注射用重组人TNK组织型纤溶酶原激活剂说明书.pdf

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20151218
TNK
TNK?
RecombinantHumanTNKTissue-typePlasminogenActivatorforInjectionrhTNK-
tPA
ZhusheyongChongzuRenTNKZuzhixingXianrongmeiyuanjihuoji
TNK
80
6
xio7iu/16mg/
ST1616rhTNK-tPA13
,510
rhTNK-tPA
5
28oC24
,
1
1.
rhTNK-tPA16mgrt-PA50mg
(n=124)(n=127)
1%1%
8%6%
6%4%
4%4%
3%5%
2%3%
1%4%
1%
0
%
/
ASSENT-2TNK-tPA
Tenecteplase,TNKase?Metalyse?
rt-PA%%%
ASSENT-2
2
-2
TNK-tPArt-PA
n=8461n=848895%CI
a%%089
%%
TNK-tPArt-PA
n=8461n=848895%CI
%%
1-2%%-
>2%%-
a
TNKase
1%%1%1%
1%%
%%%%
%%
TNKase(v1%
%TNKase
TNKase
TNKase
/
-
-
-2
-
-
-
-6
-2
-22
-
-
-
-6TIA
-
GPIIb/IIIa
K
GPIIb/IIIa
30min
-CABG
-
-10
-
-2
-180mmHg/IIOmmHg
-
-
-
-
-
-/
-
-
-
-
-75
-v50kg
-
-GPllb/llla
-
-
-
/
PClPCl
PCI
ASSENT-2TNKase
845865495859%65742256
27%75124415%3
-2
30
6559%%%1%%
657427%%%%%
7515%%%3%%
K
GPlib/Illa
187012ST
TNKST
16mg510
RecombinantHumanTissue
PlasminogenActivatorforInjectionrt-PA50mg8mg
42mg90
70IU/kg
5000IU151000IU/24
APTT50701200IU/APTT
241mg/kg12
35PCI4
APTT<501mg/kg12
35
300mg100
300mg/35100mg/
300mg75mg/16
251rhTNK-tPArt-PA124127
938990
12ST16mgrhTNK-tPA
904
4.
rhTNK-tPA16mgrt-PA50mg
(n=93)(n=89)[95%CI]
TIMI23%%
[,]
TIMI3%%
[,]
rhTNK-tPArt-PA30(%)%%
(p>。30
()
(p>
16mg/rhTNK-tPASTrt-PA
()
5.
rhTNK-tPA16mgrt-PA50mg
(n=124)(n=127)
1%1%
8%6%
64
44
35
23
14
01
rhTNK-tPArt-PA%%
/
TNK
AmesCHL
rhTNK-tPA24/72mg/kg
72mg/kg
TNKasemg/kg/
TNKase
(NOEAL)5mg/kg810
,
TNKCmax
AUCtl/2147224min
,30004000ml
TNKase
2024min
90130min1049999119
mL/min
TNKase
28oC
10ml10ml
1/
24
YBS00012015
S
1
510530
/2