CN109939223A - A kind of interleukin-22 is preparing the application for treating pemphigus vulgaris oral cavity anabrosis drug - Google Patents
A kind of interleukin-22 is preparing the application for treating pemphigus vulgaris oral cavity anabrosis drug Download PDFInfo
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- CN109939223A CN109939223A CN201910281417.2A CN201910281417A CN109939223A CN 109939223 A CN109939223 A CN 109939223A CN 201910281417 A CN201910281417 A CN 201910281417A CN 109939223 A CN109939223 A CN 109939223A
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Abstract
The invention belongs to pharmaceutical preparation field, specifically discloses a kind of interleukin-22 and preparing the application for treating the drug of pemphigus vulgaris oral cavity anabrosis.The rhIL-2 of the present invention innovatively mucous membrane of mouth erosion face local topical low dosage caused by pemphigus vulgaris, can be such that mucous membrane of mouth erosion caused by pemphigus vulgaris restores more rapidly, and pain is effectively relieved.
Description
Technical field
The invention belongs to pharmaceutical preparation fields, and in particular to a kind of interleukin-22 is in preparation for treating pemphigus vulgaris
The application of the drug of oral cavity anabrosis.
Technical background
Pemphigus vulgaris is a kind of dermatology's clinically more typical bullous skin disease, shows as whole skin and glutinous
There are a large amount of blisters, bleb, easily ulceration in film, and rotten to the corn face is difficult to heal.About 60% Pemphigus Vulgaris may occur in which oral cavity
Blister, the bleb of mucous membrane, and the rotten to the corn face that spontaneous ulceration, formation do not recover for a long time, since such oral cavity anabrosis usually persistently counts
The moon or even several years seriously affect patients diet, drinking-water and daily life, bring greatly to patient's body and mind with obvious tenderness
Painful [1].In addition, a part of patient can be showed only as duration mucous membrane of mouth it is rotten to the corn and without any skin lesion [1].
The treatment of pemphigus vulgaris at present relies primarily on system and uses glucocorticoid and (or) immunosuppressor, administration
Approach includes oral, intravenous injection;Patient with severe symptoms can also be used in combination intravenous injection of immunoglobulin (IVIG) treatment [1-
3].These therapies usually have curative effect relatively certainly to pemphigus vulgaris skin lesion, but to the mucous membrane of mouth of most of patient
It is slower to damage curative effect;It has been controlled even across regular treatment skin lesion, oral cavity anabrosis lesion still sustainable several weeks to the several months is difficult
With healing, pain is obvious, and patients ' life quality is by extreme influence.For this case, recommend alkalinity at fibre in clinical guidelines
It is used for rotten to the corn face outside dimension Porcine HGF, can also configure containing lidocaine, nystatin, physiological sodium chloride solution ingredient
Gargle is used to containing gargling, and to promote healing, mitigate pain, prevention local infection [2], however these local therapeutic approaches are promoting
The healing of oral cavity anabrosis, mitigation pain aspect effect are dissatisfied.
In recent years, some biological agents for targeting B cell, such as anti-CD-20 monoclonal antibody (including Rituximab
(Rituximab), trastuzumab (Veltuzumab) etc. is tieed up) and the invasive treatment means such as plasma exchange, immuno absorbence,
The curative effect [2-7] of affirmative is shown to pemphigus vulgaris, but the two price is high and the latter invasive, limits
The use of quite a few patient;Moreover, therapeutic effect of these new treatment means to pemphigus vulgaris mucous membrane of mouth erosion
It there is no targetedly large sample clinical data report [4];Single Case report prompt receives what dimension trastuzumab treatment improved
Pemphigus Vulgaris, there are still the recurrent exerbation of mucous membrane of mouth erosion [8] during maintenance therapy.Therefore, how to solve
The cureless oral cavity anabrosis of Pemphigus Vulgaris is the problem of clinically urgently concern.
[1] Zhao distinguishes that Chinese Clinical dermatology [M] phoenix publishes Mass Media Groups, Jiangsu science tech publishing house .2010
On January 1, in
[2] Chinese doctors'associations' dermatologist branch autoimmune disease Asia Professional Committee vulgaris vulgaris day
The expert advice Chinese journal of dermatology of blister sore diagnosing and treating, 2016,49 (11): 761-65
[3]Harman KE,Brown D,Exton LS,et al.British Association of
Dermatologists’guidelines for the management of pemphigus vulgaris
2017.British J Dermatol.2017,177:1170-1201.
[4]Pollmann R,Schmidt T,Eming R,et al.Pemphigus:a Comprehensive
Review on Pathogenesis,Clinical Presentation and Novel Therapeutic
Approaches.Clin Rev Allergy Immunol.2018Feb;54(1):1-25.
[5]Behzad M1,C,Kneisel A,et al.Combined treatment with
immunoadsorption and rituximab leads to fast and prolonged clinical remission
in difficult-to-treat pemphigus vulgaris.Br J Dermatol.2012Apr;166(4):844-52.
[6]Huang A,Madan RK,Levitt J.Future therapies for pemphigus vulgaris:
Rituximab and beyond.J Am Acad Dermatol.2016Apr;74(4):746-53
[7]Baum S,Gilboa S,Greenberger S,et al.Adjuvant rituximab therapy in
pemphigus:a single-center experience of 18cases.J Dermatolog Treat.2013Dec;24
(6):427-30
[8]Ellebrecht CT,Choi EJ,Allman DM,et al.Subcutaneous veltuzumab,a
humanized anti-CD20antibody,in the treatment of refractory pemphigus
vulgaris.JAMA Dermatol.2014Dec;150(12):1331-5.
Summary of the invention
An object of the present disclosure is, provides a kind of for treating the drug of pemphigus vulgaris oral cavity anabrosis.
Second purpose of the invention is, provides a kind of application of rhIL-2.
For the treatment of pemphigus vulgaris, current dermatology authority teaching material, monograph, practice guidelines and Consensus of experts
In systematically discuss, including system use (i.e. oral, be injected intravenously, subcutaneous injection etc.) glucocorticoid, immunosuppressor,
The drugs such as intravenous injection of immunoglobulin (IVIG), biological agent, the invasive treatment such as plasma exchange, immuno absorbence and skin
The treatment such as the soak in rotten to the corn face, external applied anti-infectious drug, these means usually have the control of the pemphigus vulgaris totality state of an illness
Effect, but in clinical practice, the oral cavity anabrosis of most of patient usually still exists after skin lesion is healed substantially for a long time
Or recurrent exerbation.For oral cavity anabrosis, the basic fibroblast growth factor local topical recommended in clinical guidelines, Yi Jihan
There are lidocaine, nystatin, gargle of physiological sodium chloride solution ingredient etc., in the healing for promoting oral cavity anabrosis, mitigates pain
Pain aspect effect is not very ideal.
Present invention is generally directed to the cureless clinical difficult points of pemphigus vulgaris oral cavity anabrosis, provide a kind of for controlling
The drug of pemphigus vulgaris oral cavity anabrosis is treated, it includes the rhIL-2s of pharmacy effective dose.
The research of the invention finds that the drug comprising rhIL-2 can effectively treat pemphigus vulgaris
Oral cavity anabrosis.
Preferably, the drug is the external preparation of direct oral cavity application.
By the way that directly in the external preparation that affected part topical application includes rhIL-2, oral cavity anabrosis can be accelerated
Healing process alleviates oral cavity pain, promotes Pemphigus Vulgaris oral rehabilitation.
Further preferably, the drug is spray formulation, paint or gargle;Preferably spray formulation.
Preferably, the drug also includes pharmaceutically acceptable auxiliary material;The auxiliary material is further preferably used
In by interleukin-22 be made it is spraying, facilitate the auxiliary material that drug adheres in mucous membrane of mouth.
Drug of the present invention, the rhIL-2 are preferably the preparation of low dosage.
Preferably, the dosage of the rhIL-2 is 1~1,000,000 units/mL;Preferably 10~500,000 is single
Position/mL.In the present invention, the drug comprising the low dosage rhIL-2, especially external preparation, in treatment vulgaris day
Oral cavity anabrosis caused by blister sore has good effect.
The present invention also provides a kind of application of rhIL-2, it is used to prepare for treating pemphigus vulgaris mouth
The drug of chamber erosion.
Preferably, being used to prepare mouth of the pemphigus vulgaris through glucocorticoid and/or in the immunosuppressant treatment phase
The drug of chamber erosion.
RhIL-2 can be applied individually to any controlling for oral cavity anabrosis caused by pemphigus vulgaris by the application
It treats, the patient for being used or having used glucocorticoid and (or) immunosuppressor can also be applied to, utilize recombination
The interaction of human interleukin 2, glucocorticoid and immunosuppressor, collaboration improve therapeutic effect.
Further preferably, the application is used to prepare the external drug for being applied to pemphigus vulgaris oral cavity anabrosis face.
Still more preferably, it is used to prepare the rhIL-2 dosage for being applied to pemphigus vulgaris oral cavity anabrosis face
For 1~1,000,000 units/mL, preferably 10~500,000 units/mL drug.
The research of the invention finds that recombinant human interleukin low dose of described in the local topical of pemphigus vulgaris oral cavity anabrosis face
Element 2, can achieve good therapeutic effect.
It will be combined containing rhIL-2 and pharmaceutically acceptable auxiliary material, and be used to prepare the drug.
Mucous membrane of mouth erosion caused by pemphigus vulgaris has its particularity, and treatment is intractable, healing time is long.The present invention
The innovatively rhIL-2 of low dosage described in the affected part local use of the erosion of the mucous membrane of mouth caused by pemphigus vulgaris,
Mucous membrane of mouth erosion caused by pemphigus vulgaris can be made to restore more rapidly, and pain is effectively relieved.
Beneficial effect
The method of the present invention provides sharp weapon for the treatment of the erosion of mucous membrane of mouth caused by pemphigus vulgaris, for conventional at present
Invalid patient is treated, on the basis of original Conventional treatment regimens plus with after " rhIL-2 external preparation " of the invention,
Feeling of pain is substantially reduced, and the oral cavity anabrosis of the long-term disunion of script can largely reach healing completely in 2-4 weeks or be cured substantially
It closes.The external preparation is substantially better than what domestic guide at present was recommended in terms of mitigating oral cavity pain, promoting the healing of oral cavity anabrosis face
Basic fibroblast growth factor local topical, and contain lidocaine, nystatin, physiological sodium chloride solution ingredient
The local therapeutic approaches such as gargle.
Detailed description of the invention
Fig. 1 is the pretherapy and post-treatment comparison diagram of embodiment 1;
Fig. 2 is the pretherapy and post-treatment comparison diagram of embodiment 2;
Fig. 3, Fig. 4 are the pretherapy and post-treatment comparison diagram of embodiment 3;
Fig. 5 is the pretherapy and post-treatment comparison diagram of embodiment 4.
Fig. 6 is the pretherapy and post-treatment comparison diagram of embodiment 5.
Fig. 7 is the pretherapy and post-treatment comparison diagram of embodiment 6.
Fig. 8 is visual analogue scales (Visual Analogue Scale/Score, the letter of 1~embodiment of embodiment 6
Claim VAS) pain scores statistical chart.RhIL-2 treats the VAS pain scores before and after pemphigus.People is white with administered recombinant
Interleukin 2 is compared before treating, and applying the drug therapy, VAS pain scores are remarkably decreased (P < 0.0001, N=6) after two weeks, prompts pain
Pain mitigates.
Fig. 9 is in the autoimmune bullous diseases severity scale (ABSIS) of 1~embodiment of embodiment 6
Mucous membrane of mouth damages severity scale statistical chart.The pretherapy and post-treatment ABSIS mucous membrane of mouth of rhIL-2 damages severity
Scoring.Compared with before administered recombinant human interleukin 2 treatment, applying the drug therapy, the damage of ABSIS mucous membrane of mouth is serious after two weeks
Degree scoring is remarkably decreased (P < 0.05, N=6), and mucous membrane of mouth damage is prompted to mitigate.
Figure 10 is that the mucous membrane of mouth damage in the pemphigus disease area index (PDAI) of 1~embodiment of embodiment 6 is serious
Degree scoring statistical chart.The pretherapy and post-treatment PDAI mucous membrane of mouth of rhIL-2 damages severity scale.With administered recombinant people
Interleukin-22 treatment before compare, apply the drug therapy after two weeks PDAI mucous membrane of mouth damage severity scale be remarkably decreased (P <
0.05, N=6), the damage of prompt mucous membrane of mouth mitigates.
Specific embodiment
RhIL-2 is prepared into the externally applied spray for being easily adhered to oral cavity wall, drug concentration is 10~500,000
IU/ml, when treatment, are sprayed on oral cavity anabrosis face, each 1-2 spray every square centimeter, 2 times a day, last for days to several weeks until
It heals completely in rotten to the corn face.For receiving the pemphigus vulgaris of systematicness (oral, intravenously administrable) glucocorticoid treatment
Patient can continue existing system therapeutic scheme, on this basis plus with this therapeutic scheme to promote the healing of oral cavity anabrosis, alleviate
Pain.
Embodiment 1:
Perhaps so-and-so, female, 61 years old, because " oral cavity, pharyngeal rotten to the corn September, aggravate half a month " moved on August 22nd, 2018 it is Central-South big
Learn refined two hospital dermatology department in Hunan, admission number 144**95.Patient oral cavity, the erosion of pharyngeal mucous membrane many places, pain, ache when feeding, drinking water
Pain aggravates, and the rotten to the corn continuous September in face fails to heal, and Chinese medicine treatment is voluntarily taken before being admitted to hospital and is treated (specifically not in local clinic
In detail), less effective.
Vulgaris is diagnosed as through pemphigus vulgaris antibodies detection, skin biopsy and direct immunofluorescence inspection after being admitted to hospital
Pemphigus only gives rhIL-2 and locally applies outside because patient's refusal uses glucocorticoid, immunosuppressor after being admitted to hospital
In oral cavity anabrosis position, 100,000 units/time, twice daily, oral cavity anabrosis position is healed substantially after treatment 10 days, and pain is complete
Alleviate (Fig. 1).
Embodiment 2:
Liu, male, 82 years old, because " oral cavity anabrosis 2 months, exacerbation 1 week " on October 6th, 2018 to move in Central South University Hunan refined
Two hospital dermatology departments, admission number 145**73.There is mucous membrane of mouth erosion, pain without obvious inducement in patient, continues 2 months, in
It goes to a doctor in Xiangya Hospital, Central-South China Univ. on September 29th, 2018, is diagnosed as " pemphigus vulgaris simultaneously infects ", gives glucocorticoid
(methylprednisolone 48mg/ days), immunosuppressor (imuran 50mg bid) treatment, less effective.
After on October 6th, 2018 moves in dermatology, Xiangye No. 2 Hospital of Central South University, added with rhIL-2 part
It is applied to oral cavity anabrosis position outside, 100,000 units/time, twice daily, while original glucocorticoid dosage is reduced into methylprednisolone
40mg/ days, original immunosuppressor (imuran) was stopped using, and program after one week treatment oral cavity anabrosis position improves,
Largely there is epithelium covering in rotten to the corn face, and pain is relieved (Fig. 2).
Embodiment 3:
Liu, male, 44 years old, because " oral lesions April repeatedly, exacerbation more than 40 days " moved on December 3rd, 2018 it is Central-South
Refined two hospital dermatology department in university Hunan, admission number 147**54.Patient continued oral cavity anabrosis before April, it is difficult to heal, in local clinic
(specifically unknown) once took a favorable turn after treatment, but oral cavity anabrosis recurs before 40 days, through local hospital glucocorticoid treatment without improvement.
Vulgaris is diagnosed as through pemphigus antibody test, skin biopsy and direct immunofluorescence inspection after being admitted to hospital on December 3rd, 2018
Pemphigus.
After being admitted to hospital while maintaining existing dose glucocorticoid treatment, added outer with rhIL-2 part
It is applied to oral cavity anabrosis position, 100,000 units/time, twice daily, heal substantially at oral cavity anabrosis after treatment 1 week, pain is obvious
Alleviate, improve discharge (Fig. 3,4).
Embodiment 4:
Mr. Li, female 65 years old, move on October 15th, 2018 because of " whole body is dispersed in rotten to the corn face with oral lesions half a year "
Southern refined two hospital dermatology department in university Hunan, admission number 145**77.It is glimmering through pemphigus antibody test, skin biopsy and direct immunization
Optical test is diagnosed as pemphigus vulgaris.Give prednisone 45mg qd oral medication in outpatient service, skin improves, but lip and mouth
Intracavitary mucosal erosion, pain do not control yet.
After being admitted to hospital while maintaining existing dose glucocorticoid treatment, give being applied to outside rhIL-2 part
Oral cavity anabrosis position, 100,000 units/time, one time a day, mucous membrane of mouth pain relief, rotten to the corn face start zooming out after treatment 2 weeks, mouth
The rotten to the corn basic healing of lip.When the 4th week, further consultation twice in the 8th week, pain has been relieved, and erosion on lips has healed, mucous membrane in oral cavity
Rotten to the corn face is obviously reduced (Fig. 5).
Embodiment 5:
Slowly so-and-so, male, 48 years old, because " whole body is dispersed in rotten to the corn face companion's oral cavity anabrosis 2 months " moved on October 9th, 2018 it is Central-South
Refined two hospital dermatology department in university Hunan, admission number 145**94.Patient once treated in Xinjiang hospital before being admitted to hospital, at that time system
Property has used glucocorticoid (20mg/ days+prednisone of methylprednisolone 10mg/ days, total amount are converted into prednisone 35mg/ days), has exempted from
Epidemic disease inhibitor (mycophenolate mofetil 500mg tid oral) and Tripterygium wilfordii Polyglycosidium Tablets 20mg tid are external application Halometasone ointment, more
Colistin B ointment, is not improved.
After Xiangye No. 2 Hospital of Central South University is admitted to hospital, added with rhIL-2 localised application in oral cavity anabrosis face,
100000 units/time, twice daily, and the treatment medication such as original glucocorticoid, immunosuppressor and dosage are constant, the program
Skin and oral cavity anabrosis face are obviously reduced, improve after treating 2 weeks, and pain is relieved (Fig. 6).
Embodiment 6:
Xiao, female, 52 years old, because " oral lesions 6 years repeatedly, face, chest and back erythema, blister 3 days " is in August, 2018
Move within 31st dermatology, Xiangye No. 2 Hospital of Central South University, admission number 144**83.Nearly 6 years of patient oral cavity anabrosis repeatedly, it is difficult to more
It closes, Zeng Duoci takes Chinese medicine treatment, the ulcer still sustainable several months, occurs repeatedly;On May 28th, 2018 medical Yu Xiangya hospital mouthful
Chamber section is diagnosed as " recurrent oral ulceration ", gives the immunoregulation medicaments oral medication such as Thalidomide, total glucoside, effect
It is bad.It is checked really after being admitted to hospital on August 31st, 2018 through pemphigus vulgaris antibodies detection, skin biopsy and direct immunofluorescence
It examines as pemphigus vulgaris.
Because patient's refusal uses glucocorticoid, immunosuppressor, only gives rhIL-2 after being admitted to hospital and locally apply outside
In oral cavity anabrosis position, 100,000 units/time, twice daily, at the same give rhIL-2 subcutaneous injection, the next day it is primary, often
Secondary 800,000 IU heals at skin and oral cavity anabrosis substantially after treatment 2 weeks, and pain is relieved, and heals completely after treatment 4 weeks
(Fig. 7).
Embodiment 7:
Pain caused by pemphigus patients mucous membrane of mouth is rotten to the corn can evaluate its severity with VAS pain scores method.VAS
That is visual analogue scales (Visual Analogue Scale/Score, abbreviation VAS), the method is sensitiveer, there is comparativity.
The horizontal line of standardized 10cm on paper, one end of horizontal line are 0, are indicated painless;The other end is 10, represents most pain;Middle section
Indicate different degrees of pain, patient selects a number in this 11 numbers to evaluate at that time according to itself pain degree
Pain degree, number is bigger, and expression pain is more violent.In the present embodiment, local topical rhIL-2 treatment 6 in oral cavity
Pemphigus Vulgaris of the example (1~embodiment of embodiment 6) based on mucous membrane of mouth erosion, the VAS pain after treatment 2 weeks are commented
Divide before relatively treating and be substantially reduced, difference has statistical significance (p < 0.001) (Fig. 8, table 1).
Table 1
Embodiment 8:
Autoimmune bullous diseases severity scale (ABSIS) is the international serious journey of evaluation pemphigus
The points-scoring system of degree, the state of an illness is accurately evaluated for objective, which includes that skin lesion severity scale and oral cavity are glutinous
Membrane damage severity scale.Score value is higher, and the damage of skin or mucous membrane is more serious.Local topical recombined human is white in oral cavity
Interleukin 2 treats the Pemphigus Vulgaris of 6 (1~embodiments of embodiment 6) based on mucous membrane of mouth erosion, before and after treatment
It calculates ABSIS mucous membrane of mouth and damages severity scale, as a result prompt, the ABSIS mucous membrane of mouth after treatment 2 weeks damages serious journey
Degree scoring significantly reduces before relatively treating, and difference has statistical significance (p < 0.05) (Fig. 9, table 2).
Table 2
Embodiment 9:
Pemphigus disease area index (PDAI) is internationally recognized pemphigus coincident with severity degree of condition Score index, for visitor
The evaluation state of an illness is seen, which includes the severity scale of skin lesion and mucous membrane of mouth damage.Score value is higher, skin or
The damage of mucous membrane is more serious.It is glutinous with oral cavity to treat 6 (1~embodiments of embodiment 6) for local topical rhIL-2 in oral cavity
Pemphigus Vulgaris based on film erosion calculates PDAI mucous membrane of mouth before and after treatment and damages severity scale, as a result
Prompt, the PDAI mucous membrane of mouth damage severity scale after treatment 2 weeks significantly reduce before relatively treating, and difference is anticipated with statistics
Adopted (p < 0.05) (Figure 10, table 3)
Table 3
To sum up, the present invention is suitable for routine medication to the rotten to the corn invalid Pemphigus Vulgaris of oral mucosa, adds
In aforementioned manners after local treatment, oral cavity anabrosis restores relatively rapidly (can be almost recovered within most of patient 2-4 weeks), and pain is big
It is big to alleviate, prompt the treatment method that there is significant, quick treatment effect for mucous membrane of mouth erosion caused by pemphigus vulgaris
Fruit.
Claims (10)
1. a kind of for treating the drug of pemphigus vulgaris oral cavity anabrosis, which is characterized in that the weight comprising pharmacy effective dose
Group human interleukin 2.
2. as described in claim 1 for treating the drug of pemphigus vulgaris oral cavity anabrosis, which is characterized in that the medicine
Object is the external preparation of direct oral cavity application.
3. as claimed in claim 2 for treating the drug of pemphigus vulgaris oral cavity anabrosis, which is characterized in that the medicine
Object is spray formulation, paint or gargle.
4. as claimed in any one of claims 1 to 3 for treating the drug of pemphigus vulgaris oral cavity anabrosis, feature exists
In the dosage of the rhIL-2 is 1~1,000,000 units/mL;Preferably 10~500,000 units/mL.
5. as claimed in any one of claims 1 to 3 for treating the drug of pemphigus vulgaris oral cavity anabrosis, feature exists
In also comprising pharmaceutically acceptable auxiliary material.
6. a kind of application of rhIL-2, which is characterized in that be used to prepare the medicine for the treatment of pemphigus vulgaris oral cavity anabrosis
Object.
7. the application of rhIL-2 as claimed in claim 6, which is characterized in that be used to prepare pemphigus vulgaris warp
The drug of glucocorticoid and/or the oral cavity anabrosis in the immunosuppressant treatment phase.
8. the application of rhIL-2 as claimed in claims 6 or 7, which is characterized in that be used to prepare and be applied to vulgaris
The external drug of the pemphigus oral cavity anabrosis surface of a wound.
9. the application of rhIL-2 as claimed in claim 8, which is characterized in that be used to prepare and be applied to vulgaris day
The rhIL-2 dosage in blister sore oral cavity anabrosis face is 1~1,000,000 units/mL drug;Preferably 10~500,000 units/
mL。
10. such as the application of the described in any item rhIL-2s of claim 6~8, which is characterized in that recombined human will be contained
Interleukin-22 and pharmaceutically acceptable auxiliary material combine, and are used to prepare the drug.
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