B Y T

TRNG I HC DC H NI

IU HUY QUN ANH

KHO ST C CU V XU HNG
NHP KHU THUC IU TR
I THO NG TI VIT NAM
GIAI ON 2006-2011
KHA LUN TT NGHIP DC S

H NI 2013

B Y T
TRNG I HC DC H NI

IU HUY QUN ANH

KHO ST C CU V XU HNG
NHP KHU THUC IU TR
I THO NG TI VIT NAM
GIAI ON 2006-2011
KHA LUN TT NGHIP DC S
Ngi hng dn:
1. DS. Nguyn Vnh Nam
2. ThS. Chu Quc Thnh
Ni thc hin:
1. B mn Qun l v Kinh t dc
Trng i hc Dc H Ni
2. Phng Qun l gi thuc
Cc Qun l Dc - B Y t

H NI 2013

LI CM N
Ti xin c by t lng bit n chn thnh v su sc nht n:
ThS. Chu Quc Thnh Chuyn vin Phng Qun l gi thuc Cc
Qun l Dc B Y t, ngi cung cp cho ti cc s liu, hng dn v
gi cho ti v phng php nghin cu.
DS. Nguyn Vnh Nam B mn Qun l v kinh t Dc Trng
i hc Dc H Ni, thy lun tn tnh hng dn, ng vin v cho ti
nhiu kin thc qu bu hon thnh kha lun tt nghip ny.
ThS. Nguyn Th H B mn Qun l v kinh t Dc Trng i
hc Dc H Ni, c cho ti nh ng li khuyn qu bu v gip ti
trong sut thi gian lm kha lun.
Ti cng xin cm n cc thy c gio Trng i hc Dc H Ni,
c bit cc thy c B mn Qun l v Kinh t Dc tn tnh dy d ti
trong sut thi gian hc tp ti trng.
Cui cng ti xin gi li cm n su sc n gia nh v bn b
khch l ng vin ti t c nhng thnh cng ngy hm nay.
H ni, ngy 21 thng 05 nm 2013.
Sinh vin

iu Huy Qun Anh

MC LC
DANH MC CC CH VIT TT
DANH MC CC BNG
DANH MC CC HNH
T VN .................................................................................................. 1
Chng 1. TNG QUAN ............................................................................... 2
1.1. Tng quan v bnh i tho ng ...................................................... 2
1.1.1. nh ngha bnh i tho ng ................................................... 2
1.1.2. Phn loi i tho ng............................................................... 2
1.1.3. Tnh hnh i tho ng ti Vit Nam v trn th gii ................ 2
1.2. Tng quan v thuc v iu tr i tho ng .................................... 3
1.2.1. Cc nhm thuc iu tr i tho ng ....................................... 3
1.2.2. iu tr i tho ng .................................................................. 4
1.3. Tng quan v th trng thuc nhp khu v thuc iu tr i tho ....
ng Vit Nam............................................................................................. 8
1.3.1. Vai tr ca thuc nhp khu .......................................................... 8
1.3.2. V tr thuc iu tr i tho ng trong th trng thuc nhp ...
khu Vit Nam. ............................................................................................ 9
1.4. Tng quan v nghin cu nh lng s dng thuc ......................... 10
1.4.1. Nghin cu chi ph ....................................................................... 10
1.4.2. Nghin cu da trn s lng n v ng gi ........................... 11
1.4.3. Nghin cu da trn n thuc.................................................... 11
1.4.4. Nghin cu da trn liu trung bnh s dng hng ngy ............ 12
1.5. Cc nghin cu tng t ti Vit Nam v trn th gii ..................... 12
1.5.1. Cc nghin cu v s dng/ tiu th thuc iu tr i tho ng
trn th gii ............................................................................................... 13
1.5.2. Cc nghin cu tng t ti Vit Nam ........................................ 13

Chng 2. I TNG V PHNG PHP NGHIN CU ............. 15

2.1. i tng nghin cu ......................................................................... 15
2.2. Thi gian v a im nghin cu ...................................................... 15
2.3. Thit k nghin cu ............................................................................ 15
2.4. Ni dung nghin cu .......................................................................... 15
2.5. Cc ch s nghin cu ........................................................................ 15
2.6. Thu thp v lm sch d liu .............................................................. 16
2.7. X l s liu........................................................................................ 18
2.8. Trnh by v bo co kt qu.............................................................. 18
Chng 3. KT QU NGHIN CU ........................................................ 19
3.1. Gi tr kim ngch nhp khu v s lng s ng k cc thuc iu tr
i tho ng nhp khu vo Vit Nam (2006-2011) ............................... 19
3.1.1. Gi tr kim ngch nhp khu cc thuc iu tr i tho ng .....
nhp khu (2006-2011)............................................................................. 19
3.1.2. S lng s ng k cc thuc iu tr i tho ng nhp khu
(2006-2011)............................................................................................... 19
3.2. C cu v xu hng nhp khu cc nhm thuc iu tr i tho .........
ng (2006-2011) ...................................................................................... 20
3.2.1. Kho st da trn gi tr kim ngch nhp khu .......................... 20
3.2.2. Kho st da trn s lng s ng k........................................ 21
3.2.3. Kho st da trn tng s liu DDD ........................................... 22
3.3. C cu v xu hng nhp khu cc hot cht iu tr i tho ng ..
(2006 2011) ............................................................................................... 24
3.3.1. Kho st da trn gi tr kim ngch nhp khu .......................... 24
3.3.2. Kho st theo s lng s ng k .............................................. 26
3.3.3. Kho st theo tng s liu DDD .................................................. 28

3.4. C cu v xu hng nhp khu cc thuc iu tr i tho ng theo

quc gia xut x (2006-2011) ...................................................................... 29
3.4.1. Kho st theo kim ngch nhp khu. ........................................... 30
3.4.2. Kho st theo s lng s ng k .............................................. 32
Chng 4. BN LUN ................................................................................. 34
4.1. Bn lun v kt qu nghin cu ......................................................... 34
4.1.1. Xu hng chung v nhp khu cc thuc iu tr i tho ng ..
...................................................................................................... 34
4.1.2. Xu hng nhp khu cc nhm thuc iu tr i tho ng ... 34
4.1.3. Xu hng nhp khu cc hot cht iu tr i tho ng ....... 35
4.2. Hn ch ca ti............................................................................... 38
4.2.1. Hn ch v phng php nghin cu........................................... 38
4.2.2. Hn ch v d liu nghin cu ..................................................... 38
4.2.3. Hn ch v bin gii kt qu ........................................................ 39
KT LUN V KIN NGH ...................................................................... 40
TI LIU THAM KHO
PH LC

DANH MC CC K HIU, CH VIT TT

ADA

Hip hi i tho ng hoa k

DDD

Liu trung bnh s dng hng ngy

i tho ng

EASD

Hip hi nghin cu i tho ng Chu u

Ins

Insulin

IDF

Lin on i tho ng quc t

KNNK

Kim ngch nhp khu

Met

Metformin

NK

Nhp khu

Pio

Pioglitazon

TLS

Thay i li sng

TZD

Thiazolidinedion

SK

S ng k

Sul

Sulfonamid v dn xut ure

WHO

T chc y t Th Gii

DANH MC CC BNG
Bng 1.1. T trng thuc trong nc v nhp khu ......................................... 9
Bng 1.2. Gi tr v t trng gi tr mt s nhm thuc nhp khu ti Vit.......
Nam ................................................................................................ 10
Bng 2.1. Danh mc cc hot cht iu tr i tho ng trong nghin cu 17
Bng 3.1. Gi tr kim ngch nhp khu v t trng gi tr kim ngch nhp .......
khu thuc iu tr i tho ng (2006-2011) ........................... 19
Bng 3.2. S lng s ng k cc thuc iu tr i tho ng nhp khu....
(2006-2011) .................................................................................... 19
Bng 3.3. Gi tr kim ngch nhp khu ca mt s bit dc iu tr i tho..
ng c xut x t Php. ............................................................. 32

DANH MC CC HNH
Hnh 1.1. Phc iu tr T ca Hip hi i tho ng M v hip hi ..
nghin cu i tho ng Chu u nm 2009 .............................. 8
Hnh 3.1 Gi tr v t trng kim ngch nhp khu cc nhm thuc iu tr i.
tho ng...................................................................................... 21
Hnh 3.2 S lng s ng k ca cc nhm thuc iu tr i tho ng ......
(2006-2011) .................................................................................... 22
Hnh 3.3. Tng s liu v t trng tng s liu DDD ca cc nhm thuc ......
iu tr i tho ng (2006 2011) ........................................... 23
Hnh 3.4. Gi tr kim ngch nhp khu ca cc hot cht iu tr i tho ........
ng v t trng (2006-2011) ...................................................... 26
Hnh 3.5. S lng s ng k ca cc hot cht iu tr i tho ng nhp.
khu ................................................................................................ 27
Hnh 3.6. Tng s liu DDD v t trng tng s liu DDD ca cc hot cht...
iu tr i tho ng ................................................................... 28
Hnh 3.7. Gi tr v t trng gi tr kim ngch nhp khu theo xut x ca cc
thuc iu tr i tho ng ......................................................... 31
Hnh 3.8. S lng s ng k t cc quc gia c thuc iu tr i tho .........
ng Vit Nam giai on 2006-2011 ....................................... 33

T VN
Cng vi s pht trin v kinh t, cht lng cuc sng c nng cao
khin cho cc bnh mn tnh ni chung v bnh i tho ng ni ring ngy
cng tr nn ph bin. Theo c tnh ca T chc y t th gii, vi tc gia
tng s lng bnh nhn hin nay, khong 4,4% dn s th gii s mc bnh
i tho ng vo nm 2030 [23]. Mc d l mt quc gia ang pht trin,
cc thng k dch t hc cho thy ti Vit Nam vo nm 2010, c kho ng
3% dn s mc bnh ny [24].
Tc pht trin bnh nhanh nh vy l mt thch thc ln vi ngnh
Y t cng nh ngnh Dc Vit Nam. thc hin tt mc tiu cung ng y
c v s lng v cht lng cc thuc iu tr i tho ng, ngnh
Dc khng nhng phi pht trin v quy m v danh mc thuc sn xut
trong nc m cn phi nhp khu thuc.
Mc d vai tr thuc nhp khu trong iu tr i tho ng l rt
quan trng, tuy nhin hin nay, cha c mt kho st no nh gi c cu v
xu hng nhp khu thuc iu tr i tho ng. Trn c s , chng ti
thc hin ti Kho st c cu v xu hng nhp khu thuc iu tr
i tho ng giai on 2006-2011 vi hai mc tiu:
1. Kho st c cu nhp khu thuc iu tr i tho ng vo Vit
Nam giai on 2006-2011.
2. Kho st xu hng nhp khu thuc iu tr vo Vit Nam giai on
2006-2011.

Chng 1. TNG QUAN

1.1.

Tng quan v bnh i tho ng

1.1.1. nh ngha bnh i tho ng

Theo T chc y t th gii (WHO): i tho ng (T) l mt bnh
mn tnh gy ra bi s thiu ht tng i hay tuyt i insulin, dn n cc
ri lon chuyn ha hydratcacbon. Bnh c c trng bi tnh trng tng
ng huyt mn tnh v cc ri lon chuyn ha [4].
1.1.2. Phn loi i tho ng
i tho ng typ1: Do bnh t min dch, cc t bo beta tuyn ty
b ph hy bi cht trung gian min dch,s ph hy ny c th nhanh hay
chm. Tin trin nhanh hay gp ngi tr <30 tui. Th tin trin chm hay
gp ngi ln. iu tr bt buc bng insulin, t l gp <10% [2],[4].
i tho ng typ 2: c trng ca T typ 2 l khng insulin i
km vi thiu ht insulin tng i. Bnh hay gp ngi trn 30 tui.C th
iu tr bng ch n ung, thuc ung, insulin. T l gp 90-95% [2],[4].
i tho ng thai k: T thai k l tnh trng ri lon dung np
ng huyt xy ra trong thi k mang thai [2].
Cc tnh trng tng ng huyt c bit khc: Gim chc nng t bo
beta do khim khuyt gen, gim hot tnh insulin do khim khuyt gen, bnh
l tuyn ty, mt s bnh ni tit nh hi chng Cushing, [2].
1.1.3. Tnh hnh i tho ng ti Vit Nam v trn th gii
Theo WHO, 2012 trn th gii c 347 triu ngi b bnh T, trong
hn 80% bnh nhn T sng cc nc c thu nhp thp v trung bnh.
D on tng s ngi cht do T s tng thm 50% trong 10 nm ti.
T typ 2 hin nay chim t l 90% trong tng s bnh nhn T v ang
c xu hng tng nhanh tr em [23].

Theo Lin on T quc t (International Diabetes Federation IDF)

cng trong nm 2012 c ti 4,8 triu ngi cht v bnh i tho ng,
mt na trong s tui di 60 tui. Th gii chi hn 471 t USD
cho bnh T nm 2012 [15].
Nm 2002, theo iu tra trn phm vi ton quc la tui 30-64 ca
Bnh vin Ni tit Trung ng, t l mc bnh T chung ca c nc l
2,7%, cc thnh ph l 4,4%, vng ng bng ven bin 2,2% v min ni l
2,1% [1]. Ti 2010 theo t chc y t th gii Vit Nam c khong 2,64
triu ngi tng ng 3% dn s mc bnh [24].
1.2.

Tng quan v thuc v iu tr i tho ng

1.2.1. Cc nhm thuc iu tr i tho ng

1.2.1.1. Insulin
o Ch nh:
L bt buc vi T typ1 v T thai k [2].
S dng cho T typ 2 khi c: nhim trng, vt thng cp, tng
ng huyt vi tng ceton mu cp nng, c thai, suy gan,suy thn, d ng
hay tht bi vi cc thuc ung h ng huyt, khi c ch nh tm thi ngay
khi ng huyt tng >250-300 mg/dl hay HbA1c>11%, v mt s trng
hp khc [2].
o Phn loi insulin theo thi gian tc dng [2],[4],[12].
- Loi tc dng nhanh nh Lispro, Aspart,Glulisin.
- Loi tng i nhanh nh Regular.
- Loi tc dng trung gian nh Lente hay NPH.
- Loi tc dng ko di nh Glargin, Ultralente, Detemir .
- Loi hn hp nh 70%NPH /30%Regular hay 75%NPH /25%Lispro.
Trong : meal-insulin l loi tc dng nhanh v tng i nhanh [12].

1.2.1.2. Cc thuc iu tr i tho ng ng ung

- Nhm thuc kch thch ty bi tit insulin (sulfonamide/xut ure):
glyclazid, glimepirid, glibenclamid, gliburid, glipizid [2].
- Nhm thuc lm tng nhy cm insulin ngoi vi, gim khng
insulin: biguanid, thiazolidinedion [2].
Biaguanid: metformin.
Thiazolidinedione: pioglitazon, rosiglitazon.
- Nhm c ch emzyme alpha glucosidase lm gim hp thu glucose:
acarbose, voglibose, miglitol [2].
- Nhm glinid: kch thch t bo beta tuyn ty tit insulin. Gm cc hot
cht nh: meglitinid, repaglinid.
- Nhm cc thuc tc dng trn h incretin:
Cc thuc ng phn GLP-1 (glucagon-like peptide 1): lm gim
ng huyt sau n. V d: exenatid.
Thuc c ch emzym phn hy GLP-1 l DPP IV (dipeptidyl
peptidase IV): lm tng nng v tc dng ca GLP-1 ni sinh.
ng phn amylin: tc dng theo c ch lm chm trng d dy,
c ch tit glucagon, tng GLP [4].
1.2.2. iu tr i tho ng
1.2.2.1. iu tr khng dng thuc
- Ch n: vi T typ 1 n calo, vi T typ 2 n t calo (t hn
1200Kcal/ngy ), n nhiu ba nh v gi n phi u. Khu phn n
cn i (50-60% glucid, 30-35% lipid, 10% protid), m bo vitamin,
khong cht, hn ch cc loi ng hp thu nhanh, king ru [4],[2].
- Vn ng th lc l rt quan trng v cn thit, c bit l T typ 2.
Luyn tp ty theo la tui v tnh trng tim mch ca bnh nhn [4].

- Kim sot ng huyt bng cch nh lng ng huyt thng

xuyn chnh liu thuc cho ph hp [4].
- Gio dc bnh nhn nhng kin thc v T bnh nhn phi hp
tt trong iu tr, bit cch t dng thuc v phng nga c bin
chng [4].
- Khm nh k theo di cc bin chng v c tham vn ca bc s
khi c vn c bit xy ra [4].
1.2.2.2. Cc phc iu tr
a. Cc phc iu tr bng insulin
C nhiu phc iu tr insulin khc nhau. i vi T typ 1 thng
s dng cc phc 2- 4 mi/ ngy. i vi T typ 2 ngoi phc nh
T typ 1 c th s dng thm phc 1 mi insulin kt hp vi thuc vin
(insulatard, lantus) [2].
T thai k thng s dng phc 1-4 mi/ ngy ty theo nng
ng huyt bnh nhn. Ch s dng loi insulin tng hp (actrapid, mixtard,
insulatard) [2].
- Phc 1 mi insulin : phi hp thuc vin iu tr T vi 1 mi
insulin tc dng trung gian hoc hn hp vo trc ba n ti hoc 1
mi insulin tc dng trung gian hoc Glargin (lantus) vo bui ti trc
khi i ng.
- Phc 2 mi insulin : thng s dng 2 mi insulin tc d ng trung
gian hoc insulin hn hp tim trc n sng v ti. Chia liu 2/3 trc
ba im tm sng, 1/3 trc ba n ti. Khi vi phc trn tht bi,
ch n v ch sinh hot tht thng hoc khi cn kim sot cht
ch ng huyt nh khi c thai hoc khi c cc bin chng nng cn
s dng cc phc khc vi nhiu mi insulin [2].

- Phc nhiu mi insulin: tim 3 ln trong ngy: 2 mi nhanh v 1 mi

bn chm hoc 2 mi bn ch m hoc insulin nn. Tim 4 ln trong
ngy: 3 mi insulin tc dng nhanh trc 3 ba n v 1 mi insulin nn
loi NPH trc khi ng hoc Glargin (lantus) [2].
b. Phc iu tr T typ 2 ca IDF nm 2005 v 2012
Trong c 2 phc ny, metformin l u tin s dng u tin cho
kim sot ng huyt, tip n l sulfonamid/dn xut ure. iu ny cho
thy trong giai on nghin cu, khng c s thay i v vai tr ca
metfomin v sulfonamid trong vic kim sot ng huyt.
- Phc iu tr T ca IDF nm 2005 [16]
Bc 1. Thay i li sng.
Bc 2. S dng metformin, theo di chc nng thn khi s dng.
Bc 3. S dng sulfonamid/dn xut ure khi metformin khng kim
sot c ng huyt. Insulin tc dng nhanh c th thay th sulfonamid.
Bc 4. S dng (thiazolidindion + metformin) hoc (thiazolidinedion
+ sulfonamid) hoc (thiazolidinedion + mt thuc dng kt hp ca
metformin v sufonamid) khi bc 3 khng t c mc tiu iu tr.
Bc 5. S dng cht c ch alpha glucosidase nh mt thuc thm
vo.
Bc 6. Tng liu, dng thm cc thuc h ng huyt khc, dng
insulin.
- Phc iu tr T typ 2 ca IDF nm 2012 [14]
Bt u vic iu tr bng cch thay i li sng, nu khng t mc
tiu mi bc (thng l HbA1C <7,0%). S s dng cc bin php iu tr
sau:
Bc 1. S dng metformin, c th thay th bng sulfonamid/dn xut
ure hay cht c ch alphaglucosidase.

Bc 2. S dng sulfonamid/dn xut ure, c th thay th bng mt

trong cc thuc: metformin, cht c ch alphaglucosidase, thiazolidinedion,
DPP-4.
Bc 3. La chn mt trong cc thuc: insulin tc dng ko di, insulin
dng hn hp, c ch alpha-glucosidase, DPP-4, thiazolidinedion, c th thay
th bng cht ng vn GLP1.
Bc 4. La chn mt trong cc thuc: mt insulin tc dng ko di v
mt meal-time insulin, insulin nn hoc insulin hn hp.
c. Phc iu tr T ca hip hi T M v hip hi nghin cu T
Chu u
Chin lc iu tr T typ 2 theo ng thun ca Hip hi T M
(American Dental Asociation -ADA) v Hip hi nghin cu T chu u
(European Association for the Study of Diabetes - EASD) a ra nm 2009
c trnh by trong hnh 1.1.
T hnh 1.1 pha di ta thy:
Trong phc loi 1, l phc c u tin iu tr th metformin,
sulfonamid/dn xut ure v insulin l nhng nhm thuc quan trng nht
trong vic kim sot ng huyt.
Phc 1 l cc phc iu tr hiu qu v kinh t nht. Cc phc
ny c a ra da vo cc kt qu th nghim lm sng, v c chng
minh l gip t c HbA1c ch nn c la chn cho hu ht cc bnh
nhn.
Phc loi 2 khc vi loi 1 bc th hai v th ba. Phc loi 2
ny thng c p dng t ph bin hn phc loi 1.

LOI 1: iu tr c bn, y bng chng

TLS
+Met+Sul

Chn on T: Thay
i li sng (TLS) +
Met

TLS+ Met+
Insulin nn

LOI 2: t c bng chng hn

Ghi ch:
TLS: Thay i li
sng,
Met: metformin,
Sul: Sulfonamid/dn
xut ure,
Pio: Pioglitazone,
Ins: Insulin.

BC 1

TLS +
Met+ Ins tch
cc

TLS + Met+ Pio

Khng gy h Gluose mu
Gy ph,suy tim, Mt
xng
TLS +Met+ ng vn
GLP-1
Khng h glucose mu
Gim cn, nn, bun nn

BC 2

TLS
+ Met+
Pio+
Sul

TLS +
Met+
Ins nn

BC 3

Hnh 1.1. Phc iu tr T ca ADA v EASD nm 2009 [17]

1.3.

Tng quan v th trng thuc nhp khu v thuc iu tr i

tho ng ti Vit Nam

1.3.1. Vai tr ca thuc nhp khu

Trong thi gian gn y, nhu cu s dng thuc ca ngi dn ngy
cng tng cao. Tin thuc bnh qun u ngi 2008 (16,45 USD/ ngi) tng
gp hn 2 ln so vi nm 2004 (8,6 USD/ngi) [5]. Trc nhu cu s dng
thuc ca ngi dn ngy cng tng v c s lng v cht lng th ngnh

dc cn khng ngng pht trin v quy m v cht lng. Bn cnh , kh

nng sn xut thuc trong nc cn hn ch (thuc thnh phm ch p ng
c 50% nhu cu s dng thuc ca nhn dn, 90% nguyn liu lm thuc
vn phi nhp khu). Do , thuc nhp khu ng vai tr r t quan trng
trong h thng y t nc ta.
So snh t trng thuc trong nc v thuc nhp khu da trn tng gi
tr tin thuc t nm 2006-2010 c th hin bng 1.2. Theo ta thy, t
trng thuc nhp khu l tng ng vi thuc trong nc.
Bng 1.1. T trng thuc trong nc v nhp khu [9]
Nm

Tng gi tr tin
thuc
(Triu USD)

2006
2007
2008
2009
2010

956,353
1136,350
1425,660
1686,140
1913,660

Thuc trong nc
Gi tr
(Triu USD)

475,400
600,630
715,440
831,210
919,040

T trng
%

49,71
52,86
50,18
49,01
48,03

Thuc nhp khu

Gi tr
(Triu USD)

T trng
%

548,200
597,082
759,752
859,763
994,529

50,29
47,14
49,82
50,99
51,97

1.3.2. V tr thuc iu tr i tho ng trong th trng thuc nhp khu

Vit Nam
Ti Vit Nam, thuc iu tr cc bnh nhim khun c t trng kim
ngch nhp khu (KNNK) ln nht (>21% mi nm). ng th 2 l cc thuc
iu tr cc bnh v ng tiu ha v chuyn ha (> 18% mi nm) [5].
Thuc iu tr bnh T nm trong nhm cc thuc iu tr bnh
ng tiu ha v chuyn ha (nhm A) v lun c t trng KNNK ln th 3
trong nhm A, ln lt l 16,1%, 13,3%, 17,0% trong 3 nm t 2006-2008 so
vi tng KNNK ca nhm A [5].
Gi tr v t trng 1 s nhm thuc c KNNK ln vo Vit Nam c
th hin bng 1.2 [5].

10

Bng 1.2. Gi tr v t trng gi tr mt s nhm thuc nhp khu ti

Vit Nam [5]
Nhm thuc theo
m bc 1 phn loi
ATC
A - ng tiu ha
v chuyn ha.
J - H khng khun
C - H tim mch
Tng cc nhm
thuc

1.4.

Nm 2006
Gi tr
T
(Triu
trng
USD)
%

Nm 2007
Gi tr
T
(Triu
trng
USD)
%

Nm 2008
Gi tr
T
(Triu
trng
USD)
%

93,5

18,2

138,0

20,0

148,7

18,1

129,1
48,5

25,1
9,4

148,7
60,9

21,4
8,8

206,3
77,7

24,8
9,4

513,7

100,0

690,5

100,0

829,5

100,0

Tng quan v nghin cu nh lng s dng thuc

Ni dung chnh ca ti l kho st c cu v xu hng nhp khu

thuc iu tr T. Trong qu trnh phn tch k t qu, cc ch s nghin cu

khc nhau bao gm kim ngch nhp khu (th hin gi tr bng tin), tng s
liu trung bnh s dng hng ngy (Defined Daily Dose DDD) (th hin gi
tr s dng), tng s ng k (th hin mc cnh tranh) s c a vo
phn tch song song vi tng ni dung nghin cu. Cc ch s ny c rt ra
da trn cc nghin cu nh lng v s dng, tiu th thuc. Do , chng
ti thc hin phn tng quan ny nhm m t cc loi nghin cu v cc ch
s tng ng cc nghin cu v s dng/tiu th thuc.
1.4.1. Nghin cu chi ph
Cc nghin cu v chi ph thuc em li thng k ban u v tng
quan gia chi ph s dng thuc so vi tng chi ph y t, c bit trn quy m
quc gia. Trn thc t, khi trin khai cc nghin cu ny, nh nghin cu
thng thc hin so snh gia chi ph s dng thuc vi thu nhp bnh qun
u ngi [13].
Nghin cu v chi ph c mt s hn ch nh: khng cung cp chnh
xc v s lng thuc c bn ra hay s lng thuc thc t c ngi dn

11

s dng, hn na gi thuc khc nhau gia cc quc gia gy ra nhng kh

khn trong vic so snh chi ph tiu th thuc gia cc quc gia. Nghin cu
di hn cng gp kh khn do nhng bin ng v tin t v nhng thay i
trong gi thuc [11],[20].
1.4.2. Nghin cu da trn s lng n v ng gi
nh gi s tiu th da trn s lng n v ng gi (vin, l,
ng,...) a ra nhng nh gi chnh xc v tiu th thuc hn l nh gi
theo chi ph. Nghin cu ny hay c s dng nh gi s dng thuc
trong c mt giai on hoc so snh gia cc quc gia [11].
Hn ch ca nghin cu ny l ng vi cng mt hot cht theo thi
gian v gia cc quc gia c th c nhiu bit dc vi dng bo ch, nng
, hm lng v quy cch ng gi khc nhau, do gy kh khn cho vic
nh lng tiu th. Tuy nhin, nu lm c cc nghin cu ny s cho thy
bin ng v chng loi bit dc ng vi dng mt hot cht, theo thi gian
[11].
1.4.3. Nghin cu da trn n thuc
Nghin cu ny c th phn nh mi quan h gia ngi thy thuc v
bnh nhn v s thay i ca mi quan h trong mt giai on thi gian.
Hn ch ca phng php ny l khng th thc hin c tr khi s kho st
bao gm c nhng chn on v nhng vn lin quan khc. Khng may l,
nhng thng tin ny thng rt kh c c v mt vi l do hn n a s
kho st loi ny c tr ngi l thng t [11].

12

1.4.4. Nghin cu da trn liu trung bnh s dng hng ngy

Liu DDD: l liu tng cng trung bnh ca mt thuc dng cho mt
ngy cho mt ch nh ngi trng thnh [3].
ngha: DDD l mt n v o lng k thut v s dng thuc, c
ngha theo di, gim st, nh gi v tnh hnh tiu th v s dng hp l
hay khng [3].
DDD c s dng trong cc nghin cu tiu th thuc thng qua tnh
ton v tng s liu DDD. Cc nghin cu ny s cho thy thc t v tng
lng thuc tiu th ca qun th nghin cu.
Cc nghin cu ny ph hp gim st, nh gi v tnh hnh tiu th
v s dng ca cc thuc iu tr bnh mn tnh c liu quy nh gn vi liu
DDD. V d nh: cc thuc iu tr T, c bit l cc thuc iu tr T
ng ung [11],[20].
Hn ch ca phng php nghin cu ny:
- Th nht l, nghin cu tiu th thuc s dng cc d liu trn cc
thuc c k n hoc bn ra cho bnh nhn. Tuy nhin, khng phi
tt c cc thuc ny u c bnh nhn s dng ht [11].
- Mt s thuc khng th dung liu DDD theo di, nh gi tnh hnh
s dng thuc: dch truyn, vac xin,thuc t, m, thuc ngoi da, cn
quang [3].
1.5.

Cc nghin cu tng t ti Vit Nam v trn th gii

Tnh ti thi im nghin cu, chng ti cha tm c nghin cu no

trn th gii kho st thc trng nhp khu thuc iu tr T cng nh phn
tch vai tr ca thuc iu tr T nhp khu. Tuy nhin, c mt s nghin
cu v tiu th v s dng thuc iu tr T c thc hin. C th l:

13

1.5.1. Cc nghin cu v s dng/tiu th thuc iu tr i tho ng

trn th gii
Nghin cu v xu hng k n cho bnh nhn i tho ng ca
Marta Baviera v cng s trn hn 9 triu dn Lombardy-Italia thc hin
nm 2008. Nghin cu ly s liu t c s d liu qun l sc khe ca
Lombardy giai on 2000-2008. Kt qu nghin cu cho thy:
Trong giai on nghin cu.
- T l bnh nhn c iu tr bng biguanid v sulfonamide/dn cht
ure l cao nht (> 50%).
- T l bnh nhn c iu tr bng biguanid tng t 53,4% - 66,5%.
- T l bnh nhn c iu tr bng sulfonamid/dn xut ure gim dn
t 78,6% xung cn 56,4%
- T l bnh nhn s dng insulin t c s thay i.
- C s ra tng s dng thiazolidinedion t 0,8 - 5,7% [10].
Nghin cuv s dng thuc iu tr T ti Hungary ca B.Hanko
v cng s trn d liu t h s bo him y t quc gia v cng ty t vn MIS
giai on 1998-2002. Kt qu nghin cu cho thy:
- Sulfonamid/dn xut ure c dng nhiu nht trong nhng thuc iu
tr T ng ung v cao gp gn hai ln so vi biguanid l thuc
iu tr T ng ung c dng nhiu th hai [13].
1.5.2. Cc nghin cu tng t ti Vit Nam
a. Cc nghin cu v s dng thuc iu tr i tho ng ti Vit Nam
Nghin cu ca o Mai Hng v s dng thuc iu tr T ng
ung ti khoa khm bnh bnh vin Bch Mai thc hin trn 200 bnh n nm
2009 cho t l cc nhm thuc c s dng nh sau
- T l bnh nhn c iu tr bng metformin l cao nht (73%).
- T l bnh nhn c iu tr bng sulfonamide/dn xut ure l 72,2%.

14

- T l bnh nhn iu tr bng nhm c ch alpha glucosidasel 24,3%.

- T l bnh nhn c dng thuc phi hp gia rosiglitazon v
metformin l 7,5%.
- T l bnh nhn c dng thiazolidinedion l 1,5% [8].
Nghin cu ca Kong Chunny v thc trng s dng thuc T typ 2
ti khoa ni tit v T bnh vin Bach Mai thc hin trn 200 bnh n vo
nm 2008 cho thy:
- T l bnh nhn c s dng insulin l cao nht (95,5%).
- T l bnh nhn c s dng biguanid l 34%.
- T l bnh nhn c s dng sulfonamide/ dn xut ure l 21,5%.
- T l bnh nhn c s dng c ch alpha glucosidase l 20% [6].
b. Cc nghin cu v nhp khu thuc ti Vit Nam
Nghin cu Phn tch c cu thuc thnh phm nhp khu giai on
2006-2010 ca Chu Quc Thnh trn c s cc d liu v thuc nhp khu t
Tng cc Hi quan. Nghin cu tp trung kho st v c cu thuc nhp khu
theo xut x, theo phn loi ATC, theo c quan gii phu...[5].
Nghin cu Phn tch thc trng nhp khu cc thuc khng khun
trong giai on 2006-2010 ca L Th Phng Hoa cng d a trn c s d
liu v thuc nhp khu t Tng cc Hi. Nghin cu tp trung kho st quan
v c cu nhp khu thuc khng sinh theo xut x, theo hot cht, theo nhm
thuc v theo hn bo h c quyn [9].

15

Chng 2. I TNG V PHNG PHP NGHIN CU

2.1.

i tng nghin cu
i tng nghin cu ca ti l ton b cc thuc thnh phm iu

tr T nhp khu vo Vit Nam trong giai on t nm 2006 ti nm 2011.

2.2.

Thi gian v a im nghin cu

o Thi gian nghin cu:

Nghin cu c thc hin trong thi gian t 1/2/2013 ti 21/5/2013.
o a im nghin cu:
B mn Qun l v kinh t Dc - i hc Dc H Ni
Phng Qun l gi thuc - Cc Qun l Dc - B Y t
2.3.

Thit k nghin cu
Thit k nghin cu m t.

2.4.

Ni dung nghin cu

o Kho st c cu v xu hng nhp khu cc nhm thuc iu tr T giai

on 2006-2011.
o Kho st c cu v xu hng nhp khu cc hot cht iu tr T giai
on 2006-2011.
o Kho st c cu v xu hng nhp khu cc thuc iu tr T theo quc
gia xut x giai on 2006-2011.
2.5.

Cc ch s nghin cu

o Gi tr KNNK v t trng gi tr KNNK ca cc nhm thuc, hot cht v

ca cc quc gia xut khu thuc iu tr T vo Vit Nam.
o S lng v t trng s lng s ng k (SK) ca cc nhm thuc, hot
cht v ca cc quc gia xut khu thuc iu tr T vo Vit Nam.
o S lng v t trng tng s liu DDD trong mi nm ca cc nhm
thuc, hot cht v ca cc quc gia xut khu thuc iu tr T vo
Vit Nam.

16

- Tng s liu DDD nhp khu ca mt hot cht trong mi nm c

tnh theo cng thc:
Tng s liu DDD =
- Tng s liu DDD nhp khu ca nhm thuc = tng s liu DDD
nhp khu ca cc hot cht trong nhm
2.6.

Thu thp v lm sch d liu

D liu nhp khu thuc lu tr ti Tng Cc hi quan Vit Nam t

1/1/2006 ti 31/12/2011 c thu thp v x l theo quy trnh:

Sng lc d liu v
thuc thnh phm

D liu thuc nhp

khu ca cc Hi quan
D liu thuc thnh
phm
B sung mc hot cht
(nu cn)
D liu thuc thnh
phm hon chnh

Sng lc d liu v
thuc iu tr T

D liu ban u v
thuc iu tr T
D liu thuc iu tr
T hon thin

Gn m ATC, liu
DDD v SK cho cc
thuc nghin cu

Hnh 2.1. S x l s liu

Gii thch quy trnh:
Bc 1: Sng lc d liu v thuc thnh phm
D liu ban u do Tng cc Hi quan Vit Nam cung cp bao gm
tng t nhp hng trong nm ca nhiu nhm hng khc nhau (thuc thnh

17

phm, nguyn liu lm thuc, thuc th y, ha cht st khun,...). Do ,

ph hp vi i tng nghin cu ca ti l thuc thnh phm, ch thng
tin v thuc thnh phm (m hng 3004) c chit tch v a vo nghin
cu.
Bc 2: B sung thng tin v hot cht (nu cn)
Trong d liu ban u ti Tng cc Hi quan, thng tin v hot cht c
th khng c, hoc khng y . Do , cn b sung thng tin ny do thng
tin hot cht l thit yu cho ni dung phn tch ca nghin cu.
hn ch cc sai s c th xy ra, thng tin c tra cu ti hai c s
d liu c lp v ch a vo nghin cu khi c s nht qun gia hai c s
ny.
Bc 3: Sng lc d liu thuc iu tr i tho ng
Sng lc d liu tt c cc thuc m hot cht tng ng c m bc 2 l
A10 theo phn loi ATC/WHO (Cc thuc s dng trong iu tr bnh
T).
Danh mc hot cht a vo nghin cu c trnh by bng 2.1.
Bng 2.1.Danh mc cc hot cht iu tr T trong nghin cu
Tn hot cht

M ATC

Tn hot cht

M ATC

Acarbose
Benfluorex
Chlorpropamid
Glibenclamid
Glibenclamid v Metformin
Gliclazid
Gliclazid v Metformin
Glimepirid

A10BF01
A10BX06
A10BB02
A10BB01
A10BD02
A10BB09
A10BD02
A10BB12

Insulin
Metformin
Pioglitazon
Repaglind
Rosiglitazon
Rosiglitazon v Metformin
Glimepirid v Metformin
Pioglitazon v Metformin

A10A
A10BA02
A10BG03
A10BX02
A10BG02
A10BD03
A10BD02
A10BD05

18

Bc 4: Gn m ATC, liu DDD v SK cho cc thuc nghin cu

Tt c cc thuc nghin cu s c gn m ATC v liu DDD theo
phn loi ATC/WHO.
Trong trng hp thng tin v SK ca thuc khng y , thng tin
v SK ca thuc s c b sung da trn d liu qun l v SK lu tr
ti Cc qun lDc Vit Nam.
2.7.

X l s liu
Cc s liu nghin cu c nhp v x l trn phn mm Microsoft

Excel 2007.
2.8.

Trnh by v bo co kt qu
Cc kt qu nghin cu c trnh by trn phn mm Microsoft Word

2007 v Microsoft PowerPoint 2007.

19

3.1.

Chng 3. KT QU NGHIN CU
Gi tr KNNK v s lng SK cc thuc iu tr T nhp khu
vo Vit Nam (2006-2011)

3.1.1. Gi tr KNNK cc thuc iu tr T nhp khu (2006-2011)

Gi tr KNNK v t trng KNNK thuc iu tr T trn tng gi tr
KNNK thuc nhp khu giai on 2006-2011 c th hin bng 3.1.
Bng 3.1. Gi tr KNNK v t trng gi tr KNNK thuc iu tr T
(2006-2011)
2006
KNNK thuc T
(triu USD)
Tng KNNK
(triu USD)
T trng KNNK
(%)

2007

2008

2009

2010

2011

15,05

18,41

25,44

27,84

35,43

40,98

513,68

690,52

829,52

1051,04

1162,44

1328,21

2,93

2,67

3,07

2,65

3,05

3,09

T bng kt qu trn, ta thy:

Gi tr KNNK thuc iu tr T tng ng k trong thi gian kho
st. C th, gi tr KNNK tng 2,7 ln: t 15,05 triu USD (2006) ln 40,98
triu USD (2011). Trong khi , t trng gi tr KNNK thuc iu tr T so
vi tng KNNK thuc nhp khu tng i n inh: t trng cc thuc ny
chim khong t 2,7-3,1% tng gi tr KNNK ca thuc nhp khu.
3.1.2. S lng SK cc thuc iu tr T nhp khu (2006-2011)
Tng s lng s ng k (SK) ca tt c cc thuc iu tr T
nhp khu vo Vit Nam c th hin trong bng 3.2 bn di.
Bng 3.2. S lng SK cc thuc iu tr T nhp khu (2006-2011)
S lng SK

2006

2007

2008

2009

2010

2011

126

141

151

155

182

186

T bng kt qu trn ta thy:

20

Tng s lng SK ca 16 hot cht c nghin cu trong ti tng

dn qua tt c cc nm. Tng mnh nht l tng 27 SK mt nm (20092010). V tng t nht ch tng 4 SK mt nm (2008-2009 v 2010-2011).
3.2.

C cu v xu hng NK cc nhm thuc iu tr T (2006-2011)

By nhm thuc iu tr T theo phn loi ATC c a vo

nghin cu bao gm: insulin (A10A), cc biguanid (A10BA), sulfolnamid/

dn cht ure (A10BB), thuc iu tr T ng ung dng kt hp
(A10BD), cc cht c ch alphaglucosidase (A10BF), cc thiazolindinion
(A10BG) v cc thuc h ng huyt khc ngoi tr insulin (A10BX). C
cu nhp khu cc nhm thuc ny c kho st da trn ba ch s: gi tr/t
trng KNNK, tng s liu/t trng s lng liu DDD v s lng SK.
3.2.1. Kho st da trn gi tr kim ngch nhp khu
C cu nhp khu cc nhm thuc iu tr T theo gi tr KNNK v
t trng gi tr KNNK c trnh by trong hnh 3.1. T trng gi tr KNNK
ca mt nhm thuc trong mt nm c tnh bng t l phn trm gia gi
tr KNNK ca nhm thuc trong nm trn tng gi tr KNNK ca tt c cc
thuc iu tr T trong nm.
T hnh 3.1, v s liu chi tit ti ph lc 1, ph lc 2, ta thy:
Trong giai on 2006-2011, cc nhm thuc c t trng gi tr KNNK
ln nht l: sulfonamid/dn xut ure (37,0-48,4%), biguanid (17,8-24,2%) v
insulin (16,2-27,7%). Trong 3 nhm ny, t trng gi tr KNNK ca nhm
sulfonamid/dn xut ure c xu hng tng trong giai on 2006-2008 (nm
2008 t ti gn 50% tng gi tr KNNK cc thuc iu tr T) v gim
trong giai on 2008-2011. Trong khi , hai nhm cn li cho thy xu hng
ngc li: t sau nm 2008, t trng KNNK ca hai nhm thuc ny c xu
hng tng dn.

21

i vi cc nhm thuc khc, kt qu cho thy: t trng KNNK tng

nhm cht c ch alpha glucosidase v cc thuc T ng ung dng kt
hp. Cc nhm thuc cn li c xu hng gim t trng, c bit l nhm

Triu USD

thiazolidinedion: gim t 10.5% (2006) xung cn 2% (2011).

18

60.0%
Biguanid

16
50.0%
14
12

Sulfonamid/dn
xut ure
40.0%

10
30.0%
8
6

20.0%

Thuc T
ng ung
dng kt hp
Cht c ch
alpha
glucosidase
Thiazolidindion

4
10.0%
2
0

0.0%

Cc cht h
ng huyt
khc tr insulin
Insulin

Hnh 3.1 Gi tr v t trng KNNK cc nhm thuc iu tr T

3.2.2. Kho st da trn s lng s ng k
C cu nhp khu cc nhm thuc iu tr T ti Vit Nam theo s
lng SK c th hin hnh 3.2.
T hnh 3.2, v s liu c th ti ph lc 3, ta thy:
Trong giai on 2006-2011,cc nhm thuc iu tr T c s lng
SK nhiu nht l sulfonamid/dn xut ure (47-76 SK), biguanid (29-43

22

SK), insulin (17-34 SK) v thiazolidindion (17-27 SK). Trong bn

nhm, ngoi tr thiazolidindion, cc nhm cn li c xu hng tng dn s
lng SK.
i vi cc nhm thuc khc, kt qu cho thy: cc thuc iu tr T
ng ung dng kt hp c s lng SK tng dn t 6 SK (2006) ti 13
SK (2010). Hai nhm cn li (cht c ch alpha glucosidase v cc thuc h
ng huyt khc ngoi tr insulin) c rt t SK (khng qu 3 SK/nhm).
80

70

60

Biguanid

50

Sulfonamid v dn xut
ure

40

Thuc T ng ung
dng kt hp

30

Thiazolidindion

20

Cc cht h ng huyt
khc tr insulin

Cht c ch alpha
glucosidase

Insulin
10

0
Nm
2006

Nm
2007

Nm
2008

Nm
2009

Nm
2010

Nm
2011

Hnh 3.2 S lng SK ca cc nhm thuc iu tr T (2006-2011)

3.2.3. Kho st da trn tng s liu DDD
T trng tng s liu DDD ca mt nhm thuc c tnh bng t l
phn trm gia tng s liu DDD ca nhm thuc trn tng s liu DDD ca
tt c cc thuc iu tr T. Ngoi tr cc thuc iu tr T ng ung

23

dng kt hp (A10BD), tt c cc nhm thuc cn li c th tnh ton c

theo ch s ny.
Tng s liu DDD ca cc nhm thuc cn li c tnh ton v c

Triu liu

th hin hnh 3.3.

180

80.00%
Biguanid

160
140

70.00%

60.00%

Sulfonamid/dn
xut ure

120
50.00%
100
40.00%
80
60
40

30.00%

20.00%

20

10.00%

0.00%

Thuc T
ng ung
dng kt hp
Cht c ch
alpha
glucosidase
Thiazolidindion

Cc cht h
ng huyt
khc tr insulin
Insulin

Hnh 3.3. Tng s liu v t trng tng s liu DDD ca cc nhm thuc
iu tr T (2006 2011)
T hnh 3.3, v s liu chi tit ti ph lc 4, ph lc 5, ta thy:
Bn nhm thuc c t trng tng s liu DDD ln nht l:
sulfonamid/dn xut ure (57,07-76,06%), biguanid (11,42-31,93%), insulin
(5,27-8,33%) v thiazolidinedion (1,93-4,09%). Tip tc phn tch su hn
bn nhm cht ny:

24

- i vi hai nhm sulfonamid/dn cht ure v biguanid:

T 2006-2008: sulfonamid/dn cht ure tng mnh v t trng
(57,07%-76,06%) trong khi biguanid gim mnh v t trng (31,67%11,42%).
T 2008-2010: biguanid tng mnh v t trng (11,42%19,62%) trong khi sulfonamid/dn cht ure gim mnh v t trng
(76,06%-66,50%)
- i vi hai nhm cn li:
T nm 2007, t trng Insulin c xu hng tng lin tc (5,27%8,74%) trong khi thiazolidinedion n nh mc 3-4%, ch gim xung
di 2% vo nm 2011.
Cc nhm khc (cc cht c ch alphaglucosidase v cc cht h
ng huyt khc ngoi tr insulin) c t trng s lng liu DDD rt
nh (< 1,3%).
3.3.

C cu v xu hng nhp khu cc hot cht iu tr T

Danh mc cc hot cht iu tr T nghin cu trnh by trong bng

2.1. C cu nhp khu cc hot cht ny c kho st da trn ba ch s: gi

tr/t trng KNNK, tng s liu/t trng s lng liu DDD v s lng SK.
3.3.1. Kho st da trn gi tr kim ngch nhp khu
C cu nhp khu cc hot cht iu tr T ti Vit Nam theo gi tr v
t trng gi tr KNNK c th hin hnh 3.4.
T trng KNNK ca mt hot cht c tnh bng t l phn trm gia
gi tr KNNK ca hot cht so vi tng gi tr KNNK ca tt c cc hot
cht. T hnh 3.4, v chi tit s liu ph lc 6, ph lc 7, ta thy:
Cc hot cht c t trng KNNK ln nht l gliclazid (22,6-34,5%),
metformin (17,8-24,2%), insulin (19,3-24,7%) v glimepirid (8,5-14,9%).

25

Tm hiu su hn v xu hng ca hai nhm thuc l gliclazid v

metformin:
- Trong giai on 2006-2007: gliclazid c t trng KNNK tng t
22,6%-34,5% trong khi metformin c t trng KNNK gim t 24,2%17,8%.
- Trong giai on 2007-2008: metformin c t trng KNNK tng
(17,8%-18,3%), trong khi gliclazid c t trng KNNK gim (34,5%30,9%).
- Trong giai on 2009-2010: metformin c t trng KNNK tng
(18,9%-22,9%) trong khi gliclazid c t trng KNNK gim (33,4%28,3%).
Xt v gi tr KNNK, trong giai on t 2006-2011, cc hot cht c
gi tr KNNK tng lin tip l: gliclazid (3,64-11,08 triu USD), insulin (2,43
-10,10 triu USD), metformin tng t (3,64-8,71 triu USD).
Trong cc hot cht cn li:
- Benfluorex c t trng KNNK gim t 2,23% (2006) n 0%(2010).
- Rosiglitazon c t trng KNNK gim t 7,26% (2006) n 0%(2011).
- Hot cht dng kt hp gia rosiglitazon v metformin c t trng
KNNK gim t 1,69% (2010) xung 0%(2011).
Xu hng nhp khu cc hot cht iu tr T theo KNNK c th
hin trong hnh 3.4 di y.

Triu USD

26

12

40.00%
acarbose
35.00%

benfluorex

10
chlorpropamid
30.00%
glibenclamid
8
25.00%

glibenclamid v
metformin
gliclazid

20.00%

gliclazid v
metformin
glimepirid

15.00%
4

insulin
metformin

10.00%

pioglitazon
repaglind

2
5.00%

rosiglitazon
rosiglitazon v
metformin

0.00%

glimepirid v
metformin
pioglitazon v
metformin

Hnh 3.4. KNNK ca cc hot cht iu tr T v t trng (2006-2011)

3.3.2. Kho st theo s lng s ng k
C cu nhp khu cc hot cht iu tr T theo s lng SK c
th hin trong hnh 3.5 di y.

27

50

acarbose

45

benfluorex
chlorpropamid

40

glibenclamid

35

glibenclamid v metformin

30

gliclazid
gliclazid v metformin

25

glimepirid

20

insulin

15

metformin
pioglitazon

10

repaglind

rosiglitazon

rosiglitazon v metformin
Nm
2006

Nm
2007

Nm
2008

Nm
2009

Nm
2010

Nm
2011

glimepirid v metformin
pioglitazon v metformin

Hnh 3.5. S lng SK ca cc hot cht iu tr T nhp khu

T hnh 3.5 v chi tit s liu ph lc 8 ta thy:
Bn hot cht c s lng SK nhiu nht l meformin (29-43 SK),
glimepirid (17-46 SK), gliclazid (16-24 SK) v insulin (18-34 SK).
Nhn xt v xu hng bin ng s lng SK ca tng hot cht trn nh
sau:
- Trong giai on 2008-2011: metformin c xu hng tng s lng (t
30-43 SK), glimepirid c xu hng tng s lng SK (29-46 SK).
- Trong giai on 2007-2011: insulin tng gp i s lng SK (1734 SK), gliclazid c s lng SK tng i n nh (22-24 SK).
Vi cc hot cht cn li: rosiglitazon c s lng SK gim 8-4 SK
(2006-2010) v khng cn SK no nm 2011. Benfluorex ch c duy nht
mt SK trong bn nm (2006-2009),v khng c SK no nm 2010 v
2011.

28

3.3.3. Kho st theo tng s liu DDD

T trng s liu DDD ca cc hot cht c tnh bng t l phn trm
gia s lng liu DDD ca mt hot cht so vi tng s lng liu DDD ca
tt c cc hot cht c tnh ton (A10BD khng c tnh ton liu DDD).
Ngoi tr cc hot cht iu tr T dng kt hp (A10BD), s lng
liu DDD v t trng ca cc hot cht iu tr T c th hin trong hnh

Triu liu

3.6 di y.
90

50.00%

acarbose

80

45.00%

benfluorex
chlorpropamid

70

60

40.00%
glibenclamid
35.00%
30.00%

50
25.00%

gliclazide v
metformin
glimepirid

20.00%

insulin

15.00%

metformin

40

30

20

glibenclamide v
metformin
gliclazid

pioglitazon
10.00%
repaglind

10

5.00%

rosiglitazon

0.00%

rosiglitazon v
metformin
glimepirid v
metformin
pioglitazon v
metformin

Hnh 3.6. Tng s liu DDD ca cc hot cht iu tr T v t trng

29

T hnh 3.6 v chi tit s liu ti ph lc 9, ph lc 10, ta thy :

Ba hot cht c t trng s liu DDD ln nht l gliclazid (29,0545,59%), metformin (11,42- 31,93%), glimepirid (8,04- 29,38%). Xt v xu
hng bin ng t trng cc hot cht ny thy rng :
- i vi gliclazid: trong giai on 2006-2009 c t trng tng s liu
DDD tng t 29,05%-45,59% v gim t 45,59%-34,44% trong giai
on t 2009-2011.
- i vi glimepirid: hot cht ny c xu hng tng t trng tng s
liu DDD t 8,04% (2007) ti 29,38% (2011).
- i vi metformin: hot cht ny c t trng tng s liu DDD gim
mnh t 31,93-11,42% (2007-2008) v tng mnh t 11,42-19,62%
(2008-2010).
- c bit, giai on 2007-2008: t trng tng s liu DDD: gliclazid
tng (37,42-40,54%) v glimepirid tng (8,04-22,25%) trong khi
metformin gim mnh (31,93-11,42%).
Trong cc hot cht cn li: glibenclamid c xu hng gim t trng
s liu DDD t 11,93-3,96% trong giai on 2006-2010. Insulin c xu hng
tng t trng s liu DDD t 5,79% (2006) ti 8,33% (2011). Benfluorex v
rosiglitazon u gim dn t trng tng s liu DDD v 0. (benfluorex c t
trng gim v 0 nm 2010, rosiglitazon c t trng gim v 0 nm 2011).
3.4.

C cu v xu hng nhp khu cc thuc iu tr i tho ng

theo quc gia xut x (2006-2011)
Cc thuc iu tr T nhp khu ti Vit Nam c ngun gc t 23

quc gia trn ton th gii. Gm c Argentina, Bangladesh, Canada, Trung

Quc, Cyprus, an Mch, Php, c, n , Indonesia, , Hn Quc,
Malaysia, Pakistan, Ba Lan, Singapo, Ty Ban Nha, i Loan, Th Nh K,
Anh, M, Israel, c.

30

C cu nhp khu t cc quc gia ny c kho st da trn ba ch s:

gi tr/t trng KNNK, v s lng SK. Ngoi ra cc quc gia c t trng
KNNK ln cng c kho st c th hn.
3.4.1. Kho st theo kim ngch nhp khu.
T trng KNNK ca mt quc gia c tnh bng t l phn trm gia
gi tr KNNK ca quc gia so vi tng gi tr KNNK ca tt c cc quc
gia.
T hnh 3.7 v chi tit s liu ti ph lc 11, ph lc 12, ta thy:
Bn quc gia c t trng KNNK ln nht ln lt l Php (42,148,2%), an mch (8,5-16,3%), n (7,3-13,4%), (6,0-11,7%). Nhn xt
ta thy:
- Giai on 2009-2011: n c xu hng tng dn t trng KNNK t
7,4-13,4%, tng t 6-7,6%, trong khi t trng KNNK t Php c xu
hng gim dn 48,1-42,1%.
- Trong giai on 2006 - 2011, Php c t trng KNNK gim t 48,2%42,1%, tuy nhin gi tr KNNK ca Php li tng mnh 7,25-17,27
triu USD.
- Trong giai on nghin cu t trng KNNK ca an Mch ln xung
qua tng nm, tuy nhin gi tr KNNK li tng dn 1,56-6,69 triu
USD.
Trong cc quc gia cn li, Ba Lan c t trng KNNK tng dn t
3,4%-7,1% giai on (2006-2008) v gim dn t 7,1-2,7% giai on (20082011). Hn Quc c t trng KNNK thp nhng l quc gia duy nht c t
trng KNNK tng dn sau 6 nm t 1,7%-3,9% (2006-2011).
Kim ngch nhp khu v t trng KNNK t cc quc gia c th hin
trong hnh 3.7 di y.

Triu USD

31

20

60.0%

Argentina
Bangladesh

18

Canada
50.0%

16

Trung Quc
Cyprus
an Mch

14
40.0%
12

Php
c
n
Indonesia

10

30.0%

Hn Quc

Malaysia
20.0%

Pakistan
Ba Lan
Singapo

10.0%

Ty Ban Nha
a Loan

Th nh k
0.0%

Anh
M
Israel
c

Hnh 3.7. Gi tr KNNK v t trng gi tr KNNK theo quc gia xut x

T hnh 3.7 trn ta thy:
Php l quc gia c gi tr KNNK v t l KNNK cao nht trong tt c
cc quc gia trong c 6 nm t 2006 n 2011. V vy ta nghin cu k hn
v c cu nhp khu mt s bit dc t Php.
KNNK mt s bit dc t c t trng ln nht t Php c trnh by
trong bng 3.3 di y.

32

Bng 3.3.Gi tr KNNK ca mt s bit dc iu tr T c xut x t Php.

Tn Bit dc
KNNK
Diamicron (Triu USD)
T trng %
KNNK
(Triu
USD)
Glucophage
T trng %
KNNK
(Triu
USD)
Glucovance
T trng %
KNNK t
KNNK
Php
(Triu USD)

2006

2007

2008

2009

2010

2011

3,04

5,57

6,51

8,15

8,84

9,67

41,9

63,4

58,2

60,9

57,8

56,0

2,85

2,04

3,28

3,54

4,70

5,75

39,3

23,2

29,3

26,4

30,7

33,3

0,64

0,76

0,95

1,23

1,40

1,85

8,8

8,6

8,5

9,2

9,2

10,7

7,25

8,79

11,19

13,39

15,29

17,27

T bng trn ta thy:

Hai bit dc Diamicron v Glucophage chim hn 86% tng KNNK
ca cc bit dc c xut x Php.
Trong Diamicron vi hot cht gliclazid t trng chim 41,9- 63,4%
tng KNNK ca cc thuc t Php v chim ti 20,2-30,3% t trng KNNK
ca tt c cc thuc iu tr T nhp khu vo th trng Vit Nam. ng
th 2 l bit dc Glucophage (hot cht metformin) vi t trng KNNK
23,2-39,3% tng KNNK ca cc thuc c ngun gc t Php. Cao th 3 trong
cc bit dc nhp khu t Php l Glucovance (kt hp gia glibenclamid v
metformin) vi t trng 8,8 10,7% tng KNNK t Php v ang c xu
hng tng ln (8,8 % nm 2006 ti 10,7% nm 2011).
3.4.2. Kho st theo s lng s ng k
Cc quc gia c SK nhiu nht Vit Nam l n (41-78 SK),
Hn Quc (10- 20 SK), Php (9-14 SK), c (11-13 SK), an Mch (810 SK). Nhn xt t hnh 3.8 v chi tit s liu ti ph lc 13, ta thy:

33

- S lng SK t n v Hn Quc ang c xu hng gia tng, n

tng t 53- 78 SK (2008-2011), Hn Quc c s lng SK tng
gp i trong 6 nm t 10-20 SK (2006-2011).
- Php, c v an Mch c s lng SK tng i n nh. Php (914 SK), c (11-13SK), an Mch (8-10SK).
Trong nhm cc quc gia cn li Pakistan l quc gia c SK tng
nhanh t 3 SK (2009) ti 13 SK (2011) (gp hn 4 ln).
S lng SK cc thuc iu tr T theo quc gia c th hin
trong hnh 3.8 di y:
90

Argentina
Bangladesh
Canada

80

Trung Quc
Cyprus

70

an Mch
Php
c

60

n
Indonesia

50

Hn Quc

40

Malaysia
Pakistan

30

Ba Lan
Singapo
Ty Ban Nha

20

a Loan
Th nh k

10

Anh
M

Israel
Nm 2006 Nm 2007 Nm 2008 Nm 2009 Nm 2010 Nm 2011

Hnh 3.8. S lng SK t cc quc gia c thuc iu tr T Vit

Nam giai on 2006-2011

34

Chng 4. BN LUN
4.1.

Bn lun v kt qu nghin cu

4.1.1. Xu hng chung v nhp khu cc thuc iu tr i tho ng

Trong thi gian thc hin kho st (2006-2010), gi tr KNNK ca cc
thuc iu tr T Vit Nam lin tc tng: t 15,05 triu USD (2006) ti
40,98 triu USD (2011) (tng gp 2,7 ln). Xt v t trng KNNK, t trng
KNNK cc thuc iu tr T duy tr khong 3%, ph hp vi m hnh
bnh T Vit Nam (t l hin mc bnh T ti Vit Nam l 3%) [24].
S lng SK cc thuc iu tr T nhp khu vo Vit Nam tng
dn qua cc nm: mc tng mnh nht ghi nhn giai on 2009-2010 (tng
27 SK), trong i vi ring hot cht pioglitazon, mc tng l 11
SK.
4.1.2. Xu hng nhp khu cc nhm thuc iu tr i tho ng
Ba nhm thuc iu tr T c nhp khu nhiu nht (v t trng
gi tr KNNK, t trng tng s liu DDD, s lng SK) vo Vit Nam l:
biguanid, sulfonamide/dn xut ure, v insulin. Kho st k cho thy gi tr
KNNK, s lng SK, tng s liu DDD ca c ba nhm thuc ny c xu
hng tng ln trong giai on nghin cu. C ba nhm thuc ny u c
khuyn co s dng sm trong cc phc iu tr T ca IDF v ca
ADA/EASD.
Nhm thiazolidinedion khng tng nhiu v gi tr KNNK, t trng
KNNK lin tc gim, c bit, vo nm 2011 gim xung mc di 2%. Hai
hot cht ca nhm thuc ny c nhp khu vo th trng Vit Nam l
rosiglitazon v pioglitazon. Trong , hot cht rosiglitazon b Cc Qun
l dc Vit Nam cho ngng nhp khu vo 22/03/2011, v tc dng ph gy
nguy c tim mch v au tht ngc [7].

35

Theo cc phc iu tr ca IDF, ADA/EASD, metformin (thuc

nhm biuanid) l u tin hng u kim sot ng huyt bnh nhn
T typ 2. Tuy nhin, t trng gi tr KNNK v t trng tng s liu DDD
nhp khu ca nhm thuc biguanid thp hn ca nhm thuc
sulfonamide/dn xut ure, iu ny khc so vi nghin cu ca o Mai
Hng, ca Kong Chunny v ca Marta Baviera [6],[8],[10].
T l nhp khu sulfonamide/dn xut ure cao hn biguanid ging vi
nghin cu ca B.Hanko v cng s v vic s dng thuc T ti
Hungary. Tuy nhin nghin cu ny c thc hin vo giai on 1998
2002, khc vi giai on nghin cu 2006 2011 trong kha lun [13].
4.1.3. Xu hng nhp khu cc hot cht iu tr i tho ng
Cc hot cht c t trng gi tr KNNK, s lng SK v t trng tng
s liu DDD ln nht trong giai on nghin cu l gliclazid, metfomin,
insulin, glimepirid. Cc hot cht ny cng thu c cc nhm hot cht c t
trng gi tr KNNK ln nht trong thi gian kho st.
Nhn xt v s ph hp gia c cu nhp khu v cc thng tin y hc
ca mt s hot cht iu tr T:
a. Benfluorex:
Benfluorex l thuc iu tr T thuc nhm A10BX theo phn loi
ATC/WHO. Ti Vit Nam, hot cht ny ch c mt s ng k duy nht ca
Mediator (Php).
Kho st gi tr KNNK ca hot cht ny ta thy:
- Trong giai on t 2006 2008, gi tr KNNK ca benfluorex tng lin
tc t 335.000 USD ti 454 nghn USD.
- Tuy nhin, vo nm 2009, KNNK ca benfluorex gim nhxung cn
413.000 USD. Ti nm 2010, benfluorex khng cn c nhp khu vo Vit
Nam

36

Tm hiu cc thng tin lin quan ti hot cht ny, chng ti nhn thy
c s lin quan gia vic NK ca benfluorex v cc thng tin y hc, c th l:
- Vic gim nh gi tr KNNK ca benfluorex lin quan ti quyt nh
thu hi Mediator ca C quan qun l thuc Chu u (European Medicines
Agency) do nghi ng v nguy c gy b nh van tim ca benfluorex trn bnh
nhn T typ 2 [19],[21].
- Vic ngng nhp khu benfluorex lin quan n quyt nh s 260/QQLD v vic rt s ng k i vi bit dc Mediator ti Vit Nam.
b. Rosiglitazon.
Rosiglitazon l mt trong hai hot cht thuc nhm thiazolidinedion
c nhp khu vo Vit Nam (hot cht cn li l Pioglitazon). Nm 2010,
rosiglitazon nhp khu vo Vit Nam vi cc bit dc l Avandia, Rogelin,
Rosiglen, Rapzole. Ngoi ra, Vit Nam cn c Avandamet l bit dc ca
hot cht rosiglitazon kt hp vi metformin.
Kho st gi tr KNNK ca hot cht rosiglitazon ta thy:
- Trong giai on 2006 2007, gi tr KNNK gim 6,3 ln t 1,1 triu
USD xung cn 173.000 USD.
- Trong giai on 2009 2010, gi tr KNNK gim khong 5,8 ln t
475.000 USD xung cn 82.000 USD. Trong khi , hot cht cng nhm l
pioglitazon li c s gia tng ng k v gi tr KNNK (tng 2,3 ln t
589.000USD n 1,35 triu USD).
- Nm 2010, rosiglitazon khng cn c nhp khu vo Vit Nam.
Trong khi t trng KNNK ca pioglitazon li ng th ba trong s cc
hot cht c gi tr KNNK cao nht.
Tm hiu cc thng tin lin quan ti hot cht ny, chng ti nhn thy
c s lin quan gia vic NK rosiglitazon v cc thng tin y hc, c th:

37

- Vic gim mnh gi tr KNNK ca rosiglitazon nm 2007 ph hp vi

thi im cng b ca Nissen Steven v cng s v nguy c xut hin nhi
mu c tim bnh nhn T s dng rosiglitazon [18]. Trong giai on
2007-2010, do khng c thng tin no khc, gi tr KNNK li tng dn.
- Nm 2010, gi tr KNNK ca rosiglitazon mt ln na gim mnh ph
hp vi khuyn co hn ch k n v s dng cc thuc c hot cht l
rosiglitazon (Avandia, Avandamet, Avandaryl) ca Cc qun l Thc phm
v Dc phm Hoa K [22].
- Vic ngng NK cc thuc c hot cht rosiglitazon ti Vit Nam c
lin quan ti cng vn s 3886/QLD-DK ca Cc qun l Dc Vit Nam v
vic ngng tip nhn h s NK nguyn liu v thuc thnh phm c cha
hot cht rosiglitazon do nguy c tim mch hay gp cc thuc ny [7].
Kt qu nghin cu cng cho th y rng thng tin bt li v mt hot
cht c th nh hng ng k ti gi tr KNNK ca thuc . Tuy nhin,
thng tin ny li c th to iu kin thun li i vi cc thuc khc trong
cng phn nhm iu tr (trong trng hp ca pioglitazon).
4.1.4. Xu hng nhp khu theo quc gia xut x
n l quc gia c s lng SK cc thuc iu tr T nhp khu
vo Vit Nam l ln nht (47-78 SK). S lng SK ca n thng
xuyn ln gp 3-4 ln s lng SK ca quc gia ng th hai l Hn Quc.
Tuy nhin t trng gi tr KNNK ca n khng cao (ch bng 1/7-1/3 t
trng KNNK ca Php).
Trong khi , mc d s lng SK khng nhiu (ch bng 1/6-1/5 s
lng SK ca n ), t trng KNNK ca Php li l ln nht (chim
khong 45% tng gi tr KNNK ca tt c cc quc gia). Mc d vy, t trng
gi tr KNNK ca Php li lin tc gim trong sut thi gian nghin cu trong
khi t trng gi tr KNNK ca n li c xu hng tng ln. iu ny

38

chng t rng, s cnh tranh ca cc quc gia sn xut thuc generic c nh

hng nht nh ti cc quc gia sn xut thuc pht minh.
4.2.

Hn ch ca ti

4.2.1. Hn ch v phng php nghin cu

V phng php nghin cu, ti c mt s hn ch sau:
Mt trong nhng ch s nghin cu ti la chn l tng s liu
DDD. Vic nghin cu da trn ch s ny c hn ch l DDD l liu c
tnh ton cho ngi trng thnh, do , khi s dng liu DDD nh gi
tiu th thuc ni chung th thng khng hon ton chnh xc. Tuy nhin,
im ny t nh hng khi nh gi tiu th thuc iu tr T do bnh T
thng t gp tr nh. Bn cnh , liu thc t s dng li gn ging vi
liu DDD ca cc hot cht.
D liu v thuc nhp khu khng nh gi c ht tnh hnh s dng
thuc trong thc t, do kt qu ca nghin cu khng c gi tr cho vic
ngoi suy thc trng s dng thuc iu tr T ti Vit Nam.
Giai on nghin cu cn ngn v khng c d liu v cc thuc NK
nm 2012 v vy c th cha nh gi chnh xc c v xu hng cc thuc
iu tr T nhp khu ti Vit Nam.
Khng c d liu v cc thuc sn xut trong nc, do khng th so
snh v nh gi ton din v tiu th thuc iu tr T ti Vit Nam.
Do hn ch v phn tch kt qu, cc hot cht trong nhm thuc
insulin cha chit tch ring c, do nghin cu cha phn tch c xu
hng v c cu ca cc hot cht insulin nhp khu vo Vit Nam.
4.2.2. Hn ch v d liu nghin cu
D liu nghin cu khng c thng nht gia nhng trng d liu
nhp trong Microsoft Excel, thiu hot cht ca mt s thuc. Cc thiu st v
danh mc hot cht ny cn c b sung v kim tra li.

39

hn ch nhng sai s khi b sung danh mc hot cht, tt c cc d

liu ngoi suy u c kim tra t nht hai ln ti hai c s d liu khc nhau
v ch a vo nghin cu khi hai ngun thng tin l nht qun.
4.2.3. Hn ch v bin gii kt qu
Do hn ch ca ngi nghin cu, cc so snh v s ph hp gia vic
nhp khu thuc v cc phc iu tr ch da vo cc phc iu tr T
ca nc ngoi m cha so snh vi cc phc trong nc.
Cc thng tin lin quan n cht lng, phn ng c hi hay thay i
hng dn iu tr cn cha c cp nht y , do qu trnh bi n lun
cc xu hng nhp khu cn hn ch.

40

KT LUN V KIN NGH

1. Kt lun
Kt qu ca ti cho thy:
Gi tr KNNK, s lng SK v tng s liu DDD ca cc thuc iu
tr T vo Vit Nam ngy cng tng. Trong :
Cc nhm thuc iu tr T nhp khu c t trng KNNK, s lng
SK v t trng tng s liu DDD cao nht l sulfonamid /dn xut ure,
biguanid v insulin. Cc nhm thuc ny c gi tr KNNK v s lng SK
c xu hng tng dn trong giai on 2006- 2011. Xu hng ny l ph hp
so vi cc khuyn co v iu tr T trn th gii
Cc hot cht iu tr T nhp khu vo Vit Nam c t trng gi tr
KNNK, s lng SK, v t trng tng s liu DDD ln nht l gliclazid,
metfomin, glimepirid. Cc hot cht ny u l cc hot cht nm trong nhm
cc thuc c khuyn co s dng sm kim sot ng huyt.
n l quc gia c s lng SK thuc iu tr T ln nht nhng
Php mi l quc gia c t trng gi tr KNNK vo Vit nam l ln nht. Tuy
nhin, t trng gi tr KNNK ca Php c xu hng gim dn trong khi ca
n c xu hng tng dn.
Cc thng tin y hc v cc quyt nh qun l c tc ng quan trng
ti xu hng nhp khu, th hin qua vic gim t trng nhp khu do thng
tin v phn ng c hi trng hp ca benfluorex v rosiglitazon.
2. Kin ngh v xut.
thun tin cho vic qun l v nghin cu cc thuc nhp khu vo
th trng Vit Nam, xut Tng cc Hi Quan v Cc Qun l kt hp xy
dng chng trnh qun l cc thuc nhp khu vi y thng tin v qun
l xut nhp khu v thng tin v qun l dc.

41

nh gi ton din v thuc iu tr T ti Vit Nam, chng ti

xut thc hin ti nghin cu v c cu v xu hng cc thuc iu tr
T c sn xut ti trong nc v ti v c cu v xu hng nhp khu
cc thuc insulin ti Vit Nam.
Cc doanh nghip nhp khu thuc iu tr T vo Vit Nam nn cp
nht thng xuyn cc thng tin y hc (c bit l cc thng tin v cnh gic
dc), s thay i cc phc iu tr T v cc quyt nh lin quan n
qun l thuc c th d on c cc xu hng nhp khu ph hp vi
tnh hnh bnh tt v cc thng tin y hc nh trng hp ca benfluorex v
rosiglitazon.

TI LIU THAM KHO

TING VIT:
1.

B Thu H (2009), Nghin cu thc trng bnh i tho ng iu tr

ti bnh vin a khoa tnh Bc Kn, Lun vn thc s, Trng i hc
Y Dc Thi Nguyn.

2.

Bnh vin Bch Mai (2012), Hng dn chn on v iu tr bnh ni

khoa, Nh xut bn Y hc, H Ni.

3.

B Y T (2011), Php ch Dc, Nh xut bn Gio Dc Vit Nam,

H Ni.

4.

B Y t (2010), Bnh hc, Nh xut bn y hc, H Ni.

5.

Chu Quc Thnh (2009), Phn tch c cu thuc thnh phm nhp
khu giai on 2006-2008, Lun vn thc s, i hc Dc H Ni,
H Ni.

6.

Chunny Kong (2008), Kho st thc trng s dng thuc iu tr i

tho ng typ 2 ti khoa ni tit v i tho ng bnh vin Bch
Mai, Lun vn thc s dc hc, i hc Dc H Ni, H Ni.

7.

Cc Qun l Dc Vit Nam - B Y t (2011), Quyt nh v ng k,

sn xut, lu hnh, s dng thuc cha Rosiglitazone - S 3886/QLDK.

8.

o Mai Hng (2012), Nhn xt vic s dng thuc iu tr i tho

ng dng ung ti khoa khm bnh - Bnh vin Bch Mai, Lun vn
thc s, i hc Dc H Ni, H Ni.

9.

L Th Phng Hoa (2011), Phn tch thc trng nhp khu cc thuc
khng khun trong giai on 2006-2010, Lun vn thc s, i hc
Dc H Ni, H Ni.

TING ANH:
10.

Baviera Marta, Monesi Lara, Marzona Irene, et al. (2011), "Trends in

drug prescriptions to diabetic patients from 2000 to 2008 in Italy's
Lombardy Region: a large population-based study", Diabetes Research
and Clinical Practice, 93(1), pp. 123-130.

11.

Dukes Maurice Nelson Graham (1993), Drug utilization studies:

methods and uses, WHO Regional Office for Europe.

12.

Goei Monica (2010), Premixed Insulin for Type 2 Diabetes: A Guide

for Adults, DIANE Publishing, pp. 6,7,8,12.

13.

Hank Balzs, Tukarcs va, Kumli Pter, et al. (2005), "Antidiabetic

drug utilization in Hungary", Pharmacy World and Science, 27(3), pp.
263-265.

14.

International Diabetes Federation (2012), Global Guideline for Type 2

Diabetes, pp. 55-57.

15.

International Diabetes Federation (2012), IDF Diabetes Atlas 5th

Edition 2012 Update.

16.

International Diabetes Federation (2005), Global Guideline for Type 2

Diabetes, pp. 35-38.

17.

Nathan DM, Buse JB, Davidson MB (2009), "European Association for

Study of Diabetes. Medical management of hyperglycemia in type 2
diabetes: a consensus algorithm for the initiation and adjustment of
therapy: a consensus statement of the American Diabetes Association
and the European Association for the Study of Diabetes", Diabetes
Care, 32(1), pp. 193-203.

18.

Nissen Steven E, Wolski Kathy (2007), "Effect of rosiglitazone on the

risk of myocardial infarction and death from cardiovascular causes",
New England Journal of Medicine, 356(24), pp. 2457-2471.

19.

Weill Alain, Pata Michel, Tuppin Philippe, et al. (2010), "Benfluorex

and valvular heart disease: a cohort study of a million people with
diabetes mellitus", Pharmacoepidemiology and drug safety, 19(12), pp.
1256-1262.

20.

World Health Organization (2003), Introduction to drug utilization

research, World Health Organization, pp. 38-44.

WEBSITES:
21..http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events
/news/2010/01/news_detail_000977.jsp&mid=WC0b01ac058004d5c1.
Truy cp ngy 20/5/2013.
22.

http://www.fda.gov/Drugs/DrugSafety/ucm241411.htm. Truy cp ngy

20/5/2013.

23.

http://www.who.int/features/factfiles/diabetes/en/index.html. Truy cp
ngy 20/5/2013.

24.

http://www.who.int/nmh/countries/vnm_en.pdf.
20/5/2013.

Truy

cp

ngy

PH LC
Ph lc 1. T trng gi tr KNNK cc nhm thuc iu tr T (2006-2011)
Ph lc 2. Gi tr KNNK cc nhm thuc iu tr T (2006-2011)
Ph lc 3. S lng SK cc nhm thuc iu tr T NK (2006-2011)
Ph lc 4. T trng tng s liu DDD cc nhm thuc T NK (2006-2011)
Ph lc 5. Tng s lng liu DDD cc thuc iu tr T NK (2006- 2011)
Ph lc 6. T trng gi tr KNNK cc thuc iu tr T (2006-2011)
Ph lc 7.Gi tr KNNK ca cc hot cht iu tr T (2006-2011)
Ph lc 8. S lng SK ca hot cht iu tr T NK (2006-2011)
Ph lc 9. T trng tng s liu DDD ca cc hot cht iu tr T NK giai
on (2006-2011)
Ph lc 10. Tng s liu DDD ca cc hot cht iu tr T NK (20062011)
Ph lc 11. T trng gi tr KNNK thuc iu tr T ca cc quc gia xut
x giai on (2006-2011)
Ph lc 12. Gi tr KNNK thuc iu tr T ca cc quc gia xut x giai
on (2006-2011)
Ph lc 13. S lng SK cc thuc iu tr T t cc quc gia xut x
giai on (2006 - 2011)

Ph lc 1. T trng gi tr KNNK cc nhm thuc iu tr T

(2006-2011)
n v: %
Nhm thuc
Biguanid
Sulfonamid
v dn xut ure
Thuc T ng
ung dng kt hp
Cht c ch alpha
glucosidase
Thiazolidindion
Cc cht h ng
huyt khc tr insulin
Insulin
Tng

Nm
2006
24,2

Nm
2007
17,8

Nm
2008
18,3

Nm
2009
18,9

Nm
2010
22,9

Nm
2011
21,2

37,0

46,1

48,4

45,2

40,9

40,7

5,6

6,3

5,3

7,2

8,5

7,5

4,1

3,3

3,3

3,5

3,8

3,9

10,5

4,9

5,9

3,8

4,0

2,0

2,5

2,5

1,9

1,7

0,2

0,1

16,2
100,0

19,3
100,0

16,9
100,0

19,6
100,0

19,5
100,0

24,7
100,0

Ph lc 2. Gi tr KNNK cc nhm thuc iu tr T (2006-2011)

n v: Nghn USD
Tn nhm thuc
Biguanid
Sulfonamid
v dn xut ure
Thuc T ng
ung dng kt hp
Cht c ch
alpha glucosidase
Thiazolidindion
Cc cht h ng
huyt khc tr insulin
Insulin
Tng

Nm
2006

Nm
2007

Nm
2008

Nm
2009

Nm
2010

Nm
2011

3.640

3.270

4.658

5.272

8.127

8.706

5.564

8.488

12.302

12.593

14.496

16.663

843

1.151

1.342

2.006

3.023

3.078

613

603

847

984

1.361

1.584

1.583

898

1.508

1.063

1.433

816

373

454

486

459

69

30

2.432
15.048

3.544
18.408

4.297
25.441

5.462
27.839

6.921
35.429

10.104
40.981

Ph lc 3. S lng SK cc nhm thuc iu tr T nhp khu giai

on 2006-2011

Nhm thuc
Biguanid
Sulfonamid
v dn xut ure
Thuc T ng
ung dng kt hp
Cht c ch alpha
glucosidase
Thiazolidindion
Cc cht h ng
huyt khc tr insulin
Insulin
Tng

S lng SK
Nm
Nm
2008
2009
30
38

Nm
2006
29

Nm
2007
31

Nm
2010
39

Nm
2011
43

47

55

62

59

66

76

15

19

13

22

27

27

17

26

17

18
126

17
141

21
151

21
155

27
182

34
186

Ph lc 4. T trng tng s liu DDD cc nhm thuc T nhp khu

(2006-2011)
n v: %
Nm
2006
31,67

Nm
2007
31,93

Nm
2008
11,42

Nm
2009
16,01

Nm
2010
19,62

Nm
2011
16,59

57,07

58,20

76,06

71,83

66,50

72,29

0,72

0,52

0,59

0,78

0,98

0,84

Thiazolidindione
Cc cht h ng huyt
khc tr insulin

3,46

2,95

3,28

2,85

4,09

1,93

1,29

1,15

0,99

0,93

0,06

0,02

Insulin

5,79

5,27

7,66

7,59

8,74

8,33

100,00

100,00

100,00

100,00

100,00

100,00

Nhm thuc
Biguanid
Sulfonamid
v dn xut ure
Cht c ch
alpha glucosidase

Tng

Phu lc 5. Tng s lng liu DDD cc thuc iu tr T nhp khu

(2006-2011)
n v: Nghn liu DDD
Nm
2006

Nm
2007

Nm
2008

Nm
2009

Nm
2010

Nm
2011

Biguanid

34.555

48.607

21.269

25.935

34.057

38.373

Sulfonamid
v dn xut ure

62.273

88.607

141.714

116.338

115.436

167.187

784

787

1.106

1.259

1.702

1.941

3.780

4.487

6.105

4.619

7.106

4.469

1.412

1.743

1.845

1.513

109

45

6.321
109.126

8.018
152.250

14.278
186.317

12.290
161.953

15.175
173.587

19.266
231.281

Nhm thuc

Cht c ch
alpha glucosidase
Thiazolidindion
Cc cht h ng
huyt khc tr
insulin
Insulin
Tng

Ph lc 6. T trng gi tr KNNK cc thuc iu tr T (2006-2011)

T trng: %
Nm
2006
4,07
2,23
0,64
2,56

Nm
2007
3,27
2,26
0,48
2,60

Nm
2008
3,33
1,79
0,28
2,22

Nm
2009
3,53
1,48
0,31
1,22

Nm
2010
3,84
0,00
0,15
0,77

Nm
2011
3,87
0,00
0,12
1,40

4,62

4,53

4,74

5,55

4,61

5,63

Gliclazid

22,64

34,53

30,92

33,44

28,32

27,04

Gliclazid,
metformin

0,11

0,08

0,13

0,30

0,86

1,10

Glimepirid
Insulin
Metformin
Pioglitazon
Repaglind
Rosiglitazon

11,14
16,16
24,19
3,26
0,25
7,26

8,51
19,25
17,77
3,94
0,20
0,94

14,93
16,89
18,31
3,65
0,13
2,28

10,26
19,62
18,94
2,11
0,17
1,71

11,68
19,53
22,94
3,81
0,19
0,23

12,10
24,66
21,24
1,99
0,07
0,00

Rosiglitazon,
metformin

0,88

1,64

0,41

1,14

1,69

0,00

Glimepirid,
metformin

0,00

0,00

0,00

0,21

0,51

0,28

Pioglitazon,
metformin

0,00

0,00

0,00

0,00

0,86

0,50

100,00

100,00

100,00

100,00

100,00

100,00

Tn hot cht
Acarbose
Benfluorex
Chlorpropamid
Glibenclamid
Glibenclamid,
metformin

Tng

Ph lc 7. Gi tr KNNK ca cc hot cht iu tr T

(2006-2011)
n v: Nghn USD
Tn hot cht

Nm
2006

Nm
2007

Nm
2008

Nm
2009

Nm
2010

Nm
2011

Acarbose
Benfluorex
Chlorpropamid
Glibenclamid

613
335
96
386

603
416
88
478

847
454
71
566

984
413
87
339

1.361

1.584

52
272

47
574

Glibenclamid,
metformin

695

834

1.207

1.545

1.635

2.308

3.406

6.356

7.867

9.309

10.035

11.083

16

15

32

83

304

452

Glimepirid
Insulin
Metformin
Pioglitazon
Repaglind
Rosiglitazon

1.676
2.432
3.640
490
38
1.093

1.566
3.544
3.271
725
38
173

3.798
4.297
4.658
928
32
580

2.858
5.462
5.272
589
47
475

4.136
6.921
8.127
1.352
69
82

4.958
10.104
8.706
816
30

Rosiglitazon,
metformin

132

302

103

318

600

59

179

114

305

205

35.429

40.981

Gliclazid
Gliclazid,
metformin

Glimepirid,
metformin
Pioglitazon,
metformin
Tng

15.048

18.408

25.441

27.839

Ph lc 8. S lng SK ca hot cht iu tr T nhp khu

(2006-2011)
Tn hot cht
Acarbose
Benfluorex
Chlorpropamid
Glibenclamid
Glibenclamid,
metformin
Gliclazid
Gliclazid,
metformin
Glimepirid
Insulin
Metformin
Pioglitazon
Repaglind
Rosiglitazon
Rosiglitazon,
metformin
Glimepirid,
metformin
Pioglitazon,
metformin
Tng

Nm
2006

Nm
2007

S lng SK
Nm
Nm
2008
2009
2
2
1
1
2
2
9
6

2
1
2
12

2
1
2
8

16

24

Nm
2010

Nm
2011
3
0
1
8

2
0
1
7

22

22

24

22

17
18
29
14
1
8

21
17
31
19
1
8

29
21
30
21
1
6

29
21
38
11
2
6

33
27
39
22
2
4

46
34
43
17
1
0

182

186

126

141

151

155

Ph lc 9. T trng tng s liu DDD ca cc hot cht iu tr T

nhp khu (2006-2011)
n v: %
Tn hot cht
Acarbose
Benfluorex
Chlorpropamid
Glibenclamid
Gliclazid
Glimepirid
Insulin
Metformin
Pioglitazon
Repaglind
Rosiglitazon
Tng

Nm
2006
0,72
1,25
2,88
11,93
29,05
13,20
5,79
31,67
2,37
0,04
1,10
100,00

Nm
2007
0,52
1,12
1,67
11,07
37,42
8,04
5,27
31,93
2,45
0,03
0,50
100,00

Nm
2008
0,59
0,97
3,82
9,46
40,54
22,25
7,66
11,42
2,60
0,02
0,67
100,00

Nm
2009
0,78
0,89
1,87
5,35
45,59
19,02
7,59
16,01
1,67
0,05
1,18
100,00

Nm
2010
0,98
0,00
1,02
3,96
40,02
21,51
8,74
19,62
3,74
0,06
0,35
100,00

Nm
2011
0,84
0,00
0,64
7,82
34,44
29,38
8,33
16,59
1,93
0,02
0,00
100,00

Ph lc 10. Tng s liu DDD ca cc hot cht iu tr T nhp khu

giai on 2006-2011
n v: nghn liu DDD
Tn hot cht

Nm
2006

Nm
2007

Nm
2008

Nm
2009

Nm
2010

Nm
2011

Acarbose
Benfluorex
Chlorpropamid
Glibenclamid
Gliclazid
Glimepirid
Insulin
Metformin
Pioglitazon
Repaglind
Rosiglitazon
Tng

784
1.367
3.146
13.016
31.703
14.408
6.321
34.555
2.581
45
1.199
109.126

787
1.698
2.540
16.859
56.973
12.235
8.018
48.607
3.723
45
764
152.249

1.106
1.800
7.117
17.624
75.525
41.448
14.278
21.269
4.850
45
1.254
186.317

1.259
1.440
3.031
8.670
73.840
30.797
12.290
25.935
2.709
73
1.910
161.953

1.702
0
1.767
6.868
69.461
37.341
15.175
34.057
6.500
110
606
173.587

1.941
0
1.489
18.094
79.648
67.957
19.266
38.373
4.469
45
0
231.281

Ph lc 11. T trng gi tr KNNK thuc iu tr T ca cc quc gia

xut x (2006-2011)
n v: %
Nm
2006
0,1

Nm
2007
0,0

Nm
2008
0,1

Nm
2009
0,1

Nm
2010
0,1

Nm
2011
0,0

Bangladesh

0,0

0,0

0,0

0,3

0,4

0,3

Canada

1,6

1,7

1,1

0,4

0,7

0,4

Trung Quc

0,0

0,0

1,0

0,0

0,0

0,1

Cyprus

0,7

2,0

1,0

0,5

0,7

0,3

an Mch

10,4

14,2

8,5

12,2

10,0

16,3

Php

48,2

47,8

44,0

48,1

43,1

42,1

7,8

6,5

6,6

7,0

6,5

9,0

7,3

9,7

8,2

7,4

12,2

13,4

Indonesia

0,8

0,4

1,1

1,1

0,4

0,3

8,5

6,5

11,7

6,0

7,1

7,6

Hn Quc

1,7

2,3

2,4

3,2

3,5

3,9

Malaysia

0,4

0,5

0,3

0,5

0,0

0,2

Pakistan

1,6

0,4

1,2

1,1

2,5

0,9

Ba Lan

3,4

4,5

7,1

6,6

4,9

2,7

Singapo
Ty Ban
Nha

0,0

0,0

0,0

0,1

0,1

0,0

1,6

1,7

3,3

1,9

1,4

0,0

a Loan

0,0

0,7

1,5

1,3

1,1

0,9

Th nh k

0,0

0,2

0,1

0,6

0,4

0,5

Anh

0,0

0,0

0,0

0,5

0,1

0,0

6,0

1,0

0,8

1,3

1,1

0,8

Israel

0,0

0,0

0,0

0,0

3,7

0,0

0,0

0,0

0,0

0,0

0,0

0,4

100,0

100,0

100,0

100,0

100,0

100,0

Tn quc
gia
Argentina

Tng

Ph lc 12. Gi tr KNNK thuc iu tr T ca cc quc gia xut x

(2006-2011)
n v: Nghn USD
Tn quc
gia
Argentina
Bangladesh
Canada
Trung Quc
Cyprus
an Mch
Php
c
n
Indonesia

Hn Quc
Malaysia
Pakistan
Ba Lan
Singapo
Ty Ban
Nha
a Loan
Th nh k
Anh
M
Israel
c
Tng

Nm
2006

Nm
2007

Nm
2008
18

Nm
2009
20
71
100

Nm
2010
30
136
254

141
3.386
13.388
1.954
2.061
299
1.661
898
140
295
1.825
35

257
3.554
15.285
2.318
4.320
139
2.515
1.227
10
896
1.733
22

235

314

107
1.560
7.254
1.175
1.093
120
1.279
259
63
235
515

370
2.613
8.790
1.202
1.779
67
1.192
426
95
81
827

287
260
263
2.150
11.188
1.674
2.090
284
2.974
607
81
309
1.800

248

306

827

535

484

126
36

372
33
10
214

364
168
139
360

395
138
23
397
1.294

896

15.048

176

18.408

25.441

27.839

35.429

Nm
2011
20
129
161
34
125
6.690
17.273
3.677
5.477
112
3.124
1.591
63
352
1.089
11

357
198
320
179
40.981

Ph lc 13. S lng SK cc thuc iu tr T t cc quc gia xut x

Tn quc
gia
Argentina
Bangladesh
Canada
Trung Quc
Cyprus
an Mch
Php
c
n
Indonesia

Hn Quc
Malaysia
Pakistan
Ba Lan
Singapo
Ty Ban
Nha
a Loan
Th nh k
Anh
M
Israel
c
Tng

Nm
2006

Nm
2007

S lng SK
Nm
Nm
2008
2009
2
1
4
6
3

Nm
2010

Nm
2011

3
9
14
12
41
4
3
10
4
7
5

3
8
12
11
56
2
4
13
4
4
8

4
8
9
12
53
6
3
16
2
7
10

3
8
10
11
55
5
3
17
3
3
10
1

2
10
13
11
77
7
3
16
1
9
5
1

2
1

3
1
2
3

4
1
5
6

4
1
4
4
1

126

141

151

155

1
7
3

182

1
5
3
1
5
9
10
13
78
4
2
20
2
13
9
1

3
1

4
2
186