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• Nghien CIFU - Ky thuat

T a i l i e u t h a m k h a o 4. Hoang Thj Thu Huang (2013), "Phin tich hoat 1. Benh viin Noi tiit TW (2015), B^o cao thyc ddng ton trii cip phat va ca cau thuoc duoc SLP dung hi§n nhi^m vu cua B$nh vi§n N6i tilt TW nam 2014 va i^' S^"^ " ^ n Sio ve sue khoe tim thin Quang Nmh".

phuang hudng k l hogch nam 2015. Lugn van Duyc sT Chuyen khoa d p i , Trudng Dai hpc 2 Dodn Thj Mmh Hue (2014), "Phan tich hoatd^ng Duyc Ha Npi

tin tru, cip phit vi sd dung thuSc ngo^i tnj tai B$nh 5. pgui Spivey (2012). Ensuring good dispensing vi$n Dai hpc Y Th^i Binh nSm 2013". Lu^n vSn Duyc

sT Chuy&n khoa d p I, Trudng Dgi hpc Duyc Ha N^i practices. In MDS-3: Managing Access to Medicines and Health Technologies. Arlington, VA: Management 3. VQ Thi ThuHuyen (2013), -Phon tloh ho,t d0ng ^^.^^^ ,^ 30.5-30.10.

quin ly ton tru. cap phat vd huang dan su dung thuoc

tai Khoa Du^c B$nh vien Tnjng uang Quan doi 108 6. Worid Health Organization (1993), "How to nam 2012". Lu|n van Thge sT Duyc hgc, Trudng Dgi investigate drug use in health facilities: selected drug hpc Duyc Hi Npi. use indicators", p. 17-22.

(Ngiy nhin bii: 03/08/2015 - Ngiy duyjt ding: 02/11/2015)

^Phan tich dac diem benli than

• • •

r

do thuoc can quang chua iod su dung trong ch4n doan hinh anh

tai Benh vien Bach Mai

• • • •

Bui Thi Ngoc Thuc'*, Vii Dinh HdaS Pham Minh Thong' Tran Nhan Thdng', Ducmg Due Hung', C4n T\iyet Nga' Nguyen Thu Minh', Nguyen Hoang Anh^

' Khoa Duac. B^nh vi^n Bach Mai

^Truong Bgi hpc Du^c Hd Nqi 'E-mail: [email protected] S u m m a r y

The incidence and risk factors associated with contrast-induced nephropathy (CIN) in patients undergoing contrast-enhanced CT and diagnostic coronary angiography (CAG) or percutaneous coronary intervention at Bach Mai hospital from 12/2014 to 04/2015 were assessed. The studied cohort consisted of 566 patients being exposed to contrast media. CIN was defined as an increase in serum creatinine greater than 0.5mg/dl or 25 % from the baseline 3 days after contrast media exposure. Overall, CIN occurred In 40 (7.1 %) patients. Incidences of CIN were 6.6 % and 7.4 % in patients undergoing contrast-enhanced CT and diagnostic coronary angiography (CAG) and/or percutaneous coronary intervention, respectively. Incidence of clinically significant CIN (CSCIN) was 1.1 % and that of acute kidney injury was 2.8% on RIFLE and AKIN criteria. Multiple logistic regression analysis identified the older age (>70). reduced GFR (< 30 ml/min/1.73 m^) and large volume media (> 200ml) as independent predictors of CIN. In conclusion, these findings would be helpful to careful consideration in the use of contrast media.

Keywords: Contrast media, contrast-induced nephropathy (CIN).

TAP CHI ni Iftr H n r . n n m * /cr» Alc: *

(2)

Nghien ciru - Ky thuat

Dat van de

Vdi s y phat t r i l n eua ky thugt c h i n doan hinh anh, t h u l c d n quang (TCQ) ngdy cang d u y e s u dyng rpng rdi. Ty' Id ton thuang thgn do thuoc can quang hay cdn gpi Id benh than do t h u l c d n quang (contrast-induced nephropathy - CIN) d u y c bao cdo dao dflng t u 0% - 33% tren cae doi t u y n g bpnh nhan khdc nhau ' " • " ' dua nhom t h u l c ndy trd thdnh nguyen nhan ddng thu 3 gdy suy thdn m i c phai tgi bpnh vien '^^. Trong thye hdnh lam sdng, ton thuang than thudng d i l n b i l n khdng efl tripu ehung nen it d u y c theo dfli ch$t ehe. Bpnh vien Bach Mai hien Id benh vipn ed s l l u y n g Idn bpnh nhan s u dyng t h u i e can quang. Do viy. de tdi nay d u y c thyc hipn vdi 2 mye tieu: 1. Khao sat ty lp xuat hipn vd dac d i l m bdnh than do thuoc d n quang chua iod; 2. Phdn tfch eae y l u to dnh hudng d i n khd ndng x u i t hi$n bdnh thdn do t h u l c d n quang chua iod.

Doi tu'O'ng va phu'ang phap nghien CU'U

Ooi tu'ang nghien ci>u

Nghien cuu d u y c thyc hidn trdn cdc bpnh nhdn npi tru tgi Bpnh vien Bgeh Mai d u y e chi djnh tiem thuoc can quang chua iod trong thdi gian t u 12/2014 - 04/2015. Cae bpnh nhan khdng d u y c Idm xet nghipm creatinin huylt thanh (serum creatinin - SCr) trudc hogc sau khi tiem t h u l c d n quang chua iod, cde bpnh nhan dang d u y e chgy thgn nhdn tgo hoac tham phan phOc mac lien tye vd cdc benh nhan da hodc se d u y e phdu thugt thgn trong thdi gian ndm vipn se d u y c logi trif i'^.

Phu'O'ng phdp nghien ci>u

Nghien cdu thuan tap tren eac b^nh nhdn npi tni d u y c tiem thuoc d n quang chua iod d l chup CT, chyp dpng mgch vanh, can thldp dpng mgch vdnh qua da. Do s l dan vi ehyp can quang nhieu trong khi nhdn lyc cd hgn, chung tdi ap dyng bi#n phdp lya chpn mdu thu^n lyi cac bdnh nhan tgi m | t phdng chyp. Thong tin ve ehi s l creatinin h u y l t thanh d thdi diem gan nhat trudc khi tiem t h u l c trong thdi gian benh nhan n i m vien vd eae ehi s l SCr sau khi tiem t h u l c den khi ra vi0n d u y c thu thgp tren c a s d d u li^u tai Khoa Hda sinh. Cdc thong tin ve y l u to nguy c a m i c kem n h u t u l i cao (> 70 t u l i ) , dai thao d u d n g . suy tim, dgt bdng doi xung dpng mgch chij, nhoi mau

c a tim sdm (< 24 gid), muc do suy than dya tren muc lpc c l u than u d c tinh (eGFR) cung duyc ghi nhgn. Cac t h u l c dung kem co kha nang gay doc vdi thgn neu co bao g i m cisplatin, cyclosporin, cdc khang sinh aminoglycosid, thuoc ching viem phi steroid (NSAlDs) d u y c ghi nhan tu trudc khi s u dyng TCQ chda iod den ngay thd 3 sau khi tiem thuoc hoac d i n ngay xuat hien CIN.

Chi tieu nghien CLPU

Chi tieu nghien cdu chinh la ty le xudt hien benh than do TCQ (CIN) d u y c dinh nghia la tinh trgng suy giam chdc nang than vdi SCr tang tren 25% hoac 44 pmol/l (0,5 mg/dl) xay ra trong vong 3 ngay sau khi tiem thuoc so vdi thai diem ban ddu ma khong do mpt nguyen nhan nao khac theo djnh nghTa trong Huang ddn cua Hpi chan doan hinh anh nieu due Chau Au nam 2012 (ESUR) I'^i. Cac chi tieu nghien cuu khac cung d u y c ghi nhan gflm co ty le CIN co y nghTa lam sdng (Clinically significant contrast-induced nephropathy - CSCIN} i^i va muc do ton thu'ang than ddnh gia theo phan loai cua RIFLE va AKIN '"'. Cdc trudng hap CSCIN duac xac dinh khi benh nhan xudt hien SCr tang gap doi so vdi ban d i u trong vong 1 tuan hoac can loc mau cap cii'u sau khi tiem TCQ ''^K Cac trudng hyp xuit hien CIN nhung SCr tang khong qua 2 i l n duyc coi la khflng co y nghTa lam sang.

Xi> ly sd lieu

s l lieu duac x u ly theo phuang phap thong ke y hpc bdng phdn m i m SPSS 16.0. Phan tich hoi quy logistic de tim h i l u cac y l u to co tu'ang quan vdi s y xudt hien CIN Kiem tra kha nang gap da cong tuyen (multicollineanty) trudc khi thyc hien phan tich h l i quy vdi he so lam phat phuang sai < 5. S6 lieu d u y c phan tich dan bien va phan tich da b i l n theo phuang phap rut bien so (stepwise backward) vdi ngudng thong ke rjl khdi mo hinh da b i l n la 0,1.

Ket qua nghien CLKU

Trong thdi gian t d thang 12/2014 - 04/2015, ed 1346 benh nhan npi tru chup CT hoac chup dpng mach vanh va/hoac can thiep dpng mach vanh qua da co tiem TCQ chua iod tai cac phong chup trong toan benh vien d u y c ghi nhan, Co 566 bdnh nhan trong s l do dap ung du tieu chuan lya chpn va dwgc dua vao nghien cuu.

10 TAWC^i n i i n r H n r _ ^^/•>n^e,l*in41^ \AM55)

(3)

• Nghien CLPU - Ky thuat

Mdt s o dac d i l m cua b e n h nhan n g h i e n cieu Bang 1 : Die diim nhin trie hoc va lam sing

Tufii (nam)*

B§nh n h i n cao tuoi { > 70 tuoi) {%) Gibi tinh: nam/ nO (%)

Dac diem

ban dau cua

S6 BN CO t)enh m i c kem (flai thao dirang, suy tim, nhoi mau co tim som (< 24 gicr))

benh ntian trong miu nghien aiu

N'SOS 63.0(53,0-72,0)

177 (31,3) 372/194 (65,7;34,3)

164 (29,0%) So BN c6 phan bai eGFR t)an d i u (ml/phiWI ,73 m^)

4 5 S e G F R < 6 0 30 s eGFR < 45 eGFR < 30

97(17,1%) 39 (6,9%) 15 (2,7%) s l BN diirtg k ^ thu6c c6 kh^ nang gay SQC tren than (NSAIDs, khang sinh anynoglycosid. cyckisporin, cisplatin) 264 (46,6%) S6 BN dung TCQ chipa iod' Tnjng hpp, ion hoa, W.TT thSp/don phSn tCr, khftig ion h6a. NJT Mp (%) 166/400 (29,3/70,7)

530/36 (94,0/6,4) S6 BN diing TCQ theo t h i Hch TCQ: s 200 ml/ > 200 ml (%)

Ghi c / i i i ; Lo^i TCQ (ning hpp, ion hoa, AUT thap bao gim: loxaglal (Hexabrix) Loai dan phan tir. khong ion hoa, ALTT thip bao gdm cic thudc: topromide (Ultravist), lobitridol (Xenetic), lohexol (Omnipaque), lopamidol (lopamiro).': S6 li$u bieu diin dudi dang trung vj (khoing tir phin vj)

Nhan xit: Dp tuoi eua bpnh nhan trong d u y e s u dung vdi ty lp cao. Loai TCQ d u y e s u nghien c d u kha cao (trung vj Id 63,0 t u l i ) vd ty Id

bpnh nhan eao tuoi (tren 70) chiem 31,3%. Benh nhdn nam c h i l m da s l (65,7%). Cd 29,0% bpnh nhdn ed bpnh m i e kem trong dd cao n h i t Id benh nhdn ddi thdo d u d n g . Trong eae thuoc dung kem cd dpc tinh tren than, NSAIDs Id nhdm t h u l c

Bang 2: Ty li binh nhan xuit hi$n CIN

dyng eho bpnh nhan da so la logi dan phdn t u , khdng ion hda, dp lyc t h i m thau (ALTT) thap (70,7%) va da so bpnh nhan d u y c tidm t h u l c vdi the tich t d 200 ml t r d x u i n g (94,0%).

Ty le va dgc diem cua benh t h a n do t h u d c cdn quang chi^a iod

S6 luang BN xuit hl^n CIN (ty l# %) Trong t6ng miu nghi&n aiu (n = 566)

Trong s6 BN chyp vMlogc can thigp tm mgch (n = 323) Trong s6 BN chyp CT (n = 243)

40(7,1) 24(7,4) 16(6,6) Ty 1$ % BN x u ^ hien CSCIN (n - 6)

Trang tfing miu nghien cuu (n = 566) Trong s6 benh nhan CIN (n = 40)

1,1 15 Nh$n xet: Cd 40 b§nh nhdn ggp CIN (7,1%).

s l bpnh nhdn x u i t hi^n CIN khi chyp mgch vd/

hogc can thipp tim mgch Id 24/323 (7,4%) va khi chyp CT la 16/243 (6,6%), 16 bpnh nhan x u i t hi$n CIN ndy d u y e phan logi theo thang RIFLE

va AKIN (bdng 3). Cd 6 tm'dng hyp CSCIN c h i l m 15% trong so bpnh nhan CIN va 1,1% trong tong so bpnh nhan nghidn cuu. Trong so ndy cd 3 benh nhdn c i n phai lpc mau.

Bang 3: Miic dp nghiim frpng ctia binh thin do Uiudc can quang c/jtia iod theo phin lo^i RIFLE va AKIN Thang phSn I09I S6 /i/<png BN Ty le % so vai sc

hl^n CIN (n ••

1 BN xuat --40)

Ty / | % so vai quan th^

miu nghien ciru (n = 566) PhSn io^i AKIN (Tang nong dQ creatinin huyit thanh)

Miic dt 1: 1,5-2 lin MCK dt 2: >2-3 lin Mirc dt 3: >3 lin

T6ng:

10 4 2 IS

25%

10%

5%

«)%

1,8%

0,6%

0,4%

2,B%

TAP THI n i r i i r H n r . ii/7ni« /co ^te M*

(4)

• Nghien CLFU - Ky thuat

Phin loai RIFLE (Tang nong do creatinin huyit thanh) Co nguy ccr 1,5 - dudi 2 lan

Tdn thuang: 2 - dudi 3 lan Suy than: >3 lin

Tong:

10 4 2 16

25%

10%

5%

40%

1.8%

0,6%

0,4%

2,8%

Wft^n x e t : So b?nh nhan CO mipc dp suy th^n lpc mau la 6/16 (37,5%) vS chi^m 1.1% t6ng s6 tLT mCpcdp 1 d^n 3 theo thang phan loai cuaAKIN b^nh nhan trong m i u nghien CLFU.

tuwng i>ng tip miJc -co nguy cor" den mipc "suy p h a n t f c h cac y e u tA anh h i r i n g den klia than" ciia RIFLE la 16, chi4m 40% tong sd b?nh nang xuat h i ^ n b e n h t h | i n do t h u o c can quang nhan mac CIN, chiem 2,8% tong so b?nh nhSn chtra iod

trong m i u nghien ciru, trong do s6 b^nh nhan

Bdng 4: Ket qui phan tich dem biin va da biin cac yiu to anh hw&ng din tthi n^ng xuit hien CIN trong miu nghien ciiu

Bien ^c f^p Tuoi ben 70

Oai thdo diKmg Suy tim

Nhli mdu CO- tim s6m (< 24 gio)

Phan tfch don tuin OR(CI95%) 23(1,37-5,01) 2,13(1,00-4,55) 1,17(0,44-3,12) 2,29(0,64-8,12)

Phan tK^f) da bien OR (0195%) 2,28(1,11-4,68)

eGFR ban dau (mtlphilHl.lZ nfj 45SeGFR<60 30SeGFR<45 eGFR < 30

1,46(0,64-3,37) 0,88(0,20-3,87) 10,86(3,57-33,02)

1,00(0,41-2,42) 0,59(0,13-2,70) 7,97(2,49-25,57) NSAIDs

Khang sinh aminoglycosid L09i TCQ chua iod

Trung ti9p. ion h6a Don phdn tir, khong ion hoa

1,51(0,79-2,88) 0,64(0,08-4,96) 1.17(0,59-233)

1 7)K«c/irC0(rn!l

<100 101-200

>200

2.08(0.99-4,34) 3.57(1.35-9.48)

1.66(0,78-3,69) 3,12 (1,12-B,6B) Bt/dngdung

TTnh mach

O^ngmgch 1,14(0,59-219)

Nh#n xet: Trong phan tfch dcrn bien, cac yeu to tuoi > 70. dai thao d u ^ n g . eGFR < 30 (ml/

phut/1,73 np) vd the tich thuoc can quang tren 200 ml la cac yeu t6 co lien quan den nguy co xuat hipn CIN (p < 0,05). Tuy nhien, khi phan tfch da bi^n thi chf con lai ba yeu t6 co lien quan den nguy ca x u i t hi#n CIN g6m tuoi cao (OR = 2,28, k h o i n g tin cgy 95%: 1.11 - 4,68) eGFR < 30 (ml/

phut/1,73 m^) (OR = 7,97, k h o i n g tin cay 95%:

2.49 - 25.57) v4 the tich TCQ trSn 200 ml (OR = 3.12. khoang tin c#y 95%: 1 , 1 2 - 8 , 6 8 ) .

B a n l u a n

v l t y le va dac d i e m b § n h thSn do thudc c i n quang c h i r a iod

Ty ie bpnh nhan x u i t hien b$nh t h | n do TCQ chira iod (CIN) la 7 , 1 % theo dinh nghTa cua ESUR 2012 i'=i. Ty l# x u i t hiSn CIN cua cac b^nh nhSn chup vS/hoac can thipp m^ch vanh qua da va bpnh nhSn chup CT tirong irng la 7.4 va 6.6%. Cac ty 16 nSy t h i p hon so vai ket qua c ^ nghien cuu cua Ho Van PhuiK, TA P r HI n, rnr HOT- _, i /7ni S « 6 47s N A M SB

(5)

Nghien CIFU - Ky thuat

Ivanes F va Mitchell A M '^•^•^'" nhung tuang t y vdi k i t qua d u y c ghi nhan trong mpt s l nghien euu cCia Chong E, H i p p A v d Weisbord '3-^'^.

Ty le b§nh nhdn mac CIN cd y nghTa lam sang (SCCIN) la 1,1%, ty le nay t h i p han so vdi k i t qua nghidn c u u cOa Kashif >^>. Valette va cpng s y da thye h i | n mpt nghien cuu cohort trdn 101 bpnh nhdn tai khoa h l i sdc tich c y c ngoai khoa, tjf lp bpnh nhan bj suy than e l p theo phan Iopi eua AKIN va RIFLE d i u la 19%, cao han n h i l u so vdi nghidn cdu cCia chung tdi (2,8%) ''^.

Ve cdc y e u t l anh hu'dng den kha nang x u i t hidn bdnh t h d n d o t h u o c can quang chu'a iod

T u l i cao Id mpt y l u to cd nguy ca xuat hidn CIN, dieu nay d u y c t h i y trong nghien c u u cua Rihal va cpng s y ' " i . K i t qua ve tuoi tren 70 la y l u t l nguy ca t u a n g t y vdi k i t qua thu d u y e cua Chong vd Fu Naikuan i^^'. Trong nghidn cuu nay, eGFR < 30 ml/phut/1,73 m^ la y l u t l lam tang nguy ea m I e CIN tuang t y vdi k i t qud cua Kashif '^', trong khi do mue lpe cau than trong khodng 30 - 60 (ml/phCit/1,73 m^) ehua the hien Idm tdng nguy ca x u i t hi^n CIN nhu k i t qud cua mpt so nghien euu khdc ^•^. D i l u nay co the do s y khac nhau v l doi t u y n g bdnh nhdn va ed mau nghidn c d u . Nhu vpy, m$c diJ y l u t l eGFR

< 30 ml/phut/1,73 m^ chua hoan todn d i n g n h i t vdi ngudng eGFR nguy c a cua ede nghien cuu trudc nhung day cQng Id m | t con s l dang luu y trong t h y c hanh lam sdng giup d y doan nguy ca x u i t hidn CIN, thye hien cac bipn phdp d y ph6ng e I n t h i l t vd giam sdt ehgt che s y x u i t hipn b i l n co trdn nhdm d l i t u y n g bpnh nhan nay.

Tang the tfch t h u l c tiem se Idm tang nguy ea x u i t hipn CIN ^-^^K K i t qua nghien edu ndy t i l p tgc k h i n g djnh k i t qua cua cac nghien euu da cong bo.

M^t s6 han chi cua nghiin cim: Thu nhat, do tinh ehat cua nghidn cuu la khdng can thldp vdo chl djnh Idm xdt nghipm creatinin huyet thanh ndn thdi d i l m bpnh nhdn d u y e Idm xdt nghipm cd U i l khdng trting vao thdi d i l m tang creatinin sau khi bpnh nhdn d u y c tiem TCQ chua iod, gay ra sal s l trong vipc tinh todn t j lp xuat hien CIN vd d y dodn eae y l u t l nguy ca. T h u hai, mdu

nghien cuu trong phdn danh gia bpnh thpn do TCQ khdng d u y c lay ngau nhien va t d dd ed t h i tdm anh hudng tdi tinh dai dien eua k i t qua. C u l i cung, mdt s l y l u to nguy ca khong d u y c dua vdo phan tieh dan d i n vide danh gia cdc y l u to cd lidn quan d i n khd nang xuat hien CIN chua day du.

K e t l u a n

Nghien euu xdc djnh d u y c mOt ty lp dang ke bdnh nhdn dung t h u l c can quang gpp CIN. Cae trudng h y p bpnh nhdn cao tuoi, ed mdc lpe cau than t h i p vd phai dung the tich Idn thuoc cdn quang la nhung trudng hyp can luu y theo doi nguy ca dpc tinh tren thpn, ey t h i nhu sau:

- Ty Id chung b i l n eo tren than hay bpnh than do TCQ chua iod Id 7 , 1 % . Ty lp bpnh thdn do TCQ chda iod ed y nghTa lam sdng la 1,1%.

- Ty Id benh nhan co muc dp suy thpn t u mdc dp 1 d i n 3 cua AKIN tuang ung vdi t d mue " e l nguy ea" d i n muc "suy thdn" eua RIFLE Id 16, c h i l m 40% t i n g so bpnh nhdn m i c CIN, c h i l m 2,8% tong so benh nhdn nghien cuu.

- Bpnh nhdn trdn 70 tuoi, muc lpc c l u thpn <

30 ml/phut/1,73 m^ dung t h i tieh TCQ tren 200 ml Id cdc y l u to lien quan den vide tang nguy ca x u i t hien benh thdn do TCQ.

D e x u a t

c i n t r i l n khai nghien euu t h u i n tgp c6 can thipp d l t i l p tyc danh gid b i l n co b i t lyi eua TCQ nham xdc djnh ehinh xac vd d i y du han ve ty lp xuat hipn b i l n c l vd cac y l u to nguy c y tien luyng khd nang xuat hipn b i l n c l .

C i n c6 quy trinh p h i i hyp giua cdc khoa lam sang vdi cac dan vj c h i n doan va can thipp dipn quang nham d y phong nguy ca x u i t hidn benh than do thuoc can quang chua iod. Bpnh nhan nen d u y c I d l m tra chde nang thgn trude khi thye hipn c h i l u ehyp eo tiem t h u l c can quang chua iod. Cae benh nhdn cd nguy ca (tuoi cao, giam mue lpc c l u than, d u a c tiem t h i tich t h u l c Idn) can d u y c theo doi, giam sat chat che chdc nang than it n h i t 3 ngay sau khi tiem thuoc can quang ehua iod.

(Xem tiip trang 37) TAP C H I n i r n r unr. 11 / ^ m * / e n J-JC M A

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Chi plii san xuat la nhCrng chi phi dijng de chuyen cac nguon lUc dau vao thanh ket qui dau ra hoac la phi san xuat true tiep Trong khi do chi phi giao dich la chi phi thuc hien trao