JOURNAL OF 108 - CLINICAL MEDICINE A N D PHARMACY Vol.12 - N"3/201'7
Danh gia hieu qua lam sang va tinh an toan cua dung djch Diquas tren benh nhan mo lasik
Efficacy and safety of Diquas in padents after lasik surgery
Nguyen XuSn Hiep B^nh vien Mat Trung uang
Tom tat
Muc tiiu: Danh gia hieu qud lam sang va tinh an toan cCia dung djch Diquas tren benh nhan mo lasik. Ddi tugng vd phuong phdp: Nghien cdu tien cUu, can thiep lam sang, khdng ed nhdm chUng. 50 mdt/25 b i n h nhan sau md lasik. Ddnh gia test TBUT, Schlrmer I, Fluorescein, Rose Bengal vd ede trieu chdng chu quan (cdm vUdng, dau rat, khd m l t , ndng mat, mdi, md, chay nude mdt) trudc vd sau dung thude 1 thang, 2 thang vd 3 thdng. Ghi nhdn cdc tdc dung khdng mong mudn (cUOng tu ket mac, phu mi, ket mac, dau rat, nhin md, dau dau...). Ker qud: 6 thdi diem 1 thang, 2 thdng va 3 thdng sau dung thude: TBUT, Schlrmer I tang len tren benh nhan md lasik, diem nhudm bdt mau Fluorescein, Rose Bengal gidm di cd y nghia vdi p<0,01. Cdc t r i i u ehUng chCi quan (cdm vUdng, dau rdt, khd mat, nong mdt, mdi, md, chdy nUdc mat) deu gidm vdi p<0,01. Cd 6 mdt mo lasik cUOng tu ket mac sau diing thudc 1 tuan kem theo dau rat mat. Kit ludn: Diquas cd hieu qud trong cdi t h i i n trieu chdng khd mat va an todn tren b i n h nhan sau mo lasik.
TUkhda: Diquas, lasik, khd mat.
Summary
Objective: To evaluate the efficacy and safety of Diquas in patients after lasik surgery. Subject and method: Prospective non comparative trial. Fifty eyes of 25 patients after lasik. Accessed TBUT, Schlrmer I, Fluorescein, Rose Bengal staining score and the subjective symptoms (foreign body sensation, eye pain, dry feeling, feeling of burning, fatigue of the eyes, blurred vision, lacrlmatlon) before and after treatment with Diquas 1 month, 2 months and 3 months. Recorded the symptoms of adverse reactions (red eye, swelling of the conjunctiva or eyelid, pain eye, blurred vision, headache...). Result: At the 1 month, 2 months and 3 months after treatment with Diquas: TBUT, Schirmer I increased significantly in eyes after lasik, fluorescein and rose bengal staining score decreased significantly with p<0.01.The subjective symptoms (foreign body sensation, eye pain, dry feeling, feeling of burning, fatigue of the eyes, blurred vision) were improved as well (p<0.01). Six eyes after lasik were red and pain itching after treatment 1 week. Conclusion: Diquas has the efficacy and safety In patients after lasik surgery.
Keywords: Diquas, lasik, dry eye.
Ngdy nhdn bdi: 23/01/2017, ngdy chap nhdn ddng: 10/03/2017
Nguaiphdn hoi: Nguyin Xuan Hi0p. Email: [email protected] - Benh vien Mat Trung uong
JOURNALOF108-CLINICALMED1CINEAND PHARMACY Vol.12-N'3/2017
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Bleu d6 4. Mdi mat trudc vd sau dieu trj Cdm giac khd mat rat t h u d n g gap d benh nhdn sau phau thuat lasik vdi 11 mat khd t h u d n g x u y i n nhung khdng dnh hudng den sinh boat, 18 mat khd mat thodng qua (36%). Sau d u n g Diquas 2 thang, trieu chdng nay cdi t h i i n rd ret vdi 33 mdt (66%) khdng cdm thay khd mat, chi cd 1 benh nhdn vdi 2 mat cdn cdm gidc khd mat t h u d n g xuyen, benh nhan nay da dupe ke ddn bo sung nudc mdt nhdn tao va dung djch restasis. Sau 4 thdng dieu trj, benh nhan eh! cdn cam giac k h d mdt nhe thodng qua. Mdi mat cung gap t h u d n g x u y i n d benh nhan sau md lasik cd dau hieu khd mdt. Cd the do ddy la ddi tUOng tr^ t u o i , cd nhu cdu dpc sach, sd d u n g mdy vi tfnh nhieu nen de mdi mdt sau mo vdi 40 mat (80%) mdi mat t h o d n g qua. Sau dung Diquas 1 thdng cdn 34 mat (68%), 2 thdng cdn 26 mat (52%) mdi mat thoang qua. SU cdi thien nay cd y nghTa t h d n g ke vdi p<0,01.
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Bleu do 6. Ndng mdt trUde va sau dieu trj Nhin m d thodng qua la dSu hieu tinh te ma b i n h nhan sau md lasik tre tuoi thUdng phdt hi&n thay vdi 30 mat (60%) nhin m d thodng qua miJc i36 nhe. Sau diJng Diquas 2 thang, trieu chdng nay chi cdn gap d 20 mat chiem 40%.
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Ndng mat, cdm gidc ndng nhu bdng trong mat ft gap. Dau hieu ndy thudng gap trong nhdng trUdng hpp kho mat ndng. Bdi vdi b i n h nhdn sau md lasik, khd mdt thudng d mdc dp nhe hoac vda nen ft gap cam giac ndng mdt. Trong nhdm nghien cdu, chung tdi chi gap 6 mSt ndng mdt nhe thodng qua, 4 mat ndng mat vda. Sau dung Biquas 2 thdng, trieu ehdng nay cdi t h i i n chi cdn 4 mat ndng mdt nhe thodng qua.
Chdy nude mat cung la m o t trong cac dau hieu thudng gap trong benh ly khd m a t Benh nhdn khd mat thudng bj kfch thfch che tiet nUdc mat phdn xa n i n du nhieu nUdc mat nhUng chat lupng nUdc mat kem, khdng giCf dupe film nude mdt (mat on dinh
cCia film nude mat), d benh nhdn sau phau thuat lasik, do Idp thdn kinh cdm gidc be mat gidc mac bj cat ddt trong qua trinh phau thuat lam giam cdm gidc cua giac mac, gidm phdn xa che ti^t nude mat.
Vl vay, chdy nude mdt khdng phai la dau hieu phd bien t r i n benh nhdn khd mat sau phau thuat lasik.
Trong 50 mat nghien edu, ehung tdi chi ghi nhdn dupe 14 mat chay nUdc mdt thodng qua, 12 mdt chdy nude mdt thudng xuyen hon. Sau 2 thang sd dung Diquas, trieu chdng nay chi cdn gap d 15 mat chdy nudc mat thoang qua, ph^n Idn b i n h nhan khdng bj chdy nude mat vdi 31 mat (62%).
Bang 1 . Gia tri TB test TBUT, Schirmer I, Fluorescein, Rose Bengal trudc va sau dieu tri
X ± S D Trucfc dieu tri Sau 1 thang dieu tn Sau2th^ngdieutrj Sau 3 thang di^u tn
P
TBUT (s) 3,16+1,38 4,06 ±1,41 5,32 ±1,32 6,79 ± 0,43
<0,001
Schirmer 1 (mm) 5,10 ±1,00 5,74 ± 0,62 7,94 ± 0,62 8,64 ± 0,50
<0,001
Fluorescein (diem nhudm]
4,30 ± 0,58 3,30 ± 0,58 2,30 + 0,58 0,43 ±0,51
<0,001
Rose Bengal (diem nhudm)
4,86 ±1,00 3,90 ± 0,71 2,44±1,16 0,86 ± 0,53
<0,007
Thdi gian v d phim nUde mat sau mo 1 tuan cda benh nhan lasik trong nhdm nghien cdu la 3,16 ± 1,38 gidy. Sau dung Diquas, thdi gian v d phim nUdc mdt dugc cai thien tang dan d cd 3 thdi diem vdi p<0,001. Den thang t h d 3, t h d i gian v d phim nude mat trung binh la 6,79 ± 0,43 giay. Nghien cdu cua Corrales vd cdng sU (2011) chi ra rang thdi gian vd phim nude mdt ngdn la bieu hien eua sU suy gidm chat nhay (mucin) trong thanh phan film nude mat dan den mat dn djnh cua film nude mat.
Hyaluronate thUdng dugc sd dung trong dieu trj khd mat nhung ft hieu qua vdi nhdng trudng hpp khd mat do thieu mucin [5]. Viic sd dung Diquas vdi cO che tdc dpng mdi len te bao ddi cOa ket mac lam tang che tiet mucin giup dn djnh film nUdc mat.
Nghien cdu cua Ayaml Masuda (2013) cung cho ket qud tuang tU vdi TBUT trUde dieu trj tU 3,10 ± 0,80 gidy tdng len 6,50 ± 3,80 giay tren benh nhdn khd mat ndng sau md lasik [6].
Lupng nude mdt dupe the hien qua test Schirmer I. Ci benh nhan khd mat, lUpng nUdc mat thudng bj thieu hut, khi do lupng nudc mat bdng bang giay tham Schirmer ket qud tham thudng <
10mm. Trong nghien edu cua ehung tdi, test Schirmer I trUde khi diJng Diquas la 5,10 ± 1,00mm.
Sau dung Diquas 1 thdng, sU che tiet nude mat tdng rat ft, nhung sau 2 thang, nUde mat dupe che tiet nhieu hon, Schirmer I Id 7,94 ± 0,62mm.
Ket qud di^m nhudm Fluorescein trUdc dung Diquas cua chung tdi la 4,30 ± 0,58. Sau diing Biquas diem nhudm Fluorescein da gidm di d ed 3 thdi diem theo ddi vdi p<0,001. N g h i i n cdu cCia Ayami Masuda cung chi ra sU cdi thien cua cac ton thuang viem giac mac chdm ndng tren benh nhdn khd mat sau phau thuat lasik sau khi dung Diquas 1 thang, sd diem nhudm Fluorescein gidm dl rd ret [6].
JOURNAL OF 108 - CLINICAL MEDICINE AND PHARMACY
TUdng t u thi Diquas ciing cd vai trd lam hdi phuc cae tdn thuong t r i n ket mac trong b i n h ly khd mat. Biem nhudm Rose Bengal cung gidm di d nhdng benh nhdn khd mix sau phau thuat lasik cd SLf dung Diquas. Ket qud eCia chung tdi tuang dong vdi ket qua cua Ayami Masuda [6], diem nhudm Rose Bengal trUde dieu trj eCia chung tdi Id 4,86 ± 1,00 da giam xudng cdn 0,86 ± 0,53 sau 3 thang tra dung djch Diquas.
3.3. Ddnh gid tinh an todn cia dung dich Diquas
Bang 2. Cac dau h i i u tac dung phu cua thudc Trigu chilmg
Phu mi Phu ket mac CUOng tu ket mac dau rat sau tra thuoc Nhin md sau tra thuoc Dau hi^u toan than (dau d^u, buon non, chong mat, dau bung, ndi me day...)
Tong
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TOO Trong 50 mat sU dung Biquas, chung tdi ghi nhdn duac 6 mat cd cUOng tu ket mac kem theo dau rat mdt nhe sau sd dung Biquas 1 tudn. Nhdng b i n h nhdn nay sau khi dUpc hudng dan tra dung djch acid hyaluronic trudc 10 phdt, tra Diquas tiep sau do thi benh nhan khdng cdn cam gidc dau rdt nOa, cUOng tu ket mac cung giam dan va t u het sau 1 tuan.
Nhi^u n g h i i n cdu cung ehl ra vai trd phdi hop gida acid hyaluronic va Diquas gidp lam tdng hieu qua dieu trj khd mat, sU phdi hpp nay vda giup cdi t h i i n cdc trieu chUng chd quan cua khd mdt, vda keo ddi thdi gian v d phim nUdc mdt cung nhU lam Idnh cac ton thuang ket gidc mac gay ra do b i n h ly khd mat [7]. Trong nhdm nghien cdu ndy cung khdng cd benh nhan nao ed cdc phdn Ung phu nhU phu ml, phu ket mac, nhin m d do tra thudc hay cae trieu ehUng toan than dan den phai ngUng thudc. Tuy n h i i n trong nghien cdu m d nhdn eCia Diquafosol 3%
tai Nhdt Bdn (2012) da chi ra den 25,8% benh nhdn ed tdc dung phu khi dung thudc nhUng deu d mdc dp nhe va cd the hdi phuc hoan toan ngay ca khi dang tiep tuc dung thudc cung nhusau khi ngUng thudc.
Sau phdu thudt lasik ed nhieu b i n h nhan co bleu h i i n eua khd mdt sau mo. Nghiin cdu nay cho thay dung djch Diquas ed khd ndng lam cdi thien cac trieu chdng chu quan (cdm vudng, dau rat, khd mIt, ndng mat, mdi, m d , chay nude mdt), giup dn dinh film nude mdt (TBUT tang l i n d cd 3 thdi diem sau dCing thude), tang che ti^t nude mat (Schirmer I tang d ca 3 thdi diem sau diJng thuoc) vd giup lam lanh cae tdn thuong ket giac mac do b i n h ly khd mat gay ra (diem nhudm Fluorescein vd Rose Bengal giam xudng d cd 3 thdi di^m sau dCing thudc). Chi co 6 mdt euang t u ket mac kem dau rat nhe sau dijng thudc nhung t r i i u ehdng nay mat dan khi tra phoi hop eung dung djch acid hyaluronic. NhU vdy co the coi Diquas cd hieu qua trong cdi thien trieu chUng khd mat va an todn tren benh nhdn sau mo lasik.
Tai lieu tham khilo
1. Toda 1, Asano KN, Komai HY et al (2001) Dry eye after laser in situ keratomileusis. Am J Ophthalmol 132:17.
2. Tauber J, Davitt WF, Bokosky JE et al (2004) Double-masked, placebo-controlled safety and efficacy trial of diquafosol tetrasodium (INS365) ophthalmic solution for the treatment of dry eye.
Cornea 23: 784-792.
3. Kenichi M, Taisuke N (2012) Evaluation of the efficacy of 3% diquafosol sodium ophthalmic In dry solution in dry eyes. Japanese Journal of Clinical Ophthalmology 66:1191-1194.
1 Akihiko Y, Kazuo T, Yuichi O (2012) An open label long-term study of 3% diquafosol sodium in dry eyes.
Journal of the Eye 29:527-535.
5. Corrales RM, Narayanan S, Fernandez I etal (2011) Ocular mucin gene expression levels as biomarkers for the diagnosis of dry eye syndrome. Invest Ophthalmol Vis Sci 52:8363-8369.
6. Ayami M, Yosai M, Ryohei N et al (201) Efficacy of Long-Term Treatment with Diquafosol Sodium for Dry Eye Due to Laser In Situ Keratomileusis. Journal ofthe Eye 30(2): 249-253.
7. Kamiya K, Nakanishi M et al (2012) Clinical evaluation of the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome: A prospective, randomized, multicenter study. Eye 26:1363-1368.
