Results
1.
Physical
sign
140
patients in 3 groups finished haemodialysis that lasting up
to 4-5 hours, totally 190 times. Patients' breath, pulse,
blood pressure and body temperature were stable. No patients
was superseded and terminated.
2.
Clotting of blood in dialyzator
Table 2
|
group
|
case
|
clotting of blood in dialyzator
|
P
|
| |
|
I-II n(%)
|
III n(%)
|
|
|
JIPAILIN
|
100
|
92(92.0)
|
8 (8.0)
|
|
|
Fragmin
|
50
|
46(92.0)
|
4 (8.0)
|
>0.05
|
|
UFH
|
40
|
36 (90.0)
|
4 (10.0)
|
>0.05
|
3.
Coagulation deposition in catheter
Table 3
|
group
|
case
|
coagulation deposition in catheter
|
P
|
| |
|
I-II n(%)
|
III n(%)
|
|
|
JIPAILIN
|
100
|
96(96.0)
|
4 (4.0)
|
|
|
Fragmin
|
50
|
47(94.0)
|
3 (6.0)
|
>0.05
|
|
UFH
|
40
|
38 (95.0)
|
2 (5.0)
|
>0.05
|
4.
Change of dialyzator capacity
Table 4
|
group
|
case
|
lowering dialyzaor capacity (%)
|
P
|
| |
|
|
|
|
JIPAILIN
|
100
|
6.15±6.82
|
|
|
Fragmin
|
50
|
5.65±5.85
|
>0.05
|
|
UFH
|
40
|
7.22±6.34
|
>0.05
|
5. Time of bleeding arresting at puncture site
Table 5
|
group
|
administration procedure
|
case
|
time of bleeding arresting (min)
|
P
|
|
JIPAILIN
|
single bolus
|
70
|
6.65±3.95
|
|
| |
continuous bolus
|
30
|
5.77±3.14
|
|
|
Fragmin
|
single bolus
|
50
|
6.68±3.20
|
>0.05
|
|
UFH
|
continuous bolus
|
40
|
6.95±3.50
|
>0.05
|
6. Anti-factor Xa activity of plasma
Table 6
|
group
|
Administration
|
case
|
|
time (min)
|
|
P
|
| |
procudure
|
|
15
|
180
|
300
|
|
|
JIPAILIN
|
single bolus
|
30
|
0.95±0.16
|
0.64±0.18
|
0.48±0.18
|
>0.05
|
| |
continuous bolus
|
30
|
0.40±0.13
|
0.52±0.18
|
0.60±0.20
|
|
|
Fragmin
|
single bolus
|
30
|
1.00±0.16
|
0.69±0.15
|
0.69±0.15
|
>0.05
|
|
UFH
|
continuous bolus
|
30
|
0.41±0.20
|
0.25±0.15***
|
0.18±0.29***
|
|
After JIPAILIN administration, anti-FXa activity
(0.48-0.95 anti FXa IU/ml) was maintained through the dialysis
even without infusion, exhibiting the same anti-coagulant
efficacy as Fragmin. JIPAILIN's anti-FXa activity was higher
than UFH, with significant difference appeared at 180 and
300 minute.
7.
Plasma value of APTT
Table 7
|
group
|
Administration
|
case
|
|
time (min)
|
|
P
|
| |
procudure
|
|
15
|
180
|
300
|
|
|
JIPAILIN
|
single bolus
|
50
|
58.1±27.5
|
24.4±21.0
|
2.72±9.27
|
>0.05
|
| |
continuous bolus
|
30
|
24.4±11.7
|
15.3±13.4
|
9.26±12.1
|
|
|
Fragmin
|
single bolus
|
50
|
81.6±41.4*
|
36.0±30.7*
|
7.82±16.8
|
>0.05
|
|
UFH
|
continuous bolus
|
40
|
99.8±51.8***
|
63.3±52.0***
|
47.6±54.4***
|
|
JIPAILIN's effect on APTT prolongation was weaker than
that of Fragmin, with significant difference appeared at 15
and 180 minute (P<0.05).
When
administered as a continuous bolus, JIPAILIN's effect on APTT
prolongation was weaker than that of UFH, with significant
difference appeared at 15, 180 and 300 minute (P<0.01).
8.
Adverse
reaction
Table 8
|
group
|
case
|
nasal haemorrhage n(%)
|
blood at the puncture site
|
skin itch
|
| |
|
|
of the internal fistula n (%)
|
n (%)
|
|
JIPAILIN
|
100
|
3 (3.0)
|
1 (1.0)
|
2 (2.0)
|
|
Fragmin
|
50
|
1 (2.0)
|
1 (2.0)
|
0 (0)
|
|
UFH
|
40
|
1 (2.5)
|
1 (2.5)
|
0 (0)
|
2
patients with history of bleeding tendency reported gingival
haemorrhage, which disappeared after haemodialysis. One patient
observed nasal haemorrhage after returned home. 2 patients
had tolerable skin itch during haemodialysis, which disappeared
later. 1 patient observed oozing blood at the puncture
site of the internal fistula, which may be caused by puncture
technology.
9.
Synthesized endpoint
9.1 Anti-coagulation efficacy
Table
9 Anticoagulation effect of different drugs
|
group
|
case
|
I n(%)
|
II n(%)
|
III n(%)
|
total n(%)
|
|
JIPAILIN
|
100
|
90 (90.0)
|
10 (10)
|
0 (0)
|
100 (100)
|
|
Fragmin
|
50
|
46 (92.0)
|
4 (8.0)
|
0 (0)
|
50 (100)
|
|
UFH
|
40
|
36 (90.0)
|
4 (10.0)
|
0 (0)
|
40 (100)
|
Table
10 Anticoagulation effect of different administration route
|
group
|
administration
procedure
|
case
|
I n(%)
|
II n(%)
|
III n(%)
|
Total
n (%)
|
P
|
|
JIPAILIN
|
single
bolus
|
70
|
64
(91.4)
|
6
(8.6)
|
0
(0)
|
70
(100)
|
|
|
Fragmin
|
single
bolus
|
50
|
46
(92.0)
|
4
(8.0)
|
0
(0)
|
50
(100)
|
>0.05
|
|
Jipailin
|
continuous
bolus
|
30
|
28
(93.3)
|
2
(6.67)
|
0
(0)
|
30
(100)
|
|
|
UFH
|
continuous
bolus
|
40
|
36
(90.0)
|
4
(10.0)
|
0
(0)
|
40
(100)
|
>0.05
|
The synthesized
endpoint (total anticoagulation effect) did not differ among
3 groups during dialysis (P>0.05), they were all 100%.
Jipailin had the same anticoagulation effect as Fragmin and
UFH.
9.2
Anti-coagulated safety
According to patients’ bleeding tendency, time needed
for pressure at puncture site and adverse reactions, JIPAILIN
is of same or higher safety than Fragmin, and much safer than
UFH.
Discussion
JIPAILIN has shown to be effective as an anticoagulant
during dialysis. In this study, with dialysis lasting up to
4-5 hours, single dose of 70-80 anti-Xa IU/kg of JIPAILIN
had sufficient anti-coagulation effects. Anti-Xa activity
was used for laboratory assessment of the anti-coagulation
effect of JIPAILIN. JIPAILIN’s anti-Xa activity maintained
at clinical standard level during dialysis, higher than UFH.
JIPAILIN has shown to be safe as an anticoagulant during
dialysis. If UFH is given as a single injection only,
it has to be administered with a higher dose in order to maintain
sufficient anticoagulation through the dialysis, which may
cause increasing risk of bleeding complications. In the present
study, dialysis lasting up to 4-5 hours was performed with
single dose of JIPAILIN. APTT was less prolonged than UFH.
No thrombotic or bleeding complication occurred.
A single injection of JIPAILIN is a simple method for
anticoagulation as compared to UFH. A single dose of
JIPAILIN can be recommended for anticoagulation during dialysis.
Conclusion
Clinical studies show that a single I.V. bolus injection
of JIPAILIN can maintain long and high plasma anti-Xa activity.
For patients with acute or chronic renal failure undergoing
haemodialysis, JIAPILIN has the same anti-coagulant effect
as UFH and Fragmin. JIPAILIN has less effect on APTT and less
hemorrhagic risk compared with UFH, similar to Fragmin with
respect to efficacy and safety. In addition, JIPAILIN has
comparatively longer half-life period, requiring neither further
infusion nor supervision. In conclusion, JIPAILIN is an effective
and safe anticoagulant that is convenient for clinical use.
Jipailin
of Jiuyuan, new generation against UFH(unfractionated heparin);
Jipailin, warm your heart by antithrombosis.
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