C\u00e1ch \u0111\u00e2y v\u00e0i tu\u1ea7n, FDA \u0111\u00e3 th\u00f4ng b\u00e1o cho c\u00e1c c\u00e1n b\u1ed9 y t\u1ebf v\u1ec1 nguy c\u01a1 t\u0103ng t\u1ef7 l\u1ec7 t\u1eed vong khi s\u1eed d\u1ee5ng l\u00e2u d\u00e0i b\u00f3ng ph\u1ee7 thu\u1ed1c paclitaxel v\u00e0 stent ph\u1ee7 thu\u1ed1c paclitaxel (g\u1ecdi chung l\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c b\u1ecdc paclitaxel)<\/strong> \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh \u0111\u1ed9ng m\u1ea1ch ngo\u1ea1i bi\u00ean (PAD) \u1edf \u0111\u1ed9ng m\u1ea1ch ch\u00e2n, \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh trong m\u1ed9t b\u00e1o c\u00e1o ph\u00e2n t\u00edch t\u1ed5ng h\u1ee3p g\u1ea7n \u0111\u00e2y v\u1ec1 c\u00e1c th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 tr\u00ean T\u1ea1p ch\u00ed c\u1ee7a Hi\u1ec7p h\u1ed9i Tim m\u1ea1ch Hoa K\u1ef3.<\/p>\n

Hi\u1ec7n t\u1ea1i FDA \u0111\u00e3 ti\u1ebfn h\u00e0nh ph\u00e2n t\u00edch s\u01a1 b\u1ed9 d\u1eef li\u1ec7u theo d\u00f5i d\u00e0i h\u1ea1n (t\u1ed1i \u0111a n\u0103m n\u0103m trong m\u1ed9t s\u1ed1 nghi\u00ean c\u1ee9u) v\u1ec1 c\u00e1c th\u1eed nghi\u1ec7m ng\u1eabu nhi\u00ean quan tr\u1ecdng tr\u01b0\u1edbc khi l\u01b0u h\u00e0nh \u0111\u1ed1i v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ph\u1ee7 paclitaxel \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh cho PAD.<\/p>\n

Trong khi c\u00e1c ph\u00e2n t\u00edch \u0111ang di\u1ec5n ra, \u0111\u00e1nh gi\u00e1 s\u01a1 b\u1ed9 c\u1ee7a FDA v\u1ec1 d\u1eef li\u1ec7u n\u00e0y \u0111\u00e3 x\u00e1c \u0111\u1ecbnh \u0111\u01b0\u1ee3c m\u1ed9t t\u00edn hi\u1ec7u li\u00ean quan \u0111\u1ebfn t\u1ef7 l\u1ec7 t\u1eed vong \u1edf c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb d\u00e0i h\u1ea1n b\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m ph\u1ee7 paclitaxel so v\u1edbi b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb kh\u00f4ng tr\u00e1ng ph\u1ee7. Trong ba th\u1eed nghi\u1ec7m v\u1edbi d\u1eef li\u1ec7u theo d\u00f5i 5 n\u0103m, m\u1ed7i th\u1eed nghi\u1ec7m cho th\u1ea5y t\u1ef7 l\u1ec7 t\u1eed vong cao h\u01a1n \u1edf nh\u1eefng \u0111\u1ed1i t\u01b0\u1ee3ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c b\u1ecdc b\u1eb1ng paclitaxel so v\u1edbi c\u00e1c \u0111\u1ed1i t\u01b0\u1ee3ng \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng c\u00e1c thi\u1ebft b\u1ecb kh\u00f4ng tr\u00e1ng ph\u1ee7. T\u1ed5ng c\u1ed9ng, trong s\u1ed1 975 \u0111\u1ed1i t\u01b0\u1ee3ng trong 3 th\u1eed nghi\u1ec7m n\u00e0y, nguy c\u01a1 t\u1eed vong t\u0103ng kho\u1ea3ng 50% \u1edf nh\u1eefng ng\u01b0\u1eddi \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thi\u1ebft b\u1ecb \u0111\u01b0\u1ee3c b\u1ecdc b\u1eb1ng paclitaxel so v\u1edbi nh\u1eefng ng\u01b0\u1eddi \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thi\u1ebft b\u1ecb ki\u1ec3m so\u00e1t (20.1% so v\u1edbi 13.4% nguy c\u01a1 t\u1eed vong ti\u1ec1m t\u00e0ng khi \u0111i\u1ec1u tr\u1ecb trong 5 n\u0103m).<\/p>\n

Nh\u1eefng d\u1eef li\u1ec7u n\u00e0y n\u00ean \u0111\u01b0\u1ee3c x\u1eed l\u00fd m\u1ed9t c\u00e1ch th\u1eadn tr\u1ecdng v\u00ec nhi\u1ec1u l\u00fd do.<\/p>\n

– \u0110\u1ea7u ti\u00ean, c\u00f3 s\u1ef1 bi\u1ebfn thi\u00ean l\u1edbn trong \u01b0\u1edbc t\u00ednh r\u1ee7i ro t\u1eed vong do s\u1ed1 l\u01b0\u1ee3ng d\u1eef li\u1ec7u d\u00e0i h\u1ea1n c\u00f3 h\u1ea1n.<\/p>\n

– Th\u1ee9 hai, nh\u1eefng nghi\u00ean c\u1ee9u n\u00e0y ban \u0111\u1ea7u kh\u00f4ng \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf \u0111\u1ec3 g\u1ed9p chung, d\u1eabn \u0111\u1ebfn vi\u1ec7c k\u1ebft qu\u1ea3 \u0111\u01b0a ra kh\u00f4ng th\u1ef1c s\u1ef1 ch\u1eafc ch\u1eafn. Th\u1ee9 ba, nguy\u00ean nh\u00e2n v\u00e0 c\u01a1 ch\u1ebf c\u1ee5 th\u1ec3 c\u1ee7a vi\u1ec7c gia t\u0103ng t\u1ef7 l\u1ec7 t\u1eed vong v\u1eabn ch\u01b0a \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh.<\/p>\n

Bong b\u00f3ng v\u00e0 stent b\u1ecdc Paclitaxel c\u00f3 t\u00e1c d\u1ee5ng c\u1ea3i thi\u1ec7n l\u01b0u l\u01b0\u1ee3ng m\u00e1u \u0111\u1ebfn ch\u00e2n v\u00e0 gi\u1ea3m t\u1ea7n su\u1ea5t s\u1eed d\u1ee5ng c\u00e1c th\u1ee7 thu\u1eadt m\u1edf th\u00f4ng c\u00e1c m\u1ea1ch m\u00e1u b\u1ecb ch\u1eb7n. Tuy nhi\u00ean, do th\u00f4ng tin an to\u00e0n m\u1edbi n\u00e0y, FDA khuy\u1ebfn c\u00e1o s\u1eed d\u1ee5ng c\u00e1c li\u1ec7u ph\u00e1p \u0111i\u1ec1u tr\u1ecb thay th\u1ebf cho h\u1ea7u h\u1ebft b\u1ec7nh nh\u00e2n trong khi ti\u1ebfp t\u1ee5c \u0111\u00e1nh gi\u00e1 th\u00eam nguy c\u01a1 gia t\u0103ng t\u1ef7 l\u1ec7 t\u1eed vong v\u00e0 c\u00e2n nh\u1eafc gi\u1eefa l\u1ee3i \u00edch v\u00e0 nguy c\u01a1 c\u1ee7a c\u00e1c thi\u1ebft b\u1ecb n\u00e0y. FDA d\u1ef1 \u0111\u1ecbnh s\u1ebd ti\u1ebfn h\u00e0nh c\u00e1c ph\u00e2n t\u00edch b\u1ed5 sung \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh xem l\u1ee3i \u00edch c\u00f3 ti\u1ebfp t\u1ee5c v\u01b0\u1ee3t tr\u1ed9i h\u01a1n r\u1ee7i ro \u0111\u1ed1i v\u1edbi khi s\u1eed d\u1ee5ng b\u00f3ng ph\u1ee7 Paclitaxel v\u00e0 stent ph\u00f9 Paclitaxel theo \u0111\u00fang ch\u1ec9 \u0111\u1ecbnh hay kh\u00f4ng. FDA c\u0169ng s\u1ebd \u0111\u00e1nh gi\u00e1 c\u00e1c ph\u00e2n t\u00edch n\u00e0y xem vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c thi\u1ebft b\u1ecb n\u00e0y trong n\u1eefng ch\u1ec9 \u0111\u1ecbnh kh\u00e1c c\u00f3 \u1ea3nh h\u01b0\u1eddng \u0111\u1ebfn s\u1ef1 an to\u00e0n c\u1ee7a b\u1ec7nh nh\u00e2n hay kh\u00f4ng, ch\u1eb3ng h\u1ea1n nh\u01b0 \u0111i\u1ec1u tr\u1ecb h\u1eb9p van \u0111\u1ed9ng m\u1ea1ch ho\u1eb7c thi\u1ebfu m\u00e1u c\u1ee5c b\u1ed9 nguy k\u1ecbch \u1edf ch\u00e2n.<\/p>\n

V\u00ec nh\u1eefng lo ng\u1ea1i li\u00ean quan \u0111\u1ebfn v\u1ea5n \u0111\u1ec1 n\u00e0y, FDA s\u1ebd tri\u1ec7u t\u1eadp cu\u1ed9c h\u1ecdp \u1ee6y ban T\u01b0 v\u1ea5n c\u1ee7a H\u1ed9i \u0111\u1ed3ng Thi\u1ebft b\u1ecb H\u1ec7 th\u1ed1ng Tu\u1ea7n ho\u00e0n \u0111\u1ec3:<\/p>\n

– T\u1ea1o \u0111i\u1ec1u ki\u1ec7n cho m\u1ed9t cu\u1ed9c th\u1ea3o lu\u1eadn c\u00f4ng khai, minh b\u1ea1ch v\u1ec1 s\u1ef1 hi\u1ec7n di\u1ec7n v\u00e0 m\u1ee9c \u0111\u1ed9 c\u1ee7a nguy c\u01a1 t\u1eed vong d\u00e0i h\u1ea1n;<\/p>\n

– Th\u1ea3o lu\u1eadn v\u1ec1 nh\u1eefng nguy\u00ean nh\u00e2n gi\u1ea3i th\u00edch cho nguy c\u01a1 t\u1eed vong d\u00e0i h\u1ea1n bao g\u1ed3m b\u1ea5t k\u1ef3 c\u01a1 ch\u1ebf sinh h\u1ecdc ti\u1ec1m n\u0103ng n\u00e0o;<\/p>\n

– Ki\u1ec3m tra l\u1ea1i c\u00e2n b\u1eb1ng l\u1ee3i \u00edch-guy c\u01a1 c\u1ee7a nh\u00f3m thi\u1ebft b\u1ecb n\u00e0y;<\/p>\n

– Xem x\u00e9t s\u1eeda \u0111\u1ed5i c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng t\u1ea1i Hoa K\u1ef3 trong th\u1eddi gian t\u1edbi \u0111\u1ec3 \u0111\u00e1nh gi\u00e1 c\u00e1c thi\u1ebft b\u1ecb c\u00f3 ch\u1ee9a paclitaxel, bao g\u1ed3m gi\u00e1m s\u00e1t b\u1ed5 sung, th\u00f4ng tin c\u1eadp nh\u1eadt v\u00e0 ph\u00e1n quy\u1ebft m\u1edf r\u1ed9ng \u0111\u1ed1i v\u1edbi c\u00e1c t\u00e1c d\u1ee5ng ph\u1ee5 v\u00e0 nguy c\u01a1 t\u1eed vong li\u00ean quan \u0111\u1ebfn thu\u1ed1c.<\/p>\n

– H\u01b0\u1edbng d\u1eabn c\u00e1c h\u00e0nh \u0111\u1ed9ng ph\u00e1p l\u00fd kh\u00e1c, khi c\u1ea7n thi\u1ebft.<\/p>\n

Th\u00f4ng tin chi ti\u1ebft li\u00ean quan \u0111\u1ebfn th\u1eddi gian v\u00e0 \u0111\u1ecba \u0111i\u1ec3m c\u1ee7a cu\u1ed9c h\u1ecdp \u1ee6y ban T\u01b0 v\u1ea5n s\u1ebd \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 trong v\u00e0i tu\u1ea7n t\u1edbi.<\/p>\n

KHUY\u1ebeN C\u00c1O C\u1ee6A FDA<\/p>\n

D\u1ef1a tr\u00ean \u0111\u00e1nh gi\u00e1 s\u01a1 b\u1ed9 c\u1ee7a FDA v\u1ec1 d\u1eef li\u1ec7u hi\u1ec7n c\u00f3, c\u00e1n b\u1ed9 y t\u1ebf c\u1ea7n:<\/p>\n

– Ti\u1ebfp t\u1ee5c theo d\u00f5i th\u01b0\u1eddng tr\u1ef1c nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng b\u00f3ng b\u1ecdc thu\u1ed1c paclitaxel v\u00e0 stent b\u1ecdc thu\u1ed1c paclitaxel.<\/p>\n

– Khi \u0111\u01b0a ra khuy\u1ebfn c\u00e1o \u0111i\u1ec1u tr\u1ecb ,c\u1ea7n xem x\u00e9t v\u1ec1 nguy c\u01a1 gia t\u0103ng t\u1ef7 l\u1ec7 t\u1eed vong \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb l\u00e2u d\u00e0i b\u1eb1ng b\u00f3ng b\u1ecdc paclitaxel v\u00e0 stent b\u1ecdc paclitaxel.<\/p>\n

– Th\u1ea3o lu\u1eadn v\u1ec1 c\u00e1c r\u1ee7i ro v\u00e0 l\u1ee3i \u00edch c\u1ee7a t\u1ea5t c\u1ea3 c\u00e1c ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb PAD c\u00f3 s\u1eb5n v\u1edbi b\u1ec7nh nh\u00e2n. \u0110\u1ed1i v\u1edbi h\u1ea7u h\u1ebft b\u1ec7nh nh\u00e2n, c\u00e1c l\u1ef1a ch\u1ecdn \u0111i\u1ec1u tr\u1ecb thay th\u1ebf cho b\u00f3ng b\u1ecdc paclitaxel v\u00e0 stent b\u1ecdc paclitaxel \u0111\u01b0\u1ee3c khuy\u1ebfn c\u00e1o s\u1eed d\u1ee5ng cho \u0111\u1ebfn khi ph\u00e2n t\u00edch b\u1ed5 sung t\u00edn hi\u1ec7u an to\u00e0n \u0111\u00e3 \u0111\u01b0\u1ee3c ho\u00e0n thi\u1ec7n.<\/p>\n

– \u0110\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 b\u1ec7nh nh\u00e2n c\u00f3 nguy c\u01a1 b\u1ecb h\u1ea1n ch\u1ebf \u0111\u1eb7c bi\u1ec7t cao, c\u00e1c b\u00e1c s\u0129 c\u1ea7n xem x\u00e9t v\u1ec1 l\u1ee3i \u00edch c\u1ee7a vi\u1ec7c s\u1eed d\u1ee5ng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c b\u1ecdc b\u1eb1ng paclitaxel c\u00f3 th\u1ec3 v\u01b0\u1ee3t tr\u1ed9i h\u01a1n c\u00e1c r\u1ee7i ro.<\/p>\n

– \u0110\u1ea3m b\u1ea3o b\u1ec7nh nh\u00e2n \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb PAD v\u00e0 c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1 tim m\u1ea1ch kh\u00e1c theo c\u00e1c ph\u01b0\u01a1ng ph\u00e1p t\u1ed1i \u01b0u, c\u0169ng nh\u01b0 h\u01b0\u1edbng d\u1eabn v\u1ec1 l\u1ed1i s\u1ed1ng l\u00e0nh m\u1ea1nh bao g\u1ed3m ki\u1ec3m so\u00e1t c\u00e2n n\u1eb7ng, cai thu\u1ed1c l\u00e1 v\u00e0 t\u1eadp th\u1ec3 d\u1ee5c.<\/p>\n

Ngu\u1ed3n: https:\/\/www.fda.gov\/MedicalDevices\/Safety\/LetterstoHealthCareProviders\/ucm633614.htm<\/a><\/p>\n

Ng\u01b0\u1eddi t\u1ed5ng h\u1ee3p: \u0110\u1ed7 Thu Thanh – Nguy\u1ec5n Ph\u01b0\u01a1ng Th\u00fay<\/p>\n<\/div>\n

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