{"id":7981,"date":"2022-10-11T10:40:11","date_gmt":"2022-10-11T07:40:11","guid":{"rendered":"http:\/\/doctorexpres.ro\/?p=7981"},"modified":"2022-10-11T10:45:56","modified_gmt":"2022-10-11T07:45:56","slug":"57-din-medicamentele-pentru-cancer-sint-inutile","status":"publish","type":"post","link":"http:\/\/doctorexpres.ro\/index.php\/2022\/10\/11\/57-din-medicamentele-pentru-cancer-sint-inutile\/","title":{"rendered":"57% din medicamentele pentru cancer s\u00eent inutile"},"content":{"rendered":"

Mai mult de jum\u0103tate din autoriza\u021biile de comercializare a medicamentelor anticancer <\/a>\u00een Uniunea European\u0103 nu au demonstrat c\u0103 \u00eembun\u0103t\u0103\u021besc supravie\u021buirea<\/a> sau calitatea vie\u021bii pacien\u021bilor, potrivit unui studiu publicat \u00een British Medical Journal. <\/p>\n

O astfel de situa\u021bie \u201epoate d\u0103una pacien\u021bilor \u0219i poate cauza o risip\u0103 semnificativ\u0103 de resurse publice<\/em>\u201d \u0219i \u201eridic\u0103 \u00eentreb\u0103ri serioase cu privire la standardele actuale privind reglementarea medicamentelor<\/a><\/em>\u201d, comenteaz\u0103 echipa de speciali\u0219ti \u00een s\u0103n\u0103tate public\u0103 de la King’s College din Londra \u0219i \u0218coala Economic\u0103 din Londra.<\/p>\n

Pe l\u00eeng\u0103 o metodologie bun\u0103, studiile necesare pentru aprobarea unui medicament<\/a> pentru o nou\u0103 indica\u021bie trebuie s\u0103 aib\u0103 un efect semnificativ asupra parametrilor cheie. \u00cen domeniul tratamentului pentru cancer<\/a>, aceste criterii s\u00eent, \u00een principal, cre\u0219terea duratei de via\u021b\u0103<\/a> sau a calit\u0103\u021bii vie\u021bii (pentru \u00eengrijirea paliativ\u0103) a pacien\u021bilor. Cu toate acestea, ace\u0219ti parametri s\u00eent adesea \u00eenlocui\u0163i cu criterii alternative care, conform autorilor, \u201edemonstreaz\u0103 ac\u0163iunea biologic\u0103, dar nu o \u00eembun\u0103t\u0103\u021bire a supravie\u021buirii<\/a><\/em>\u201d.<\/p>\n

P\u00een\u0103 \u00een 2014 \u0219i 2015 au fost publicate dou\u0103 revizuiri ale studiilor care arat\u0103 c\u0103 rezultatele pozitive cu privire la aceste criterii alternative nu garanteaz\u0103 o \u00eembun\u0103t\u0103\u021bire a supravie\u021buirii. Scopul noului studiu este de a sublinia omniprezen\u021ba acestor criterii de substitu\u021bie \u00een studiile examinate de Agen\u021bia European\u0103 pentru Medicamente (AEM), care duc la o aprobare \u00een ciuda neechivalen\u021bei lor.<\/p>\n

Astfel, pe parcursul celor cinci ani studia\u0163i, 48 de noi agen\u021bi antineoplazici<\/a> au primit autoriza\u021bie de comercializare de la AEM pentru 68 de indica\u021bii diferite. Fiecare nou\u0103 indica\u021bie a necesitat studii dedicate. Din aceste 68 de cerin\u0163e de indica\u021bii, 39 (57%) au primit lumin\u0103 verde de la autoritatea european\u0103 de reglementare, f\u0103r\u0103 a demonstra o \u00eembun\u0103t\u0103\u021bire a speran\u021bei de via\u021b\u0103<\/a> sau a calit\u0103\u021bii vie\u021bii pacien\u021bilor, \u00een compara\u021bie cu tratamentele existente.<\/p>\n

\u00cen ciuda afirma\u021biei AEM c\u0103 supravie\u021buirea global\u0103 este \u201erezultatul cel mai persuasiv\u201d al studiilor privind siguran\u021ba clinic\u0103 \u0219i eficacitatea noilor medicamente<\/a> oncologice, multe au fost autorizate pe baza rezultatelor preliminare, analizeaz\u0103 cercet\u0103torii. \u0218i chiar \u0219i pentru studiile pentru prelungirea duratei de via\u0163\u0103, acestea \u201eerau adesea marginale\u201d, adaug\u0103 ei.<\/p>\n

\u201eAEM \u0219i alte autorit\u0103\u021bi de reglementare \u00een domeniul medicamentelor<\/a> ar trebui s\u0103-\u0219i reconsidere c\u00eend \u0219i \u00een ce m\u0103sur\u0103 trebuie aprobate noi medicamente \u00eempotriva cancerului<\/a> pe baza unor criterii de substituire. \u00cen plus, atunci c\u00eend s\u00eent prezentate c\u00ee\u0219tigurile de supravie\u021buire<\/a> \u0219i calitate a vie\u021bii, aceste c\u00ee\u0219tiguri ar trebui s\u0103 fie semnificative pentru pacien\u021bi \u0219i medici<\/em>\u201d, concluzioneaz\u0103 autorii. \u00centrebat de AFP, Agen\u021bia European\u0103 pentru Medicamente a subliniat c\u0103 \u201ea discutat pe scar\u0103 larg\u0103 dovezile care sus\u021bin medicamentele \u00eempotriva cancerului<\/a>\u201d \u0219i este deschis\u0103 oric\u0103rei \u201enoi dezbateri\u201d pe aceast\u0103 tem\u0103.<\/p>\n

Sursa: sciencesetavenir.fr<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Mai mult de jum\u0103tate din autoriza\u021biile de comercializare a medicamentelor anticancer \u00een Uniunea European\u0103 nu au demonstrat c\u0103 \u00eembun\u0103t\u0103\u021besc supravie\u021buirea<\/p>\n","protected":false},"author":4,"featured_media":4503,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[96,93,91],"tags":[11922,11925,11920,11923,11919,11921,7103,11924,11918,1580],"class_list":["post-7981","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-boli","category-cancer","category-stiri","tag-agenti-antineoplazici","tag-agentia-europeana-pentru-medicamente","tag-calitatea-vietii-cancer","tag-ingrijire-paliativa","tag-medicamente-cancer","tag-medicamente-oncologice","tag-prelungirea-vietii-cancer","tag-reglementarea-medicamentelor","tag-supravietuire-cancer","tag-tratament-cancer"],"yoast_head":"\n57% din medicamentele pentru cancer s\u00eent inutile - 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