CN106491611A - A kind of Western medicine compound and its application for treating idiopathic pulmonary fibrosises - Google Patents
A kind of Western medicine compound and its application for treating idiopathic pulmonary fibrosises Download PDFInfo
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- CN106491611A CN106491611A CN201611116005.6A CN201611116005A CN106491611A CN 106491611 A CN106491611 A CN 106491611A CN 201611116005 A CN201611116005 A CN 201611116005A CN 106491611 A CN106491611 A CN 106491611A
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- idiopathic pulmonary
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- pulmonary fibrosises
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
- A61K31/24—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
- A61K31/245—Amino benzoic acid types, e.g. procaine, novocaine
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of Western medicine compound and its application for treating idiopathic pulmonary fibrosises, the Western medicine compound is combined by nanaimo division and rifampicin, and wherein, the mass ratio of nanaimo division and rifampicin is 1.6 2.4：1；For treating during idiopathic pulmonary fibrosises, its dosage of being grown up was 0.45 0.50mg/kg/ days.Clinical experiment shows, Western medicine compound of the present invention is for the idiopathic pulmonary fibrosises of each phases such as acute, subacute, chronic, chronic acute outbreak, there is preferable therapeutic effect, it is 92 96% to the total effective rate of idiopathic pulmonary fibrosises, and control difficulty in relapse after healing, have no toxic side effect, be with a wide range of applications.
Description
Technical field
The present invention relates to technical field of western medicines, specifically a kind of Western medicine compound for treating idiopathic pulmonary fibrosises and
Which is applied.
Background technology
Idiopathic pulmonary fibrosises（Idiopathic pulmonary fibrosis, abbreviation IPF）It is chronic interstitial pneumonopathy
One kind of the not clear apoplexy due to endogenous wind of reason, and the chronic inflammation lung disease with plain edition interstitial pneumonia being characterized property pathological change,
Its definite pathogenesis is not still fully aware of at present.American Thoracic Society, European respirology can be delivered jointly within 2000
International joint declaration has been made to clearly define to idiopathic pulmonary fibrosises, it is believed that idiopathic pulmonary fibrosises are independent diseases,
Its pathomorphology performance is common interstitial pneumonia（UIP）It is different from other idiopathic interstitial pneumonias, such as desquamation
Type interstitial pneumonia（DIP）, acute interstitial pneumonia（AIP）, nonspecific interstitial pneumonia（NSIP）Deng.According to existing money
The pathogenesis of idiopathic pulmonary fibrosises can be summarized as alveolitises by material, pulmonary parenchyma injury, and excessive reparation and fibrosiss are several
The individual stage.The epidemiologic data of idiopathic pulmonary fibrosises is still imperfect, but its sickness rate increasingly increases, it has also become commonly encountered diseases,
Make a definite diagnosis rear Average Survival 3-5.Up to the present, for the treatment glucocorticoid of pulmonary fibrosiss is still first-selection, but it is only right
20% idiopathic pulmonary fibrosis are effective, and usually from temporary response.Immunosuppressant does not only exist potential serious
Side effect, and substantially invalid to idiopathic pulmonary fibrosises treatment.Therefore, find treatment idiopathic pulmonary fibrosises other are effective
Method is the task of top priority.
At present, idiopathic pulmonary fibrosises are mainly using anti-inflammatory agent and/or immunosuppressant, anti-fibrosis medicine, anticoagulation
The measures such as medicine, lung transplantation are treated.The medicine of conventional treatment idiopathic pulmonary fibrosises, including glucocorticoid, ring
Phosphamide, nitroimidazole sulfur pyrimidine, ciclosporin, mycophenolate, and Colchicine and the penicillium sp of collagen formation can be affected
Amine etc..However, there is the shortcomings of therapeutic effect is not good, toxic and side effects are larger in the medicine of above-mentioned treatment idiopathic pulmonary fibrosises.Cause
This, the medicine for studying the treatment idiopathic pulmonary fibrosises that new therapeutic effect is good, toxic and side effects are little is significant.
Nanaimo division（nafamostat）For the serine protein hydrolase inhibitor of synthetic, with anticoagulant, anti-fibre
Fibrillarin lyase and the effect of antiplatelet aggregation, which is to trypsin, kallikrein（Kallidinogenase）, fibrin
The trypsin-like serine proteases such as CL-r, CL-s of lyase, brinase and complement system classical pathway have very
Strong selective inhibitory.Nanaimo division can suppress inflammatory mediator IL-6, IL-8, TNF-α, the generation of IL-1 β and NOS,
Clinically it is mainly used in the treatment of acute pancreatitis at present.
Rifampicin is a kind of semisynthetic antibiotics obtained from rifamycin B.DNA of bacteria transcription synthesis RNA can be suppressed, can
For treating tuberculosis, enterococcal infection etc..In addition to as antibiotic application, can be used as from antibacterial in molecular biology
Reagent except plasmid.
Present invention research finds, by nanaimo division and rifampicin compounding use, idiopathic pulmonary fibrosises are had preferably
Therapeutical effect.
Content of the invention
It is an object of the invention to provide the little west for treating idiopathic pulmonary fibrosises of a kind of good effect, toxic and side effects
Drug composition and its application.
For achieving the above object, the present invention provides following technical scheme：
A kind of Western medicine compound for treating idiopathic pulmonary fibrosises, is combined by nanaimo division and rifampicin, wherein, how
The mass ratio of Mo Sita and rifampicin is 1.6-2.4：1.
As further scheme of the invention：The mass ratio of described nanaimo division and rifampicin is 1.8-2.0：1.
As further scheme of the invention：The mass ratio of described nanaimo division and rifampicin is 1.9：1.
Application of the described Western medicine compound in treatment idiopathic pulmonary fibrosises medicine is prepared.
As further scheme of the invention：Adult's dosage of described Western medicine compound is 0.45-0.50mg/
Kg/ days.
As further scheme of the invention：Adult's dosage of described Western medicine compound is 0.48mg/kg/ days.
Compared with prior art, the invention has the beneficial effects as follows：Clinical experiment shows that Western medicine compound of the present invention is for urgency
Property, the idiopathic pulmonary fibrosises of each phase such as subacute, chronic, chronic acute outbreak, have preferable therapeutic effect, to idiopathic
The total effective rate of pulmonary fibrosiss is 92-96%, and controls difficulty in relapse after healing, has no toxic side effect, is with a wide range of applications.
Specific embodiment
Below in conjunction with the embodiment of the present invention, to the embodiment of the present invention in technical scheme be clearly and completely described,
Obviously, described embodiment is only a part of embodiment of the invention, rather than whole embodiment.In based on the present invention
Embodiment, the every other embodiment obtained under the premise of creative work is not made by those of ordinary skill in the art, all
Belong to the scope of protection of the invention.
Embodiment 1
In the embodiment of the present invention, a kind of Western medicine compound for treating idiopathic pulmonary fibrosises, by nanaimo division and rifampicin
Combine, wherein, the mass ratio of nanaimo division and rifampicin is 1.6：1.
Embodiment 2
In the embodiment of the present invention, a kind of Western medicine compound for treating idiopathic pulmonary fibrosises, by nanaimo division and rifampicin
Combine, wherein, the mass ratio of nanaimo division and rifampicin is 2.4：1.
Embodiment 3
In the embodiment of the present invention, a kind of Western medicine compound for treating idiopathic pulmonary fibrosises, by nanaimo division and rifampicin
Combine, wherein, the mass ratio of nanaimo division and rifampicin is 1.8：1.
Embodiment 4
In the embodiment of the present invention, a kind of Western medicine compound for treating idiopathic pulmonary fibrosises, by nanaimo division and rifampicin
Combine, wherein, the mass ratio of nanaimo division and rifampicin is 2.0：1.
Embodiment 5
In the embodiment of the present invention, a kind of Western medicine compound for treating idiopathic pulmonary fibrosises, by nanaimo division and rifampicin
Combine, wherein, the mass ratio of nanaimo division and rifampicin is 1.9：1.
In above-described embodiment, the described preparation process for treating the Western medicine compound of idiopathic pulmonary fibrosises is：With
Nanaimo division and rifampicin are effective ingredient, and using acceptable technique and adjuvant on pharmaceuticss, making can on various pharmaceuticss
The peroral dosage form of acceptance.
Now Western medicine compound obtained in above-described embodiment is applied on the clinical treatment of idiopathic pulmonary fibrosises, below for
The related data of its clinical trial.
Clinical trial
1st, basic document
In order to verify therapeutic effect of the Western medicine compound of the present invention to idiopathic pulmonary fibrosises, fine selected from idiopathic lung is diagnosed as
Dimensionization patient 400 carries out clinical observation, 400 patients is divided into treatment 1-5 groups at random and control 1-3 groups are each 50,
And record its medical history, the state of an illness, age and former Therapeutic Method and carry out contrast experiment.The course of disease, symptom weight journey between each group patient
Degree is basically identical, without significant difference, with comparability.
2nd, Therapeutic Method
Treatment 1-5 groups：Take respectively embodiment 1-5 preparation Western medicine compound, orally, consumption be 0.48mg/kg/ days, daily 2
Secondary, surrounding is a course for the treatment of, continuously uses three courses for the treatment of.
Compare 1 group：Prednisone is taken, orally, consumption is 0.5mg/kg/d, and one time a day, is used in conjunction surrounding；Consumption after four weeks
0.25mg/kg/d is changed to, one time a day, is used in conjunction 8 weeks, be within 12 weeks a course for the treatment of.
Compare 2 groups：Nanaimo division is taken, orally, consumption is 0.48mg/kg/ days, and 2 times a day, continuous using 12 weeks.
Compare 3 groups：Rifampicin is taken, orally, consumption is 0.48mg/kg/ days, and 2 times a day, continuous using 12 weeks.
3rd, curative effect determinate standard
The evaluation criterion that international consensuses are recommended is diagnosed and treats with reference to American Thoracic association in 2000 with regard to pulmonary fibrosiss.
【Improve or reaction is good】Meet following at least 2 conditions, i.e.,：（1）Cough, expectorant, asthma shape are obviously improved, movable energy
Power is improved；（2）X-ray or HRCT interstitial lungs pathological changes mitigate；（3）Meet following at least 2：A, total lung capacity（TLC）Or vital capacity
（VC）Increase by 10% or increase ＞ 200ml；B, diffusion capacity for carbon monoxide of lung（DLco）Increase by 15% or increase 3ml；C, cardiopulmonary transport
Disorder of internal organs arterial oxygen saturation raises >=4% or alveolar gass-art pO2 difference rising >=4%mmHg.
【Stable】Meet following at least 2 conditions, i.e.,：（1）TLC or VC change ＜ 10% or ＜ 200ml；（2）DLco changes
＜ 15% or ＜ 3ml；（3）SaO in cardiopulmonary exercise experiment2Change ＜ 4%, PO2Change ＜ 4mmHg.
【Increase】（1）Exacerbation of symptoms：Dyspnea and cough increase；（2）X-ray rabat or HRCT show that interstitial lung pathological changes add
, particularly there is honeycomb lung or pulmonary hypertension sign in weight；（3）When meeting following at least 2：A.TLC or VC decline >=10% or
≥200ml；B.DLco declines >=15% or >=3ml；15% or ＜ 3ml；C. cardiopulmonary exercise experiment in SaO2Decline >=4% or PO2
Rising >=4mmHg.
Symptom assessment standard：Uncomfortable in chest to primary disease, shortness of breath, cough, the symptom such as expectoration according to without, light, in, weigh four stages,
Meter 0-3 divides respectively.
【Effective】After treatment, primary symptom integrated value reduces more than 70%, and uncomfortable in chest, shortness of breath is clearly better.
【Effectively】Primary symptom integrated value reduces 30-60%, uncomfortable in chest, and shortness of breath takes a turn for the better, and gentle activity has shortness of breath, makees, words during cough
Slightly cyanosis.
【Invalid】Main symptom is integrated less than 30%, and uncomfortable in chest, shortness of breath is serious, and quiescent condition has shortness of breath, cough often to make, and cyanosis is obvious.
Specifically can refer to table 1 to be scored.
The 1 clinical disease table of integrals of table
Above evaluation criterion is based on, using the process of 13.0 medical statisticses of SPSS, the employing of measurement data Normal Distribution is in groups
The t inspections of design data, it is that difference is statistically significant to take P ＜ 0.05, and concrete clinical trial results are as shown in table 2.
4th, result of the test
As can be seen from Table 2：The total effective rate that treatment group is treated to idiopathic pulmonary fibrosises is 92-96%, and 1 group of control is to special
Property pulmonary fibrosiss treatment total effective rate only 48%, compareing 2-3 groups does not have the effect for treating idiopathic pulmonary fibrosises substantially, controls
Treatment group evident in efficacy higher than matched group, P ＜ 0.05, illustrate that Western medicine compound of the present invention has to the treatment of idiopathic pulmonary fibrosises
There is effect well.Additionally, in above-mentioned therapeutic process, by the hematuria routine before and after to patient medication, hepatic and renal function, electrocardio
Figure etc. has done and has checked and record, and contrasts no abnormal, it is seen that Western medicine compound of the present invention has no toxic side effect.
The comparitive study of 2 each group of table
| Project | Case load | Effective number | Significant figure | Invalid number | Obvious effective rate | Total effective rate |
| Treat 1 group | 50 | 21 | 25 | 4 | 42% | 92% |
| Treat 2 groups | 50 | 21 | 25 | 4 | 42% | 92% |
| Treat 3 groups | 50 | 22 | 25 | 3 | 44% | 94% |
| Treat 4 groups | 50 | 22 | 25 | 3 | 44% | 94% |
| Treat 5 groups | 50 | 22 | 26 | 2 | 44% | 96% |
| Compare 1 group | 50 | 5 | 19 | 26 | 10% | 48% |
| Compare 2 groups | 50 | 0 | 6 | 44 | 0% | 12% |
| Compare 3 groups | 50 | 0 | 1 | 49 | 0% | 2% |
In sum, Western medicine compound of the present invention is for each phase idiopathic lungs such as acute, subacute, chronic, chronic acute outbreaks
Fibrosiss, have preferable therapeutic effect, are 92-96% to the total effective rate of idiopathic pulmonary fibrosises, and are difficult after curing multiple
Send out, have no toxic side effect, be with a wide range of applications.
5th, model case
Patient's relative, women, 69 years old, main suit's being repeated property dyspnea, activity postemphasis, with dry cough without phlegm nearly 20
Year, the nearly one and a half months state of an illness more increases, coughs and tell a large amount of yellow sputum, soreness of the waist and knees, shortness of breath and fatigue, dynamic then aggravate, and is hospitalized for treatment then.
Patient also suffered from diabetes more than 5 years, and once oral administration of metformin was treated, fasting glucose 6.4mmol/L after treatment.Through having a medical check-up：T：
37.2℃；P：90 beats/min；R：26 beats/min；BP：132/79mmHg, patient's mind are clear, spirit can, development is normal, whole body of having a medical check-up
It is mucocutaneous that whole body superficial lymph knot does not touch enlargement without xanthochromia and petechia, head face without deformity, Dual-eyelid without edema,
Sclera without xanthochromia, conjunctiva without hyperemia, the positive great circle of dicoria, to light reflection sensitive, without deformity, external auditory meatus is unobstructed without exception point for auricle
Secretion, without tenderness, external nose is normal, and ventilation is smooth for mastoid process, and each nose room is hit exactly without tenderness, die Blausucht, Shen tongue, the soft passivity of neck, gas
Pipe is placed in the middle, and, without enlargement, in bucket breast, percussion hyperresonant note, the double pulmonary respiration sounds of auscultation are weak, hear and fraction of dry and wet sieve for thorax for thyroid
Sound, audible and crackles rale, pareordia are restrained together without noise without protuberance, 89 beats/min of heart rate, and abdomen is flat without tenderness, does not touch under liver spleen rib
And, borborygmus normal presence, without deformity, without redness, extremity muscular strength is normal, and double lower limb is without edema in each joint for spinal column extremity.Chest
CT；Under double lungs, ground glass sample changes, and emphysema change；Fasting glucose 7.5mmol/L；Routine blood test：WBC 8.8×109/ L,
S83%、L16%；Electrocardiogram：Substantially normal；Routine urinalysis：No abnormality seen；Pulmonary function test：Moderate restricted type ventilatory dysfunction；
Arterial blood gas analysis PaO2Drop to 57mmHg.It is diagnosed as idiopathic pulmonary interstitial fibrosis, diabetes.
After taking one course for the treatment of of Western medicine compound of the preparation of embodiment 5, patient feels that dyspnea substantially mitigates, after activity
Exacerbation of symptoms is not obvious, and soreness of the waist and knees symptom takes a turn for the better, and dry cough takes a turn for the better, and cyanosis mitigates, and double lung dry and wet rales substantially disappear.Check breast
Portion CT：Under double lungs, ground glass sample changes shadow and has absorbed；Lung function：Still there is moderate restrictive ventilatory functional disturbance, but examine
Survey VC numerical value to have increased；Arterial blood gas analysis：PaO281mmol/L contrasts have been increased.Continue to take the preparation of embodiment 5
Two courses for the treatment of of Western medicine compound, symptom continue to take a turn for the better, and are checked every six months afterwards, 2 years patient experiences stable diseases of follow-up,
The readme state of an illness mitigated more in the past.
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, Er Qie
In the case of spirit or essential attributes without departing substantially from the present invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, embodiment all should be regarded as exemplary, and be nonrestrictive, the scope of the present invention is by appended power
Profit is required rather than described above is limited, it is intended that all in the implication and scope of the equivalency of claim by falling
Change is included in the present invention.
Moreover, it will be appreciated that although this specification is been described by according to embodiment, not each embodiment is only wrapped
Contain an independent technical scheme, this narrating mode of description is only that those skilled in the art should for clarity
Using description as an entirety, the technical scheme in each embodiment can also form those skilled in the art through appropriately combined
Understandable other embodiment.
Claims (6)
1. a kind of Western medicine compound for treating idiopathic pulmonary fibrosises, it is characterised in that by nanaimo division and rifampicin group
Conjunction is formed, and wherein, the mass ratio of nanaimo division and rifampicin is 1.6-2.4：1.
2. the Western medicine compound for treating idiopathic pulmonary fibrosises according to claim 1, it is characterised in that described
The mass ratio of nanaimo division and rifampicin is 1.8-2.0：1.
3. the Western medicine compound for treating idiopathic pulmonary fibrosises according to claim 2, it is characterised in that described
The mass ratio of nanaimo division and rifampicin is 1.9：1.
4. answering in treatment idiopathic pulmonary fibrosises medicine is being prepared according to the arbitrary described Western medicine compound of claim 1-3
With.
5. application of the Western medicine compound according to claim 4 in treatment idiopathic pulmonary fibrosises medicine is prepared, which is special
Levy and be, adult's dosage of described Western medicine compound is 0.45-0.50mg/kg/ days.
6. application of the Western medicine compound according to claim 5 in treatment idiopathic pulmonary fibrosises medicine is prepared, which is special
Levy and be, adult's dosage of described Western medicine compound is 0.48mg/kg/ days.
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2016
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| CN103479612A (en) * | 2013-08-27 | 2014-01-01 | 冯世庆 | Pharmaceutical application of nafamostat |
| CN106580961A (en) * | 2016-12-07 | 2017-04-26 | 郑州仁宏医药科技有限公司 | Western medicine composition used for treating idiopathic pulmonary fibrosis and application thereof |
| CN106619609A (en) * | 2016-12-30 | 2017-05-10 | 郑州掌盟网络科技有限公司 | Pharmaceutical composition for treating idiopathic pulmonary fibrosis and application of such pharmaceutical composition |
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