{"id":4408,"date":"2019-03-12T15:09:09","date_gmt":"2019-03-12T08:09:09","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4408"},"modified":"2019-03-13T15:09:31","modified_gmt":"2019-03-13T08:09:31","slug":"chuong-trinh-kiem-soat-su-dung-dung-dich-tiem-truyen-chua-hydroxyethyl-starch","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/chuong-trinh-kiem-soat-su-dung-dung-dich-tiem-truyen-chua-hydroxyethyl-starch\/","title":{"rendered":"Ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t s\u1eed d\u1ee5ng dung d\u1ecbch ti\u00eam truy\u1ec1n ch\u1ee9a hydroxyethyl starch"},"content":{"rendered":"<p>T\u1eeb n\u0103m 2013, EMA \u0111\u00e3 gi\u1edbi h\u1ea1n vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c <strong>d\u1ecbch truy\u1ec1n c\u00f3 ch\u1ee9a hydroxyethyl<\/strong> ngu\u1ed3n g\u1ed1c t\u1eeb tinh b\u1ed9t (HES) \u1edf nh\u1eefng \u0111\u1ed1i t\u01b0\u1ee3ng b\u1ec7nh nh\u00e2n b\u1ec7nh n\u1eb7ng v\u00e0 b\u1ec7nh nh\u00e2n nhi\u1ec5m tr\u00f9ng huy\u1ebft, c\u00f3 t\u1ed5n th\u01b0\u01a1ng th\u1ead nh\u1eb1m h\u1ea1n ch\u1ebf nguy c\u01a1 \u0111\u1ed9c t\u00ednh tr\u00ean th\u1eadn v\u00e0 t\u1eed vong. Tuy nhi\u00ean, k\u1ebft qu\u1ea3 c\u1ee7a nh\u1eefng nghi\u00ean c\u1ee9u v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng d\u1ecbch truy\u1ec1n HES g\u1ea7n \u0111\u00e2y cho th\u1ea5y nh\u1eefng gi\u1edbi h\u1ea1n ch\u1ec9 \u0111\u1ecbnh trong vi\u1ec7c s\u1eed d\u1ee5ng HES \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7. Do \u0111\u00f3, v\u00e0o th\u00e1ng 6 n\u0103m 2018, ANSM \u0111\u00e3 y\u00eau c\u1ea7u th\u1ef1c hi\u1ec7n m\u1ed9t bi\u1ec7n ph\u00e1p m\u1edbi \u0111\u1ec3 gi\u1ea3m thi\u1ec3u r\u1ee7i ro li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng HES.<\/p>\n<h2>B\u1ed1i c\u1ea3nh<\/h2>\n<p>M\u1eb7c d\u00f9 c\u00f3 nh\u1eefng gi\u1edbi h\u1ea1n ch\u1ec9 \u0111\u1ecbnh \u0111\u01b0\u1ee3c \u0111\u01b0a ra v\u00e0o n\u0103m 2013, k\u1ebft qu\u1ea3 c\u1ee7a nh\u1eefng nghi\u00ean c\u1ee9u v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng d\u1ecbch truy\u1ec1n c\u00f3 ch\u1ee9a hydroxyethyl ngu\u1ed3n g\u1ed1c t\u1eeb tinh b\u1ed9t (HES) cho th\u1ea5y nh\u1eefng gi\u1edbi h\u1ea1n ch\u1ec9 \u0111\u1ecbnh trong vi\u1ec7c s\u1eed d\u1ee5ng HES \u0111\u00e3 kh\u00f4ng \u0111\u01b0\u1ee3c tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7. K\u1ebft qu\u1ea3 n\u00e0y \u0111\u1eb7t ra c\u00e2u h\u1ecfi v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng \u0111\u00fang nh\u1eefng s\u1ea3n ph\u1ea7m n\u00e0y theo c\u00e1c ch\u1ec9 \u0111\u1ecbnh \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t. Do \u0111\u00f3, v\u00e0o th\u00e1ng 6 n\u0103m 2018, ANSM \u0111\u00e3 y\u00eau c\u1ea7u th\u1ef1c hi\u1ec7n m\u1ed9t g\u00f3i c\u00e1c bi\u1ec7n ph\u00e1p m\u1edbi \u0111\u1ec3 gi\u1ea3m thi\u1ec3u r\u1ee7i ro li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng HES.<\/p>\n<p>G\u00f3i bi\u1ec7n ph\u00e1p n\u00e0y bao g\u1ed3m m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh truy c\u1eadp d\u1eef li\u1ec7u c\u00f3 ki\u1ec3m so\u00e1t k\u1ebft h\u1ee3p v\u1edbi h\u1ec7 th\u1ed1ng ki\u1ec3m \u0111\u1ecbnh ch\u1ea5t l\u01b0\u1ee3ng vi\u1ec7c k\u00ea \u0111\u01a1n dung d\u1ecbch ti\u00eam truy\u1ec1n c\u00f3 ch\u1ee9a HES. Ch\u00ednh v\u00ec v\u1eady, th\u00e1ng 8-9\/2018, ANSM \u0111\u00e3 g\u1eedi th\u01b0 th\u00f4ng b\u00e1o v\u1ec1 c\u00e1c quy \u0111\u1ecbnh m\u1edbi trong vi\u1ec7c k\u00ea \u0111\u01a1n HES cho c\u00e1n b\u1ed9 y t\u1ebf.<\/p>\n<p>Ch\u01b0\u01a1ng tr\u00ecnh ki\u1ec3m so\u00e1t dung d\u1ecbch ti\u00eam truy\u1ec1n ch\u1ee9a hydroxyethyl c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb tinh b\u1ed9t (t\u00ean theo ti\u1ebfng Ph\u00e1p: hydroxy\u00e9thylamidon \u2013 HEA, t\u00ean theo ti\u1ebfng Anh l\u00e0 Hydroxyethyl starch &#8211; HES) s\u1ebd ch\u00ednh th\u1ee9c ho\u1ea1t \u0111\u1ed9ng t\u1eeb ng\u00e0y 16 th\u00e1ng 4 n\u0103m 2019 v\u1edbi s\u1ef1 tham gia c\u1ee7a nhi\u1ec1u \u0111\u1ed1i t\u00e1c kh\u00e1c nhau (b\u00e1c s\u0129 g\u00e2y m\u00ea \u2013 ch\u0103m s\u00f3c chuy\u00ean s\u00e2u, d\u1ecbch v\u1ee5 nh\u00e0 thu\u1ed1c, d\u1ecbch v\u1ee5 c\u1ea5p c\u1ee9u).<\/p>\n<h2>Ch\u01b0\u01a1ng tr\u00ecnh truy c\u1eadp c\u00f3 ki\u1ec3m so\u00e1t<\/h2>\n<p>Ch\u01b0\u01a1ng tr\u00ecnh truy c\u1eadp d\u1eef li\u1ec7u c\u00f3 ki\u1ec3m so\u00e1t s\u1ebd c\u00f3 hi\u1ec7u l\u1ef1c t\u1eeb ng\u00e0y 16 th\u00e1ng 4 n\u0103m 2019. K\u1ec3 t\u1eeb th\u1eddi \u0111i\u1ec3m \u0111\u00f3, c\u00e1c b\u1ec7nh vi\u1ec7n, chuy\u00ean gia y t\u1ebf s\u1ebd kh\u00f4ng c\u00f2n c\u00f3 th\u1ec3 \u0111\u1eb7t h\u00e0ng dung d\u1ecbch ti\u00eam truy\u1ec1n ch\u1ee9a HES130 m\u00e0 kh\u00f4ng c\u00f3 ki\u1ec3m \u0111\u1ecbnh, t\u1ee9c l\u00e0 t\u1ea5t c\u1ea3 c\u00e1n b\u1ed9 y t\u1ebf k\u00ea toa s\u1ea3n ph\u1ea9m n\u00e0y c\u1ea7n ph\u1ea3i \u0111\u01b0\u01a1c \u0111\u00e0o t\u1ea1o \u0111\u1ec3 s\u1eed d\u1ee5ng h\u1ee3p l\u00fd HES, trong c\u00e1c \u0111i\u1ec1u ki\u1ec7n ph\u00f9 h\u1ee3p v\u1edbi th\u00f4ng tin s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t \u1edf ch\u00e2u \u00c2u, v\u00e0 kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng khi kh\u00f4ng \u0111\u01b0\u1ee3c ki\u1ec3m \u0111\u1ecbnh.<\/p>\n<p>S\u1ef1 ki\u1ec3m \u0111\u1ecbnh s\u1ebd \u0111\u01b0\u1ee3c ban h\u00e0nh sau khi ho\u00e0n th\u00e0nh kh\u00f3a \u0111\u00e0o t\u1ea1o b\u1eaft bu\u1ed9c. T\u00e0i li\u1ec7u \u0111\u00e0o t\u1ea1o ch\u1ee9a c\u00e1c th\u00f4ng tin c\u1ea7n thi\u1ebft theo y\u00eau c\u1ea7u c\u1ee7a EMA. Ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o s\u1ebd \u0111\u01b0\u1ee3c tri\u1ec3n khai sau khi \u0111\u01b0\u1ee3c c\u00e1c c\u01a1 quan c\u00f3 th\u1ea9m quy\u1ec1n c\u1ee7a c\u00e1c qu\u1ed1c gia thu\u1ed9c li\u00ean minh ch\u00e2u \u00c2u (EU) ph\u00ea duy\u1ec7t v\u00e0o \u0111\u1ea7u n\u0103m 2019. Trong v\u00f2ng 15 ph\u00fat c\u1ee7a ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o, c\u00e1c c\u00e1n b\u1ed9 y t\u1ebf s\u1ebd \u0111\u01b0\u1ee3c cung c\u1ea5p nh\u1eefng th\u00f4ng tin c\u1ea7n thi\u1ebft sau \u0111\u00e2y:<\/p>\n<p>R\u1ee7i ro li\u00ean quan \u0111\u1ebfn vi\u1ec7c s\u1eed d\u1ee5ng dung d\u1ecbch ti\u00eam truy\u1ec1n ch\u1ee9a HES v\u00e0 nh\u1eefng n\u1ed9i dung kh\u00f4ng ph\u00f9 h\u1ee3p v\u1edbi th\u00f4ng tin s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t t\u1ea1i EU\/EEE.<br \/>\nB\u1ed1i c\u1ea3nh v\u00e0 k\u1ebft qu\u1ea3 c\u1ee7a 2 nghi\u00ean c\u1ee9u s\u1eed d\u1ee5ng HES.<br \/>\nS\u1eed d\u1ee5ng dung d\u1ecbch ti\u00eam truy\u1ec1n ch\u1ee9a HES theo th\u00f4ng tin s\u1ea3n ph\u1ea9m \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t: ch\u1ec9 \u0111\u1ecbnh, li\u1ec1u l\u01b0\u1ee3ng, th\u1eddi gian \u0111i\u1ec1u tr\u1ecb v\u00e0 ch\u1ed1ng ch\u1ec9 \u0111\u1ecbnh.<br \/>\nBi\u1ec7n ph\u00e1p b\u1ed5 sung \u0111\u1ec3 h\u1ea1n ch\u1ebf r\u1ee7i ro.<\/p>\n<h2>Quy tr\u00ecnh \u0111\u00e0o t\u1ea1o v\u00e0 ki\u1ec3m \u0111\u1ecbnh quy tr\u00ecnh:<\/h2>\n<h3>Quy tr\u00ecnh \u0111\u00e0o t\u1ea1o<\/h3>\n<p>T\u1ea5t c\u1ea3 c\u00e1c chuy\u00ean gia y t\u1ebf ph\u1ea3i tr\u1ea3i qua qu\u00e1 m\u1ed9t kh\u00f3a h\u1ecdc tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c ph\u00e9p k\u00ea toa dung d\u1ecbch truy\u1ec1n ch\u1ee9a HES 130 t\u1eeb ng\u00e0y 16 th\u00e1ng 4 n\u0103m 2019. Ch\u01b0\u01a1ng tr\u00ecnh c\u00f3 th\u1ec3 truy c\u1eadp \u1edf website https:\/\/academy.esahq.org\/volumetherapy. K\u1ebft th\u00fac kh\u00f3a h\u1ecdc, c\u00e1c chuy\u00ean gia y t\u1ebf s\u1ebd \u0111\u01b0\u1ee3c nh\u1eadn ch\u1ee9ng ch\u1ec9 \u0111\u00e0o t\u1ea1o<\/p>\n<h3>Ki\u1ec3m \u0111\u1ecbnh quy tr\u00ecnh<\/h3>\n<p>Ngay sau khi c\u00e1c chuy\u00ean gia y t\u1ebf ho\u00e0n th\u00e0nh kh\u00f3a h\u1ecdc v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng HES, m\u1ed9t th\u01b0 cam k\u1ebft s\u1ebd \u0111\u01b0\u1ee3c k\u00fd b\u1edfi ng\u01b0\u1eddi \u0111\u1ee9ng \u0111\u1ea7u b\u1ed9 ph\u00e2n. L\u00e1 th\u01b0 cam k\u1ebft n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c \u0111\u1ec7 tr\u00ecnh \u0111\u1ec3 c\u00f3 ch\u1eef k\u00fd x\u00e1c nh\u1eadn c\u1ee7a \u0111\u1ea1i di\u1ec7n nh\u00e0 s\u1ea3n xu\u1ea5t HES 130.<\/p>\n<h3>\u0110\u1eb7t h\u00e0ng s\u1ea3n ph\u1ea9m<\/h3>\n<p>Khi c\u00e1c l\u00e1 th\u01b0 cam k\u1ebft \u0111\u01b0\u1ee3c k\u00fd b\u1edfi nh\u1eefng ng\u01b0\u1eddi qu\u1ea3n l\u00fd d\u1ecbch v\u1ee5 c\u00f3 li\u00ean quan, b\u1ec7nh vi\u1ec7n s\u1ebd ki\u1ec3m \u0111\u1ecbnh v\u00e0 h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd s\u1ea3n ph\u1ea9m (BRAUN MELSUNGEN et FRESENIUS KABI FRANCE) s\u1ebd s\u1eeda \u0111\u1ed5i \u0111\u1ec3 c\u00e1c \u0111\u01a1n \u0111\u1eb7t h\u00e0ng c\u1ee7a b\u1ec7nh vi\u1ec7n c\u00f3 hi\u1ec7u l\u1ef1c.<\/p>\n<h3>Th\u1ee7 t\u1ee5c m\u1edbi v\u1ec1 ki\u1ec3m \u0111\u1ecbnh<\/h3>\n<p>B\u1ea5t k\u1ef3 chuy\u00ean gia y t\u1ebf l\u00e0m vi\u1ec7c t\u1ea1i b\u1ec7nh vi\u1ec7n ph\u1ea3i \u0111\u01b0\u1ee3c c\u00f4ng nh\u00e2n tu\u00e2n th\u1ee7 theo \u0111\u00e0o t\u1ea1o ho\u1eb7c \u0111\u01b0\u1ee3c cung c\u1ea5p ch\u1ee9ng ch\u1ec9 h\u1ee3p l\u1ec7 \u0111\u01b0\u1ee3c c\u00f4ng nh\u1eadn b\u1edfi m\u1ed9t b\u1ec7nh vi\u1ec7n \u0111\u1ec3 \u0111\u01b0\u1ee3c \u1ee7y qu\u00ean k\u00ea toa dung d\u1ecbch ti\u00eam truy\u1ec1n HES 130.<\/p>\n<h3>Tuy\u00ean b\u1ed1 v\u1ec1 t\u00e1c d\u1ee5ng ph\u1ee5<\/h3>\n<p>Tuy\u00ean b\u1ed1 ngay l\u1eadp t\u1ee9c b\u1ea5t k\u1ef3 ph\u1ea3n \u1ee9ng b\u1ea5t l\u1ee3i n\u00e0o b\u1ecb nghi ng\u1edd do thu\u1ed1c t\u1edbi trung t\u00e2m qu\u1ed1c gia v\u1ec1 c\u1ea3nh gi\u00e1c d\u01b0\u1ee3c Ph\u00e1p ho\u1eb7c website www.signalement-sante.gouv.fr. \u0110\u1ec3 bi\u1ebft th\u00eam th\u00f4ng tin v\u1ec1 thu\u1ed1c, hay truy c\u1eadp ansm.sante.fr ho\u1eb7c base-donneespublique.medicaments.gouv.fr.<\/p>\n<p>C\u00e1c thu\u1ed1c n\u00e0y s\u1ebd \u0111\u01b0\u1ee3c gi\u00e1m s\u00e1t \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh c\u00e1c th\u00f4ng tin m\u1edbi li\u00ean quan t\u1edbi an to\u00e0n thu\u1ed1c.<\/p>\n<p>Ngu\u1ed3n:<a href=\"https:\/\/ansm.sante.fr\/S-informer\/Informations-de-securite-Lettres-aux-professionnels-de-sante\/Solutions-pour-perfusion-a-base-d-hydroxyethylamidon-HEA-programme-d-acces-controle-des-le-16-avril-2019-Lettre-aux-professionnels-de-sante\" rel=\"noopener\"> https:\/\/ansm.sante.fr\/S-informer\/Informations-de-securite-Lettres-aux-professionnels-de-sante\/Solutions-pour-perfusion-a-base-d-hydroxyethylamidon-HEA-programme-d-acces-controle-des-le-16-avril-2019-Lettre-aux-professionnels-de-sante<\/a><\/p>\n<p>Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: V\u0169 \u0110\u1ee9c Ho\u00e0n \u2013 Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay<\/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<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u1eeb n\u0103m 2013, EMA \u0111\u00e3 gi\u1edbi h\u1ea1n vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c d\u1ecbch truy\u1ec1n c\u00f3 ch\u1ee9a hydroxyethyl ngu\u1ed3n g\u1ed1c t\u1eeb tinh b\u1ed9t (HES) \u1edf nh\u1eefng \u0111\u1ed1i t\u01b0\u1ee3ng b\u1ec7nh nh\u00e2n b\u1ec7nh n\u1eb7ng v\u00e0 b\u1ec7nh nh\u00e2n nhi\u1ec5m tr\u00f9ng huy\u1ebft, c\u00f3 t\u1ed5n th\u01b0\u01a1ng th\u1ead nh\u1eb1m h\u1ea1n ch\u1ebf nguy c\u01a1 \u0111\u1ed9c t\u00ednh tr\u00ean th\u1eadn v\u00e0 t\u1eed vong. Tuy nhi\u00ean, k\u1ebft [&#8230;]\n","protected":false},"author":1,"featured_media":4409,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4408","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\/4408","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=4408"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4408\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4409"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4408"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4408"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}