MD493Z - Method for prophylaxis of postradiation complications in oncological diseases - Google Patents
Method for prophylaxis of postradiation complications in oncological diseases Download PDFInfo
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- MD493Z MD493Z MDS20110121A MDS20110121A MD493Z MD 493 Z MD493 Z MD 493Z MD S20110121 A MDS20110121 A MD S20110121A MD S20110121 A MDS20110121 A MD S20110121A MD 493 Z MD493 Z MD 493Z
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Abstract
Description
Invenţia se referă la medicină, şi anume la tratamentul radioterapeutic în oncologie. The invention relates to medicine, namely to radiotherapeutic treatment in oncology.
Radioterapia în oncologia clinică ocupă unul din locurile de bază ale tratamentului. Ea este indicată la 2/3 dintre bolnavii oncologici. Datorită unei diferenţe neesenţiale a sensibilităţii la iradiere a tumorilor şi ţesuturilor adiacente sănătoase, în cazul radioterapiei nu este posibil de a evita iradierea ultimelor, cu deteriorarea lor. În funcţie de manifestările lor, reacţiile adverse ale radioterapiei pot fi locale şi generale. Organismul reacţionează prin apariţia febrei, dereglărilor din partea tubului digestiv (inapetenţă, greaţă, vomă, diaree), dereglărilor din partea sistemului cardiovascular, sistemului nervos şi hematopoietic. Reacţiile locale apar exclusiv în zona de iradiere, manifestându-se prin hiperemia pielii în unele cazuri cu combustii de diverse grade şi afectarea ţesuturilor şi mucoaselor organelor din această regiune [1, 2]. Radiotherapy in clinical oncology occupies one of the basic places of treatment. It is indicated for 2/3 of oncological patients. Due to an insignificant difference in the sensitivity to irradiation of tumors and adjacent healthy tissues, in the case of radiotherapy it is not possible to avoid irradiation of the latter, with their damage. Depending on their manifestations, adverse reactions of radiotherapy can be local and general. The body reacts by the appearance of fever, disorders of the digestive tract (loss of appetite, nausea, vomiting, diarrhea), disorders of the cardiovascular, nervous and hematopoietic systems. Local reactions occur exclusively in the irradiation area, manifesting themselves as hyperemia of the skin in some cases with burns of varying degrees and damage to the tissues and mucous membranes of the organs in this region [1, 2].
Este cunoscută metoda de diminuare a complicaţiilor radioterapiei prin utilizarea preparatului Canefron H la pacienţii oncologici cu tumori ale organelor bazinului mic [3]. The method of reducing radiotherapy complications by using the preparation Canephron H in oncological patients with tumors of the pelvic organs is known [3].
Dezavantajele acestei metode constau în posibilitatea apariţiei reacţiilor alergice la componenţii acestui produs şi utilizarea limitată a lui. The disadvantages of this method are the possibility of allergic reactions to the components of this product and its limited use.
Problema pe care o rezolvă invenţia constă în extinderea arsenalului de metode utilizate pentru prevenirea complicaţiilor locale şi generale în urma aplicării radioterapiei la bolnavii oncologici. The problem that the invention solves consists in expanding the arsenal of methods used to prevent local and general complications following the application of radiotherapy to oncological patients.
Esenţa invenţiei constă în aceea că o dată pe zi, îndată după mese, timp de 15 zile de la începutul cursului de radioterapie, se administrează în doze prestabilite următoarele preparate: intramuscular soluţie de acid ascorbic (vitamina C) şi peroral câte o capsulă de retinol (vitamina A), tocoferol (vitamina E) şi un comprimat de metiluracil. Totodată, începând cu 2…3 zile înainte de iniţierea cursului de radioterapie, precum şi pe tot parcursul lui, se administrează peroral un amestec de ulei din seminţe de struguri şi ulei din seminţe de dovleac, în proporţie de 1:1, câte o lingură de masă (15 mL) de 2 ori pe zi, concomitent se aplică amestecul de ulei pe piele în regiunea supusă iradierii. The essence of the invention consists in that once a day, immediately after meals, for 15 days from the beginning of the radiotherapy course, the following preparations are administered in predetermined doses: intramuscularly ascorbic acid solution (vitamin C) and peroral one capsule of retinol (vitamin A), tocopherol (vitamin E) and one tablet of methyluracil. At the same time, starting 2…3 days before the initiation of the radiotherapy course, as well as throughout it, a mixture of grape seed oil and pumpkin seed oil is administered peroral, in a ratio of 1:1, one tablespoon (15 mL) 2 times a day, simultaneously applying the oil mixture to the skin in the area subject to irradiation.
Rezultatul constă în diminuarea complicaţiilor postradiante locale şi generale la bolnavii oncologici. The result is the reduction of local and general post-radiation complications in oncological patients.
Avantajul metodei constă în faptul că utilizarea combinată a amestecului de uleiuri înainte de cursul de radioterapie, datorită proprietăţilor acestuia, previne apariţia complicaţiilor acute survenite în urma radioterapiei, iar utilizarea lui în asociere cu vitamine şi uracil, în timpul cursului de radioterapie, diminuează vădit gradul de manifestare a complicaţiilor precoce ale iradierii. Metoda propusă diminuează esenţial gradul de manifestare a complicaţiilor radioterapiei şi permite suportarea întregii cure de tratament. The advantage of the method is that the combined use of the oil mixture before the course of radiotherapy, due to its properties, prevents the occurrence of acute complications arising from radiotherapy, and its use in combination with vitamins and uracil, during the course of radiotherapy, significantly reduces the degree of manifestation of early complications of irradiation. The proposed method essentially reduces the degree of manifestation of complications of radiotherapy and allows to withstand the entire course of treatment.
Rezultatul invenţiei constă în diminuarea complicaţiilor postradiante locale şi generale la bolnavii oncologici. The result of the invention consists in reducing local and general post-radiation complications in oncological patients.
Metoda propusă se efectuează în felul următor: o dată pe zi, îndată după mese, timp de 15 zile de la începutul curei de radioterapie, se administrează intramuscular 5 mL soluţie de 5% de acid ascorbic şi peroral o capsulă (33000 UI) de retinol, o capsulă (0,2 g) de tocoferol şi un comprimat (0,2 g) de metiluracil. Totodată, începând cu 2…3 zile înainte de iniţierea cursului de radioterapie, precum şi pe tot parcursul lui, se administrează peroral un amestec de ulei din seminţe de struguri şi ulei din seminţe de dovleac, în proporţie de 1:1, câte o lingură de masă (15 mL) de 2 ori pe zi, concomitent se aplică amestecul de ulei pe piele în regiunea supusă iradierii. The proposed method is carried out as follows: once a day, immediately after meals, for 15 days from the beginning of the radiotherapy course, 5 mL of 5% ascorbic acid solution is administered intramuscularly and perorally one capsule (33000 IU) of retinol, one capsule (0.2 g) of tocopherol and one tablet (0.2 g) of methyluracil. At the same time, starting 2…3 days before the initiation of the radiotherapy course, as well as throughout it, a mixture of grape seed oil and pumpkin seed oil is administered perorally, in a ratio of 1:1, one tablespoon (15 mL) 2 times a day, simultaneously applying the oil mixture to the skin in the area subject to irradiation.
Exemplu de studiu clinic Example of a clinical study
Caracteristicile radioprotectoare ale metodei propuse au fost studiate pe pacienţi oncologici supuşi radioterapiei în Secţia de Radioterapie a Institutului Oncologic. The radioprotective characteristics of the proposed method were studied on oncological patients undergoing radiotherapy in the Radiotherapy Department of the Oncological Institute.
Scopul studiului: aprecierea eficacităţii metodei pentru profilaxia şi tratamentul complicaţiilor survenite în urma radioterapiei la pacienţii oncologici. Purpose of the study: assessing the effectiveness of the method for the prophylaxis and treatment of complications arising from radiotherapy in oncological patients.
Material şi metode Material and methods
Studiul a fost efectuat asupra a 20 pacienţi cu cancer al regiunii cap şi gât (preponderent cu cancer faringian) supuşi radioterapiei. Vârsta pacienţilor a variat de la 46 până la 66 ani (în medie 53 ani). Pacienţii au fost repartizaţi în 2 grupe. Grupa de bază a fost constituită din 10 pacienţi, la care radioterapia a fost efectuată pe fundalul aplicării metodei propuse, şi grupa de control, formată din 10 pacienţi, care au fost supuşi radioterapiei fără aplicarea ei. The study was conducted on 20 patients with head and neck cancer (mainly pharyngeal cancer) undergoing radiotherapy. The patients' age ranged from 46 to 66 years (average 53 years). The patients were divided into 2 groups. The base group consisted of 10 patients, who underwent radiotherapy against the background of the proposed method, and the control group consisted of 10 patients, who underwent radiotherapy without its application.
Radioterapia a fost efectuată cu instalaţia TERABALT (ca sursă a servit Cobaltul-60). Durata şedinţelor a fost în medie de 1…1,8 min (cu o frecvenţă de 60…80 impulsuri pe şedinţă). Radiotherapy was performed with the TERABALT installation (Cobalt-60 served as the source). The duration of the sessions was on average 1…1.8 min (with a frequency of 60…80 pulses per session).
Pacienţii cu cancer de faringe au fost supuşi la 21 şedinţe de radioterapie la distanţă. Patients with pharyngeal cancer underwent 21 remote radiotherapy sessions.
Pe parcursul perioadei de radioterapie pacienţii au fost supuşi supravegherii zilnice cu colectarea analizei generale a sângelui (la începutul şi sfârşitul radioterapiei). During the radiotherapy period, patients were subjected to daily monitoring with collection of general blood tests (at the beginning and end of radiotherapy).
Aprecierea eficacităţii metodei propuse a fost efectuată în funcţie de gradul de manifestare a afectării mucoaselor şi pielii regiunii supuse radioterapiei. The assessment of the effectiveness of the proposed method was carried out depending on the degree of manifestation of the damage to the mucous membranes and skin of the region undergoing radiotherapy.
Pentru aprecierea rezultatelor au fost selectaţi următorii indici: The following indices were selected to assess the results:
- timpul apariţiei simptomelor afectării mucoasei cavităţii bucale (în funcţie de numărul de şedinţe din cura de radioterapie); - the time of appearance of symptoms of damage to the oral mucosa (depending on the number of sessions in the radiotherapy course);
- nivelul de exprimare a simptomelor. - the level of expression of symptoms.
Gradele de exprimare a complicaţiilor postradiante precoce din partea regiunilor supuse iradierii - hiperemia şi edemul mucoasei cavităţii bucale, au fost apreciate conform următoarei scheme: The degrees of expression of early post-radiation complications from the regions subjected to irradiation - hyperemia and edema of the oral mucosa, were assessed according to the following scheme:
- gradul I (+) - hiperemie şi edem neesenţial; - grade I (+) - hyperemia and non-essential edema;
- gradul II (++) - hiperemie şi edem al mucoasei de intensitate mică fără dureri în cazul masticării; - grade II (++) - low-intensity hyperemia and edema of the mucosa without pain when chewing;
- gradul III (+++) - hiperemie şi edem al mucoasei de intensitate medie cu dureri numai în cazul masticării, fără stoparea radioterapiei; - grade III (+++) - hyperemia and edema of the mucosa of medium intensity with pain only when chewing, without stopping radiotherapy;
- gradul IV (++++) - hiperemie şi edem al mucoasei foarte exprimate, ce provoacă o dereglare gravă a procesului de masticare la pacienţi cu dureri insuportabile, care au impus stoparea şedinţelor de radioterapie. - grade IV (++++) - very pronounced hyperemia and edema of the mucosa, which causes a serious disruption of the chewing process in patients with unbearable pain, which forced the cessation of radiotherapy sessions.
De asemenea, au fost înregistrate nivelul leucocemiei şi VSH din analiza generală a sângelui. The leukaemia and ESR levels from the general blood test were also recorded.
Rezultatele studiului. Aplicarea metodei propuse a demonstrat o eficacitate înaltă în profilaxia complicaţiilor mucoasei cavităţii bucale şi organelor adiacente la pacienţii cu cancer faringian supuşi tratamentului radiologic. Eficacitatea utilizării ei este adeverită prin faptul că complicaţiile în urma radioterapiei la pacienţii pentru care s-a aplicat această metodă apar cu 8… 9 zile mai târziu, comparativ cu cei pentru care metoda nu s-a aplicat (tab. 1). Results of the study. The application of the proposed method demonstrated high efficacy in the prophylaxis of complications of the oral mucosa and adjacent organs in patients with pharyngeal cancer undergoing radiation treatment. The effectiveness of its use is confirmed by the fact that complications following radiotherapy in patients for whom this method was applied appear 8… 9 days later, compared to those for whom the method was not applied (tab. 1).
Tabelul 1 Table 1
Indici şi simptome Grupul martor (n=10) Grupul de bază (n=10) Timpul apariţiei simptomelor (numărul de cure de radioterapie) 4±1,4 13±1,44 Nivelul de exprimare a durerilor permanente puternice periodice neesenţiale Apariţia epitelitei şi depunerilor de exsudat fibrinos focare multiple lipsăIndices and symptoms Control group (n=10) Baseline group (n=10) Time of onset of symptoms (number of radiotherapy courses) 4±1.4 13±1.44 Level of expression of permanent, strong, periodic, non-essential pain Appearance of epithelitis and deposits of fibrinous exudate multiple foci absent
De asemenea, din tabel se observă o diminuare a intensităţii şi durabilităţii durerilor cu lipsa epitelitei şi depunerilor de exsudat fibrinos pe mucoasa cavităţii bucale la pacienţii din grupul de bază, pentru care pe perioada radioterapiei s-a aplicat metoda propusă. Also, the table shows a decrease in the intensity and durability of pain with the absence of epithelitis and fibrinous exudate deposits on the oral mucosa in patients from the base group, for whom the proposed method was applied during radiotherapy.
Gradele de exprimare a hiperemiei şi edemului mucoasei cavităţii bucale la pacienţii cu cancer faringian sunt prezentate în tab. 2. The degrees of expression of hyperemia and edema of the oral mucosa in patients with pharyngeal cancer are presented in Table 2.
Tabelul 2 Table 2
Pacienţi cu cancer faringian Hiperemia mucoasei cavităţii bucale Edemul mucoasei cavităţii bucale Pacienţi din grupul de bază, pentru care s-a aplicat metoda propusă 1 ++ ++ 2 + + 3 ++ ++ 4 ++ + 5 ++ + 6 ++ + 7 + + 8 ++ ++ 9 ++ + 10 ++ + Pacienţi din grupul de control 1 +++ +++ 2 +++ +++ 3 ++++ ++++ 4 +++ +++ 5 +++ +++ 6 +++ +++ 7 +++ +++ 8 +++ +++ 9 ++++ ++++ 10 +++ +++Patients with pharyngeal cancer Hyperemia of the oral mucosa Edema of the oral mucosa Patients from the base group, for whom the proposed method was applied 1 ++ ++ 2 + + 3 ++ ++ 4 ++ + 5 ++ + 6 ++ + 7 + + 8 ++ ++ 9 ++ + 10 ++ + Patients from the control group 1 +++ +++ 2 +++ +++ 3 ++++ ++++ 4 +++ +++ 5 +++ +++ 6 +++ +++ 7 +++ +++ 8 +++ +++ 9 ++++ ++++ 10 +++ +++
Din tabel se observă o diminuare a gradului de exprimare a edemului mucoasei cavităţii bucale la pacienţii supuşi radioterapiei regiunii date din grupul de bază, care suplimentar au utilizat pe parcursul curei de radioterapie amestecul de uleiuri. Nivelul edemului la 7 pacienţi din acest grup a fost stabilit de gradul I, caracterizat ca un edem de intensitate mică neesenţial, şi doar la 3 pacienţi din grupul de bază a fost stabilit edemul mucoasei cavităţii bucale de gradul II, caracterizat ca un edem al mucoasei de intensitate mică fără dureri în timpul masticării. Rezultate similare de diminuare a gradelor de exprimare au fost obţinute şi în cazul hiperemiei mucoasei cavităţii bucale, care la pacienţii din grupul de bază a fost apreciată de gradul I - II. The table shows a decrease in the degree of expression of the edema of the oral mucosa in patients undergoing radiotherapy of the given region from the base group, who additionally used the oil mixture during the course of radiotherapy. The level of edema in 7 patients from this group was established as grade I, characterized as a non-essential low-intensity edema, and only in 3 patients from the base group was established grade II edema of the oral mucosa, characterized as a low-intensity edema of the mucosa without pain during chewing. Similar results of the decrease in the degrees of expression were obtained in the case of hyperemia of the oral mucosa, which in patients from the base group was assessed as grade I - II.
La pacienţii din grupul martor gradele de exprimare a edemului şi hiperemiei mucoasei sunt mult mai exprimate. Edemul şi hiperemia mucoasei la 8 pacienţi din acest grup au fost stabilite de gradul III, caracterizate ca edem şi hiperemie de intensitate medie cu dureri numai în cazul masticării, fără stoparea radioterapiei. Iar 2 pacienţi au fost nevoiţi să stopeze cursul de radioterapie din cauza hiperemiei şi edemului mucoasei foarte exprimate, care au provocat o dereglare gravă a procesului de masticare cu dureri insuportabile. In the patients in the control group, the degrees of mucosal edema and hyperemia are much more pronounced. Edema and hyperemia of the mucosa in 8 patients in this group were determined as grade III, characterized as edema and hyperemia of moderate intensity with pain only in the case of chewing, without stopping radiotherapy. And 2 patients had to stop the course of radiotherapy due to very pronounced mucosal hyperemia and edema, which caused a serious disruption of the chewing process with unbearable pain.
Rezultatele determinării numărului de leucocite şi nivelului VSH la pacienţii participanţi la studiu, prelucrate statistic, sunt prezentate în tab. 3. The results of determining the number of leukocytes and the ESR level in patients participating in the study, statistically processed, are presented in Table 3.
Tabelul 3 Table 3
Indicii hematologici Grupul martor (n=10) Grupul de bază (n=10) Nivelul leucocitelor în sângele periferic 16 ± 1,4 7 ± 1,1 Nivelul VSH-ului 13 ± 1,2 6± 1,2Hematological indices Control group (n=10) Baseline group (n=10) Leukocyte level in peripheral blood 16 ± 1.4 7 ± 1.1 ESR level 13 ± 1.2 6± 1.2
Conform rezultatelor din tabel se observă o diminuare esenţială a numărului de leucocite şi nivelului VSH la pacienţii din grupul de bază, pentru care pe perioada curei de radioterapie s-a aplicat metoda propusă. According to the results in the table, an essential decrease in the number of leukocytes and the ESR level is observed in patients in the base group, for whom the proposed method was applied during the radiotherapy course.
1. Ролик И.С. Биологические препараты в реабилитации больных раком: руководство для врачей. Москва, Арнебия, 2000 1. Ролик И.С. Biological preparations in the rehabilitation of cancer patients: instructions for doctors. Moscow, Arnebiya, 2000
2. Справочник Видаль. Лекарственные препараты в России, издание 15-е, 2009 2. Справочник Видаль. Medicinal preparations in Russia, edition 15, 2009
3. Каприн А.Д., Семин А.В., Костин А.А. Эффективность препарата "Канефрон Н" у онкологически больных получающих лучевую терапию на органы малого таза. Человек и лекарство, №5, том 15, 2007 3. Kaprin A.D., Semin A.V., Kostin A.A. The effectiveness of the preparation "Kanefron H" in oncological patients receiving radiation therapy on pelvic organs. Man and medicine, №5, volume 15, 2007
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| MD1140C2 (en) * | 1997-07-15 | 1999-06-30 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Remedy possessing a regenerative and cytoprotective activity |
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| MD2070G2 (en) * | 2002-07-12 | 2003-06-30 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Utilization of the unrefined grapestone oil in the treatment of gastric and duodenal ulcers |
| WO2005089412A2 (en) * | 2004-03-17 | 2005-09-29 | Takemoto Arnold C | Tissue detoxification and health supplements and methods of making and using them |
| MD2933G2 (en) * | 2005-06-23 | 2006-08-31 | Виктор ГИКАВЫЙ | Method of treatment of the skin affections |
| EA200601705A1 (en) * | 2004-03-17 | 2008-04-28 | Арнольд К. Такемото | DETOXIFICATION OF TISSUES AND HEALTHY ADDITIVES, METHODS OF THEIR PRODUCTION AND APPLICATION |
| MD3773G2 (en) * | 2008-05-30 | 2009-09-30 | Ион МЕРЕУЦЭ | Agent for treating precancerous mucous membrane and tegument affections |
| EA201001000A1 (en) * | 2010-04-19 | 2011-10-31 | Алмагуль Тулеуовна Маншарипова | ANTIOXIDANT MEANS OIL BALSAM "JEWELAX" |
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| MD1140C2 (en) * | 1997-07-15 | 1999-06-30 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Remedy possessing a regenerative and cytoprotective activity |
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| MD2070G2 (en) * | 2002-07-12 | 2003-06-30 | Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова | Utilization of the unrefined grapestone oil in the treatment of gastric and duodenal ulcers |
| WO2005089412A2 (en) * | 2004-03-17 | 2005-09-29 | Takemoto Arnold C | Tissue detoxification and health supplements and methods of making and using them |
| EA200601705A1 (en) * | 2004-03-17 | 2008-04-28 | Арнольд К. Такемото | DETOXIFICATION OF TISSUES AND HEALTHY ADDITIVES, METHODS OF THEIR PRODUCTION AND APPLICATION |
| MD2933G2 (en) * | 2005-06-23 | 2006-08-31 | Виктор ГИКАВЫЙ | Method of treatment of the skin affections |
| MD3773G2 (en) * | 2008-05-30 | 2009-09-30 | Ион МЕРЕУЦЭ | Agent for treating precancerous mucous membrane and tegument affections |
| EA201001000A1 (en) * | 2010-04-19 | 2011-10-31 | Алмагуль Тулеуовна Маншарипова | ANTIOXIDANT MEANS OIL BALSAM "JEWELAX" |
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| Ролик И.С. Биологические препараты в реабилитации больных раком: руководство для врачей. Москва, Арнебия, 2000 * |
| Справочник Видаль. Лекарственные препараты в России, издание 15-е, 2009 * |
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| MD493Y (en) | 2012-03-31 |
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