CN106563121A - Application of recombinant bovine basic fibroblast growth factor gel in repairing acne rosacea skin lesion - Google Patents
Application of recombinant bovine basic fibroblast growth factor gel in repairing acne rosacea skin lesion Download PDFInfo
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- CN106563121A CN106563121A CN201610974886.9A CN201610974886A CN106563121A CN 106563121 A CN106563121 A CN 106563121A CN 201610974886 A CN201610974886 A CN 201610974886A CN 106563121 A CN106563121 A CN 106563121A
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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- A61K9/0012—Galenical forms characterised by the site of application
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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Abstract
The invention relates to a new clinical application of a medicine, particularly to an application of recombinant bovine basic fibroblast growth factor gel in repairing acne rosacea skin lesion. The recombinant bovine basic fibroblast growth factor gel disclosed by the invention has a remarkable curative effect on acne rosacea, particularly on repairing erythema, dryness and furfuration. The invention provides a new method for repairing acne rosacea skin lesion, so that benefits are brought to many patients.
Description
Technical field
The invention belongs to field of medicaments, is related to a kind of new application of medicine, acne rosacea skin is repaired more particularly, to a kind of
Application in the medicine and clinic of damage.
Technical background
Acne rosacea is a kind of common chronic inflammatory skin, involves skin of face blood vessel and pilosebaceous unit.Rose
The generation of rare acne and heredity, the destruction of skin barrier, nerve are relevant with immunity, blood vessel and lymphatic vessel change etc., and skin lesion is with one
With the characteristics of the property crossed or erythema perstanss, telangiectasis, pimple and pustule and pachydermatosis etc..The pathological change of acne rosacea because
Stadium and it is different.Erythema is mainly shown as intradermal telangiectasis with telangiectasis, nonspecific inflammation around blood vessel
Disease infiltrates.In pimple skin lesion, visible intradermal diffusivity inflammatory cell infiltration, has big amount lymphocyte around hair follicle or sebaceous gland,
A small amount of histiocyte and plasma cell, the visible epithelioid cell of some cases and macrophage, it is seen that perifolliculitises are with hair follicle
Granuloma formation.The pachydermatosis phase is mainly sebaceous gland and increases, body of gland increase, and horn cell and sebum are expanded and be full of to gland mouth, and has
Subcutaneous connective tissue hypertrophy and telangiectasis, perivascular inflammatory cell infiltration or hair follicle internal granuloma are formed.
BFGF bovine basic fibroblast growth factor（recombinant bovine basic fibroblast
Growth factor, rbFGF）（Yisheng Biological Pharmaceutical Co., Ltd., Shuhai）Belong to fibroblast growth factor class medicine.Weight
Group human/bovine basic fibroblast growth factor is applied to wound repair, is mainly used in burn wound, chronic wound and treats and fresh
The treatment that god's systemic disease such as wound surface and Parkinson's disease and corneal injury are repaired, but which is applied to the reparation of acne rosacea skin lesion also
Have no report.
The content of the invention
It is an object of the invention to provide bFGF bovine basic fibroblast growth factor gel is repairing acne rosacea skin
Application in damage, technical problem to be solved be expand bFGF bovine basic fibroblast growth factor gel for treating scope,
Improve acne rosacea clinical cure rate, shorten acne rosacea treatment time.
Acne rosacea some patientss skin lesion occurs ulceration, shape without bFGF bovine basic fibroblast growth factor reparation
Into cicatrix, the physical and mental health of patient has been had a strong impact on.BFGF bovine basic fibroblast growth factor is applied to clinic by us
Treatment acne rosacea, observes its therapeutic effect, and discovery has definite therapeutical effect（Fig. 2-6）, recombinant bovine basic fibroblast
Somatomedin can significantly improve the quality of life of patient, be beneficial to patient physically and mentally healthy.
BFGF bovine basic fibroblast growth factor can promote blood vessel, tissue regeneration, prevent skin lesion from further developing, very
To reparation acne rosacea skin lesion completely.
The mechanism explanation of the present invention
(Basic fibroblast growth factor, are abbreviated as bFGF to the basic fibroblast growth factor having found）
The processes of wound repair of internal Various Tissues is participated in, is one of important wound healing factor, it is specific as follows：Chemotaxiss,
Inflammatory cell, fibroblast is attracted to enter wound surface, to anti-inflammatory response；Promote the regeneration of wound surface blood capillary, improve local
Blood circulation；Directly stimulate the albumen synthesis of fibroblast and extracellular matrix, to form collagen protein, increase wound surface and resist
Tensile strength；Induced proximity cell cytokine production；Promote dividing a word with a hyphen at the end of a line, divide, breaking up for hypodermal cell.In sum,
BFGF can promote the reparation of skin, so as to accelerate wound healing.A large amount of basic research and clinical trial confirm that basic fibroblast is thin
Intracellular growth factor pair burn, injure outward various chronic wounds there is significant plerosis function, and safely, effectively,
Have no adverse reaction.
And bFGF bovine basic fibroblast growth factor gel of the present invention is to from mesoderm and ectoderm
Cell（Such as epithelial cell, hypodermal cell, fibroblast, vascular endothelial cell etc.）Repair with promotion and regeneration.
The bFGF bovine basic fibroblast growth factor gel is external preparation.
The composition and physicochemical property of the bFGF bovine basic fibroblast growth factor gel be：
Composition：Main Ingredients and Appearance is bFGF bovine basic fibroblast growth factor, is by containing high efficient expression human/bovine basic fibroblast
The escherichia coli of cell growth factor gene, it is fermented, separate and it is highly purified after make.Adjuvant is protein protective agent（Human blood
Albumin）, gel-type vehicle（Hydroxypropyl methyl cellulose and carbomer）, pH adjusting agent（Sodium hydroxide or hydrochloric acid）In right amount, process
Form.
Character：Colorless transparent gel.
Specification：21000IU/5g/.
Usage and dosage：After euthermic clear water face cleaning, will be bFGF bovine basic fibroblast growth factor gel direct
Embrocate at skin lesion, 300IU/cm2, 2 times a day, is within 2 weeks 1 course for the treatment of.
Storage：2～8 DEG C keep in dark place and transport.
Packaging：Aluminium soft tube, per 1, box.
Points for attention：This product is aseptic packaging, in operating process, is kept as far as possible aseptic；This product high temperature is not placed in into
Or in freezing environment；The protein denaturants such as high concentration iodine tincture, ethanol, hydrogen peroxide, heavy metal can affect this product activity, conventional clear
This product is being used with after normal saline flushing after wound；Athlete uses with caution.
Description of the drawings
The acne rosacea skin lesion pathology figure that Fig. 1 is arrived for basis of microscopic observation.
Fig. 2 is comparison diagram before and after the reparation of face red spot pimple acne rosacea skin lesion.
Fig. 3 is comparison diagram before and after the erythematous papules acne rosacea skin lesion reparation of mouth week.
Fig. 4 is comparison diagram before and after facial diffusivity erythematous papules acne rosacea skin lesion reparation.
Fig. 5 is comparison diagram before and after facial scaling erythematous papules acne rosacea skin lesion reparation.
Fig. 6 is comparison diagram before and after facial diffusivity erythema acne rosacea skin lesion reparation.
Specific embodiment
Hereinafter with clinical trial case, the present invention is further elaborated：
We in March, 2015 in December, 2015 during 205 papulopustular types being treated in our hospital's Dermatology Outpatient Department
Acne rosacea patient, wherein women 151, male 54 are randomly divided into two groups：BFGF bovine basic fibroblast growth factor
103 people of reparation group；Without reparation 102 people of blank group.Reparation group is using bFGF bovine basic fibroblast growth factor gel local
It is applied at skin lesion, blank group does not use any external used medicine, observes curative effect after 2 weeks.Reparation group lesions of patients has different journeys
Degree takes a turn for the better, and total effective rate is 82.35%～98.33%（Table one）；Blank group patient total effective rate is 18.99%～66.67%（Table
Two）, contrast the therapeutic index of reparation group and blank group（Table three）, it is seen that Flos Rosae Rugosae can be made using recombinant bovine alkaline cell somatomedin
The erythema of acne lesions, pimple, desquamation and drying significantly take a turn for the better.
Above-mentioned 103 people of use bFGF bovine basic fibroblast growth factor gel is compared with without 102 people of blank group is repaired
Compared with its clinical trial shows：There is to acne rosacea skin lesion bFGF bovine basic fibroblast growth factor significant reparation to make
With.
It is below clinical observation model case
1st, Wang, female, 44 years old, in March, 2015 went to a doctor in Lanzhou hospital general department of dermatologry because of " mouth Zhou Fanfu erythematous papules companion itch January "
Outpatient service, is diagnosed as " acne rosacea ", and patient's complexion is obscure, feels that face is dried, has tight feeling, clean using euthermic clear water
Behind face, bFGF bovine basic fibroblast growth factor gel is directly embrocated at skin lesion, 300IU/cm2, it is early, late each 1 time,
Treat 2 weeks, facial skin lesion disappears substantially, patient feels that face prurituss, tight feeling are relieved, and the colour of skin takes a turn for the better, and face continues to use
Medicine 2 weeks, facial skin lesion recovery from illness, follow-up December skin lesion is without recurrence（Fig. 3）.
2nd, Zhang, female, 37 years old, in March, 2015 went to a doctor in Lanzhou hospital general skin because of " facial diffusivity erythematous papules 2 months "
Section's outpatient service, is diagnosed as " acne rosacea ", using euthermic clear water face cleaning after, will restructuring human/bovine basic fibroblast growth because
Sub- gel is directly embrocated at skin lesion, 300IU/cm2, early, late each 1 time, after treating 2 weeks, skin lesion disappears substantially, and patient feels face
Portion feels fine and smooth, and follow-up December skin lesion is without recurrence（Fig. 4）.
3rd, Lee, female, 40 years old, in May, 2015 went to a doctor in orchid because of " facial scaling erythematous papules with itch, burn feeling half a year "
State hospital general Dermatology Outpatient Department, is diagnosed as " acne rosacea ", and prurituss are difficult to stand patient's private prosecution sometimes, using euthermic clear
After water face cleaning, bFGF bovine basic fibroblast growth factor gel is directly embrocated at skin lesion, 300IU/cm2, early, evening is respectively
1 time, after treatment 2 weeks, facial squama is reduced, and patient feels that face prurituss, burn feeling are alleviated, skin of face not re-dry, is continued
Medication 2 weeks, face red spot pimple disappear, and continue to strengthen medication 2 weeks, lesions of patients recovery from illness, and follow-up December skin lesion is without recurrence（Figure
5）.
4th, in certain, female, 26 years old, in June, 2015 went to a doctor in Lanzhou hospital general department of dermatologry because of " facial diffusivity erythema first quarter moon "
Outpatient service, is diagnosed as " acne rosacea ", and patient facial region's color is obscure, using euthermic clear water face cleaning after, by recombinant bovine alkalescence
Fibroblast growth factor gel is directly embrocated at skin lesion, 300IU/cm2, early, late each 1 time, after treating 2 weeks, face is red
Speckle disappears, and private prosecution skin is smooth earlier above, fine and smooth, and glossy, follow-up December skin lesion is without recurrence（Fig. 6）.
The experimental observation step that the present invention is applied to clinic is as follows：
（1）Clinical data：What we were treated in our hospital's Dermatology Outpatient Department during choosing in March, 2015 in December, 2015
205 acne rosacea patients, wherein women 151（73.66%）, male 54（26.34%）, between 20～45 years old age, put down
（32.05+7.68）Year, the course of disease 0.11～20 year, averagely（3.52+4.12）Year.All patients are randomly divided into two groups：Recombinant bovine
103 people of basic fibroblast growth factor reparation group；Without reparation 102 people of blank group.Two groups of patients are general, and clinical data is compared,
There was no significant difference（P ＞ 0.05）, with comparability.Reparation group uses bFGF bovine basic fibroblast growth factor gel office
Portion is applied at skin lesion, 300IU/cm2, 2 times a day, is within 2 weeks 1 course for the treatment of, and substantially person can the proper extension course for the treatment of for curative effect；Blank group
Any external used medicine is not used.
（2）Reagent and material
BFGF bovine basic fibroblast growth factor 21000IU/5g/（Manufacturing enterprise：The limited public affairs of hundred million victory bio-pharmaceuticals of Zhuhai
Department）
（3）Inclusion criteria
Inclusive criteria：Clinical manifestation meets acne rosacea：The acne sample pimple in batch on the basis of erythema, forms without acne.
Exclusion standard：Anemia of pregnant woman and women breast-feeding their children；It is associated with the severe primary disease such as cardiovascular, liver, kidney and hemopoietic system
Patient；Psychosiss, tumor patients in heilongjiang；Once diagnosed and treated the patient of acne rosacea；Previously to human/bovine basic fibroblast of recombinating
The patient of cell growth factor allergy.
It is all enter group patient sign Informed Consent Form.
（4）Therapeutic Method
Reparation group：After euthermic clear water face cleaning, by bFGF bovine basic fibroblast growth factor gel directly embrocate in
At skin lesion, 300IU/cm2, 2 times a day, is within 2 weeks 1 course for the treatment of；
Blank group：Any medicine is not used；
Follow-up December after the completion of reparation.
（5）Observation index and efficacy assessment standard.
All patients are before and after bFGF bovine basic fibroblast growth factor gel for treating by fixed doctor to its skin
Damage is scored, and index includes erythema, pimple, desquamation, drying, and each index is scored according to level Four point system：Without meter 0
Point, 1 point of slight meter, 2 points of moderate meter, 3 points of severe meter.
Therapeutic index=（Before reparation-repair after）Total mark × 100% before total mark/reparation.
Recovery from illness：Therapeutic index >=90%, skin lesion clinical manifestation disappear substantially for skin lesion；
It is effective：60%≤therapeutic index<90%, skin lesion is most of to disappear；
Take a turn for the better：30%≤therapeutic index<60%, skin lesion has mitigated；
It is invalid：Therapeutic index<30%, skin lesion is not improved.
Total effective rate is based on fully recovering plus be effective.
（6）As a result
Table one. rbFGF reparations group indices information slip after 2 weeks（Unit：People）
Table two. without repairing indices information slip after blank group 2 weeks（Unit：People）
Table three. the skin lesion of reparation group and blank group repairs effective percentage contrast table（Unit：%）
From the contrast of the indices of table 3, the observation of bFGF bovine basic fibroblast growth factor reparation group patient can be drawn
Index erythema, pimple, desquamation, the total effective rate of drying are respectively 97.09%, 82.35%, 98.33%, 97.50%, blank group patient
Observation index erythema, pimple, desquamation, drying total effective rate be respectively 24.51%, 66.67%, 52.08%, 18.99%.Jing
х2Inspection understands that the erythema of reparation group, pimple, desquamation, the effect of dry four observation indexs are better than blank group（P ＜
0.05）.Visible accordingly, bFGF bovine basic fibroblast growth factor gel can make acne rosacea show as erythema, pimple, take off
Bits and be dried skin lesion be clearly better, bFGF bovine basic fibroblast growth factor can promote epithelial cell, hypodermal cell, into
The isocellular reparation of fibrocyte, vascular endothelial cell and regeneration, and treatment cycle is short, Small side effects.
Claims (1)
1. application of the bFGF bovine basic fibroblast growth factor gel in acne rosacea skin lesion is repaired.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201610967911 | 2016-11-05 | ||
| CN2016109679110 | 2016-11-05 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107802895A (en) * | 2017-12-08 | 2018-03-16 | 广州赛莱拉干细胞科技股份有限公司 | A kind of scar repair material and its preparation method and application |
| CN110624102A (en) * | 2019-11-08 | 2019-12-31 | 罗洋 | Clinical application of bevacizine as medicine for repairing demodex disease skin damage |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733294A (en) * | 2005-08-10 | 2006-02-15 | 南海朗肽制药有限公司 | Recombined human alkaline fibroblast growth factor gelling agent and process for preparing the same |
| CN102357242A (en) * | 2011-11-02 | 2012-02-22 | 珠海亿胜生物制药有限公司 | Recombination cattle alkaline fibroblast growth factor gel |
| CN102362856A (en) * | 2011-11-02 | 2012-02-29 | 珠海亿胜生物制药有限公司 | Recombinant bovine basic fibroblast grow factor external solution |
| CN104586778A (en) * | 2015-02-12 | 2015-05-06 | 珠海亿胜生物制药有限公司 | External recombinant bovine basic fibroblast growth factor lyophilized preparation |
-
2016
- 2016-11-07 CN CN201610974886.9A patent/CN106563121B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1733294A (en) * | 2005-08-10 | 2006-02-15 | 南海朗肽制药有限公司 | Recombined human alkaline fibroblast growth factor gelling agent and process for preparing the same |
| CN102357242A (en) * | 2011-11-02 | 2012-02-22 | 珠海亿胜生物制药有限公司 | Recombination cattle alkaline fibroblast growth factor gel |
| CN102362856A (en) * | 2011-11-02 | 2012-02-29 | 珠海亿胜生物制药有限公司 | Recombinant bovine basic fibroblast grow factor external solution |
| CN104586778A (en) * | 2015-02-12 | 2015-05-06 | 珠海亿胜生物制药有限公司 | External recombinant bovine basic fibroblast growth factor lyophilized preparation |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107802895A (en) * | 2017-12-08 | 2018-03-16 | 广州赛莱拉干细胞科技股份有限公司 | A kind of scar repair material and its preparation method and application |
| CN110624102A (en) * | 2019-11-08 | 2019-12-31 | 罗洋 | Clinical application of bevacizine as medicine for repairing demodex disease skin damage |
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