J'
Nghien curu tinh an toan, ket qua dieu trj roi loan chuyen hoa Lipid mau
cua bai thuoc HSN tren lam sang
STUDYON THE SAFETY AND THE EFFECTS OF HSN REMEDY ON DYSLIPIDEMIA ADJUSTMENT IN CLINICAL
Tran Thj Hong Ngai 1 Y Duoc hoc cd truven Uiet N a m
SUMMARY
Objective: To evaluate the HSN treatment results of dyslipidemia tn clinical setting.
Research methods: The open-clinical trial compared with controlled group has been. There has been a comparision before and after treatment.performed. The study sample consisted oflSOpattents divided into three groups, 50 patients in each group will use remedy in 30 successive days and the effects ofdrughave been evaluated after 30 day treatment through the indicators of weight, body mass index (BMI), blood pressure, complete blood count, lipidemia (TC, TG, HDL-C, LDL-C) glucose, urea, creatinine, uric acid, AST and ALT.
The results and conclusions: After 30 days of treatment, the dyslipidemia have been adjusted by the HSN at the dose of 100 ml/day. The changes of indicators have showed that: reduction in TC (l 6%), reduction in TG (24.6%), reduction in LDL-C (16.5%), reduction in HDL-C (7.3%), reduction m TC/HDL-C (19.6%) and reduction in LDL-C/HDL-C (l8.0%). In terms of modem medicine, the effectiveness of dyslipidemia treatment with HSN has showed that excellent results (58%), good (26%), ineffective (lO%) and bad effects (6%). In terms of traditional medicine, the effectiveness of the HSN has showed significantly in patients with phlegm-stasis syndrome (88.2%), better than in the patients with spleen-kidney yangdefldency and liver-kidney yin deficiency patients. After 30 days of treatment with, the HSN, there haven't been any clinical and subclinical side effects such as changes in blood function, liver function, and kidney function in patients with dyslipidemia.
Keywords: Dyslipidemia, HSN remedy, clinical setting.
Ngay nhan bai 7/1/2019 Ngayphdnbien 10/1/2019 Ngay chap nhan dang 10/1/2019
TAP CHI Y DUOC CO TRUYEN VI|T NAM k<»i»Maiill:kii.J3B |103
BAI NGHIEN c d u
DAT VANDE
Cung vdi sii phat trien cua eac Urih viic ddi sdng xa hpi, md hinh benh tat cung thay dpi. Xa hgi hien dai ngdy eang phdt triin, ti le mac cac binh chuyen hda ngay cang gia tang. Rdi loan chuyen hda Upid la danh td dung dl milu td mdt hdi chdng benh man tinh difdc dac tnmg bdi sii thay ddi cdc chi sd Upid trong mdu. Khi hdi chiing nay xuat hiln ddng nghia vdi vile ngtfdi benh phai gdnh chiu rdt nhieu yeu td nguy cd mac cdc benh ly nguy hiem nhtf: viia xd ddng mach, nhdi mdu cd tim... Bdi thudc HSN la mgt bai thudc diidc tad thanh bdi sii phdi ngii cua 6 vi thudc nam ed tae dung trif thdp, hda dam.
Bai thude da dtfdc cde thay thudc y hgc cd truyen sii dung trong cdc tnfdng hdp tang huylt dp, tdng Upid mdu, beo blu; bifdc dau da dat diidc nhieu tdc dung trin lam sang. Tuy nhien, bai thudc HSN chda diidc nghien cdu ddy du vl tinh an toan va hieu qua dieu tri rdi loan Upid mau tren ldm sdng.
Chinh vi vay, ehung tdi tien hdnh de tai "Nghien eiiu tinh an toan, kit qua dilu tri rdi loan chuyin hda Upid mau cua bai thudc HSN trin lam sang "
vdi hai muc tilu:
- Danh gid kit qua dilu tri rdi loan chuyen hda Upid mau ciia bai thudc HSN tren lam sdng.
- Danh gid dtfdc tac dung khdng mdng mudn cua Cao long HSN tren Iam sang
Ddi TUDNG, PHUONG PHAP NGHIEN CUU
Doi tiidng nghien cita
Nghien cdu gdm 150 benh nhan, cdc BN deu dddc ldm benh dn, khai thdc ky tien sd, benh sd, kham Idm sang toan dien va thiic hien cac xet nghiem vd chia lam 3 nhdm:
Nh6m 1; Dung HSN 100ml/ ngay dung 1 lan, sau an, trong 30 ngay
Nhdm 2: Dung Fenofibrat 200mg, dung 1 lan, sau an, trong 30 ngay
Nhdm 3: Nhdm phdi hcfp: Dung Fenofibrat 200mg, 1 viln/ngay kit hdp vdi HSN 100ml/ngay, trdng 30 ngdy
Phiidng phap nghiin ciiu
Nghiin ciiu dtfdc thilt kl theo md hinh thif nghiim ldm sang cd ddi chdng (so sdnh tnfdc va sau dieu tri, so sanh giiJa ba nhdm nghiin cdu).
Cac chi sd nghiin ciiu
- Cdc dac dilm chung cua benh nhan NC: Tin, tudi, gidi, nghe nghi|p.
- Cdc chi tilu ldm sang: tiln hanh kham tai thdi diem tnfdc dieu tri (DO), sau dilu tri 30 ngay ( D 3 0 ) : Chieu eao, can niing, chi sd khdi cd the, huyet dp.
- Cdc chi tilu caji ldm sang: Benh nhan ddcjfc lay mau tinh mach vao buoi sang khi chifa an va cdch biia an hdm trddc it nhdt Id 12 gid. Trong do:
-I- Cdc chi sd huyet hgc: Hong cdu, bach cau, tilu can, hemoglobin.
-I- Cac ehi sd sinh hda: Ure, creatimn, AST, ALT, glucose, Cholesterol, triglycerid, HDL-C, LDL-C.
- Cdc chi tieu theo YHCT: Benh nhdn cd trieu chdng ciia chdng dam thap: the dam thap; the can than am hd; the ty than dddng hd.
- Cdc tdc dung khdng mong mu6n tren Iam sang: Met mdi, dau ed, man ngiia, khd tieu, tilu chay....
Xii lysd lilu
Sd Ueu difde nhap va xd ly bang phddng phdp va thudt tddn thdng kl y sinh hgc tren phan mIm Micrdsoft dtfice Excel, SPSS 20.0. S6 Ulu dddc bleu dien difdi d ^ g X ± SD. Kiem dinh cdc gid tri bang t-test Student hoac test tnfdc-sau (Avant - Apres).
Sii khac biet cd y nghia thdng kl khi p < 0.05.
KET QUA NGHIEN CUU
1041 TAP CHI Y DUOC C 6 TRUYtN VIET NAM
J-
g i. Su thay dot Cholesterol vd Triglycerid cda binh nhdn sau diiu tri
\ Nhom
T h t l i X diem \
TC
TG D ,
D »
P D,
D,„
P
Cao long HSN (ii=50) ( X ± S D ) (minol/l) 6,08±0,82
5,07±0,S4 Mijrc giani(%)
i l 6 , 6 %
PD.IO<0,OOI 2,97±1,2S
2,24±0,96 4-24,6%
P..,.<0,01
Fibrat (n=50) (X + SD) (mm„l/I) 5,88±0,76
5,02±0,96 Mile gidm(%)
i l 4 , 6 %
PHO < 0,001 3,31±1,30
2,38±1,05 ^28,1%
P „ < 0 , 0 0 1
Phoi hop (n=50) (X±SD) (mmol/I) 6,15+0,92
5,13+0,95 Miic giain(%)
4-16,5%
P „ < 0 , 0 0 1 3,28±1,43
2,41+1,02 ^26,5%
P„o< 0,001
P
P,.,>0,OS Pi-i> 0,05 Pu>0,OS
P,.,>0,05 Pi-,>0,05 Pi-3>0,05
Nhgnxet: Tif bdng 1, nhdn thdy kegidacdenh6mvdip>0,05.
- Sau 30 ngay dieu tri, ca 3 nhdm NC deu Iam - Sau 30 ngay dieu tri, ca 3 nhdm NC deu Iam giam rd ret ndng dp TC so vdi trddc dilu tri, sii khde gidm rd rit ndng dd TG so vdi trddc dilu tri. Nhdm bilt la CO y nghia thdng kl vdi p < 0,001. Trong dd, Fibrat lam gidm 28,1% so vdi 26,5% d nhom phdi nhdm HSN ldm gidm TC nhilu nhdt vdi 16,6% va hdp va 24,6% d nhdm HSN. Tuy nhiin sif khac biet 16,5% d nhdm phdi hdp va 14,6% nhdm phoi hdp. Id khdng cd y nghia thdng kl khi gida cdc nhdm vdi Tuy nhiin, sii khde bilt Id khdng cd y nghia thdng p > 0,05.
Bdng 2. Su thay ddi HDL-C, LDL-C cua benh nhdn sau diiu tri
\ Nhom Th6i \ di^m \
HDL-C Do
D ,
Cao long HSN (n-SO) ( X ± S D ) (mmol/l) 1,23±0,35
1,32+0,44
% thay ddi
t 7 , 3 %
Pooo>0,OS
Fibrat (n=50) (X±SD) (mmol/I) 1,I4±0,25
1,19+0,31
% thay doi
4,3%
P. JO > 0,05
Phdi hop (n=SO) (X + SD) (mmoI/l) 1,27±0,27
1,37+0,65
% thay doi
t 7,9%
PHO > 0,05
P
Pi-2>0,05 Pj,>0,05 Pu>0,05
TAP CHiY DUOC CO TRUYEN VIET NAM BSE
BAI NGHIEN c d u ^'
LDL-C
D„
D j , 3,64+0,98
3,04±0,85 4l6,S%
Pojo< 0,001
3,33+0,99
2,82+0,84 4-15,3%
Po-jo<0,01
3,50±I,14
2,89±0,87 4l7,4%
Po»<0,01
P,j>0,OS P2-j>0,0S P,j>0,05
Nhdn xit:
- T d ket q u a bdng 2 n h a n thay; sau 3 0 ngay d i l u tri, n d n g d p H D L - C d n h d m u d n g cao Idng H S N va p h d i h d p cd xu hifdng tang l l n vdi 7,3% d n h d m H S N va 7,9% d n h d m p h d i h d p . CJ n h d m Fibrat n o n g d o H D L - C t r u n g b i n h d t h d i d i e m sau 3 0 ngay la cd xu h d d n g thay ddi k h o n g d a n g ke. Tuy n h i i n stf khde b i l t giiia cac n h d m la
k h d n g cd y nghia t h d n g k l vdi p > 0,05.
- N d n g dp L D L - C d cd 3 n h d m deu cd xu h d d n g gidm, sii thay ddi la cd y nghia thdng k l sau 30 ngay dieu tri. Trong do, n h d m phdi hcfp gidm c h i l m t y 11 cao nhat vdi 17,4%, t i l p d e n la nhdm H S N 16,5% va n h o m Fibrat la 15,3%. Tuy nhien sd khde biet gida 3 n h d m la k h d n g cd y nghia th6ng k&
vdi p > 0,05.
Tot Klii Klionghi^u qua
• Ph6ih(?p •Fibrat • Cao long HSN Biiu dd 1. Kit qua diiu tri rdi hgn lipid mdu theo tiiu chudn YHHD
Nh4n xit: T d b i l u d o 1 trong khi dd, k h d n g h i l u qud la 24%
- Sau 3 0 ngay d u n g thudc, n h d m cao long H S N - Sau 30 ngay d u n g thudc, n h d m sd d u n g thudc cho k i t qua d i l u tri tdt la 58%, kha la 26%, k h d n g p h d i h d p cho k i t qua d i l u tri lan Iddt n h d sau: Tdt h i l u q u a l a l 6 % ( 4 8 % ) , khd ( 2 2 % ) , k h d n g h i l u qud ( 3 0 % ) . Tuy - Sau 30 ngdy dung thudc, n h d m Fibrat chd k i t n h i i n , khdng c6 sii khde b i l t cd y nghia t h d n g k l d qua dieu tri tdt va khd lan Iddt la 56% va 20,0%; ca 3 n h d m vdi p > 0,05.
1061 TAP CHI Y DUpc CO TRUYEN VIET NAM L-l»l>MJillilAlill1
• J
Khong hieu qua
• Cao long HSN Biiu do 2. Kit qud dHu trt rdi loan lipid mdu theo tieu chudn YHCT
Nhgn xet: 16%. Ket qua nay tdt hdn ket qua nhdm sd dung Td bieu dd 2 nh|n thdy; sau 30 ngay dieu tri Fibrat va nhdm phdi hc*p. Trong do, nhdm Fibrat chdng tdi nhan thay d nhdm benh nhdn sd dung 30% benh nhan dat kit qua tdt, 42% benh nhan dat cao long HSN, benh nhan d^t hieu qua tdt la 38% ket qua khd va ty le nay d nhdm phdi hdp la 32%
vd 46% dat hilu qua khd, khdng dat hilu qud chilm tdt, 48% khd, 20,0% khdng hilu qud.
t. Thay dd'i mdt sd chi sd huyit hgc, sinh hda sau diiu tri
\ Nhdm
Chi so \ ^
Glucose (mmol/l)
Ure (oimoI/1)
Creatinin (pnol/l)
Caol6ngHSN(n=50) ( X + SD) D, 5,86+0,75
D j ,
S,95±l,12 Po-,>0,OS 5,22+1,34 S,45±l,07
PHO > 0,05 74,0±13,65 76,68+11,96
P„o>0,05
Fibrat (n=SO)
(X±SD) D, 6,26+1,52
D„
6,16+1,35 Po3o>0,OS 5,S6±1,11 5,52+1,40
Po»>0,05 78,88±14,12 78,5+14,83
Po»>0,OS
Phdi hop (n=50) (X±SD) D , 6,08+1,22
D,o 6,21±1,26 Po-io>0,05 5,49±1,4 5,66+1,26
P,i.>0,OS 75,86±13,82 75,74± 13,57
PHO > 0,05
TAP CHI Y DUOC C6 TBUYtN VtT NAM UihlMJl»*lilll 107
BAI NGHIEN cdu
Acid Uric (mmo!/l)
AST (U/L)
ALT (U/L)
SL hong cau (T/l)
Hemoglobin (g/i)
So liidng bach cau(G/l)
Soliiongtieu cau (G/I)
372,2+87,0 358,3+89,5 Po-jo>0,05 28,28+8,65 26,78+5,99
Po-j.>0,05 28,53±17,11 25,9+7,93
Po-«>0,OS 4,12+0,32 4,21±0,28
PHO > 0,05 125,43
±14,21 124,12
±12,26 Pojo>0,05 6,23+1,23 6,34±1,31
Po-jD>0,05 246,12
±43,21 223,11
±45,28 PHO > 0,05
379,5±86,9 354,6±101,1 PHO > 0,05 32,3± 12,36 31,18±10,84
Po.jo>0,05 33,0±19,84 30,94+16,14
Po,o>0,05 4,33±0,41 4,52+0,22
Po-3o>0,05 123,25
±14,11
126,43 +11,65 Poio>0,05 6,73±1,23 6,84+1,62
P«jo>0,05 251,32
±32,61
248,32 +40,21 Po.3D>0,05
346,24+97,6 337,68+99,3 Po-»>0,05 28,84+9,22 29,8±11,21
PHO > 0,05 24,6±9,39 28,2+14,98
PHO > 0,05 4,45±0,62 4,42+0,46
Po-3D>0,05 121,41
±15,15
123,43
±14,29 PHO > 0,05 6,49±1,72 6,53+1,13
Po-io>0,05 240,19
±42,65 246,52 +45,76 Pojo>0,OS
Nhgn xit: - Sau 30 ngay sd dung thude, tdt cd cdc chi sd bda - Sau 30 ngay dieu tri, eac chi sd huyet hpc sinh glucose, ure, creatinin, acid uric, ALT, AST cd khdng cd sd thay ddi sau khi dilu tri, stf thay ddi biln ddi tnfdc vd sau khi dieu tri. Tuy nhiin, gia tri khdng CO y nghia thdng ke vdi p > 0,05. cdc chi sd vSn nam trong gidi ban binh thddng.
Bdng 4. Mdt sd tdc dgng khdng mong mudn
Trieu ehiilng
Met moi Dau CO
Cao long HSN (n=50) SdBN
1 0
Tyle(%) 2%
0%
Fibrat (n=50) SdBN
2 1
Tyl6(%) 4%
2%
Phdi hop (n-SO) SdBN
1 1
Tyle(%) 2%
2%
Tdngsd (n=150) SdBN
4 2
Tyl«(%) 2,67%
1,33%
1081 TAP CH(Y DUOC CO TRUY£N VIIT NAM
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Man ngda Kho tieu
la chay Tao bon
0 2 1 0
0%
4%
2%
0%
0 1 0 0
0%
2%
0%
0%
0 1 1 0
0%
2%
2%
0%
0 4 2 0
0% 2,67%
1,33%
0%
Nhdn xit: Td bang 4, nhdn thdy trong qua trinh dilu tri, cd 3 benh nhdn d nhom cao long HSN cd bieu hiln rdi l o ^ tieu hoa chilm 6% va 1 benh nhan c6 bilu hiln mlt mdi chiem ty ll 2%. Cdc trilu chttog d miic dp nhe vd tii khdi sau vai ngay md khdng cdn dilu tri. U 2 nhom Fibrat vd nhdm phdi hdp mdi nhdm cd 4 benh nhdn xudt hiln cac tdc dung phu nhtf: mlt moi, dau ed, kho tilu, ia chay. Tuy ngoai ra chung tdi chda nhdn thdy cdc tac dung khdng mong mudn khde tren ldm sang.
BAN LUAN
Theo YHHD: Rdi loan hpid mau dddc coi la mdt nguy cd quan trpng chd sii hinh thanh, phat trien cua benh xd viia dgng manh. Vifa xd ddng mach da gay ra nhilu biln chdng nghiem trgng de dga din tinh mang con ngifdi: benh mach vdnh, nhdi mau cd tim, tai biln mach mau nao.... Vi thi, viec lam gidm cdc chi sd hpid trong mdu ed tdc diing lam giam ty le mac ciing nhd giam ty ll td vong eho cdc benh nhdn.
Kit qud ng^en ciiu cho thdy: Cao long HSN c6 hilu life dieu chinh hpid mdu d nhiing benh nhdn cd hdi ehiing RLLPM. Thude dddc ddng diidi dang thudc sde, ddng tui, vdi hlu Iddng 100ml/
ngay trong 30 ngdy bin tuc cho ket qua nhd sau:
* Ndng do Cholesterol:
Sau 30 ngay dilu trj, ca 3 nhdm NC deu lam giam rd ret ndng do TC so vdi trifdc dilu tri vdi p < 0,001. Trong dd, nhdm HSN lam gidm TC
nhilu nhdt vdi 16,6% vd 16,5% d nhdm phdi hdp va 14,6% nhdm phdi hg'p. Mgt sd nghiin eiiu trin the gidi da chi ra rang, TC mdu cao la mgt trong eae nguyin nhdn ddn den tinh trang xd vda dpng majih va benh mach vanh.... Vi the, giam dtfdc ndng dd TC mdu la gidm nguy cd ddn tdi cdc benh nlu trin. Theo nghiin edu LRC (Lipid Research CHnic Coronary Primary Prevention Trial, 1984) trin 3806 nam gidi theo ddi trong 7 - 1 0 nam da eho thdy: Nlu gidm dilde 1% Cholesterol thi gidm dddc 2% nguy ed benh manh vanh; neu gidm dtfdc 20,0% cholesterol thi gidm dddc 40,0%; va vdi cholesterol > l,8g/l thi cd tang 0,lg/l thi se tdng 5% td vong chung va 9% nguy cd td vong do tim mach. So sanh ket qua vdi mpt sd cac nghien cdu khde, chiing tdi nhdn thdy tdc dung gidm cholesterol toan phan cua eao long HSN la tifdng dddng so vdi viln ha md NK cua Tnidng Qudc Chinh (2014) va bai thude "Tilu thiic hanh kbi trd thap thang" cua Nguyen Vinh Thanh (2016
* Ndng dd tnglycend:
Theo khuyen cao cua Hdi Tim mach hge Viet Nam 2015 chi ra: Mgt trong cac nguy cd cad tren ldm sang la khi TG tdng qud eao cd thi gdy vilm tuy cap. TG cao ehilm tdi 10% trong cac nguyin nhdn gay vilm tuy, dde bilt khi TG tang eao tren 10 mmoI/1 (880mg/dl). Nhilu trddng hdp xdy ra vilm tyy ngay ea khi TG chi 5-10 mmdl/1 (440- 880mg/dl).Vi thi, dilu tri hg triglycerid cung la mdt trong nhdng muc tilu quan trpng trong dilu
TAP CHlY DUgC C 6 TRUYEN VIET NAM ^ ! 1109
BAl NGHIEN CLTU •
tri rdi loan hpid mdu.
Sau 30 ngay dieu tri, cd 3 nhdm NC diu lam giam rd rit ndng dp TG so vdi trddc dilu tri; sii khde biet la cd y nghia thdng kl khi p<0,01. Trong do, nhdm Fibrat lam gidm 28,1% so vdi 26,5% d nhdm phdi hgp va 24,6% d nh6m HSN. Tuy nhien sii khde bilt Id khdng co y nghia thong ke vdi p >
0,05 d ca 3 nhdm.
So sdnh vdi mot so kit qua nghiin edu, chung tdi nh^n thay eao Idng HSN ed hilu qua lam giam TG tddng dddng vdi cao Idng Dai An eiia Ta Thu Thuy (2016) vd HSN cd tac dung gidm TG tdt hdn so vdi nghiin eilu cua Ly Thi Lan Hddng(2013) vdi bai thudc "Trif dam tilu thdp thang"
* Ndng do HDL-C:
Sau 30 ngay dilu tri, nhdm udng cao Idng HSN va phdi hdp cd xu hddng tang len vdi 7,3% d nhdm HSN vd 7,9% d nhdm phdi hdp. 0 nhdm Fibrat nong do HDL-C trung binh d thdi dilm sau 30 ngay la cd xu hddng thay ddi khdng dang ke. Tuy nhiin sii khde bilt gida cde nhdm Id khdng cd y nghia thdng kl vdi p > 0,05.
HDL-C la mdt lipid cd tdc dung loai trif Cholesterol thda, va dgn dep mang xd vfla. Cho nin HDL-C cdn dddc gpi la "Cholesterol tdt cho cd thi" vd ddng vai trd quan trgng trong viec ngan ngda va phdng chdng VXDM. Vi thi, vile lam tang nong dp HDL-C chdng td vile chuyen hda trong ed thi tot va sii dao thai tdt Iddng Chdlesterol dtf thda gdp phdn Idm giam ty le mac cde benh VXDM.
* Ndng dp LDL-C:
Theo khuyin cao cua Hdi Tim mach hgc Viet Nam 2015 LDL-C dtfdc khuyin cao nhd mue tilu thd nhat de dieu tri. Cholesterol dddc xem Id muc tieu dilu tri nlu cac chi sd xet nghiem lipid khac khong cd san vd Non HDL-C nen difdc xem la mgt muc tieu thd hai trong dilu tri rdi loan lipid mdu.
Theo bang nghien cdu nhan thay sau 30 ngay
dieu tri, ndng dd LDL-C d ea 3 nhdm deu cd xu hddng gidm. Sd thay ddi la cd y nghia thdng kl (p< 0,01) vdi giam 16,5% d nhom eao Idng HSN so vdi 15,3% va 17,4% d 2 nhdm Fibrat vd nhdm phdi hdp. Sd khac bilt gida 3 nhdm nghiin cdu la khdng cd y nghia thdng ke sau 30 ngay dieu tri vdi p > 0,05. Ket qua ndy cao hcfn so vdi nghiin cdu "Cdm GCL" cua Vu Viet Hang giam 10,49%
LDL-C va "Thudc TMPl" cua Le Thi En (2010) gidm 11,49% LDL-C sau khi dilu tn.
Hieu qua dieu tri rdi loan lipid mau cua cao long HSN theo tieu chujb cua YHHD
Theo kit qua nghiin oiu, bilu dd 1 sau 30 ngay dilu tri Cao Idng HSN, dda theo tieu chuan ddnh gia hieu qua cua YHHD, chiing tdi nhan thay cd 29 benh nhdn dat kit qud tdt; ehilm ty 11 58% va 13 benh nhdn dat ket qua kha, chiem 26%. Nhii vij, sau 30 ngay, cao long HSN cho 84% binh nhdn dat kit qud dilu tri tdt vd khd. Kit qud nay cao hdn so vdi nhdm sd dung Fibrat la 76% va nhdm phdi hc^
thudc la 70% sd benh nhan dat kit qua tdt va kha.
Tuy nhien, sd khac biet gifla cac nhdm la khdng cd y nghia thdng kl.
Ngoai ra, vol nhijlig benh nhan tang TG ddn thuan (phan do theo De Gennes), thi nhiing binh nhdn d nhom eao long HSN cho hilu qud dieu tn tot vd khd lln tdi 90,4%, tdng TC ddn thuan hieu qud tdt va khd la 91%. NhdvEiy, cao long HSN co the sfl dung rat tdt cho nhiing benh nhdn tang TG ddn thuan, tang cholesterol hoac tang lipid mau hdn hdp.
Hilu qua dilu tri rdi loan Upid mau cua cao Idng HSN theo tieu chuan cua YHCT
Theo kit qud nghien cdu, bieu do 2 sau 30 ngay dilu tri Cao Idng HSN, diia theo tilu chuan danh gid hieu qud cua YHCT, chiing tdi nhdn thay co 19 benh nhan dat hilu qua tdtj chiem 38% vd 23 benh nhdn dat hilu qud khd, ehilm 46% va 8 benh
1101 TAP CHfY DUOC C 6 TRUYfiN VIET NAM
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nhan khdng dat hilu qud chilm 16%. Kit qua nay tdt hdn ket qua nhdm sfl dung Fibrat vdi 30% benh nhan dat ket qud tdt, 42% benh nhan dat kit qud kha. Ddi vdi nhflng benh nhan cd tang huylt dp, thi sau 30 ngay sd dung cao Idng HSN, ehiing tdi nhdn thay ed 13/17 benh nhan dat kit qua dilu tri tdt vd khd; chilm ty II 81,3% va 18,7% binh nhan khdng dat hieu qud.
Nhfl vay, so vdi cd 3 nhdm thudc nghiin cflu thi nhdm thudc sfl dung ddn ddc HSN cd flu thi hdn trong viec dilu tri cung nhfl Iam giam cde tneu chflng cd nang tren benh nhan cd chdng dam thap:
dau dau, dn kem, hoa mdt, chdng mat... cung nhd ed tac dung tdt cho cdc benh nhan cd tdng huylt ap kem theo rdi loan Upid mdu. Qua do cho thay, bai thude HSN vdi sd phdi ngu cua 6 vi thudc Nam eo tdc dung cung nhfl hd trd trong vile dilu tri va cho hieu qua tdt.
Tac dung khdng mong mudn ciia cao long HSN De ddnh gid tdc dung khdng mong mudn cda cao long HSN, chung tdi tiln hanh theo ddi stf xudt hiln cua mdt sd trilu chflng khdng mong mudn trin lam sang cung nhd mdt sd tdc dung khdng mong mudn trin can lam sang.
Vi ldm sdng
Tflbang 4 nhdn thay, trong qua trinh die'u tn, cd 3 benh nhan d nhdm cao Idng HSN cd bieu hien rdi loan tilu hda chiem 6% va 1 benh nhdn co bilu hien met mdi ehilm ty 11 2%. Cde tneu chdng d mfle dp nhe vd ttf khdi sau vai ngdy ma khdng can dieu tri. O 2 nhdm Fibrat va nhdm phdi hdp mdi nhdm cd 4 benh nhan xuat hiln cdc tdc dung phu nhfl: met mdi, dau cd, khd tieu, ia chay. Ngoai ra chiing tdi chda nhan thay cac tac dung khong mong mudn khac trin ldm sang.
Vicgnldmsdng
Theo bdng kit qua bang 3 dl danh gia tac dung khdng mong mudn cua cao Idng HSN trin can lam
sang, chflng tdi da tien hanh lam cac xet nghiim ddnh gid ehfle nang nhfl edng thflc mau (chi so hdng cau, bach eau, tilu cdu vd hemoglobin) ciing nhd eac xet nghiem ve Glusdse, Ure, Creatinin, AST, ALT. Sau 30 ngdy dimg eao long HSN, chflng t6i nhan thay khdng cd sd thay ddi nhilu vl cdc chi sd trin, Sd khac bilt la khdng c6 y nghia thdng kl vdi p > 0,05 ddi vdi tdt cd cdc cbi sd.
Tuy nbiln, ddy la nhiing trieu chflng chu quan cua ngfldi benh va la nhdng trilu ehdng ed thi bi anh hfldng bdi ehi do an cflng nhfl che do luyen tap, cd dia va hoan canh td nhiin; vi thi can ed nhflng nghien cflu vdi ed mdu Idn de khdo sat dfldc ddy du va toan diln nhtfng trieu chdng khdng mong mudn cua thudc.
KETLUAN
- Sau 30 ngay dung thudc cao long HSN lieu lOOml/ngay cd tdc dung dilu chinh rdi loan Hpid mdu 6 nhflngbenhnhan RLLPM: giam 16,6% TC, gidm 24,6% TG, giam 16,5% LDL-C, tdng 7,3%
HDL-C, gidml9,6% TC/HDL-C va giam 18,0%
LDL-C/HDL-C.
- Hilu qua dieu tri RLLPM cua eao long HSN tiheo tilu chuan YHHD: dat kit qua tdt 58%, khd Id 26%, kh6ng hilu qua la 10% va hilu qud xau la 6%.
- Hieu qud dilu tri eua eao long HSN theo thi binh eua YHCT, nhom sd dung eao long HSN cho ty le benh nhdn dat hilu qud tdt va kha d thi benh Ddm trgc fl tre tot hdn d thi binh Ty than dfldng hd vd Can than dm hfl. Trong do, nhdm sd dung cao long HSN dat hieu qud tdt vd khd chiem 88,2%
d thi benh Dam trgc fl tre
- Sau 30 ngdy sd dung thudc, cao Idng HSN khdng gay cac tae dung phu trin lam sang cung nhfl can lam sang: nhfl thay ddi chdc nang he thdng tao mau, chdc nang gan, than d cac benh nhan rdi loan chuyin hda Hpid mdu.
TAP CHI Y DUOC CO TRUYEN VIET NAM ^
BAI NGHIEN CdU •
tri rdi loan Hpid mdu.
Sau 30 ngdy dieu tri, cd 3 nhdm NC diu lam giam ro r|t ndng do TG so vdi tnidc dilu tri; sfl khac bilt la ed y nghia thdng kl khi p<0,01. Trong do, nhdm Fibrat lam gidm 28,1% so vdi 26,5% d nhdm phoi hdp vd 24,6% d nhom HSN. Tuy nhiin sfl khac biet la khdng ed y nghia thdng kl vdi p >
0,05 d ed 3 nhdm.
So sanh vdi mgt sd kit qud ngbien cflu, ehung tdi nhdn thdy cao Idng HSN co hieu qua ldm gidm TG tfldng dfldng vdi cao Idng Dai An cfla Ta Thu Thuy (2016) va HSN c6 tdc dung gidm TG tdt hdn so vdi nghiin cflu cua Ly Thi Lan Hfldng(2013) vdi bdi thuoc "Trd ddm tilu thap thang"
* Ndng dp HDL-C:
Sau 30 ngay dieu tri, nh6m udng cao long HSN vd phdi hdp cd xu hddng tang len vdi 7,3% d nhdm HSN vd 7,9% d nhdm phdi hc^. 0 nhdm Fibrat ndng do HDL-C trung binh d thdi diem sau 30 ngay la cd xu hfldng thay ddi khdng ddng ke. Tuy nhiin sii khde bilt gifla cae nhdm Id khdng cd y nghia thdng kl vdi p > 0,05.
HDL-C Id mdt lipid cd tdc dung loai trfl Cholesterol thfla, va dgn dep mang xd vfla. Cho nen HDL-C cdn dddc gpi Id "Cholesterol tdt cho cd the" vd ddng vai trd quan trgng trong viec ngdn ngfla vd phdng ehdng VXDM. Vi thi, vile lam tang ndng dp HDL-C chdng td vile chuyen hda trong cd thi tdt va sfl dao thai tdt Ifldng Cholesterol dd thda gdp phdn Iam gidm ty 11 mac cdc benh VXDM.
* Ndng do LDL-C:
Theo khuyin cdo cua Hdi Tun mach hpc Viet Nam 2015 LDL-C dddc khuyen cdo nhfl muc tilu thd nhdt dl dilu tri. Cholesterol dddc xem la mue tieu dieu bri nlu cde chi sd xit nghiem hpid khde khdng c6 san va Non HDL-C nin dfldc xem la mdt mue tieu thfl hai trong dieu tri rdi loan lipid mau.
Theo bang nghien cflu nhdn thay sau 30 ngdy
dilu tri, nong do LDL-C d ca 3 nhdm diu cd xu hfldng giam. Sd thay ddi la ed y nghia th6ng ke (p < 0,01) vdi giam 16,5% d nhdm cao long HSN so vdi 15,3% va 17,4% cf 2 nhdm Fibrat va nhdm phdi hpp. Sfl khac biet gifla 3 nhdm nghiin cflu la khdng cd y nghia thdng kl sau 30 ngay dieu tri vdi p > 0,05. Ket qud ndy cao hdn so vdi nghien cflu "Cdm GCL" cua Vu Viet Hang giam 10,49%
LDL-C va "Thudc TMPl" cua Ll Thi En (2010) gidm 11,49% LDL-C sau khi dilu tri.
Hieu qua dieu tri rdi l o ^ lipid mau cua cao Idng HSN theo tieu chuan cua YHHD
Theo ket qua nghiin cflu, bieu do 1 sau 30 ngay dilu tri Cao Idng HSN, dfla theo tilu chuan danh gid hilu qua cua YHHD, chung tdi nhdn thdy cd 29 binh nhdn dat kit qud tdt; chiem ty le 58% va 13 b|nh nhan dat kit qua khd, chilm 26%. Nhfl vay, sau 30 ngdy, cao Idng HSN eho 84% benh nhan dat kit qud dilu tn tdt va kha. Kit qua nay cao hdn so vdi nhdm sd dung Fibrat Id 76% vd nhdm phdi hdp thudc la 70% sd benh nhan dgt ket qua tdt va kha.
Tuy nhiin, sd khde bilt gifla cdc nhdm la khdng co ynghia thdngke.
Ngoai ra, vdi nhiing benh nhan tang TG ddn thuan (phan dp theo De Geimes), thi nhflng benh nhdn d nhdm cao long HSN cho hilu qua dilu tri tdt vd khd len tdi 90,4%, tang TC ddn thuan hilu qua tdt va kha la 91%. Nhfl vdy, eao Idng HSN co the sfl dung rat tdt cho nhflng binh nhan tang TG ddn thuan, tang cholesterol ho|c tang hpid radu hdn hdp.
Hieu qud dilu tri rdi loan lipid mdu ciia cao Idng HSN theo tieu chuSn cua YHCT
Theo kit qua nghien cflu, bilu dd 2 sau 30 ngdy dilu tri Cao Idng HSN, dfla theo tilu chuan danh gia hilu qua cua YHCT, chflng tdi nhdn thay cd 19 benh nhdn dat hilu qua tdt; chilm 38% va 23 benh nhan dat hieu qud khd, ehilm 46% vd 8 binh
1101 TAP CHIY DUOC C 6 TRUY6N VIET NAM 0 3 3
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nhan khdng dat hilu qua chilm 16%. Kit qud nay tdt hdn kit qua nhom sd dung Fibrat vdi 30% benh nhan dat kit qud tdt, 42% binh nhdn dat kit qua khd. Ddi vdi nhiing benh nhan cd tang huylt dp, thi sau 30 ngay sfl dung cao long HSN, chflng tdi nhdn thay cd 13/17 benh nhan dat kit qud dilu tri tdt va khd; ehilm tyle 81,3% va 18,7% benh nhan kh6ng dat hieu qua.
Nhfl vdy, so vdi ca 3 nhdm thudc nghiin eflu thi nhdm thude sfl dung ddn dpc HSN cd flu thi hdn trong viec dieu tri cung nhd lam gidm cac tneu chflng ed ndng tren benh nhan cd chflng dam thap:
daudau, an kem, hoa mat, chdng mat... cung nhfl cd tac dung tot cho cdc benh nhan cd tang huyet ap kem theo rdi loan Hpid mdu. Qua dd cho thay, bdi thudc HSN vdi sfl phdi ngfl cua 6 vi thuoc Nam cd tae dung cung nhfl hd trd trdng vile dieu tri va chd hieu qua tdt.
Tac dung khdng mong mudn cua cao long HSN Dl danh gia tac dung khdng mong mudn cua cao Idng HSN, chiing tdi tiln hdnh theo doi sfl xuat hiln cua mdt so trilu chflng khdng mong mudn trin Iam sang ciing nhfl mdt sd tac dung khdng mong mudn tren can Iam sang.
Vi ldm sdng
Tfl bdng 4 nhdn thdy, trong qud trinh dieu tri, co 3 benh nhan d nhdm cao Idng HSN co bilu hiln rdi lo2Ui tieu hda ehilm 6% va 1 benh nhan cd bieu hiln met mdi chiem ty 11 2%. Cdc trieu ehiing d mde dp nhe va tfl khdi sau vdi ngay md khdng can dilu tri. 0 2 nhdm Fibrat va nhdm phdi hdp mdi nhdm cd 4 binh nhdn xuat hien cdc tac dung phu nhfl: met mdi, dau cd, khd tilu, la chay. Ngodi ra chiing tdi chfla nhdn thay cac tac dung khdng mong mudn khae tren lam sang.
Vicgnldmsdng
Theo bdng kit qua bang 3 d l ddnh gid tdc dung khdng mong mudn cua cao Idng HSN tren can lam
sang, chung tdi da tiln hanh ldm cac xet nghiim danh gia chdc nang nhd cdng thflc mdu (chi sd hdng cdu, bach cdu, tilu cdu va hemoglobin) cung nhfl cdc xet nghiim vl Glusose, Ure, Creatinm, AST, ALT. Sau 30 ngdy dung cao Idng HSN, chung tdi nhdn thdy khdng cd sfl thay ddi nhilu ve cac chi so tren. Sfl khde bilt Id khdng cd y nghia thong ke vdi p > 0,05 ddi vdi tat ca cac chi sd.
Tuy nhiin, ddy la nhflng trilu chflng chu quan cua ngddi benh va la nhdng trieu chflng cd the bi dnh hfldng bdi ehi dd dn cung nhfl che do luyen tdP) cd dia va hoan canh tfl nhiin; vi the cln cd nhflng nghiin cdu vdi cd radu ldn de khdo sdt dfldc day du vd todn diln nhiing trilu chflng khdng mong mudn cua thudc.
KETLUAN
- Sau 30 ngay dung thudc eao Idng HSN Ulu lOOml/ngdy cd tdc dung dieu chinh rdi loan Hpid mau d nhiing benh nhdn RLLPM: gidm 16,6% TC, gidm 24,6% TG, giam 16,5% LDL-C, tang 7,3%
HDL-C, gidml9,6% TC/HDL-C va gidm 18,0%
LDL-C/HDL-C.
- Hieu qua dieu tri RLLPM eua cao long HSN theo tilu chuan YHHD: dat kit qud tdt 58%, kha la 26%, khdng hieu qua la 10% va hilu qud xdu la 6%.
- Hilu qua dieu tri cua cao Idng HSN theo the benh cfla YHCT, nhdm sd dung eao Idng HSN cho ty 11 benh nhan dat hieu qua tdt va kha d the benh Dam troc fl tre tdt hdn d the benh Ty than dfldng hfl va Can thdn dm hfl. Trong do, nhdm sd dung cao long HSN dat hilu qua tdt va kha chiem 88,2%
d thi b|nh Dam trgc fl tre
- Sau 30 ngdy sd dung thudc, cao Idng HSN khdng gdy cdc tdc dung phu tren lam sang ciing nhfl can Iam sdng: nhfl thay ddi chflc nang he thdng tao mdu, ehflc nang gan, than d cac benh nhan rdi loan chuyin hda Hpid mdu.
TAP CHI Y DUOC C b TRUYEN VIET NAM U»l»MJ:ll:lAliffil | H I
BAI NGHIEN CLTU •
TAI LIEU T H A M KHAO
1. Hoang Bao Chau (1997), Ddm dm, Ngi khoa Y hpc cd truyen, Nha xuat ban Y hpc, tr. 326-343.
2. Viln Yhoc cd truyen Qudn dpi (2002), Hpi chiing tdng lipid mdu vd binh xd vUa dgng mach, Kit hc(p dong tay y chfla mgt sd benh kho, tr. 38-45,75- 85.
3. Le Thi En (lOlO), Danh gia tdc dungdiiu tri rdi loan lipid mdu cua bdi thudc TMPl, Ludn vdn tdt nghiep BSCKE, Trfldng Dai hpc Y Ha Ngi.
4.WnnghiencufuYhocdant9cThfl0ngHai(l992),Amc/it?«g, Chfla benh bang YHCT Trung Qudc, Nhd xudt bdn Thanh Hda, tr. 41-45.
5. Nguyen Van Khiem (2016), Ddnh gio tdc dungdiiu chinh roi loan lipid ciia cao longHSNtren ldm sdng Ludn van Thac si, Hgc viln Y Dfldc hgc cd truyin Vilt Nam.
6. Bo mon Noi - Hpc viln YDiidc hoc co truyen Viet Nam (2015), "Rdi logn chuyin hda lipid mdu", Bai giang dieu tri hpc ndi khoa, Nha xuat bdn Yhgc, tr. 163-167.
7. Hpi Tim m^ch hpc Qudc gia Viet Nam (2015), "Khuyen cdo vl chan dodn vd dilu tn 2015".
8. Khoa Y hpc CO truyen - Dai hpc Y Ha N6i (2005), Bfli g(fl«g Y/ipc CO fru^'en f^p J, Nha xuat bdn Y hoc, tr. 114-117.
9. T? Thu Thuy (2016), Ddnh gid tdc dung diiu tri hgi chiing rdi logn lipid mdu cua cao longDgiAn, Luan van Tien si, Trfldng Dai hgc Y Ha Ngi.
10. Asmann G (1993), Lipid metabolism disorders and coronary heart disease, MMV medieme, Munchen, pp 57-59.
11. GlobalData (2016), EpiCast Report: Dyshpidemia-Epidemiology Forecast to 2015
12.4>*AS*W a « * (2015). + H 4> EBWK i±l mt.
Dtfgic diSn niiofc CHND Trung Hoa (2015). Nha xuat ban Khoa hoc ky thuat YDuac Tmng Qudc.
1121 TAP CHIY DUOC CO TRUYiN VIET NAM
