent treatment patient) (approximately 25～30 ℃ of water temperatures) are washed/soak in external, each 30 minutes, every day each 1 time sooner or later, finish front 2 courses for the treatment of of observing time to the targeted drug treatment, selects the dextrin placebo to compare with the placebo of food coloring allotment.
3, treatment distributes
Double blinding at random,, comparative study: all qualified cases all enter group.The patient presses the 1:1 pro rate to treatment group and matched group.
4, research index
A situation arises and the order of severity to record in treatment group and matched group skin lesion, and record patient causes targeted drug decrement and drug withdrawal situation because of Skin toxicity.
Concrete skin lesion grade scale is as follows:
(1), the erythra classification is known together and in December, 2007 China oncologist Consensus of experts according to the relevant dermal toxicity seminar of U.S. EGFRIs in 2006:
I level (slightly): scope is limited to (as the papulopustular type pathological changes mainly is confined to Head And Face and upper trunk), almost without subjective symptom, on daily life without impact, without secondary infection sign.
II level (moderate): scope is more extensive, and subjective symptom is light, and daily life is had to minimal effect, without secondary infection sign.
III level (severe): in extensive range, subjective symptom is serious, larger on the daily life impact, and the possibility of secondary infection is arranged.
(2), the hand-foot skin reaction adopts the NCI standard grading
The I level: slight skin change or dermatitis (as erythema, desquamation), without pain; ;
The II level: skin change (as desquamation, vesicle, hemorrhage, edema) or pain do not affect daily routines;
The III level: ulcer dermatitis or skin change companion pain have a strong impact on daily life;
(2) result
Enter to organize tumor-targeting drug and treat for the first time patient's totally 128 examples, placebo group 63 examples, I level skin lesion incidence rate 47.62%, II level skin lesion incidence rate 15.87%, III level skin lesion incidence rate 11.11%, add up to skin lesion incidence rate 74.61%, 12 routine patient to reduce targeted drug treatment consumption because of dermoreaction, wherein 4 examples finally are forced to drug withdrawal; Powder 1 treatment group 65 examples, I level skin lesion incidence rate 20.00%, II level skin lesion incidence rate 7.69%, III level skin lesion incidence rate 0.00%, add up to skin lesion incidence rate 27.69%, comparing difference remarkable (result is specifically in Table 2) between treatment group and matched group does not appear because dermoreaction reduces targeted drug treatment consumption or drug withdrawal situation.
Between table 3 treatment group and matched group, the incidence rate of skin lesion relatively
According to the method described above, Chinese medicine compound decoction prepared by the embodiment 1 of take is medicine, gets the decoction 1000ml of embodiment 1 during use.
Efficacy result is specifically in Table 4:
Between table 4 treatment group and matched group, the incidence rate of skin lesion relatively
The effect of powder prepared by all the other embodiment or the curative effect of decoction and embodiment 1 or 8 preparations is suitable.
This research prompting: intervene the skin lesions such as the pruritus that can obviously reduce targeted drug and cause, pain, erythra, vesicle, edema, ulcer through the Chinese medicine compound prevention, can effectively avoid the decrement, drug withdrawal and the interruption that cause because of Skin toxicity in the targeted drug treatment, improve the compliance of patient's targeted drug treatment, guaranteed carrying out smoothly of tumor-targeting drug treatment.
Claims (7)
1. a Chinese medicine composition that prevents and/or treats the relevant skin lesion of oncotherapy, the raw material of making it comprises the Chinese crude drug of following mass parts: Cortex Moutan 1-3 part, Rhizoma Chuanxiong 0-3 part Flos Carthami 0-3 part, and the mass parts sum of Rhizoma Chuanxiong, Flos Carthami is 1-3 part.
2. Chinese medicine composition according to claim 1, it is characterized in that: the raw material of making described Chinese medicine composition also comprises the Chinese crude drug of following mass parts: Cortex Phellodendri 0-2 part and/or Herba Erodii 0-3 part.
3. Chinese medicine composition according to claim 1 and 2, it is characterized in that: described Chinese medicine composition is made by the Chinese crude drug of following mass parts: Cortex Moutan 1-3 part, Rhizoma Chuanxiong 0-3 part, Flos Carthami 0-3 part, Cortex Phellodendri 0-2 part and Herba Erodii 0-3 part; The mass parts sum of above-mentioned Rhizoma Chuanxiong, Flos Carthami is 1-3 part.
4. Chinese medicine composition according to claim 3, it is characterized in that: described Chinese medicine composition is made by the Chinese crude drug of following mass parts: 2 parts of 2 parts of Cortex Moutans, 2 parts of Rhizoma Chuanxiongs, 1 part, Flos Carthami, 2 parts of Cortex Phellodendris and Herba Erodiis.
5. an external used medicine that prevents and/or treats the relevant skin lesion of oncotherapy, its active component is arbitrary described Chinese medicine composition in claim 1-4.
6. in claim 1-4, arbitrary described Chinese medicine composition prevents and/or treats the application in the external used medicine of the relevant skin lesion of oncotherapy in preparation.
7. application according to claim 6 is characterized in that: the relevant skin lesion of described oncotherapy comprises: the skin lesion that 1) tumor-targeting drug causes, 2) skin lesion that causes of radiotherapy, 3) the chemotherapeutic skin lesion of exosmosing and causing.
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