RO118842B1 - Method for the treatment of non-hodgkin malignant lymphomas of low malignancy associated with a chronic liver disease of c viral etiology - Google Patents
Method for the treatment of non-hodgkin malignant lymphomas of low malignancy associated with a chronic liver disease of c viral etiology Download PDFInfo
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- RO118842B1 RO118842B1 ROA200000769A RO200000769A RO118842B1 RO 118842 B1 RO118842 B1 RO 118842B1 RO A200000769 A ROA200000769 A RO A200000769A RO 200000769 A RO200000769 A RO 200000769A RO 118842 B1 RO118842 B1 RO 118842B1
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- 229960000329 ribavirin Drugs 0.000 claims abstract description 13
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- 208000006454 hepatitis Diseases 0.000 claims abstract description 4
- 108010078049 Interferon alpha-2 Proteins 0.000 claims description 16
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- 229940079593 drug Drugs 0.000 claims description 6
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Abstract
Description
RO 118842 ΒRO 118842 B
Invenția se referă la o metodă de tratament a limfoamelor maligne nonhodgkin de mică malignitate asociate cu boala cronică de ficat de etiologie virală C.The invention relates to a method of treatment of malignant non-hodgkin lymphomas of low malignancy associated with chronic liver disease of viral etiology C.
Din datele rezultate din literatura medicală mondială se cunoaște posibilitatea asocierii limfoamelor maligne nonhodgkin de mică malignitate cu boala cronică de ficat: hepatică cronică sau ciroză hepatică, determinată de infecția cronică cu virusul heptatitei C. Această asociere apare în 10 - 35% dintre cazurile de limfoame maligne nonhodgkin de mică malignitate.From the data obtained from the world medical literature, it is known the possibility of association of malignant non-hodgkin lymphomas of low malignancy with chronic liver disease: chronic liver disease or liver cirrhosis, determined by chronic infection with the hepatitis C virus. This association occurs in 10 - 35% of lymphoma cases malignant nonhodgkin of low malignancy.
La ora actuală, tratamentul limfoamelor maligne nonhodgkin de mică malignitate se face cu asocieri de 2-3-4 medicamente citostatice. Această medicație poate exercita efecte nefavorabile la bolnavii infectați cronic cu virusul hepatitei C, prin favorizarea replicării virale în hepatocite și sedii extrahepatice (celule mononucleare).Currently, the treatment of malignant non-Hodgkin lymphomas of low malignancy is done with combinations of 2-3-4 cytostatic drugs. This medication can exert unfavorable effects in patients chronically infected with the hepatitis C virus, by favoring viral replication in hepatocytes and extrahepatic sites (mononuclear cells).
Schemele de tratament utilizate în prezent asociază mai multe citostatice cu un preparat cortizonic.Currently used treatment regimens associate several cytostatics with a cortisone preparation.
Toate aceste medicamente au efect imunosupresor și pot avea un efect de favorizare a replicării virusului hepatic C. Acest fapt, reprezintă un mare dezavantaj terapeutic al asocierilor de medicamente citostatice utilizate în prezent. în multe cazuri infecția cronică cu virusul hepatitei C este latentă din punct de vedere clinic și biochimic și ea devine manifestă, cu progresiune deosebit de rapidă, după administrarea tratamentelor citostatice admise în prezent pentru tratamentul limfoamelor maligne nonhodgkin de mică malignitate.All these drugs have an immunosuppressive effect and can have an effect favoring the replication of the hepatitis C virus. This fact represents a great therapeutic disadvantage of the currently used cytostatic drug combinations. In many cases, chronic hepatitis C virus infection is clinically and biochemically latent, and it becomes manifest, with particularly rapid progression, after the administration of cytostatic treatments currently approved for the treatment of malignant non-Hodgkin's lymphomas of low malignancy.
în numeroase cazuri acești bolnavi decedează ca urmare a terapiei citostatice administrate, prin complicații ale bolii cronice de ficat. Prezența infecției cronice cu virusul hepatitei C în momentul stabilirii diagnosticului de limfom malign nonhodgkin cu grad mic de malignitate, nu este cercetată în mod uzual la toți bolnavii.in many cases these patients die as a result of the administered cytostatic therapy, through complications of chronic liver disease. The presence of chronic infection with the hepatitis C virus at the time of establishing the diagnosis of malignant non-Hodgkin's lymphoma with a low degree of malignancy is not usually investigated in all patients.
Depistarea bolii presupune un examen clinic riguros, determinarea repetată a valorilor transaminazelor serice și cercetarea prezenței în ser a anticorpilor antivirus hepatitic C. La bolnavii la care se constată prezența în ser a anticorpilor antivirus hepatitic C este obligatorie biopsia hepatică.The detection of the disease requires a rigorous clinical examination, the repeated determination of serum transaminase values and the investigation of the presence of hepatitis C antiviral antibodies in the serum. Liver biopsy is mandatory in patients with the presence of hepatitis C antiviral antibodies in the serum.
Creșterea replicării virale ca urmare a administrării asocierilor de citostatice utilizate în prezent, accelerează progresiunea bolii hepatice spre stadiile finale (ciroză hepatică, hepatocarcinom) și/sau favorizează apariția fenomenelor de insuficiență hepatică (indiferent care este stadiul clinic și histolo gic al bolii cronice de ficat). De asemenea, se cunoaște faptul că interferonul alfa 2a și interferonul alfa 2b exercită efecte terapeutice favorabile asupra limfoamelor maligne nonhodgkin de mică malignitate.The increase in viral replication as a result of the administration of currently used combinations of cytostatics accelerates the progression of liver disease towards the final stages (liver cirrhosis, hepatocarcinoma) and/or favors the appearance of liver failure phenomena (regardless of the clinical and histological stage of chronic liver disease ). Interferon alpha 2a and interferon alpha 2b are also known to exert favorable therapeutic effects on low-grade non-Hodgkin lymphomas.
La ora actuală se cunoaște, de asemenea, că tratamentul acceptat al hepatitelor cronice produse de virusul hepatitei C, este asocierea dintre interferon alfa 2a și ribavîrină sau interferon alfa 2b și ribavîrină. Administrarea acestei asocieri este admisă în prezent și la bolnavii cu ciroză hepatică încadrați în clasa Child A.Currently, it is also known that the accepted treatment of chronic hepatitis caused by the hepatitis C virus is the combination of interferon alfa 2a and ribavirin or interferon alfa 2b and ribavirin. The administration of this association is currently also allowed for patients with liver cirrhosis classified in the Child A class.
Pe de altă parte, se cunoaște faptul că fludarabina, un analog purinic, are acțiune favorabilă în leucemia limfocitară cronică și în limfoamele maligne nonhodgkin. Fludarabina nu are efect de creștere asupra replicării virale la bolnavii infectați cu virusul hepatitei C.On the other hand, fludarabine, a purine analog, is known to have favorable action in chronic lymphocytic leukemia and malignant non-Hodgkin lymphomas. Fludarabine does not increase viral replication in patients infected with hepatitis C virus.
Problema ce o rezolvă invenția este eliminarea asocierii de medicamente citostatice din tratamentul bolnavilor, care au efecte nefavorabile hepatice.The problem that the invention solves is the elimination of the association of cytostatic drugs from the treatment of patients, which have adverse liver effects.
Metoda, conform invenției, constă în aceea că se administrează pe o perioadă deThe method, according to the invention, consists in the fact that it is administered over a period of
12...18 luni, o asociere de medicamente compusă din: interferon alfa 2a și/sau interferon alfa12...18 months, a drug combination consisting of: interferon alfa 2a and/or interferon alfa
2b pe cale subcutanată, ribavîrină pe cale orală și fludarabină pe cale intravenoasă.2b subcutaneously, ribavirin orally and fludarabine intravenously.
Asocierea terapeutică de trei medicamente prezintă următoarele avantaje:The therapeutic association of three drugs presents the following advantages:
- se elimină asocierile de citostatice, utilizate până acum în tratamentul limfomului malign nonhodgkin de mică malignitate, asociat cu boala cronică de ficat de etiologie virală C;- the combinations of cytostatics, used until now in the treatment of malignant non-Hodgkin's lymphoma of low malignancy, associated with chronic liver disease of viral etiology C are eliminated;
RO 118842 ΒRO 118842 B
- administrarea combinată a asocierii celor trei medicamente exercită efecte favo- 50 rabile asupra ambelor boli deopotrivă;- the combined administration of the association of the three drugs exerts favorable effects on both diseases alike;
- prin adoptarea acestei terapii combinate, crește durata de supraviețuire a bolnavilor tratați anterior cu citostatice;- by adopting this combined therapy, the survival time of patients previously treated with cytostatics increases;
- se reduc sau dispar afectările ganglionare existente la diagnostic și se previne apariția altora noi, totodată cu încetinirea evoluției bolii hepatice. 55- existing ganglion lesions at diagnosis are reduced or disappear and new ones are prevented, along with slowing down the evolution of the liver disease. 55
Metoda de tratament propusă, constă în administrarea unei asocieri compusă din interferon alfa 2a, ribavirină și fludarabină sau interferon alfa 2b, ribavirină și fludarabină în cazurile de limfoame maligne nonhodgkin de mică malignitate, asociate cu boală cronică de ficat de etiologie virală C (hepatite cronice sau ciroze hepatice). Administrarea se poate face cu prudență și la bolnavii cu ciroză încadrați în calasa Child A. 60The proposed treatment method consists in the administration of a combination composed of interferon alfa 2a, ribavirin and fludarabine or interferon alfa 2b, ribavirin and fludarabine in cases of malignant non-Hodgkin lymphomas of low malignancy, associated with chronic liver disease of viral etiology C (chronic hepatitis or liver cirrhosis). The administration can also be done with caution in patients with cirrhosis classified in Child A. 60
Se prezintă, în continuare, un exemplu de realizare a metodei de tratament.An example of the implementation of the treatment method is presented below.
Exemplu. Dozele de interferon alfa 2a sau interferon alfa 2b sunt de 3 milioane de unități, administrate în injecții subcutanate tot a doua zi, timp de 12-18 luni.Example. Doses of interferon alfa 2a or interferon alfa 2b are 3 million units, administered as subcutaneous injections every other day for 12-18 months.
Dozele de ribavirină sunt cuprinse între 1000 - 1200 mg, administrate oral zilnic, pe o perioadă de 12 -18 luni. 65Ribavirin doses are between 1000 - 1200 mg, administered orally daily, over a period of 12 -18 months. 65
Dozele de fludarabină sunt de 25 mg/m2 suprafață corporală, administrate intravenos zilnic pe o perioadă de 5 zile, la 28 zile interval; numărul de cicluri de administrare fiind de 6.Fludarabine doses are 25 mg/m 2 body surface, administered intravenously daily for a period of 5 days, at 28 day intervals; the number of administration cycles being 6.
Asocierea unui medicament antiviral -ribavirină- cu un medicament care are efecte favorabile asupra limfomului nonhodgkin de mică malignitate-fluda-rabina- cu administrarea concomitentă de interferon alfa 2a sau interferon alfa 2b, are efecte terapeutice favorabile 70 asupra ambelor boli.The association of an antiviral drug -ribavirin- with a drug that has favorable effects on non-hodgkin's lymphoma of low malignancy -fluda-rabina- with the simultaneous administration of interferon alfa 2a or interferon alfa 2b, has favorable therapeutic effects 70 on both diseases.
Efectele favorabile ale administrării asocierii de interferon alfa 2a, ribavirină și fludarabină sau interferon alfa 2b, ribavirină și fludarabină, se exercită asupra ambelor boli (atât asupra limfomului malign nonhodgkinian de mică malignitate, cât și asupra hepatitei cronice de etiologie virală C sau cirozei hepatice de etiologie virală C, încadrată în clasa 75 Child A), prin efectele de eradicare a infecției virale sau scăderii cantitative a numărului de genoame virale din sânge, evidențiabile prin tehnici de biologie moleculară (RT-PCR=reacția în lanț a polimerazei prin revers transcriptază).The favorable effects of the administration of the combination of interferon alfa 2a, ribavirin and fludarabine or interferon alfa 2b, ribavirin and fludarabine, are exerted on both diseases (both on malignant non-Hodgkin's lymphoma of low malignancy and on chronic hepatitis C of viral etiology or liver cirrhosis of viral etiology C, classified in class 75 Child A), by the effects of eradicating the viral infection or the quantitative decrease in the number of viral genomes in the blood, detectable by molecular biology techniques (RT-PCR=polymerase chain reaction by reverse transcriptase) .
Efectele favorabile asupra limfomului nonhodgkin de mică malignitate se pot evidenția prin: 80Favorable effects on non-hodgkin lymphoma of low malignancy can be highlighted by: 80
- reducerea sau dispariția maselor tumorale ganglionare periferice și/sau profunde și prevenirea apariției unor determinări ganglionare periferice sau profunde noi (față de cele de la diagnostic);- reduction or disappearance of peripheral and/or deep nodal tumor masses and prevention of new peripheral or deep nodal determinations (compared to those at diagnosis);
- reducerea sau dispariția afectărilor extraganglionare existente la diagnostic și prevenirea apariției unora noi;. 85- reduction or disappearance of existing extranodal lesions at diagnosis and prevention of the appearance of new ones;. 85
Efectele favorabile asupra bolii cronice de ficat se evidențiază prin:The favorable effects on chronic liver disease are highlighted by:
- ameliorare clinică, biochimică, histologică;- clinical, biochemical, histological improvement;
- dispariția ARN aparținând virusului hepatitei C din sânge sau scăderea cantității de genoame virale;- the disappearance of RNA belonging to the hepatitis C virus in the blood or the decrease in the amount of viral genomes;
- încetinirea progresiunii bolii hepatice cronice spre stadiile finale. 90- slowing down the progression of chronic liver disease towards the final stages. 90
Raportul beneficiu terapeutic/risc terapeutic al asocierii prin metoda propusă este mai mare decât în cazul utilizării asocierii de medicamente citostatice, ca terapie unică (pentru tratamentul limfomului malign nonhodgkin de mică malignitate fără a trata boala cronică de ficat) sau a utilizării chimioterapiei citostatice (pentru tratamentul limfomului malign nonhodgkin de mică malignitate), asociată cu interferon alfa 2a și ribavirină sau interferon 95 alfa 2b și ribavirină.The therapeutic benefit/therapeutic risk ratio of the combination by the proposed method is higher than in the case of using the combination of cytostatic drugs, as a single therapy (for the treatment of malignant non-Hodgkin's lymphoma of low malignancy without treating chronic liver disease) or the use of cytostatic chemotherapy (for treatment of low-grade non-Hodgkin lymphoma), combined with interferon alfa 2a and ribavirin or interferon 95 alfa 2b and ribavirin.
Ca urmare a efectelor favorabile exercitate asupra ambelor boli se constată ameliorarea calității vieții bolnavilor, evidențiabilă în plan fizic, psihologic și social, precum și creșterea duratei de supraviețuire a acestora, față de cei tratați cu asocieri de medicamente citostatice. 100As a result of the favorable effects exerted on both diseases, there is an improvement in the quality of life of the patients, evident in physical, psychological and social terms, as well as an increase in their survival time, compared to those treated with combinations of cytostatic drugs. 100
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2345787C2 (en) * | 2006-12-25 | 2009-02-10 | Государственное образовательное учреждение высшего профессионального образования "Самарский Государственный медицинский университет" | Method of treatment of chronic viral hepatitis type c |
| WO2017189978A1 (en) | 2016-04-28 | 2017-11-02 | Emory University | Alkyne containing nucleotide and nucleoside therapeutic compositions and uses related thereto |
-
2000
- 2000-08-02 RO ROA200000769A patent/RO118842B1/en unknown
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2345787C2 (en) * | 2006-12-25 | 2009-02-10 | Государственное образовательное учреждение высшего профессионального образования "Самарский Государственный медицинский университет" | Method of treatment of chronic viral hepatitis type c |
| WO2017189978A1 (en) | 2016-04-28 | 2017-11-02 | Emory University | Alkyne containing nucleotide and nucleoside therapeutic compositions and uses related thereto |
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