{"id":4561,"date":"2015-11-19T06:57:51","date_gmt":"2015-11-18T23:57:51","guid":{"rendered":"http:\/\/ttud.com.vn\/?p=4561"},"modified":"2017-10-02T08:24:56","modified_gmt":"2017-10-02T01:24:56","slug":"bang-chung-khoa-hoc-ve-tinh-an-toan-va-hieu-qua-cua-quinvaxem","status":"publish","type":"post","link":"https:\/\/casta.ttud.com.vn\/index.php\/bang-chung-khoa-hoc-ve-tinh-an-toan-va-hieu-qua-cua-quinvaxem\/","title":{"rendered":"B\u1eb1ng ch\u1ee9ng khoa h\u1ecdc v\u1ec1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a Quinvaxem"},"content":{"rendered":"

G\u1ea7n \u0111\u00e2y, tr\u00ean nhi\u1ec1u m\u1ea1ng x\u00e3 h\u1ed9i (facebook, c\u00e1c di\u1ec5n \u0111\u00e0n) v\u00e0 m\u1ed9t s\u1ed1 trang th\u00f4ng tin \u0111i\u1ec7n t\u1eed \u0111ang lan truy\u1ec1n m\u1ed9t th\u00f4ng tin kh\u00f4ng c\u00f3 th\u1eadt v\u1ec1 v\u1eafc-xin Quinvaxem \u0111\u00e3 l\u00e0m \u1ea3nh h\u01b0\u1edfng t\u1edbi uy t\u00edn c\u1ee7a ng\u00e0nh y t\u1ebf v\u00e0 g\u00e2y ra t\u00e2m l\u00fd hoang mang trong c\u1ed9ng \u0111\u1ed3ng.<\/strong><\/p>\n

\"\"<\/p>\n

\u0110\u1ec3 r\u1ed9ng \u0111\u01b0\u1eddng d\u01b0 lu\u1eadn v\u00e0 nh\u1eb1m gi\u00fap c\u1ed9ng \u0111\u1ed3ng c\u00f3 \u0111\u1ea7y \u0111\u1ee7 th\u00f4ng tin v\u1ec1 vaccine Quinvaxem, d\u01b0\u1edbi \u0111\u00e2y gi\u1edbi thi\u1ec7u b\u00e0i vi\u1ebft c\u1ee7a BS Ho\u00e0ng B\u1ea3o Long v\u00e0 nh\u1eefng d\u1eabn ch\u1ee9ng khoa h\u1ecdc v\u1ec1 t\u00ednh an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a vaccine Quinvaxem.<\/p>\n

B\u1ea5t c\u1ee9 m\u1ed9t lo\u1ea1i thu\u1ed1c, v\u1eafc-xin, ho\u1eb7c bi\u1ec7n ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u1edbi n\u00e0o tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c \u00e1p d\u1ee5ng trong \u0111i\u1ec1u tr\u1ecb b\u1ec7nh cho con ng\u01b0\u1eddi (hay n\u00f3i m\u1ed9t c\u00e1ch kh\u00e1c l\u00e0 tr\u01b0\u1edbc khi \u0111\u01b0\u1ee3c th\u01b0\u01a1ng m\u1ea1i h\u00f3a) \u0111\u1ec1u ph\u1ea3i tr\u1ea3i qua nhi\u1ec1u pha th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng (Clinical Trial Phases) r\u1ea5t nghi\u00eam ng\u1eb7t, th\u1eadm ch\u00ed ph\u1ea3i m\u1ea5t r\u1ea5t nh\u1ec1u n\u0103m th\u00ec c\u00e1c th\u1eed nghi\u1ec7m n\u00e0y m\u1edbi c\u00f3 th\u1ec3 cho ra k\u1ebft qu\u1ea3 cu\u1ed1i c\u00f9ng. N\u1ebfu th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng th\u00e0nh c\u00f4ng, t\u1ee9c l\u00e0 thu\u1ed1c c\u00f3 hi\u1ec7u qu\u1ea3 trong \u0111i\u1ec1u tr\u1ecb b\u1ec7nh v\u1edbi \u0111\u1ed9 an to\u00e0n cho ph\u00e9p, th\u00ec s\u1ebd \u0111\u01b0\u1ee3c \u0111\u01b0a v\u00e0o s\u1ea3n xu\u1ea5t v\u00e0 cung c\u1ea5p ra th\u1ecb tr\u01b0\u1eddng d\u01b0\u1edbi s\u1ef1 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng r\u1ea5t nghi\u00eam ng\u1eb7t \u1edf t\u1ea5t c\u1ea3 c\u00e1c b\u01b0\u1edbc (s\u1ea3n xu\u1ea5t, b\u1ea3o qu\u1ea3n v\u00e0 cung c\u1ea5p…).<\/p>\n

M\u1ed9t v\u00e0i kh\u00e1i ni\u1ec7m v\u1ec1 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng<\/strong><\/p>\n

– C\u00e1c pha th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng: c\u00f3 4 pha ch\u00ednh: Pha I: \u0111\u00e1nh gi\u00e1 ban \u0111\u1ea7u tr\u00ean nh\u00f3m nh\u1ecf v\u1ec1 an to\u00e0n, t\u00e1c d\u1ee5ng ph\u1ee5 v\u00e0 li\u1ec1u d\u00f9ng; Pha II: \u0111\u00e1nh gi\u00e1 tr\u00ean nh\u00f3m trung b\u00ecnh v\u1ec1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3; Pha III: \u0111\u00e1nh gi\u00e1 tr\u00ean nh\u00f3m l\u1edbn v\u1ec1 hi\u1ec7u qu\u1ea3, so s\u00e1nh v\u1edbi c\u00e1c bi\u1ec7n ph\u00e1p tr\u01b0\u1edbc \u0111\u00e2y v\u00e0 thu th\u1eadp th\u00eam c\u00e1c th\u00f4ng tin v\u1ec1 an to\u00e0n (nh\u1ea5t l\u00e0 c\u00e1c bi\u1ebfn c\u1ed1 ch\u01b0a \u0111\u01b0\u1ee3c bi\u1ebft \u0111\u1ebfn) \u0111\u1ec3 chu\u1ea9n b\u1ecb tri\u1ec3n khai ra th\u1ecb tr\u01b0\u1eddng; Pha IV: \u0111\u00e1nh gi\u00e1 sau khi \u0111\u00e3 \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng, nh\u1eb1m x\u00e1c \u0111\u1ecbnh s\u1ef1 kh\u00e1c bi\u1ec7t tr\u00ean c\u00e1c qu\u1ea7n th\u1ec3 kh\u00e1c nhau, v\u00e0 theo d\u00f5i c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 l\u00e2u d\u00e0i.<\/p>\n

– Bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i (Adverse event [AE]): l\u00e0 m\u1ecdi tri\u1ec7u ch\u1ee9ng l\u00e2m s\u00e0ng v\u00e0 c\u1eadn l\u00e2m s\u00e0ng xu\u1ea5t hi\u1ec7n ho\u1eb7c t\u0103ng n\u1eb7ng trong th\u1eddi gian th\u1eed nghi\u1ec7m.<\/p>\n

– Bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng (Severe adverse event [SAE]) l\u00e0 1 trong 6 bi\u1ebfn c\u1ed1 sau: t\u1eed vong, \u0111e d\u1ecda t\u00ednh m\u1ea1ng, nh\u1eadp vi\u1ec7n ho\u1eb7c k\u00e9o d\u00e0i th\u1eddi gian n\u1eb1m vi\u1ec7n, d\u1ecb t\u1eadt b\u1ea9m sinh, t\u00e0n t\u1eadt k\u00e9o d\u00e0i ho\u1eb7c v\u0129nh vi\u1ec5n, b\u1ea5t k\u1ef3 t\u00ecnh tr\u1ea1ng n\u00e0o \u0111\u00f2i h\u1ecfi can thi\u1ec7p c\u1ea5p c\u1ee9u \u0111\u1ec3 tr\u00e1nh 5 t\u00ecnh tr\u1ea1ng tr\u00ean (v\u00ed d\u1ee5: t\u0103ng kali m\u00e1u n\u1eb7ng ph\u1ea3i l\u1ecdc m\u00e1u c\u1ea5p c\u1ee9u \u0111\u1ec3 tr\u00e1nh rung th\u1ea5t v\u00e0 ng\u1eebng tim).<\/p>\n

– M\u1ee9c \u0111\u1ed9 li\u00ean quan t\u1edbi s\u1ea3n ph\u1ea9m th\u1eed nghi\u1ec7m: \u0111\u00e2y l\u00e0 v\u1ea5n \u0111\u1ec1 quan tr\u1ecdng nh\u1ea5t trong \u0111\u00e1nh gi\u00e1 AE, b\u1edfi kh\u00f4ng ph\u1ea3i AE n\u00e0o c\u0169ng do s\u1ea3m ph\u1ea9m th\u1eed nghi\u1ec7m g\u00e2y ra. C\u00f3 nhi\u1ec1u h\u1ec7 th\u1ed1ng ti\u00eau ch\u00ed \u0111\u00e1nh gi\u00e1, v\u00ed d\u1ee5: xu\u1ea5t hi\u1ec7n sau khi d\u00f9ng s\u1ea3n ph\u1ea9m th\u1eed nghi\u1ec7m v\u1edbi nhi\u1ec1u l\u1ea7n l\u1eb7p \u0111i l\u1eb7p l\u1ea1i ho\u1eb7c v\u1edbi nhi\u1ec1u \u0111\u1ed1i t\u01b0\u1ee3ng nghi\u00ean c\u1ee9u, gi\u1ea3m \u0111i ho\u1eb7c h\u1ebft khi ng\u1eebng s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m th\u1eed nghi\u1ec7m, c\u00f3 b\u1eb1ng ch\u1ee9ng v\u1ec1 c\u01a1 ch\u1ebf, th\u1ed1ng k\u00ea cho th\u1ea5y xu\u1ea5t hi\u1ec7n nhi\u1ec1u h\u01a1n \u1edf nh\u00f3m th\u1eed nghi\u1ec7m so v\u1edbi nh\u00f3m kh\u00f4ng th\u1eed nghi\u1ec7m…<\/p>\n

C\u00e1c b\u1eb1ng ch\u1ee9ng khoa h\u1ecdc c\u1ee7a Quinvaxem<\/strong><\/p>\n

1. Kanra et al (2006): th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean nh\u00e3n m\u1edf pha II. S\u1ed1t l\u00e0 bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i th\u01b0\u1eddng g\u1eb7p nh\u1ea5t (12.5% [95% CI: 7.7-18.8%]), kh\u00f4ng c\u00f3 kh\u00e1c bi\u1ec7t c\u00f3 \u00fd ngh\u0129a th\u1ed1ng k\u00ea v\u1edbi nh\u00f3m ch\u1ee9ng.<\/p>\n

2. Suare et al (2010): th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean nh\u00e3n m\u1edf pha III. C\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i th\u01b0\u1eddng g\u1eb7p l\u00e0 tri\u1ec7u ch\u1ee9ng t\u1ea1i ch\u1ed7 (\u0111au, c\u1ee9ng, \u0111\u1ecf n\u01a1i ti\u00eam) v\u00e0 qu\u1ea5y kh\u00f3c, thay \u0111\u1ed5i th\u00f3i quen \u0103n u\u1ed1ng, bu\u1ed3n ng\u1ee7, v\u00e0 ti\u00eau ch\u1ea3y; kh\u00f4ng c\u00f3 kh\u00e1c bi\u1ec7t v\u1edbi nh\u00f3m vaccine c\u0169 (th\u1eadm ch\u00ed t\u1ef7 l\u1ec7 AE c\u00f2n th\u1ea5p h\u01a1n). Kh\u00f4ng c\u00f3 SAE.<\/p>\n

3. Gentile et al (2011): th\u1eed nghi\u1ec7m kh\u00f4ng ng\u1eabu nhi\u00ean nh\u00e3n m\u1edf pha II. C\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i th\u01b0\u1eddng g\u1eb7p l\u00e0 qu\u1ea5y kh\u00f3c, bu\u1ed3n ng\u1ee7, thay \u0111\u1ed5i th\u00f3i quen \u0103n u\u1ed1ng, s\u1ed1t, tri\u1ec7u ch\u1ee9ng t\u1ea1i ch\u1ed7 (\u0111au, c\u1ee9ng, \u0111\u1ecf n\u01a1i ti\u00eam). C\u00f3 t\u1ed5ng c\u1ed9ng 25 SAE: 1 t\u1eed vong v\u00e0 24 tr\u01b0\u1eddng h\u1ee3p kh\u00e1c (c\u00f3 th\u1ec3 l\u00e0 nh\u1eadp vi\u1ec7n, v\u00e0 24 tr\u01b0\u1eddng h\u1ee3p \u0111\u1ec1u h\u1ed3i ph\u1ee5c ho\u00e0n to\u00e0n, kh\u00f4ng di ch\u1ee9ng). C\u1ea3 25 SAE n\u00e0y \u0111\u1ec1u \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 l\u00e0 kh\u00f4ng li\u00ean quan t\u1edbi s\u1ea3n ph\u1ea9m th\u1eed nghi\u1ec7m. Ch\u1ec9 duy c\u00f3 1 tr\u01b0\u1eddng h\u1ee3p vi\u00eam ti\u1ec3u ph\u1ebf qu\u1ea3n l\u00e0 \u0111\u01b0\u1ee3c cho c\u00f3 li\u00ean quan t\u1edbi vaccine.<\/p>\n

4. Aspinall et al (2012): th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean m\u00f9 \u0111\u00f4i. K\u1ebft qu\u1ea3 v\u1ec1 an to\u00e0n t\u01b0\u01a1ng t\u1ef1 v\u1edbi th\u1eed nghi\u1ec7m c\u1ee7a Gentile v\u00e0 c\u1ed9ng s\u1ef1. Giai \u0111o\u1ea1n core c\u1ee7a th\u1eed nghi\u1ec7m c\u00f3 8 SAE: 2 t\u1eed vong v\u00e0 6 tr\u01b0\u1eddng h\u1ee3p kh\u00e1c. 2 tr\u01b0\u1eddng h\u1ee3p t\u1eed vong: 2 tr\u1ebb n\u1eef 3 th\u00e1ng tu\u1ed5i t\u1eed vong 3 tu\u1ea7n sau ti\u00eam, 1 nghi do vi\u00eam ph\u1ed5i, 1 nghi do ti\u00eau ch\u1ea3y v\u00e0 m\u1ea5t n\u01b0\u1edbc n\u1eb7ng. Giai \u0111o\u1ea1n booster c\u1ee7a th\u1eed nghi\u1ec7m c\u00f3 1 SAE – tr\u1ebb b\u1ecb vi\u00eam c\u1ea7u th\u1eadn, kh\u00f4ng li\u00ean quan t\u1edbi s\u1ea3n ph\u1ea9m th\u1eed nghi\u1ec7m.<\/p>\n

5. Eregowada et al (2013): th\u1eed nghi\u1ec7m kh\u00f4ng ng\u1eabu nhi\u00ean nh\u00e3n m\u1edf \u0111a trung t\u00e2m pha III. C\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i \u0111\u01b0\u1ee3c th\u1ed1ng k\u00ea bao g\u1ed3m tri\u1ec7u ch\u1ee9ng t\u1ea1i ch\u1ed7 (d\u01b0\u1edbi 30%) v\u00e0 s\u1ed1t (20% tr\u1ebb s\u1ed1t d\u01b0\u1edbi 39 \u0111\u1ed9 C). C\u00f3 3 SAE tr\u00ean m\u1ed9t tr\u1ebb \u0111\u01b0\u1ee3c ghi nh\u1eadn (thi\u1ebfu m\u00e1u, vi\u00eam ph\u1ebf qu\u1ea3n ph\u1ed5i v\u00e0 tr\u00e0o ng\u01b0\u1ee3c d\u1ea1 d\u00e0y th\u1ef1c qu\u1ea3n, l\u00e0m tr\u1ebb ph\u1ea3i r\u00fat kh\u1ecfi nghi\u00ean c\u1ee9u s\u1edbm), nh\u01b0ng kh\u00f4ng li\u00ean quan t\u1edbi vaccine.<\/p>\n

6. Capeding et al (2014): th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean c\u00f3 \u0111\u1ed1i ch\u1ee9ng m\u00f9 \u0111\u01a1n pha IV. So s\u00e1nh gi\u1eefa Quinvaxem v\u00e0 m\u1ed9t c\u00e1ch ti\u00eam ch\u1ee7ng m\u1edbi h\u01a1n (1 li\u1ec1u Tritanrix HB + Hib + 2 li\u1ec1u Quinvaxem). Bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i ch\u1ee7 y\u1ebfu l\u00e0 \u0111au n\u01a1i ti\u00eam, ngo\u00e0i ra, s\u1ed1t, c\u1ee9ng v\u00e0 \u0111\u1ecf n\u01a1i ti\u00eam g\u1eb7p \u00edt h\u01a1n (kho\u1ea3ng 30% tr\u1edf xu\u1ed1ng). 2 SAE thu\u1ed9c nh\u00f3m Tritanrix: m\u1ed9t tr\u01b0\u1eddng h\u1ee3p suy h\u00f4 h\u1ea5p do vi\u00eam ph\u1ed5i, th\u1ee9 ph\u00e1t sau vi\u00eam m\u00e0ng n\u00e3o virus, kh\u1edfi ph\u00e1t 1 tu\u1ea7n sau m\u0169i Quinvaxem th\u1ee9 3, v\u00e0 m\u1ed9t tr\u01b0\u1eddng h\u1ee3p gi\u1ea3m ti\u1ec3u c\u1ea7u xu\u1ea5t hi\u1ec7n 12 ng\u00e0y sau ti\u00eam Tritanrix. T\u1ea5t c\u1ea3 SAE \u0111\u01b0\u1ee3c k\u1ebft lu\u1eadn l\u00e0 kh\u00f4ng li\u00ean quan t\u1edbi vaccine.<\/p>\n

7. B\u00e1o c\u00e1o c\u1ee7a WHO n\u0103m 2013 v\u1ec1 Quinvaxem.<\/p>\n

Nh\u01b0 v\u1eady, cho \u0111\u1ebfn hi\u1ec7n t\u1ea1i, ch\u01b0a b\u1eb1ng ch\u1ee9ng n\u00e0o ph\u1ee7 nh\u1eadn \u0111\u1ed9 an to\u00e0n c\u1ee7a Quinvaxem.<\/p>\n

SK&\u0110S<\/em>
\n khoahocvacongnghevietnam.com.vn<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

G\u1ea7n \u0111\u00e2y, tr\u00ean nhi\u1ec1u m\u1ea1ng x\u00e3 h\u1ed9i (facebook, c\u00e1c di\u1ec5n \u0111\u00e0n) v\u00e0 m\u1ed9t s\u1ed1 trang th\u00f4ng tin \u0111i\u1ec7n t\u1eed \u0111ang lan truy\u1ec1n m\u1ed9t th\u00f4ng tin kh\u00f4ng c\u00f3 th\u1eadt v\u1ec1 v\u1eafc-xin Quinvaxem \u0111\u00e3 l\u00e0m \u1ea3nh h\u01b0\u1edfng t\u1edbi uy t\u00edn c\u1ee7a ng\u00e0nh y t\u1ebf v\u00e0 g\u00e2y ra t\u00e2m l\u00fd hoang mang trong c\u1ed9ng \u0111\u1ed3ng. \u0110\u1ec3 r\u1ed9ng \u0111\u01b0\u1eddng […]<\/p>\n","protected":false},"author":17,"featured_media":5033,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[47],"tags":[],"class_list":["post-4561","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"_links":{"self":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts\/4561","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/users\/17"}],"replies":[{"embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/comments?post=4561"}],"version-history":[{"count":2,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts\/4561\/revisions"}],"predecessor-version":[{"id":5034,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/posts\/4561\/revisions\/5034"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/media\/5033"}],"wp:attachment":[{"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/media?parent=4561"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/categories?post=4561"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/casta.ttud.com.vn\/index.php\/wp-json\/wp\/v2\/tags?post=4561"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}