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JOURNAL OF PHARMACEUTICAL RESEARCH AND DRUG INFORMATION

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'TrUdng Dai hgc Dugc Ha Ngi

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Nguyen DuQuynh Nhu, Duong Xuan ChU, Nguyen Thi Ngpc Van Khoa Dugc, Truing Dai hgc Y Dugc Can Tho

Thong tin thuoc - canh giac dufofc 236 S° ^ ' d l ' s ^ d " n 9 d i c h truyen chuta hydroxyethyl starch (HES)

Tong hop: Tran Thuy Ngan, Nguyen Hoang Anh

Diem tin hoat ddng

239 K'1oa N9hien CIAI sinh nam 2014

239 Nlft tinh ki niem Ngay Nha giao Viet Nam 20/11 va Hoi dien van nghe

TONG BIEN TAP PGS.TS. Nguyen Dang Hoa

i P H 6 T 6 N G BIENTAP GS.TS. Nguyen Thanh Binh

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In tai: Xi nghiep in / Nha may Zl 76

TRIM TAMMIAQR QUOC GIA

THONGTINTHUOC-CANH GIAC DUOC ^

Mot so Itfu y khi suf dung dich truyen chtfa hydroxyethyl starch (HES)

Tong hpp: Tran Thuy Ngan, Nguyen Hoang Anh.

Dich truyen chUa hydroxyethyl starch (HES) la chat trung phan tong hap, co nguon goc tUtinh botsLtdung dethay the huyet tuong khi co giam tuan hoan trong choang mat mau, nhiem khudn, chdn thuong hogc phauthugt. Dung dich con duac sCf dung trong tuan hoan ngoai ca the [I]. Trong dieu tri soc giam the tich, HES duac cho la co hieu qua phuc hoi the tich tot va nhanh chong han so vdi dich truyen tinh the [3].

Td cuoi nam 2012 mot so co quan quan ly duOc pham tren the gicri dda ra quan ngai ve do an toan cua djch truyen HES sau khi ket qua cua mot so thCr nghiem lam sang Idn duqc cdng bo cho thay djch truyen HES lam tang nguy co tCr vong va nguy co ton thuong than nghiem trqng can lieu phap thay the than tren benh nhan nang [4]. Ngay 11/10/2013, Uy ban Oanh gia Nguy CO Canh giac DuOc (PRAC) thudc Co quan Quan ly Dupe pham Chau Au (EMA) da khang djnh nguy co tren va khuyen cao khong dung djch truyen HES tren benh nhan nhiem trung huyet, ton thuong do bong hoac benh nhan nang do da co bang chdng rd rang ve sd tang nguy coton thuong than va tCr vong tren nhdng doi tUpng benh nhan nay. Khuyen cao cua PRAC tiep tuc nhan duqc sd dong thuan tit Nhomdieu phoi cua Quytrinh dang ky thudc sCrdung tren ngUdi khong tap trung va thda nhan Ian nhau gida cac thanh vien trong Lien minh Chau Au (CMDh) ngay 23/10/2013 va phe duyet cua Hoi dong Chau Au (EC) ngay 19/12/2013 [5]. Co quan quan ly dupe pham cac nude Phap, Hoa Ky, Canada, Uc va Singapore cung da co canh bao venguy co cua djch truyen HES va yeu cau cac cong ty ddoc pham bo sung thong tin canh bao vao tdthong tin san pham [6]-[10]. Rieng Co quan Quan ly Ddoc pham va San pham y te Anh (MHRA) da co thong bao ngay 27/06/2013 ve viec thu hoi hoan toan cac che pham djch truyen HES lUu hanh tai Anh [11].

Cac hudng dan dieu trj hien hanh trong linh vdc chan thuong, nhiem trung huyet, sdc nhiem trung

tren the gidi cung da cap nhat thdng tin ve do an toan cua djch truyen HES. HdOng dan Ida chon djch truyen tinh mach sir dung cho benh nhan ngddi Idn trong benh vien nam 2013 cua Vien Qudc gia ve y te va djch vu cham sdc site khde cua Anh (National institute for health and care excellence - NICE) da canh bao ve sif tang ty le tu1 vong va cac bien chdng, dac biet bien chung tren than lien quan den viec sir dung djch truyen HES 6% [12]. Hudng dan dieu trj nhiem trung huyet nang va sdc nhiem trung nam 2012 trong Chien djch cai thien spsdng sot cho benh nhan nhiem trung huyet nang (Surviving Sepsis Campaign - SSC) cung khuyen cao djch truyen tinh the la Ida chon dau tay trong bdi phu djch tren benh nhan, khdng khuyen cao sir dung djch truyen HES cho benh nhan nhiem trung huyet nang hoac sdc nhiem trung [13].

236 Nghien CLIU duoc Thong tin thuoc So 6/2014

Cac nha chuyen mdn dda ra nhieu y kien trai chieu ve cac nghien cdu ddpc sd dung lam cd sd cho quyet djnh gidi han viec sd dung HES cua co quan quan ly. Ben canh cac nghien cdu vdi cd mau Idn ddpc thiet ke tot, mot so nghien cdu con ton tai mot so van de nhd khdng dda ra each tinh toan dang tin cay va chuan hda ve dap dng djch tren benh nhan cung nhuchi sd ve huyet ddng cua benh nhan trddc khi sddung djch truyen HES; khdng tuan thu theo dung lieu dung dddc khuyen cao; thdi gian sd dung djch truyen HES dao ddng Idn gida cac nghien cdu td 90 phut - 90 ngay [14], [15]. Ngoai ra, cac nha chuyen mdn cho rang quyet djnh gidi han sd dung HES dddc cac co quan quan ly ddpc pham dda ra sau khi da ngoai suy ket qua danh gia dp an toan cua HES tren benh nhan nang dieu trj tai khoa ICU cho tat ca cac ddi tdpng benh nhan. Tai thdi diem nay, dd lieu cua mot so thd nghiem lam sang Idn danh gia dp an toan cua djch truyen HES tren benh nhan khdng nhiem khuan (benh nhan chan thddng/phau thuat) chda ddpc cdng bd. Viec gidi han sd dung djch tuyen HES cung dan den quan ngai ve viec sd dung khdng hpp ly cac djch truyen thay the khac nhd albumin, gelatin va dextran mac du dd lieu ve dp an toan cua cac djch truyen nay han che hon nhieu so vPi djch truyen HES va nhieu bien cd bat Ipi nghiem trpng da ddpc biet ro lien quan den cac djch truyen nay nhu nguy co nhiem khuan va bien cd tren ddng mau lien quan den albumin, phan dng phan ve lien quan den gelatin va dextran da ddpc ghi nhan vPi ty le cao hon nhieu so vdi HES [3], [15].

Hieu qua cua djch truyen HES da ddpc ghi nhan trong cac tai lieu cung nhd trong thdc te dieu trj tren lam sang. Djch truyen HES ddpc bat dau sd dung td nhdng nam 1960 va da trd nen phd bien tai cac khoa dieu trj tich ede (ICU) va phau thuat. Mdi nam tren the gipi cd khoang 6 trieu benh nhan sd dung djch truyen HES. Vdi pham vi sd dung rdng rai va vai trd quan trpng trong viec cai thien sU song sot cho benh nhan nang, cac thong tin ve dp an toan cua djch truyen HES la mdi quan tam Idn cua cac can boy te va benh nhan. Hien cac nghien cdu danh gia dp an toan cua djch truyen HES tren nhieu ddi tdpng benh nhan van dang ddpc tiep tuc tien hanh va bdsung them ddlieu vedd an toan cua djch truyen nay. Vdi nhdng ddlieu hien cd ve hieu qua va dp an toan cua djch truyen HES, de tdi Uu hda viec sd dung djch truyen nay, can bp y te can Idu y [2], [5]:

Chi sd dung djch truyen HES de phuc hoi the tich tuan hoan ban dau do mat mau cap cho benh nhan khi cac djch truyen tinh the don thuan khdng cho hieu qua day du.

Chdng chi djnh djch truyen HES cho benh nhan nhiem trung huyet, bong, suy than hoac dung lieu phap thay the than, xuat huyet nao hoac xuat huyet ndi so, benh nhan nang dieu trj tai cac khoa dieu trj tich ede, benh nhan thda nddc, phu phdi, mat nddc, tang kali mau (ap dung vdi cac che pham chda kali), tang natri hoac tang do mau nghiem trpng, suy giam chdc nang gan nghiem trpng, suy tim sung huyet, rdi loan ddng mau nghiem trpng va benh nhan ghep tang.

Khdng khuyen cao sd dung djch truyen HES tren benh nhan phau thuat tim hd can dat tuan hoan ngoai co the do nguy co chay mau qua mdc.

Lieu dung tdi da cua 6% HES (130/0,40) va 6% HES (130/0,42) la < 30 ml/kg/ngay; ddi vdi cac che pham HES khac, lieu dung tdi da can ddpc tinh toan tdong dng. Sd dung djch truyen HES vdi lieu thap nhat cd hieu qua trong thdi gian ngan nhat cd the (khdng qua 24 gid). Trong vdng 10 - 20 ml djch truyen dau, truyen thudc cham va theo ddi chat che tinh trang benh nhan de phat hien sdm cac dau hieu cua phan dng dang phan ve. Trong qua trinh dieu trj, can theo ddi lien tuc huyet ddng cua benh nhan va ngdng truyen djch ngay khi dat muc tieu huyet ddng phu hpp. Chu y khdng sd dung vdpt qua lieu tdi da khuyen cao.

Ngdng truyen HES ngay khi benh nhan cd cac dau hieu ton thdOng than dau tien. Do da cd bao cao ve sd tang nhu cau can dung lieu phap thay the than sau 90 ngay dung djch truyen HES, khuyen cao theo ddi chdc nang than cua benh nhan trong vdng it nhat 90 ngay.

Ngdng truyen HES ngay khi benh nhan cd cac dau hieu rdi loan ddng mau. Trong trddng hpp van tiep tuc sddung djch truyen nay, can theo ddi chat che cac chi so ve ddng mau cua benh nhan.

Cac dd lieu ve dp an toan cua djch truyen HES tren tre em con han che; do dd, chi khuyen cao sd dung djch truyen HES tren ddi tdpng benh nhan nay theo cac hddng dan dieu trj hien hanh cua Bp Y te.

Hien con thieu cac dd lieu ve dp an toan dai han cua djch truyen HES sddung tren benh nhan chan thddng va benh nhan phau thuat. Do do, can than trpng danh gia hieu qua/nguy co khi xet den dp an toan dai han va can nhac nhdng Ida chpn dieu trj s§n cd khac khi sd dung HES tren ddi tdpng benh nhan nay.

S6 6/2014 Nghien CLIU duoc Thong tin thuoc 1237

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Cac nha chuyen mdn dua ra nhieu y kien trai chieu ve cac nghien cUu dupe sd dung lam ccr sd cho quyet djnh gidi han viec sir dung HES cua CO quan quan ly. Ben canh cac nghien cud vdi cd mau Idn dupe thiet ke tot, mot so nghien cud con ton tai mot sd van de nhu khdng dua ra each tinh toan dang tin cay va chuan hda ve dap Ung djch tren benh nhan cung nhUchi sd ve huyet ddng cua benh nhan trirdc khi sir dung djch truyen HES; khdng tuan thu theo dung lieu dung dupe khuyen cao; thdi gian sir dung djch truyen HES dao ddng Idn giUa cac nghien cUu tU 90 phut - 90 ngay [14], [15]. Ngoai ra, cac nha chuyen mdn cho rang quyet djnh gidi han sU dung HES dupe cac co quan quan ly dupe pham dua ra sau khi da ngoai suy ket qua danh gia dp an toan cua HES tren benh nhan nang dieu trj tai khoa ICU cho tat ca cac ddi tupng benh nhan. Tai thdi diem nay, dU lieu cua mot so thU nghiem lam sang Idn danh gia dp an toan cua djch truyen HES tren benh nhan khdng nhiem khuan (benh nhan chan thuong/phau thuat) chUa dupe cdng bd.Viec gidi han sU dung djch tuyen HES cung dan den quan ngai ve viec sU dung khdng hpp ly cac djch truyen thay the khac nhu albumin, gelatin va dextran mac du dU lieu ve dp an toan cua cac djch truyen nay han che hon nhieu so vdi djch truyen HES va nhieu bien cd bat Ipi nghiem trpng da dupe biet rd lien quan den cac djch truyen nay nhu nguy co nhiem khuan va bien cd tren ddng mau lien quan den albumin, phan Ung phan ve lien quan den gelatin va dextran da dupe ghi nhan vdi ty le cao hon nhieu so vdi HES [3], [15].

Hieu qua cua djch truyen HES da dupe ghi nhan trong cac tai lieu cung nhu trong thuc te dieu trj tren lam sang. Djch truyen HES dupe bat dau sU dung tU nhUng nam 1960 va da trd nen phd bien tai cac khoa dieu trj ti'ch cue (ICU) va phau thuat. Mdi nam tren the gidi cd khoang 6 trieu benh nhan sU dung djch truyen HES. Vdi pham vi sU dung rdng rai va vai trd quan trpng trong viec cai thien sU song sot cho benh nhan nang, cac thong tin ve dp an toan cua djch truyen HES la mdi quan tam Idn cua cac can boy te va benh nhan. Hien cac nghien cUu danh gia dp an toan cua djch truyen HES tren nhieu ddi tupng benh nhan van dang dupe tiep tuc tien hanh va bd sung them dQ lieu ve dp an toan cua djch truyen nay. Vdi nhifng dCrlieu hien cd ve hieu qua va dp an toan cua djch truyen HES, de tdi Uu hda viec sir dung djch truyen nay, can bp y te can lUu y [2], [5]:

Chi sir dung djch truyen HES de phuc hoi the tich tuan hoan ban dau do mat mau cap cho benh nhan khi cac djch truyen tinh the don thuan khdng cho hieu qua day du.

Chdng chi djnh djch truyen HES cho benh nhan nhiem trung huyet, bong, suy than hoac dung lieu phap thay the than, xuat huyet nao hoac xuat huyet ndi so, benh nhan nang dieu trj tai cac khoa dieu trj tich cUc, benh nhan thifa nude, phu phdi, mat nude, tang kali mau (ap dung vdi cac che pham chda kali), tang natri hoac tang clo mau nghiem trpng, suy giam chdc nang gan nghiem trpng, suy tim sung huyet, rdi loan ddng mau nghiem trpng va benh nhan ghep tang.

Khdng khuyen cao sir dung djch truyen HES tren benh nhan phau thuat tim hd can dat tuan hoan ngoai co the do nguy co chay mau qua mut.

Lieu dung tdi da cua 6% HES (130/0,40) va 6% HES (130/0,42) la < 30 ml/kg/ngay; ddi vdi cac che pham HES khac, lieu dung tdi da can difpc tinh toan toong dng. Sir dung djch truyen HES vdi lieu thap nhat cd hieu qua trong thdi gian ngan nhat cd the (khdng qua 24 gid). Trong vdng 10 - 20 ml djch truyen dau, truyen thudc cham va theo ddi chat che tinh trang benh nhan de phat hien sdm cac dau hieu cua phan Ung dang phan ve. Trong qua trinh dieu trj, can theo ddi lien tuc huyet ddng cua benh nhan va ngdng truyen djch ngay khi dat muc tieu huyet ddng phu hpp. Chu y khdng sir dung vUpt qua lieu tdi da khuyen cao.

NgUng truyen HES ngay khi benh nhan cd cac dau hieu ton thuOng than dau tien. Do da cd bao cao ve sp tang nhu cau can dung lieu phap thay the than sau 90 ngay dung djch truyen HES, khuyen cao theo ddi chut nang than cua benh nhan trong vdng it nha't 90 ngay.

NgOng truyen HES ngay khi benh nhan cd cac dau hieu rdi loan ddng mau. Trong trirdng hpp van tiep tuc sCrdung djch truyen nay, can theo ddi chat che cac chi so ve ddng mau cua benh nhan.

Cac dCr lieu ve dp an toan cua djch truyen HES tren tre em con han che; do do, chi khuyen cao sir dung djch truyen HES tren ddi tppng benh nhan nay theo cac hudng dan dieu trj hien hanh cua Bp Y te'.

Hien con thieu cac duf lieu ve dp an toan dai han cua djch truyen HES sUdung tren benh nhan chan thuong va benh nhan phau thuat. Do dd, can than trpng danh gia hieu qua/nguy co khi xet den dp an toan dai han va can nhac nhCfng lUa chpn dieu trj sin cd khac khi stir dung HES tren ddi tupng benh nhan nay.

S6 6/2014 Nghien CLIU duoc Thong tin thudc 237

THONG TIN THUOC - CANH GlAC DUOC

TAI LIEU THAMKHAO

1. Bo Y te (2007), Duac thu quoc gia dung cho tuyen y te CO sd, pp.

2. Bp Y te. Cue Quan ly DuOc (2014). Cong van so 11039/QLD-DK ve viec cap nhgt thong tin duoc ly doi vdi dich truyen hydroxyethyl starch (HES).

3. Nolan J.P., Mythen M. G. (2013). "Hydroxyethyl starch: here today, gone tomorrow". British Journal of Anaesthesia, 111(3): 321-324.

4. Myburgh John A, Finfer Simon, Bellomo Rinaldo, Billot Laurent, Cass Alan, Gattas David, Glass Parisa, Lipman Jeffrey, Liu Bette, McArthur Colin (2012), "Hydroxyethyl starch or saline for fluid resuscitation in intensive care", New England Journal of Medicine, 367(20), pp. 1901-1911.

5. European Commission (EC). Commission implementing decision of 19/12/2013 concerning, in the framework of Articles 31 and 107i of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of "hydroxyethyl starch" (HES) containing medicinal products, solutions for infusion. Retrieved 12 February 2014 from http://ec.europa.eu/health/ documents/community-register/2013/20131219127286/dec 127286 en.pdf.

6. Agence nationale de securite du medicament et des produits de sante (ANSM) (2013), "Medicaments contenant de I'hydroxyethylamidon : Point d'etape sur la revaluation du benefice/risque - Mise a jour du point d'information du 28/06/2013", Retrieved 12 February 2014 from http://ansm.sante.fr/S-informer/Actualite/Medicaments-contenant-de-l-hydroxyethylamidon-Point-d-etape-sur-la-reevaluation-du-benefice-risque-Mise-a-jour-du-point-d-information-du-28-06-2013.

7. U.S. Food and Drug Administration (2013), "Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding", Retrieved 15 August, 2013, from http://www.fda.gov/Safety/ MedWatch/Safetylnformation/SafetyAlertsforHumanMedicalProducts/ucm358349.htm.

8. Healthy Canada (2013), "Hydroxyethyl starch solutions should not be used in some critically ill patients", Retrieved 12 February 2014 from http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34299a-eng.php.

9. Australian Government. Department of health. Therapeutic Goods Administration (TGA) (2013). "Hydroxyethyl starch (Volven and Volulyte) and increased risk of mortality", Retrieved 12 February 2014 from http://www.tga.gov.au/safety/ews-medicine-hydroxyethyl-starch-130709.htm.

10. Health Sciences Authority (HSA) (2013). "Safety update on hydroxyethyl starch (HES)-containing products", Retrieved 12 February 2014 from http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safetyjnformation/product_safety_ alerts/Safety_Alerts_2013/safety_update_on_hydroxyethyl.html.

11. Regulating medicines and medical devices (MHRA) (2013),"MHRA suspends use of hydroxyethyl starch (HES) drips", Retrieved 12 February 2014 from http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON287028.

12. National institute for health and care excellence (NICE). NICE clinical guideline 74. Intravenous fluid therapy in adults in hospital. Issued: December 2013.

13. Dellinger et al. "Surviving sepsis campaign: International guidelines for management of severe sepsis and septic shock: 2012". Critical Care Medicine. Vol. 41, No. 2. Feb 2013.

14. Moral V., Aldecoa C, Asuero M.S. (2013). "Tetrastarch solutions: are they definitely dead". British Journal of Anaesthesia, 111(3): 324-327.

15. Patrick meybohm et al (2013). "Re-evaluating currently available data and suggestions for planning randomised controlled studies regarding the use of hydroxyethyl starch in critically ill patients - a multidisciplinary statement". Critical Care, 17:R166.

238 Nghien cOu duoc Thong tin thuoc So 6/2014