MD1004Z - Method for the treatment of infravesical obstruction caused by benign prostatic hyperplasia - Google Patents

Method for the treatment of infravesical obstruction caused by benign prostatic hyperplasia Download PDF

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MD1004Z
MD1004Z MDS20150054A MDS20150054A MD1004Z MD 1004 Z MD1004 Z MD 1004Z MD S20150054 A MDS20150054 A MD S20150054A MD S20150054 A MDS20150054 A MD S20150054A MD 1004 Z MD1004 Z MD 1004Z
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treatment
benign prostatic
prostatic hyperplasia
zinc oxide
cold pressing
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Виталие ГИКАВЫЙ
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Abstract

The invention relates to medicine, in particular to urology and can be used for the treatment of infravesical obstruction caused by benign prostatic hyperplasia.According to the invention, the method consists in that once a day, per rectum, through microclysters is administered in a volume of 30 ml an ozonated mixture based on pumpkin oil, obtained by cold pressing, which contains 5 mg of zinc oxide and silver nanoparticles, taken in the ratio of 9:1, with the ozone concentration of 9000 µg/L and 5 mg of a 5-alpha-reductase inhibitor, then after 2.5 hours is completely emptied the urinary bladder and instilled 150 ml of an ozonated mixture based on amaranth oil, obtained by cold pressing with the ozone concentration of 10000 µg/L, which contains 5 mg of zinc oxide and silver nanoparticles, taken in the ratio of 9:1, the treatment course is 40 days.

Description

Invenţia se referă la medicină, în special la urologie şi poate fi utilizată pentru tratamentul obstrucţiei infravezicale cauzate de hiperplazia benignă de prostată. The invention relates to medicine, in particular to urology and can be used for the treatment of infravesical obstruction caused by benign prostatic hyperplasia.

Obstrucţia infravezicală apare cel mai frecvent la vârstă înaintată şi în majoritatea cazurilor este cauzată de dezvoltarea unui proces hiperplazic în prostată. Hiperplazia benignă a prostatei (HBP) este una dintre cele mai răspândite maladii polietiologice la bărbaţii de vârstă înaintată şi senilă, care apare în urma proliferării zonei tranzitorii a prostatei şi a glandelor parauretrale, ce duce la obstrucţia căilor urinare inferioare. O dovadă în acest sens este faptul că potrivit datelor cercetărilor epidemiologice, HBP a fost depistată la 40% dintre bărbaţii cu vârste cuprinse între 50 şi 60 ani, la 50% dintre bărbaţii trecuţi de 60 ani şi la 90% - după 80 ani. Se consideră că majoritatea bărbaţilor cu vârste mai mari de 50 ani au unele sau altele simptome determinate de HBP, iar durata vieţii bărbaţilor în creştere contribuie la sporirea numărului bolnavilor care suferă de această maladie. Clinic această maladie se manifestă prin diferite simptome legate de dereglarea pasajului urinei prin căile urinare inferioare. Cauzele tulburării micţiunii sunt obstrucţia infravezicală şi slăbirea funcţiei detrusorului. Obstrucţia are la bază creşterea în dimensiuni a prostatei cu îngustarea treptată a lumenului uretrei (componenta mecanică) şi hipertonusul fibrelor musculare netede ale prostatei şi uretrei posterioare (componenta dinamică). Tratamentul hiperplaziei benigne a prostatei rămâne până în prezent o problemă actuală. Pe parcursul ultimilor 20 ani a apărut posibilitatea de a trata bolnavii la stadii incipiente ale acestei maladii cu preparate medicamentoase corespunzătoare. Infravesical obstruction occurs most frequently in old age and in most cases is caused by the development of a hyperplastic process in the prostate. Benign prostatic hyperplasia (BPH) is one of the most common polyetiological diseases in old and senile men, which occurs as a result of proliferation of the transitional zone of the prostate and paraurethral glands, which leads to obstruction of the lower urinary tract. Evidence in this regard is the fact that according to epidemiological research data, BPH was detected in 40% of men aged between 50 and 60 years, in 50% of men over 60 years and in 90% - after 80 years. It is believed that most men over 50 years have some or other symptoms caused by BPH, and the increasing life expectancy of men contributes to the increase in the number of patients suffering from this disease. Clinically, this disease manifests itself through various symptoms related to the disorder of the passage of urine through the lower urinary tract. The causes of micturition disorder are infravesical obstruction and weakening of the detrusor function. The obstruction is based on the increase in the size of the prostate with the gradual narrowing of the urethral lumen (mechanical component) and hypertonicity of the smooth muscle fibers of the prostate and posterior urethra (dynamic component). The treatment of benign prostatic hyperplasia remains a current problem to this day. Over the past 20 years, the possibility of treating patients in the early stages of this disease with appropriate medicinal preparations has emerged.

Dintre metodele existente de terapie medicamentoasă a obstrucţiei infravezicale, provocată de hiperplazia benignă a prostatei, cea mai eficientă constă în administrarea remediului medicamentos „Vitaprost Forte”, sub formă de supozitorii rectale, în doză de 100 mg, o dată în zi, timp de 60 zile. Dintre 30 de pacienţi care au fost supuşi tratamentului un efect pozitiv înalt s-a observat la 8 (26,7%), efect satisfăcător s-a observat la 12 (40%) şi slab pozitiv la 10 (33,3%) din bolnavi [1]. Among the existing methods of drug therapy of infravesical obstruction caused by benign prostatic hyperplasia, the most effective is the administration of the drug "Vitaprost Forte", in the form of rectal suppositories, in a dose of 100 mg, once a day, for 60 days. Among 30 patients who underwent treatment, a high positive effect was observed in 8 (26.7%), a satisfactory effect was observed in 12 (40%) and a weak positive effect in 10 (33.3%) of the patients [1].

Dezavantajele acestei metode constau în aceea că manifestă un efect de scurtă durată 2,5…3 luni după tratament şi se aplică la un contingent limitat de bolnavi cu HBP în stadiul I. Cele mai radicale continuă să fie considerate doar metodele chirurgicale, care includ adenomectomia deschisă şi rezecţia transuretrală a HBP, iar în tratamentul hiperplaziei benigne a prostatei de dimensiuni mari, metoda chirurgicală principală este adenomectomia transvezicală transversală. The disadvantages of this method are that it has a short-term effect 2.5…3 months after treatment and is applied to a limited contingent of patients with stage I BPH. Only surgical methods continue to be considered the most radical, which include open adenomectomy and transurethral resection of BPH, and in the treatment of large benign prostatic hyperplasia, the main surgical method is transverse transvesical adenomectomy.

Problema pe care o soluţionează invenţia constă în sporirea eficienţei tratamentului medicamentos la pacienţii cu obstrucţia infravezicală provocată de hiperplazia benignă a prostatei, deoarece majoritatea bărbaţilor care suferă de această maladie au o vârstă înaintată, nu la toţi este posibil să se efectueze intervenţii chirurgicale din cauza maladiilor cronice persistente. The problem solved by the invention consists in increasing the efficiency of drug treatment in patients with infravesical obstruction caused by benign prostatic hyperplasia, since most men suffering from this disease are of advanced age, not all of them are able to undergo surgical interventions due to persistent chronic diseases.

Esenţa invenţiei constă în aceea că o dată în zi, per rectum, prin microclisme se administrează în volum de 30 ml un amestec ozonat pe bază de ulei de dovleac, obţinut prin presare la rece, ce conţine 5 mg de nanoparticule de oxid de zinc şi argint, luate în raport de 9:1, cu concentraţia ozonului de 9000 µg/l şi 5 mg de un inhibitor al 5α reductazei, apoi după 2,5 ore se goleşte complet vezica urinară şi se instilează 150 ml de un amestec ozonat, pe bază de ulei de amarant, obţinut prin presare la rece cu concentraţia ozonului de 10000 µg/l, ce conţine 5 mg de nanoparticule de oxid de zinc şi argint, luate în raport de 9:1, seria de tratament constituie 40 zile. The essence of the invention consists in that once a day, per rectum, through microenemas, an ozonated mixture based on pumpkin oil, obtained by cold pressing, is administered in a volume of 30 ml, containing 5 mg of zinc oxide and silver nanoparticles, taken in a ratio of 9:1, with an ozone concentration of 9000 µg/l and 5 mg of a 5α reductase inhibitor, then after 2.5 hours, the urinary bladder is completely emptied and 150 ml of an ozonated mixture based on amaranth oil, obtained by cold pressing with an ozone concentration of 10000 µg/l, containing 5 mg of zinc oxide and silver nanoparticles, taken in a ratio of 9:1, is instilled, the treatment series is 40 days.

Rezultatul invenţiei constă în evidenţierea unei metode de tratament care manifestă o eficacitate sporită faţă de cea mai apropiată soluţie şi prin aceasta se evită o intervenţie chirurgicală, este simplă în executare şi poate fi aplicată la pacienţii de orice vârstă. The result of the invention consists in highlighting a treatment method that exhibits increased effectiveness compared to the closest solution and thereby avoids surgical intervention, is simple to perform and can be applied to patients of any age.

Rezultatele tratării pacienţilor cu obstrucţie infravezicală provocată de hiperplazia benignă de prostată conform celei mai apropiate soluţii şi conform soluţiei revendicate Results of treating patients with infravesical obstruction caused by benign prostatic hyperplasia according to the closest solution and according to the claimed solution

Criteriile de apreciere a rezultatelor tratamentului La începutul tratamentului Peste 30 zile Peste 40 zile Peste 60 zile Suma de puncte conform scării IPSS (International Prostate Symptom Score), valori absolute 13,9±2,1 14,1±1,5 11,8±2,3 8,8±2,1 6,8±1,1 9,7±1,7 6,0±1,5 Calitatea vieţii conform scării QOLS (Quality of Life Scale), valori absolute 3,8±0,4 3,5±0,7 3,0±0,7 2,7,0±0,2 2,1,0±0,2 2,6±0,5 1,5±0,3 Viteza maximă a urinei Qmax, ml/s 9,3±0,9 9,8±1,2 10,5±0,6 10,8±0,6 13,0±0,2 12,9±0,4 15,0±0,1 Cantitatea urinei restante, ml 65,5±12,9 60,1±10,3 42,4±10,5 35,6±8,5 30,2±2,5 33,8±9,1 20,5±1,5 Volumul prostatei, cm3 48,5±5,5 51,5±3,5 47,8±6,1 48,8±1,2 45,8±0,7 44,2±3,7 40,1±0,3Criteria for assessing treatment results At the beginning of treatment Over 30 days Over 40 days Over 60 days Sum of points according to the IPSS scale (International Prostate Symptom Score), absolute values 13.9±2.1 14.1±1.5 11.8±2.3 8.8±2.1 6.8±1.1 9.7±1.7 6.0±1.5 Quality of life according to the QOLS scale (Quality of Life Scale), absolute values 3.8±0.4 3.5±0.7 3.0±0.7 2.7.0±0.2 2.1.0±0.2 2.6±0.5 1.5±0.3 Maximum urine velocity Qmax, ml/s 9.3±0.9 9.8±1.2 10.5±0.6 10.8±0.6 13.0±0.2 12.9±0.4 15.0±0.1 Amount of remaining urine, ml 65.5±12.9 60.1±10.3 42.4±10.5 35.6±8.5 30.2±2.5 33.8±9.1 20.5±1.5 Prostate volume, cm3 48.5±5.5 51.5±3.5 47.8±6.1 48.8±1.2 45.8±0.7 44.2±3.7 40.1±0.3

Conform datelor din tabelul de mai sus, durata tratamentului este mai mică în comparaţie cu cea mai apropiată soluţie, deoarece deja la a 40-a zi rezultatele sunt superioare faţă de cea mai apropiată soluţie, unde abia la a 60-a zi se obţine un efect pozitiv. Rezultatul tehnic se datorează selectării reuşite a componentelor, precum şi combinării lor atât calitative cât şi cantitative cu nanoparticule de oxid de zinc şi argint, dar şi datorită modului de administrare reuşit ales. According to the data in the table above, the duration of treatment is shorter compared to the closest solution, because already on the 40th day the results are superior to the closest solution, where a positive effect is achieved only on the 60th day. The technical result is due to the successful selection of components, as well as their qualitative and quantitative combination with zinc oxide and silver nanoparticles, but also due to the successful administration method chosen.

Metoda se realizează în felul următor: o dată în zi, per rectum, prin microclisme se administrează în volum de 30 ml un amestec ozonat pe bază de ulei de dovleac, obţinut prin presare la rece, ce conţine 5 mg de nanoparticule de oxid de zinc şi argint, luate în raport de 9:1, cu concentraţia ozonului de 9000 µg/l şi 5 mg de un inhibitor al 5α reductazei, apoi după 2,5 ore se goleşte complet vezica urinară şi se instilează 150 ml de un amestec ozonat, pe bază de ulei de amarant, obţinut prin presare la rece cu concentraţia ozonului de 10000 µg/l, ce conţine 5 mg de nanoparticule de oxid de zinc şi argint, luate în raport de 9:1, seria de tratament constituie 40 zile. The method is performed as follows: once a day, per rectum, through microenemas, an ozonated mixture based on pumpkin oil, obtained by cold pressing, is administered in a volume of 30 ml, containing 5 mg of zinc oxide and silver nanoparticles, taken in a ratio of 9:1, with an ozone concentration of 9000 µg/l and 5 mg of a 5α reductase inhibitor, then after 2.5 hours, the bladder is completely emptied and 150 ml of an ozonated mixture based on amaranth oil, obtained by cold pressing with an ozone concentration of 10000 µg/l, containing 5 mg of zinc oxide and silver nanoparticles, taken in a ratio of 9:1, is instilled, the treatment series is 40 days.

Uleiul de dovleac, uleiul de amarant, obţinute prin presare la rece, şi inhibitorul 5α reductazei (Proscar) pot fi procurate în reţeaua de comerţ a Republicii Moldova, iar nanoparticulele de oxid de zinc şi argint pot fi uşor procurate în reţelele de comerţ ale Federaţiei Ruse din octombrie 2012. Nanoparticulele sunt destinate pentru transportarea eficientă a substanţelor biologic active în locul ţintă al patologiei. O particularitate semnificativă a nanoparticulelor este că ele pătrund în membrana celulară şi pot precipita la suprafaţa sferică mai multe celule de substanţe biologic active, medicamente, polimere etc. Aceste caracteristici au stat la baza aplicării nanoparticulelor în scopul dezintoxicării şi în calitate de conductor. În aşa fel, în anul 2000 nanoparticulele au fost utilizate la pacienţii oncologici care au fost supuşi radio- şi chimioterapiei. Pumpkin seed oil, amaranth oil, obtained by cold pressing, and 5α reductase inhibitor (Proscar) can be purchased in the retail network of the Republic of Moldova, and zinc oxide and silver nanoparticles can be easily purchased in the retail networks of the Russian Federation since October 2012. Nanoparticles are intended for the efficient transport of biologically active substances to the target site of pathology. A significant feature of nanoparticles is that they penetrate the cell membrane and can precipitate on the spherical surface several cells of biologically active substances, drugs, polymers, etc. These characteristics formed the basis for the application of nanoparticles for the purpose of detoxification and as a conductor. Thus, in 2000 nanoparticles were used in oncological patients who underwent radio- and chemotherapy.

Amestecul pentru utilizare în microclisme se obţine în felul următor: într-un vas de 15 l se toarnă 10 l de ulei de dovleac, obţinut prin presare la rece, apoi se adaugă 5 mg de praf de nanoparticule de oxid de zinc şi argint, luate în raport de 9:1, şi 5 mg de un inhibitor al 5α reductazei (Proscar), după care soluţia se malaxează până la omogenizare şi se ozonează până la conţinutul de ozon de 9000 µg/l. The mixture for use in microenemas is obtained as follows: in a 15 l vessel, pour 10 l of pumpkin seed oil, obtained by cold pressing, then add 5 mg of zinc oxide and silver nanoparticle powder, taken in a ratio of 9:1, and 5 mg of a 5α reductase inhibitor (Proscar), after which the solution is kneaded until homogenized and ozonized to an ozone content of 9000 µg/l.

Amestecul pentru instilarea vezicii urinare se obţine în felul următor: într-un vas de 15 l se toarnă 10 l de ulei de amarant obţinut prin presare la rece, apoi se adaugă 5 mg de praf de nanoparticule de oxid de zinc şi argint luate în raport de 9:1, după care soluţia se malaxează până la omogenizare şi se ozonează până la conţinutul de ozon de 10000 µg/l. The mixture for instillation of the urinary bladder is obtained as follows: in a 15 l vessel, pour 10 l of amaranth oil obtained by cold pressing, then add 5 mg of zinc oxide and silver nanoparticle powder taken in a ratio of 9:1, after which the solution is kneaded until homogenized and ozonized to an ozone content of 10,000 µg/l.

Exemplu concret de realizare Concrete example of achievement

Pacientul A., 56 ani, a fost internat în secţia urologie cu acuze la micţiune întreruptă care se efectuează prin depunerea de efort, senzaţia de golire insuficientă a vezicii urinare, micţiuni nocturne de 5 ori pe noapte şi odată în decursul zilei micţiuni involuntare, a fost determinată suma de puncte conform scării IPSS - 14; Calitatea vieţii conform scării QOLS - 4; Viteza maximă a urinei Qmax - 10; Cantitatea urinei restante - 60 ml şi volumul prostatei - 52 cm3, s-a stabilit diagnosticul clinic de obstrucţie infravezicală provocată de hiperplazia benignă a prostatei asociată cu hipertonie arterială de gr. II. Pacientul a urmat un tratament conform metodei revendicate, peste 40 zile s-au determinat următorii indici: micţiunea fără efort şi neîntreruptă, a dispărut senzaţia de golire insuficientă a vezicii urinare, micţiunile nocturne s-au redus la 2, iar cele involuntare au dispărut, IPSS - 7; QOLS - 3; Viteza maximă a urinei Qmax - 13; Cantitatea urinei restante - 30 ml şi volumul prostatei - 45 cm3. Patient A., 56 years old, was admitted to the urology department with complaints of interrupted urination that occurs with effort, the feeling of insufficient emptying of the bladder, nocturnal urination 5 times a night and once during the day involuntary urination, the sum of points according to the IPSS scale was determined - 14; Quality of life according to the QOLS scale - 4; Maximum urine velocity Qmax - 10; Amount of remaining urine - 60 ml and prostate volume - 52 cm3, the clinical diagnosis of infravesical obstruction caused by benign prostatic hyperplasia associated with grade II arterial hypertension was established. The patient underwent treatment according to the claimed method, over 40 days the following indices were determined: effortless and uninterrupted urination, the feeling of insufficient bladder emptying disappeared, nocturnal urinations were reduced to 2, and involuntary ones disappeared, IPSS - 7; QOLS - 3; Maximum urine velocity Qmax - 13; Amount of remaining urine - 30 ml and prostate volume - 45 cm3.

Conform metodei revendicate au fost trataţi 203 pacienţi care au fost monitorizaţi pe parcursul a 2 ani, perioada de remisie a constituit 7 luni în comparaţie cu cea mai apropiată soluţie, în care a fost de 3 luni. According to the claimed method, 203 patients were treated and monitored for 2 years, the remission period was 7 months compared to the closest solution, in which it was 3 months.

1. Ткачук В.Н., Ткачук И.Н. Эффективность препарата Витапрост форте у больных с доброкачественной гиперплазией предстательной железы. Санкт-Петерсбург, Государственный медицинский университет, 2014 <URL: http://medi.ru/doc/g2401204.htm> 1. Tkachuk V.N., Tkachuk I.N. Effectiveness of the drug Vitaprost forte in patients with benign prostate hyperplasia. Saint Petersburg, State Medical University, 2014 <URL: http://medi.ru/doc/g2401204.htm>

Claims (1)

Metodă de tratament al obstrucţiei infravezicale cauzate de hiperplazia benignă de prostată, care constă în aceea că o dată în zi, per rectum, prin microclisme se administrează în volum de 30 ml un amestec ozonat pe bază de ulei de dovleac, obţinut prin presare la rece, ce conţine 5 mg de nanoparticule de oxid de zinc şi argint, luate în raport de 9:1, cu concentraţia ozonului de 9000 µg/l şi 5 mg de un inhibitor al 5α reductazei, apoi după 2,5 ore se goleşte complet vezica urinară şi se instilează 150 ml de un amestec ozonat, pe bază de ulei de amarant, obţinut prin presare la rece cu concentraţia ozonului de 10000 µg/l, ce conţine 5 mg de nanoparticule de oxid de zinc şi argint, luate în raport de 9:1, seria de tratament constituie 40 zile.Method of treatment of infravesical obstruction caused by benign prostatic hyperplasia, which consists in administering once a day, per rectum, through microenemas, a 30 ml volume of an ozonated mixture based on pumpkin oil, obtained by cold pressing, containing 5 mg of zinc oxide and silver nanoparticles, taken in a ratio of 9:1, with an ozone concentration of 9000 µg/l and 5 mg of a 5α reductase inhibitor, then after 2.5 hours the bladder is completely emptied and 150 ml of an ozonated mixture based on amaranth oil, obtained by cold pressing with an ozone concentration of 10000 µg/l, containing 5 mg of zinc oxide and silver nanoparticles, taken in a ratio of 9:1, is instilled. The treatment series is 40 days.
MDS20150054A 2015-04-10 2015-04-10 Method for the treatment of infravesical obstruction caused by benign prostatic hyperplasia MD1004Z (en)

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CN109528806B (en) * 2018-12-19 2021-08-06 刘东波 Sterol composition in pumpkin seed oil and its application and medicine for treating benign prostatic hyperplasia

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