C\u01a1 quan Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 \u0111\u00e3 ph\u00ea duy\u1ec7t thu\u1ed1c Evenity(romosozumab-aqqg) \u0111\u1ec3 \u0111i\u1ec1u tr\u1ecb b\u1ec7nh lo\u00e3ng x\u01b0\u01a1ng \u1edf ph\u1ee5 n\u1eef sau m\u00e3n kinh c\u00f3 nguy c\u01a1 g\u00e3y x\u01b0\u01a1ng cao<\/strong>. Thu\u1ed1c d\u00e0nh cho \u0111\u1ed1i t\u01b0\u1ee3ngph\u1ee5 n\u1eef c\u00f3 ti\u1ec1n s\u1eed g\u00e3y x\u01b0\u01a1ng ho\u1eb7c c\u00f3 nhi\u1ec1u y\u1ebfu t\u1ed1 nguy c\u01a1 g\u00e3y x\u01b0\u01a1ng, ho\u1eb7c nh\u1eefng ng\u01b0\u1eddi \u0111\u00e3 th\u1ea5t b\u1ea1i ho\u1eb7c kh\u00f4ng dung n\u1ea1p v\u1edbi c\u00e1c ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb lo\u00e3ng x\u01b0\u01a1ng kh\u00e1c.<\/p>\n Theo th\u1ed1ng k\u00ea s\u01a1 b\u1ed9, hi\u1ec7n nay Hoa K\u1ef3 c\u00f3 h\u01a1n 10 tri\u1ec7u ng\u01b0\u1eddi b\u1ecb lo\u00e3ng x\u01b0\u01a1ng, th\u01b0\u1eddng g\u1eb7p nh\u1ea5t \u1edf nh\u1eefng ph\u1ee5 n\u1eef sau m\u00e3n kinh. Nh\u1eefng ng\u01b0\u1eddi b\u1ecb lo\u00e3ng x\u01b0\u01a1ng c\u00f3 x\u01b0\u01a1ng y\u1ebfu d\u1ec5 b\u1ecb g\u00e3y h\u01a1n.<\/p>\n Hylton V. Joffe, M.D,M.M.Sc,Gi\u00e1m\u0111\u1ed1c Trung t\u00e2m \u0110\u00e1nh gi\u00e1 v\u00e0 Nghi\u00ean c\u1ee9u C\u00e1c s\u1ea3n ph\u1ea9m Thu\u1ed1c X\u01b0\u01a1ng kh\u1edbp,Ti\u1ebft ni\u1ec7u, Sinh s\u1ea3n (FDA) cho bi\u1ebft, l\u1ea7n ph\u00ea duy\u1ec7t n\u00e0y gi\u00fap cung c\u1ea5p th\u00eam ph\u01b0\u01a1ng ph\u00e1p \u0111i\u1ec1u tr\u1ecb m\u1edbi \u0111\u1ec3 gi\u1ea3m thi\u1ec3u nguy c\u01a1 g\u00e3y x\u01b0\u01a1ng cho ph\u1ee5 n\u1eef m\u1eafc ch\u1ee9ng lo\u00e3ng x\u01b0\u01a1ng sau m\u00e3n kinh.Tuy nhi\u00ean, Evenity c\u00f3 th\u1ec3 l\u00e0m t\u0103ng nguy c\u01a1 \u0111au tim, \u0111\u1ed9t qu\u1ef5 v\u00e0 t\u1eed vong do tim m\u1ea1ch, v\u00ec v\u1eady vi\u1ec7c lo\u1ea1i tr\u1eeb c\u00e1c b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed \u0111au tim ho\u1eb7c \u0111\u1ed9t qu\u1ecb tr\u01b0\u1edbc khi ch\u1ec9 \u0111\u1ecbnh thu\u1ed1c n\u00e0y c\u00f3 vai tr\u00f2 h\u1ebft s\u1ee9c quan tr\u1ecdng.<\/p>\n Evenity<\/strong> l\u00e0 m\u1ed9t kh\u00e1ng th\u1ec3 \u0111\u01a1n d\u00f2ng ng\u0103n ch\u1eb7n t\u00e1c d\u1ee5ng c\u1ee7a protein sclerostin v\u00e0 ho\u1ea1t \u0111\u1ed9ng ch\u1ee7 y\u1ebfu b\u1eb1ng c\u00e1ch t\u0103ng s\u1ef1 h\u00ecnh th\u00e0nh x\u01b0\u01a1ng m\u1edbi. M\u1ed9t li\u1ec1u Evenitybao g\u1ed3m hai m\u0169i ti\u00eam li\u00ean ti\u1ebfp nhau, \u0111\u01b0\u1ee3cti\u00eam m\u1ed7i th\u00e1ng m\u1ed9t l\u1ea7n. Hi\u1ec7u qu\u1ea3 t\u1ea1o x\u01b0\u01a1ng c\u1ee7a Evenity m\u1ea5t d\u1ea7n \u0111i sau 12 li\u1ec1u n\u00ean kh\u00f4ng n\u00ean s\u1eed d\u1ee5ng qu\u00e112 li\u1ec1u. N\u1ebfusau 12 li\u1ec1u b\u1ec7nh nh\u00e2n ti\u1ebfp t\u1ee5c ph\u1ea3i \u0111i\u1ec1u tr\u1ecb ti\u1ebfp lo\u00e3ng x\u01b0\u01a1ng, b\u1ec7nh nh\u00e2n n\u00ean b\u1eaft \u0111\u1ea7u s\u1eed d\u1ee5ng thu\u1ed1c gi\u1ea3m g\u00e3y x\u01b0\u01a1ng.<\/p>\n S\u1ef1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a Evenity \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh trong hai th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng bao g\u1ed3m t\u1ed5ng c\u1ed9ng h\u01a1n 11.000 ph\u1ee5 n\u1eef lo\u00e3ng x\u01b0\u01a1ng sau m\u00e3n kinh. Trong th\u1eed nghi\u1ec7m \u0111\u1ea7u ti\u00ean, m\u1ed9t n\u0103m \u0111i\u1ec1u tr\u1ecb v\u1edbi Evenity \u0111\u00e3 gi\u1ea3m 73% nguy c\u01a1 g\u00e3y \u0111\u1ed1t s\u1ed1ngso v\u1edbi gi\u1ea3 d\u01b0\u1ee3c. L\u1ee3i \u00edch n\u00e0y \u0111\u01b0\u1ee3c duy tr\u00ec trong n\u0103m th\u1ee9 hai c\u1ee7a th\u1eed nghi\u1ec7m khi Evenity \u0111\u01b0\u1ee3c ch\u1ec9 \u0111\u1ecbnh sau m\u1ed9t n\u0103ms\u1eed d\u1ee5ngdenosumab (m\u1ed9t thu\u1ed1c \u0111i\u1ec1u tr\u1ecb lo\u00e3ng x\u01b0\u01a1ng kh\u00e1c) so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng sau. Trong th\u1eed nghi\u1ec7m th\u1ee9 hai, m\u1ed9t n\u0103m \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Evenity, sau \u0111\u00f3 l\u00e0 m\u1ed9t n\u0103m \u0111i\u1ec1u tr\u1ecb alendronate (m\u1ed9t thu\u1ed1c \u0111i\u1ec1u tr\u1ecb lo\u00e3ng x\u01b0\u01a1ng kh\u00e1c) \u0111\u00e3 gi\u1ea3m 50% nguy c\u01a1 g\u00e3y x\u01b0\u01a1ng \u0111\u1ed1t s\u1ed1ng m\u1edbi so v\u1edbi hai n\u0103m ch\u1ec9 d\u00f9ng alendronate. Ph\u00e1c \u0111\u1ed3 \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p Evenity v\u00e0 alendronate c\u0169ng l\u00e0m gi\u1ea3m nguy c\u01a1 g\u00e3y x\u01b0\u01a1ng \u1edf c\u00e1c x\u01b0\u01a1ng kh\u00e1c ngo\u00e0i x\u01b0\u01a1ng \u0111\u1ed1t s\u1ed1ng so v\u1edbi alendronate \u0111\u01a1n thu\u1ea7n.<\/p>\n Evenity l\u00e0m t\u0103ng nguy c\u01a1 t\u1eed vong do tim m\u1ea1ch, \u0111au tim v\u00e0 \u0111\u1ed9t qu\u1ef5 trong th\u1eed nghi\u1ec7m alendronate, nh\u01b0ng kh\u00f4ng ph\u1ea3i trong th\u1eed nghi\u1ec7m gi\u1ea3 d\u01b0\u1ee3c. Do \u0111\u00f3,tr\u00ean nh\u00e3n thu\u1ed1c Evenity ch\u1ee9a g\u00f3c c\u1ea3nh b\u00e1o v\u1ec1 vi\u1ec7c giat\u0103ng nguy c\u01a1 \u0111au tim, \u0111\u1ed9t qu\u1ef5 v\u00e0 t\u1eed vong do tim m\u1ea1ch v\u00e0 kh\u00f4ng n\u00ean \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u1edf nh\u1eefng b\u1ec7nh nh\u00e2n c\u00f3 ti\u1ec1n s\u1eed\u0111au tim ho\u1eb7c \u0111\u1ed9t qu\u1ef5. C\u00e1c c\u00e1n b\u1ed9 y t\u1ebfc\u0169ng n\u00eanc\u00e2n nh\u1eafc gi\u1eefa l\u1ee3i \u00edch-nguy c\u01a1 c\u1ee7a Evenity \u1edf nh\u1eefng ng\u01b0\u1eddi c\u00f3 c\u00e1c y\u1ebfu t\u1ed1 nguy c\u01a1tim m\u1ea1ch kh\u00e1c v\u00e0 n\u00ean ng\u1eebng s\u1eed d\u1ee5ng Evenity \u1edf b\u1ea5t k\u1ef3 b\u1ec7nh nh\u00e2n n\u00e0o b\u1ecb \u0111au tim ho\u1eb7c \u0111\u1ed9t qu\u1ef5 trong khi \u0111i\u1ec1u tr\u1ecb.<\/p>\n T\u00e1c d\u1ee5ng ph\u1ee5 th\u01b0\u1eddng g\u1eb7p c\u1ee7a Evenity bao g\u1ed3m \u0111au kh\u1edbp v\u00e0 \u0111au \u0111\u1ea7uv\u00e0 ph\u1ea3n \u1ee9ng t\u1ea1i ch\u1ed7 ti\u00eam.<\/p>\n