TAP CHl NGHliN CO'U Y HQC
Summary
PRELIMINARY RESULTS OF MINIRADICAL TRANSCANAL
M A S T O I D E C J O M Y
The study was to evaluate the preliminary results of miniradieal transcanal mastoidectomy.
The results showed that 17 females / 8 males, aged from 16 to 67 years olds. 22 pafients (pts) were done reeonstruefive tympanal cavity. By the 10"^ day post -operation 22/25 pts were without otorrhea, 2 months post operafion the miniradieal mastoidectomies were stable,with the width of external auditory canal twice than a nomal one with ear-hole enough to drain. In conclusion, this is an minisurgery with perfect cavity of mastoidectomy, which has faster recover time and make good conditions for hearing reconstruction.
Keywords: cholesteatoma, retraction of tympanic membrane, transcanal antrotomy, miniradieal mastoidectomy
HIEU QUA VA TiNH AN
T O A NCUA
V I G A D E X A T R O N G D I ^ UTR! VIEM KET MAC
Nguyin DiPC Anh Trwdng Dai hpc Y Ha Npi Nghien cuv nham danh gid hipu qua deu trj va tinh an todn cua thude tra mat Vigadexa® (moxifloxacin 0.5% vd dexamethasone 0,1%) d benh nhdn vidm kit mpc cap. Kit qua cho thiy trwdc deu tri 118 mat (79,2%) vidm mdc dd nhp vd tmng binh, 31 mat (20,8%) viem npng, trong dd 14 mat (9,4%) cd gia mac vd 8 mat (5,4%) vidm gidc mpc. Sau diu th, tl lp khdi bpnh hoan toan Id 67,8 % sau 8 ngay va 87,2% sau 12 ngdy. Khdng xuit hipn biin Chung do dung thudc. Kit lupn: Vigadexa® td ra cd hipu qua cao tmng deu tri vidm kit mpc cip. Thudc khdng gdy kich dng hope tdc dung phu tai mat. Dpng thude phdi hgp thupn tien han cho sw dpng, gidm chi phi va tang hipu qua diu trj.
Td khoa: Vigadexa, viem kit mac
I. DAT
VANDt
ViOm k i t mac la mdt bOnh m i t thudng gdp nhat Oilu trj viOm k i t mac thudng bing mOt thudc tra m i t khang sinh phd rdng phdi hgp vdi mot thude chdng viOm. ViOc su dung cung IQc 2 thudc tra m i t lam tang chi phi dilu trj vd Id bat tlOn ddi vdi nhilu bOnh nhan khiln eho thude dung khong du lilu va giam hiOu qua dilu trj. G i n day, mot thude tra m i t mdi la Vigadexa® eua Alcon duge dua ra thj trudng, trong dd k i t hgp ca 2 y l u td khdng sinh (moxifloxacin 5%) vd chdng viOm
(dexamethasone 0,1%). O ViOt Nam, chua ed nghiOn c&u ddnh gid hiOu q u i cua Vigadexa®
ddi vdi viOm k i t mge. NghiOn c&u ndy nhim 2 mge fiOu: (1) ddnh gid hiOu qua diOt khuln vd chdng viOm eua Vigadexa® ddi vdi bOnh viOm kit mac d p ; vd (2) ddnh gid tinh an todn cua thude ddi vdi ede bOnh nhdn dugc dilu trj.
II.
D 6 |TU'QNG VA PHU'ONG
PHAPTieu chuln lua chgn: ede benh nhdn viOm k i t mge clp, tudi t& 18 trd lOn, kham tgi bOnh viOn m i t trung uang trong nam 2010.
TAP CHI NGHIEN CU'U Y HQC
Tieu chuan loai tru (1) vifim ket mac muc do rat nhe, (2) c6 ton tlui'O'ng gi^c mge ho^c dau hieu cua benh mat kh,-1c, (3) tien su' tang nhan ap, dl irng vo'i cac thnnh phan cua th.u6c (4) phu niT dang c6 thai/cho con bii
oanh gia bao gom trieu chu'ng chi'i qunn (cam giac dau nhue mat va ngua rat d mat) Cam giac dau a mat duo'C chia thanh cac muc 0 = khong dau: 1 = dau nhe, 2 = dau trung binh, chua can thuoc giam dau, 3 = dau nang, can phai dung thuoc giam dau Cam giac ngu'a rat a mat du'O'c chia thanh cac mu'C do 0 = khong ngu'a rdt, 1 = ngu'a rat nhe, 2 ngua rat trung binh, 3 = ngu'a rat nang Kham mat bao gom do thi lu'c, kham smh hien vi Viem a mi va ket mac dup'c chia thanh cac muc 0 = khong viem, 1 = phii ne nhe, 2 = phu ne trung binh, 3 = phu nang, phai vanh mi mo'i thay toan bp giac mac, co the co gia mac.
c a c b6nh nhdn d u g c dung mot thuoc duy nhat la Vigadexa'" tra mdt 3 den 4 lln/ng^y Uanh gia cac thOng so nghien cu'u trong lan kham d^u ti6n (ngdy 0), sau 4 ngdy, 8 ngay va 1? ngay Thong kd bdng phan mem Medcalc 11,G va siV dung test x,^ de kiem dinh khac bi^t cua ket qua dieu tn
III. K^TQUA
Dac diem benh nhan
Nghien cu'u bao gom 82 benh nhan (149 mat) viem ket mac cap, trong do co 44 (53,7%) benh nhan nam va 38 (46,3%) benh nhan nu' Tuoi benh nhan trong khoang 18 den 56 (tuoi trung bmh la 32 8 ± 10 55) Thai gian ke ti)' khi co trieu chung den khi duac dieu tn la tu' 1 den 4 ngay,
Thi iwc tnjx>c va sau dieu tri
140 120 '
100 - 80 60 40 20 0
109 112
31 29 9 12 8
116
21
6 17
126
;-
5/106/10 7/10 8/10 9/10 10/10
NR<ivO Np..iv4 Np,,iv8 NR.IV 12
B i l u do 1. Thay doi thj Igc tro.ng d i l u trj
Trcng so 82 benh nhan, co 21 (25,6%) benh nhan co thi luc trong khoang 5/10 den 10/10 va 109 mat (73,2 %) co thi luc trong khoang 9/10 den 10/10 Sau 12 ngay, so mdt co thi luc trong khoang 9/10 den 10/10 la 126 (84,6 %) (Bieu do 1) S u thay doi thj luc sau dieu tn khong coy nghTa thong ke (p > 0,05),
Mire do dau va ngifa rat mit
So benh nhdn c6 dau d mdt (miic do nhe va trung binh) la 15 (18,2%), Sau 8 ngay dieu trj, chi con 3 (9,8%) benh nhan dau nhe. Khong co trudng hgp ndo con dau 2 tuan (bieu do 2). S u khac biet CO y nghia thong ke (p < 0,05),
54 TCNCYH 78 (1) - 2012
TiD^P CHl NGHlfeN CU'U Y HQC
9 0 80 70 6 0 50 4 0 30 20 10 0
6 7
r
78I 'A
7 9 82
•- I
1 1
NR.nv 0 Nn-^v ^ Nr.iV 8 IMp.,-iv 12
K h o i U I (1,111 D.ui n h e • O.m l l imp, b i n h
Bieu do 2. Cam giac dau mat
Cam giac ngua rat tai mat gap nhieu hon cam giac dau trong so benh nhan nghien c&u. 38 30nh nhan (46,3%) co ngua rat mat, phan Ion a muc do nhe So benh nhan nay giam dl nhanh :hdng sau dieu tn, sau 4 ngay con 29 benh nhan (35,3%), sau 8 ngay chi con 6 benh nhdn [7,3%). Khong con benh nhan nao keu ngua rat mat sau 12 ngay (bieu do 3) Trong so 82 bOnh ihdn, chl CO 7 truong hop (8,5%) cam thay com mat khi tra thuoc. Su khac biet nay co y nghTa :hdng ke (p < 0.05).
90 80 70 60 50 40 30 20 10 0
7 6
82
4 4 27
11
Ngay 0
B, K h o n g rat 5 3
I 20
Ngay 4 Rat n h e
Ngay 8 I Rat t r u n g b i n h
N g a y 1 2
Bilu dd 3. Cam giac ngua rat mat
140 120 100 80 60 4 0 2 0 0
130
101
(MgayO Ngay 4 Ngay 8 Ngny 12 i i K h o n g v i e m V i e m n h ^ • V i e m I r u n g b m h V i e m n a n g
Bleu dd 4. Thay ddi cua viem kdt mac
iTAP CHl NGHliN CO'U Y HQC
H/Ou qui diiu trj doi v&i vlim ket m^c Trudc dilu trj, ed 118 mit (79,2%) viOm d m&c (JO nh9 vd trung binh, 31 mit (20,8%) viOm ndng. Trong sd mdt viOm ndng, 14 mit (9,4%) cd gii mac, 8 mit (5,4%) ed viOm gidc mac chim nOng. Sau 8 ngdy, chi edn 48 mdt vIOm nh? vd trung binh (32,2%) vd 2 mit viOm ndng (1,34%). Thdi gian didu trj kOo ddi han gdp d nh&ng tru-dng hp-p cd gii mac ho$c viOm gidc mac (Bidu dk A). Sg khde blOt ed </
nghia thdng kO (p < 0,05).
IV. BAN LUAN
ViOm kdt mac Id mOt bOnh thu-dng xult hiOn clp tinh vd tdn tai trong thdi gian ngin nlu dwgc dieu trj thich hp-p. MOt thudc khdng sinh tra mit dung tdt trong didu trj viOm kit mac clp cin phii ddp &ng nh&ng yOuelu sau: (1) phd khdng khuln rOng; (2) kha ndng thdm nhdp tdt vdo cde md eua mit vd ed hiOu qui diOt khuln manh vd nhanh; (3) tdc dgng ddi vdi ede vl khuln khdng thude; (4) khdng gdy kieh thieh mit vd khdng ddc hai ddi vdi mit. Moxifloxacin 0,5 % Id mOt fluoroquinolone the hO 4 phd rOng ed tdc dung tdt ddi vdi c l vl khuln gram dm gram du-ang vd ede vi khuln khdng thude [4, 5]. Moxifloxacin 0,5% dd du-p-c ch&ng minh ed hiOu qua trong du- phdng vd dieu trj nhidm trung sau phlu thudt phaco [2]
vd phlu thudt LASIK [1]. Moxifloxacin 0,5% ed kha ndng xuyOn thim vdo ket mac tdt vd dgt ndng xJO cao han ede fluoroquinolone khde Id do nd cd pH 6,8, gin vdi pH sinh 11.
Dexamethasone 0,1% Id mdt thude ehdng viOm mgnh cQng dd ch&ng td hiOu qui giam viOm tdt trong didu trj ede nhidm trung. ViOc phdi ho-p 2 thdnh phin trOn trong mdt sin phim Id Vigadexa® ngodi viOc giup cho bOnh nhdn thudn tiOn han cdn cd khi ndng tdng eu-dng hiOu qua didu trj.
Trong nghiOn c&u ndy, tru-dc didu trj sd mit viOm d m&c trung binh vd ndng Id 126 (84,5%). Sau 8 ngdy dieu trj, ed 101 mit
(67,8%) hdt ViOm hodn todn vd 27 m^t (18,1%) chl edn viOm d m&c dO nho. Sau 12 ngdy, 130 mit (87,2%) khdi hodn todn, chic6n 10,1% mit viOm nho vd 2,7% mit viOm mii-c dO trung binh. Nh&ng trudng hgp chua kh6i hodn todn sau 2 tuin ddu Id nh&ng mdt c6 viOm ndng ed xult hiOn gii mac hodc vidm gidc mge.
VIOm kdt mac thu-dng khdng Inh hu-dng ddn thj lu-c. Tuy nhiOn, trong 4 ngdy diu sau didu trj, ed 3 mit thj lu'c gilm nho do viOm gidc mac mdi xult hiOn. Sau 12 ngdy, sd mit c6 thj
\gc trong khoing 9/10 ddn 10/10 dgt 84.6 %.
Sd mit cd thj lyc du-di m&c binh thu-dng c6n Igl Id do thj lye vdn cd eua bOnh nhdn.
Vigadexa® dd ch&ng td khi ndng dung nap tdt vd dO an todn eao. Khdng cd bdnh nhdn ndo elm thiy dau d mit khi dimg thu6c.
Sau 2 tuin dieu tri vd theo ddi, khdng c6 tru'dng hap ndo cd xult hiOn tdn hgi mdi a gidc mge vd the thuy tinh. Mdt trong nhO-ng ydu td ldm cho thude It gdy nh&ng kieh ung tai mit cung nhu- khdng gdy ra ede bidn chu-ng ddi vdi gidc mge dd Id do thude khdng chi>a chit bao quin benzalkonium chloride.
NghiOn c&u khdng gdp tru-dng hap ndo c6 tdng nhdn dp trong qud trlnh didu trj. Kit qua ndy cung phu hap vdi nghiOn c&u eua mOt so tdc gii khde [1, 3]. Nh&ng tru'dng hep vidm kdt mge khiln cho bOnh nhdn phii den bdnh viOn thu'dng Id viOm d m&c dd nhidu, trong nghiOn c&u ndy, viOm d m&c dd trung binh v^
ndng chidm 84,5%. Odi vdi nh&ng tru-dng htyp ndy, ndu chl du-cp-c didu trj bing khdng sinh dan thuin md khdng s& dung corticosteroid thl thdi gian viOm ed thd kOo ddi vd eO nguy ea gdy ra nh&ng tdn hgi khde eho gidc mge, vi vdy dCmg corticosteroid ed Ic^i nhidu han Id c6 hgi. V I lgi vdi thdi gian dieu trj thdng thu-dng eua viOm kdt mge (trong vdng 2 tuin) thl kha ndng gdy tdng nhdn dp eua thudc Id rit it. Neu ed xiy ra tdng nhdn dp thl ehi dan gian ngOng thude Id nhdn dp Igi trd Igi binh thu-dng.
56 TCNCYH 78 (1) - 2012
Mdc du Vigadexa® Id mOt thudc khdng inh phd rong vd ehdng viOm manh, theo hung toi thude ndy thieh hp-p nhit Id eho h&ng tru'dng ho-p viem ket mge vdi bleu hiOn iOm d muc dp t& trung binh trd lOn. Nh&ng udng hap vlOm ket mac nhe d m&c khOng I n dung thude chdng viOm thl ehi ein dung lot thudc khang sinh khOng cd steroid Id du.
^ K^T LUAN
Vigadexa® Id mpt dgng thudc tra m i t mdi hdi hap mdt khdng sinh quinolone thd hO 4
•noxifloxaein 5%) vd mOt corticosteroid mgnh lexamethasone 0,1%) eho hlOu q u i khdng huln va giam viOm tdt trong dieu trj viOm ket lac. Thude khdng gdy kieh ung cho mdt vd n todn eho benh nhdn. Dang thudc phdi hap hang sinh vd chdng viOm dung thuan tlOn vd iup cho benh nhan tuan thu lieu didu tri va ing hiOu qua didu trj. Chi phi eho mpt thude ang phdi hap cung thap han dieu tri bdng 2 ludc riOng le.
TAI LIEU THAM
K H A O1. Campos M. et al (2008). Efficacy and ilerability of a fixed-dose moxifloxacln- Bxamethasone formulation for topical
•ophylaxis in LASIK: a comparative double-
TAP CHl NGHliN CCPU Y HQC
masked clinical trial. Clinical Ophthalmology.
2: 331-338.
2. Esplritu CR. et al (2007). Safety of prophylactic intraeameral moxifloxacin 0.5%
ophthalmic solution in cataract surgery patients. J Cataract Refract Surg 33: 63-68.
3. Freitas LL. et al (2007). Efficacy and tolerability of a combined moxifloxacin/
dexamethasone formulation for topical prophylaxis and reduction of Inflammation in phacoemulsification: a comparative double masked clinical trial. Current medical research and opinion. 23 (12): 3123-3130.
4. Katz HR. et al (2003). Moxifloxacin^
ophthalmic solution 0.5% hastens cure and eradicates the causative pathogens of bacterial conjunctivitis in pediatric and adult patients. Presented at Annual Meeting of the Association for Research in Vision and Ophthalmology.
5. Regis PK. et al (2004). Topical prophylaxis with Moxifloxacin prevents endophthalmitis In a rabbit model. Am J Ophthalmol 138: 33-37.
6. Rookaya M. et al (2002). Fourth generation fluoroquinolones: New weapons in the arsenal of ophthalmic antibiotics. Am J Ophthalmol 133:463-466.
Summary
EFFICACY AND SAFETY OF VIGADEXA IN THE TREATMENT OF CONJUCTIVITIS
The study was conducted to evaluate the efficacy and safety of Vigadexa® (0.5% moxifloxacin id 0.1% dexamethasone) in the treatment of bacterial conjunctivitis. The results showed that jfore treatment, the inflamation level was mild and moderate In 118 (79,2%) eyes and severe In (20.8%) eyes. Of these 31 severe eyes, 14 (9. 4%) had pseudomembrane and 8 (5.4yo) had perfieal punctate keratitis. With treatment, complete resolution was 67.8% of eyes in 8 days, id 87.2% in 12 days. No complications were noted in all patients. In conclusion, Vigadexa®
edrop appeared to be a highly effective treatment for baterial conjunctivitis. The eyedrops was 50 safe and well tolerated. The combination formulation was convenient for use, reducing cost d increasing effectiveness of treatment.
lywords: vigadexa, conjunctivitis
