Do vay, de cd ddgc gdc nhin tdong ddi toan dien ve bien co bat Igi cua thuoc trong dieu tri lao da khang va sieu khang da dugc ghi nhan tren the gidi, t d d d cung cap nhdng thong t[r]
(1)i • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • i i
mmi mm mmi mm • • • • • • • • • •
• • • • W A | \ y } i i • • • • • • • • • • • • • • • • • • • • • • • • • • ( • • • • • • • j i l W l P • • • • • • • * • • • • • • • • • • • • • • • • • • • • • • • • mm i i • • • •
I • • • • . f • • • • • • • • • • • • • • • • • • • • • • •
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Nghien cuuduoc
(2)Nghien cull dirge & Thong tin thuoc 2017, Tap 8, So
Journal of pharmaceutical Research and Drug information 2017, Vol 8, N°1
M U C L U C
So 1,2017 BAI NGHIEN CUU
2 Tong quan he thong va phan tkh gpp cac nghien ciiu quan sat ve bien co bat Idi cua thuoc dieu tri lao da khang/lao sieu khang
Nguyen Thi Thuy', Nguyen Hong Duong1, Cao Thi Thu Huyen', Vu flinh Hoa',
Nguyen Hoang Anh!, Nguyen Viet Nhung'
'Berth mn Phoi Bang Hang, 'fritting Bgi hoc Bddc hit Mi
C O N T E N T S
No 1,2017 RESEARCH
Adverse drug events in the treatment of multidrug and extensively drug - resistant tuberculosis: a systematic review and meta-analysis
Nguyen Thi Thuy, Nguyen Hong Duong, (ao Thi Thu Huyen, Vu Dinh Hoa, Nguyen Hoang Anh, Nguyen Viet Nhung 'national Lung Hospital, 'Ha Hoi University of Pharmacy 1 Loai bd anh hiking nen phan tich khang sinh cloramphenicol
bang cot sac kyai life mien dich
Nguyen Brie Thinh';, Chu Pham Nggc Son', Tran linh Thucic'
'Wen Pre'Cong rang DM phSHo ChiMinh, 'JnHxg Bgi hoc khoa hoc Idnhien (BHBC-HCM), 'Leung tarn Sac ky Hai Sang
Removal of sample matrix effects for chloramphenicol analysis by affinity immunochromatography column
Nguyen DucThinh, Chu Pham Ngoc Son, Tran Linh Thuoc
1 Institute of Public Health
'University ofSciencesfVietnam national University Ho Chi Minh City] 'Lighthouse Chromatography Center 1 Xay dung quy trinh dinh lUdng ddng thiri paracetamol, ibuprofen va tap Simultaneous determination of paracetamol, ibuprofen and related
C cua ibuprofen bang phddng phap UPLC/DAD impurity of ibuprofen by UPLC/DAD
Nguyen Thi Nggc Van, Tran Thi Tie't Nghia Nguyen Thi Ngoc Van, Tran Thi Tiet Nghia Khoa Ddpcjnlimg Dai hoc YDircc Can Ihd faculty of Pharmacy-Can Iho University of Medicine and Pharmacy 21 Tong hgpva thOrtac dung Uc die enzym glutaminyl cyclase cua mot so
dan chat pyrimidin cua N-(5-methyl-1 H-imidazol-1 -yl) propyl-N' - (3-methoxy-4-alkyloxyphenyl) thiourea
Tran Phirong Thao1, Tran Thi Thu Hien!
'InldngDgihgcDiigcHdHpi, 'Hgcvien YBagchgcCdtruyen Vietnam
Synthesis and evaluation of human glutaminylcyclase inhibition activity of new pyrimidine derivatives bearing N-(S-methyl-1 H-imidazol-1 -yl) propyl-N'-(3-methoxy-4-alkyloxyphenyl) thiourea
Tran Phuong Thao, Tran Thi Thu Hien 'Hanoi University of Pharmacy, 'institute of Iraditional Medicine and Pharmacy Vietnam
2 Nghien cUu dac diem hinh thai va xac dinh lai ten khoa hoc cua cay thuoc Tdmanh
Nghiem Dure Trgng, Tran Van On', Nguyen Van HieV Tracing Bgi hoc Dupe Ha Hgf 'Vien Thdc vgthgc, Wen ban lam khoa hoc Trung Owe
Study on morphological characteristics and identify scientific name of the medicinal plant named "To manh"
Nghiem Due Trong1, Tran Van On', Nguyen Van Hieu'
'Manor University of Pharmacy 'Institute of Botany, Chinese kademy of Sciences, Beijing 100093, China 3 ^c dung giam ho, long derm cua cao dac hai thudc AZKtren md hinh
thuc nghiem
Nguyen Manh Tuyen, Phung Hoa Binh, Do Thi Thu Thiiy, Nguyen Thuy Duong InriSngBgihgcDtlgcHaHoi
Antitussive and expectorant effects of the soft extracts made from AZK remedy on experiment models
Nguyen Manh Tuyen, Phung Hoa Binh, Do Thi Thu Thuy, Nguyen Thuy Duong Hanoi University of Pharmacy
THONG TIN THUOC • CANH GIAC DUOC
3 C a c bien chitog tim mach cua nhiem toan ceton
DIEM TIN HOAT DONG
Nguon: 05 Ptorm 2016; 41(21:39-42 Nguoi djch: LeThj Quynh Giang, Luong Anh Tung
(3)Nghien cull dutfc & Thong tin thuoc 2017, Tap 8, So 1, trang 2-9
BAI NGHIEN ClTU •
Tong quan he thong vd phdn tich gop
cdc nghien cuu quan sat ve bien cb bat lai cua thubc ctieu tri lao da khang/lao sieu khang
Nguyen ThjThuy1, Nguyen Hong Duong2, Cao Thi Thu Huyen2, Vu Dinh Hoa2,
Nguyen Hoang Anh2, Nguyen Viet Nhung1
'Benh vien Phoi Trung dang, 2Trudng Dai hoc Dugc Ha Ngi
S U M M A R Y
Adverse drug events (ADE) have been mentioned as the most crucial obstacle in the management of multi/extensively drug-resistant tuberculosis (MDR/XDR-TB) using second-line drug chemotherapy The information of such ADE was found diverse among studies and a systematic summary was therefore required to assist clinical practice The study aimed to identify the proportion and type of ADEs reported in published medical literature A systematic search for ADEs in MDR/XDR-TB treatment from Medline in January 2016 was carried out and subsequently the search result was reviewed under pre-defined criteria Extracted data was summarized and the pooled incidence for each specific ADE and for cases with at least one ADE was presented Of 1504 searched articles, 69 were selected for the review A total of 5313 (68.2%) patients in 49 studies experienced at least one ADE In addition, 2000 patients (21.8%) in 46 studies required change of MDR/XDR-TB treatment The most three common side effects were gastrointestinal disorders (39.6%), red blood cell disorders (18.8%/), and general disorders
(18.3%) Most of the I2 values were over 90% These results revealed that ADE was found to be common in MDR/XDR-TB
treatment The high heterogeneity of the result suggested a wide variation among studies in assessing and reporting ADE during the treatment of MDR/XDR-TB
TCfkhda: Bien co bat Igi, MDR-TB, XDR-TB, tong quan he thong, phan tfch gqp
Oat van de
Lao khang thuoc da va dang t r d m o t t h d thach Idn doi vdi viec kiem soat benh lao tren toan cau Rieng nam 2014, da co khoang 190 000 trddng hop t d vong lao da khang (MDR-TB) Lfdc tinh chl co 50% so benh nhan MDR-TB dugc dieu trj khdi va da co khoang 9,7% so ca MDR-TB bi sieu khang thuoc (XDR-TB) Viet Nam nam nhdrn 27 quoc gia co ganh nang lao da khang cao nhat the gidi, xep t h d 11/20 nUdc co so lupng benh nhan MDR-TB nhieu nhat [5] Benh nhan MDR/XDR-TB phai s d d u n g nhieu thuoc dong thdi vdi thdi gian dieu trj benh keo dai, dac biet cac thuoc lao hang hai thudng co doc tinh cao hon thuoc lao hang mot, dan den tang kha nang xuat hien bien co bat Igi Vi vay, viec nhan dien, danh gia va x d t r i bien co bat Igi dieu tri lao da khang dong m o t vai tro quan trgng
trong viec sd dung thuoc hgp ly, an toan va dieu trj cong MDR/XDR-TB [9].Tuy nhien, thong tin ve cac bien co thuoc dieu trj MDR/XDR-TB t h u ddgc tren thdc te t d he thong bao cao t u nguyen tai Viet Nam rat han che so Idgng va chat lugng bao cao chda cao Ben canh do, cac nghien cdu theo doi chu dgng bien co bat Igi cua thuoc dieu trj lao mdi bat dau ddgc trien khai nhdng nam gan day tai mot so co sd trgng diem va chua cong bo ket qua dau Tren the gidi, da cd nhieu nghien cdu ghi nhan va phan tich ve bien co bat Igi dieu trj MDR va XDR-TB, nhdng ket qua cua cac nghien cdu rieng le kho phan anh dugc day du ve bien co bat Igi va nhdng yeu to anh hudng den sd xuat hien cua bien co sd dung nhdng phac dieu trj MDR va XDR-TB Mac du mot nghien cdu tong quan he thong va phan tich ggp ve bien co bat Igi dieu trj lao
(4)Nghien cull dutfc & Thong tin thuoc 2017, Tap 8, So 1, trang 2-9 ^
B A l NGHIEN c G f u * da khang da dugc tien hanh vao nam 2012 [10],
nhung ke t d thdi diem den da cd them nhieu nghien cdu dugc thUc hien bo sung them vao d d lieu bien co bat Igi dieu tri MDR/XDR-TB Do vay, de cd ddgc gdc nhin tdong ddi toan dien ve bien co bat Igi cua thuoc dieu tri lao da khang va sieu khang da dugc ghi nhan tren the gidi, t d d d cung cap nhdng thong tin hdu ich phuc vu cho cdng tac dieu tri MDR/XDR-TB, nghien cdu ddgc thdc hien vdi muc tieu phan tich tan suat xuat hien cac bien co bat Igi xay dieu trj lao da khang/sieu khang thudc thong qua tdng quan he thong va phan tich ggp t d cac nghien cdu quan sat
Doi tvong va phvong phdp nghien cuu Doi twang nghien cdu
Cac bai bao t d nguon d d lieu PubMed/Medline dugc cap nhat den thang 1/2016 Chien luge t i m kiem la sd dung MeSH de thu dugc danh muc cac t d dong nghia cua "MDR-TB","XDR-TB" va "Adverse Drug Events"; gidi han ngdn n g d la tieng Anh
Phi/Ong phdp nghien cdu
Quy thnh Ida chgn nghien cdu
Hai vien nhdm nghien cdu dgc tieu de va torn tat cua cac nghien cdu mot each dgc lap va soat cheo Neu cd ket qua khac nhau, tien hanh thao luan lai hoac xin y kien vien t h d ba nhdm nghien cdu de thong nha't Sau do, dgc ban day du cac nghien cdu da chgn Nhdng nghien cdu thda man tieu chuan Ida chgn va khdng nam tieu chuan loai trd ddgc dda vao tong quan he thong
Tieu chudn Ida chon
Cac nghien cdu quan sat phai thda man nhdng tieu chuan n h d sau: cd d d lieu dau la bien co cd hai cua thudc; nghien cdu ve lao da khang va lao sieu khang thuoc; la tai lieu cap mot; phac dieu trj lao cua cac nghien cdu cd bao g d m cac thuoc hang hai; ngdn n g d bang Tieng Anh
Tieu chudn logitrd
Cac nghien cdu ddgc loai b d neu doi t d g n g nghien cdu cd tre em, phu n d e d thai, ngddi caotuoi Ngoai ra, cac nghien cdu bao cao ca, bao cao chuoi, nghien cdu benh chdng, nghien cdu chi quan sat mot bien cd bat Igi hoac chi quan sat bien cd bat Igi cua m o t thudc cung khdng ddgc dda vao tong quan he thong
Ddnh gid chat Idgng nghien cdu
Sddung thang NOS (Newcastle-Ottawa Scale) [6] de danh gia chat lugng cac nghien cdu trudc dda vao phan tich g g p dda tren tieu chi: Kha nang Ida chgn (tdi da diem); kha nang so sanh (tdi da diem); ket qua dau (toi da diem).Thang diem
da dugc nhieu nghien cdu sd dung de danh gia chat lugng phan tich g g p , dac biet la cac phan tich danh gia bien co bat Igi cua thuoc dieu trj lao [2], [3], [4] Trong tong quan he thong nay, nhdm nghien cdu quy djnh nhdng nghien cdu co mdc diem danh gia theo thang NOS dat t d diem t r d len (> 50%) ddgc coi la nghien cdu dat chat Idgng de dda vao tien hanh phan tich ggp
Chietxudtddlieu
Mot vien n h o m nghien cdu tien hanh phan loai va nhap d d lieu theo cac trUdng d d lieu xac djnh, vien t h d hai nhom nghien cdu kiem tra lai Trong tracing hgp co y kien khdng d o n g nhat, tien hanh thao luan lai hoac xin y kien vien t h d ba n h o m nghien cdu Cac trUdng d d lieu lien quan den nghien cdu dagc chiet xuat bao g o m : Thong tin chung ve nghien cdu (ten tac gia chinh, nam xuat ban, thiet ke nghien cdu, dja diem nghien cdu, thdi gian tien hanh nghien cdu, cd mau); dac diem benh nhan (tuoi trung binh, gidi tinh, tien sddieu trj lao, dong nhiem HIV, sd thuoc dieu trj lao bj khang trung binh); phac dieu trj (thdi gian dieu trj, so thuoc trung binh phac do, phac chuan hda/ca nhan hda); ket cudc cua ADE lien quan den dieu trj (sd benh nhan xuat hien it nhat ADE, so benh nhan xuat hien it nha't ADE nghiem trpng, sd benh nhan t d vong ADE, sd benh nhan phai thay ddi phac do ADE, so benh nhan xuat hien tdng loai ADE)
Phdn tich ddlieu
Ket qua tdng quan he thong ddgc trinh bay dddi dang bang torn tat thong tin cua cac nghien cdu dat tieu chuan Sddung phan m e m Microsoft Excel 2010 Sd dung m d hinh anh hadng ngau nhien de phan tich va ddc Idgng ket qua gdp bang phan mem Open MetaAnalyst [1], [7] D o dj biet gida cac nghien cdu dugc danh gia thong qua chi so I2 Tien hanh phan
tich g d p tdng n h d m nhd/phan tich dudi nhom (sub-group) theo mot so tieu chive dac diem quan the benh nhan, cd mau nghien cdu, tien sddieu trj,
Ket qua nghien cuu
Td 1504 bai bao ddgc t i m thay, qua cac bade Ida chgn va loai trd, da co 69 nghien cdu ddgc dda vao tdng quan he thong Quy trinh lua chgn cac nghien cdu s d d u n g tdng quan he thong va phan tich gdp dugc trinh bay d hinh (Xem bang)
Ddc diem ede nghien cdu ddgc Ida chgn
(5)Nghien culidifoc & Thong tin thuoc 2017, Tap8, S61,trang 2-9
BAI NGHIEN CQU •
tai 35 quoc gia, An Dp la nude co nhieu nghien cdu nhat vdi 15 nghien cdu Dac biet, co nghien cdu dupe thUc hien tai Viet Nam CP mau cua nghien cdu dao dpng tCr den 1390 benh nhan, co 37 nghien cdu co cd mau dudi 100 va 32 nghien cdu c o e d mau tren 100 benh nhan Quan the nghien cdu cd tuoi trung binh t d 26 den 46 tuoi, cd 49 nghien cdu co tuoi trung binh nam khoang t d 30 den 40 tuoi Phan Idn benh nhan am tinh vdi HIV va da cd tien sd dieu tri lao Ve mat phac dieu trj, cd 41 nghien cdu sd dung phac ca nhan hda, 26 nghien cdu sd dung phac chuan, nghien cdu bao gom ca phac ca nhan hda va phac chuan, nghien cdu khdng rd thong tin ve phac s d d u n g
Bang Mot so thong tin cua cac nghien cdu dugc dUa vao tong quan he thong
STT Ta/l a c y la UdU l i e l l l U d - n i a n a n t i o n /"iia
nghien aifu
N a m n a m
xuat ban Co mau (n)
T i o n c i V r t i b n t r i I c l l >U U l c U III
TB (%)
T u l b rtnnn n h i o m i v i c u u n y m u c i n
HIV(%)
r i l a c u u dieu t r j
Sn RN n a n it
J U DIM ija p i i nhat ADE
1 Ng.B.Hoa 2015 282 Chuan 143
2 Pym 2015 233 94,8 4,0 Chuan 219
3 Meressa 2015 612 98,5 21,7 Chuan 544
4 Cavanaugh 2016 77 100 0(n=15) Khong rd 55
5 Lytvynenko 2014 484 86 3,1 Ca nhan hda 226
6 Vaghela 2015 101 100 2,0 Ca nhan hoa
7 Kuaban 2015 150 20,0 Chuan
8 Kibleur 2015 231 59 Ca nhan hda
9 Avong 2015 460 10,0 Chuan 203
10 Hire 2014 110 0,0 Chuan 55
11 Piubello 2014 65 98 1,7(n=58) Chuan 41
12 Charles 2014 110 88,88 25,0 Ca nhan hda 61
13 Jain 2014 130 Chuan
14 Bharty 2014 930 Chuan
15 Mpagama 2013 61 98 14,0 Chuan 49
16 Shean 2013 115 42,0 Ca nhan hda 67
17 Jiang 2013 158 74 0,0 Ca nhan hda 81
18 Walt 2013 1390 91 39,1 Chuan
19 Rodriguez 2013 289 92,4 4,5 Chuan va ca
nhan hda 287
20 Brust 2013 91 84,0 Chuan 90
21 Sagwa 2012 59 92 53,0 Ca nhan hda 53
22 Isaakidis 2012 67 92,5 100,0 Ca nhan hda
23 Bhatt 2012 81 53.1 1,2 Chuan 76
24 Brust 2012 80 82,5 Chuan 70 (n=71)
25 Xu 2012 18 100 0,0 Ca nhan hda 17
Tong so nghien cuu tim dupe tren Pubmed (N=1504)
Doc tieu de va torn tat (N=l 504)
Tim doc ban d4y du (N=288)
Cac nghien cuu dat tieu chuan (N=101)
Nghien cuu dupe dua vao tong quan he thong va ph^n tich gpp (N=69)
1 -Khongphiihop vui tieu chuan lua chpn va I tieu chuan loai tructia tong quan (N—1216) |
I J I -Khong co toan van bang tieng Anh N—l *
^| -Khong tim dupe ban day diiN—8 I I - Khong phu hop voi tieu chuan lua chgn I
va tieu chuan loai truciia tong quan j
1 (N-178)
_ _>| -Chi quan sat mot loai ADE; hoac chi
quan sat ADE ciia mot thuoc (N=32) I
Hinh 7. Quy trinh Itfa chgn cac nghien cifu
(6)Nghien cull difcfc & Thong tin thudc 2017, Tap 8, So 1, trang 2-9
BAI NGHIEN CL/U STT Tac gia dau tien cua
nghien ciifu
Nam
xuat ban Cor mau (n)
Tien surdieu tri TB (%)
Ty le dong nhiem HIV(%)
Phacdo dieu t r i
So BN gap it nhat ADE
26 Carrol 2012 655 66 Ca nhan hoa
27 Miller 2012 407 Ca nhan hda 367
28 Isaakidis 2011 58 91 (n=56) 100,0 Ca nhan hda 26
29 Abbate 2012 17 94/1 0,0 Ca nhan hda
30 Kennedy 2011 1? 84,6 14,0 Chuan 12
31 Singla 2012 29 100 0,0 Ca nhan hda
32 Lee 2011 171 49,4 0,6 Ca nhan hda 81
33 Joseph 2011 38 100 0,0 Chuan 33
34 Kvasnovsky 2011 206 100 55,4 Ca nhan hda
35 Dheda 2010 174 72 47,0 Ca nhan hda 67(n=115)
36 Van Deun 2010 427 100 Chuan 203
37 Anger 2010 16 100 19,0 Ca nhan hda 16
38 Bloss 2010 1027 63 3,1 Ca nhan hda 807
39 Singh Datta 2010 52 1,9 Chuan 36
40 Malla 2009 175 98,2 (n=166) Chuan
41 Karagoz 2009 142 100 0,0 Ca nhan hda 79
42 Baghaei 2011 80 5,0 Chuan 45
43 Pawar 2009 25 65 8,0 Ca nhan hda
44 Singla 2009 126 100 0,0 Chuan 73
45 O'Donnel 2009 60 70 72,0 Ca nhan hda 31
46 Jacob 2009 23 56,5 5(n=21) Ca nhan hda 23
47 Keshavjee 2008 608 99,5 0,8 Ca nhan hda 407
48 Prasad 2005 46 100 0,0 Chuan 16
49 Masjedi 2008 43 100 0,0 Chuan
50 Shin 2007 244 100 Ca nhan hda 179
51 Cox 2007 87 100 Ca nhan hda
52 Thomas 2007 66 100 Ca nhan hda 39
53 Uffredi 2007 45 47 20,0 Ca nhan hda 15
54 Escudero 2006 25 88 0,0 Ca nhan hda
55 Codecassa 2006 38 54 5,3 Ca nhan hda 32
56 Torun 2005 263 0,0 Ca nhan hda 182
57 Nathanson 2004 818 Ca nhan hda
58 Palmero 2004 141 64,5 0,0 Ca nhan hda
59 Van Deun 2004 58 Chuan
60 Yew 2003 99 0,0 Ca nhan hda 41
61 Furrin 2001 60 100 1,7 Ca nhan hda 60
62 Tahaoglu 2001 158 100 Ca nhan hda
63 Singla 2001 100 0,0 Chuan
64 Geerligs 2000 44 34 0,0 Ca nhan hda 44
65 Wai Yew 2000 63 65,1 100,0 Ca nhan hda 25
66 Mannheimer 1997 13 23 100,0 Ca nhan hda
67 Lee 1996 36 100 Ca nhan hda 10
68 Hadiarto 1996 57 100 0,0 Chuan
(7)Nghien cull difcfc & Thong tin thudc 2017, Tap8, So 1,trang 2-9
BAl NGHIEN cCfu
Phan tich gdp ve bien cdbdt Igi dieu tri lao da khang va lao sieu khdng thudc
Ket qua danh gid chat It/gng cac nghien cCfu
V6i 69 bai bao dupe dda vao tong quan he thong, chung toi thUc hien cham diem de danh gia sit dong deu ve chat lupng cua cac nghien cud trudc dua vao tien hanh phan tich gpp Ket qua: tat ca nghien cud deu dat m u t >5 diem (tren thang toi da diem) tat ca cac tieu chi danh gia nen deu dupe dua vao phan tich gpp, cu the: 23 nghien cud (33%) dat diem, 40 nghien cud (58%) dat diem va nghien cud (9%) dat diem
Phan tich gdp ve ty le xuat hien bien co chung
Bang Phan tich ggp ve ty le xuat hien bien co
S t u d i e s E s t i m a t e ( C I ) E v / T r t
N g u y e n B i n h H o a : 5 ( 4 , - 5 ) 1 /
A l e x a n d e r S P y m 0 -; ( 9 , 7 9 ) 2 / 3
M e r e s s a 0 B I , 9 1 ) 5 4 /
C a v a n a u g h 0 1 6 , 8 ) 5 / 7
L y t v y n e n k o 0 1 4 , 5 ) 2 /
A v o n g ) ( ( 3 , 7 ) 2 /
H i r e 3 0 1: , 5 ) 5 / 1
P i u b e l i o 6 ( , : 7 ) 4 /
C h a r l e s 0 5 4 , ; ) 6 / 1
M p a g a m a 0 E i 6 , 8 ) 4 /
K a r e n S h e a n 0 i : 4 , 6 ) 6 / 1
J i a n g 0 1 4 , 5 ) 8 /
R o d r i g u e z : 7 ( 9 , 9 ) 2 /
B r u s t ( ) 2 0 78 10 , 9 ) 9 /
S a g w a 2 0 =6 10 , 7 ) 5 /
B h a t t 2 0 ( , 9 ) 7 /
B r u s t ( ) 0 ( , 0 ) 7 /
X u 2 0 4 10 , 9 ) 1 /
M i l l e r 2 0 ( , 0 ) 3 /
I s a a k i d i s 1 0 I?1 , 0 7 ) 2 /
A b b a t e 2 0 1 3 , 7 ) 9 /
K e n n e d y 1 0 10 , 9 ) 1 /
L e e ( ) 1 0 1 0 , 5 ) 8 /
J o s e p h 1 0 • ( , 9 4 ) 3 /
D h e d a 0 ( 3 , 0 ) 6 /
V a n D e u n 0 ( , 5 ) 2 /
A n g e r 0 - - : 10 6 , 9 ) 1 /
B l o s s 0 ( , 8 ) 8 /
S i n g h D a t t a 0 i -i ( 5 , 8 ) 3 /
K a r a g o z 0 0 - [ , 6 ) 7 /
B a g h a e i 1 0 i 1 ( , 6 ) 4 /
S i n g l a ( ) 0 0 ( , 6 ) 7 / O' D o n n e l 0 0 ( , 6 ) 3 /
J a c o b 0 0 7 ? ( , 9 9 ) 2 /
K e s h a v j e e 0 0 <o , 0 ) 4 /
P r a s a d 0 0 : ( 2 , 4 ) 1 /
S h i n 0 0 34 ( , 0 ) 1 / 4
T h o m a s 0 0 ( , 0 ) 3 / 6
U f f r e d i 0 0 3 ( 2 , 0 ) 1 /
E s c u d e r o 0 0 ( , ' 4 B ) 7 /
C o d e c a s s a 0 0 ( , 0 ) 3 /
T o r u n 0 0 ( , 3 ) 1 /
Y e w 0 0 4 ( 2 , 0 ) 4 / 9
F u r r i n 0 0 7 ( 8 , 7 9 ) 6 /
S i n g l a ( ) 0 0 7 ( , 0 4 ) 7 /
G e e r t i g s 0 0 ( , 0 9 ) 4 / 4
W a i Y e w 0 0 77 ( , 1 ) 2 /
M a n n h e i m e r 9 0 S ( , 0 ) 4 /
L e e ( ) 9 0 ( 1 , 0 4 ) 1 /
O v e r a l l ( l « « % , P < 0 ) ( , 0 ) 5 3 /
*7tfc gia cohort bai bao Suae ky hieu (1), (2,
Sd NC 99P
So BN xuat hien
ADE So BN
don
Ty le xuat hien ADE (95% CI) (%)
Chi so
BN xuat hien it nhat
1 ADE 49 5313 7875 68,2 (62,4-73,5) 95,07 BN xuat hien it nhat
1 ADE nghiem 21 571 2526 26,9 (20,0-35,2) 91,77 BN thay doi phac
do ADE 46 2000 4959 21,8 (17,0-27,4) 95,67 BNtufvong ADE 11 112 2709 3,2 (0,2-5,2) 61,77
ben cgnh nam xuat ban
Hinh Bieu ggp ve ty le xuat hien it nhat mot ADE
0 56 L o g r t P r o p o r t i o n
(8)Nghien cuu duoc & Thong tin thuoc 2017, Tap 8, So 1, trang 2-9
BAI NGHIEN CQU
Phan tich gdp ve so ty le xuat hien it nhat mot bien cd bat Igi
Co 49 nghien cud thu thap thong tin ve so luting benh nhan xuat hien it nhat mot ADE Trong do, cd mau g p p la 7875 benh nhan va so benh nhan xuat hien it nha't ADE la 5313 benh nhan Ty le gpp thu duoc la 68,2% (95% CI: 62,4% - 73,5%)
Phan tich gdp ve bien cd bat Igi tren tdng he co quan
Bang Ty le xuat hien ADE tren cac he co quan
STT Bien cd bat Igi Sd NC
Cn RM > DIM xuat
hien
ADE
Tong so BN phfli nhiem
Ty le xuat
hien ADE IQCOX cn itt/A
Chi sol2
(%)
1 Roi loan tieu hoa 47 3415 7910 39,6 (30,4- 49,6) 97,79
2 Rdi loan hong cau 61 856 18,8 (04,4-53,9) 92,67
3 Rdi loan toan
than 10 278 2088 10 -}
' (12,7-25,7) 89,43
4
Roi loan than kinh trung uong va than kinhngoaivi
50 1715 9676 15,2 (12,0-19,2) 94,91
5 Roi loan ca xiiong
khcfp 41 1783 8975 14,7 (10,9- 19,5) 96,80
6 Rdi loan thinh
giac va tien dinh 45 1517 8967 14,0 (10,8-18,0) 95,13
7 Rdi loan tarn than 40 1511 8612 13,6 (10,3-178) 95,73
8 Rdi loan chuyen
hda 17 985 5984 1 , (7,0-18,4) 97,66
9 Rdi loan da va td*
chdc dudi cua da 43 725 8741 8,8 (6,7-11,4) 91,08
10 Rdi loan tai cho 125 1804 6,5 (1,7-21,4) 96,86
11 Rdi loan not tiet
(suygiap) 20 418 6030 64
' (3,8-10,4) 95,27
12 Roi loan bach cau 44 1537 6,0 (1,5-21,1) 93,58
13 Rdi loan gan mat 37 569 8604 5,0 (3,6-7,0) 91,49
14 Rdi loan tiet nieu 23 249 5490 4,3 (3,0-6,2) 85,53
15 Rdiloan thjgiac 19 134 4650 3,3 (2,3-4,6) 66,15
Nhufng bien co tren he tieu hoa, roi loan hong cau, roi loan toan than, roi loan tren he than kinh trung uong va tai cho, roi loan he CO xuOng khdp la nhdng bien co co ty le gpp cao nhat Bien co bat Ipi tren dudng tieu hoa co ty le gpp cao rd ret: 34,8% (95% CI: 26,2% - 44,6%) Cac roi loan tren he than kinh trung uOng, he tieu hoa, roi loan thinh giac va tien dinh dupe nhieu nghien cud ghi nhan nha't
Kit qua phan tich ggp difcri nhom
Bang Phan tich gdp dudi nhom ve ty le xuat hien it nhat 7 ADE
Tieu chi So NC Ty le xuat hien it nhat
ADE(95%CI)(%)
Chi so I2
(%)
Quan the nghien ciu
Chau A 24 61,2 (54,3-67,6) 92,76
Cac khuvilc khac 24 74,9 (65,4-82,5) 96,01
CaChauAvacacKVkhac
Thiet ke nghien aitu
Tien cdu 16 62,8 (51,3-72,9) 92,73
Hoi cdu 33 70,9 (64,0-77,0) 95,68
Tien si dieu triftheo % so benh nhan tham gia nghien chu da ting dieu hi lao)
<75% 12 63,8 (48,9-76,5) 94,70
> 75% 26 71,2 (63,0-78,1) 95,54
Khdng cd thong tin 11 67,4 (55,2-77,7) 95,84
Bong nhiem HIV
Khdng nhiem HIV 14 59,1 (50,4-67,2) 83,69
Co dong nhiem HIV 29 73,5 (65,7-80.0) 95,93
Khdng cd thong tin 61,1 (42,5-77,0) 97,32
Thhi gian dieu trj
<18 thang 18 63,7 (53,4-72,9) 91,95
>18thang 27 72,1 (65,1-78,1) 95,42
Khdng cd thong tin 53,8 (18,9-85,3) 97,45
Cimiu
<100 29 70,7 (61,5-78,4) 88,01
>100 20 66,9 (58,4-74,3) 97,42
(9)Nghien cuu dirgfc & Thong tin thuoc 2017, Tap 8, S6l,trang 2-9
Ban luan
Trong nghien cud nay, 69 bai bao da dupe dua vao tong quan he t h o n g va phan tich gpp, vupt trdi hon han ve so lupng cong trinh t i m kiem ban dau cung n h u bao g o m phan tich cuoi cung so vdi nghien cUu cua Shanshan Wu, m o t t o n g quan cd p h u o n g phap t u o n g tU dupe tien hanh vao n a m 2012 vdi 39 nghien cUu [7] Nghien cUu cua Wu da danh gia cac nghien cUu dua tren thang diem dupe de xuat bdi nhdm nghien cUu "Phan tich ggp cua cac
nghien ctfu quan sat" [1], [2] Thang
Newcasle-Ottawa (NOS) dupe s d d u n g nghien cUu cua chung tdi giup danh gia cac nghien cUu m o t each toan dien h o n thang diem nghien cUu cua Wu, the hien qua m o t so mat nhU: mdc dp day du cua viec theo ddi, so sanh cac nghien cUu dua tren thiet ke [6], [10]
Trong tong so 69 nghien cUu quan sat dupe dUa vao tong quan he thong, cd 39 nghien cUu sif dung phuong phap hoi cUu tU benh an de lay thong tin ve ADE (cac ket qua xet nghiem, ban ghi chep cua nhan vien y te nhdng Ian tai kham dinh ky va m o t nghien cUu thu thap ADE tU bao cao t u nguyen cua benh nhan) va 30 nghien cUu tien cUu cd p h u o n g phap t h u thap ADE, d d chu yeu la phuong phap theo ddi tich c u t (theo ddi djnh ky) vdi mau bao cao dupe thiet ke san.Tat ca cac bien cd ghi nhan tU cac nghien cUu da dupe chuan hda lai theo thuat ngU WHO-ART [7] So vdi nghien cUu cua Wu [10], nghien cUu cua chung tdi da tdng hop cac ket qua phan tich g d p ve ty le xuat hien it nhat m o t ADE nghiem trpng (26,9%), ty le benh nhan tU vong ADE (3,2%), day la nhUng so rat cd y nghia ddi vdi thUc hanh lam sang, djnh hudng cho cac bac si dieu trj thay thuc sU quan trpng hon cdng tac theo ddi, danh gia, x d trf va bao cao ADE dieu trj MDR/XDR-TB
Ty le g p p xuat hien it nhat bien cd la 68,2% tU 7875 benh nhan cua 49 nghien cUu Rdi loan tieu hda la bien cd bat Ipi phd bien nha't vdi ty le gpp la 39,6% tU47 nghien cUu NhUng rdi loan khac cung co ty le gdp kha cao dd la rdi loan hong cau (18,8%), rdi loan toan than (18,3%), rdi loan than kinh trung uong va than kinh ngoai vi (15,2%) C6 the.thay, ty le xuat hien bien cd d benh nhan MDR/XDR-TB la rat cao, vdi khoang m o t phan ba so (21,8%) can phai thay ddi phac do, anh hudng rat Idn den qua trinh dieu trj cung nhUchat lUpng song cua ngUdi benh Cd nhieu bien cd la phan Ung khdng mong mudn
BAI NGHIEN c a u '
dien hinh cua cac thudc lao hang hai dupe de cap y van da dupe nhieu nghien cUu ghi nhan (> 40/69 nghien cUu) n h u rdi loan than kinh, thinh giac-tien dinh, tieu hda, da va to chUc dudi cua da, rdi loan tarn than M o t so bien cd khac dupe ft nghien cUu ghi nhan hpn nhUng lai la nhUng bien cd bat Ipi nghiem trpng n h u bien cd tren huyet hoc (rdi loan hong cau, bach cau), rdi loan dien giai (ha kali mau), rdi loan chuyen hoa (tang acid uric), rdi loan ndi tiet (suy giap).Trong do, rdi loan hong cau la m o t bien cd bat loi dang chu y va cd ty le kha cao mac du chi dupe ghi nhan nghien cUu Ket qua cho thay sucan thiet phai theo ddi sat cdng thUc mau cua benh nhan, dac biet theo ddi tren nhOng benh nhan dupe chi djnh phac chUa cac thudc co ddc tinh tren he tao mau n h u linezolid
Mot nhUng han che chu yeu cua nghien
v cUu la chi so bat ddng nhat I2 kha cao, dao ddng
tU61,77% den 97,72%, khien cho ket qua g d p chUa dai dien dupe cho tUng nhdm phan tich gdp Mac du ty le g d p xuat hien it nha't m o t ADE mot so phan nhdm cu the la cao han cac nhdm khac, phan tich gdp dudi nhdm cho thay khdng cd sU khac biet dang ke giUa cac phan nhdm nay, cd the tU cac yeu to cd kha nang gay sai lech, vi du n h u cac benh mac kem (suy than, viem gan, dai thao dudng, ) Chi so bat ddng nha't cao nhU vay chu yeu sU khac biet kha rd giOa cac nghien cUu phan, cu the la nhUng khac biet ve phuong phap nghien cUu n h u each djnh nghia hoac tieu chi chan doan bien cd bat Ipi/bien cd bat loi nghiem trpng, each theo ddi va t h u thap bien cd bat Ipi (vi d u : nghien cUu tien cUu cd can bp y te dupe dao tao bai ban so vdi nghien cUu hoi cUu dua tren bao cao tU nguyen tU benh nhan); khac biet ve mat lam sang n h u phac d o chuan ap dung d tUng qudc gia, yeu to nhan chung hoc, tieu chi lua chpn benh nhan dan den khac biet Idn ve thong ke Nguy co tiem tang gay sai lech theo ddi ADE n h u cac bien cd chi ghi nhan theo Idi ke cua benh nhan cung cd the anh hudng den tinh chinh xac cua ket qua nghien cUu Ngoai ra, nghien cUu gidi han ngudn tai lieu t i m kiem tU d u y nha't m o t ngudn dU lieu PubMed/Medline vdi chien lupc t i m kiem sUdung cac tU ddng nghla tren MeSH va chi I pa chpn bai baoTieng Anh khan hiem ve ngudn lUc tiep can vdi cac ngudn tai lieu it dupe chia se rdng rai khac n h u Embase, Google Scholar Mot han che khac nghien cUu la viec chUa thUc hien danh gia thien vj xuat ban de hudng tdi xac
(10)Nghien cuti difcfc & Thong tin thuoc 2017, Tap 8, So 1, trang 2-9
BAI NGHIEN CQU djnh them nhufng yeu to gay bat dong nha't giufa cac
nghien cud va kha nang anh hudng den ket qua phan tich gpp Ben canh do, nghien cUu cung khong the danh gia dope anh hudng cua ADE den ket qua dieu trj thieu cac duf lieu can thiet co lien quan chung toi khong the tiep can sau hon tdi dO lieu gdc cua cac nghien cud va ton trpng ghi nhan cua tdng bai bao dupe Ida chpn
Ket luan
TO phan tich gdp cho thay ty le xuat hien it nha't mot ADE la kha cao (68,2%) ty le gap it nha't
mot ADE nghiem trpng la 26,9% va ty le tO vong ADE la 3,2% (I2 = 61,77%) Cac bien co tren he tieu
hda la bien nha't (39,6%) sau la bien co tren rdi loan hong cau (18,8%) va cd tinh trang roi loan toan than (18,3%) Ket qua nghien cUu nhan manh viec can thiet phai theo ddi bieu hien lam sang cung n h u giam sat tinh trang cua benh nhan thong qua cac ket qua xet nghiem can lam sang t h u d n g quy suot qua trinh dieu trj de tarn soat cac bien co bat Ipi nghiem trpng cd nguy co xay de tU dd cd nhUng can thiep dieu trj phu hop
T A I L I E U T H A M K H A O
1. Egger Matthias, Davey-Smith George, et al (2008), Systematic reviews in health care: meta-analysis in context, John Wiley & Sons, pp.336-346
2 DeyT., Brigden G., et al (2013), "Outcomes of clofazimine for the treatment of drug-resistant tuberculosis: a systematic review and meta-analysis", J Antimicrob Chermother, 68(2), pp 284-293
3 Jiang R H., Xu H B., et al (2015), "Outcomes of Chinese herb medicine for the treatment of multidrug-resistant tuberculosis: a systematic review and meta-analysis", Complement Ther Med, 23(4), pp 544-554
4 Langendam M.W.,Tiemersma E.W., et al (2013), "Adverse events in healthy individuals and MDR-TB contacts treated with anti-tuberculosis drugs potentially effective for preventing development of MDR-TB: a systematic review", PLOS ONE, 8(1), pp 53599
5 Stroup D.F., Berlin J.A., et al (2000), "Meta-analysis of observational studies in epidemiology: a proposal for reporting Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group", JAMA, 283(15), pp 2008-2012
6 Wells G.A., Shea B., et al (2000), The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised
studies in meta-analyses, "http://www.ohri.ca/programs/clinical epidemioloqy/nos manual.pdf"
7 World Health Organisation - The Uppsala Monitoring Centre (2012), WHO Adverse Reaction
Terminology- WHO-ART
8 World Health Organisation (2015), Global tuberculosis report, pp.66-73
9 World Health Organisation (2014), Companion handbook to the WHO guidelines for the programmatic
management of drug-resistant tuberculosis pp 8-9; 18; 76-86; 149; 152-165
10 Wu S., Zhang Y., et al (2013), "Adverse Events Associated With the Treatment of Multidrug-Resistant Tuberculosis: A Systematic Review and Meta-analysis", American journal oftherapeutics, 23(2), pp 521-30
*Do khudn kho gidi ban so trang theo quy dinh cua tap chi, danh sdeh day du cac nghien cdu: lien he nhdm tdc gia deed thong tin chi tiet
"http://www.ohri.ca/programs/clinical epidemioloqy/no