免费文献传递   相关文献

Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine

中药上市后临床再评价样本含量估算



全 文 :rÇ_S¾?@Ö9:¨¤Z·©P
“”•
#
cde
!
!
9<9IJ¯K 9I°±²³I¯MNO
#
´µ
PMM[MM
$
ž;
%!
”÷;
!
\]­æArÇ
$
rÚÇ
%
_S¾Ö9:[‰?
!
Ø6rǟ ÏËJÓV—±_S¾[?@Ö9:ƒ
„

êAÆÖ9:0•³]|Ô[+/Ñ*+›
!
k»‰•ýO
!
¨¤·/Ô]?@ç¨á.r³]¼Ô›E›

Ý+
£ßè6ArÇ_S¾?@Ö9:ƒ„¨¤Z·.P[Fㅔ
!
t7ê)?@ƒ„¨¤·/Ô[s¤…”0ÄrÇ_S
¾?@Ö9:[¯-
!
6©F†´rÇèé›GEO›Ö9:r¨¤·[/ԅ”
!
êrÇ_S¾?@Ö9:¨¤Z·[©
Pµo‘

$
Ÿ ¡
%!

&
_S¾
&
?@9:
&
¨¤·
$
8$f
%!WMPPMNMXM^O
$
‘’Ep
%!
­æ
)
i¬ŠÇBÜ
*
ö÷i¬«u
$WMM_e+M_LMW;
MOM%&
r­rUö]Vl‚´Dƒ„uv
$eMPOO%
$
“Ž>”
%!
!
­®¯
!
ƒ„°
!
?@ãûA
!
ƒ„…†êrU?@9
:…”ƒ„
!@(&.$MPM% X^MP^^PP;OOMW!-;I$&. #`)$)bWMPM\A$#//F
G/IFG)
$
>”š›
%!
Üm›
!
?@ƒ„ã
!
‚&±×rUÇ?@bé9:ƒ
„
!@(&.$MPM% X^MP^^PP;OOLP!-;I$&. 6AVMOP[\ PWXfG/I
!!
\]­æArÇ
$
rÚÇ
%
_S¾ƒ„[iæ
!
Ø6rU
Ç­W»‚ÊJÑÊ[Aj‰Ÿ —±_S¾[?@Ö9
:ƒ„

]?@9:…ú[á.r
!
ûâ/ÔĚ[¨¤Z
·:,]rUǃ„±°

¤7Vê)rÇlá[¯-
F†rÇ_S¾?@Ö9:r©P¨¤Z·[…”•A
±×rÇ_S¾?@Ö9:NE[ZX貀


!
r
Ç_S¾[?@Ö9:ƒ„YZ­®ÇÌ[?@Ö9:
ƒ„
$
çi9:ÇÌ[EO›
%!
jÎ|Ø6rÇ[?@Ö
9:×&AÇÌ[èé›RÉÖ9:

ϝñõÈÃ
!
Ø6
rÇ_Sh?@ƒ„™ÂYgÞßAÇÌèé›9:ƒ„
[&

ÃÍrÇ[_S¾?@Ö9:¼èèé›9:´
èEO›9:

ê)?@Ö9:…úAèé›9:iEO
›9:i-[YZ
!
¨¤Z·[©P…”åè²YZ
!
ª
T<6©ArÇèé›9:ÑEO›9:r¨¤Z·©P
r[j‰DRÉF†

!
èé›9:[¨¤Z·©P
!b!
èé›9:Rè[¨¤Z·©P…”
!
¼è[èé›
?@9:ƒ„
!
¨¤Z·mê)(¨•-Ñ
$
J
%
#¨•-
[À+RÉ/Ô


!
¦)ùÔ*n8 
$
JÛÔ[(¨
•-
%
ª‰•[93´µ¨¤·
!
Ó¬›936‹
$U%(;
G0/) $)$&A00%
[…”.P¨¤·

936‹[…-Îï
%»)§CE[;äY6

ÃÍEêݵ
!
m]ƒ„hE
ýO6‹
$U/E(%$)$&A00%
.P¨¤·

ýO6‹Óê
ùÔ[(¨•-´µ|*ï¿[#¨•-

OÔ/h
!
´
µ[¨¤·\è•:[ýO
!
Ó]ùÔ[(¨•-Pª»
/ï%Kwè?@
Z
ö]@è[CE

]¬Ø6rÇ_S¾
?@èé›9:[á.r
!
.P¨¤·[ƒ„hýO6‹
䵨¤·À›[…”
P(

ê)?@ç¨[YZÉ|
RÉýO6‹
!
/Ô¨¤·

!b#
¨¤·©P[hµ¦q
!
]/ÔÖ9:?@ƒ„[¨
¤·h
!
ƒ„F×ù\‘ºªT[D

./‰£?@Ö9:ƒ„v[JvÀàá
W(

]¯
6rÇ_S¾?@èé›9:?@ç¨r
!
‚&ƒ„v[™
Î9:rÇ[èé›
!
ûƧ¿çÇÌiEÓÛjXAh.
Ærš\¥[èé›ÑEO›Jê´Æ.¿çÇiқA
“ÇjX‡é
#
ééJbéj”[0,

ƒ„àás‚&
ƒ„v[fµK
!
Ή¿çÇ[U]Jö]D[


ÛÔ[ƒ„v[
!
*!Ôj\[àá

àá[´µ#¼ƒ
„[v[

rÇèé›?@9:ç¨r[àám!Aç
¨rÇ]j‰±G[è雳K[I%
#
àÔJÙ.

P
û
!
Ù.ç¨rÇèûï[é•Î‰abé\[àá

š
é¿çrÇê_S¾ÇÌ
!
Ïè_ShJ_S¾Ø6?@ƒ
„n
!
ìû•ƒ„FåY/ÔÇÌiқA“ÇJEÓÛ
jX[é“É´
!
Y&p´‡éàáÑééàá
!
Ãê¼
W
 àáωá´ç¨ÇiA“ÇabjX[0•

þèË
èé[ƒ„á.
!
Ag”Ƀ„v[[àᴛĚ[ã.
…”AàáRÉ9:
!
8gAÆç¨0•wè|Ô[+/
Ñ*+›
!
k»‰•ýO
!
.PK²×&[¿çF

ÃÍ
!
ÎRɨ¤·.P7
!
\./‰.àá
!
ê)vÀàáï¨
/Ô¨¤·

ƒ„v[
$
àá
%#
ƒ„á.
#
ã.6‹
$
ï¨
ã.·
%
Ѩ¤·gš&|q

êk»j\降•[ýO

!
²×&[¿çF(vÓꨤ·

¨¤·/Ô]?@ç
¨á.r݉i&

´µÄš[ã.ï¨

‡é›ï¨J-“éï¨Ï6
/^M_W/
{
OX
ï{
WM
•
WMPP
÷
PM
²
!!!!!! ! ! ! ! ! !!!! ! ! ! !
S/&fOX! :004(!WM
TG2/b(%! WMPP
È\›rÇ_S¾èé›[?@9:

rÇab*g’
E›e
!
•bé|J耛X

ÃÍ
!
Ƨ¿çr
ÇiқA“Çwèjß[é•-i&

jߛ*Ôè
êl‡é›JH-“é›

Z‡¦qªl‡é›ç
¨²×[¨¤·m¬H-“é›ç¨
!
¾F´¬é
é›ç¨

]á.‡é›ç¨J-“é›ç¨7
!
¨¤·/
Ôތ]‹Å
!
Ãꨤ·/Ô#¼‡é#

‡é#ê2
Å
!
œ²×[¨¤·ê¬

ê)[j߃„0•/Ô[©
._
!
\Œ0ª´µ¥Ï

!b$
¨¤·©Pl§
!
ê)ýO6‹Rɨ¤·©P
!
&ƒ„F/ԏªn
.

!
´µu¡›8 
!
]t8
 
!
§1,CE¨&KCEŒ][•-0,
$
(¨•-
%

P֝*ï¿[8 
!
ÎÇÌק_,é
!
fƒ„F&»[
ÇÌèé[0,7
!
œKR(¨•-
!
|ŸÉ´ª´µ
Lg
[
u¡›8 
!
”Éßí([
_Lg
*n8 
&
ª5
!
]CE
[/Œ]7
!
»/ï%»CE[¢P\ꉕ8 
!
Ó´µ
‰•[ýO
!
ÎÇÌק_èé
!
fƒ„F&»[ÇÌ,
é[0,7
!
œKR#¨•-
!
|Ÿ#¨•-}Ü]
MfP h
MfW!
ÓýO
$P Q
#
%
´µ]
_Mg
J
NMg
]rÇ_S¾?
@Ö9:r
!
A¨¤·©Pr(¨•-J#¨•-[áÔ
D
!
ƒ„FY9:KR_£lâ| •-

ϝm(ê
(¨•-ê9:¸¹[i&Ñ
$
J
%
2i[•-
!
Òâ[…
”ζ·¸¹(¨•-
!
Z7Æe#¨•-
!
ÍÇ̧1
èé7»/ï%ÇÌbé[¢PYÁ

ìÎ(¨•- $Ñ
#¨•- #gšÎ͐1x
!
$\ #[3ÁfªW
!
WX #f
$´ 3Á

Z7WX $Ñ # [f|…}Îòa¨¤·

m
[³”Îm¡´µšÎ[¨¤·
!
}Ü $Ý*ï¿8 
!
>¶NÆ6 #

À¾
!
‘çÓÔwè?@@è[CE


Ø6rÇ_S¾?@Ö9:r
!
ƒ„[v[ÎƧç¨Çi
EÓÛ
$
JқA“Ç
%
jX[bé

ÃÍ
!
ÓÔs¨[‚&
0-CEwè?@@èJö]›œ-i&

m›*¼
½_£CE

û•ƒ„FáÔçï%Y¬[CE
!
V×&Y
e[¿çF

û•CEjAY6
!
V×&¬·[¿çF

*
_ÎD„]ã.]¥,s©g_[|?@¢Ð
!
\Ï?@
«æÑã.]æÐZ;/Ô
!
±«W`”j,Æ>0ÄÚ
¤éë9©
!
.PK*¿Î[CE

vh
!
Ïè|c–([
*_*‘
!
ûH¢M[?@L_*#
L II.*!
xùu[?
@L_*#ê
MfLW II/&/B
QP

Î?@L_w/Ô7
!
*
²#
PZL hPZW
À+CJXٌ([
PZPM hPZL
;RÉ
©P
O(

AÞæèã|?@L_$i[9:
!
<×&á.
Fê)?@«æiã.«æ[˨;RÉӏ

rÇ_S
¾?@èé›Ö9:rïÐ[pFêR§r[ÇÌ͛F
!
pF[ïÐ2ÿaÂÈ
!
Ä>›Ç*gaj£
!
ÇÌ[
bé;¬a™8

ÃÍ
!
_S¾èé›9:?@ç¨*_
[áÉYg_Sh&6

À0¨¤·/Ô×&‰tƒ„
r‚&0-À+C
$
!
%
[n

]ï%¼ÔCEÉ´ª
!
%
·…”ê9/
$
Óê6[ !
%!
0-!À[DE›ê6
!
²×
[¨¤·ê6

ϝ_S¾?@èé›9:[ïбG
aÂÈ
!
0-!À[DE›ò¬
!
ûïûq_S¾?@ƒ„
×&[¨¤·ò¬

Ώ_n/Ô¾Ó*Rɨ¤·©P
!
wþê)ç¨
á.
#
()¨âGã.…”[YZ´µYZ[.P–}

û
 ÉA“á.
W
¨¤Œ([XY
#
 ÉA“á.
W
¨¤
P[XY
#
 ÉA“á.™ÙŒ(GP[XY
#
Êùá.
#
Û
·
;
é\ƒ„‡

–}.P7×&ç¨ÙiA“Ù‚&
0-!À[j‰(
!
ûŒ(JP‡
!
¼c([/Ô*C
gjß[h•ƒ„7«J—±6â[‰§¨&»
!
]7«s
©E¼Ñ‰§¨w—±[É´ª*0Ä?@«æ[@#
RÉ©.

#
EO›9:[¨¤Z·©P
EO›Ö9:ÎrÇ_S¾?@Ö9:[i-
!
ƒ„i
-]RÑï%ǟ_S¾]6¬±Gr\›É´ªŠ
[
#
¸#[Y“”!
Â#aOT[ǟEO›…T[n


EO›Ö9:ƒ„[—±×&ßÝ[¨¤Z·
!
Â&
Y|[ï¨ég

û•¨¤Z·Yß
!
{wR|cãP
-X[¸#Y“”
vh
!
rÇ[EO›9:ß&»irÇbé9:jZ
[‰?
!
rÇ,
)
-’E›
*
[!ã(©
!
a…t´r
Ç[EO›9:

ÃÍ]?@Ö9:…úrmê)A‚
&béD·[ƒ„h‚&béD·ýO6‹
!
Rɨ¤·
.P

û•ê)EO›D·
!
ûY“×qãP.P¨¤·
*g×&Y¬[¨¤·
!
DªãPYX7

Pûû•ã

PZP
þ
!
œêº»|P×q
!
V×&
PM MMM
M¿çF

)ã.¬Ø6?@ç¨*RÉïC[ãP¬6Qê
MfMP
G_
^(

캻›ÔJƒ„m*9:[ãPê
MfMMP
G_

ièé›9©YZ[Î
!
EO›9:[j‰àám
ß&»á6[Ôè

ÃÍ
!
6AEO›9:[ã.]…”
Yêè#

A“Ñ-A“?@ç¨rÂ&[EO›()™
›¾£›ã.
!
&»[0,™ê
.
ðñÙrY“×q[
ãPJY“×qãPYZ[¿aÙpF[lâ6ñJý
}

ק_
!
]?@ç¨r
!
þÎê)§|Y“”\[
ãPJjAH|AEO›()RÉ50

ÃÍ
!
—Ä
¥[ã.]…”;+/f*+Q9©ÇÌ[EO›Dê
‡Ø

û&RrÇ[¸#Y“”\׫üá.º»›ƒ
„…ú
!
>©.‘»×q[ãPJ©.=Ö¥Ùgš[
CE

9›¢P,6‹]R訤·ªR§Y“”\[
¢P

$
60
rÇ_S¾?@èé›9:¨¤Z·[/ÔÓÎ]‰
•[ýOщÔu¡›8 gª
!
A,éàáRÉï¨

rÇ_S¾EO›Ö9:¨¤Z·[.PÞæèڎ[…
/LM_W/
{
OX
ï{
WM
•
WMPP
÷
PM
²
!!!!!! ! ! ! ! ! !!!! ! ! ! !
S/&fOX! :004(!WM
TG2/b(%! WMPP
”!
×ê)ÇÌláY“”\[ãPGƒ„á.¨â/
Ô
!
ArÇ?@èé›9:rßgk»ã.]u¡@è[
EO›9:0•`ÎÇÌEO›[i&nO
!
Y…æ

r
Ç_S¾?@9:¨¤·.P]§1•Er£ä<»|c
§1D
!
ûÎrÇèé›?@9:šÄbéûƤ¾
(
#
§¨À!À¾(GãY·RÉ9:7
!
.P¨¤·
׏ƒ„F(êÀi&[|!À;RÉ.P
!
JÎê)Y
Z[bé!À6©.P¨¤·À0´#À¬F
&
¨¤·.P
²×[Ði&(û0-!À[Œ(JP
#
wè?@@è
[CE¬6G‚&0-À+C‡[/ÔYê:w


TÎϝrÇh•?@ƒ„s©[Yß
!
Q|…TÎrÇ_
S¾ƒ„åÎ|Š[ƒ„¯°
!
ª…”]!ûÞY¶O
!
_S¾?@ƒ„(i?@h2Å\;A“ç¨[(Y
Z
!
ìÎö]*+[Â#¼c(åÎ|wD

ÃÍ
!
r
Ç_S¾?@9:¨¤Z·.P…”£è6¬rǃ„
NEF™NEr[UÅ
!
Z7×&iã.]æÐZ;N@
ĚÄrÇ_S¾?@9:¯-
!
Rè¦qgÝÞß
!

›C[•E…”

$
œ‡ˆ
%
P(!1#() #4)*!94) 1#$/!.$)0#()*a$)*f1$IU&(0`(G$&G4&$2/)0
) G&)G$&%(0($%G#<(FW)5 (52/)fB/)5/).@$A&/%mJ%$)G0
?%/4U!WMMN.[f
W(!
­æhŸÇŸWi¥2
f
Ç̃„÷Ñ!ûȜ
$WMML
÷
%
<(f
øù
.
r­UÇö÷KÂÈ
!WMMX.PXPf
O(!
4RÖ
f
F†ÇÌ?@ç¨r¨¤Z·Gj‰D
9(f

?@Ç¥]£¤
!WMM[!WO$P%.XNf
^(!1#() #4)*!9()U(B4fR(0*) $)5 $)$&A00/6G&)G$&2%$&0.
G/)G(U20$)5 I(2#/5/&/*(0<(fW)5 (52/)f./b/V(). 9/#);:);
2(%0G()G(:)G!WMM^.^ONf
=/.O1AK0ZAL/1LI1/D0BC0CL10C0L/1OBKD-./GVAD0CW AS/1I/D0BC
BNDG/H0D0BC/12E0CAKA.AH0L0CA
J,c)*V4)! +:-c$)I)*
!
$#$!%!&!()*+$%,-$+.,/ %# 01%#%,+123%,%#! 0/%#+ 4,+356()0/%#$23%,+17,%#,$! *%8%#9 PMM[MM! 0/%#+%
6MKDG/LD( :) %(G()2A($%0!$02#(#)(0(*/D(%)I()2$)5 U(/U&(U$AI/%($2()2/) /) 2#(U/02;I$%V(2)*%(0($%G# /6#)(0(
<(5G)(!U$%2/62%$52/)$&#)(0(I(5G)(b%((5 #$0/%0$b/422/b(*) $62(%2#(&02)*/6U/02;I$%V(2)*(D$&4$2/) 0245Af:) 2#(
U/02;I$%V(2)*(D$&4$2/) 5(0*)!0$IU&(0`(G$&G4&$2/) U&$A0$5(G0D(%/&(f:2)/2/)&A()04%(02#($GG4%$GA$)5 %(&$b&2A/6U/02;
I$%V(2)*(D$&4$2/)fb42$&0/$004%(02#$22#()2()5(5 2%$&0E&#$D($5(0%(5 U/E(%6/%G/%(G2&A5(2(G2)*$G&)G$&AI($))*64&
56(%()G(/656(%()2I(5G)(4)5(%0245A604G# $56(%()G(2%4&A(K020f,U 2/)/E! 2#(%(0)/0A02(IGI(2#/5 /60$IU&(0`(G$&;
G4&$2/) ) D(E/62#(2%$52/)$&#)(0(I(5G)(f:) 2#0U$U(%!$GG/%5)*2/2#(b$0GI(2#/5 /60$IU&(0`(G$&G4&$2/) $)5 2#(
G#$%$G2(%02G/62#(2%$52/)$&#)(0(I(5G)(G&)G$&(D$&4$2/)! 2#(0$IU&(0`(G$&G4&$2/) I(2#/50/62#(#)(0(I(5G)((6;
G$GA$)5 0$6(2A$%(50G400(5 %(0U(G2D(&Afa(#/U(2#(U$U(%E/4&5 b(b()(6G$&2/I(5G$&%(0($%G#(%0! $)5 U#$%I$G(42G$&0G();
2020E#/$%(()*$*(5 ) 2#($%($0/6#)(0(I(5G)(%(0($%G#
[AF XBGHK(!2%$52/)$&#)(0(I(5G)(& U/02;I$%V(2)*& G&)G$&(D$&4$2/)& 0$IU&(0`(
HB0.!+c%#)RLYL..#+!!#+$*
$
•–$Q
!
—˜™
%
/XM_W/
{
OX
ï{
WM
•
WMPP
÷
PM
²
!!!!!! ! ! ! ! ! !!!! ! ! ! !
S/&fOX! :004(!WM
TG2/b(%! WMPP