{"id":1791,"date":"2021-01-19T10:51:52","date_gmt":"2021-01-19T08:51:52","guid":{"rendered":"https:\/\/dermitzaki.gr\/?p=1791"},"modified":"2022-09-22T18:57:48","modified_gmt":"2022-09-22T15:57:48","slug":"%cf%80%cf%8c%cf%83%ce%bf-%ce%b1%cf%83%cf%86%ce%b1%ce%bb%ce%ad%cf%82-%ce%b5%ce%af%ce%bd%ce%b1%ce%b9-%ce%bd%ce%b1-%cf%83%cf%85%ce%bc%ce%bc%ce%b5%cf%84%ce%ad%cf%87%cf%89-%cf%83%ce%b5-%ce%bc%ce%b9%ce%b1","status":"publish","type":"post","link":"https:\/\/dermitzaki.gr\/sq\/%cf%80%cf%8c%cf%83%ce%bf-%ce%b1%cf%83%cf%86%ce%b1%ce%bb%ce%ad%cf%82-%ce%b5%ce%af%ce%bd%ce%b1%ce%b9-%ce%bd%ce%b1-%cf%83%cf%85%ce%bc%ce%bc%ce%b5%cf%84%ce%ad%cf%87%cf%89-%cf%83%ce%b5-%ce%bc%ce%b9%ce%b1\/","title":{"rendered":"SA \u00cbSHT\u00cb E SIGURT\u00cb PJES\u00cbMARRJA N\u00cb NJ\u00cb PROV KLINIKE P\u00cbR MIGREN\u00cbN E MIJA?"},"content":{"rendered":"

Q\u00eb nga viti 2015, klinika e dhimbjes s\u00eb kok\u00ebs dhe migren\u00ebs i ka dh\u00ebn\u00eb mund\u00ebsin\u00eb dhe zgjedhjen \u00e7do pacienti t\u00eb marr\u00eb pjes\u00eb n\u00eb nj\u00eb studim klinik p\u00ebr dhimbjen e kok\u00ebs. Zakonisht k\u00ebto studime jan\u00eb p\u00ebr barnat q\u00eb jan\u00eb gati t\u00eb l\u00ebshohen (faza 3) ose q\u00eb jan\u00eb l\u00ebshuar tashm\u00eb (faza 4).<\/p>\n

Pjes\u00ebmarrja n\u00eb nj\u00eb studim klinik<\/h2>\n

Le t'i nisim gj\u00ebrat nga e para. Studimet klinike jan\u00eb arma m\u00eb e fuqishme e shkenc\u00ebs n\u00eb luft\u00ebn kund\u00ebr s\u00ebmundjeve n\u00eb p\u00ebrgjith\u00ebsi. Vet\u00ebm me studime tani mund t\u00eb gjenden ila\u00e7e t\u00eb reja dhe m\u00eb efektive p\u00ebr nj\u00eb s\u00ebmundje dhe ve\u00e7an\u00ebrisht p\u00ebr migren\u00ebn. Studimet jan\u00eb bazuar n\u00eb pacient\u00eb vullnetar\u00eb, pa ta nuk mund t\u00eb b\u00ebhet asgj\u00eb. Barnat e reja q\u00eb jan\u00eb n\u00eb studim duhet t\u00eb jen\u00eb M\u00cb EFEKTIVE se ato tashm\u00eb n\u00eb treg, por edhe absolutisht t\u00eb sigurta. Vet\u00ebm n\u00eb k\u00ebt\u00eb m\u00ebnyr\u00eb autoritetet kompetente (FDA, EMA, EOF, etj., etj.) japin miratimin e marketingut. Kompanit\u00eb farmaceutike n\u00eb 90% raste financojn\u00eb nj\u00eb studim klinik. Q\u00ebllimi i kompanive farmaceutike \u00ebsht\u00eb padyshim edhe fitimi q\u00eb do t\u00eb ken\u00eb n\u00ebse ila\u00e7i i tyre rezulton efektiv dhe i sigurt dhe del n\u00eb shitje. N\u00ebse studimi klinik p\u00ebr nj\u00eb medikament nuk ka rezultate t\u00eb mira dhe nuk miratohet, kompania farmaceutike humbet shum\u00eb miliona apo miliarda dollar\u00eb q\u00eb kishte investuar n\u00eb studimin e barit...<\/p>\n

Fazat<\/h2>\n

Fazat, pra hapat e studimit t\u00eb nj\u00eb ila\u00e7i:
\nFaza I<\/strong>: 20-80 vullnetar\u00eb dhe \u00ebsht\u00eb vler\u00ebsuar siguria e barit. Ka nj\u00eb koh\u00ebzgjatje t\u00eb shkurt\u00ebr (2-3 jav\u00eb).
\nFaza II<\/strong>: zakonisht 100-300 vullnetar\u00eb dhe mund t\u00eb zgjas\u00eb muaj. K\u00ebtu zakonisht p\u00ebrcaktohet doza q\u00eb do t\u00eb administrohet medikamenti dhe vler\u00ebsohet m\u00eb tej siguria, si dhe efektiviteti i nj\u00eb medikamenti.
\nFaza III<\/strong>: zakonisht 500 deri n\u00eb 3000 vullnetar\u00eb ku b\u00ebhet nj\u00eb regjistrim i detajuar i efektivitetit t\u00eb barit (me pyet\u00ebsor\u00eb elektronik\u00eb) dhe n\u00eb lidhje me placebo (zakonisht jan\u00eb studime dyfish t\u00eb verb\u00ebr, d.m.th. as pacienti dhe as mjeku hulumtues nuk e din\u00eb n\u00ebse jan\u00eb duke marr\u00eb nj\u00eb ila\u00e7 p\u00ebr \u00e7do periudh\u00eb kohore), regjistrohen efektet an\u00ebsore dhe krahasohen me barnat ekzistuese. Jan\u00eb studimet q\u00eb e miratojn\u00eb ose jo ila\u00e7in.
\nFaza IV<\/strong>: pas l\u00ebshimit t\u00eb barit studim shtes\u00eb p.sh. p\u00ebr t\u00eb krahasuar me nj\u00eb ila\u00e7 tashm\u00eb t\u00eb p\u00ebrdorur p\u00ebr t\u00eb nj\u00ebjt\u00ebn gjendje (studime kok\u00eb m\u00eb kok\u00eb) ose p\u00ebr t\u00eb regjistruar p\u00ebrfitimin afatgjat\u00eb t\u00eb ila\u00e7it t\u00eb ri.<\/p>\n

Cilat jan\u00eb p\u00ebrfitimet e pjes\u00ebmarrjes n\u00eb nj\u00eb studim p\u00ebr nj\u00eb pacient me migren\u00eb?<\/h2>\n
    \n
  • \u00a0Ila\u00e7i q\u00eb po studiohet konsiderohet nga studiuesit si m\u00eb efektiv se ila\u00e7et ekzistuese dhe ndoshta do t\u00eb reduktoj\u00eb migren\u00ebn e tij<\/li>\n
  • \u00a0Monitorim i shpesht\u00eb dhe i plot\u00eb mjek\u00ebsor dhe teste laboratorike p\u00ebr koh\u00ebzgjatjen e studimit<\/li>\n
  • \u00a0Ai ndihmon shkenc\u00ebn dhe njer\u00ebzit e tjer\u00eb p\u00ebr nj\u00eb t\u00eb ardhme me m\u00eb pak dhimbje<\/li>\n<\/ul>\n

    Cilat jan\u00eb disavantazhet?<\/h2>\n
      \n
    • \u00a0Angazhimi p\u00ebr vizit\u00eb t\u00eb rregullt n\u00eb qendr\u00ebn e studimit dhe procedurat e mundimshme si p.sh. Marrja e shpesht\u00eb e gjakut n\u00eb disa studime.<\/li>\n
    • \u00a0Shfaqja e efekteve an\u00ebsore nga ila\u00e7i i studiuar.<\/li>\n<\/ul>\n

      Megjithat\u00eb, kur nj\u00eb ngjarje negative serioze ndodh n\u00eb nj\u00eb studim n\u00eb mbar\u00eb bot\u00ebn, t\u00eb gjith\u00eb hetuesit n\u00eb t\u00eb gjitha qendrat informohen dhe hetuesit informojn\u00eb pacient\u00ebt e tyre. Konkretisht, n\u00eb studimin ARISE, i cili ishte nj\u00eb studim i faz\u00ebs III, t\u00eb cilin pat\u00ebm k\u00ebnaq\u00ebsin\u00eb ta b\u00ebnim n\u00eb Selanik, NUK kishte asnj\u00eb efekt an\u00ebsor serioz p\u00ebr ila\u00e7in n\u00eb studim dhe shumica e pjes\u00ebmarr\u00ebsve raportojn\u00eb nj\u00eb reduktim spektakolar t\u00eb migren\u00ebs s\u00eb tyre.<\/p>\n

      konkluzioni<\/h2>\n

      Si p\u00ebrfundim, n\u00eb studimet e m\u00ebdha t\u00eb miratimit t\u00eb nj\u00eb medikamenti, ai tashm\u00eb \u00ebsht\u00eb testuar n\u00eb kafsh\u00eb laboratorike dhe vullnetar\u00eb t\u00eb tjer\u00eb kryesisht n\u00eb lidhje me sigurin\u00eb e tij. S\u00eb fundi, askush, as nj\u00eb mjek dhe as industria farmaceutike (secila p\u00ebr arsyet e veta), nuk do t\u00eb donte t\u00eb b\u00ebnte nj\u00eb studim dhe t\u00eb kishte efekte serioze negative tek pjes\u00ebmarr\u00ebsit. T\u00eb dy kan\u00eb dyshime t\u00eb bazuara se po hulumtojn\u00eb nj\u00eb ila\u00e7 efektiv dhe t\u00eb sigurt q\u00eb do ta \u00e7oj\u00eb shkenc\u00ebn p\u00ebrpara.<\/p>\n

      Kontrolli nga autoritetet p\u00ebrkat\u00ebse qeveritare \u00ebsht\u00eb p\u00ebrgjith\u00ebsisht i rrept\u00eb dhe mbik\u00ebqyrja \u00ebsht\u00eb e vazhdueshme dhe t\u00eb gjitha provat klinike t\u00eb kryera nd\u00ebrkomb\u00ebtarisht duhet t\u00eb raportohen n\u00eb: www.clinicaltrials.gov
      \nProvat klinike t\u00eb kryera n\u00eb vendet e Bashkimit Evropian jan\u00eb t\u00eb listuara n\u00eb: www.clinicaltrialsregister.eu\/<\/p>","protected":false},"excerpt":{"rendered":"

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