I HC DC H NI

B mn Dc Lm sng

Bo co kt qu phin gii RCT

Nhm 2- N1K69
 BO CO KT QU PHIN GII RCT
I. Tnh hung s:Bi 2.
II. Bng phn cng cng vic cc thnh vin trong nhm:

STT H v tn T - lp Phn cng cng vic

1 iu Minh Chu 05-N1K69 Cu 1,2,3

2 Phan c Bnh 04-N1K69 Cu 4,5

3 L Hng Giang 04-N1K69 Cu 4,5

4 Trn Vn Hng 05-N1K69 Cu 1,2,3

5 Trn Linh Giang 04-N1K69 Cu 1,2,3

6 Trn Th Thu Qunh 04-N1K69 Cu 6

III. Ni dung bo co
Phn tch ni dung ca bi bo co RCT:
Phn tch ni dung ca bi bo co RCT bng cch tr li cc cu hi di y mt cch NGN GN:
1. Cu hi nghin cu: (Ni dung cu hi? Cu hi nghin cu c r rng khng? Gii thch)
2. Tiu ch nh gi chnh/ph: (Ni dung cc tiu ch? Tiu ch nh gi c khch quan v phc v cho
mc tiu nghin cu?)
3. c tnh ban u trc khi dng thuc ca hai nhm c ging nhau? (Thng xem bng 1 ca cc
RCT, bn lun nu c bt thng).
4. Kt qu ca cc tiu ch chnh v ph? Phin gii kt qu cho tiu ch chnh.
5. Kt qu ca cc phn tch phn nhm (nu c). Phin gii kt qu ca cc phn tch phn nhm.
6. T l bnh nhn b d? (Bn lun nu c bt thng)
1.Cu hi nghin cu:
Nghin cu RCT nh gi hiu qu bo v khi s dng sm cc statin thn nc
(rosuvastatin) trn tn thng thn cp do s dng thuc cn quang (CI-AKI), tn
thng tim, kt tp tiu cu v iu ho min dch bnh nhn c hi chng vnh cp
khng c khong ST chnh ln.

P Population/Pati Hi chng vnh cp khng c khong ST chnh

ents ln

I Intervention Statin (rosuvastatin)

C Comparison Khng r rng
O Outcome Hiu qu trn d phng CI -AKI
(S) Study design Tin cu, RCT
Nhn xt: Cu hi nghin cu cha r rng v Comparison:
Do ngi c t ngm hiu so snh 2 phung php: (rovustatin v liu
php chng kt tp tiu cu)
2.Tiu ch nh gi :
Tiu ch chnh:
S tng creatinine 0.5 mg/dL hoc 25% so vi gi tr nn bnh thng sau 72h dung np
thuc.
Tiu ch thay th
CI-AKI c xc nh bi cc tiu ch khc;
Cc tiu ch xc nh khc cho CI-AKI l:
Tng creatinine huyt thanh 0.5 mg / dL hoc 25% so vi gi tr ban u trong vng 48
gi;
Tng creatinine 0,3 mg / dl trong vng 48 gi; tng creatinine 0,5 mg / dl trong vng 72
gi;
Tng creatinine 0,3 mg / dl trong vng 72 gi; gim eGRF 25% trong vng 72 gi [6,10].
Tiu ch ph :
1) S xut hin CI-AKI trong cc phn nhm ri ro c xc nh trc;
2) Cc bin c v tim mch v thn xy ra trong 30 ngy bao gm suy thn cp
tnh i hi chy thn, suy thn ko di, t vong do tt c cc nguyn nhn,
nhi mu c tim hoc t qu;;
3) t vong do mi nguyn nhn hoc t l nhi mu c tim khng gy t vong
6 thng.
3. c tnh ban u trc khi dng thuc ca 2 nhm :
- c tnh ban u ca qun th bnh nhn khng c s khc bit ng k gia nhm
chng v nhm th v: nhn khu hc, tui, i tho ng, suy gim chc nng
thn, phn sut tng mu v biu hin lm sng.
Kt lun: Khng c s khc bit gia c tnh ca 2 nhm trc khi dng thuc:
4. Kt qu tiu ch chnh:
Kt qu tiu ch chnh: T l mc Ci-AKI nhm dng statin gim ng k so vi nhm chng ln
lt tng ng vi 6.7% v 15.1%, ORadj = 0.38, khong tin cy 95%, 0.20-0.71, p=0.003).
Kt qu tiu thay th:
Kt qu tiu ch gim t l Ci-AKI c nh gi theo cc tiu chun khc:
Additional end-points (different CI-AKI criteria):
Creatinine 0.5 mg/dl or 25% trong 48 h: Nhm Statin: 16 (6.3); Nhm chng 30 (11.9%) Orc: 0.50
(0.27 - 0.95) p 0.033; ORadj 0.48 (0.25 - 0.91) p0.025
Creatinine 0.3 mg/dl trong 48 h: Nhm Statin 9 (3.6%); Nhm Chng 22 (8.7%) ORc:0.39 (0.17 -
0.86) p 0.02; ORadj: 0.35 (0.15 - 0.83) p 0.017
Creatinine 0.3 mg/dl trong 72 h Nhm Statin 11 (4.4%) ; Nhm Chng 27 (10.7%) ORc 0.38 (0.18 -
0.78) p 0.009; ORadj 0.36 (0.17 - 0.77)p 0.009
Creatinine 0.5 mg/dl trong 72 h Nhm Statin 6 (2.4%) ; Nhm Chng 15 (5.9%) ORc 0.38 (0.15 -
1.01) p 0.052; ORadj 0.43 (0.15 - 1.23)p 0.115
eGFR 25% trong 72 h Nhm Statin 14 (5.6%) ; Nhm Chng 29 (11.5%) ORc 0.45 (0.24 - 0.86) p
0.015; ORadj 0.44 (0.23 - 0.86)p 0.016
Kt qu tiu ch ph
+Kt qu tiu ch Cc bin c v tim mch v thn xy ra trong 30 ngy bao gm
suy thn cp tnh i hi chy thn, suy thn ko di, t vong do tt c cc nguyn
nhn, nhi mu c tim hoc t qu : Gim nhm dng Statin; Tng s xut hin
bin chng (t nht 1) nhm Statin 9 (3.6%) nhm chng 20 (7.9%) p=0,036. ( bng
4)
+Kt qu ca tiu ch S xut hin CI-AKI trong cc phn nhm ri ro
c xc nh trc: Nhm dng Statin gim nguy c mc CI-AKI c ngha
thng k phn nhm: tui <70; Gii tnh Nam v N; Bnh nhn khng
c tin s i tho ng; LVEF 45% vi ch s ORc; LVEF > 45% vi
Oradj; eCrCl < 60ml/ph; Bnh nhn c nguy c cao; Bnh nhn s dng thuc
cn quang 140ml v ch s nguy c CI-AKI 5. (Bng 3)
+Kt qu tiu ch t vong do mi nguyn nhn hoc t l nhi mu c tim
khng gy t vong 6 thng: nhm Statin 3,6 % so vi 7,2% nhm
chng vi p=0,07
 Kt qu tiu ph

Statin Control
p-value*
(n=252) (n=252)

Thm tch - 2 (0.8) 0. 50

CI-AKI mn tnh 5 (2) 12 (4.8) 0. 15
Nguy c tin trin thnh Nhi mu
c tim 2 (0.8) 5 (2) 0.45
t qu - - -
Tng t vong 2 (0.8) 3 (1.2) >0.90
Tng s xut hin bin chng (t
nht 1) 9 (3.6) 20 (7.9) 0.036
 Tch ly theo tiu ch chnh v tiu ch thay th:
Nhm
dng Nhm
statin chng ORc (95% CI) p-value ORadj (95% CI) p-value

Primary CI-AKI end-point

Creatinine 0.5 mg/dl or 25% within 0.41 (0.22 - 0.38 (0.20 -
72 hours 17 (6.7) 38 (15.1) 0.74) 0.003 0.71) 0.003
Additional end-points (different CI-AKI
criteria):
Creatinine 0.5 mg/dl or 25% within 0.50 (0.27 - 0.48 (0.25 -
48 hours 16 (6.3) 30 (11.9) 0.95) 0.033 0.91) 0.025
Creatinine 0.3 0.39 (0.17 - 0.35 (0.15 -
mg/dl within 48 hours 9 (3.6) 22 (8.7) 0.86) 0.02 0.83) 0.017
Creatinine 0.3 0.38 (0.18 - 0.36 (0.17 -
mg/dl within 72 hours 11 (4.4) 27 (10.7) 0.78) 0.009 0.77) 0.009
0.38 (0.15 - 0.43 (0.15 -
Creatinine 0.5 mg/dl within 72 hours 6 (2.4) 15 (5.9) 1.01) 0.052 1.23) 0.115
0.45 (0.24 - 0.44 (0.23 -
eGFR 25% within 72 hours 14 (5.6) 29 (11.5) 0.86) 0.015 0.86) 0.016
- im kt thc ca CI-AKI xut hin trn 55 bnh nhn (10.9%): 17 bnh nhn nhm
dng statin (6.7%) v 38 bnh nhn nhm chng (15.1%). Ch s ORc l 0.41 (khong
tin cy 95%: 0.22-0.74, p=0.003). Nu xt thm yu t tui, gii tnh, i tho ng,
tng huyt p, LDL-cholesterol, CrCl, LVEF, cc ch s nguy c ca CI-AIK th ch s
OR l ORadj = 0.38 (khong tin cy 95%: 0.20-0.71, p=0.003). Vi p < 0.05, khc bit
c ngha thng k.
- OR < 1 => t s odd gp bin c ca nhm dng statin thp hn odd gp bin c ca
nhm chng.
- T l mc CI-AKI nhm dng Statin gim so vi t l ca nhm chng l 8.4% ngha l
NTT l phi iu tr 12 bnh nhn ngn nga 1 ca mc CI-AKI.
5. Kt qu cc phn tch nhm:
Table 3 Crude and Adjusted Odds Ratio for primary end-point occurrence in pre-
specified risk subgroups
Nguy c / Nguy c / ORc p OR adj p
p-value p-value

Nhm dng Sau khi tc

Statin Nhm chng (95% CI) ng (95% CI) Sau khi tc ng

Tui 0.07 0.06

70 tui 13 / 117 22 / 113 0.52 (0.25-1.08) 0.081 0.55 (0.25-1.20) 0.136
< 70 tui 4 / 135 16 / 139 0.23 (0.08-0.72) 0.011 0.19 (0.06-0.63) 0.006
Gii tnh 0.61 0.50
Nam 11 / 166 22 / 165 0.46 (0.22-0.98) 0.046 0.44 (0.20-0.98) 0.044
N 6 / 86 16 / 87 0.33 (0.12-0.90) 0.030 0.28 (0.10-0.79) 0.017
C tin s i tho
ng 0.80 0.49
yes 6 / 50 13 / 57 0.46 (0.16-1.32) 0.150 0.47 (0.15-1.51) 0.205
no 11 / 202 25 / 195 0.39 (0.19-0.82) 0.013 0.32 (0.15-0.70) 0.004
C s LVEF 0.76 0.88
45% 9 / 84 21 / 85 0.37 (0.16-0.85) 0.020 0.43 (0.17-1.05) 0.063
> 45% 8 / 168 17 / 167 0.44 (0.18-1.05) 0.065 0.37 (0.15-0.92) 0.033
C s eCrCl 0.64 0.79
 < 60 ml/min 9 / 105 22 / 105 0.35 (0.15-0.81) 0.014 0.36 (0.15-0.87)
60 ml/min 8 / 147 16 / 147 0.47 (0.20-1.14) 0.094 0.39 (0.15-1.00)
PCI 0.62
yes 12 / 171 23 / 162 0.46 (0.22-0.95) 0.036 0.41 (0.19-0.89)
no 5 / 81 15 / 90 0.33 (0.11-0.95) 0.040 0.33 (0.10-1.03)
Nguy c cao 0.22
yes 16 / 180 30 / 169 0.45 (0.24-0.86) 0.016 0.44 (0.23-0.86)
no 1 / 72 8 / 83 0.13 (0.02-1.08) 0.059 0.12 (0.01-1.04)
Th tch thuc cn
quang 0.57
>140 ml 10 / 117 17 / 101 0.46 (0.20-1.06) 0.069 0.43 (0.17-1.06)
140 ml 7 / 135 21 / 151 0.34 (0.14-0.82) 0.017 0.37 (0.15-0.94)
Ch s nguy c CI-AKI 0.73
5 8 / 187 22 / 193 0.35 (0.15-0.80) 0.013 0.31 (0.13-0.72)
>5 9 / 65 16 / 59 0.43 (0.17-1.07) 0.070 0.56 (0.21-1.5)
Phin gin kt qu phn tch phn nhm:

- Tui:
+ 70 tui: p>0.05 => Khc bit khng c ngha thng k.
+ < 70 tui: p<0.05 => Kt qu c ngha thng k.

- Gii tnh:
+ Nam: p<0.05 => Kt qu c ngha thng k.
+ N: p<0.05 => Kt qu c ngha thng k.

- Tin s i tho ng:

+ C: p>0.05 => Khc bit khng c ngha thng k.
+ Khng: p<0.05 => Kt qu c ngha thng k.

- C s LVEF:
+ 45%: p ORc < 0.05 => Kt qu c ngha thng k.
p ORadj >0.05 => Khc bit khng c ngha thng k.
+ > 45%: p ORc >0.05 => Khc bit khng c ngha thng k.
p ORadj < 0.05 => Kt qu c ngha thng k.
- C s eCrCl: - Nguy c cao:
+ < 60 ml/pht: p<0.05 => Kt qu c ngha thng + C: p<0.05 => Kt qu c ngha thng k.
k. + Khng: p>0.05 => Khc bit khng c ngha
+ 60 ml/pht: p>0.05 => Khc bit khng c thng k.
ngha thng k. - Th tch thuc cn quang:
- PCI: + > 140 ml: p>0.05 => Khc bit khng c ngha
+ C: p<0.05 => Kt qu c ngha thng k. thng k.
+ Khng: p ORc < 0.05 => Kt qu c ngha thng + 140 ml: p<0.05 => Kt qu c ngha thng k.
k. - Ch s nguy c CI-AKI:
p ORadj >0.05 => Khc bit khng c + 5 : p<0.05 => Kt qu c ngha thng k.
ngha thng k.
+ > 5 : p>0.05 => Khc bit khng c ngha thng
k.
6. T l bnh nhn b d:

C 543 bnh nhn cha tng iu tr statin c ngu nhin ha sau khi nhp vin. Nh vy
271 bnh nhn c ch nh s dng rosuvastatin liu cao( nhm statin ) v 272 bnh nhn
khng iu tr statin (nhm chng). Sau khi ngu nhin ha, 39 bnh nhn c loi b khi
phn tch cui cng v nhng l do: 17 ngi khng tri qua chp mch, 22 ngi khng xc
nh c creatinine. Nh vy, tng cng 504 bnh nhn c phn tch: 252 ngi c iu tr
rosuvastatin v 252 ngi i chng.
Vy, t l bnh nhn b d l : 39/543= 7,18%
 Cc kt qu chnh ca bi bi RCT
+ Trnh by cc kt qu phn tch chnh, cc kt qu phn tch ph. Nu kh
Ni dung ca tiu ch (1) Kt qu ca tiu ch (2) Kh nng p dng lm sng (3) Kh nng p dng cho tnh hung
thng tin thuc (4)
1. T l tng creatinine Tiu ch chnh ca CI-AKI Gim tuyt i CI-AKI trong - Ch tr li c hiu qu ca
huyt thanh 0.5 mg / xut hin 55 bnh nhn nhm statin l 8,4% c ngha statin (rosuvastatin) trong d
dL hoc 25% so vi (10,9%): 17 (6,7%) nhm l s ngi cn iu tr (NNT) phng CI-AKI, cha tr li c
gi tr creatinine ban u statin v 38 (15,1%) trong l 12 bnh nhn ngn cu hi v an ton ca statin.
trong vng 72 gi sau nhm i chng vi t s nga 1 trng hp CI-AKI.
- i tng bnh nhn tha
khi dng statins ORC l 0,41 (95% tin Mc d s khc bit ca
hng: bnh nhn cha tng
cy khong [CI]: 0,22 - nhm s dng Statin vi dng statin c hi chng mch
0,74; p = 0,003). Ngay c nhm chng l c ngha
vnh cp khng c ST chnh, c
khi iu chnh tui, gii tnh, thng k nhng nghin cu
k hoch can thip sm.
tiu ng, cao huyt p, khng cp ti nh gi
LDL-cholesterol, c lng effect size v ngng NI v - Liu v liu trnh dng:
CrCl, LVEF, CI-AKI v khi vy cha kt lun c s rosuvastatin 40mg lc nhp vin
lng tng phn, OR ny dng Statin c em li ngha v gim cn 20mg/ngy
vn rt c ngha (ORadj: lm sng hay khng. Do (10mg/ngy i vi BN c eGFR <
0.38, 95% CI: 0.20 - 0.71, p p dng trong lm sng cn 30 ml/pht/m2)
=0,003). thu thp thm thng tin, d
Vy a ra cu tr li thng tin
liu a ra quyt nh.
thuc cn tham kho thm cc bi
bo, ti liu khc.
2. CI-AKI c Creatinine 0.5 iu tr statin khi nhp vin lin quan n vic gim t l
xc nh bi cc mg/dl or 25% CI-AKI ph hp khi s dng cc tiu ch CI-AKI khc: CI-
tiu ch khc within 48 hours AKI ca creatinine 0,3 mg / dl trong 48 gi (ORadj:
(p=0,025) 0,35, 95% CI: 0,15 - 0,83; p = 0,017) Cc kt qu cho
Creatinine 0.3 thy s gim ng k s pht trin CI-AKI trong tt c
mg/dl within 48 cc loi ri ro c xc nh trc ca bnh nhn. c
hours (p=0,017) bit gim ng k, dao ng trong khong t 54 n
Creatinine 0.3 65%, c quan st nhng bnh nhn c eCrCl
mg/dl within 72 ng c s <60 ml / pht (p = 0.014), EF <45% (0.020),
hours (p=0,009) cc c im lm sng c nguy c cao pht trin CI-
Creatinine 0.5 AKI p = 0,016) v nhng i tng c PCI (p = 0,036).
mg/dl within 72 Hn na, li ch ca iu tr statin l khng ph thuc
hours(p=0,115) vo gii tnh v c xu hng tch cc nhng bnh
eGFR 25% within nhn c (p = 0.081), nhng ngi c CI-AKI> 5 (p =
72 hours(p=0,016) 0.07)
3. S xut hin CI-AKI Nhm dng Statin gim nguy c mc CI-
trong cc phn nhm ri ro AKI c ngha thng k phn nhm:
c xc nh trc tui <70; Gii tnh Nam v N; Bnh
nhn khng c tin s i tho ng;
LVEF 45% vi ch s ORc; LVEF >
45% vi Oradj; eCrCl < 60ml/ph; Bnh
nhn c nguy c cao; Bnh nhn s
dng thuc cn quang 140ml v ch s
nguy c CI-AKI 5.

4. Cc bin c v tim mch Tng s xut hin bin chng t nht mt

v thn xy ra trong 30 ln gim nhm dng statin c ngha
ngy bao gm suy thn cp thng k.
tnh i hi chy thn, suy
thn ko di, t vong do tt
c cc nguyn nhn, nhi
mu c tim hoc t qu
5. T vong do mi nguyn T l ny nhm dng statin l 3.6% so Khng p dng trong tnh
nhn hoc t l nhi mu vi 7.2%, vi p=0.07 khng c ngha hung thng tin thuc
c tim khng gy t vong thng k.
6 thng
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