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Nghien cipu - Ky thuat

cCa polymer nen tao thanh mang bao dong nh^t, trang bang phu'ang phap bao dap". Tap chi Dime hoc, liSn ket chat ehe voi nhau, con trong phu'ong so 444 nam 53, tr. 17-20.

phSp bao dap chi dCing Itfc nen tao khoi co dinh, ^ " ' " " = " =' "'• (2""^)' "'" " ' r a '»"<• ' " " ™ ,. . . . . . , . , • evaluation of a novel capsule for colon- specific drug Chua CO s y t u a n g tac tgo mang thong nhat. So delivery". Journal of Pharmaceutical Sciences. 98(8) vdi phuang phap bao dap, phuang phap bao bdi pp.2626-2635

kh6ng ddi hdi t h i i t bj phuc tap, de trien khai qui 3. Sagarika Bose, Robin H Bogner (2007), m6 san x u i t Idn. "Solventless pharmaceutical coating process. A rev]evj", Pharmaceutical Development and Technology,

Tai lieu tham khao ^^- PP ^^^""^^

4. Yanfeng Luo ef al (2008), "Dry coating, a novel 1. Nguyen Thu Quynh, Pham Thi Minh Hue, coating technology for soltd pharmaceutical dosage Nguyen Thanh Hai, Vo Xuan Minh (2013), "Nghien forms", International Journal of Pharmaceutics. 358, cuu bao ehe vien nen metronidazol giai phong tgi dai pp.16-22

(Ngay nhan bai: 10/03/2014 - Ngay duyet dang:12/05/2014)

^Khao sat cac yeu to anh hirong den ket qua dieu tri dai thao dutrng typ 2 tai Khoa Noi tiet - Benh vien Cap cuu Trung Vuong Thanh pho Ho Chi Minh

Bui Tung Hiep

Benh vien Cap cim Trung Vuong E-mail [email protected]

Summary

The therapy effectiveness related factors for type 2 diabetes inpatients was investigated by cross sectional research involving 410 disease records of type 2 diabetes inpatients in Trung Vuong Hospital - Ho Chi Minh City (diagnosed based on America Diabetes Association 2012). The effectiveness of antihyperglycemia regimens was evaluated according to the guideline of America Diabetes Association 2013 for type 2 diabetes inpatients. 11 factors possibly related to therapy effectiveness including age, gender, history of diabetes, hospitalized duration, HbAlc, major diseases, total disease number, white blood cell count, randomized blood glucose concentration at admitted time, antihyperglycemia therapy, glomerular filtration rate were accessed by logistic regression. Four factors significantly associating to therapy effectiveness included age (age < 60 had better glucose control than age s 60 with OR: 3.74 [95%Cl:1.97-7.11]), HbA1c(group with HbAlc in range of (6.5% to < 7 5%) had better glucose control than group with HbAlc < 6.5% with OR: 1.46 [95%CI: 0.38-5.58], group with HbAlc > 7.5% had lower glucose control than the group with HbAlc < 6.5% with OR: 0.22 [95%CI: 0.09-0.58]), total disease number (group with total diseases s 3 had better glucose control than group with total diseases > 3 with OR: 3.92 [95%Cl: 2.17-7.07}) and antihyperglycemia therapy (non insulin therapy had lower glucose control thaninsulin therapy with OR: 0.49195%CI: 0.23-1.03]). In short, for type 2 diabetes inpatients, the more advanced age and greater total diseases, the lower glucose control was; also, the higher and so lower HbA 1c, the lower glucose control was. Insulin therapy was optimal for type 2 diabetes inpatients.

Keywords: Diabetes, Trung Vuong Hospital, therapy effectiveness related factors.

T - \ P C H I DU'OC H Q C - 5/2014 (SO 457 N A M 54)

(2)

Nghien CIFU - Ky thuat

D a t v a n d e

Oai thao dudng la mpt benh mgn tinh ddi hdi cd c h i dd cham sdc y t i dae bidt. Benh nay lam gia tang nhi>ng nguy ea dSn d i n eae roi loan bao gdm benh ddng mgeh vanh, benh mgch mau ngoai bien va benh mach mau nao, benh thgn, n h i l m trung va eat cut chi'^'. Khae vdi nhung benh nhan DTB dieu tri ngoai tru, viec k i i m soat tot glucose m^u se giup giam thdi gian n i m vien va dem lai k i t qua d i i u trj tot cho benh nhan'^'.

Tuy nhien, k i t qua dieu trj cd the bj anh hudng eua r i t n h i i u y i u to. Xuat phat t u cac ly do tren, chung tdi t i i n hanh nghien euu: "Khao sat eac y i u to anh hudng d i n k i t qua d i i u tri dai thao dudng typ 2 tai Khoa Ndi t i i t - Benh vien C i p cdu Trung Vuong".

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

CLPU

Ooi tucrng nghien ciru Tieu chuan chgn miu

Benh nh^n dai thao d u d n g (DTD) typ 2 dup'c c h i n doan theo tieu ehuan khuyen cao Hiep hdi DTD Hoa Ky 2012 va nhung benh nh§n da CO t i i n s u DTD typ 2 d u g c chl djnh dieu trj tgi Khoa Ndi t i i t - Benh vien C i p c u u Trung V u a n g (BVCCTV) - TP. Hd Chi Minh.

Tieu chuan loai fru*

Benh an tron vlen, c h u y i n vien, benh nhan xm v i , benh nh§n khdng lam xet nghiem n i n g dd glucose mau ddi ngay trudc khi ra vien.

Co-miu

T i t ca h i s o b#nh an t d thang 9/2012 d i n thang 07/2013 (410 benh an).

PhiFang phap nghi§n c u u Nghien c d u c i t ngang md ta.

Tieu chuan danh gia

Hidu qua dieu tn cua eac phae do ha glucose mau d u a c danh gia theo mue tieu dieu trj DTD typ 2 trong ndi vidn d nhung benh nhan khdng cd benh nguy kjch cua ADA 2013: Dat khi n i n g do glucose mau doi lue ra vien < 7,8 mmol/l kem vdi khdng cd b i i n chung ha glucose mau trong thdi gian nam vi^n. Khdng dat khi nong do glucose mau ddi iuc ra vien > 7,8 mmol/l hoae < 7,8 mmol/l kem cd bien ehung ha glucose mau trong thdi gian n i m vien.

Khao sat cac yeu to anh hu^g den kit qui dieu trj

Phuung trinh hdi quy logistic d u g c s u dung de phan tieh s y t u a n g quan giua hi$u qua dieu trj v d i 11 y i u t i nguy e a (gidi, tuoi, tien s u DTD, thdi gian n i m vlen, H b A l c , c h i n doan benh ehinh, tong so benh, so l u y n g bach e i u luc vSo vlen, nong do glucose mau b i t k j ICic v&o vien, phae do dieu tn, muc lgc c i u t h | n ) .

Bien y cd hai gia trj la d^t va khong d^t, la bien nhj phan nen ehung tdi s u dung hoi quy logistic nhj phan.

Biin tudi la b i i n lien tuc, nhung ehiing tdi chia thanh 2 nhdm la < 60 tuoi va ^ 60 tuoi de thu^n tien trong viec phan ti'eh.

Biin thai gian nim vlen la bien lien tgc, nhung Chung tdi chia thanh 2 nhdm la s 3 ngay va > 3 ngay de thuan tien trong vi#e phan tieh.

Biin HbAlc d u g c phan chia thanh 3 mue dp k i i m soat theo k h u y i n cao cua Bd Y t i VIdt Nam nam 2011: kiem soat tot ( H b A l c £ 6,5%), kiim soat chap nhan ( H b A l c > 6,5% den < 7,5%), k i i m soat kem (HbA1e > 7,5%).

Bien chan doan benh chinh d u g c chia thanh 2 nhdm, la nhdm ed benh ehinh la dai thao dudng typ 2, va nhdm ed benh chinh khdng phai la DTD typ 2.

Biin tong s6 benh IS bien lien tyc, nhung chiing tdi chia thanh 2 nhdm la < 3 b0nh va > 3 bdnh Qe thuan tien trong vi?e phan tich.

Bien s6 luung b^ch ciu lOc vio vi&n \i bien lien tue, nhung ehung tdi chia thSnh 2 nhdm la nhdm cd so lugng bach c i u > 11 x 10^/1 va nhdm ed so lugng bach cau < 11 x 10^/1).

Bien ning do glucose miu bat ky luc vao vien la bien lien tue, nhung chung tdi chia thanh 2 n h d m l a < 1 1 , 1 mmol/l va > 11,1 mmol/l de thu?n ti$n trong viec phSn tich.

Biin phic dd diiu trj d u g c chia thanh 2 nhdm phae do d d la phae do cd Insulin v ^ ph^c do khdng ed insulin.

Bien mOc lgc ciu thin \i b i i n lien tyc, nhung chung tdi chia thanh 5 nhdm theo Hoi th$n hpc Hoa Ky de tidn phan tich: nhdm 1 : > 90 ml/

phut/1,73 m^, nhdm 2: 60 - 89 ml/phut/1,73 m^

nhdm 3: 30 - 59 ml/phut/1,73m^ nhdm 4: 15 - 29 ml/phut/1,73 m^ nhdm 5: < 15 ml/phut/1,73 m ^

TAP CHI DlfgfC HOC - 5/2014 (SO 457 NAM 54)

(3)

Nghien CCFU - Ky thuat

K i t qua d u g c trinh bSy d u d i dang tJ sd chenh (Odds ratio = OR) va khoang tin egy 95% (95%

confident interval = 95% CI), vdi p < 0,05 duge xem la ed y nghTa thong ke.

C^e y i u td dwgc xem la anh hudng d i n k i t qua d i i u trj khi p < 0,05 d ca hai m5 hinh dan b i i n v^ da bien.

Phwong phap xif (^ s6 lieu S d dyng p h i n m i m SPSS 16.

Ket qua nghien CLFU D|ic diem cua mau nghien cuu Dge diem chung cua 410 benh nhSn DTD typ 2 d u g c the hien trong bang 1.

Bang 1: £?ac diem chung cua miu nghien cuv

STT Dac diem n

%

Tu6i 1 <50 260

145 265

35,37 64,63 Gi&l

2 NO Nam

283 127

69,02 30,98 TiSn su-benh BTD typ 2

3 C6 Khong

Muc d0 liiim soat HbA 1c

> 6,5% - < 7,5%

> 7,5%

356 54 266 31 24 211

86,83 13,17 100 11,65

9,02 79,32 Ly do vao vien

Trf$u chLfng tang glucose mau Hg glucose mau C^c trieu Chung kh^c

200 19 191

48,78 4,64 46,58

STT Dac diem 6

Chan doan

Benh chinh khong phai DTD typ 2 B^nh chinti la DTD typ 2 Benh mic kem

n

201 209

%

49,02 50,98 Tang huyet ap (n= 410)

ROI logn lipid mau (n=268) Benh mgch vanh (n= 410) Tang b$ch c i u (n= 410) Giam bach cau (n= 410) Roi loan dien giai (n=403) Cac b#nh khac (n= 410)

307 74,88 228 85,07 97 23,66 120 29,27

1 0,24 228 56,57 250 60,98

8

9

Th&i gian nim vien it nhat Nhieu nhit Trung binh Phae do dieu tri Phae d i co insulin Khong co insulin

Muc loc ciu than (ml/phCit/1,73m^) 2 41 9,72 ± 6,51

333 81,22 77 18,78

2 90 60-89 30-59 15-29

<15

60 14,63 168 40,98 140 34,15 33 8,05

9 2,20 Cac yeu to nguy co" anh hU'dng d4n ket qua dieu trj

K6t qua nghien ci>u 11 y^u t6 nguy c a xir ly tiieo phi^ang trinh h6i quy logistic dan bl^n va da bign du'ge the hi§n trong bang 2 va 3.

Bang 2: Phuvng trinh hdi quy logistic don bien xet cac yeu to nguy ca rieng ie anh huong din l<4t qua dieu hi

Yen Gidi (n=410)

Nam NQ Nhdm tuoi (n=410)

2 60 tu6l

< 60 tuoi Tiin sit BTB (n=410)

Co KhOnq Th&i gian nim vi€n (n=

^ 7 ng^y

> 7 ngay

t6 anh htmng

=410)

Khong dat

44 (33,3%) 88 (66,7%) 105(79,5%) 27 (20,5%) 117 (88,6%) 15(11,4%) 64 (48,5%) 68(51,5%)

Dat

83 (29,9%) 195(70,1%) 154(55,4%) 124 (44,6%) 239 (86%)

39(14%) 111 (39,9%) 167(60,1%)

OR [95%CI1 1 1,1710,75-1,83)

1 3,13 [1.92-5,081

1 1,27(0,67-2,401

1 1,41 [0,93-2,14]

P

>0,05

10,01

>0,05

>0,05

T4P CHi Dirac H Q C - s/2014 ( s 6 457 N A M 54)

(4)

• Nghien ciru - Ky thuat

HbAlc (n=266) i 6,5%

> 6,5% den < 7,5%

> 7,5%

Chan doan (n=410) Benh chinh la OTD Benh chinh khong phai DTD rdngsofaen/i (n=410}

^ 3 benh

> 3 benh

So / u w i g bach cau luc vao vien (n=410)

< 11 X 109/llt

> 11 X 109/lit

Nong do glucose mau bat Ity iuc vao vien (n=410)

< i l , 1 mmol/l

> 11,1 mmol/l Phae do dieu tri

Phae cjo khong co insulin Phae do CO insulin

9 (7,2%) 6 (4,8%) 110(88%) 67 (50,8%) 65 (49,2%) 34 (25,8%) 98 (74,2%) 77 (58,3%) 55(41,7%) 56 (42,4%) 76 (57,6%) 35 (26,5%) 97 (73,5%)

22 (15,6%) 18(12,8%) 101 (71,6%) 142(51,1%) 136(48,9%) 142(51,1%) 136(48,9%) 191 (68,7%) 87(31,3%) 101 (36,3%) 177 (63,7%) 42(15,1%) 236 (84,9%)

1 1,22(0,36^1,10]

0,37(0,16-0,85]

1 0,98 [0,65-1,49]

1 0.33 10.21-0.521

1 0,63 [0,41-0,97]

1 1,29 [0,84-1.97]

1 2,02(1,22-3,36]

<0,01

>0,05

<0,0S

>0,05

<0,01

<0,05

>0,05

<0,01

Mire lgc cau th$n Nhom 1 Nhom 2 Nhom 3 Nhom 4 Nhom 5

22(16,7%) 38(13,7%) 3,45(0,87-15,20] > 0,05 45(34,1%) 123(44,2%) 5,46[1,31-22,78] > 0,05 49 (37,1%) 91 (32,7%) 3,71[0,89-15,50] < 0,05 10(7,6%) 23(8,3%) 4,60 [0,95-22,1] > 0,05

6(4,5%) 3(1,1%) 1 >0,05 Bang 3: Phuang trinh hdi quy logistic da bien xet cac yeu tc

Yeu to anh hifcmg Giai (n=410}

Nam Nu Nhom tu6i(n=410}

> 60 tuoi

< 60 tuoi Tiensu'DTD(n=4W)

Co Khong

Thoi gian nam viin(n=410}

> 7 ngay s 7 ngay HbAlc (n=266)

< 6,5%

> 6,5% den < 7,5%

> 7,5%

Chan doan (n=410) Benh Chinh la DTD Benh chinh khong phai DTD Tong s6 benh {n=410)

> 3 benh s 3 benh

So luo-ng b^ch cau ide vao vien (n=410)

> 11X i09;iit s 11 X 109/lit

Khdng d^t 44 (33.3%) 88 (66.7%) 105 (79,5%) 27 (20,5%) 117(88,6%) 15(11,4%) 68(51,5%) 64 (48,5%) 9 (7,2%) 6 (4,8%) 110(88%) 67 (50,8%

65 (49,2%) 98 (74,2%) 34 (25.8%) 55(41.7%) 77 (58.3%)

i nguy ca anh Bat 83 (29.9%) 195 (70.1%) 154(55.4%) 124(44.6%) 239 (86%) 39(14%) 167 (60,1%) 111 (39.9%) 22(15.6%) 18(12,8%) 101 (71,6%) 142(51,1%) 136 (48,9%) 136(48,9%) 142(51,1%) 87(31,3%) 191 (68,7%)

huung den ket qua diSu tii OR I95%CIJ

1 1,04 10,56-1,901

1 3,74 [1,97-7,11]

1 1,3210,58-2,981

1 0.81 [0,47-1.42]

1 1.46 [0.38-5.58]

0.22 [0.09-0.58]

1 1.35 [0.75-2.42]

1 3.92 [2.17-7,07]

1 1.40(0.97-2.47]

P

>0,05

<0,0(

>0,05

>0,05

<0,01

>0.06

<0,01

>0.05

<0,01

>0,05

TAP CHi DirpC HOC - 5/2014 (S6 457 NAM 54)

(5)

• Nghien ciru - Ky thuat

Nong tfp glucose mau bit ky luc vao vien (n=410)

£11,1 mmol/l

< 11.1 mmol/l Phae do dieu tri

Phae do CO Insulin Phae do khOng cd insulin

76 (57.6%) 56 (42.4%) 97 (73.5%) 35 (26.5%)

177 (63.7%) 101 (36.3%) 236 (84.9%) 42(15.1%)

1 0.71 10,38-1.34]

1 0.49 10.23-1.03]

>0.05

<0,05 Muv life cau than

<15ml/phijt/1.73m2 a 90 ml/phul/l .73m2 6 0 - 8 9 ml/phut/1.73m2 3 0 - 5 9 ml/phut/1.73m2 15-29ml/phOt/1.73m2

6 (4.5%) 22 (16.7%) 45(34.1%) 49(37.1%,) 10(7.6%)

3(1.1%) 38(13.7%) 123 (44.2%) 91 (32.7%)

23 (8.3%) 1 3.1910.38-26.55]

7.5510.96-59.22]

7.2910.93-57.12]

5.3010.61-46.04]

>0.05

>0,05

<0,05

>0.05 Ban luan

Trong p h u o n g trinh hoi quy don b i i n va da b i i n ta xet 11 yeu to, cho t h i y chi co 04 y i u to CO y nghTa a ea hai phuong trinh. Yeu to so luong bach c i u anh h u o n g d i n k i t qua dieu trj 6- phuong trinh hoi quy don b i i n , tuy nhien khi xet phuung trinh hoi quy da bien thi no khong con i n h h u o n g d i n k i t qua dieu trj.

Ve yiu to tu6i: Nhom tuoi < 60 cd xac s u i t dgt cao g i p 3,74 l i n so vo'i nhom co tuoi £ 60 tuoi (p

< 0,01). Th^t vay, khi tuoi cang eao, kha nang de khang insulin cang nhieu, cang eo nhieu b^nh ly phoi hgp, cang eo n h i i u bien ehung, s y tuan thu d i i u tri cua b§nh nhan cung giam di. Do vay k i i m soat glucose mau 6' nhu'ng doi t u o n g cang Ion tuoi eang kho. Theo k h u y i n cao cua ADA nam 2013 ve mye ti^u k i i m soat glucose mau eua DTD typ 2 thi eang Ion tuoi thi mue dO kiem soat glucose m^u eang it nghiem nggt'^'.

HbAlc: Nhom co mipc H b A l c kiem soat kem CO xac s u i t dat chi bang nhdm ed mue H b A l c kiem soat tot 0,22 l i n (p < 0,01). That vay, nhi>ng nguoi da e6 t i i n s u eo H b A l c a mue kiem soat kem thi kho dat d u o c muc kiem soat glucose mauf^i. D i i u nay co the ly giai la nhung nguoi nay da eo t i i n s u tuan thu kem voi dieu tn, tinh trang glucose mau va c h i do an eua hp eung kho k i i m soat.

Tong s6 b0nh: Nhom co tong s i benh ^ 3 benh CO xac s u i t dgt eao hon 3,92 l i n so v6i nhom co tong so benh > 3 b#nh (p < 0,01). Khi cac benh ly p h i i h o p cang nhieu thi eang kho dat d u o c mij-c kiem soat glucose maui^'^'i. Dac biet nhiing ngud-i co n h l i u bien chung eCia dai thao d u o n g g§y ra n h u b i i n ehung b#nh than man lam giam dO thanh thai t h u i c hg glucose mau trong do cd

insulin, rat de gay bien chung ha glucose mau, t u do lam eho eae nha thuc hanh lam sang rat than trong khi d i i u ehinh lieu insulini"^'. Do cung ia ly do cho s y kho dgt duge mue tieu dieu tn a nhOng nguoi eo n h i i u benh ph6i hop.

Phae dd dieu tri: Phae d i khong co insulin CO xac s u i t dat chi b i n g 0,49 lan so voi phae do CO insulin (p < 0,05) D i i u do cho thay ph^c do CO insulin la phae d i t i i uu tien de kiem soat glucose mau cua benh nhan DTD typ 2 noi vien.

K i t luan

Khi benh nhan cang cao tuoi, cang m i e nhieu benh va muc dg kiem soat glucose mau kem khi n h | p vien thi kha nang dat muc tieu dieu tri DTD typ 2 ngi vien cang khd hon. Ben canh do, viee lua chgn phae d i d i i u tri cho tung b&nh nhan cung rat quan trgng, anh huong d i n k i t qua dieu tn. Nhu vgy, ehung ta nen ca the hda trong viSc dieu tri 6' benh nhan DTD typ 2.

Tai lieu tham khao 1 AmericanAssociation of Clinical Endocrinologists and Amencan Diabete Association (2009), "Consensus Statement on Inpatient Glycemic Control", Diabetes Care, vol. 32, 6, pp. 4 - 6 .

2. American diabetes Association (2013), "Standards of medical care in diabetes". Diabetes Care, 36 (1), pp.

1 1 - 5 0 .

3. Amencan Diabetes Association (2012), "Standards of Medical Care in Diabetes", Diabetes Care. vol. 35, supplement 1, S30.

4. Koro C. E., Bourgeois N et al (2004), "Glycemic Control From 1988 to 2000 Among U.S. Adults Diagnosed With Type 2 Diabetes", Diabetes Care, 27(1), pp. 17-20.

5 Clement S. et al (2004), "Management of diabetes and hyperglycemia in hospitals", Diabetes Care, vol. 27, 2, pp. 553-579.

(Ngay nhan bai: 19/03/2014 - Ngay duyet dang: 12/05/2014)

T ^ CHi DU'gfC H p c - 5/2014 (SO 457 NAM 54)

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