CHUYEN DE: BENH VIEN 103 - HOC VIEN QUAN Y <- CHAO MLTNG 60 NAM NGAY TRUYEN THONG
4.
thudng, ngudi tang huyet ap. lufin an Tien sy Y hoc, Dai hoc Y Ha Noi, 1993.
Trdn Vdn Trung (2009) Nghien ciiu hinh thai, chiic nang dong mach canh doan ngoai so bang sieu am Dppler d bfnh nhan nhoi mau nao. Luan van chuyen khoa ca'p 2, Hoc Vien Quan Y.
Rebecca L Pollex, Khalid Z AL-Shali et al (2006). Relationship of the metabolic syndrome to carotid ultrasound traits.
Cardiovascular Ultrasound,, 4, pp 2 - 7.
6.
Al-Nimer MS et al (2009) "Increased mean]
carotid intima media thickness in type 2 • diabetes mellitus patients with non-blood- pressure component metabolic syndrome: A, preliminary report", Int .1 Diabetes Dev i
Ctries,. 29(1): 19-22 ! Antonini-Canterin F et al (2010) "'
Association between carotid atherosclerosis' and metabolic syndrome: results from the \ ISMIR study", Angiologv..61(5i:443- ^
NGHIEN CCru TINH AN TOAN VA TAC DUNG KHONG MONG MUON !
CUA VACXIN TRirC KHUAN MU XANH ^
Kieu Chi Thanh* va cong sir i
TOMTAT
Nghien ciiu tfnh an toan va tac dung khong mong mudn cua vacxin P. aeruginosa do Viet Nam san xuat tren benh nhan bdng cho thay:
- Vacxin dat tieu chuan an toan khi tiem cho 20 ngUdi tinh nguyen, sau 15 ngay khong co bieu hien bat thUdng.
- Tac dung khong mong mudn khi tiem cho benh nhan bong: vacxin khong gay cac trieu chu'ng nang nhU sdc phan ve, di iing. Chi cd 8,35% benh nhan sdt dUdI 38 dp C va 2 benh nhan (5,71%) cd dau hieu buon non. Cac trieu chu'ng nay het sau 24h. Can cd nghien ciiu d qui mo Idn hdn de dUa vacxin vao sii dung.
SUMMARY
TO STUDY THE SAFETY AND SIDE EFFECTS OF VACCINES P. AERUGINOSA IN PATIENTS WITH BURNS
To study the safety and side effects of
* Benh vien 103 - Hgc vien qudn y 182
1
vaccines P. aeruginosa produced by Vietnam on I
burns patients showed: J - Vaccine safety standards when given to 20 J
volunteers, after 15 days Is not abnormal. People j
are still working normally. ! - Side effects when given to patients with
burns, vaccines do not cause severe symptoms i such as anaphylaxis, an allergic reaction. Only 1 8.35% of patients below 38 degrees C fever and ; bA/o patients (5.71%) with signs of nausea. \ These symptoms end after 24 hours. There j should be studied in larger scale to bring I vaccines into use.
I. OAT VAN OE I
Bdng la mdt benh thudng gap do tai nan ';
trong thdi binh va thdi chie'n. Khi dien tich : bdng sau, dien r6ng de lai hau qua ra[t nang j ne lam ma't kha nang lao ddng va ty le tit I vong cao. Cdng tac dilu tri bdng gap rit'\
I
Y HOC VIET NAM THANG 12 - SO 2/2010
nhieu khd khan do nhiem khu^n bdng va nhiem khuan huye't bdng, dac biet la nhiem khuan do true khuan mu xanh (P.aeruginosa). Vi khuan nay la loai vi khuan da khang lai hSu bet cac khang sinh thong thudng va dac biet (ki ca cacbapenem). Gan day, cac thong tin ciia WHO cho tha'y xuat hien vi khuan da khang d India, Pakistan lam tang them khd khan trong dieu tri. Viec tim kie'm giai phap tri lieu mien dich da duoc dat ra. Nhiing nam 1998-2000, chiing tdi da san xuat vacxin phdng P. aeruginosa dimg cho dong vat va thit nghiem thanh cdng ve kha nang bao ve tren ddng vat. Nam 1996, chiing toi da chuyen giao cdng nghe san xuat vacxin cho vien Vacxin va sinh pham Da Lat san xua't de dimg thii nghiem tren ngudi tai Vien Bong Qud'c gia. Muc tieu ciia de tai nay la:
- Ddnh gid tinh an todn cua vacxin P.
aeruginosa do Viet Nam sdn xudt tren ngudi tinh nguyen. J .„ '_
- Ddnh gid cdc tdc dung khong mong mudn Ciia vacxin P. aeruginosa tren benh nhdn bdng
•" f • •
II. 0 6 l TUONG VAT LIEU VA PHUONG PHAP NGHIEN CCfU \
2.1. Ddi tuang.
+ Danh gia tinh an toan tren ngudi Idn tinh nguyen : 20 ngudi la nhihig ngudi san
xuat ra vacxin va nhdm can bd nghien ciiu duoc tiem 2 miii vacxin lieu 0,5ml, dudng tiem dudi da, mdi mQi each nhau 1 tuan, theo ddi cac tac dung khdng mong mudn sau 15 phiit, 24h va 15 ngay sau tiem vacxin.
+ Danh gia tac dung khdng mong mudn:
- Nhdm thir nghiem tren 35 benh nhan bdng dudi 15%, do sau dudi 5% nam dieu tri tai Vien Bdng. Lieu tiem 0,5ml vacxin toan te' bao, ndng do vi khuan lOVml, bat boat nhiet do va bao quan bang Thiomersal 0,001%.
Loat vacxin 0406- ban dung 08/2008
-I- Nhdm chiing tiem tren 35 benh nhan 0,5 ml NaCl 0,9%
Theo ddi cac phan iing khdng mong mudn benh nhan duoc tiem vacxin va nhdm chiing sau 15 phut, 2h, 24h, 7ngay va 15 ngay
2.2. Phuang phdp - Ky thuat nghien citu.
- Dung phuong phap mu ddi de' theo ddi tac dung khdng mong mudn ciia vacxin.
Ngudi tiem va ngudi benh khdng bie't minh duoc tiem vacxin hay NaCl 0,9%.
- Ket hop phuong phap nghien ciiu tie'n ciiu theo ddi trifu chiing sau tiem va ghi chep, lay mSu mau lam xet nghiem khang the ve sau.
2.3. Dia diem, thdi gian nghien cdu - Nghien ciiu thuc hien tai Vien Bdng Le Hiha Trac, Hoc vien quan y
- Thdi gian thang 6 - 10/2007
III. KET QUA NGHIEN COU - i - -^ 1 — - . - .^i ^ 3.1. Ddnh gid tinh an todn tren 20ngudi Idn
Bang 1: Tac dung khdng mong mudn ciia nhdm ngudi Idn tinh nguyen sau 2h va 24h va 7, 15 ngay sau tiem vacxin (ca 2 lan tiem)
Bieu hien tac dung khong mong mudn sau tiem vacxin 1. Tai cho
Dau tai ch6 Dau hieu khac
Lan 1 (n=20) Lan 2 (n=20)
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CHUYEN DE: BENH VIEN 103 - HOC VIEN QUAN Y <- CHAO MLfNG 60 NAM NGAY TRUYEN THONG
2. Toan than dau dau
Mach dap nhanh (tren 100 Ian/phut) i ••
Dau hieu toan than khac: choang, chong mat, gai ret...
Buon non, non ...
0 1 0 0
0 0 0 0
Nhan xet: sau tiem vacxin lieu 0,5ml, dudng tiem bap thit, 20 ngudi Idn duoc theo ddi, j phdng va'n sau 30 phiit, 24b khong cd trudng hop nao cd bao cao cd trieu chiing ba't thudng, I chi cd 1 ngudi cd mach nhanh dap tren 90 lan /phiit sau tiem 15 phiit, sau 24h binh thudng. j
3.2. Tdc dung khdng mong mudn cua vacxin tren benh nhdn bong \ Bang 2. Phan bd tudi gidi d nhdm benh nhan tiem vacxin I
^•^-^^^^ Gidi Tuoi ^""^.^^
Nam
NL?
Cong
Nhom tiem vacxin Sd IUdng
28 7 35
Tyle 80.00 20.00 100%
Nhom chiing Sd lUcfng
24 11 35
Tyle 68.57 31.43 100%
Benh nhan bdng chii yeu la benh nhan nam d ca 2 nhdm, nhdm tiem vacxin la 80%, i
nhdm chiing la68,57% . ivu - ,;.,.. j Bang 3: Tac dung khdng mong mudn d nhan thdi diem 1, 3, 7 ngay sau tiem 2 mui d 2 nhdm ;
benh nhan nghien ciiu.
Bieu hien tac dung khong mong mudn 1. Tai ch5
Sung dau, ap xe Dau hieu khac 2. Toan than Soc phan ve Sot (dudi 38 do) Buon non
Dau hieu toan than khac
Nhom tiem vacxin N1
0 0
0 3 (8,35%)
2(5,71%) 0
N2 0 0
0 0 0 0
N7 0 0
0 0 0 0
Nhom chufng N1
0 0
0 0 0 0
N2 0 0
0 0 0 0
N7 0 0
0 0 0 0 Nhan xet, sau tiem vacxin , chi cd 3/35 (8,35%) benb nhan cd dau hieu sdt dudi 38 dd, 2 benh nhan (5,71%) cd dau hieu budn ndn. Ty le nay la chap nhan duoc.
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Y HOC VIET NAM THANG 12 - SO 2/2010
IV. BAN LUAN
+ v e tinh an toan cua vacxin P.aeruginosa
Trudc khi dung tren ngudi, chiing toi da sir dung tren chuot va dat tieu chuan ciia Duoc dien Viet Nam, vacxin duoc tiem cho chudt nhat trSng 25g, lieu tiem tuong duong ngudi Idn va theo ddi sau 10 ngay, chudt tang trong binh thudng, khdng cd sdt hoac chet trong sudt thdi gian nghien ciiu [I]. Viec vacxin P. aeruginosa tiem tren ngudi duoc thuc hien lan dau bdi Feller (My) vao nam 1964. Tac gia dung 1 typ huyet thanh va cho tha'y vacxin nay dam bao an toan tren ngudi tinh nguyen [2]. Khdng cd ba't cii phan iing nghiem trong nao cua co the sau khi tiem vacxin. Trong nghien ciiu ciia chiing toi, tren 20 ngudi tinh nguyen tiem vacxin cung khong cd thanh vien nao cd da'u hieu bat thudng va vacxin nay da duoc thdng qua Hoi d6ng y ditc Bd Y te' de sir dung tren ngudi.
+ Ve phan iing khdng mong mudn d tre tiem vacxin P.aeruginosa
Viec nghien ciiu tac dung khdng mong mudn ciia vacxin dugc Schiller (Ba Lan) diing 5 typ huye't thanh P che' tao vacxin dung de du phdng nhiim khuan bdng. Tac gia tren cho tha'y vacxin gay ra mdt sd phan iing khdng mong mudn cho ngudi dugc tiem nhu sdt, budn ndn nhung ty le thap (dudi 10%).
Ty le sinh khang the cao, giam ty le mac P.aeruginosa tur 51% xudng 20%. [3]
Trong nghien eun cua chiing tdi, khi nghien ciiu tac dung khdng mong mudn tren benh nhan bdng cd 3/35 benb nhan cd sdt sau tiem (dudi 38 do), ty le 8,35% d ngay dau tien, cac ngay sau benh nhan bdt sdt. Tuy nhien do la benh nhan bi bdng van phai tiep tuc dung thudc, khang sinh nen khd cd the danh gia sdt do vacxin hay do bi bdng va nguyen nhan bet sdt cd the do dung thudc.
Van de nay cSn cd mdt thir nghiem d cap do Idn hon. Hien nay, cac nudc phat trien dang nghien ciiu vacxin tinh che' ciia P. aeruginosa nhu vacxin chi cd polysacharide ngoai tie't hoac exotoxin A de lam giam tac dung khdng mong mudn [4]. Cac vacxin nay ddi hdi trang bi ky thuat rat cao nen d Viet Nam la chua kha thi nen vacxin toan te' bao van cd gia tri khoa hgc
V. KITLUAN
-)- O 20 ngudi Idn tinh nguyen sau khi tiem vacxin P. aeruginosa vdi lieu 0,5ml dudi da chiing toi khong thay cd tac dung khong mong mudn nao xay ra
+ Tren benb nhan bdng, ty le nhiing tac dung khong mong mudn ra't tha'p va h^u he't la cac dau hieu nhe nbu sdt dudi 38°C (8,35%), budn ndn (5,71%). Cac trieu chiing nay bet ban sau 2 ngay tiem vacxin
TAI LIEU THAM K H A O .
1. Vu Chien ThSng (1996): Budc ddu nghien citu che tgo vacxin te bdo vi khudn mu xanh vd ddnh gid hieu luc bdo ve cua vacxin tren dpng vdt thuc nghiem "- Luan an tien sT y hoc - Hoc vien quan y - 1997
2. Jones R.J, Roe E.A (1980): Controlled trial of Pseudomonas immunoglobulin and vaccin in burn patients - The Lancet 1980, 8207:1263-1265.
3. Schiller B, Buchowicz 1.(1985): Polish preparation for the prophylaxis and
treatment of P. aeruginosa infection . i infect- epider-micro-immuno, Moskva 4, 1985:30-32
4. Vetkova L.G. (1999): Vaccine development for P. aeruginosa: base on antigent cloning
of clinical vacccines ; J infect- epider-micro- immuno, Moskva 3, 1985: 53-56
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