Journal of research in viet nam traditional medicine and pharmacy No 44 - 2015
J D A N H GIA TAC DUNG DIEU TRI HOI CHlTNG ROI L O A N LIPID M A U N G U Y E N P H A T - T H E T Y HU^ D A M THAP
CUA VIEN H C T 1
The effects of " H C T l " capsules in the treatment of primary hyperlipidemia (spleen deficiency type)
* Tang Thi Bich Thuy \ ** Nguyin Nhirp-c Kim ^ ' Benh vien YHCT Bo Cong an, ^ Trudng Dai hoc YHd Noi Tdm t3t
Danh gid tdc dung diiu tri hgi chdng rdi loan Lipid mdu nguyin phdt thi Ty hu ddm thdp ciia vien HCT L M^c tiiu: 1, Bdnh gid tdc dung diiu tri cOa viin HCT 1 lewrdi loan lipid mdu. 2. Theo doi tdc dung khdng mong mudn cua vien HCT I. Ddi tu^g vi phuang phdp nghien cuu: 60 b$nh nhdn du^c chdn dodn la rdi loan lipid mdu chia 2 nhdm theo phuang phdp ghep cdp, mdt nhdm diing vien HCT 1, mgt nhom dimg Lipanthyl li$u trinh diiu tri 60 ngdy. Ket qud: Sau 60 ngdy diiu tri vien HCT I cd tdc dung diiu chinh rdi loan lipid mdu, trong do gidm CT dat 17,2% (p<0,001), gidm TG dgt 30% (P<0,001), gidm LDL-C dat 21,5% (p<0,001) vd tdng HDL-C dgt 10% (p<0.05).
Tdc dung diiu chinh rdi loQn lipid mdu cua viin HCT 1 tuang duang vdi Lipanthyl (p>0,05).
Kit lugn: 1. Viin HCT 1 co tdc d^ng dieu chinh rdi loan lipid mdu dqt 93,3% b^nh nhdn a nhdm nghien cuu vd tuang duang vdi Lipanthyl (p>0,05). 2. Thudc khong cd tdc dungphu
Tir khoa; TSng lipid mau, HCTl, TC, TG, HDL-C, LDL-C.
Summary
THE E F F E C T S OF " H C T l " CAPSULES IN T H E T R E A T M E N T OF PRIMARY HYPERLIPIDEMIA (SPLEEN DEFICIENCY TYPE) Objective: 1. To evaluate the effects of "HCTl" capsules in the treatment of primary hyperlipidemia. 2. To follow the side effects of the capsules. Method: propective study. 60 patients with hyperlipidemia were devided into 2 groups: study group were treated by HTCl capsules and control group were given Lipanthyl for 60 days. Results before and after treatment and between the 2 groups were compared. Results: offer 60 days of treatment, the capsules had effects of regulating blood lipid level. Total cholesterol (TC), triglycerid (TG) and LDL-C level were reduced an average of 17,2%, 30% and 21,5% respectively. (p<0.001) HDL-C level increased of 10% with p<0,05 Conclusion: 1. The HCTl capsules had effects in the treatment of primary hyperlipidemia, The overall clinical efficiency reached 93,3% which is equivalent to the result in control group.
2 There were no case with side effects.
Keywords: hyperlipidemia, HCTl, TC, TG, HDI^C, LDL-C.
Dja cbi lien hg: Nguyen Nhuoc Kim - Tmong Dai hoc Y HN NgJiy nhSn bfii: 16/01/2015 Dja chi email: [email protected] Ngay phan bifn: 08/02/2015 Phan bi?n khoa h9c: PGS.TS. Trin Qu6c Binh Ngay dang bao: 25/3/2015
*ThS.BS;** PGS.TS
56
NghUn cau YDHCT Viet Nam Si 44.2015 LDATVANDE
Nguoi ta nhan thiy trong cac yeu t6 nguy CO dan den benh tim mach thi rfii loan lipid mau. (RLLPM) dupe coi la mpt y£u to nguy co quan trpng nhat.
Theo cac cong trinh nghien ciiu dich tl hpe cho thiy co moi tuong quan ty le thuan giua ndng dp CT, TG mau vdi ty le vua xo dpng mach, nguy co mac benh mach vanh va ty le tu vong do RLCH lipid gay ra benh nay [1], [2]
Theo WHO dir bao dSn nam 2020, cac benh tim mach dac biet la tinh trang vua xo dpng mach se tro thanh nguyen nhan hang dau gay benh tat tren toan tbi gicri [3]. Ci Viet Nam, theo nghien cuu ciia WHO nam 2010 CO 100.000 nguoi tii vong do benh dpng mach vanh [4]. Y hoc hien dai da ap dung nhieu bien phap dieu tri , trong do c6 sii dung cac nhom thuoc CO tac dung dieu chinh roi loan lipid mau, cac thuoc nay deu dat dupe hieu qua dieu tri nhat dinh song de lai nhieu
tac dung phu khi sii dung lau dai nhu tang men gan, diy bimg, buon non, dau CO... va co mpt ty le gay dpt bien din qua trinh phat triSn thai nhi [5].
Vi vay, cac nha y dupe hpe da nghien ciiu, sang loc tim ra cac bai thudc YHCT c6 hieu qua trong dieu tri chiing dam thap - mpt chiing benh gin v6i RLLPM trong YHHD. Bai thu6c
"Huong sa luc quan tii thang" la bai thu6c c6 phucmg dupe bao che duoi dang vien nen mang ky hieu HCT 1 vira tien sii dung cho ngucri benh va ii bao quan. DS tai nghien ciiu voi 2 muc tieu:
1. Bdnh gid tdc difng diiu tri ciia vien HCT 1 len hpi chAng roi lofn lipid mdu nguyen phdt thi Ty hu-dim thdp
2. Theo doi tdc dung khdng mong muon cua vien HCT 1
II. CHAT LIEU, DOI TlTONG VA PHU'ONG PHAP NGHIEN ClTU
2.1. Chat li^u nghidn cuu Stf
1.
2.
3.
4.
5.
6.
7.
8.
Ten thuoc Dang sam Bach truat Phuc linh Trich cam thao Tranbi Ban ha che Mpc huong Sanhan
Ten khoa hpe Codonopsis pilosula Atractylodis ovata Poria cocos Glycyrrhira uralensis Pericarpium Citri deiiciosa Pinellia temata Sausure Lappa Amomum xanthioides
Bp phan diing Recu
Cu Nam
Ri Voqua
Cu Re Hat
So lirpng 80g 80g 80g 40g 40g 80g 32g 32g
Journal of research in viet nam traditional medicine and pharmacy No 44 - 2015
- Dang bao chS: Vien nen bao film trong luong 550mg, ham lirgmg m6i vien HCT 1 tucmg duong voi 3,3g duoc lieu theo diing ty le trong bai thuoc CO phuong
- San xuat tai Benh vien YHCT Bp Cong an
2.2. Doi tugnng nghien cihi: 60 benh nhan dugc ehan doan xac dinh co hoi chung RLLPM nguyen phat - kem trieu chiing the ty hu dam thap theo YHCT den dieu tri tai BSnh vien YHCT Bo C6ng an tu thang 6-2007 din thang 12/2008
* Tieu chuan chpn benh nhan theo YHHD:
+ Xac dinh co RLLPM theo tieu chuan WHO 1990:
- Xet nghiem Iiic doi (sau an 9-12 gio) CO mot hay nhieu bieu hiSn sau
CT toan phan > 6,5 mmol/1, TG>2,3mmol/l
LDL-C > 3,9 mmol/I, CT toan phan tu 5,2 - 6,5mmol/l nhung HDL- C < 0,91 mmol/1
- Chua diing thuoc ha lipid mau lan nao hoac da ngimg dung > 3 thang
- Tu nguyen tham gia nghien cuu va chip hanh dly du nhiing ySu cau trong qua trinh nghien cuu
* Tieu chuan lua chon doi tupng nghien cuu theo YHCT (chung dam thap the ty hu):
- Vpng; Nguoi beo, chat luoi nhpt beu, reu luoi trang nhan
- Van: Tieng noi nho yeu, met moi - Van: Nguoi met moi, co the nang ne, an kem, di tieu it, d^i tien nat
- Thiet: Mach tram hoat
* Tieu chuan loai tru:
- RLLPM thu phat
- Benh nhan suy gan, suy than, tai bien mach nao, tang huyet ap
- Dang dimg thuoc dieu chinh roi loan lipid mau khae
2.3. Phiroug phap nghien cthi:
* ThiSt ke nghien euu
+ Nghien ciiu l&m sang mo, so sanh truac sau dieu trj va co nhom doi chung
+ C5 mau chpn chu dich 60 benh nhan chia lam 2 nhom theo phuang phap ghep cap, bao dam su tuong dong ve tuoi, giai, miic dp RLLPM
* Tien hanh nghi6n cuu:
Nghien cttu YDHCT Viet Nam. So 44.2015 + Nhom nghien ciiu dung vien
HCT 1. 18 vien/ngay chia 3 lin, u6ng lien tuc 60 ngay
+ Nhom d6i chimg u6ng Lipanthyl lOOmg X 3v/ngay, chia 3 lan, uflng lien tuc 60 ngay
* Chi tieu nghien ciiu:
- Trieu chiing lam sang - Chi so thanh phan lipid mau - Tac dung khong mong muon Cac chi tieu nay danh gia truoc va sau dieu tri 60 ngay
Ca 2 nhom nghien ciru trong qua trinh diSu trj dupe huong dan diiu chinh che dp an va the due 30 phut/ngay x 5 ngay trong tuan. Rieng xet nghiem chiic nang gan danh gia 30 ngay/lan
Xet nghiem dupe tien hanh 6 khoa xet nghiem Benh vien YHCT Bp Cong an
- Xet nghiem cong thirc mau: May dem te bao CELLTAX a tang Nippon (Nhat Ban)-2002
Xet nghiem sinh hoa: May HUMALYZER H2000 - CHLB Diic - 2000
* Tieu chuin danh gia ket qua:
+ Danh gia theo YHCT: Tieu chuin theo TQ (6) cai thien trieu chiing lam sang vpng, van, van, thiet
+ Tieu chuin Danh gia theo YHHD
- Khoi: Sau dieu tri cac xet nghiem tra vi gia tri binh thucmg
Co hieu qua t6t khi: giam CT > 20%, HDL-C tang > 0,26mmol/l dat 1 trong cac chi tieu sau Triglycerid giam > 40%, LDL-C giam < 3,9mmol/l
- Co hieu qua khi dat 1 trong cac chi tieu sau:
10% < Cholesterol giam < 20%
20% < Triglycerid giam < 40%
HDL-C tang 0,12 mmol/1 - 0,26 mmol/l so voi truoc diiu tri
LDL-C giam dat 4,0 - 4,9 mmol/1
* Cac so lieu nghien ciiu dupe phan tich xu ly tren may tinh theo chuong trinh EPI-INFO 6.04 cua WHO
* Da thong qua Hpi dong dao dire y smh hpe - Benh vien YHCT Bo Cong an
Journal of research in viet nam traditional medicine and pharmacy III. KET QUA NGHIEN CUtJ
Bang 3.1. Thay doi triiu chumg YHCT
^^"•"-^Hieu qua dieu tri Trieu chirng^^^^^^
Co thi nangne An diy churmg Tiic ngirc
suon Met moi
Mach hoat Luoi nhpt beu Reu luoi trang ban Dai tien
nat Tieu tien
it
NC DC NC DC NC DC NC DC NC DC NC DC NC DC NC DC NC DC
s6
bn 26 27 23 17 16 18 28 24 29 26 25 26 24 26 21 13 7 5
H6t n 8 9 14 9 5 7 12
1 12 6 1 3 15 7 6 2 1 2
%
30,7 33,3 60,9 52,9 31,3 38,9 42,9 4,2 41,4 23,1 4,0 11,5 62,5 26,9 28,6 15,4 14,3 40,0
sau dieu tri Giam n 14 16 8 5 8 7 14 12 12 18 17 14 8 12 14 5 5 2
%
53,9 59,3 28,6 29,4 50,0 38,9 50 50 41,4 69,2 68,0 53,9 33,3 46,2 66,7 38,5 71,4 40,0
No 44-2015
it 2 nhom NC va BC Khong thay doi
n 4 2 1 3 3 4 2 11 5 2 7 9 1 7 1 6 1 1
%
15,4 7,4 4,3 17,7 18,8 22,2 7,1 45,8 17,2 7,7 28,0 34,6 4,1 26,9 4,7 46,2 14,3 20,0
P 2 nhom
>0,05
<0,05
>0,05
<0,05
>0,05
>0,05
<0,01
<0,05
>0,05
Nhan xet: Kit qua bang 3.1 cho thay trieu chiing co the nang ne, tiic ngue suon, m^ch ho^t, luoi nhpt b?u, tieu tien it thi su khac biet giira nhom nghien ciru (NC) vai nhom doi chung
(DC) khong CO y nghia thong ke vai p>0,05. Cac trieu chiing an day chuong, met moi, reu luoi trang ban, dai tien nat thi nhom NC cai thien tot hon nhom DC voi p<0,05.
NghUn citu YDHCT Viet Nam Sd 44-2015 Bang 3.2. Ket qua dieu tri tren cac chi so lipid man cila 2 nhom NC va DC
Nhom
NC n=30
DC n=30
Truoc dieu tri X ± S D Sau dieu tri
X ± S D Thay doi p truoc sau Truoc dieu tri
X ± S D Sau dieu tri
X + SD Thay doi p truoc sau p2 nhom
CT (mmol/1) 5,79 ±1,22
4,94 ± 1,0 -1,03 (17,2%)
< 0,001 5,97+1,11 4,89 ± 0,87 -1,08 (18%)
< 0,001
>0,05
Thanh phan TG (mmol/I) 4,50 + 2,45 3,17+1,56 -1,33 (30%)
< 0,001 4,74 + 2,53 2,65 + 1,36 - 2,08 (44%)
< 0,001
>0,05
lipid mau HDL-C (mmol/I) 0,89 + 0,27 0,97 + 0,16 + 0,08 (10%)
<0,05 0,93 + 0,23 1,04 + 0,26
0,11 (12%)
<0,05
>0,05
LDL-C (mmol/1) 3,77+1,18 2,97+1,08 -0,81 (21,5%)
< 0,001 3,61 + 0,95 2,83 ± 0,96
-0,78 (22%)
< 0,001
>0,05 Mian xet: Voi chi s6 Cholesterol toan phin chi s6 TG, chi s6 HDL-C va chi s6 LDL-C ca 2 nhom deu giam so vol truoc dieu tri co y nghia thong ke vi5i p<0,001.
Rieng chi s6 HDL-C tang so vol trudc diiu trj co y nghia th6ng ke vol p<0,05 nhung su khac biet giiia 2 nhom khong co y nghia thflng ke voi p>0,05
Bang 3.3. Ket qua dieu tri theo tieu chuan Y hoc hien dai ciia 2 nhom Nhom
NC DC
Kit qua dieu tri (%) Khoi
10 10
Hifu qua tot 50 56,7
Hieu qua 33,3
30
Khong hifu qua 6,7 3,3
P 2 nhom
>0,05
Nhan xet: Dieu tri theo tieu chuan y hoc hien dai thi ca 2 nhom di^u tri d£u d^t hieu qua chiem ty le cao, nhom NC la 93,3%, nhom DC la 96,7%. Tuy nhien su khac biet ve ty le giua 2 nhom la khong co y nghia thong ke vai p>0,05.
Journal of research in viet nam traditional medicine and pharmacy No 44 - 2015 Bang 3.4. Ket qua dieu tri theo tieu chuan y hoc co truyen ciia 2 nhom Nhom
Nghien ciiu Dpi chung
Kit qua dieu tri (%) Khoi
10 0
Hieu qua tot 53,4 60,0
Hieu qua 33,3 16,7
Khong hieu qua 3,3 23,3
P 2 nhom
<0,05
Nhan xet: Nhom nghien ciiu tot hem nhom d6i chiing voi p<0,05.
- • (
63.3% ^ • .70%
H Z ] 30%
- 6.7%
23.3%
T
I Nh6m NC I Nh6m DC
Khd) Hi$u qud t6t Hi^u qu^ Khdng Hi^u qud
Bieu do 1. Ket qua dieu trj Nhan xet: Ket qua bieu do 1 cho
thay:
Ty le dieu tri co hieu qua cua nhom nghien ciiu la rat cao 93,3%, con 6 nhom ddi chiing chi co 76,7%.
Trong do ty le hieu qua tot eua nhom NC la 30%, con a nhom DC la 6,7%.
Ty le khong hieu qua 6 nhom NC la 6,7%, a nhom DC 23,3%. Su khac biet ty 1? giiJa 2 nhom la co y nghia th6ng kev6ip<0,05.
* Cac chi tieu can lam sang khac:
Ure, Creatinin, ALT, AST, HC, BC, TC, Hb, Glucose a ca 2 nhom truac va
sau dieu tri, su thay doi khong co y nghia thong ke vai p>0,05
* Tac dung khong mong mu6n khi su dung thuoc a 2 nhom
+ Nhom nghiSn cuu: Hau nhu khong CO tae dung phu nao
+ Nhom dfii ehung:
- 1 benh nhan c6 min ngiia (3,3%) - 1 benh nhan co buon non (3,3%) - 1 benh nhan c6 dau dau (3,3%) - 16 benh nhan co roi loan dai tien (20%)
6/30 benh nhan co xuit hien giam nhu cau tinh due
Nghien ciiu YDHCT Viet Nam So 44 - 2015
- 8/30 benh nhan met moi 3.5. Theo d5i tac dung khong mong muon
Qua theo doi benh nhan nghien cuu khong co benh nhan nao xuat hien di ling, noi man, buon non, non, hay dau b\ing.
IV. BAN LUAN
4.L Ban luan ve sir cai thien cac trieu chung lam sang
Trong nghien ciiu ciia chung toi, cac trieu chiing lam sang cua benh nhan phu hap voi thi Ty hu dam thap cua YHCT. Theo y ly YHCT thi ty hu lam chuc nang kien ^ n bi suy giam vi vay tan dich trong C( the khong dupe van hoa ma ngung tu lai thanh dam thap nen nguoi benh thay met moi, bung chuong day, nguoi nang ne, luoi beu nhpt, reu luoi trang nhon, mach boat [6]. HCT 1 vai cac vi: Sam, linh, truEit, thao co tac dung lam ty khi kien van va dam tri hoa di. Bac mpc huang va Sa nhan on hanh khi a trung tieu lam bai thuoc co tac dung hoa vi, tinh ty va ket hop Tran bi, Ban ha chS la tang tac dung hoa dam, tru thap, vi vay, benh nhan a nhom NC sau 60 ngay dieu tri da cai thien trieu chiing lam sang theo YHCT > 78,1%
4.2. Kit qua dieu tri tren cac chi so Lipid mau
Kdt qua nghien ciiu cua chiing toi eho thay, vien HCT 1 co hieu qua dieu tri vai eac benh nhan co hpi chung RLLPM: Sau 60 ngay dung HCT 1
lien tuc chi s6 CT, TG, LDL-C a cac benh nhan dhu giam eo y ngMa thong ke vdi p<0,001 va chi s6 HDL-C tang voi p<0,05.
So voi Lipanthyl su khac biet giua 2 nhom khong co y nghia thong ke voi p>0,05. Nhu vay, HCT 1 co hieu lire tuong duong voi Lipanthyl vai p>0,05. Ket qua nay phu hpp vol nghien cuu ciia Phan Viet Ha (1998) khi sir dung bai thuoc "Giang chi am"
cung dat dupe ket qua dieu chinh roi loan lipid mau tuong duang voi Lipanthyl.
Nhu vay, tac dung dieu chmh roi loan lipid mau cua HCT 1 la rat kha quan, vien HCT 1 vai cau tnic loi la bai thuoc "Nhi tran thang" la bai thuoc da duac chung minh eo hieu qua tot trong dieu tri roi loan lipid mau qua cac cong trinh nghien cuu cua Tran Thi Hien, Doan Qudc Diing, Bui Thi Man va hieu qua se cang tang cuong khi chiing toi phoi ngu vai cae vi thuoc b6 khi va ly khi nhu bai "Huang sa luc quan tii thang" trong dieu tri the ty hu dam thap va chinh vi phan the lam sang theo dac thu cua YHCT va chpn bai thu6c tuang ling de diSu tri mai co dupe hieu qua tot nhu vay. Day chinh la c6t loi kit hop YHCT voi YHHB nhu vay giii dupe ban sic cua YHCT, dl phat huy t6i da hieu qua tri lipu.
4.3. Danh gia tac dung khong mong muon
J I I
Journal of research in viet nam traditional medicine and pharmacy No 44 - 2015 - Thong qua cac trieu chung bieu
hien tac dung khong mong mu6n tren lam sang la man ngiia, buon non, ia chay hay tao bon... thi nhom nghien CIIU khong CO khi sii dung thudc YHCT, dong thai cae xet nghiem ve sinh hoa va huyet hoc cung khong co thay doi gi truac va sau dieu tri (ngoai trir cac thanh phan lipid mau). Ban chat van de la vien HCT 1 chinh la bai thuoc CO phuang "Huang sa luc quan tii thang" la bai thuoc c6 phuang da su dung tren lam sang qua nhieu the he rat an toan.
V. K i T LUAN
1. Vien HCT 1 co tac dung dieu tri hpi chung RLLPM nguyen phat vai thi ty hu dam thip cua YHCT.
Thuoc CO tac dung dieu chmh RLLPM tren 93,3% benh nhan trong nhomNC
- Giam CT dat 17,2% (p<0,001), giam TG dat 30% (p<0,001), giam LDL-C dat 21,5% (p<0,001) va tang HDL-C dat 10% (p<0,05).
- Tac dung hg lipid mau cua vien HCT 1 tuong duang voi Lipanthyl (p>0,05)
2. Vien HCT 1 khong gay tac dung khong mong muon
TAI HEU THAM KHAO 1. Hoi tim m^ch hoc Vift Nam
(2004), Khuyen cdo xu tri cdc benh tim mach chii yeu 6 Viet Nam. Phu truong tap chi Tim mach hoc, so 38/2004, tr 133-149
2. Hoi tim mach hoc Vift Nam (2006), Khuyen cdo ve cdc berth ly tim mach va chuyen hoa giai doan 2006- 2010. Nha xudt ban Y hoc, chi nhanh Tp H6 Chi Minh, tr 365-384.
3. Pham Tu- Duomg (2004), Cdc thuoc dieu tri chimg Roi logn lipid mdu, Thuoc tim mach. Nha xuit ban Y hpe, tr 627-658
4. Garg A. and V. Simha (2007), Update on dyslipidemia, J Clin Endocrinol Metab, 92 (5), 1581-1589
5. Richard J. and Cenedella (2007), Hypocholesterolemic Drug and coronary heart disease, Modem pharmacology with clinical applications sixth edition, 268-277.
6. Virong Huy Khai, Tran Kha Di (1994), "Hien trgng vd tuong lai ciia viec nghien cuu thuoc dieu chinh ma mdu truyen thong ciia Trung Qudc ". Tap chi Trung tay y kit hop - Trung Qu6c, thang 10, tr 635-637.
