﻿{"id":4168,"date":"2019-03-09T23:22:42","date_gmt":"2019-03-09T16:22:42","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4168"},"modified":"2019-03-09T23:24:48","modified_gmt":"2019-03-09T16:24:48","slug":"nejm-nghien-cuu-pha-3-ve-solanezumab-mot-loai-igg-khang-amyloid-%ce%b2-khong-cho-thay-tac-dung-cai-thien-nhan-thuc-trong-dieu-tri-benh-alzheimer","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/nejm-nghien-cuu-pha-3-ve-solanezumab-mot-loai-igg-khang-amyloid-%ce%b2-khong-cho-thay-tac-dung-cai-thien-nhan-thuc-trong-dieu-tri-benh-alzheimer\/","title":{"rendered":"NEJM: nghi\u00ean c\u1ee9u pha 3 v\u1ec1 solanezumab, m\u1ed9t lo\u1ea1i IgG kh\u00e1ng amyloid \u03b2, kh\u00f4ng cho th\u1ea5y t\u00e1c d\u1ee5ng c\u1ea3i thi\u1ec7n nh\u1eadn th\u1ee9c trong \u0111i\u1ec1u tr\u1ecb b\u1ec7nh Alzheimer"},"content":{"rendered":"<p>C\u00e1c m\u1ea3ng amyloid beta (A\u03b2) l\u00e0 d\u1ea5u \u1ea5n ch\u1ec9 \u0111i\u1ec3m b\u1ec7nh l\u00fd trong b\u1ec7nh Alzheimer, tuy nhi\u00ean theo m\u1ed9t nghi\u00ean c\u1ee9u m\u1edbi \u0111\u00e2y \u0111\u0103ng t\u1ea3i ng\u00e0y 25\/01\/2018 tr\u00ean t\u1ea1p ch\u00ed New England Journal of Medicine (NEJM), kh\u00e1ng th\u1ec3 lo\u1ea1i IgG kh\u00e1ng A\u03b2 l\u00e0 solanezumab kh\u00f4ng cho th\u1ea5y t\u00e1c d\u1ee5ng c\u1ea3i thi\u1ec7n nh\u1eadn th\u1ee9c \u1edf b\u1ec7nh nh\u00e2n Alzheimer.<\/p>\n<p>C\u00e1c t\u00e1c gi\u1ea3 \u0111\u00e3 ti\u1ebfn h\u00e0nh th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng pha III m\u00f9 \u0111\u00f4i, so s\u00e1nh v\u1edbi gi\u1ea3 d\u01b0\u1ee3c tr\u00ean c\u00e1c b\u1ec7nh nh\u00e2n Alzheimer sa s\u00fat tr\u00ed tu\u1ec7 m\u1ee9c \u0111\u1ed9 nh\u1eb9, \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh b\u1eb1ng \u0111i\u1ec3m MMSE (\u0111i\u1ec3m \u0111\u00e1nh gi\u00e1 t\u00ecnh tr\u1ea1ng t\u00e2m th\u1ea7n r\u00fat g\u1ecdn) t\u1eeb 20-26 (tr\u00ean thang t\u1eeb 0 \u0111\u1ebfn 30, \u0111i\u1ec3m cao h\u01a1n g\u1ee3i \u00fd t\u00ecnh tr\u1ea1ng nh\u1eadn th\u1ee9c t\u1ed1t h\u01a1n) v\u00e0 k\u00e8m theo l\u1eafng \u0111\u1ecdng amyloid \u0111\u00e1nh gi\u00e1 b\u1eb1ng ch\u1ee5p c\u1eaft l\u1edbp positron (PET) v\u1edbi florbetapir ho\u1eb7c \u0111\u1ecbnh l\u01b0\u1ee3ng A\u03b21-42 trong d\u1ecbch n\u00e3o tu\u1ef7. C\u00e1c b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c ph\u00e2n b\u1ed1 ng\u1eabu nhi\u00ean v\u00e0o nh\u00f3m s\u1eed d\u1ee5ng solanezumab v\u1edbi li\u1ec1u 400 mg ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c \u0111\u01b0\u1eddng t\u0129nh m\u1ea1ch m\u1ed7i 4 tu\u1ea7n trong v\u00f2ng 76 tu\u1ea7n. Ch\u1ec9 s\u1ed1 \u0111\u1ea7u ra ch\u00ednh l\u00e0 s\u1ef1 thay \u0111\u1ed5i v\u1ec1 \u0111i\u1ec3m s\u1ed1 c\u1ee7a thang \u0111i\u1ec3m b\u1ed9 ph\u1eadn g\u1ed3m 14 ph\u1ea7n \u0111\u00e1nh gi\u00e1 b\u1ec7nh Alzheimer (ADAS-cog14; \u0111i\u1ec3m t\u1eeb 0-90, \u0111i\u1ec3m c\u00e0ng cao g\u1ee3i \u00fd t\u00ecnh tr\u1ea1ng suy gi\u1ea3m nh\u1eadn th\u1ee9c c\u00e0ng n\u1eb7ng) \u1edf tu\u1ea7n 80 so v\u1edbi tr\u01b0\u1edbc \u0111i\u1ec1u tr\u1ecb.<\/p>\n<p>Trong t\u1ed5ng s\u1ed1 2129 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o nghi\u00ean c\u1ee9u, c\u00f3 1057 b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng solanezumab v\u00e0 1072 b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng gi\u1ea3 d\u01b0\u1ee3c. S\u1ef1 thay \u0111\u1ed5i trung b\u00ecnh \u0111i\u1ec3m ADAS-cog14 so v\u1edbi tr\u01b0\u1edbc \u0111i\u1ec1u tr\u1ecb l\u00e0 6,65 \u1edf nh\u00f3m solanezumab v\u00e0 7,44 \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c, kh\u00f4ng c\u00f3 s\u1ef1 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea \u1edf tu\u1ea7n 80 gi\u1eefa c\u00e1c nh\u00f3m (hi\u1ec7u s\u1ed1 s\u1ef1 thay \u0111\u1ed5i \u0111i\u1ec3m \u1edf hai nh\u00f3m l\u00e0 -0,80; kho\u1ea3ng tin c\u1eady 95% l\u00e0 -0,73 \u0111\u1ebfn 0,14; P=0,10). Do kh\u00f4ng t\u00ecm th\u1ea5y s\u1ef1 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea khi xem x\u00e9t ch\u1ec9 s\u1ed1 \u0111\u1ea7u ra ch\u00ednh, c\u00e1c t\u00e1c gi\u1ea3 ch\u1ec9 xem x\u00e9t c\u00e1c ch\u1ec9 s\u1ed1 \u0111\u1ea7u ra ph\u1ee5 v\u1edbi \u00fd ngh\u0129a m\u00f4 t\u1ea3 v\u00e0 ghi nh\u1eadn ch\u00fang m\u00e0 kh\u00f4ng \u0111\u00e1nh gi\u00e1 m\u1ee9c \u0111\u1ed9 \u00fd ngh\u0129a: s\u1ef1 thay \u0111\u1ed5i \u0111i\u1ec3m MMSE so v\u1edbi tr\u01b0\u1edbc \u0111i\u1ec1u tr\u1ecb l\u00e0 -3,17 \u1edf nh\u00f3m solanezumab v\u00e0 -3,66 \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c. T\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n ph\u00f9 n\u00e3o hay tr\u00e0n d\u1ecbch n\u00e3o quan s\u00e1t \u0111\u01b0\u1ee3c tr\u00ean c\u1ed9ng h\u01b0\u1edfng t\u1eeb g\u1eb7p \u1edf 1 b\u1ec7nh nh\u00e2n trong nh\u00f3m solanezumab v\u00e0 2 b\u1ec7nh nh\u00e2n trong nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c.<\/p>\n<p>K\u1ebft lu\u1eadn \u0111\u01b0\u1ee3c r\u00fat ra t\u1eeb nghi\u00ean c\u1ee9u l\u00e0 solanezumab li\u1ec1u 400 mg m\u1ed7i 4 tu\u1ea7n kh\u00f4ng c\u1ea3i thi\u1ec7n m\u1ed9t c\u00e1ch c\u00f3 \u00fd ngh\u0129a t\u00ecnh tr\u1ea1ng suy gi\u1ea3m nh\u1eadn th\u1ee9c tr\u00ean b\u1ec7nh nh\u00e2n Alzheimer m\u1ee9c \u0111\u1ed9 nh\u1eb9.<\/p>\n<p>Ngu\u1ed3n:<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1705971?query=featured_home&amp;fbclid=IwAR2RN2uMNPOgZsYqN4K194JNcZEWAYJivPltmYOQwbi9HG5cZRTcImb_vLQ\" rel=\"noopener\">\u00a0https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1705971?query=featured_home&amp;fbclid=IwAR2RN2uMNPOgZsYqN4K194JNcZEWAYJivPltmYOQwbi9HG5cZRTcImb_vLQ<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u00e1c m\u1ea3ng amyloid beta (A\u03b2) l\u00e0 d\u1ea5u \u1ea5n ch\u1ec9 \u0111i\u1ec3m b\u1ec7nh l\u00fd trong b\u1ec7nh Alzheimer, tuy nhi\u00ean theo m\u1ed9t nghi\u00ean c\u1ee9u m\u1edbi \u0111\u00e2y \u0111\u0103ng t\u1ea3i ng\u00e0y 25\/01\/2018 tr\u00ean t\u1ea1p ch\u00ed New England Journal of Medicine (NEJM), kh\u00e1ng th\u1ec3 lo\u1ea1i IgG kh\u00e1ng A\u03b2 l\u00e0 solanezumab kh\u00f4ng cho th\u1ea5y t\u00e1c d\u1ee5ng c\u1ea3i thi\u1ec7n nh\u1eadn th\u1ee9c \u1edf b\u1ec7nh [&#8230;]\n","protected":false},"author":1,"featured_media":4169,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4168","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\/4168","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=4168"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4168\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4169"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4168"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4168"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4168"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}