\u0110\u00e2y l\u00e0 ch\u1ec9 \u0111\u1ecbnh th\u1ee9 hai c\u1ee7a Trulance (plecatinide) cho d\u1ea1ng vi\u00ean n\u00e9n 3 mg. Thu\u1ed1c do h\u00e3ng Synergy Pharmaceuticals s\u1ea3n xu\u1ea5t v\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p tr\u01b0\u1edbc \u0111\u00f3 cho ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb t\u00e1o b\u00f3n m\u1ea1n t\u00ednh v\u00f4 c\u0103n \u1edf ng\u01b0\u1eddi l\u1edbn.<\/p>\n
Vi\u1ec7c c\u1ea5p ph\u00e9p cho ch\u1ec9 \u0111\u1ecbnh m\u1edbi v\u1eeba n\u00eau d\u1ef1a tr\u00ean c\u01a1 s\u1edf ch\u01b0\u01a1ng tr\u00ecnh nghi\u00ean c\u1ee9u IBS-C pha 3 bao g\u1ed3m 2 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng ng\u1eabu nhi\u00ean k\u00e9o d\u00e0i 12 tu\u1ea7n, m\u00f9 \u0111\u00f4i, \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c nh\u1eb1m \u0111\u00e1nh gi\u00e1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a Trulance \u1edf h\u01a1n 2100 b\u1ec7nh nh\u00e2n ng\u01b0\u1eddi tr\u01b0\u1edfng th\u00e0nh m\u1eafc IBS-C. Ch\u1ec9 s\u1ed1 \u0111\u1ea7u ra ch\u00ednh cho 2 th\u1eed nghi\u1ec7m n\u00e0y l\u00e0 t\u1ec9 l\u1ec7 ph\u1ea7n tr\u0103m b\u1ec7nh nh\u00e2n \u0111\u00e1p \u1ee9ng to\u00e0n th\u1ec3 v\u1edbi li\u1ec7u tr\u00ecnh \u0111i\u1ec1u tr\u1ecb 12 tu\u1ea7n (\u0111\u01b0\u1ee3c FDA \u0111\u1ecbnh ngh\u0129a l\u00e0 gi\u1ea3m \u00edt nh\u1ea5t 30% m\u1ee9c \u0111\u1ed9 \u0111au b\u1ee5ng c\u1ee7a c\u01a1n m\u1ea1nh nh\u1ea5t v\u00e0 \u00edt nh\u1ea5t 1 l\u1ea7n \u0111i ngo\u00e0i t\u1ef1 nhi\u00ean ho\u00e0n ch\u1ec9nh so v\u1edbi m\u1ee9c c\u01a1 s\u1edf \u1edf c\u00f9ng m\u1ed9t tu\u1ea7n, trong \u00edt nh\u1ea5t 50% s\u1ed1 tu\u1ea7n \u0111i\u1ec1u tr\u1ecb). K\u1ebft qu\u1ea3 cho th\u1ea5y Trulance \u0111\u00e1p \u1ee9ng ti\u00eau chu\u1ea9n \u0111\u00e1nh gi\u00e1 ch\u00ednh khi so s\u00e1nh v\u1edbi gi\u1ea3 d\u01b0\u1ee3c (Nghi\u00ean c\u1ee9u 1: 30,2%; 17,8% \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c; p<0,001. Nghi\u00ean c\u1ee9u 2: 21,5%; 14,2% \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c; p=0,009). \u1ede c\u1ea3 2 nghi\u00ean c\u1ee9u, so v\u1edbi d\u00f9ng gi\u1ea3 d\u01b0\u1ee3c, b\u1ec7nh nh\u00e2n \u1edf nh\u00f3m d\u00f9ng Trulance gi\u1ea3m \u0111\u00e1ng k\u1ec3 m\u1ee9c \u0111\u1ed9 \u0111au b\u1ee5ng v\u00e0 c\u1ea3i thi\u1ec7n v\u1ec1 s\u1ed1 l\u1ea7n \u0111i ngo\u00e0i, \u0111\u1ed9 \u0111\u1ed3ng nh\u1ea5t ph\u00e2n c\u0169ng nh\u01b0 m\u1ee9c \u0111\u1ed9 r\u1eb7n khi \u0111i ngo\u00e0i trong qu\u00e1 tr\u00ecnh \u0111i\u1ec1u tr\u1ecb 12 tu\u1ea7n. \u1ede c\u1ea3 2 nghi\u00ean c\u1ee9u, t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n hay g\u1eb7p nh\u1ea5t l\u00e0 ti\u00eau ch\u1ea3y (4,3%; 1,0% \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c), trong \u0111\u00f3 ti\u00eau ch\u1ea3y n\u1eb7ng chi\u1ebfm 1%. T\u1ec9 l\u1ec7 ng\u1eebng thu\u1ed1c \u1edf c\u1ea3 2 nh\u00f3m Trulance v\u00e0 gi\u1ea3 d\u01b0\u1ee3c \u0111\u1ec1u th\u1ea5p, l\u1ea7n l\u01b0\u1ee3t l\u00e0 2,5% v\u00e0 0,4%, v\u00e0 t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n nghi\u00eam tr\u1ecdng d\u1eabn t\u1edbi vi\u1ec7c ng\u1eebng thu\u1ed1c ph\u1ed5 bi\u1ebfn nh\u1ea5t l\u00e0 ti\u00eau ch\u1ea3y (1,2%; 0% \u1edf nh\u00f3m gi\u1ea3 d\u01b0\u1ee3c).<\/p>\n