Thông tin sản phẩm
- Ho\u1ea1t ch\u1ea5t: M\u1ed7i viên ch\u1ee9a 20mg rosuvastatin d\u01b0\u1edbi d\u1ea1ng rosuvastatin canxi.
\n- Tá d\u01b0\u1ee3c:
\nThành ph\u1ea7n nhân viên thu\u1ed1c: Lactose monohydrat, cellulose vi tinh th\u1ec3, calci phosphat, crospovidon, magnesi stearat.
\nThành ph\u1ea7n bao viên: Lactose monohydrat, hypromellose, glycerol triacetat, titan dioxyd (E171), oxyd s\u1eaft \u0111\u1ecf (E172).
", "index": 1}, {"title": "C\u00f4ng d\u1ee5ng", "content": "D\u01af\u1ee2C L\u1ef0C H\u1eccC
\nCrestor lam gi\u1ea3m s\u1ef1 t\u0103ng n\u1ed3ng \u0111\u1ed9 LDL - cholesterol, cholesterol toàn phàn và triglyceride và làm t\u0103ng HDL - cholesterol. Thu\u1ed1c c\u0169ng làm gi\u1ea3m ApoB, non HDL-C, VLDL-C, VLDL-TG và làm t\u0103ng ApoA-I (xem b\u1ea3ng 1 và 2). Crestor c\u0169ng làm gi\u1ea3m các t\u1ef7 l\u1ec7 LDL-C/HDL-C, C toàn phan/HDL-C, non HDL-C/HDL-C và ApoB/ApoA-I.
\nB\u1ea3ng 2. \u0110áp \u1ee9ng theo li\u1ec1u \u1edf b\u1ec7nh nhân t\u0103ng cholesterol máu nguyên phát (Lo\u1ea1i IIa và IIb) (m\u1ee9c thay \u0111\u1ed5i trung bình (%) so v\u1edbi tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb)
\n| \n Li\u1ec1u \n | \n\n S\u1ed1 b\u1ec7nh | \n\n LDL-C \n | \n\n C toàn \nPh\u1ea7n \n | \n\n HDL-C \n | \n\n TG \n | \n\n NonHDL-C \n | \n\n ApoB \n | \n\n ApoA-l \n | \n
| \n Gi\u1ea3 \nd\u01b0\u1ee3c \n | \n\n 13 \n | \n\n -7 \n | \n\n -5 \n | \n\n 3 \n | \n\n -3 \n | \n\n -7 \n | \n\n -3 \n | \n\n 0 \n | \n
| \n 5 \n | \n\n 17 \n | \n\n -45 \n | \n\n -33 \n | \n\n 13 \n | \n\n -35 \n | \n\n -44 \n | \n\n -38 \n | \n\n 4 \n | \n
| \n 10 \n | \n\n 17 \n | \n\n -52 \n | \n\n -36 \n | \n\n 14 \n | \n\n -10 \n | \n\n -48 \n | \n\n -42 \n | \n\n 4 \n | \n
| \n 20 \n | \n\n 17 \n | \n\n -55 \n | \n\n -40 \n | \n\n 8 \n | \n\n -23 \n | \n\n -51 \n | \n\n -46 \n | \n\n 5 \n | \n
| \n 40 \n | \n\n 18 \n | \n\n -63 \n | \n\n -46 \n | \n\n 10 \n | \n\n -28 \n | \n\n -60 \n | \n\n -54 \n | \n\n 0 \n | \n
B\u1ea3ng 3. \u0110áp \u1ee9ng theo li\u1ec1u \u1edf b\u1ec7nh nhân b\u1ecb t\u0103ng triglycerid (Týp IIb ho\u1eb7c týp IV)
(% thay \u0111\u1ed5i bình quân so v\u1edbi ban \u0111\u1ea7u)
| \n Li\u1ec1u \n | \n\n N \n | \n\n TG \n | \n\n LDL-C \n | \n\n C-Toàn ph\u1ea7n \n | \n\n HDL-C \n | \n\n NonHDL-C \n | \n\n VLDL-C VLDL-TG \n | \n|
| \n Gi\u1ea3 \nd\u01b0\u1ee3c \n | \n\n 26 \n | \n\n 1 \n | \n\n 5 \n | \n\n 1 \n | \n\n -3 \n | \n\n 2 \n | \n\n 2 \n | \n\n 6 \n | \n
| \n 5 \n | \n\n 25 \n | \n\n -21 \n | \n\n -28 \n | \n\n -24 \n | \n\n 3 \n | \n\n -29 \n | \n\n -25 \n | \n\n -24 \n | \n
| \n 10 \n | \n\n 23 \n | \n\n -37 \n | \n\n -45 \n | \n\n -40 \n | \n\n 8 \n | \n\n -49 \n | \n\n -48 \n | \n\n -39 \n | \n
| \n 20 \n | \n\n 27 \n | \n\n -37 \n | \n\n -31 \n | \n\n -34 \n | \n\n 22 \n | \n\n -43 \n | \n\n -49 \n | \n\n -40 \n | \n
| \n 40 \n | \n\n 25 \n | \n\n -43 \n | \n\n -43 \n | \n\n -40 \n | \n\n 17 \n | \n\n -51 \n | \n\n -56 \n | \n\n -48 \n | \n
Hi\u1ec7u qu\u1ea3 tr\u1ecb li\u1ec7u \u0111\u1ea1t \u0111\u01b0\u1ee3c trong vòng 1 tu\u1ea7n sau khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb và 90% \u0111áp \u1ee9ng t\u1ed1i \u01b0u \u0111\u1ea1t \u0111\u01b0\u1ee3c trong 2 tu\u1ea7n. \u0110áp \u1ee9ng t\u1ed1i \u01b0u th\u01b0\u1eddng \u0111\u1ea1t \u0111\u01b0\u1ee3c vào kho\u1ea3ng 4 tu\u1ea7n và \u0111\u01b0\u1ee3c duy trì sau \u0111ó.
\nHi\u1ec7u qu\u1ea3 lâm sàng
\nCrestor \u0111\u01b0\u1ee3c ch\u1ee9ng minh có hi\u1ec7u qu\u1ea3 \u1edf nhóm b\u1ec7nh nhân ng\u01b0\u1eddi l\u1edbn t\u0103ng cholesterol máu, có hay không có t\u0103ng triglycerid máu, b\u1ea5t k\u1ef3 ch\u1ee7ng t\u1ed9c, gi\u1edbi tính hay tu\u1ed5i tác và \u1edf nh\u1eefng nhóm b\u1ec7nh nhân \u0111\u1eb7c bi\u1ec7t nh\u01b0 \u0111ái tháo \u0111\u01b0\u1eddng ho\u1eb7c b\u1ec7nh nhân t\u0103ng cholesterol máu gia \u0111ình.
\nT\u1eeb các d\u1eef li\u1ec7u nghiên c\u1ee9u pha III, Crestor ch\u1ee9ng t\u1ecf có hi\u1ec7u qu\u1ea3 trong \u0111i\u1ec1u tr\u1ecb \u1edf h\u1ea7u h\u1ebft các b\u1ec7nh nhân t\u0103ng cholesterol máu lo\u1ea1i IIa và IIb (LDL-C trung bình tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb kho\u1ea3ng 4.8mmol/l) theo các m\u1ee5c tiêu \u0111i\u1ec1u tr\u1ecb c\u1ee7a H\u1ed9i X\u01a1 V\u1eefa M\u1ea1ch Máu Châu Âu (European Atherosclerosis Society- EAS, 1998); kho\u1ea3ng 80% b\u1ec7nh nhân \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Crestor 10mg \u0111ã \u0111\u1ea1t \u0111\u01b0\u1ee3c các m\u1ee5c tiêu \u0111i\u1ec1u tr\u1ecb c\u1ee7a EAS v\u1ec1 n\u1ed3ng \u0111\u1ed9 LDL-C ( < 3mmol/l).
\nTrong 1 nghiên c\u1ee9u l\u1edbn, 435 b\u1ec7nh nhân t\u0103ng cholesterol máu di truy\u1ec1n gia \u0111ình ki\u1ec3u d\u1ecb h\u1ee3p t\u1eed \u0111ã \u0111\u01b0\u1ee3c cho dùng Crestor t\u1eeb 20 - 80mg theo thi\u1ebft k\u1ebf \u0111i\u1ec1u ch\u1ec9nh t\u0103ng li\u1ec1u. Ng\u01b0\u1eddi ta th\u1ea5y là t\u1ea5t c\u1ea3 các li\u1ec1u Crestor \u0111\u1ec1u có tác \u0111\u1ed9ng có l\u1ee3i trên các thông s\u1ed1 lipid và \u0111\u1ea1t \u0111\u01b0\u1ee3c các m\u1ee5c tiêu \u0111i\u1ec1u tr\u1ecb. Sau khi ch\u1ec9nh \u0111\u1ebfn li\u1ec1u h\u1eb1ng ngày 40mg (12 tu\u1ea7n \u0111i\u1ec1u tr\u1ecb), LDL-C gi\u1ea3m 53%. 33% b\u1ec7nh nhân \u0111\u1ea1t \u0111\u01b0\u1ee3c các m\u1ee5c tiêu c\u1ee7a EAS v\u1ec1 n\u1ed3ng \u0111\u1ed9 LDL-C ( < 3mmol/l).
\nTrong m\u1ed9t nghiên c\u1ee9u m\u1edf, \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u t\u0103ng d\u1ea7n, 42 b\u1ec7nh nhân t\u0103ng cholesterol máu di truy\u1ec1n ki\u1ec3u \u0111\u1ed3ng h\u1ee3p t\u1eed \u0111\u01b0\u1ee3c \u0111ánh giá v\u1ec1 \u0111áp \u1ee9ng \u0111i\u1ec1u tr\u1ecb v\u1edbi li\u1ec1u Crestor 20 - 40mg. T\u1ea5t c\u1ea3 b\u1ec7nh nhân nghiên c\u1ee9u \u0111\u1ec1u có \u0111\u1ed9 gi\u1ea3m trung bình LDL-C là 22%.
\nTrong các nghiên c\u1ee9u lâm sàng v\u1edbi m\u1ed9t s\u1ed1 l\u01b0\u1ee3ng b\u1ec7nh nhân nh\u1ea5t \u0111\u1ecbnh, Crestor ch\u1ee9ng t\u1ecf có hi\u1ec7u qu\u1ea3 ph\u1ee5 tr\u1ee3 trong vi\u1ec7c làm gi\u1ea3m triglyceride khi \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p v\u1edbi fenofibrate và làm t\u0103ng n\u1ed3ng \u0111\u1ed9 HDL-C khi s\u1eed d\u1ee5ng ph\u1ed1i h\u1ee3p v\u1edbi niacin (xem L\u01b0u Ý và Th\u1eadn Tr\u1ecdng Khi S\u1eed D\u1ee5ng).
\nRosuvastatin ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ee9ng minh là có th\u1ec3 ng\u0103n ch\u1eb7n các bi\u1ebfn ch\u1ee9ng có liên quan \u0111\u1ebfn s\u1ef1 b\u1ea5t th\u01b0\u1eddng v\u1ec1 lipid nh\u01b0 b\u1ec7nh m\u1ea1ch vành vì các nghiên c\u1ee9u v\u1ec1 gi\u1ea3m t\u1ef7 l\u1ec7 t\u1eed vong và gi\u1ea3m t\u1ef7 l\u1ec7 b\u1ec7nh lý khi dùng Crestor \u0111ang \u0111\u01b0\u1ee3c th\u1ef1c hi\u1ec7n.
\n\u0110ánh giá tác d\u1ee5ng trên \u0111\u1ed9 dày l\u1edbp n\u1ed9i trung m\u1ea1c: nghiên c\u1ee9u \u0111ánh giá rosuvastatin 40mg (METEOR), hi\u1ec7u qu\u1ea3 \u0111i\u1ec1u tr\u1ecb c\u1ee7a Crestor trên x\u01a1 v\u1eefa \u0111\u1ed9ng m\u1ea1ch c\u1ea3nh \u0111\u01b0\u1ee3c \u0111ánh giá b\u1eb1ng siêu âm 2 chi\u1ec1u (B-mode) \u1edf nh\u1eefng b\u1ec7nh nhân b\u1ecb t\u0103ng LDL-C, có nguy c\u01a1 b\u1ec7nh \u0111\u1ed9ng m\u1ea1ch vành th\u1ea5p (thang \u0111i\u1ec3m nguy c\u01a1 Framingham < 10% trong 10 n\u0103m) và x\u01a1 v\u1eefa \u0111\u1ed9ng m\u1ea1ch d\u01b0\u1edbi lâm sàng có dày l\u1edbp n\u1ed9i trung m\u1ea1c \u0111\u1ed9ng m\u1ea1ch c\u1ea3nh (cIMT).
Trong nghiên c\u1ee9u lâm sàng mù \u0111ôi, \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, 984 b\u1ec7nh nhân \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb ng\u1eabu nhiên (trong \u0111ó có 876 ng\u01b0\u1eddi \u0111ã \u0111\u01b0\u1ee3c phân tích), b\u1eb1ng Crestor 40mg ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c 1 l\u1ea7n/ngày v\u1edbi t\u1ec9 l\u1ec7 là 5 : 2. Siêu âm thành \u0111\u1ed9ng m\u1ea1ch c\u1ea3nh \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u0111\u1ec3 xác \u0111\u1ecbnh t\u1ec9 l\u1ec7 thay \u0111\u1ed5i trung bình l\u1edbp n\u1ed9i trung m\u1ea1c dày nh\u1ea5t hàng n\u0103m \u1edf 12 \u0111i\u1ec3m \u0111o trên m\u1ed7i b\u1ec7nh nhân so v\u1edbi ban \u0111\u1ea7u trong 2 n\u0103m. S\u1ef1 khác bi\u1ec7t v\u1ec1 t\u1ec9 l\u1ec7 thay \u0111\u1ed5i l\u1edbp n\u1ed9i trung m\u1ea1c dày nh\u1ea5t c\u1ee7a t\u1ea5t c\u1ea3 12 v\u1ecb trí \u0111\u1ed9ng m\u1ea1ch c\u1ea3nh gi\u1eefa b\u1ec7nh nhân \u0111i\u1ec1u tr\u1ecb b\u1eb1ng Crestor và b\u1ec7nh nhân dùng gi\u1ea3 d\u01b0\u1ee3c là – 0.0145 mm/n\u0103m (95% Cl -0.0196, -0.0093; p < 0.0001). T\u1ec9 l\u1ec7 thay \u0111\u1ed5i hàng n\u0103m so v\u1edbi tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb c\u1ee7a nhóm dùng gi\u1ea3 d\u01b0\u1ee3c là + 0.0131mm/n\u0103m (p < 0,0001). T\u1ef7 l\u1ec7 thay \u0111\u1ed5i h\u1ea9ng n\u0103m so v\u1edbi tr\u01b0\u1edbc khi \u0111i\u1ec1u tr\u1ecb \u1edf nhom CRESTOR là -0,0014 mm/n\u0103m (p = 0.32).
\u1ede t\u1eebng b\u1ec7nh nhân trong nhóm dùng Crestor, 52.1% b\u1ec7nh nhân ch\u1ee9ng t\u1ecf không có s\u1ef1 ti\u1ebfn tri\u1ec3n b\u1ec7nh (\u0111\u01b0\u1ee3c \u0111\u1ecbnh ngh\u0129a là t\u1ec9 l\u1ec7 thay \u0111\u1ed5i có giá tr\u1ecb âm hàng n\u0103m), so v\u1edbi 37.7% b\u1ec7nh nhân \u1edf nhóm dùng gi\u1ea3 d\u01b0\u1ee3c.
\nR\u1ed1i lo\u1ea1n beta lipoprotein máu nguyên phát (t\u0103ng lipoprotein máu týp III)
\nTrong nghiên c\u1ee9u chéo, mù \u0111ôi, \u0111a trung tâm, ng\u1eabu nhiên, có 32 b\u1ec7nh nhân (27 ng\u01b0\u1eddi có \u0111\u1ed9t bi\u1ebfn ε2/ ε2 và 4 ng\u01b0\u1eddi có \u0111\u1ed9t bi\u1ebfn apo E [Arg145Cys] b\u1ecb r\u1ed1i lo\u1ea1n bêta lipoprotein máu nguyên phát (t\u0103ng lipoprotein máu typ III) tham gia \u0111\u01b0\u1ee3c kh\u1edfi \u0111\u1ea7u b\u1eb1ng ch\u1ebf \u0111\u1ed9 \u0103n kiêng trong 6 tu\u1ea7n theo \u0110i\u1ec1u tr\u1ecb thay \u0111\u1ed5i l\u1ed1i s\u1ed1ng (TLC) c\u1ee7a NCEP.
\nSau giai \u0111o\u1ea1n 6 tu\u1ea7n \u0103n kiêng, b\u1ec7nh nhân \u0111\u01b0\u1ee3c ng\u1eabu nhiên \u0111i\u1ec1u tr\u1ecb ph\u1ed1i h\u1ee3p v\u1edbi ch\u1ebf \u0111\u1ed9 \u0103n kiêng trong 6 tu\u1ea7n b\u1eb1ng li\u1ec7u pháp rosuvastatin 10mg ti\u1ebfp theo là rosuvastatin 20mg, ho\u1eb7c rosuvastatin 20mg ti\u1ebfp theo là rosuvastatin 10mg. CRESTOR làm gi\u1ea3m cholesterol không ph\u1ea3i HDL (thông s\u1ed1 nghiên c\u1ee9u chính) và n\u1ed3ng \u0111\u1ed9 lipoprotein còn l\u1ea1i trong tu\u1ea7n hoàn. K\u1ebft qu\u1ea3 \u0111\u01b0\u1ee3c trình bày trong b\u1ea3ng bên d\u01b0\u1edbi.
\nB\u1ea3ng 4. Các tác \u0111\u1ed9ng thay \u0111\u1ed5i lipid máu c\u1ee7a rosuvastatin 10mg và 20mg trong b\u1ec7nh r\u1ed1i lo\u1ea1n beta lipoprotein máu nguyên phát (t\u0103ng lipoprotein máu týp III) sau 6 tu\u1ea7n \u0111i\u1ec1u tr\u1ecb \u0111\u01b0\u1ee3c th\u1ec3 hi\u1ec7n b\u1eb1ng trung v\u1ecb ph\u1ea7n tr\u0103m thay \u0111\u1ed5i (95% Cl) so v\u1edbi giá tr\u1ecb ban \u0111\u1ea7u (N = 32)
\n| \n | \n Giá tr\u1ecb trung v\u1ecb | \n\n Trung v\u1ecb ph\u1ea7n tr\u0103m | \n\n Trung v\u1ecb ph\u1ea7n tr\u0103m | \n
| \n Cholesterol toàn ph\u1ea7n \n | \n\n 342.5 \n | \n\n -43 3 \n(-46.9.-37.5) \n | \n\n -47.6 \n(-51.6.-42.8) \n | \n
| \n Triglycerides \n | \n\n 503.5 \n | \n\n -40.1 \n(-44.9; -33.6) \n | \n\n -43.0 \n(-52.5; -33.1) \n | \n
| \n Non-HDL-C \n | \n\n 294.5 \n | \n\n -48.2 \n(-56.7; -45.6) \n | \n\n -56.4 \n(-61.4; -48.5) \n | \n
| \n VLDL-C + IDL-C \n | \n\n 209.5 \n | \n\n -46.8 \n(-53.7; -39.4) \n | \n\n -56.2 \n(-67.7; -43.7) \n | \n
| \n LDL-C \n | \n\n 112.5 \n | \n\n -54.4 \n(-59.1; -47.3) \n | \n\n -57.3 \n(-59.4; -52.1) \n | \n
| \n HDL-C \n | \n\n 35.5 \n | \n\n 10.2 \n(1.9; 12.3) \n | \n\n 11.2 \n(8.3; 20.5) \n | \n
| \n RLP-C \n | \n\n 82.0 \n | \n\n 4 \n(-67J; -49.0) \n | \n\n -64 9 \n(-74.0; -56.6) \n | \n
| \n Apo-E \n | \n\n 16.0 \n | \n\n -42.9 \n(-46.3; -33.3) \n | \n\n -42.5 \n(-47.1; -35.6) \n | \n
B\u1ec7nh nhi t\u0103ng cholesterol máu gia \u0111ình ki\u1ec3u d\u1ecb h\u1ee3p t\u1eed
\nTrong 1 nghiên c\u1ee9u 12 tu\u1ea7n, \u0111\u1ed1i ch\u1ee9ng v\u1edbi gi\u1ea3 d\u01b0\u1ee3c, \u0111a trung tâm, ng\u1eabu nhiên, mù \u0111ôi, 176 b\u1ec7nh nhi và thi\u1ebfu niên (97 nam và 79 n\u1eef) b\u1ecb t\u0103ng cholesterol máu gia \u0111ình ki\u1ec3u d\u1ecb h\u1ee3p t\u1eed \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb ng\u1eabu nhiên b\u1eb1ng rosuvastatin 5mg, 10mg, 20mg ho\u1eb7c gi\u1ea3 d\u01b0\u1ee3c h\u1eb1ng ngày. Các b\u1ec7nh nhân có \u0111\u1ed9 tu\u1ed5i t\u1eeb 10 \u0111\u1ebfn 17 tu\u1ed5i (tu\u1ed5i trung v\u1ecb là 14 tu\u1ed5i) v\u1edbi kho\u1ea3ng 30% b\u1ec7nh nhân t\u1eeb 10 \u0111\u1ebfn 13 tu\u1ed5i và kho\u1ea3ng 17%, 18%, 40%, 25% b\u1ec7nh nhân d\u1eady thì t\u01b0\u01a1ng \u1ee9ng theo phân lo\u1ea1i Tanner \u0111\u1ed9 II, III, IV và V. Các b\u1ec7nh nhi n\u1eef ph\u1ea3i có kinh nguy\u1ec7t ít nh\u1ea5t 1 n\u0103m. M\u1ee9c LDL-C trung bình t\u1ea1i th\u1eddi \u0111i\u1ec3m ban \u0111\u1ea7u là 233 mg/dL (trong kho\u1ea3ng 129 \u0111\u1ebfn 399mg/dL). Ti\u1ebfp theo sau nghiên c\u1ee9u mù \u0111ôi 12 tu\u1ea7n là 1 pha \u0111i\u1ec1u ch\u1ec9nh li\u1ec1u nhãn m\u1edf 40 tu\u1ea7n, trong \u0111ó các b\u1ec7nh nhân \u0111\u01b0\u1ee3c dùng rosuvastatin h\u1eb1ng ngày v\u1edbi li\u1ec1u 5mg, 10mg, 20mg.
\nRosuvastatin làm gi\u1ea3m \u0111áng k\u1ec3 LDL-C (thông s\u1ed1 nghiên c\u1ee9u chính), cholesterol toàn ph\u1ea7n và n\u1ed3ng \u0111\u1ed9 apoB \u1edf m\u1ecdi m\u1ee9c li\u1ec1u khi so v\u1edbi nhóm gi\u1ea3 d\u01b0\u1ee3c. K\u1ebft qu\u1ea3 \u0111\u01b0\u1ee3c trình bày \u1edf b\u1ea3ng 5 bên d\u01b0\u1edbi.
\nB\u1ea3ng 5. Tác \u0111\u1ed9ng thay \u0111\u1ed5i lipid c\u1ee7a rosuvastatin \u1edf nh\u1eefng b\u1ec7nh nhi t\u1eeb 10 \u0111\u1ebfn 17 tu\u1ed5i b\u1ecb t\u0103ng cholesterol máu gia \u0111ình ki\u1ec3u d\u1ecb h\u1ee3p t\u1eed (bình ph\u01b0\u01a1ng nh\u1ecf nh\u1ea5t c\u1ee7a trung bình % thay \u0111\u1ed5i gi\u1eefa giá tr\u1ecb ban \u0111\u1ea7u và giá tr\u1ecb \u1edf tu\u1ea7n 12).
\n| \n Li\u1ec1u (mg) \n | \n\n N \n | \n\n LDL-C \n | \n\n HDL-C \n | \n\n C-toàn ph\u1ea7n \n | \n\n TGa \n | \n\n ApoB \n | \n
| \n Gi\u1ea3 d\u01b0\u1ee3c \n | \n\n 46 \n | \n\n -1% \n | \n\n +7% \n | \n\n 0% \n | \n\n -7% \n | \n\n -2% \n | \n
| \n 5 \n | \n\n 42 \n | \n\n -38% \n | \n\n +4%b \n | \n\n -30% \n | \n\n -13% b \n | \n\n -32% \n | \n
| \n 10 \n | \n\n 44 \n | \n\n -45 \n | \n\n +11%b \n | \n\n -34% \n | \n\n -15%b \n | \n\n -38% \n | \n
| \n 20 \n | \n\n 44 \n | \n\n -50% \n | \n\n +9%b \n | \n\n -39% \n | \n\n -16% b \n | \n\n -41% \n | \n
a % thay \u0111\u1ed5i trung v\u1ecb
\nb S\u1ef1 khác bi\u1ec7t so v\u1edbi gi\u1ea3 d\u01b0\u1ee3c không có ý ngh\u0129a v\u1ec1 m\u1eb7t th\u1ed1ng kê
\n\u1ede tu\u1ea7n th\u1ee9 12 c\u1ee7a giai \u0111o\u1ea1n \u0111i\u1ec1u tr\u1ecb mù \u0111ôi, t\u1ec9 l\u1ec7 % b\u1ec7nh nhân \u0111\u1ea1t \u0111\u01b0\u1ee3c LDL-C m\u1ee5c tiêu < 110mg/dL (2.8mmol/l) là 0% \u1edf nhóm gi\u1ea3 d\u01b0\u1ee3c, 12% \u1edf nhóm dung rosuvastatin 5mg, 41% \u1edf nhóm dùng rosuvastatin 10mg, 41% \u1edf nhóm dùng rosuvastatin 20mg. Trong giai \u0111o\u1ea1n nghiên c\u1ee9u 40 tu\u1ea7n, nhãn m\u1edf, 71% b\u1ec7nh nhân \u0111\u01b0\u1ee3c \u0111i\u1ec1u ch\u1ec9nh \u0111\u1ebfn li\u1ec1u cao nh\u1ea5t 20mg và 41% b\u1ec7nh nhân \u0111\u1ea1t \u0111\u01b0\u1ee3c LDL-C m\u1ee5c tiêu là 110mg/dL.
\nHi\u1ec7u qu\u1ea3 dài h\u1ea1n c\u1ee7a rosuvastatin khi b\u1eaft \u0111\u1ea7u \u0111i\u1ec1u tr\u1ecb t\u1eeb tu\u1ed5i thi\u1ebfu niên \u0111\u1ec3 làm gi\u1ea3m t\u1ec9 l\u1ec7 b\u1ec7nh và t\u1ec9 l\u1ec7 t\u1eed vong lúc tr\u01b0\u1edfng thành ch\u01b0a \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp.
\nPhòng ng\u1eeba b\u1ec7nh tim m\u1ea1ch nguyên phát
\nTh\u1eed nghi\u1ec7m lâm sàng can thi\u1ec7p \u0111ánh giá rosuvastatin trong phòng ng\u1eeba tiên phát (nghiên c\u1ee9u JUPITER), hi\u1ec7u qu\u1ea3 c\u1ee7a CRESTOR (rosuvastatin calcium) trên t\u1ea7n xu\u1ea5t các bi\u1ebfn c\u1ed1 tim m\u1ea1ch l\u1edbn \u0111\u01b0\u1ee3c \u0111ánh giá trên 17,802 nam (> 50 tu\u1ed5i) và n\u1eef (> 60 tu\u1ed5i) là nh\u1eefng ng\u01b0\u1eddi ch\u01b0a có b\u1eb1ng ch\u1ee9ng lâm sàng v\u1ec1 b\u1ec7nh tim m\u1ea1ch, n\u1ed3ng \u0111\u1ed9 LDL-C < 130 mg/dL (3.3mmol/l) và n\u1ed3ng \u0111\u1ed9 hs-CRP > 2mg/l. Khi b\u1eaft \u0111\u1ea7u nghiên c\u1ee9u, qu\u1ea7n th\u1ec3 nghiên c\u1ee9u có nguy c\u01a1 b\u1ec7nh m\u1ea1ch vành \u01b0\u1edbc l\u01b0\u1ee3ng là 11.6% trong 10 n\u0103m d\u1ef1a trên tiêu chu\u1ea9n thang \u0111i\u1ec3m nguy c\u01a1 Framingham và bao g\u1ed3m t\u1ef7 l\u1ec7 cao các b\u1ec7nh nhân có các y\u1ebfu t\u1ed1 nguy c\u01a1 khác nh\u01b0 t\u0103ng huy\u1ebft áp (58%), HDL-C th\u1ea5p (23%), hút thu\u1ed1c (16%) ho\u1eb7c có ti\u1ec1n s\u1eed gia \u0111ình m\u1eafc b\u1ec7nh m\u1ea1ch vành s\u1edbm (12%). Các \u0111\u1ed1i t\u01b0\u1ee3ng tham gia nghiên c\u1ee9u có giá tr\u1ecb ban \u0111\u1ea7u LDL-C trung v\u1ecb là 108mg/dL và hsCRP là 4.3mg/L. Các b\u1ec7nh nhân tham gia \u0111\u01b0\u1ee3c dùng ng\u1eabu nhiên gi\u1ea3 d\u01b0\u1ee3c (n = 8901) ho\u1eb7c rosuvastatin 20mg 1 l\u1ea7n/ngày (n = 8901) và \u0111\u01b0\u1ee3c theo dõi trong th\u1eddi gian trung bình 2 n\u0103m. Nghiên c\u1ee9u JUPITER ph\u1ea3i ng\u01b0ng s\u1edbm theo nh\u1eefng quy t\u1eafc xác \u0111\u1ecbnh tr\u01b0\u1edbc v\u1ec1 ng\u01b0ng nghiên c\u1ee9u c\u1ee7a \u1ee7y ban \u0111\u1ed9c l\u1eadp theo dõi tính an toàn d\u1eef li\u1ec7u (Data Safety Monitoring Broad) khi \u0111ánh giá hi\u1ec7u qu\u1ea3 trên b\u1ec7nh nhân dùng rosuvastatin.
\nThông s\u1ed1 nghiên c\u1ee9u chính là thông s\u1ed1 g\u1ed9p bao g\u1ed3m th\u1eddi gian cho \u0111\u1ebfn khi x\u1ea3y ra l\u1ea7n \u0111\u1ea7u b\u1ea5t kì các bi\u1ebfn c\u1ed1 tim m\u1ea1ch chính sau: t\u1eed vong do b\u1ec7nh tim m\u1ea1ch, nh\u1ed3i máu c\u01a1 tim không t\u1eed vong, \u0111\u1ed9t qu\u1ef5 không t\u1eed vong, n\u1eb1m vi\u1ec7n do \u0111au th\u1eaft ng\u1ef1c không \u1ed5n \u0111\u1ecbnh ho\u1eb7c th\u1ee7 thu\u1eadt tái t\u01b0\u1edbi máu m\u1ea1ch vành.
\nRosuvastatin làm gi\u1ea3m \u0111áng k\u1ec3 nguy c\u01a1 các bi\u1ebfn c\u1ed1 tim m\u1ea1ch chính (252 bi\u1ebfn c\u1ed1 \u1edf nhóm gi\u1ea3 d\u01b0\u1ee3c so v\u1edbi 142 bi\u1ebfn c\u1ed1 \u1edf nhóm dùng rosuvastatin) v\u1edbi s\u1ef1 gi\u1ea3m nguy c\u01a1 t\u01b0\u01a1ng \u0111\u1ed1i là 44% và gi\u1ea3m nguy c\u01a1 tuy\u1ec7t \u0111\u1ed1i là 1.2% (xem bi\u1ec3u \u0111\u1ed3 1). S\u1ef1 gi\u1ea3m này có ý ngh\u0129a th\u1ed1ng kê (p < 0.001). S\u1ef1 gi\u1ea3m nguy c\u01a1 \u1edf thông s\u1ed1 nghiên c\u1ee9u chính \u0111\u1ed3ng nh\u1ea5t v\u1edbi các phân nhóm sau: tu\u1ed5i, gi\u1edbi tính, ch\u1ee7ng t\u1ed9c, tình tr\u1ea1ng hút thu\u1ed1c, ti\u1ec1n s\u1eed gia \u0111ình m\u1eafc b\u1ec7nh m\u1ea1ch vành s\u1edbm, ch\u1ec9 s\u1ed1 kh\u1ed1i c\u01a1 th\u1ec3, LDL-C, HDL-C và n\u1ed3ng \u0111\u1ed9 hsCRP.
\nBi\u1ec3u \u0111\u1ed3 1. Th\u1eddi gian cho \u0111\u1ebfn khi x\u1ea3y ra l\u1ea7n \u0111\u1ea7u các bi\u1ebfn c\u1ed1 tim m\u1ea1ch chính trong nghiên c\u1ee9u JUPITER
\n![\"crestor-20mg-28v-0007\"](\"https://cdn.tgdd.vn/Products/Images/5792/130340/crestor-20mg-28v-0007.png\" "\\"crestor-20mg-28v-0007\\"")
S\u1ed1 l\u01b0\u1ee3ng b\u1ec7nh nhân theo dõi
\n| \n RSV \n | \n\n 8901 \n | \n\n 8412 \n | \n\n 3892 \n | \n\n 1352 \n | \n\n 543 \n | \n\n 156 \n | \n
| \n Gi\u1ea3 d\u01b0\u1ee3c \n | \n\n 8901 \n | \n\n 8353 \n | \n\n 3872 \n | \n\n 1333 \n | \n\n 534 \n | \n\n 173 \n | \n
Nh\u1eefng thành ph\u1ea7n c\u1ee5 th\u1ec3 c\u1ee7a thông s\u1ed1 nghiên c\u1ee9u chính \u0111\u01b0\u1ee3c gi\u1edbi thi\u1ec7u trong bi\u1ec3u \u0111\u1ed3 2. Rosuvastatin làm gi\u1ea3m \u0111áng k\u1ec3 nguy c\u01a1 nh\u1ed3i máu c\u01a1 tim không t\u1eed vong, \u0111\u1ed9t quy không t\u1eed vong và th\u1ee7 thu\u1eadt tái t\u01b0\u1edbi máu m\u1ea1ch vành. Không có s\u1ef1 khác bi\u1ec7t \u0111áng k\u1ec3 v\u1ec1 m\u1eb7t \u0111i\u1ec1u tr\u1ecb gi\u1eefa nhóm dùng rosuvastatin hay gi\u1ea3 d\u01b0\u1ee3c v\u1ec1 t\u1eed vong do nguy c\u01a1 tim m\u1ea1ch hay nh\u1eadp vi\u1ec7n vì \u0111au th\u1eaft ng\u1ef1c không \u1ed5n \u0111\u1ecbnh.
\nRosuvastatin làm gi\u1ea3m \u0111áng k\u1ec3 nguy c\u01a1 nh\u1ed3i máu c\u01a1 tim (6 bi\u1ebfn c\u1ed1 t\u1eed vong và 62 bi\u1ebfn c\u1ed1 không t\u1eed vong \u1edf nhóm dùng gi\u1ea3 d\u01b0\u1ee3c so v\u1edbi 9 bi\u1ebfn c\u1ed1 t\u1eed vong và 22 bi\u1ebfn c\u1ed1 không t\u1eed vong \u1edf nhóm dùng rosuvastatin) và nguy c\u01a1 \u0111\u1ed9t qu\u1ef5 (6 bi\u1ebfn c\u1ed1 t\u1eed vong và 58 bi\u1ebfn c\u1ed1 không t\u1eed vong \u1edf nhóm dùng gi\u1ea3 d\u01b0\u1ee3c so v\u1edbi 3 bi\u1ebfn c\u1ed1 t\u1eed vong và 30 bi\u1ebfn c\u1ed1 không t\u1eed vong \u1edf nhóm dùng rosuvastatin),
\nTrong 1 phân tích phân nhóm h\u1eadu ki\u1ec3m (post-hoc) trên nh\u1eefng ng\u01b0\u1eddi tham gia nghiên c\u1ee9u JUPITER (n = 1405, rosuvastatin = 725, gi\u1ea3 d\u01b0\u1ee3c = 680) v\u1edbi hsCRP > 2mg/l và không có thêm y\u1ebfu t\u1ed1 nguy c\u01a1 nào khác (hút thu\u1ed1c, huy\u1ebft áp > 140/90 ho\u1eb7c \u0111ang \u0111i\u1ec1u tr\u1ecb v\u1edbi thu\u1ed1c tr\u1ecb t\u0103ng huy\u1ebft áp, HDL-C th\u1ea5p) không tính \u0111\u1ebfn tu\u1ed5i tác, sau khi \u0111i\u1ec1u ch\u1ec9nh \u0111\u1ed1i v\u1edbi nhóm có HDL-C cao, không th\u1ea5y có ích l\u1ee3i \u0111i\u1ec1u tr\u1ecb \u0111áng k\u1ec3 khi \u0111i\u1ec1u tr\u1ecb b\u1eb1ng rosuvastatin.
\nBi\u1ec3u \u0111\u1ed3 2. Các bi\u1ebfn c\u1ed1 tim m\u1ea1ch chính \u1edf nhóm \u0111i\u1ec1u tr\u1ecb trong nghiên c\u1ee9u JUPITER
\n| \n Tiêu chí \n | \n\n S\u1ed1 l\u01b0\u1ee3ng các bi\u1ebfn c\u1ed1 \n | \n|||
| \n Rosuva (n=8901) | \n\n Gi\u1ea3 d\u01b0\u1ee3c \n20mg \n(n = 8901) \nn (t\u1ec9 l\u1ec7 *) \n | \n\n T\u1ec9 s\u1ed1 nguy h\u1ea1i | \n\n Giá tr\u1ecb P \n | \n|
| \n Tiêu chí nghiên c\u1ee9u chính \n | \n\n 142 (7.6) \n | \n\n 252 (13.6) \n | \n\n 0.56 (0.46; 0.69) \n | \n\n < 0.001 \n | \n
| \n Ch\u1ebft do b\u1ec7nh tim m\u1ea1ch** \n | \n\n 35 (1.9) \n | \n\n 44 (2.4) \n | \n\n 0.80 (0.51; 1.24) \n | \n\n 0.315 \n | \n
| \n \u0110\u1ed9t qu\u1ef5 không t\u1eed vong \n | \n\n 30 (1.6) \n | \n\n 58 (3.1) \n | \n\n 0.52 (0.33; 0.80) \n | \n\n 0.003 \n | \n
| \n Nh\u1ed3i máu c\u01a1 tim không | \n\n 22 (1.2) \n | \n\n 62 (3.3) \n | \n\n 0.35 (0.22; 0.58) \n | \n\n < 0.001 \n | \n
| \n N\u1eb1m vi\u1ec7n do \u0111au th\u1eaft ng\u1ef1c | \n\n 16 (0.9) \n | \n\n 27 (1.5) \n | \n\n 0.59 (0.32; 1.10) \n | \n\n 0.093 \n | \n
| \n Tái t\u01b0\u1edbi máu m\u1ea1ch vành \n | \n\n 71 (3.8) \n | \n\n 131 (7.1) \n | \n\n 0.54 (0.41; 0.72) \n | \n\n < 0.001 \n | \n
*T\u1ec9 l\u1ec7 bi\u1ebfn c\u1ed1/1000-b\u1ec7nh nhân n\u0103m
\n**Ch\u1ebft do b\u1ec7nh tim m\u1ea1ch bao g\u1ed3m t\u1eed vong do nh\u1ed3i máu c\u01a1 tim, t\u1eed vong do \u0111\u1ed9t qu\u1ef5 và các nguyên nhân khác c\u1ee7a t\u1eed vong do b\u1ec7nh tim m\u1ea1ch.
\nSau 1 n\u0103m, rosuvastatin làm t\u0103ng HDL-C và làm gi\u1ea3m LDL-C, hsCRP, cholesterol toàn ph\u1ea7n và n\u1ed3ng \u0111\u1ed9 triglyceride huy\u1ebft thanh (p < 0.001) \u1edf t\u1ea5t c\u1ea3 các thông s\u1ed1 khi so sánh v\u1edbi gi\u1ea3 d\u01b0\u1ee3c.
\nD\u01af\u1ee2C \u0110\u1ed8NG H\u1eccC
\nH\u1ea5p thu
\nN\u1ed3ng \u0111\u1ed9 \u0111\u1ec9nh trong huy\u1ebft t\u01b0\u01a1ng c\u1ee7a rosuvastatin \u0111\u1ea1t \u0111\u01b0\u1ee3c kho\u1ea3ng 5 gi\u1edd sau khi u\u1ed1ng. \u0110\u1ed9 sinh kh\u1ea3 d\u1ee5ng tuy\u1ec7t \u0111\u1ed1i kho\u1ea3ng 20%.
\nPhân b\u1ed1
\nRosuvastatin phân b\u1ed1 r\u1ed9ng rãi \u1edf gan là n\u01a1i ch\u1ee7 y\u1ebfu t\u1ed5ng h\u1ee3p cholesterol và thanh th\u1ea3i LDL-C. Th\u1ec3 tích phân b\u1ed1 c\u1ee7a rosuvastatin kho\u1ea3ng 134 L. Kho\u1ea3ng 90% rosuvastatin k\u1ebft h\u1ee3p v\u1edbi protein huy\u1ebft t\u01b0\u01a1ng, ch\u1ee7 y\u1ebfu là v\u1edbi albumin.
\nChuy\u1ec3n hóa
\nRosuvastatin ít b\u1ecb chuy\u1ec3n hoá (kho\u1ea3ng 10%). Các nghiên c\u1ee9u in vitro v\u1ec1 chuy\u1ec3n hoá có s\u1eed d\u1ee5ng các t\u1ebf bà