Ng\u00e0y 29\/4\/2019, C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m M\u1ef9 (FDA) \u0111\u00e3 c\u1ea5p t\u00ecnh tr\u1ea1ng Fast Track Designation \u0111\u1ed1i v\u1edbi li\u1ec7u ph\u00e1p chuy\u1ec3n \u0111\u1ed5i h\u1ec7 vi khu\u1eabn ru\u1ed9t (microbiota transfer therapy, MTT), c\u00f3 t\u00ean g\u1ecdi l\u00e0 Microbiota Full-Spectrum (FSM), \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb cho tr\u1ebb em b\u1ecb r\u1ed1i lo\u1ea1n ph\u1ed5 t\u1ef1 k\u1ef7 (Autism Spectrum Disorder, ASD). D\u1ea1ng r\u1ed1i lo\u1ea1n kh\u00f3 kh\u0103n v\u1ec1 ng\u00f4n ng\u1eef, c\u1ea3m x\u00fac v\u00e0 ho\u1ea1t \u0111\u1ed9ng trong \u0111\u00e1p \u1ee9ng v\u00e0 giao ti\u1ebfp v\u1edbi ngo\u1ea1i c\u1ea3nh c\u1ee7a tr\u1ebb.<\/p>\n
Fast track hay “\u0111\u00e1nh gi\u00e1 nhanh” l\u00e0 quy tr\u00ecnh c\u1ee7a FDA nh\u1eb1m t\u1ea1o thu\u1eadn l\u1ee3i cho vi\u1ec7c nghi\u00ean c\u1ee9u v\u00e0 th\u00fac \u0111\u1ea9y xem x\u00e9t d\u1eef li\u1ec7u, h\u1ed3 s\u01a1 \u0111\u1ec3 c\u00f3 th\u1ec3 ch\u1ea5p thu\u1eadn s\u1edbm h\u01a1n th\u1eddi gian quy \u0111\u1ecbnh \u0111\u1ed1i v\u1edbi m\u1ed9t lo\u1ea1i thu\u1ed1c hay m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u1edbi c\u00f3 nhu c\u1ea7u m\u00e0 ch\u01b0a \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c.<\/p>\n
C\u00f3 nhi\u1ec1u nghi\u00ean c\u1ee9u \u0111\u1ec1 xu\u1ea5t m\u1ed1i li\u00ean h\u1ec7 gi\u1eefa h\u1ec7 vi khu\u1eabn ru\u1ed9t (microbiome) v\u00e0 c\u00e1c h\u00e0nh vi t\u1ef1 k\u1ef7, Ru\u1ed9t v\u00e0 n\u00e3o ng\u01b0\u1eddi t\u01b0\u01a1ng t\u00e1c ph\u1ee9c t\u1ea1p v\u00e0 nh\u1eefng b\u1ea5t th\u01b0\u1eddng c\u1ee7a ru\u1ed9t c\u00f3 th\u1ec3 l\u00e0m cho c\u00e1c c\u00e1 nh\u00e2n b\u1ecb r\u1ed1i lo\u1ea1n ph\u00e1t tri\u1ec3n th\u1ea7n kinh nh\u01b0 l\u00e0 ASD, b\u1ec7nh Parkinson, b\u1ec7nh Alzheimer, tr\u1ea7m c\u1ea3m…c\u00e1c b\u1ec7nh l\u00fd n\u1ea7y \u0111\u01b0\u1ee3c bi\u1ebft l\u00e0 th\u01b0\u1eddng c\u00f3 c\u00e1c tri\u1ec7u ch\u1ee9ng r\u1ed1i lo\u1ea1n ti\u00eau h\u00f3a m\u00e3n t\u00ednh, cho th\u1ea5y s\u1ef1 hi\u1ec7n di\u1ec7n c\u1ee7a tr\u1ee5c n\u00e3o-ru\u1ed9t (Gut- Brain Axis)<\/p>\n
C\u1ea5y gh\u00e9p ph\u00e2n ( fecal microbiota transplant FMT) l\u00e0 ph\u01b0\u01a1ng ph\u00e1p l\u1ea5y ph\u00e2n t\u1eeb m\u1ed9t ng\u01b0\u1eddi hi\u1ebfn t\u1eb7ng kh\u1ecfe m\u1ea1nh \u0111\u01b0\u1ee3c tinh ch\u1ebf v\u00e0 \u0111\u01b0a v\u00e0o ru\u1ed9t c\u1ee7a ng\u01b0\u1eddi nh\u1eadn b\u1eb1ng n\u1ed9i soi, qua sonde d\u1ea1 d\u00e0y ru\u1ed9t hay u\u1ed1ng vi\u00ean nang. Hi\u1ec7n nay, FMT l\u00e0 li\u1ec7u ph\u00e1p hi\u1ec7u qu\u1ea3 \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb nhi\u1ec5m tr\u00f9ng Clostridium difficile t\u00e1i ph\u00e1t m\u00e0 kh\u00f4ng \u0111\u00e1p \u1ee9ng v\u1edbi \u0111i\u1ec1u tr\u1ecb kh\u00e1ng sinh.<\/p>\n
Li\u1ec7u ph\u00e1p chuy\u1ec3n \u0111\u1ed5i h\u1ec7 vi khu\u1eabn ru\u1ed9t MTT do c\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u c\u1ee7a c\u00f4ng ty Finch therapeutics th\u1ef1c hi\u1ec7n bao g\u1ed3m \u0111i\u1ec1u tr\u1ecb Vancomycin trong hai tu\u1ea7n, sau \u0111\u00f3 s\u00fac ru\u1ed9t v\u00e0 c\u1ea5y gh\u00e9p ph\u00e2n FMT v\u1edbi l\u01b0\u1ee3ng l\u1edbn trong 1-2 ng\u00e0y, ti\u1ebfp theo l\u00e0 7- 8 tu\u1ea7n FMT duy tr\u00ec h\u1eb1ng ng\u00e0y c\u00f9ng v\u1edbi m\u1ed9t thu\u1ed1c \u1ee9c ch\u1ebf axit d\u1ea1 d\u00e0y.<\/p>\n
Trong k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 tr\u00ean Nature ng\u00e0y 9\/4, v\u1edbi 18 tr\u1ebb ASD, sau \u0111i\u1ec1u tr\u1ecb MTT 10 tu\u1ea7n v\u00e0 th\u1eddi gian theo d\u00f5i 8 tu\u1ea7n, \u0111\u00e3 quan s\u00e1t th\u1ea5y gi\u1ea3m 77% c\u00e1c tri\u1ec7u ch\u1ee9ng \u0111\u01b0\u1eddng ti\u00eau h\u00f3a v\u00e0 c\u1ea3i thi\u1ec7n c\u00e1c tri\u1ec7u ch\u1ee9ng ASD ch\u1ee7 y\u1ebfu ( m\u1ee9c gi\u1ea3m c\u1ee7a c\u00e1c thang \u0111i\u1ec3m \u0111\u00e1nh gi\u00e1 trung b\u00ecnh 24% ), \u0111\u1ed3ng th\u1eddi, s\u1ef1 \u0111a d\u1ea1ng c\u1ee7a vi khu\u1ea9n \u0111\u01b0\u1eddng ru\u1ed9t, bao g\u1ed3m c\u00e1c vi khu\u1ea9n c\u00f3 l\u1ee3i, t\u0103ng \u0111\u00e1ng k\u1ec3. Hai n\u0103m sau khi \u0111i\u1ec1u tr\u1ecb, c\u00e1c tri\u1ec7u ch\u1ee9ng ti\u00eau h\u00f3a v\u00e0 ASD v\u1eabn duy tr\u00ec c\u00e3i thi\u1ec7n…<\/p>\n
M\u1ed9t ph\u01b0\u01a1ng ph\u00e1p m\u00e0 y h\u1ecdc Vi\u1ec7t nam c\u00f3 th\u1ec3 tham kh\u1ea3o v\u00e0 ch\u1edd xem, v\u1ec1 k\u1ef9 thu\u1eadt th\u00ec ch\u1eafc kh\u00f4ng kh\u00f3…
\nNghi\u00ean c\u1ee9u h\u1ec7 vi khu\u1eabn \u0111\u01b0\u1eddng ru\u1ed9t l\u00e0 m\u1ed9t l\u0129nh v\u1ef1c c\u00f2n nhi\u1ec1u b\u00ed \u1ea9n v\u00e0 \u0111em l\u1ea1i nhi\u1ec1u th\u00f4ng tin m\u1edbi..\/.<\/p>\n
<\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
Ng\u00e0y 29\/4\/2019, C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m M\u1ef9 (FDA) \u0111\u00e3 c\u1ea5p t\u00ecnh tr\u1ea1ng Fast Track Designation \u0111\u1ed1i v\u1edbi li\u1ec7u ph\u00e1p chuy\u1ec3n \u0111\u1ed5i h\u1ec7 vi khu\u1eabn ru\u1ed9t (microbiota transfer therapy, MTT), c\u00f3 t\u00ean g\u1ecdi l\u00e0 Microbiota Full-Spectrum (FSM), \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb cho tr\u1ebb em b\u1ecb r\u1ed1i lo\u1ea1n ph\u1ed5 t\u1ef1 k\u1ef7 (Autism Spectrum […]\n","protected":false},"author":1,"featured_media":9388,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9387","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/9387","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=9387"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/9387\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/9388"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=9387"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=9387"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=9387"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}