HIEU QUA DIEU TRI SAN LA GAN L 6 N BANG TRICLABENDAZOLE TAI PHONG KHAM VIEN SOT RET-KY SINH TRUNG-CON TRUNG QUY NHON
Nguyen Van Chu-ong, Trieu Nguyen Trung Nguyen Xuan Thien, Nguyen Van Kha
Tomtdt
Theo ddi vd diiu tri 100 binh nhdn sdn Id gan lan bang thudc triclabendazole theo 2 phdc do 10 vd 20mg/kg cdn ndng, chiing tdi nhdn thdy rdng:
- Triiu chiing dau viing hg sirdn phdi tdng len sau ngdy thic nhdt udng thuoc a nhdm I (tdng 6%), nhdm 11 (tSng 10%); tri^u chiing ndy gidm ddn vdo ngdy thu 2 vd thir 3 sau khi udng thudc.
- Cdc tri$u chirng dau viing thirgng vi, rdi logn tieu hod, sot diu gidm tir ngdy thic nhdt din nhung ngdy tiep theo sau khi udng thudc
Trieu chirng ngira, noi mdn deu tang ddn tic ngdy thir 2 vd thic 3 trd di: ngdy thii 3 tdng 9,52% a nhdm I, tang 22,22% a nhdm 11
Sau 3 thdng dieu tri, cdc trieu chiing ldm sdng gidm tic 77,5-100% a nhdm 1, gidm tir 76,92-100% a nhom IL
- Sd lugng hong cdu trudc vd sau 3 thdng diiu tri cd nhdm 1 vd 11 diu binh thudng
- Sau 3 thdng dieu tri so b?nh nhdn cd so lugng bgch cdu tdng a nhdm I gidm 61,90%, nhdm II Id 73,91%; sob?nh nhdn cd tdng ty 1$ BCAT gidm 80% dnhdm I; gidm 65,62% a nhdm II.
• Cdc xet nghiim ve chicc ndng gan: SGOT, SGPT, bilirubin todn phdn aed2 nhdm trudc vd sau 3 thdng dieu tri thay doi khdng ddng ki.
- Tdc dying phii ciia triclabendazole dcd2 nhdm I vd II bao gom: dau tdng vilng hg sudn phdi, m?t mdi, chdng mgt, nhtrc ddu, buon ndn, ngua ndi mdn. Tde dting phu ciia nhdm 11 co ty li cao han nhdm 1; tuy nhiin ty 1$ binh nhdn cd tde diing phti tuang ddi thdp, thudng mdt di sau ngdy dieu tri thu 2,3 vd khdng cdn xit tn'gi.
- Thuoc triclabendazole diing lieu lOmg/kg/24 h uong lieu duy nhdt vd liiu 20mg/kg cdn ndng chia 2 idn cdch nhau 4-6 h cho kit qud ve ldm sdng vd can ldm sdng tuang duang nhau. Tuy nhien kit qud theo ddi ddnh gid a 2 nhdm mdi a thdi diim sau 3 thdng diiu tri.
1. DAT VAN Dfe:
Benh sdn Id gan Idn (SLGL) la benh k^ sinh triing truyin qua thiic an. Trdn thi gidi bfnh sdn la gan Idn da dugc phdt hien d 65 nude, vdi gdn 180 trieu dan ndm trong vdng nguy CO vd khoang 2,4 trieu dan bi nhiem (WHO, 1995). Ty le mdc benh cao nhdt d cdc viing chdn nudi cim vd gia sdc cd simg tap trung, noi ngudi dan cd tap qudn an sdng cdc thuc vat thuy sinh. Nhieu vdng nhu Bo Ddo Nha, Nile delta, bdc Iran, Trung Qudc vd cao nguyen Andean ciia Ecuador, Bolivia, Pe Ru ty le nhiem rdt cao. Su biing phdt benh sdn Id gan Idn cdn dugc biet din d Anh, Phdp, Tdy Ban Nha, Bolivia, Cu Ba, Chi Le vd Uruquoay.
80 TAP CHI PHONG CHONG BENH SOT RET VA CAC BENH KY SINH TRUNG SO 4 - 2011
Tai Viet Nam, tir nam 1999 sd ca benh sdn Id gan Idn tang ddn, den ndm 2006 cd 2.428 ca benh. Theo thdng ke cua Vien Sdt ret- Ky sinh trimg-Cdn trimg Trung uong, tir thang 3 ndm 2008 cd tren 5.000 ca benh sdn Id gan Idn phan bd tai 47 tinh thdnh tir Bdc den Nam.
Khu vuc miin Trung-Tay Nguyen bao gdm 15 tinh cd tinh hinh nhiem sdn Id gan Idn nghiem trong nhat so vdi cdc khu vuc khdc trong ca nude. Tai phdng Kham chuyen khoa cua Vien Sdt ret-Ky sinh triing-Cdn triing Quy Nhan tir 2005 din nay da cd tren 10.000 ca sdn la gan Idn dugc phat hien va dieu tri.
De danh gia hieu qua dieu tri cua thudc triclabendazole (Egaten 250mg) trong dieu tri sdn Id gan Idn vdi 2 phdc do khdc nhau, chung tdi tien hanh de tdi:
"Ddnh gid hieu qua dieu tri benh sdn la gan Idn bdng triclabendazole tai phdng Kham Vien Sdt ret-Ky sinh triing-Cdn trung Quy Nhan", nhdm muc tieu:
1. Ddnh gid hieu qud dieu tri sdn Id gan lan bdng triclabendazole 2. Ddnh gid mot so tdc dung khong mong mudn cua thudc dieu tri
2. PHLTONG PHAP NGHIEN ClTU 2.1. Dia diem nghien cun:
Phdng Kham chuyen khoa, Vien Sdt ret-KST-CT Quy Nhan 2.2. Doi tu-ong nghien cuu:
- Benh nhan sdn Id gan Idn dieu tri tai phdng Kham - Thudc triclabendazole (Egaten 250mg)
2.3. ThM gian nghien cihi: 11/2009 - 4/2010 2.4. Phirotig phap nghien cuu:
2.4.1. Phuomg phdp thii nghiem ldm sdng khong ddi chung:
Chon benh nhan nhiem sdn la gan Idn theo tieu chudn chon benh dua vdo nghien ciiu theo ddi diiu tri xep thdnh 2 nhdm theo thu tu nhap vien, sd le vao nhdm I, sd chdn vdo nhdm IL
+ Nhdm I: dieu tri thudc triclabendazole theo phdc do lOmg/kg thi trgng/24 h, udng lilu duy nhdt sau biJa an trua. (sd le)
+ Nhom 11: dieu tri thudc triclabendazole theo phdc dd lOmg/kg thi trgng/ x 2 Idn trong 24 h, udng cdch nhau 4-6 gid sau bijra an. (sd chdn)
Tieu chudn chon benh:
+ Tieu chudn ldm sdng:
-> Dau bung: dau vdng thugng vi hodc dau ha sudn phai, tfnh chdt muc do dau khdc nhau tdy thudc tung benh nhdn.
-> Gay sut, met mdi, chan an, budn ndn, ndn -> Sdt; cd bieu hien di ung
Tiiu chudn can ldm sdng: cd mdt trong cac xet nghiem sau duang tinh:
-> Xet nghiem ELISA sdn Id gan Idn -> Xet nghiem phdn cd tning sdn Id gan Idn
- Benh nhan phai cd phieu cam ket ddng y tham gia nghien ciiu - Ca mdu nghien cuu: 100 benh nhdn nhiem sdn la gan Idn
Tieu chudn logi tru:
Benh nhdn khdng du cac tieu chudn chgn benh; Benh nhdn dudi 5 tuoi; Benh nhdn dang bi cdc benh cap tfnh khdc; Benh nhdn mdc cdc benh man tfnh khdc: tim mach, than, da ddy, gan, tdm than hodc cd khdi u nghi ngd; Benh nhdn cd tien sur man cam vdi bdt ky thanh phdn ndo cua thudc; Benh nhdn khdng tudn thu lieu d-inb theo ddi day du trudc diiu tri vd sau 3 thdng diiu tri.
2.4.2. Cdc chi tieu ddnh gid ve ddu hieu ldm sdng:
-Theo ddi cdc ddu hieu ldm sdng cua benh nhan lidn tuc 1-3 ngdy kl tu khi udng thudc vd sau 3 thdng diiu tii. Ddnh gid chuc ndng gan, chuc nang than trudc vd sau 3 thdng diiu tri.
X6t nghiem phdn vd ELISA trudc vd sau 3 thdng diiu tri.Xet nghi?m huyit hgc: sd lugng hong cau, Hemoglobine, ti le bach cdu af toan tiiidc vd sau 3 thdng diiu tri.
- Sidu dm bung tdng quat ddnh gid ton thuang gan tiardc vd sau 3 thdng diiu tri.
2.4.3. Thu thdp vd xu ly sd lieu:
- Cdc sd lieu dugc ghi chep theo mau benh dn nghien ciiu
- Xii 1^ sd lieu bdng tiidng ke y hgc: su dung phdn mim EPIINFO 6.4
82 TAP CHI PHONG CHONG BENH SOT RET VA CAC BENH KY SINH TRUNG SO 4 - 2011
3. KET QUA VA BAN LUAN:
3.1. Ket qud so sdnh theo ddi TCLS ciia benh nhdn trong 3 ngdy cdeu tri:
Bdng 1: Theo ddi TCLS cua benh nhdn trong 3 ngdy dieu tri:
TT
1
2
3
4
5
6
7
8
Trieu chung
Dau viing HSP Dau thugng
vj
RLTH
Gan to
Ngua, no! man
Sot
Khac
Sutcan
Trudc D.tri Nhom I
(n = 50) 40 80%
35 70%
29 58%
4 8%
38 76%
48 96%
I 2%
29 58%
Nhom II (n = 50)
40 80%
30 60%
26 52%
9 18%
35 70%
49 98%
0
27 54%
Theo doi dieu tri Ngay 1
Nhom I 43 86%
18 36%
12 24%
4 8%
38 76%
33 66%
1 2%
29 58%
Nhomn 45 90%
20 40%
14 28%
9 18%
35 70%
35 70%
0
27 54%
Ngay 2 Nhom I
33 41,25%
12 24%
5 10%
4 8%
38 76%
12 24%
1 2%
29 58%
N h o m n 34 68%
12 24%
8 16%
9 18%
37 74%
37 74%
0
27 54%
Ngay 3 Nhom I
10 20%
5 10%
3 6%
4 8%
42 84%
2 4%
0 29 58%
Nhomn 12 24%
5 10%
3 6%
9 18%
45 90%
2 4%
0
27
%4%
Kit qua bang tren cho thay khi diiu tri phdc dd nhdm II (lilu 20mg/kg nang chia 2 lan each nhau 4-6 h), ngdy thii 1 trieu chung dau viing ha sudn phai tang 10% so vdi 6% phdc dd nhdm I (lOmg/kg/24 h lilu duy nhdt); nhdng ngay tilp theo trieu chiing nay diu giam ddn d cd 2 nhdm I va II. Cdc trieu chung khdc diu giam ddn d cac ngdy thii 2,3 cd 2 nhdm. Rieng trieu chung ngiia, ndi mdn diu tdng d ngay thu 3 (84% cho nhdm I, 90%
cho nhdm II).
Kit qua ngdy thii 3 ti-ieu chutig dau vung ha sudn phai nhdm I giam 75%, nhdm II giam 70%; dau vimg thugng vi giam 85,71%, nhdm n giam 83,33%; rdi loan tieu bod giam 89,66%
d nhdm-1, gidm 88,46% d nhdm H; sdt giam 95,83% d nhdm I, giam 95,91% d nhdm E.
3.2. Ket qud so sdnh cdc trieu chirng ldm sdng sau 3 thdng Meu tri&2 nhdm:
Bdng 2: So sdnh trieu chiing lam sdng sau 3 thdng diiu tri d 2 nhdm:
TT
1
2
1
3
4
5
6
7 8
Trieu chirng
Dau viing HSP
Dau vung thugng vi Roi loan tieu hoa
Gan to
Ngua, noi man
Sdt
Khac Sytcan
Trirorc dieu tri Nhom I
40 80%
35 70%
29 58%
4 8%
38 76%
48 96%
1 (2%) 29 58%
Nhom II 40 80%
30 60%
26 52%
9 18%
35 70%
49 98%
0 27 54%
Sau 3 thang D.tri Nhom I
9
8
2
0
5
1
0 1
NhdmU 8
6
6
0
3
0
0 1
% Tang (+) Giam (-)
Nhom I 77,5
- 77,14
93.10
100,0
- 86.84
- 97,91
100,0 - 96.55
Nhomn -80,0
-80,0
76,92
-100,0
- 91,43
-100,0
- 96,30
Sau 3 thdng diiu tri, trieu chung dau vilng ha sudn phdi va dau vdng thugng vi d nhdm n giam nhilu ban nhdm I (nhdm I gidm 77,5-77,14%; nhdm n giam 80%). Trieu chung ngiia nii mdn nhdm II giam ban nhdm I (nhdm n gidm 91,43%, nhdm I giam 86,84%); trieu chung sot nhdm II cung cao ban nhdm I (nhdm n giam 100%, nhdm I giam 97,91%). Tuy nhien trifu chiing rdi loan tieu hda nhdm I lai gidm nhieu bom nhdm II (nhdm I giam 93,10%, nhdm n giam 76,92%).
84 TAP CHI PHONG CHONG BENH SOT RET VA CAC BENH KY SINH TRUNG SO 4-2011
3.3. Kit qud so sdnh mpt so kit qud xet nghiem can ldm sdng &2 nhdm Bdng 3: So sanh mdt sd ket qua xet nghiem can lam sang d 2 nhdm
TT
1 2
3
4
5
6
7
8
9
Trieu chung
S6 lugng HC
S6 luofng BC
Ty le BCAT
Lugng Hb
Toe do lang mau
Bilirubin toan phan
SGOT
SGPT
aFP
Trw&c dieu trj Tang
Nhom I 0 21 42%
25 50%
0 28 56%
0 6 12%
5 10%
0
Nhomn
23 46%
32 64%
35 70%
2 (4%) 12 24%
8 16%
Giam Nhom I
1(2%)
3 (6%)
Nhomn
2 (4%)
Sau 3 thang dieu tri Tang
Nhom I
8 16%
5 10%
64%
2 (4%) 3 6%
3 6%
0
Nhomn
6 72%
11 22%
31 62%
8 16%
6 72%
Giam Nhom I
2 (4%)
Nhomn
1 (2%)
Ket qua bang tren cho thay sd lugng hdng cau trudc vd sau 3 thdng diiu tri d ca 2 nhdm da sd diu binh thudng. Sd benh nhan cd sd lugng bach cau tang trudc diiu tri d nhdm II chilm ty le 46% so vdi nhdm I (42%); sau 3 thdng diiu tri so benh nhan cd so lugng BC tang d nhdm I chilm ty le 16% so vdi nhdm H (12%). Ty le BCAT tang tiirdc diiu tri d benh nhan nhdm II chilm ty le 64% so vdi nhdm I (50%); sau 3 thang diiu tri nhdm II chilm 22% so vdi nhdm I (10%). Cdc xet nghiem vl chiic ndng gan: SGOT, SGPT, bilirubin todn phan d ca 2 nhdm trudc va sau 3 thdng diiu tri thay ddi khdng ddng kl.
3.4. Kit qud so sdnh tdc dung phu cua triclabendazole d2 nhdm £eu tri Bdng 4: So sdnh tac dimg phu cua tiiclabendazole d 2 nhdm diiu tri
TT 1 2 3 4 5 6
Tac dyng phu cua thuoc Dau tdng vimg ha sudn phai Met mdi
Chdng mat Nhiic ddu Budn ndn Ngua, noi man
Nhom I (n=50) 3 rd%;
2 (4%) 2(4%) 2 (4%) 2 (4%) 4 (8%)
Nhomn (n=50) 5 (10%)
4 (8 %) 2 (4%) 3 (6%;
4 (8%) 10 (20%) Ket qua bang 18 cho thdy mdt sd tdc dung phu cua nhdm diiu tii lilu 20mg/kg ndng chia 2 lan each nhau 4-6 h cd cao ban nhdm I chi diing lilu 10mg/kg/24h udng 1 lilu duy nhdt sau khi an no; tdc dung phu thudng gap nhu dau tdng ha sudn phdi, met mdi, chdng mat, nhdc dau, budn ndn, ngiia noi man. Tuy nhi8n cdc trieu chiing ndy thudng mdt di sau ngdy thu 2, 3 vd khdng can xu tri gi.
3. KET L U ^ :
Qua theo ddi vd diiu tri 100 benh nhdn sdn la gan Idn bdng thudc triclabendazole theo 2 phdc dd lOmg/kg vd 20mg/kg cdn ndng, chdng tdi nhdn thdy rdng:
3.1. vi trieu chtmg ldm sdng cua benh nhdn sdn Id gan lan sau dieu tri:
Trieu chiing dau viing ba sudn phdi tdng 18n sau ngdy thu nhdt udng thudc d nhdm I (tdng 6%), nhdm n (tang 10%); trieu chung ndy giam ddn vdo ngdy thu 2 vd tiiu 3 sau khi u6ng thudc.
- Cdc trifu chiing dau vimg thugng vi, rdi loan ti8u hod, sdt diu gidm tir ngdy thu nhdt din nhung ngdy tilp tiieo sau khi udng tiiudc
- Trieu chiing ngua, ndi mdn diu tdng ddn tir ngdy thii 2 vd thu 3 trd di: ngdy thu 3 tdng 9,52% d nhdm I, tdng 22,22% d nhdm H
- Sau 3 thdng diiu tri, cdc trieu chiing lam sdng gidm tir 77,5-100% d nhdm I, gidm tir 76,92-100% d nhdm H.
3.2. Vi kit qud xit nghiim can ldm sdng:
- Sd lugng hong cau trudc vd sau 3 thdng diiu tri ca nhdm I vd n diu binh thudng.
86 TAP CHI PHONG CHONG BENH SOT RET VA CAC BENH KY SINH TRUNG SO 4-2011
- Sau 3 thdng dieu tri sd benh nhdn cd sd lugng bach cau tang d nhdm I giam 61,90%, nhdm n la 73,91%; sd benh nhan cd tdng ty le BCAT gidm 80% d nhdm I; giam 65,62% d nhdm n .
Cdc xet nghiem v l chuc nang gan: SGOT, SGPT, bilirubin toan phan d ca 2 nhdm trudc vd sau 3 thdng diiu tri thay ddi khdng dang kl.
4.3. Tdc dung phu cua triclabendazole:
Tdc dung phu cua triclabendazole a cai nhdm I va II bao gdm: dau tang viing ha sudn phdi, met mdi, chdng mat, nhiic dau, budn ndn, ngiia noi man. Tdc dung phu cua nhdm n cd ty le cao ban nhdm I; tuy nhien ty le benh nhdn cd tac dung phu tuomg ddi thdp, thudng mdt di sau ngdy diiu tri thii 2,3 va khdng can xii trf gi.
Thudc triclabendazole dung lilu lOmg/kg/24 h uong lilu duy nhat va lilu 20mg/kg cdn ndng chia 2 Idn each nhau 4-6 h cho kit qud v l lam sang va can lam sang tuomg duang nhau. Tuy nhien k i t qua theo ddi ddnh gid d 2 nhdm mdi d thdi dilm sau 3 thdng diiu tri; kit qua theo ddi sau 6 thdng dieu tri se cd gid tri cao ban.
TAI LIEU THAM K H A O
1. Nguyen Van Chuang, Huynh Hong Quang (2007) r^
Nhdn xet ddc diim lam sdng vd can ldm sdng cua benh sdn Id gan l&n. Ky yiu cong trinh NCKH 2001-2006. Vien Sot ret-KST-CT Quy Nhan, NXB Y hoc, 2007, tr 417-423.
2. Nguyln Van De, Nguyen Van Chuang (2003)
Nhan xet budc ddu su dung triclabendazole dieu trj benh san la gan Idn (^Fasciola) a Viet Nam.
Y hoc thirc hanh, s6 447. Bo Y te, 2003 3. Nguyen Van Kha (2007)
Hinh dnh sieu dm tdn thuxmg gan do sdn Id gan lan. Tai lieu tap huan chandoan va dieu trj benh san la gan Idn. Vien Sot ret-KST-CT Quy Nhan, 2007.
4. Huynh Hong Quang, Nguyen Van Chuang, Trieu Nguyen Trung (2007)
Hieu qua phdc do diiu tri Triclabendazole tren benh nhdn sdn Id gan l&n Fasciola gigantica tgi khu vuc miin Trung-Tay Nguyen tir 2004-2006. Ky yeu cdng trinh NCKH 2001-2006. Vi?n Sot ret- KST-CT Quy Nhan. NXB Y hoc, 2007.
5. Joachim Richter, Stefan freise, robert Mull at al (1999)
Fascioliasis: sonographic abnormalities of the biliary tract and evolution after tretment with triclabendazole. Tropical Medicine and Internation Health. Nov. 1999
6. Juan Carlos Milan (2000)
The efficacy and tolerability of triclabendazole in Cuban patient with latent and chronic Fasciola hepatica infection. Tropical Medical Hygen, 2000
7. WHO (2006)
Report of the WHO Informal Meeting on use of triclabendazole in fascioliasis control. World Health Organization headquater, Geneva, Switzerrland, 17-18 October, 2006.
THERAPEUTIC EFFICACY OF TRICLABENDAZOLE IN FASCIOLOPSIS TREATMENT AT THE CLINIC OF IMPE QUY NHON
Nguyen Van Chuong, Trieu Nguyen Trung, Nguyen Xuan Thien, and Nguyen Van Kha
Abstract
Therapeutic efficacy of triclabendazole in treatment of Fasciolopsis was investigated.
A total of 100 patients of Fasciolosis admitted to the clinic of IMPE Quy Nhon and divided into two groups were treated with two different doses (lOmg/kg body weight and 20mg/kg body weight).
Their clinical presentation was investigated upon admission and during the treatment course. Increased right abdominal pain was found after the first day of treatment in both groups I and II (6% and 10%, respectively) but came down since the second day. Epigastric pain, ingestion disorder and fever also came down from the first dosing day onwards.
Urticaria and other allergies started to increase since the second or the third day of therapy onwards. The increase was recorded 9.52% in the group I, and 22.22% in the II. The clinical manifestation was significally reduced or disappeared after three months of drug administration
The paraclinical data were investigated. The erythrocyte counts before and after 3 months of treament in both groups were normal. The patients with increased leukocytes reduced by 61.90% in the group I and 73.91% in the group IL The patients with eosinophillia were reduced by 80% in group I and 65.62% in group II. Liver functions were investigated showing that SGOT, SGPT and bilirubin did not changed significantly in both groups before and 3 months after treatment
Side effects of the patients in both groups were followed up. Increased lower abdominal pain, tiredness, dizziness, headache, nausea, anaphylactic itching were found higher in the group I compared to that of the group IL These side effects were light and disappeared automatically at day 1 or II without any medical intervention.
Triclabendazole of single dose of lOmg/kg body weight/24hours and 20mg/kg of body weight in 2 times (4-6 hours intervals) showed the equivalent therapeutic efficacy with similar clinical and para-clinical presentation. However, these results obtained only after 3 months of treatment need further studies.
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