﻿{"id":9529,"date":"2019-05-15T18:39:36","date_gmt":"2019-05-15T11:39:36","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=9529"},"modified":"2019-05-15T18:39:36","modified_gmt":"2019-05-15T11:39:36","slug":"thao-luan-du-lieu-cap-nhat-ve-nsaid-va-nguy-co-tim-mach","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/thao-luan-du-lieu-cap-nhat-ve-nsaid-va-nguy-co-tim-mach\/","title":{"rendered":"Th\u1ea3o lu\u1eadn d\u1eef li\u1ec7u c\u1eadp nh\u1eadt v\u1ec1 NSAID v\u00e0 nguy c\u01a1 tim m\u1ea1ch"},"content":{"rendered":"<h2>Medsafe (New Zealand): Th\u1ea3o lu\u1eadn d\u1eef li\u1ec7u c\u1eadp nh\u1eadt v\u1ec1 NSAID v\u00e0 nguy c\u01a1 tim m\u1ea1ch.<\/h2>\n<p>T\u1ea1i cu\u1ed9c h\u1ecdp l\u1ea7n th\u1ee9 173 c\u1ee7a \u1ee6y ban Ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i c\u1ee7a thu\u1ed1c (New Zealand) (MARC) v\u00e0o 8\/3\/2018, MARC \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u v\u1ec1 thay \u0111\u1ed5i th\u00f4ng tin thu\u1ed1c t\u1eeb NSX c\u1ee7a Celecoxib Pfizer (t\u00ean bi\u1ec7t d\u01b0\u1ee3c <a href=\"https:\/\/www.vnras.com\/drug\/celebrex\">celebrex<\/a>) 100mg v\u00e0 200mg. Trong Th\u00f4ng b\u00e1o thay \u0111\u1ed5i th\u00f4ng tin thu\u1ed1c c\u00f3 m\u1ed9t \u0111\u1ec1 xu\u1ea5t v\u1ec1 thay \u0111\u1ed5i v\u1ecb tr\u00ed c\u1ee7a n\u1ed9i dung sau \u201c b\u1ec7nh nh\u00e2n m\u1eafc b\u1ec7nh tim thi\u1ebfu m\u00e1u c\u1ee5c b\u1ed9 nghi\u00eam tr\u1ecdng, b\u1ec7nh \u0111\u1ed9ng m\u1ea1ch ngo\u1ea1i vi v\u00e0\/ ho\u1eb7c b\u1ec7nh m\u1ea1ch m\u00e1u n\u00e3o\u201d t\u1eeb m\u1ee5c Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh sang m\u1ee5c Th\u1eadn tr\u1ecdng trong t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m. Nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u00e3 g\u1eedi k\u1ebft qu\u1ea3 c\u1ee7a m\u1ed9t nghi\u00ean c\u1ee9u \u0111\u00e1nh gi\u00e1 ng\u1eabu nhi\u00ean v\u1ec1 \u0111\u1ed9 an to\u00e0n c\u1ee7a Celecoxib so v\u1edbi Ibuprofen ho\u1eb7c Naproxen (PRECISION) \u0111\u1ec3 gi\u1ea3i th\u00edch cho nh\u1eefng \u0111\u1ec1 xu\u1ea5t thay \u0111\u1ed5i n\u00e0y. Medsafe y\u00eau c\u1ea7u MARC xem x\u00e9t li\u1ec7u \u0111\u1ec1 xu\u1ea5t thay \u0111\u1ed5i c\u00f3 ph\u00f9 h\u1ee3p kh\u00f4ng v\u00e0 c\u00f3 n\u00ean th\u1ef1c hi\u1ec7n c\u00e1c thay \u0111\u1ed5i t\u01b0\u01a1ng t\u1ef1 \u0111\u1ed1i v\u1edbi c\u00e1c t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m c\u1ee7a t\u1ea5t c\u1ea3 c\u00e1c NSAID v\u00e0 aspirin hay kh\u00f4ng.<\/p>\n<figure id=\"attachment_7889\" aria-describedby=\"caption-attachment-7889\" style=\"width: 450px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-7889\" src=\"https:\/\/www.vnras.com\/drug\/wp-content\/uploads\/2019\/04\/Celebrex_2.jpg\" alt=\"Celebrex\" width=\"450\" height=\"450\" title=\"\" srcset=\"https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/04\/Celebrex_2.jpg 450w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/04\/Celebrex_2-280x280.jpg 280w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/04\/Celebrex_2-400x400.jpg 400w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/04\/Celebrex_2-350x350.jpg 350w, https:\/\/vnras.com\/drug\/wp-content\/uploads\/2019\/04\/Celebrex_2-100x100.jpg 100w\" sizes=\"auto, (max-width: 450px) 100vw, 450px\" \/><figcaption id=\"caption-attachment-7889\" class=\"wp-caption-text\">H\u00ecnh \u1ea3nh: thu\u1ed1c Celebrex 200mg c\u1ee7a Pfizer<\/figcaption><\/figure>\n<p>K\u1ebft qu\u1ea3 c\u1ee7a qu\u00e1 tr\u00ecnh th\u1ea3o lu\u1eadn gi\u1eefa c\u00e1c chuy\u00ean gia c\u1ee7a MARC cho th\u1ea5y d\u1eef li\u1ec7u nghi\u00ean c\u1ee9u PRECISION kh\u00f4ng cung c\u1ea5p \u0111\u1ee7 c\u01a1 s\u1edf cho vi\u1ec7c thay \u0111\u1ed5i v\u1ecb tr\u00ed c\u1ee7a b\u1ec7nh nh\u00e2n m\u1eafc b\u1ec7nh tim m\u1ea1ch quan tr\u1ecdng t\u1eeb m\u1ee5c Ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh sang m\u1ee5c Th\u1eadn tr\u1ecdng. MARC c\u0169ng b\u00e0y t\u1ecf lo ng\u1ea1i v\u1ec1 nguy c\u01a1 cao suy tim n\u1eb7ng h\u01a1n khi d\u00f9ng NSAID.<\/p>\n<p>Tr\u01b0\u1edbc \u0111\u00e2y, Medsafe \u0111\u00e3 tr\u00ecnh b\u00e0y c\u00e1c b\u00e0i b\u00e1o cho MARC v\u1ec1 nguy c\u01a1 tim m\u1ea1ch li\u00ean quan \u0111\u1ebfn diclofenac (6\/2013) v\u00e0 ibuprofen (3\/2015).<\/p>\n<p>MARC \u0111\u00e3 y\u00eau c\u1ea7u xem x\u00e9t l\u1ea1i nguy c\u01a1 bi\u1ebfn c\u1ed1 tim m\u1ea1ch b\u1ea5t l\u1ee3i v\u1edbi NSAID sau khi c\u00e1c m\u1ed9t s\u1ed1 nghi\u00ean c\u1ee9u g\u1ea7n \u0111\u00e2y c\u00f4ng b\u1ed1 k\u1ebft qu\u1ea3 v\u1ec1 ch\u1ee7 \u0111\u1ec1 n\u00e0y.<\/p>\n<h2>Th\u1ea3o lu\u1eadn chi ti\u1ebft<\/h2>\n<p>MARC \u0111\u00e3 th\u1ea3o lu\u1eadn v\u1ec1 nghi\u00ean c\u1ee9u PRECISION v\u00e0 th\u1ea5y r\u1eb1ng vi\u1ec7c thi\u1ebfu s\u1ef1 t\u01b0\u01a1ng \u0111\u01b0\u01a1ng v\u1ec1 li\u1ec1u trong c\u00e1c nh\u00f3m \u0111i\u1ec1u tr\u1ecb \u0111\u00e3 h\u1ea1n ch\u1ebf vi\u1ec7c gi\u1ea3i th\u00edch k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u. Li\u1ec1u trung b\u00ecnh h\u00e0ng ng\u00e0y c\u1ee7a ibuprofen (2045 \u00b1 246 mg) v\u00e0 naproxen (852 \u00b1 103 mg) \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong nghi\u00ean c\u1ee9u PRECISION l\u00e0 g\u1ea7n m\u1ee9c cao nh\u1ea5t c\u1ee7a kho\u1ea3ng li\u1ec1u \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t t\u1ea1i th\u1eddi \u0111i\u1ec3m nghi\u00ean c\u1ee9u, trong khi \u0111\u00f3, li\u1ec1u celecoxib trung b\u00ecnh h\u00e0ng ng\u00e0y (209 \u00b1 37 mg) \u1edf g\u1ea7n m\u1ee9c th\u1ea5p c\u1ee7a kho\u1ea3ng li\u1ec1u \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t. Ibuprofen li\u1ec1u cao \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong nghi\u00ean c\u1ee9u PRECISION c\u00f3 li\u00ean quan \u0111\u1ebfn vi\u1ec7c t\u0103ng nguy c\u01a1 tim m\u1ea1ch. Do \u0111\u00f3, MARC \u0111\u00e3 x\u00e1c \u0111\u1ecbnh r\u1eb1ng vi\u1ec7c ch\u1ee9ng minh t\u00e1c d\u1ee5ng kh\u00f4ng thua k\u00e9m c\u1ee7a celecoxib so v\u1edbi ibuprofen li\u1ec1u cao kh\u00f4ng suy ra r\u1eb1ng celecoxib c\u00f3 m\u1ee9c \u0111\u1ed9 an to\u00e0n tim m\u1ea1ch ch\u1ea5p nh\u1eadn \u0111\u01b0\u1ee3c.<\/p>\n<p>MARC \u0111\u00e3 xem x\u00e9t c\u00e1c t\u00e0i li\u1ec7u \u0111\u01b0\u1ee3c xu\u1ea5t b\u1ea3n g\u1ea7n \u0111\u00e2y v\u1ec1 nguy c\u01a1 tim m\u1ea1ch c\u1ee7a NSAID v\u00e0 th\u1ea5y r\u1eb1ng nguy c\u01a1 tim m\u1ea1ch c\u1ee7a m\u1ed7i NSAID kh\u00f4ng kh\u00e1c nhau nhi\u1ec1u.<\/p>\n<p>MARC l\u01b0u \u00fd th\u00f4ng tin v\u1ec1 nguy c\u01a1 tim m\u1ea1ch \u0111\u00e3 \u0111\u01b0\u1ee3c n\u00f3i gi\u1ea3m trong m\u1ed9t s\u1ed1 t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m ch\u1ee9a NSAID sau khi xem x\u00e9t v\u00e0o 6\/2013 v\u00e0 3\/2015. MARC c\u0169ng xem x\u00e9t c\u00e1c c\u1ea3nh b\u00e1o v\u1ec1 bi\u1ebfn c\u1ed1 tim m\u1ea1ch c\u1ee7a d\u1eef li\u1ec7u hi\u1ec7n t\u1ea1i. MARC x\u00e1c \u0111\u1ecbnh r\u1eb1ng c\u00e2u \u201c \u00edt t\u0103ng nguy c\u01a1 bi\u1ebfn c\u1ed1 huy\u1ebft kh\u1ed1i \u0111\u1ed9ng m\u1ea1ch\u201d \u0111\u00e3 n\u00f3i gi\u1ea3m nguy c\u01a1 c\u1ee7a thu\u1ed1c. D\u1ef1a tr\u00ean b\u1eb1ng ch\u1ee9ng hi\u1ec7n t\u1ea1i, t\u1ea5t c\u1ea3 c\u00e1c NSAID \u0111\u1ec1u c\u00f3 nguy c\u01a1 g\u00e2y ra c\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i tr\u00ean tim m\u1ea1ch, kh\u00f4ng n\u00ean n\u00f3i gi\u1ea3m trong c\u00e1c c\u1ea3nh b\u00e1o tr\u00ean c\u00e1c t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m t\u1eeb nh\u1eefng nghi\u00ean c\u1ee9u \u0111\u00e3 \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1. MARC \u0111\u1ec1 ngh\u1ecb lo\u1ea1i b\u1ecf c\u00e1c t\u1eeb \u201c\u00edt\u201d ra kh\u1ecfi c\u00e1c c\u1ea3nh b\u00e1o \u0111\u1ec3 ph\u1ea3n \u00e1nh \u0111\u00fang m\u1ee9c \u0111\u1ed9 c\u1ee7a c\u00e1c b\u1eb1ng ch\u1ee9ng hi\u1ec7n t\u1ea1i.<\/p>\n<p>MARC c\u0169ng th\u1ea3o lu\u1eadn v\u1ec1 vi\u1ec7c c\u00f3 n\u00ean ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh NSAID cho b\u1ec7nh nh\u00e2n suy tim c\u1ea5p II theo ph\u00e2n lo\u1ea1i c\u1ee7a Hi\u1ec7p h\u1ed9i Tim m\u1ea1ch New York (NYHA II). Trong c\u00e1c t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m hi\u1ec7n t\u1ea1i, c\u00e1c NSAID th\u01b0\u1eddng \u0111\u01b0\u1ee3c ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh trong suy tim n\u1eb7ng (NYHA IV), ngo\u1ea1i tr\u1eeb celecoxib \u0111\u01b0\u1ee3c ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh \u1edf b\u1ec7nh nh\u00e2n b\u1ecb suy tim t\u1eeb NYHA II \u0111\u1ebfn NYHA<\/p>\n<p>IV. MARC c\u0169ng l\u01b0u \u00fd c\u00e1c t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m c\u1ea7n c\u00f3 ph\u1ea7n c\u1ea3nh b\u00e1o khi s\u1eed d\u1ee5ng cho b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed suy tim. Do thi\u1ebfu b\u1eb1ng ch\u1ee9ng v\u1ec1 s\u1ef1 an to\u00e0n c\u1ee7a NSAID trong t\u1eebng giai \u0111o\u1ea1n suy tim, MARC kh\u00f4ng th\u1ec3 \u0111\u1ec1 xu\u1ea5t b\u1ea5t k\u1ef3 thay \u0111\u1ed5i n\u00e0o v\u1edbi c\u00e1c ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh hi\u1ec7n t\u1ea1i.<\/p>\n<p>MARC b\u00e0y t\u1ecf lo ng\u1ea1i r\u1eb1ng c\u00e1c t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m hi\u1ec7n t\u1ea1i ch\u1ec9 ph\u1ea3n \u00e1nh nguy c\u01a1 tim m\u1ea1ch li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng l\u00e2u d\u00e0i NSAID. B\u1eb1ng ch\u1ee9ng cho th\u1ea5y r\u1eb1ng v\u1eabn c\u00f3 nguy c\u01a1 tim m\u1ea1ch khi s\u1eed d\u1ee5ng NSAID ng\u1eafn h\u1ea1n, do \u0111\u00f3, t\u1ea5t c\u1ea3 c\u00e1c c\u1ea3nh b\u00e1o v\u1ec1 nguy c\u01a1 tim m\u1ea1ch d\u00f9 li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng NSAID l\u00e2u d\u00e0i hay ng\u1eafn h\u1ea1n \u0111\u1ec1u n\u00ean \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1.<\/p>\n<p>MARC \u0111\u1ec1 ngh\u1ecb c\u00e1c cu\u1ed9c th\u1ea3o lu\u1eadn n\u00e0y v\u00e0 nh\u1eefng \u0111\u1ec1 xu\u1ea5t thay \u0111\u1ed5i c\u1ea7n \u0111\u01b0\u1ee3c truy\u1ec1n \u0111\u1ea1t r\u1ed9ng r\u00e3i \u0111\u1ebfn t\u1ea5t c\u1ea3 c\u00e1c c\u00e1n b\u1ed9 y t\u1ebf, \u0111\u1ed3ng th\u1eddi s\u1ebd c\u1eadp nh\u1eadt th\u00f4ng tin n\u00e0y qua m\u1ed9t b\u00e0i b\u00e1o trong m\u1ee5c Prescriber Update.<\/p>\n<h2>\u0110\u1ec1 xu\u1ea5t:<\/h2>\n<p>&#8211; MARC \u0111\u1ec1 ngh\u1ecb Medsafe vi\u1ebft th\u01b0 cho c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t v\u00e0 kinh doanh t\u1ea5t c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m NSAID y\u00eau c\u1ea7u c\u1eadp nh\u1eadt ph\u1ea7n c\u1ea3nh b\u00e1o v\u1ec1 c\u00e1c bi\u1ebfn c\u1ed1 tim m\u1ea1ch trong t\u1edd th\u00f4ng tin s\u1ea3n ph\u1ea9m \u0111\u1ec3 lo\u1ea1i b\u1ecf ch\u1eef \u201c\u00edt\u201d khi m\u00f4 t\u1ea3 m\u1ee9c \u0111\u1ed9 r\u1ee7i ro v\u00e0 ch\u1ec9 r\u00f5 c\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i tr\u00ean tim m\u1ea1ch c\u00f3 th\u1ec3 x\u1ea3y ra khi s\u1eed d\u1ee5ng ng\u1eafn h\u1ea1n.<\/p>\n<p>&#8211; MARC \u0111\u1ec1 xu\u1ea5t c\u1ea7n c\u00f3 m\u1ed9t b\u00e0i b\u00e1o trong m\u1ee5c Prescriber Update vi\u1ebft v\u1ec1 ch\u1ee7 \u0111\u1ec1 n\u00e0y.<\/p>\n<p>Ngu\u1ed3n: <a href=\"https:\/\/www.medsafe.govt.nz\/profs\/adverse\/Minutes177.htm\" rel=\"noopener\">https:\/\/www.medsafe.govt.nz\/profs\/adverse\/Minutes177.htm<\/a>#3.2.2<\/p>\n<p>Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: V\u00f5 Th\u1ecb Th\u00f9y \u2013 Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay &#8211;\u00a0\u001dC\u1ea3nh gi\u00e1c d\u01b0\u1ee3c &#8211; trung t\u00e2m di &amp; adr qu\u1ed1c gia.<\/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<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medsafe (New Zealand): Th\u1ea3o lu\u1eadn d\u1eef li\u1ec7u c\u1eadp nh\u1eadt v\u1ec1 NSAID v\u00e0 nguy c\u01a1 tim m\u1ea1ch. T\u1ea1i cu\u1ed9c h\u1ecdp l\u1ea7n th\u1ee9 173 c\u1ee7a \u1ee6y ban Ph\u1ea3n \u1ee9ng c\u00f3 h\u1ea1i c\u1ee7a thu\u1ed1c (New Zealand) (MARC) v\u00e0o 8\/3\/2018, MARC \u0111\u00e3 nh\u1eadn \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u v\u1ec1 thay \u0111\u1ed5i th\u00f4ng tin thu\u1ed1c t\u1eeb NSX c\u1ee7a Celecoxib Pfizer (t\u00ean bi\u1ec7t [&#8230;]\n","protected":false},"author":1,"featured_media":7888,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9529","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\/9529","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=9529"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/9529\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/7888"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=9529"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=9529"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=9529"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}