Objective

2

To observe the effects of adjuvant therapy of Huayu pills on neurological recovery of patients with acute cerebral infarction (ACI) and syndrome of Qi deficiency and blood stasis

and to investigate its mechanism of action for antioxidation

anti-inflammation and improvement of microcirculation.

Method

2

One hundred and forty patients were randomly divided into control group (70 cases) and observation group (70 cases) by random number table. During the study period

there were 3 drop-out cases

2 excluded cases

and 65 completed cases in the control group. There were 1 drop-out cases

4 excluded case

and 65 completed cases in the observation group. Western medicine was given in both groups. Patients in control group additionally got oral administration of Xiaoshuang Tongluo tablets

6 tablets/time

3 times/day. The patients in observation group got oral administration of Huayu pills

5 g/time

2 times/days. The treatment course was 4 weeks in both groups. Before the treatment

and at the second and fourth week after treatment

scores of national institute of health stroke scale (NIHSS) were graded. Before and after treatment

scores of functional independent measures (FIM) scale

fugl-meyer assessment of motor function (FMA)

Qi deficiency and blood stasis syndrome were graded. Disability/mortality and safety were discussed after treatment. Levels of the whole blood viscosity (BV)

plasma viscosity (PV)

platelet aggregation rate (PAG)

fibrinogen (FIB)

P-selectin (CD62p)

D

-dimer (

D

-D)

superoxide dismutase (SOD)

malondialdehyde (MDA)

nitric oxide (NO)

lipid peroxide (PLO)

homocysteine (Hcy)

tumor necrosis factor -

α

(TNF-

α

)

serum cystatin C (Cys-C) and hypersensitive C-reactive protein (hs-CRP) were detected both before and after treatment.

Result

2

In the analysis of rank sum test

clinical efficacy in observation group was better than that in control group (

Z

=2.131

P

<

0.05). At the second and fourth week after treatment

scores of NIHSS

Qi deficiency and blood stasis

as well as levels of NO

PLO

MDA

Hcy

Cys-C

hs-CRP

TNF-

α

BV

PV

PAG

FIB

CD62 p and

D

-D in observation group were lower than those in control group (

P

<

0.01)

while levels of FIM

FMA and SOD were all higher than those in control group (

P

<

0.01).

Conclusion

2

Based on the comprehensive treatment of Western medicine

adjuvant therapy of Huayu pills can improve the degree of nerve function defect

improve the ability of exercise and daily life

reduce the degree of disability

improve the microcirculation and hemorheology

reduce the inflammatory reaction

eliminate oxygen free radicals

and relieve the oxidative stress injury in patients with ACI and Qi deficiency and blood stasis syndrome

and the clinical efficacy is better than that of Western medicine alone.