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Index arrow Roztroušená skleróza arrow Novinky v léčbě arrow Novinky v léčbě

Novinky v léčbě Tisk E-mail
Úterý, 15 květen 2007

Jak už bylo mnohokrát řečeno, léčba RS se musí odvíjet od doposud známých mechanismů, které se při rozvoji RS uplatňují. Optimálně by tedy měla pokrýt dva základní mechanismy, které jsou ve hře, a to zánět a degeneraci nervových vláken. 
1) Zánět: Dlouho je známo, že se RS vyznačuje tvorbou zánětlivých ložisek v centrálním nervovém systému (CNS). Tento zánět je autoimunitní, to znamená, že vzniká patologickou reakcí imunitního systému, který rozpoznává některé vlastní struktury CNS jako tělu cizí a zahajuje proti nim útok – zánět. V zánětlivém ložisku se nakupí buňky imunitního systému, dochází k místnímu otoku tkáně vzhledem k větší propustnosti cév v místě zánětu, a výsledkem je poničení obalů nervových vláken. Tyto obaly (myelin) jsou vlastně výběžky podpůrných buněk CNS, které se jmenují oligodendrocyty. Myelin se během vývoje nervového systému vytváří tak, že buňky oligodendrocyty svými výběžky obtáčejí vždy několik nervových vláken. Délka jednoho zatočeného výběžku („buřtíku“) na jednom nervovém vláknu je asi 1–2 mm. Myelin slouží důležitým nervovým vláknům k tomu, aby byla schopna vést nervové impulsy velmi rychle. Pokud se však na určitém úseku nervového vlákna vlivem zánětu myelin rozpadne, dojde k přerušení vedení nervového vzruchu. To znamená klinický příznak a problém, který pacienta přivede k lékaři (porucha zraku při poruše vedení ve zrakovém nervu, porucha hybnosti při poruše vedení v nervových vláknech hybné dráhy, apod.). Pokud není poškozeno vlastní nervové vlákno, vedení nervového vzruchu se po několika dnech obnoví, protože nervové vlákno je schopno fungovat i bez myelinu, jen rychlost vzruchu se zpomalí. Funkce je tedy obnovena. Během několika měsíců se za příznivých okolností může obnovit i myelin, pokud v zánětlivém ložisku zůstaly nepříliš poškozené oligodendrocyty. 
2) Neurodegenerace: V zánětlivém ložisku však nedochází bohužel jen k poškození myelinu. V různé míře (velmi individuálně) dochází i k poškození (zpřetrhání) nervových vláken zbavených ochranného myelinového obalu, a to je jev podstatně závažnější než sama ztráta myelinu (demyelinizace). Ztráta nervových vláken je totiž v CNS jevem nevratným a rozhoduje o ztrátě funkce, která je těmito vlákny zajišťovaná. Je-li tedy např. zničeno velké množství vláken nutných pro pohyblivost pravé ruky, její funkce se už nemůže plně obnovit. Naštěstí máme všichni určité rezervy. Ty se odhadují na přibližně 30-40 % nervového systému. Pakliže přijdeme o tyto rezervy, choroba dále ukrajuje z funkčně nezbytného nervového systému a obnovení funkce vázne. 
Léčba RS by tedy v ideálním případě měla být schopna utlumit zánět, dovolit obnovení myelinu a zabránit ztrátě nervových vláken. Hrozba ztráty nervových vláken vedla k zásadní změně přístupu k léčbě RS v celém světě. Heslem se stalo „time is axon“ (čas je nervové vlákno) a léčebná snaha se přesunula do časných stadií RS, optimálně již po první atace podezřelé z dalšího rozvoje RS (tzv. klinicky izolovaný syndrom – CIS). 
Jaké jsou reálné možnosti léčby? Které léky mají alespoň některé z těchto vlastností? 
Léčbu RS je možno pro přehlednost rozdělit do několika skupin podle stadia choroby: 
1. Léčba akutní ataky (relapsu) nemoci. 
2. Léčba dlouhodobá ve stadiu remitentním, kdy se střídají ataky a remise (úprava příznaků).
3. Léčba ve stadiu sekundární chronické progrese. 
4. Léčba primárně progresivního typu nemoci. 
5. Léčba maligního průběhu nemoci 
6. Léčba symptomů (příznaků) nemoci v kterémkoli stadiu RS

Ad 1. Léčba akutní ataky (relapsu) nemoci. 
Pro léčbu akutní ataky existuje mezinárodní konsenzus (souhlas), publikovaný v roce 1999. Nově vzniklé příznaky nemoci nebo zhoršení existujících příznaků (nikoli vázané na horečku při současném infekčním onemocnění) trvající alespoň 24 hodin bez přestání má být léčeno kortikosteroidy – methylprednisolonem (preparát SoluMedrol) v celkové dávce 3–5 gramů. Celkovou dávku lze podat nitrožilně nebo ústy. Po vysoké dávce methylprednisolonu by měla následovat léčba kortikosteroidy v tabletách v postupně se snižujících dávkách. 
Kortikosteroidy mají velmi intenzivní protizánětlivý účinek. Snižují proto množství imunitních buněk přítomných v zánětlivém ložisku, brání rozpadu buněk nervové tkáně v místě zánětu, a jejich opakované podání brání ztrátě mozkové tkáně, jak vyplynulo z nedávných výzkumů. V případě, že je ataka závažnější a ani 5 gramů methylprednisolonu nemá dostatečný efekt, může být dále léčba doplněna jednorázovým podáním cytostatika cyklofosfamid.
Ad 2. Léčba dlouhodobá ve stadiu remitentním, kdy se střídají ataky a remise RS. Tato léčba by měla sloužit ke snížení počtu atak, snížení jejich závažnosti a ke zpomalení/oddálení postupu (progrese) nemoci. 
Tato léčba prodělala v posledních 15 letech závratný vývoj. Nelze při této příležitosti nezmínit geniální přínos prof. Pavla Jedličky, DrSc., který přibližně 40 let před ostatní světovou komunitou lékařů, zabývajících se RS, přišel na to, že tuto nemoc nelze léčebně ovlivňovat jen ve stadiu akutní ataky, ale že je nutno tlumit zánětlivý proces trvale. Paleta léků, které měl k dispozici, nebyla velká, ale i s ní dosáhl řady úspěchů. 
Dnes existuje pro toto stadium choroby také mezinárodní konsenzus, který se s novými poznatky dále rozvíjí. Doporučení k léčbě se odvíjejí jednak od vědeckých dat, ale bohužel také od stavu ekonomiky té které země. Léky, považované za léky první volby, které by teoreticky měly být dostupné všem pacientům v časných stadiích nemoci, jsou finančně velmi nákladné (350-450 tisíc Kč/rok léčby jednoho pacienta). Jde o interferon beta a o glatiramer acetát. Proto jsou např. v naší zemi stále platná určitá kritéria, umožňující léčbu alespoň těch pacientů, kteří jsou nemocí nejvíce ohroženi, jejichž choroba je nejvíce aktivní. Kritéria zahrnují dvě ataky (správně léčené a vyhodnocené lékařem) za rok nebo tři ataky za poslední 2 roky. Je však nutné bojovat o možnost rozšíření této léčby i pro další osoby s RS a především o možnost zahájení této moderní léčby již po prvních příznacích RS (CIS), tak jak je to již dnes zvykem vyspělejších státech světa. Pokusy se všemi léky první volby po první atace jasně ukázaly schopnost této léčby významně oddálit rozvoj dalších příznaků a tím definitivní RS. 
Pro pacienty s relaps-remitentní RS, u nichž není dosaženo stabilizace i přes léčbu těmito léky první volby, máme od r.2008 k dispozici infusní lék natalizumab (Tysabri). Natalizumab má schopnost navázat se na povrch agresivních buněk a zabránit jim tak vstoupit do místa zánětu v CNS. Je proto logicky efektivní u vysoce zánětlivé RS, nemá bohužel význam u progresivní fáze, protože není schopen nahradit již jednou ztracená nervová vlákna. U tohoto léku je také popsáno velmi vzácné riziko závažné infekce CNS, která není léčitelná a může být smrtelná, proto je nutno vždy pečlivě vyhodnotit všechna pro a proti ještě před zahájením této léčby.
Pokud není možné zavést léčbu těmito drahými léky, existuje mezinárodní konsenzus pro další možnosti léčby, a těmi jsou intravenózní imunoglobuliny (které se cenou výrazně neliší od interferonu beta a glatirameracetátu) anebo azathioprin (Imuran, Azaprine, dříve Azamun). Přestože azathioprin patří do arzenálu léků užívaných v léčbě RS již více než 30 let, teprve v r. 1997 byla publikována studie, která zkoumala jeho vliv na výskyt nových zánětlivých ložisek na MRI a která prokázala, že je schopen snížit nárůst postižené bílé hmoty o 57 % – tedy velmi dobrý výsledek, uvážíme-li cenu léku. (Pokud pacient nesnáší azathioprin, lze užít léky s podobným mechanismem účinku – methotrexát, cyklosporin A, cyklofosfamid.) 
Mezinárodní konsenzus dále říká, že léčba by měla být započata co nejdříve, aby se předešlo nevratným změnám na nervovém systému pacienta s RS. 

Ad 3. Léčba ve stadiu sekundární chronické progrese. 
Pro toto stadium již neexistuje žádný mezinárodní souhlas. Toto stadium se vyznačuje menším výskytem zánětlivých změn, ale větší mírou degenerace, tedy především ztrátou nervových vláken a od ní se odvíjející trvalé invalidity. Jestliže je zde méně zánětu, nelze také předpokládat, že léky z obou předchozích skupin budou tak účinné i v tomto stadiu, protože jde především o léky protizánětlivé. Žádné léky s jednoznačnou schopností ochránit před zánikem zbylá nervová vlákna nejsou zatím bohužel k dispozici, ačkoli se pracuje pokusně s některými neurotrofními faktory (tedy faktory, které udržují při životě zdravou tkáň). 
Jediné, co v tomto stadiu umíme, je potlačit ještě zbytek zánětu, proto se postupuje podle studií, které prokázaly určitou úspěšnost při použití následujících léků: 
• pulsní léčba methylprednisolonem v kombinaci s cyklofosfamidem (pulsy se rozumí opakované podání velkých dávek v určitých časových intervalech) – tato léčba byla u nás zavedena v r. 1993, ihned po uveřejnění zprávy z Harvardské univerzity o úspěšnosti tohoto schématu. Režim je dobře snášen, zpočátku jsou infuse podávány jednou měsíčně, později se intervaly prodlužují, takže tímto způsobem lze nemoc udržet stabilizovanou i 5 let. 
• pulsní léčba mitoxantronem a methylprednisolonem nebo samotným mitoxantronem v různých dávkovacích schématech – režim je určen pro rychle se zhoršující případy nemoci, protože mitoxantron je ve svém použití omezen celkovou podanou dávkou. 
• intravenózní imunoglobuliny podávané jednou měsíčně 
• methotrexát (nebo jiná imunosupresiva) v malých dávkách. 
• interferon beta, který však je částečně účinný pouze na samotném počátku sekundární progrese v případě, že se u pacienta ještě vyskytují ataky. 
Jak cyklofosfamid, tak mitoxantron i methotrexát jsou léky užívané v léčbě nádorových onemocnění, jde o cytostatika. Jsou velmi účinné v likvidaci imunitních buněk, které se účastní zánětu při RS, přitom jejich dávky jsou mnohonásobně nižší, než je zvykem u léčby nádorových onemocnění, takže i jejich vedlejší účinky jsou oslabeny na únosnou míru. Likvidace zánětu i v tomto stadiu znamená umožnění alespoň nějaké obnovy tkáně, i když to není tak masivní jako v remitentním stadiu. Je však třeba odpovědně posoudit, zda zavedená léčba pacientovi pomáhá, a pokud ne, po půl roce ji přerušit, aby se zbytečně nehromadily nežádoucí účinky léků bez jakéhokoliv efektu!
Ve stadiu chronické progrese je třeba zdůraznit rozhodující úlohu rehabilitace, která má za úkol zachovat funkční schopnosti pacienta s RS na co nejlepší úrovni. 
Ad 4. Léčba primárně progresivního typu nemoci. 
Zdá se, že RS, která se projevuje pozvolným nárůstem invalidity bez jasných atak nemoci, má trochu jiný podklad, než klasická forma s atakami a vznikem trvalé invalidity až po řadě let. Zřejmě je od počátku přítomna hlavně degenerace nervové tkáně s daleko menší účastí zánětu, proto je snadno pochopitelné, že běžné protizánětlivé léky účinné u remitentní formy nemoci zde nemají valného efektu, i když stojí za to je vždy vyzkoušet. 
Ad 5. Léčba maligního průběhu nemoci 
Pro rychle probíhající chorobu, která hrozí časnou invalidizací nemocného, se rýsují také určité léčebné možnosti. Jde stále ještě o experimentální metody, ale předběžné výsledky u zhruba 400 pacientů po celém světě (z toho 42 v ČR) ukazují určité perspektivy. Jedná se o metodu, při níž je pacientovi zahuben celý jeho imunitní systém poté, co se mu odeberou jeho vlastní kmenové buňky, které se zamrazí a po zahubení imunitního systému se pacientovi vrátí do organismu, aby umožnily vývoj nového imunitního systému. Předpokládá se, že dojde k jeho novému nastavení, které nemusí obsahovat schopnost vyvinout RS. Dříve se kmenové buňky odebíraly z kostní dřeně, metoda se používala u některých zhoubných onemocnění a je známa jako transplantace kostní dřeně. Jde o transplantaci autologní, to znamená, že kmenové buňky pro vývoj imunitního a krevního systému jsou odebrány pacientovi samému a jemu posléze navráceny. Není tedy třeba hledat dárce ani bojovat s nedostatečnou tkáňovou slučitelností. To s sebou ovšem nese i možnost, že se z vrácených buněk vyvine původní onemocnění. V praxi by to znamenalo, že dojde k relapsu nemoci. Tato experimentální metoda je zatím všude na světě vyhrazena pro ten typ onemocnění, v jehož léčbě selhaly všechny běžně používané léčebné metody. Měla by se však pacientovi nabídnout dříve, než dojde k poškození nejdůležitějších hybných funkcí. Protože jde opět o formu protizánětlivé léčby, naděje na úspěch je tím větší, čím vyšší je aktivita nemoci. Současné doporučení pro tuto léčbu zahrnuje pacienty s velmi agresivní RS, nejlépe do pěti let délky trvání RS a ještě zachovanou schopností chůze alespoň 100 metrů bez opory a bez zastavení.
Očekávané novinky 
V roce 2001 byla přijata nová kritéria pro diagnostiku RS, tzv. McDonaldova kritéria (upravena dále v r. 2005). Je také definován klinicky izolovaný syndrom (první ataka velmi podezřelá z rozvoje definitivní RS). To umožňuje ve velké většině případů stanovení diagnózy RS již po prvních příznacích nemoci. Se zlepšením a urychlením diagnostiky je nutno bojovat i za stejně včasnou (a tak jedině správně zahájenou) léčbu moderními preparáty. 
V současnosti je velmi pozitivní zprávou, že probíhá řada klinických studií s novými, nadějnými léky pro RS. Jedná se mimo jiné o preparáty FTY720 = fingolimod, laquinimod, fumarát BG12, kladribin, které jsou již nyní (2009) všechny ve stadiu III klinického zkoumání, prokazují velmi slibný efekt na RS (u fumarátu i s potenciálním ochranným – neuroprotektivním – efektem) a jsou příjemnější svou tabletkovou formou podávání. Stále se rozšiřuje také skupina nitrožilně podáváných monoklonálních protilátek (naměřených proti jedné molekule imunitního systému). Kromě již registrovaného a výše zmíněného natalizumabu sem patří alemtuzumab (proti T- i B-lymfocytům) a protilátky proti B-lymfocytům (ofatumumab, ocrelizumab a rituximab). Jejich velkou výhodou je málo časté podávání (2-5 infusí 2x ročně) a silný protizánětlivý efekt. Stejně jako cytostatika jsou i tyto léky již delší dobu známy a podávány v léčbě nadorových (zejména hematologických) onemocnění, proto jsou vcelku známa jejich rizika, a učíme se takto dobře vytipovat pacienty, pro které bude lék velmi účinný a co nejbezpečnější.
Závěrem: Záměrem tohoto článku je upozornit na možnosti léčby, které máme v současné době k dispozici, aby je pacient mohl využít včas. To zahrnuje včasné odeslání pacienta do specializovaného RS centra, kterých je celkem 14, a jsou dobře dostupná po celé České republice. Rostoucí zkušenosti našich RS center mohou poskytnout radu stran nejvhodnější léčby pro konkrétního pacienta v kterémkoliv stadiu nemoci. 
  Eva Havrdová  

 
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