{"id":9966,"date":"2019-05-22T01:37:25","date_gmt":"2019-05-21T18:37:25","guid":{"rendered":"https:\/\/www.hmm88i.com\/drug\/?p=9966"},"modified":"2019-05-22T01:38:31","modified_gmt":"2019-05-21T18:38:31","slug":"danh-gia-hieu-qua-va-an-toan-cua-phospholipid","status":"publish","type":"post","link":"https:\/\/hmm88i.com\/drug\/danh-gia-hieu-qua-va-an-toan-cua-phospholipid\/","title":{"rendered":"\u0110A\u0301NH GIA\u0301 HI\u1eb8\u0302U QUA\u0309 VA\u0300 AN TOA\u0300N CU\u0309A PHOSPHOLIPID"},"content":{"rendered":"
\u0110A\u0301NH GIA\u0301 HI\u1eb8\u0302U QUA\u0309 VA\u0300 AN TOA\u0300N CU\u0309A PHOSPHOLIPID<\/strong> V\u01a0\u0301I C\u00c2\u0301U TRU\u0301C H\u1eb8\u0302 VI NHU\u0303 TU\u031bO\u031bNG (LIPOFILM) TRE\u0302N B\u1eb8\u0302NH NHA\u0302N BI\u0323 VIE\u0302M K\u00ca\u0301T \u2013 GIA\u0301C MA\u0323C KHO\u0302: M\u1ecc\u0302T TH\u01af\u0309 NGHI\u1eb8\u0302M LA\u0302M SA\u0300NG NG\u00c2\u0303U NHIE\u0302N, MU\u0300 \u0110O\u031bN<\/p>\n Lipofilm la\u0300 m\u1ecd\u0302t vi nhu\u0303 tu\u031bo\u031bng. V\u00ea\u0300 m\u1ea1\u0306t nhi\u1eb9\u0302t \u0111\u1ecd\u0302ng, s\u01b0\u0323 pha\u0302n ta\u0301n d\u00e2\u0300u cu\u0309a no\u0301 \u00f4\u0309n \u0111i\u0323nh trong ca\u0301c gio\u0323t nano nu\u031b\u01a1\u0301c co\u0301 ch\u01b0\u0301a lipit. Lipofilm co\u0301 ch\u01b0\u0301c na\u0306ng sinh ly\u0301 r\u00e2\u0301t g\u00e2\u0300n v\u01a1\u0301i l\u01a1\u0301p lipid co\u0301 trong nu\u031b\u01a1\u0301c m\u0103\u0301t t\u01b0\u0323 nhie\u0302n.<\/p>\n ch\u01b0\u0301ng minh r\u0103\u0300ng tri\u1eb9\u0302u ch\u01b0\u0301ng chu\u0309 quan va\u0300 kha\u0301ch quan \u0111u\u031b\u01a1\u0323c ca\u0309i thi\u1eb9\u0302n b\u0103\u0300ng Lipofilm, \u0111\u00f4\u0300ng th\u01a1\u0300i ki\u00ea\u0309m tra ti\u0301nh an toa\u0300n va\u0300 kha\u0309 na\u0306ng dung na\u0323p.<\/p>\n M\u1ecd\u0302t nghie\u0302n c\u01b0\u0301u song song, \u0111u\u031b\u01a1\u0323c ki\u00ea\u0309m soa\u0301t \u0111a\u0303 \u0111u\u031b\u01a1\u0323c th\u01b0\u0323c hi\u1eb9\u0302n gi\u01b0\u0303a nho\u0301m b\u1eb9\u0302nh nha\u0302n du\u0300ng Lipofilm so v\u01a1\u0301i nho\u0301m du\u0300ng 0,2% Natri Hyaluronate. Mu\u031b\u01a1\u0300i chi\u0301n b\u1eb9\u0302nh nha\u0302n bi\u0323 kho\u0302 m\u0103\u0301t \u0111a\u0303 \u0111u\u031b\u01a1\u0323c ghi danh. Lipofilm TM ho\u1ea1\u0306c Sodium Hyaluronate \u0111u\u031b\u01a1\u0323c du\u0300ng i\u0301t nh\u00e2\u0301t 3 l\u00e2\u0300n \/ nga\u0300y trong 90 nga\u0300y. Ca\u0301c tri\u1eb9\u0302u ch\u01b0\u0301ng (\u0111au \/ ra\u0301t; s\u01a1\u0323 a\u0301nh sa\u0301ng, m\u01a1\u0300 m\u0103\u0301t; ca\u0309m gia\u0301c co\u0301 di\u0323 v\u1ea1\u0302t trong m\u0103\u0301t) \u0111u\u031b\u01a1\u0323c thu th\u1ea1\u0302p theo thang \u0111o ba\u0301n \u0111i\u0323nh lu\u031b\u01a1\u0323ng. Ca\u0301c d\u00e2\u0301u hi\u1eb9\u0302u (ta\u0306ng k\u00ea\u0301t ma\u0323c va\u0300 phu\u0300 n\u00ea\u0300; phu\u0300 mi\u0301) \u0111u\u031b\u01a1\u0323c thu th\u1ea1\u0302p b\u0103\u0300ng Thang \u0111i\u00ea\u0309m Visual Analogic. Thu\u00f4\u0301c nhu\u1ecd\u0302m fluorescein \u0111u\u031b\u01a1\u0323c a\u0301p du\u0323ng trong thang \u0111o ba\u0301n \u0111i\u0323nh lu\u031b\u01a1\u0323ng. D\u01b0\u0303 li\u1eb9\u0302u \u0111u\u031b\u01a1\u0323c \u0111a\u0301nh gia\u0301 b\u0103\u0300ng ca\u0301c test phi tham s\u00f4\u0301 th\u00f4\u0301ng ke\u0302.<\/p>\n Tri\u1eb9\u0302u ch\u01b0\u0301ng \u0111u\u031b\u01a1\u0323c ca\u0309i thi\u1eb9\u0302n v\u01a1\u0301i ca\u0309 hai phu\u031bo\u031bng pha\u0301p \u0111i\u00ea\u0300u tri\u0323. Tuy nhie\u0302n, k\u00ea\u0301t qua\u0309 t\u00f4\u0301t ho\u031bn \u0111u\u031b\u01a1\u0323c quan sa\u0301t \u01a1\u0309 nho\u0301m b\u1eb9\u0302nh nha\u0302n \u0111i\u00ea\u0300u tri\u0323 v\u01a1\u0301i Lipofilm, ca\u0301c tri\u1eb9\u0302u ch\u01b0\u0301ng \u01a1\u0309 nho\u0301m b\u1eb9\u0302nh nha\u0302n na\u0300y \u0111a\u0303 gia\u0309m 69% (P <0,01) so v\u01a1\u0301i 52% (P <0,05) trong nho\u0301m \u0111u\u031b\u01a1\u0323c \u0111i\u00ea\u0300u tri\u0323 b\u0103\u0300ng Natri Hyaluronate. Cu\u0323 th\u00ea\u0309, m\u01a1\u0300 m\u0103\u0301t va\u0300 phu\u0300 k\u00ea\u0301t ma\u0323c chi\u0309 gia\u0309m co\u0301 y\u0301 nghi\u0303a th\u00f4\u0301ng ke\u0302 trong nho\u0301m \u0111u\u031b\u01a1\u0323c \u0111i\u00ea\u0300u tri\u0323 v\u01a1\u0301i Lipofilm TM. The\u0302m n\u01b0\u0303a, ca\u0301c d\u00e2\u0301u hi\u1eb9\u0302u \u0111a\u0303 \u0111u\u031b\u01a1\u0323c ca\u0309i thi\u1eb9\u0302n co\u0301 y\u0301 nghi\u0303a th\u00f4\u0301ng ke\u0302 chi\u0309 \u01a1\u0309 nho\u0301m \u0111u\u031b\u01a1\u0323c \u0111i\u00ea\u0300u tri\u0323 b\u0103\u0300ng Lipofilm, cu\u0323 th\u00ea\u0309 gia\u0309m 90% (P <0,01), trong khi ca\u0301c d\u00e2\u0301u hi\u1eb9\u0302u na\u0300y chi\u0309 gia\u0309m 51% \u01a1\u0309 nho\u0301m du\u0300ng Hyaluronate. Kha\u0309 na\u0306ng dung na\u0323p ta\u0323i ch\u00f4\u0303 va\u0300 toa\u0300n tha\u0302n \u0111\u00ea\u0300u tuy\u1eb9\u0302t v\u01a1\u0300i.<\/p>\n K\u00ca\u0301T LU\u1ea0\u0302N: Lipofilm du\u031b\u01a1\u0300ng nhu\u031b hi\u1eb9\u0302u qua\u0309 ho\u031bn ca\u0301c thu\u00f4\u0301c \u0111\u00f4\u0301i ch\u01b0\u0301ng (0,2% Natri Hyaluronate) trong vi\u1eb9\u0302c gia\u0309m ca\u0301c d\u00e2\u0301u hi\u1eb9\u0302u va\u0300 tri\u1eb9\u0302u ch\u01b0\u0301ng \u01a1\u0309 b\u1eb9\u0302nh nha\u0302n bi\u0323 kho\u0302 m\u0103\u0301t.<\/p>\n Vi\u1eb9\u0302c gi\u01b0\u0303 cho ma\u0300ng nu\u031b\u01a1\u0301c m\u0103\u0301t \u00f4\u0309n \u0111i\u0323nh la\u0300 r\u00e2\u0301t c\u00e2\u0300n thi\u00ea\u0301t cho b\u00ea\u0300 m\u1ea1\u0306t m\u0103\u0301t. Ma\u0300ng nu\u031b\u01a1\u0301c m\u0103\u0301t \u0111u\u031b\u01a1\u0323c ta\u0323o b\u01a1\u0309i m\u1ecd\u0302t l\u01a1\u0301p lipit be\u0302n ngoa\u0300i, l\u01a1\u0301p gi\u01b0\u0303a la\u0300 dung di\u0323ch nu\u031b\u01a1\u0301c ch\u01b0\u0301a protein va\u0300 ch\u00e2\u0301t \u0111i\u1eb9\u0302n gia\u0309i, trong cu\u0300ng la\u0300 l\u01a1\u0301p ch\u00e2\u0301t nh\u00e2\u0300y. L\u01a1\u0301p lipid \u0111u\u031b\u01a1\u0323c hi\u0300nh tha\u0300nh b\u01a1\u0309i hai pha kha\u0301c nhau: pha be\u0302n trong ti\u00ea\u0301p xu\u0301c v\u01a1\u0301i l\u01a1\u0301p nu\u031b\u01a1\u0301c \u0111u\u031b\u01a1\u0323c c\u00e2\u0301u ta\u0323o b\u01a1\u0309i lipit pha\u0302n c\u01b0\u0323c; pha ngoa\u0300i ti\u00ea\u0301p xu\u0301c v\u01a1\u0301i kho\u0302ng khi\u0301 \u0111u\u031b\u01a1\u0323c c\u00e2\u0301u ta\u0323o b\u01a1\u0309i lipit kho\u0302ng pha\u0302n c\u01b0\u0323c. Ma\u0300ng lipid co\u0301 \u0111\u1ecd\u0302 da\u0300y thi\u0301ch h\u01a1\u0323p la\u0300 m\u1ecd\u0302t ye\u0302u c\u00e2\u0300u r\u00e2\u0301t quan tro\u0323ng \u0111\u00ea\u0309 duy tri\u0300 ma\u0300ng nu\u031b\u01a1\u0301c m\u0103\u0301t \u00f4\u0309n \u0111i\u0323nh. Lipofilm la\u0300 m\u1ecd\u0302t loa\u0323i vi nhu\u0303 tu\u031bo\u031bng \u0111u\u031b\u01a1\u0323c pha\u0301t tri\u00ea\u0309n g\u00e2\u0300n \u0111a\u0302y \u0111\u00ea\u0309 s\u01b0\u0309 du\u0323ng cho nha\u0303n khoa co\u0301 ch\u01b0\u0301a phospholipids, triglyceride va\u0300 axit be\u0301o chu\u031ba ba\u0303o ho\u0300a. No\u0301 la\u0300 m\u1ecd\u0302t s\u01b0\u0323 pha\u0302n ta\u0301n \u00f4\u0309n \u0111i\u0323nh nhi\u1eb9\u0302t \u0111\u1ecd\u0302ng cu\u0309a d\u00e2\u0300u trong nu\u031b\u01a1\u0301c. Ca\u0301c gio\u0323t d\u00e2\u0300u co\u0301 ki\u0301ch thu\u031b\u01a1\u0301c sie\u0302u nho\u0309, (\u0111u\u031b\u01a1\u0300ng ki\u0301nh trung bi\u0300nh 200 nm) va\u0300 \u0111u\u031b\u01a1\u0323c pha\u0302n ta\u0301n b\u01a1\u0309i ch\u00e2\u0301t hoa\u0323t \u0111\u1ecd\u0302ng b\u00ea\u0300 m\u1ea1\u0306t.<\/p>\n C\u00e2\u0301u tru\u0301c ho\u0301a ly\u0301 cu\u0309a vi nhu\u0303 tu\u031bo\u031bng, \u0111\u1ea1\u0306c bi\u1eb9\u0302t la\u0300 s\u01b0\u0323 co\u0301 m\u1ea1\u0306t cu\u0309a gio\u0323t d\u00e2\u0300u v\u01a1\u0301i ki\u0301ch thu\u031b\u01a1\u0301c sie\u0302u hi\u00ea\u0309n vi mang la\u0323i cho Lipofilm kha\u0309 na\u0306ng ca\u0309i thi\u1eb9\u0302n ch\u01b0\u0301c na\u0306ng ha\u0300ng ra\u0300o lipid b\u0103\u0300ng ca\u0301ch kho\u0302i phu\u0323c l\u01a1\u0301p lipid cu\u0303ng nhu\u031b \u0111\u1ecd\u0302 \u00e2\u0309m tu\u031bo\u031bng t\u01b0\u0323 nhu\u031b nu\u031b\u01a1\u0301c m\u0103\u0301t t\u01b0\u0323 nhie\u0302n. V\u01a1\u0301i nh\u01b0\u0303ng \u0111\u1ea1\u0306c \u0111i\u00ea\u0309m na\u0300y, vi nhu\u0303 tu\u031bo\u031bng Lipofilm \u0111a\u0303 \u0111u\u031b\u01a1\u0323c \u0111\u00ea\u0300 xu\u00e2\u0301t trong \u0111i\u00ea\u0300u tri\u0323 ca\u0301c b\u1eb9\u0302nh ly\u0301 b\u00ea\u0300 m\u1ea1\u0306t m\u0103\u0301t co\u0301 lie\u0302n quan \u0111\u00ea\u0301n r\u00f4\u0301i loa\u0323n ma\u0300ng nu\u031b\u01a1\u0301c m\u0103\u0301t. Trong m\u1ecd\u0302t nghie\u0302n c\u01b0\u0301u g\u00e2\u0300n \u0111a\u0302y, vi\u1eb9\u0302c s\u01b0\u0309 du\u0323ng vi nhu\u0303 tu\u031bo\u031bng ta\u0323i ch\u00f4\u0303 cho b\u1eb9\u0302nh nha\u0302n bi\u0323 mo\u0300n giac ma\u0323c kho\u0302ng nhi\u00ea\u0303m tru\u0300ng \u0111a\u0303 \u0111u\u031b\u01a1\u0323c ti\u0300m th\u00e2\u0301y la\u0300 co\u0301 hi\u1eb9\u0302u qua\u0309 trong vi\u1eb9\u0302c \u0111\u00e2\u0309y nhanh th\u01a1\u0300i gian phu\u0323c h\u00f4\u0300i \u0111\u00f4\u0300ng th\u01a1\u0300i gia\u0309m m\u01b0\u0301c \u0111\u1ecd\u0302 nghie\u0302m tro\u0323ng cu\u0309a tri\u1eb9\u0302u ch\u01b0\u0301ng.<\/p>\n Mu\u0323c \u0111i\u0301ch cu\u0309a nghie\u0302n c\u01b0\u0301u na\u0300y nh\u0103\u0300m ch\u01b0\u0301ng minh \u01a1\u0309 nh\u01b0\u0303ng b\u1eb9\u0302nh nha\u0302n kho\u0302 m\u0103\u0301t v\u01a1\u0301i ca\u0309 tri\u1eb9\u0302u ch\u01b0\u0301ng chu\u0309 quan va\u0300 kha\u0301ch quan \u0111\u00ea\u0300u \u0111u\u031b\u01a1\u0323c ca\u0309i thi\u1eb9\u0302n b\u0103\u0300ng ca\u0301ch s\u01b0\u0309 du\u0323ng Lipofilm ta\u0323i ch\u00f4\u0303. \u0110\u1ecd\u0302 an toa\u0300n va\u0300 ti\u0301nh dung na\u0323p cu\u0303ng \u0111a\u0303 \u0111u\u031b\u01a1\u0323c th\u01b0\u0309 nghi\u1eb9\u0302m.<\/p>\n Nghie\u0302n c\u01b0\u0301u theo thi\u00ea\u0301t k\u00ea\u0301 cu\u0309a th\u01b0\u0309 nghi\u1eb9\u0302m la\u0302m sa\u0300ng 2 nho\u0301m song song, ng\u00e2\u0303u nhie\u0302n, mu\u0300 \u0111o\u031bn, \u0111u\u031b\u01a1\u0323c ki\u00ea\u0309m soa\u0301t v\u01a1\u0301i thu\u00f4\u0301c tham chi\u00ea\u0301u la\u0300 Natri Hyaluronate 0,2%. Th\u01a1\u0300i gian \u0111i\u00ea\u0300u tri\u0323 la\u0300 90 nga\u0300y. Mu\u031b\u01a1\u0300i chi\u0301n b\u1eb9\u0302nh nha\u0302n bi\u0323 kho\u0302 m\u0103\u0301t \u0111u\u031b\u01a1\u0323c ghi danh theo ca\u0301c tie\u0302u chi\u0301 sau \u0111a\u0302y:<\/p>\n Tie\u0302u chi\u0301 chi\u0301nh bao g\u00f4\u0300m: B\u00ea\u0300 m\u1ea1\u0306t m\u0103\u0301t du\u031bo\u031bng ti\u0301nh v\u01a1\u0301i thu\u00f4\u0301c nhu\u1ecd\u0302m fluorescein va\u0300 lissamine ma\u0300u xanh huy\u0300nh quang; Test Scherter cho k\u00ea\u0301t qua\u0309 th\u00e2\u0301p ho\u031bn 7 mm \/ 5 phu\u0301t ho\u1ea1\u0306c th\u01a1\u0300i gian v\u01a1\u0303 phim nu\u031b\u01a1\u0301c m\u0103\u0301t (BUT) < 10 gia\u0302y; tu\u00f4\u0309i t\u01b0\u0300 18 \u0111\u00ea\u0301n 75 tu\u00f4\u0309i; ti\u0300nh nguy\u1eb9\u0302n tham gia.<\/p>\n Tie\u0302u chi\u0301 loa\u0323i tr\u01b0\u0300 chi\u0301nh: ph\u00e2\u0303u thu\u1ea1\u0302t khu\u0301c xa\u0323 tru\u031b\u01a1\u0301c \u0111o\u0301; \u0111eo ki\u0301nh a\u0301p tro\u0300ng; vie\u0302m m\u0103\u0301t do vi khu\u00e2\u0309n, virus ho\u1ea1\u0306c n\u00e2\u0301m; kho\u0302ng \u0111u\u031b\u01a1\u0323c phe\u0301p \u0111i\u00ea\u0300u tri\u0323 \u0111\u00f4\u0300ng th\u01a1\u0300i.<\/p>\n Sa\u0309n ph\u00e2\u0309m nghie\u0302n c\u01b0\u0301u Lipofilm (Tubilux Pharma S, p.A., Pomezia, Italy) \u0111u\u031b\u01a1\u0323c du\u0300ng va\u0300o tu\u0301i k\u00ea\u0301t ma\u0323c, i\u0301t nh\u00e2\u0301t 3 l\u00e2\u0300n \/ nga\u0300y. Thu\u00f4\u0301c tham chi\u00ea\u0301u \u0111u\u031b\u01a1\u0323c s\u01b0\u0309 du\u0323ng la\u0300 m\u1ecd\u0302t gia\u0309i pha\u0301p nha\u0303n khoa \u0111a li\u00ea\u0300u co\u0301 ba\u0301n tre\u0302n thi\u0323 tru\u031b\u01a1\u0300ng co\u0301 ch\u01b0\u0301a Natri Hyaluronate 0,2% (Hy-drop, Baush & boo). Tu\u031bo\u031bng t\u01b0\u0323 nhu\u031b Lipofilm, no\u0301 \u0111u\u031b\u01a1\u0323c du\u0300ng va\u0300o tu\u0301i k\u00ea\u0301t ma\u0323c i\u0301t nh\u00e2\u0301t 3 l\u00e2\u0300n \/ nga\u0300y. M\u00f4\u0303i b\u1eb9\u0302nh nha\u0302n \u0111u\u031b\u01a1\u0323c chi\u0309 \u0111i\u0323nh m\u1ecd\u0302t trong ca\u0301c phu\u031bo\u031bng pha\u0301p \u0111i\u00ea\u0300u tri\u0323, theo danh sa\u0301ch ng\u00e2\u0303u nhie\u0302n, va\u0300 tra\u0309i qua 3 l\u00e2\u0300n tha\u0306m kha\u0301m nhu\u031b \u0111a\u0303 ba\u0301o ca\u0301o trong k\u00ea\u0301 hoa\u0323ch nghie\u0302n c\u01b0\u0301u sau \u0111a\u0302y: kha\u0301m l\u00e2\u0300n 1; tha\u0306m kha\u0301m l\u00e2\u0300n 2 (sau 30 nga\u0300y \u0111i\u00ea\u0300u tri\u0323); tha\u0306m kha\u0301m l\u00e2\u0300n 3 (sau 60 nga\u0300y \u0111i\u00ea\u0300u tri\u0323); tha\u0306m kha\u0301m l\u00e2\u0300n 4 (sau 90 nga\u0300y \u0111i\u00ea\u0300u tri\u0323).<\/p>\n Trong m\u00f4\u0303i l\u00e2\u0300n tha\u0306m kha\u0301m, ca\u0301c bi\u00ea\u0301n sau \u0111a\u0302y \u0111u\u031b\u01a1\u0323c thu th\u1ea1\u0302p: Ca\u0301c tri\u1eb9\u0302u ch\u01b0\u0301ng chu\u0309 quan (g\u00f4\u0300m ch\u01b0\u0301ng s\u01a1\u0323 a\u0301nh sa\u0301ng; no\u0301ng ra\u0301t \/ \u0111au; m\u01a1\u0300 m\u0103\u0301t, ca\u0309m gia\u0301c co\u0301 di\u0323 v\u1ea1\u0302t trong m\u0103\u0301t) \u0111u\u031b\u01a1\u0323c \u0111a\u0301nh gia\u0301 b\u0103\u0300ng thang \u0111o ba\u0301n \u0111i\u0323nh lu\u031b\u01a1\u0323ng 4 \u0111i\u00ea\u0309m.<\/p>\n Ca\u0301c d\u00e2\u0301u hi\u1eb9\u0302u kha\u0301ch quan (g\u00f4\u0300m sung huy\u00ea\u0301t k\u00ea\u0301t ma\u0323c, phu\u0300 k\u00ea\u0301t ma\u0323c; phu\u0300 mi\u0301) \u0111u\u031b\u01a1\u0323c \u0111a\u0301nh gia\u0301 b\u0103\u0300ng thang \u0111i\u00ea\u0309m VAS 10 mm. Nhu\u1ecd\u0302m fluorescein gia\u0301c ma\u0323c \u0111u\u031b\u01a1\u0323c \u0111a\u0301nh gia\u0301 b\u0103\u0300ng thang \u0111i\u00ea\u0309m ba\u0301n \u0111i\u0323nh lu\u031b\u01a1\u0323ng 4 \u0111i\u00ea\u0309m. Th\u01a1\u0300i gian pha\u0301 v\u01a1\u0303 phim nu\u031b\u01a1\u0301c m\u0103\u0301t (BUT) s\u01b0\u0309 du\u0323ng da\u0309i fluorescein \u0111a\u0303 \u0111u\u031b\u01a1\u0323c th\u01b0\u0323c hi\u1eb9\u0302n.<\/p>\n Tie\u0302u chi\u0301 chi\u0301nh la\u0300 \u0111i\u00ea\u0309m s\u00f4\u0301 cu\u0309a ca\u0301c tri\u1eb9\u0302u ch\u01b0\u0301ng chu\u0309 quan (\u0111au \/ ra\u0301t, m\u01a1\u0300 m\u0103\u0301t, tra\u0301nh ca\u0309m gia\u0301c co\u031b th\u00ea\u0309, ch\u01b0\u0301ng s\u01a1\u0323 a\u0301nh sa\u0301ng). Tie\u0302u chi\u0301 phu\u0323 la\u0300 ca\u0301c tri\u1eb9\u0302u ch\u01b0\u0301ng (ta\u0306ng k\u00ea\u0301t ma\u0323c, phu\u0300 k\u00ea\u0301t ma\u0323c, phu\u0300 mi\u0301) \u0111u\u031b\u01a1\u0323c \u0111a\u0301nh gia\u0301 b\u0103\u0300ng thang \u0111i\u00ea\u0309m tu\u031bo\u031bng t\u01b0\u0323 tr\u01b0\u0323c quan (VAS), BUT va\u0300 \u0111a\u0301nh gia\u0301 hi\u1eb9\u0302u qua\u0309 \u0111u\u031b\u01a1\u0323c th\u00ea\u0309 hi\u1eb9\u0302n b\u01a1\u0309i \u0111i\u00ea\u0300u tra vie\u0302n.<\/p>\n \u0110a\u0301nh gia\u0301 kha\u0309 na\u0306ng dung na\u0323p \u0111u\u031b\u01a1\u0323c th\u01b0\u0323c hi\u1eb9\u0302n b\u01a1\u0309i \u0111i\u00ea\u0300u tra vie\u0302n (s\u01b0\u0309 du\u0323ng VAS), \u0111a\u0301nh gia\u0301 kha\u0309 na\u0306ng dung na\u0323p \u0111u\u031b\u01a1\u0323c th\u00ea\u0309 hi\u1eb9\u0302n b\u01a1\u0309i b\u1eb9\u0302nh nha\u0302n (s\u01b0\u0309 du\u0323ng thang \u0111o \\ ba\u0301n \u0111i\u0323nh lu\u031b\u01a1\u0323ng) va\u0300 ca\u0301c ba\u0301o ca\u0301o v\u00ea\u0300 ta\u0301c du\u0323ng phu\u0323 (AE) \u0111a\u0303 \u0111u\u031b\u01a1\u0323c \u0111a\u0301nh gia\u0301. \u0110\u00f4\u0301i v\u01a1\u0301i m\u00f4\u0303i b\u1eb9\u0302nh nha\u0302n, chi\u0309 co\u0301 m\u1ecd\u0302t m\u0103\u0301t \u0111u\u031b\u01a1\u0323c \u0111i\u00ea\u0300u tra vie\u0302n l\u01b0\u0323a cho\u0323n trong tha\u0306m kha\u0301m \u0111\u00ea\u0309 xem xe\u0301t hi\u1eb9\u0302u qua\u0309, trong khi ca\u0309 hai m\u0103\u0301t \u0111u\u031b\u01a1\u0323c xem xe\u0301t \u0111\u00ea\u0309 pha\u0302n ti\u0301ch ti\u0301nh an toa\u0300n.<\/p>\n Th\u00f4\u0301ng ke\u0302: Vi\u0300 ki\u0301ch thu\u031b\u01a1\u0301c m\u00e2\u0303u la\u0300 nho\u0309 do \u0111o\u0301 pha\u0302n ph\u00f4\u0301i kho\u0302ng chu\u00e2\u0309n ne\u0302n chi\u0309 a\u0301p du\u0323ng ca\u0301c th\u01b0\u0309 nghi\u1eb9\u0302m phi tham s\u00f4\u0301 (vi\u0301 du\u0323: th\u01b0\u0309 nghi\u1eb9\u0302m Wilcoxon va\u0300 th\u01b0\u0309 nghi\u1eb9\u0302m Mann-Whitney). D\u01b0\u0303 li\u1eb9\u0302u bi\u0323 m\u00e2\u0301t \u0111u\u031b\u01a1\u0323c ngoa\u0323i suy theo LOCF (l\u00e2\u0300n quan sa\u0301t cu\u00f4\u0301i cu\u0300ng \u0111u\u031b\u01a1\u0323c ti\u00ea\u0301n ha\u0300nh). Ph\u00e2\u0300n m\u00ea\u0300m BMDP \u0111a\u0303 \u0111u\u031b\u01a1\u0323c s\u01b0\u0309 du\u0323ng cho mu\u0323c \u0111i\u0301ch th\u00f4\u0301ng ke\u0302. Gia\u0301 tri\u0323 P \u0111u\u031b\u01a1\u0323c bi\u00ea\u0309u thi\u0323 2 \u0111\u00e2\u0300u (2-tailed).<\/p>\n Nha\u0302n kh\u00e2\u0309u ho\u0323c \u0111u\u031b\u01a1\u0323c ba\u0301o ca\u0301o trong Tab I. Kho\u0302ng ti\u0300m th\u00e2\u0301y s\u01b0\u0323 kha\u0301c bi\u1eb9\u0302t gi\u01b0\u0303a hai nho\u0301m. Tab l: Nha\u0302n kh\u00e2\u0309u ho\u0323c cu\u0309a \u0111\u00f4\u0301i tu\u031b\u01a1\u0323ng nghie\u0302n c\u01b0\u0301u<\/p>\n<\/div>\n<\/div>\n LIPOFILM<\/p>\n<\/div>\n<\/div>\n<\/td>\n 0 2% Sodium hyaluronate<\/p>\n<\/div>\n<\/div>\n<\/td>\n P<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Gi\u01a1\u0301i: Nam (N,%)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1 (89%)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1 (90%)<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS O<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n N\u01b0\u0303 (N,%)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 8 (11%)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 9 (10%)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Tu\u00f4\u0309i (Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 53,1 \u00b1 13,9<\/p>\n<\/div>\n<\/div>\n<\/td>\n 60,8 \u00b1 13,8<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Schirmer\u2019s test: mm (Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 4,1 \u00b1 1,8<\/p>\n<\/div>\n<\/div>\n<\/td>\n 4,4 \u00b1 1,3<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n S\u01a1\u0323 a\u0301nh sa\u0301ng: score (Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1,1 \u00b1 0,8<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1,2 0,9<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n No\u0301ng ra\u0301t\/\u0111au: score (Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1,9 \u00b1 0,6<\/p>\n<\/div>\n<\/div>\n<\/td>\n 2,0 \u00b1 0,8<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Nhi\u0300n m\u01a1\u0300: score (MeaniSD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1,2 \u00b1 1,2<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1,0 \u00b1 0,8<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Ca\u0309m gia\u0301c co\u0301 di\u0323 v\u1ea1\u0302t: score (Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 2.1 \u00b1 0,3<\/p>\n<\/div>\n<\/div>\n<\/td>\n 2,3 \u00b1 0,7<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Sung huy\u00ea\u0301t k\u00ea\u0301t ma\u0323c: VAS (MeaniSD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 37.4 \u00b1 17,5<\/p>\n<\/div>\n<\/div>\n<\/td>\n 48,5 \u00b1 22,3<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Phu\u0300 n\u00ea\u0300 k\u00ea\u0301t ma\u0323c: VAS (Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 15,4 \u00b1 12,2<\/p>\n<\/div>\n<\/div>\n<\/td>\n 14,2 \u00b1 13,5<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Phu\u0300 mi\u0301: VAS ((Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 19,1 \u00b1 21,3<\/p>\n<\/div>\n<\/div>\n<\/td>\n 19,5 \u00b1 25,8<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Nhu\u1ecd\u0302m fluorescein: score (Mean\u00b1SD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1,4\u00b1 \u00b1 0,5<\/p>\n<\/div>\n<\/div>\n<\/td>\n 1,8 \u00b1 0,8<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n BUT : sec (MeartfcSD)<\/p>\n<\/div>\n<\/div>\n<\/td>\n 4,6 \u00b1 1,3<\/p>\n<\/div>\n<\/div>\n<\/td>\n 5,1 \u00b1 1,4<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS (*)<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n \u00b0 Fisher\u2019s test; * Mann-Whitney\u2019s test; NS = kho\u0302ng co\u0301 y\u0301 nghi\u0303a th\u00f4\u0301ng ke\u0302<\/p>\n Ngoa\u0300i ra ca\u0301c d\u00e2\u0301u hi\u1eb9\u0302u kha\u0301ch quan \u0111u\u031b\u01a1\u0323c ca\u0309i thi\u1eb9\u0302n \u0111a\u0301ng k\u00ea\u0309 khi \u0111i\u00ea\u0300u tri\u0323 v\u01a1\u0301i Lipofilm. Tre\u0302n th\u01b0\u0323c t\u00ea\u0301, vi\u1eb9\u0302c \u0111i\u00ea\u0300u tri\u0323 la\u0300m gia\u0309m \u0111a\u0301ng k\u00ea\u0309 \u0111i\u00ea\u0309m s\u00f4\u0301 cu\u0303ng nhu\u031b cu\u0309a t\u00e2\u0301t ca\u0309 ca\u0301c d\u00e2\u0301u hi\u1eb9\u0302u chu\u0309 quan \u0111u\u031b\u01a1\u0323c \u0111a\u0301nh gia\u0301 v\u00ea\u0300 m\u1ea1\u0306t th\u00f4\u0301ng ke\u0302 (-90%) so v\u01a1\u0301i \u0111u\u031b\u01a1\u0300ng co\u031b s\u01a1\u0309, loa\u0323i tr\u01b0\u0300 phu\u0300 mi\u0301 (Tab II). Ngoa\u0300i ra, vi\u1eb9\u0302c gia\u0309m \u0111i\u00ea\u0309m s\u00f4\u0301 cu\u0303ng phu\u0323 thu\u1ecd\u0302c va\u0300o th\u01a1\u0300i gian (Fig 2). K\u00ea\u0301t qua\u0309 tu\u031bo\u031bng t\u01b0\u0323 cu\u0303ng thu \u0111u\u031b\u01a1\u0323c \u01a1\u0309 nho\u0301m \u0111i\u00ea\u0300u tri\u0323 Natri Hyaluronate 0,2%, nhu\u031bng \u0111i\u00ea\u0300u tri\u0323 v\u01a1\u0301i Lipofilm cho k\u00ea\u0301t qua\u0309 t\u00f4\u0301t ho\u031bn \u0111a\u0301ng k\u00ea\u0309. Trong th\u01b0\u0323c t\u00ea\u0301 lipofilm cho th\u00e2\u0301y k\u00ea\u0301t qua\u0309 t\u00f4\u0301t ho\u031bn ca\u0309 v\u00ea\u0300 m\u01b0\u0301c \u0111\u1ecd\u0302 a\u0309nh hu\u031b\u01a1\u0309ng va\u0300 s\u00f4\u0301 lu\u031b\u01a1\u0323ng tham s\u00f4\u0301 kha\u0301c nhau v\u00ea\u0300 m\u1ea1\u0306t th\u00f4\u0301ng ke\u0302 so v\u01a1\u0301i \u0111u\u031b\u01a1\u0300ng co\u031b s\u01a1\u0309 (Fig 1, 2 va\u0300 Tab. II).<\/p>\n<\/div>\n<\/div>\n<\/div>\n Tab II: To\u0301m t\u0103\u0301t k\u00ea\u0301t qua\u0309<\/p>\n<\/div>\n<\/div>\n LIPOFILM<\/p>\n<\/div>\n<\/div>\n<\/td>\n 0.2% Sodium hyalurcnate<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Bi\u00ea\u0301n change<\/p>\n<\/div>\n<\/div>\n \u20191LM<\/p>\n<\/div>\n<\/div>\n<\/td>\n P*<\/p>\n<\/div>\n<\/div>\n<\/td>\n change<\/p>\n<\/div>\n<\/div>\n<\/td>\n P*<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n No\u0301ng ra\u0301t\/\u0111au -71%<\/p>\n<\/div>\n<\/div>\n<\/td>\n P<0.05<\/p>\n<\/div>\n<\/div>\n<\/td>\n -55%<\/p>\n<\/div>\n<\/div>\n<\/td>\n P<0.05<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n S\u01a1\u0323 a\u0301nh sa\u0301ng -30%<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS<\/p>\n<\/div>\n<\/div>\n<\/td>\n -50%<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n Nhi\u0300n m\u01a1\u0300 -100%<\/p>\n<\/div>\n<\/div>\n<\/td>\n P<0.05<\/p>\n<\/div>\n<\/div>\n<\/td>\n -60%<\/p>\n<\/div>\n<\/div>\n<\/td>\n NS<\/p>\n<\/div>\n<\/div>\n<\/td>\n<\/tr>\n\u0110\u1ea0\u0306T V\u00c2\u0301N \u0110\u00ca\u0300:<\/h2>\n
MU\u0323C \u0110I\u0301CH:<\/h2>\n
PHU\u031bO\u031bNG PHA\u0301P:<\/h2>\n
K\u00ca\u0301T QUA\u0309:<\/h2>\n
GI\u01a0\u0301I THI\u1eb8\u0302U<\/h2>\n
\nM\u1ecd\u0302t s\u00f4\u0301 nghie\u0302n c\u01b0\u0301u chi\u0309 ra r\u0103\u0300ng thi\u00ea\u0301u lipid trong ma\u0300ng nu\u031b\u01a1\u0301c m\u0103\u0301t la\u0300m ta\u0306ng h\u1ecd\u0302i ch\u01b0\u0301ng kho\u0302 m\u0103\u0301t. S\u01b0\u0323 bay ho\u031bi la\u0300 co\u031b ch\u00ea\u0301 quan tro\u0323ng nh\u00e2\u0301t cu\u0309a vi\u1eb9\u0302c la\u0300m mo\u0309ng ma\u0300ng nu\u031b\u01a1\u0301c m\u0103\u0301t cu\u00f4\u0301i cu\u0300ng co\u0301 th\u00ea\u0309 ga\u0302y ra s\u01b0\u0323 v\u01a1\u0303 ma\u0300ng nu\u031b\u01a1\u0301c m\u0103\u0301t va\u0300 hi\u0300nh tha\u0300nh \u0111i\u00ea\u0309m kho\u0302.
\nCli\u0301nica Oculi\u0301stica,
\nBiomedico\u201d
\nTubilux Pharma, Research Department, Pomezia, Italy; (6)
\n\u201cLa Sapienza\u201d
\nItaly,
\nCa\u0301c phu\u031bo\u031bng pha\u0301p tri\u0323 li\u1eb9\u0302u kha\u0301c nhau \u0111\u00ea\u0309 gia\u0309m bay ho\u031bi, ca\u0309i thi\u1eb9\u0302n ch\u01b0\u0301c na\u0306ng ha\u0300ng ra\u0300o lipid t\u01b0\u0300 \u0111o\u0301 la\u0300m gia\u0309m ti\u0300nh tra\u0323ng kho\u0302 m\u0103\u0301t \u0111a\u0303 \u0111u\u031b\u01a1\u0323c th\u01b0\u0309 nghi\u1eb9\u0302m tuy nhien k\u00ea\u0301t qua\u0309 \u0111\u00ea\u0300u kho\u0302ng nhu\u031b mong \u0111\u01a1\u0323i.<\/p>\nPHU\u031bO\u031bNG PHA\u0301P NGHIE\u0302N C\u01af\u0301U<\/h2>\n
K\u00ca\u0301T QUA\u0309<\/h2>\n
\nHi\u1eb9\u0302u qua\u0309: \u0110i\u00ea\u0300u tri\u0323 v\u01a1\u0301i lipofilm la\u0300m gia\u0309m \u0111a\u0301ng k\u00ea\u0309 \u0111i\u00ea\u0309m s\u00f4\u0301 tri\u1eb9\u0302u ch\u01b0\u0301ng toa\u0300n c\u00e2\u0300u cu\u0303ng nhu\u031b ca\u0301c tri\u1eb9\u0302u ch\u01b0\u0301ng chu\u0309 quan v\u00ea\u0300 m\u1ea1\u0306t th\u00f4\u0301ng ke\u0302 (-69%) so v\u01a1\u0301i \u0111u\u031b\u01a1\u0300ng co\u031b s\u01a1\u0309, ngoa\u0323i tr\u01b0\u0300 ch\u01b0\u0301ng s\u01a1\u0323 a\u0301nh sa\u0301ng (Tab II). Vi\u1eb9\u0302c gia\u0309m \u0111i\u00ea\u0309m tri\u1eb9\u0302u ch\u01b0\u0301ng toa\u0300n c\u00e2\u0300u phu\u0323 thu\u1ecd\u0302c va\u0300o th\u01a1\u0300i gian (Fig 1).<\/p>\n\n
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