﻿{"id":4068,"date":"2019-03-08T22:06:26","date_gmt":"2019-03-08T15:06:26","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4068"},"modified":"2019-03-08T22:24:13","modified_gmt":"2019-03-08T15:24:13","slug":"fda-us-tong-hop-tin-tuc-tu-cuc-quan-li-duoc-hoa-ki-tuan1-thang-3-2019","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/fda-us-tong-hop-tin-tuc-tu-cuc-quan-li-duoc-hoa-ki-tuan1-thang-3-2019\/","title":{"rendered":"[FDA-US] T\u1ed5ng h\u1ee3p tin t\u1ee9c t\u1eeb c\u1ee5c qu\u1ea3n l\u00ed d\u01b0\u1ee3c Hoa K\u00ec tu\u1ea7n1 th\u00e1ng 3\/2019"},"content":{"rendered":"<h2>C\u1ea5p ph\u00e9p Spravato d\u1ea1ng X\u1ecaT M\u0168I cho \u0111i\u1ec1u tr\u1ecb tr\u1ea7m c\u1ea3m<\/h2>\n<p>Tr\u1ea7m c\u1ea3m kh\u00e1ng tr\u1ecb l\u00e0 m\u1ed9t t\u00ecnh tr\u1ea1ng b\u1ec7nh l\u00ed nghi\u00eam tr\u1ecdng \u0111e do\u1ea1 t\u00ednh m\u1ea1ng. M\u1edbi \u0111\u00e2y C\u1ee5c qu\u1ea3n l\u00ed d\u01b0\u1ee3c Hoa K\u00ec FDA \u0111\u00e3 c\u1ea5p ph\u00e9p thu\u1ed1c Spravato (esketamine) c\u1ee7a h\u00e3ng Janssen, m\u1ed9t thu\u1ed1c \u0111\u1ed1i v\u1eadn kh\u00f4ng c\u1ea1nh tranh th\u1ee5 th\u1ec3 NMDA (N-methyl D-aspartate), cho ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb h\u1ed9i ch\u1ee9ng tr\u1ea7m c\u1ea3m kh\u00e1ng tr\u1ecb ph\u1ed1i h\u1ee3p v\u1edbi thu\u1ed1c ch\u1ed1ng tr\u1ea7m c\u1ea3m \u0111\u01b0\u1eddng u\u1ed1ng.<\/p>\n<p>C\u01a1 s\u1edf c\u1ea5p ph\u00e9p d\u1ef1a v\u00e0o k\u1ebft qu\u1ea3 c\u1ee7a nghi\u00ean c\u1ee9u pha 3 tr\u00ean h\u01a1n 1700 b\u1ec7nh nh\u00e2n tr\u01b0\u1edfng th\u00e0nh s\u1eed d\u1ee5ng thu\u1ed1c ch\u1ed1ng tr\u1ea7m c\u1ea3m \u0111\u01b0\u1eddng u\u1ed1ng ph\u1ed1i h\u1ee3p ho\u1eb7c v\u1edbi gi\u1ea3 d\u01b0\u1ee3c ho\u1eb7c esketamine d\u1ea1ng x\u1ecbt m\u0169i. \u1ede nh\u00f3m d\u00f9ng esketamine, sau 4 tu\u1ea7n th\u1ea5y c\u1ea3i thi\u1ec7n c\u00e1c tri\u1ec7u ch\u1ee9ng tr\u1ea7m c\u1ea3m v\u01b0\u1ee3t tr\u1ed9i so v\u1edbi nh\u00f3m ph\u1ed1i h\u1ee3p v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. Tuy nhi\u00ean, h\u1ea7u h\u1ebft c\u00e1c tr\u01b0\u1eddng h\u1ee3p kh\u00e1c bi\u1ec7t ch\u1ec9 quan s\u00e1t \u0111\u01b0\u1ee3c sau 24 gi\u1edd (h\u1ea7u h\u1ebft c\u00e1c thu\u1ed1c ch\u1ed1ng tr\u1ea7m c\u1ea3m c\u1ea7n \u0111i\u1ec1u tr\u1ecb v\u00e0i tu\u1ea7n m\u1edbi nh\u1eadn th\u1ea5y t\u00e1c d\u1ee5ng c\u1ea3i thi\u1ec7n r\u00f5 r\u1ec7t). X\u00e1c su\u1ea5t t\u00e1i ph\u00e1t tri\u1ec7u ch\u1ee9ng \u1edf nh\u00f3m b\u1ec7nh nh\u00e2n d\u00f9ng Spravato ph\u1ed1i h\u1ee3p v\u1edbi thu\u1ed1c ch\u1ed1ng tr\u1ea7m c\u1ea3m \u0111\u01b0\u1eddng u\u1ed1ng c\u0169ng \u00edt h\u01a1n 51% so v\u1edbi nh\u00f3m ph\u1ed1i h\u1ee3p v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n hay g\u1eb7p nh\u1ea5t l\u00e0 b\u00e0ng quan (c\u1ea3m th\u1ea5y t\u00e1ch bi\u1ec7t v\u1edbi th\u1ebf gi\u1edbi xung quanh), hoa m\u1eaft, bu\u1ed3n n\u00f4n, an th\u1ea7n, gi\u1ea3m c\u1ea3m gi\u00e1c ho\u1eb7c s\u1ef1 nh\u1ea1y c\u1ea3m, lo \u00e2u, ki\u1ec7t s\u1ee9c, t\u0103ng huy\u1ebft \u00e1p, n\u00f4n v\u00e0 c\u1ea3m gi\u00e1c say.<\/p>\n<p>Esketamine do \u0111\u00f3 s\u1ebd \u0111\u01b0\u1ee3c ki\u1ec3m so\u00e1t \u1edf Hoa K\u00ec theo ch\u1ebf \u0111\u1ed9 III v\u00e0 ch\u1ec9 c\u00f3 \u1edf h\u1ec7 th\u1ed1ng ph\u00e2n ph\u1ed1i gi\u1edbi h\u1ea1n (REMS) do c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 c\u1ee7a n\u00f3 c\u0169ng nh\u01b0 nguy c\u01a1 g\u00e2y l\u1ea1m d\u1ee5ng. B\u1ec7nh nh\u00e2n ch\u1ec9 \u0111\u01b0\u1ee3c ph\u00e1t thu\u1ed1c \u1edf c\u01a1 s\u1edf y t\u1ebf \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c mang thu\u1ed1c v\u1ec1 nh\u00e0. Esketamine c\u00f3 li\u00ean quan ketamine, m\u1ed9t thu\u1ed1c g\u00e2y m\u00ea d\u00f9ng theo \u0111\u01a1n c\u0169ng n\u1eb1m trong nh\u00f3m hay b\u1ecb l\u1ea1m d\u1ee5ng.<\/p>\n<h2>C\u1ea5p ph\u00e9p Herceptin Hylecta cho m\u1ed9t s\u1ed1 lo\u1ea1i ung th\u01b0 v\u00fa HER2 d\u01b0\u01a1ng t\u00ednh<\/h2>\n<p>Herceptin Hylecta c\u1ee7a Genetech l\u00e0 thu\u1ed1c d\u00f9ng ngay \u0111\u01b0\u1ee3c v\u00e0 c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng trong 2 \u0111\u1ebfn 5 ph\u00fat, so v\u1edbi d\u1ea1ng \u0111\u01b0\u1eddng d\u00f9ng t\u0129nh m\u1ea1ch 30 \u0111\u1ebfn 90 ph\u00fat.<\/p>\n<p>Herceptin Hylecta (trastuzumab v\u00e0 hyaluronidase-oysk) \u0111\u01b0\u1eddng ti\u00eam d\u01b0\u1edbi da \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho \u0111i\u1ec1u tr\u1ecb m\u1ed9t s\u1ed1 th\u1ec3 ung th\u01b0 v\u00fa HER2 d\u01b0\u01a1ng t\u00ednh giai \u0111o\u1ea1n s\u1edbm ph\u1ed1i h\u1ee3p v\u1edbi c\u00e1c thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ho\u00e1 ch\u1ea5t kh\u00e1c; v\u00e0 \u0111i\u1ec1u tr\u1ecb \u0111\u01a1n \u0111\u1ed9c ho\u1eb7c ph\u1ed1i h\u1ee3p v\u1edbi paclitaxel trong ung th\u01b0 v\u00fa HER2 d\u01b0\u01a1ng t\u00ednh di c\u0103n tr\u01b0\u1edbc \u0111\u00f3 \u0111\u00e3 d\u00f9ng m\u1ed9t ho\u1eb7c nhi\u1ec1u ph\u00e1c \u0111\u1ed3 ho\u00e1 ch\u1ea5t kh\u00e1c.<\/p>\n<p>\u0110\u00e2y l\u00e0 ph\u1ed1i h\u1ee3p gi\u1eefa trastuzumab, ch\u1ea5t \u0111\u1ed1i v\u1eadn th\u1ee5 th\u1ec3 HER2\/neu v\u00e0 hyaluronidase PH20 ng\u01b0\u1eddi t\u00e1i t\u1ed5 h\u1ee3p, m\u1ed9t enzyme gi\u00fap ph\u00e2n ph\u1ed1i trastuzumab d\u01b0\u1edbi da. C\u00e1c t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n hay g\u1eb7p bao g\u1ed3m m\u1ec7t m\u1ecfi, \u0111au kh\u1edbp, ti\u00eau ch\u1ea3y, ph\u1ea3n \u1ee9ng t\u1ea1i v\u1ecb tr\u00ed ti\u00eam.<\/p>\n<h2>C\u1ea5p ph\u00e9p Adhansia XR cho \u0111i\u1ec1u tr\u1ecb ADHD \u1edf b\u1ec7nh nh\u00e2n t\u1eeb 6 tu\u1ed5i tr\u1edf l\u00ean<\/h2>\n<p>Adhansia XR (methylphenidate hydrochloride) d\u1ea1ng vi\u00ean nang gi\u1ea3i ph\u00f3ng k\u00e9o d\u00e0i l\u00e0 m\u1ed9t thu\u1ed1c k\u00edch th\u00edch h\u1ec7 th\u1ea7n kinh trung \u01b0\u01a1ng v\u00e0 l\u00e0 m\u1ed9t l\u1ef1a ch\u1ecdn m\u1edbi trong \u0111i\u1ec1u tr\u1ecb r\u1ed1i lo\u1ea1n t\u0103ng \u0111\u1ed9ng gi\u1ea3m t\u1eadp trung \u1edf b\u1ec7nh nh\u00e2n 6 tu\u1ed5i tr\u1edf l\u00ean.<\/p>\n<p>Thu\u1ed1c d\u00f9ng 1 l\u1ea7n v\u00e0o bu\u1ed5i s\u00e1ng, c\u00f3 6 d\u1ea1ng h\u00e0m l\u01b0\u1ee3ng (25, 35, 45, 55, 70, v\u00e0 85 mg), gi\u00fap cho vi\u1ec7c \u0111\u1ecbnh li\u1ec1u m\u1ed9t c\u00e1ch linh ho\u1ea1t.<\/p>\n<p>T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n hay g\u1eb7p nh\u1ea5t (t\u1ea7n su\u1ea5t tr\u00ean 5% v\u00e0 g\u1ea5p 2 l\u1ea7n nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c) bao g\u1ed3m r\u1ed1i lo\u1ea1n gi\u1ea5c ng\u1ee7, kh\u00f4 mi\u1ec7ng, gi\u1ea3m c\u1ea3m gi\u00e1c ngon mi\u1ec7ng v\u00e0 s\u00fat c\u00e2n.<\/p>\n<h2>M\u1edf r\u1ed9ng ch\u1ec9 \u0111\u1ecbnh cho Soliqua 100\/33 Insulin trong \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng type 2<\/h2>\n<p>Soliqua 100\/33 Insulin (insulin glargine v\u00e0 lixisenatide \u0111\u01b0\u1eddng ti\u00eam) l\u00e0 m\u1ed9t d\u1ea1ng ph\u1ed1i h\u1ee3p insulin ti\u00eam t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i v\u1edbi GLP-1 gi\u00fap t\u0103ng c\u01b0\u1eddng s\u1ea3n xu\u1ea5t insulin.<\/p>\n<p>Tr\u01b0\u1edbc \u0111\u00e2y thu\u1ed1c \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho \u0111i\u1ec1u tr\u1ecb h\u1ed7 tr\u1ee3 v\u1edbi ch\u1ebf \u0111\u1ed9 \u0103n v\u00e0 t\u1eadp luy\u1ec7n trong \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng type 2 tr\u01b0\u1edbc \u0111\u00f3 kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c b\u1eb1ng insulin t\u00e1c d\u1ee5ng k\u00e9o d\u00e0i ho\u1eb7c lixisenatide (Adlyxin).<\/p>\n<p>Nay c\u0169ng \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p cho ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb b\u1ec7nh nh\u00e2n \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng type 2 kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c b\u1eb1ng thu\u1ed1c ch\u1ed1ng \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng d\u1ea1ng u\u1ed1ng.<\/p>\n<p>C\u01a1 s\u1edf c\u1ea5p ph\u00e9p d\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng LixiLan-O, trong \u0111\u00f3 c\u00e1c b\u1ec7nh nh\u00e2n kh\u00f4ng ki\u1ec3m so\u00e1t \u0111\u01b0\u1ee3c \u0111\u01b0\u1eddng huy\u1ebft d\u00f9ng metformin c\u00f3 k\u00e8m theo ho\u1eb7c kh\u00f4ng m\u1ed9t thu\u1ed1c u\u1ed1ng \u0111i\u1ec1u tr\u1ecb \u0111\u00e1i th\u00e1o \u0111\u01b0\u1eddng c\u00f3 n\u1ed3ng \u0111\u1ed9 \u0111\u01b0\u1eddng huy\u1ebft gi\u1ea3m c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea khi d\u00f9ng c\u00f9ng v\u1edbi Soliqua 100\/33 so v\u1edbi nh\u00f3m d\u00f9ng c\u00f9ng insulin glargine v\u00e0 lixisenatide (m\u1ee9c \u0111\u1ed9 gi\u1ea3m l\u1ea7n l\u01b0\u1ee3t l\u00e0 -1.6%, -1.3%, -0.9%; p&lt;0.0001). Ngo\u00e0i ra t\u1ec9 l\u1ec7 b\u1ec7nh nh\u00e2n \u0111\u1ea1t m\u1ee5c ti\u00eau \u0111\u01b0\u1eddng huy\u1ebft \u1edf nh\u00f3m Soliqua 100\/33 c\u0169ng cao h\u01a1n.<\/p>\n<p>T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n bao g\u1ed3m h\u1ea1 \u0111\u01b0\u1eddng huy\u1ebft, bu\u1ed3n n\u00f4n v\u00e0 n\u00f4n.<\/p>\n<h2>Nghi\u00ean c\u1ee9u l\u1edbn nh\u1ea5t hi\u1ec7n nay cho th\u1ea5y kh\u00f4ng c\u00f3 m\u1ed1i li\u00ean h\u1ec7 n\u00e0o gi\u1eefa vaccin s\u1edfi v\u00e0 t\u1ef1 k\u1ec9<\/h2>\n<p>Theo T\u1ed5 ch\u1ee9c Y t\u1ebf th\u1ebf gi\u1edbi, s\u1ef1 do d\u1ef1 khi d\u00f9ng vaccin l\u00e0 m\u1ed9t trong 10 m\u1ed1i \u0111e do\u1ea1 l\u1edbn nh\u1ea5t \u0111\u1ed1i v\u1edbi s\u1ee9c kho\u1ebb c\u1ed9ng \u0111\u1ed3ng. Ng\u01b0\u1eddi ta \u0111\u00e3 ghi nh\u1eadn 6 \u0111\u1ee3t b\u00f9ng ph\u00e1t d\u1ecbch s\u1edfi \u0111\u00e1ng b\u00e1o \u0111\u1ed9ng ch\u1ec9 trong 2 th\u00e1ng \u0111\u1ea7u 2019 t\u1ea1i Hoa K\u00ec. Trong tu\u1ea7n n\u00e0y m\u1ed9t nghi\u00ean c\u1ee9u l\u1edbn nh\u1ea5t cho t\u1edbi nay \u0111\u00e1nh gi\u00e1 m\u1ed1i li\u00ean h\u1ec7 gi\u1eefa vaccin s\u1edfi, quai b\u1ecb, rubella (MML) v\u00e0 t\u1ec9 l\u1ec7 xu\u1ea5t hi\u1ec7n t\u1ef1 k\u1ec9 \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u0103ng t\u1ea3i tr\u00ean t\u1ea1p ch\u00ed Annals of Internal Medicine.<\/p>\n<p>Nghi\u00ean c\u1ee9u n\u00e0y d\u1ef1a tr\u00ean d\u1eef li\u1ec7u trong v\u00f2ng h\u01a1n 10 n\u0103m \u1edf h\u01a1n 500.000 tr\u1ebb em. C\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u \u0111\u00e3 theo d\u00f5i 657,461 tr\u1ebb em sinh ra \u1edf \u0110an M\u1ea1ch t\u1eeb n\u0103m 1999 \u0111\u1ebfn 2010 k\u1ec3 t\u1eeb khi 1 tu\u1ed5i \u0111\u1ebfn th\u00e1ng 8\/2013. H\u1ecd nh\u1eadn th\u1ea5y kh\u00f4ng c\u00f3 s\u1ef1 gia t\u0103ng nguy c\u01a1 t\u1ef1 k\u1ec9 \u1edf tr\u1ebb ti\u00eam vaccine MMR so v\u1edbi tr\u1ebb kh\u00f4ng ti\u00eam. H\u01a1n n\u1eefa, kh\u00f4ng c\u00f3 s\u1ef1 gia t\u0103ng nguy c\u01a1 k\u1ec3 c\u1ea3 \u1edf ph\u00e2n nh\u00f3m c\u00e1c tr\u1ebb c\u00f3 nguy c\u01a1 cao.<\/p>\n<p>C\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u kh\u00f4ng ch\u1eafc l\u00e0 c\u00e1c d\u1eef li\u1ec7u m\u1edbi n\u00e0y s\u1ebd thay \u0111\u1ed5i t\u01b0 t\u01b0\u1edfng c\u1ee7a nh\u1eefng ng\u01b0\u1eddi &#8220;anti-vaccin&#8221;, nh\u01b0ng hi v\u1ecdng r\u1eb1ng b\u1ed9 d\u1eef li\u1ec7u l\u1edbn nh\u1ea5t t\u1eebng c\u00f3 n\u00e0y c\u00f3 th\u1ec3 \u0111\u01b0a ra b\u1ea3o \u0111\u1ea3m cho c\u00e1c b\u1eadc ph\u1ee5 huynh s\u1eb5n s\u00e0ng l\u1eafng nghe c\u00e1c b\u1eb1ng ch\u1ee9ng khoa h\u1ecdc.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u1ea5p ph\u00e9p Spravato d\u1ea1ng X\u1ecaT M\u0168I cho \u0111i\u1ec1u tr\u1ecb tr\u1ea7m c\u1ea3m Tr\u1ea7m c\u1ea3m kh\u00e1ng tr\u1ecb l\u00e0 m\u1ed9t t\u00ecnh tr\u1ea1ng b\u1ec7nh l\u00ed nghi\u00eam tr\u1ecdng \u0111e do\u1ea1 t\u00ednh m\u1ea1ng. M\u1edbi \u0111\u00e2y C\u1ee5c qu\u1ea3n l\u00ed d\u01b0\u1ee3c Hoa K\u00ec FDA \u0111\u00e3 c\u1ea5p ph\u00e9p thu\u1ed1c Spravato (esketamine) c\u1ee7a h\u00e3ng Janssen, m\u1ed9t thu\u1ed1c \u0111\u1ed1i v\u1eadn kh\u00f4ng c\u1ea1nh tranh th\u1ee5 th\u1ec3 NMDA [&#8230;]\n","protected":false},"author":1,"featured_media":4069,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4068","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\/4068","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=4068"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4068\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4069"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4068"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4068"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4068"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}