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/Patients Hi chng vnh cp khng c khong ST chnh 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) 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
1) CI-AKI c xc nh bi cc tiu ch khc;
Tiu ch ph :
2) S xut hin CI-AKI trong cc phn nhm ri ro c xc nh trc;
3) 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;;
4) t vong do mi nguyn nhn hoc t l nhi mu c tim khng gy t vong 6 thng.
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].
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:
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 ch 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
 Table 4 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

Phin gii kt qu tiu ch chnh:

Table 2 Tch ly theo tiu ch chnh v tiu ch thay th:
 Nhm Nhm
dng 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 72 hours 17 (6.7) 38 (15.1) 0.41 (0.22 - 0.74) 0.003 0.38 (0.20 - 0.71) 0.003
Additional end-points (different CI-AKI
criteria):

Creatinine 0.5 mg/dl or 25% within 48 hours 16 (6.3) 30 (11.9) 0.50 (0.27 - 0.95) 0.033 0.48 (0.25 - 0.91) 0.025

Creatinine 0.3 mg/dl within 48 hours 9 (3.6) 22 (8.7) 0.39 (0.17 - 0.86) 0.02 0.35 (0.15 - 0.83) 0.017

Creatinine 0.3 mg/dl within 72 hours 11 (4.4) 27 (10.7) 0.38 (0.18 - 0.78) 0.009 0.36 (0.17 - 0.77) 0.009

Creatinine 0.5 mg/dl within 72 hours 6 (2.4) 15 (5.9) 0.38 (0.15 - 1.01) 0.052 0.43 (0.15 - 1.23) 0.115

eGFR 25% within 72 hours 14 (5.6) 29 (11.5) 0.45 (0.24 - 0.86) 0.015 0.44 (0.23 - 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 Sau khi tc

Statin Nhm chng (95% CI) ng (95% CI) 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:
+ < 60 ml/pht: p<0.05 => Kt qu c ngha thng k.
+ 60 ml/pht: p>0.05 => Khc bit khng c ngha thng k.
- PCI:
+ C: p<0.05 => Kt qu c ngha thng k.
+ Khng: p ORc < 0.05 => Kt qu c ngha thng k.
p ORadj >0.05 => Khc bit khng c ngha thng k.
- Nguy c cao:
+ C: p<0.05 => Kt qu c ngha thng k.
+ Khng: p>0.05 => Khc bit khng c ngha thng k.
- Th tch thuc cn quang:
+ > 140 ml: p>0.05 => Khc bit khng c ngha thng k.
+ 140 ml: p<0.05 => Kt qu c ngha thng k.
- Ch s nguy c CI-AKI:
+ 5 : p<0.05 => Kt qu c 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
nng p dng vo tr li cc cu hi lm sng.
Ni dung ca tiu ch (1) Kt qu ca tiu Kh nng p dng Kh nng p
ch (2) lm sng (3) dng cho
tnh hung
thng tin
thuc (4)
1. T l tng creatinine Tiu ch chnh ca Gim tuyt i CI- - Ch tr li
huyt thanh 0.5 mg / dL CI-AKI xut hin AKI trong nhm c hiu
hoc 25% so vi gi tr 55 bnh nhn statin l 8,4% c qu ca statin
creatinine ban u trong (10,9%): 17 (6,7%) ngha l s ngi cn (rosuvastatin)
vng 72 gi sau khi dng nhm statin v 38 iu tr (NNT) l 12 trong d
statins (15,1%) trong nhm bnh nhn ngn phng CI-
i chng vi t s nga 1 trng hp AKI, cha tr
ORC l 0,41 (95% CI-AKI. Mc d s li c cu
tin cy khong khc bit ca nhm hi v an
[CI]: 0,22 - 0,74; p = s dng Statin vi ton ca
0,003). Ngay c khi nhm chng l c statin.
iu chnh tui, gii ngha thng k
- i tng
tnh, tiu ng, cao nhng nghin cu
bnh nhn
huyt p, LDL- khng cp ti
tha hng:
cholesterol, c nh gi effect size
bnh nhn
lng CrCl, LVEF, v ngng NI v vy
cha tng
CI-AKI v khi cha kt lun c
dng statin
lng tng phn, s dng Statin c
c hi chng
OR ny vn rt c em li ngha lm
mch vnh
ngha (ORadj: 0.38, sng hay khng. Do
cp khng c
95% CI: 0.20 - 0.71, p dng trong
ST chnh, c
p =0,003). lm sng cn thu
k hoch can
thp thm thng tin,
2. CI- Creatinine iu tr statin khi thip sm.
d liu a ra
AKI 0.5 mg/dl or nhp vin lin quan
quyt nh. - Liu v liu
c xc 25% within 48 n vic gim t l
trnh dng:
nh bi hours CI-AKI ph hp khi
(p=0,025) s dng cc tiu ch
cc tiu Creatinine CI-AKI khc: CI- rosuvastatin
ch khc 0.3 mg/dl AKI ca creatinine 40mg lc
within 48 0,3 mg / dl trong 48 nhp vin v
hours gi (ORadj: 0,35, gim cn
(p=0,017) 95% CI: 0,15 - 0,83; 20mg/ngy
p = 0,017) Cc kt (10mg/ngy
Creatinine
qu cho thy s i vi BN
0.3 mg/dl
gim ng k s c eGFR <
within 72
pht trin CI-AKI 30
hours
trong tt c cc loi ml/pht/m2)
(p=0,009)
ri ro c xc nh
Vy a
Creatinine trc ca bnh nhn.
ra cu tr li
0.5 mg/dl c bit gim ng
thng tin
within 72 k, dao ng trong
thuc cn
hours(p=0,115) khong t 54 n
tham kho
65%, c quan st
eGFR 25% thm cc bi
nhng bnh nhn
within 72 bo, ti liu
c eCrCl ng c
hours(p=0,016) khc.
s <60 ml / pht (p =
0.014), EF <45%
(0.020), cc c
im lm sng c
nguy c cao pht
trin CI-AKI p =
0,016) v nhng
i tng c PCI (p
= 0,036). Hn na,
li ch ca iu tr
statin l khng ph
thuc vo gii tnh
v c xu hng tch
cc nhng bnh
nhn c (p = 0.081),
nhng ngi c
CI-AKI> 5 (p =
0.07)
3. S xut hin CI-AKI Nhm dng Statin
trong cc phn nhm ri gim nguy c mc
ro c xc nh trc 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.
4. Cc bin c v tim Tng s xut hin
mch v thn xy ra trong bin chng t nht
30 ngy bao gm suy thn mt ln gim
cp tnh i hi chy thn, nhm dng statin c
suy thn ko di, t vong ngha thng k.
do tt c cc nguyn nhn,
nhi mu c tim hoc t
qu
5. T vong do mi nguyn T l ny nhm Khng p
nhn hoc t l nhi mu dng statin l 3.6% dng trong
c tim khng gy t vong so vi 7.2%, vi tnh hung
6 thng p=0.07 khng c thng tin
ngha thng k. thuc