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457
Entecavir and Granulocyte-Macrophage
Colony Stimulating Factor Combination
Treatment of Patients with Hbeag-Positive
Chronic Hepatitis B and Effect on Function of
NK Cell
Ping Zhao1, Hanwei Li2,3, Tao Yan4, Tao Yuan Liu4, Yongqian
Cheng4, Xueyuan Jin4, Xiao Yan Jia4, Yi Xuan Wang4,5, Jian
Jun Wang4, Hong Hong Liu4 and HAN WEI LI, (1)International
Center for Diagnosis and Treatment of Liver Diseases, 302
Military Hospital, (2)Liver Cirrhosis Diagnostic and Therapeutic
Centre, 302 Military Hospital, (3)Beijing University 302 Clinical
Medical College, (4)302 Military Hospital,, (5)Hebei North
University
Background: In order to improve the efficacy of hepatitis B
antiviral treatment.To evaluate antiviral efficacy of entecavir
(ETV) combined with granulocyte-macrophage colony
stimulating factor (GM-CSF) and effect of the therapy on
NK cell function in patients with HBeAg-positive chronic
hepatitis B (CHB). Methods: Since February 2016, 199
HBeAg-positive CHB patients who met indications for antiviral
therapy have been enrolled in the clinical study, and randomly
assigned to two groups: ETV monotherapy group (103
patients), 0.5mg/ day oral administration. Or ETV combined
with GM-CSF treatment group (96 patients), GM-CSF is
used for subcutaneous injection of 100 ug at the 3th, 4th, 5th
day of week 1, 4, 12, 24, 48 .After 48 weeks of treatment,
patients in both groups continued to receive oral entecavir
alone and were followed up for 48 weeks.HBVDNA, HBeAg,
HBsAg and liver function tests (LFTs) were quantitatively
tested at each follow-up time point (week 0, 12, 24, 36, 48,
60, 72, 84, 96). At 24th and 48th weeks after treatment, the
total frequency and function of NK cells in patients’ peripheral
blood samples were tested Results: After 48 weeks of
treatment, HBVDNA load and HBeAg significantly decreased
and liver function improved in both groups, but there was no
significant difference between the two groups.There were
different changes in HBsAg levels between the two groups.
In patients of the ETV monotherapy group, paired t test
showed a significant difference in the HBsAg level between
baseline and week 24 (3.87±0.77 IU/mL vs. 3.45±1.15 IU/mL,
p=0.038); but no significant difference between baseline and
week 48 (3.43±0.80 IU/mL vs. 3.25±1.31 IU/mL, p=0.590)
; While in the combined treatment group, the paired t test
results were shown at baseline and at week 24 (3.86±0.84
IU/mL vs. 3.34±1.13 IU/mL, p=0.001) and baseline and week
48 There was a significant difference between (3.98±0.80 IU/
mL vs. 3.35±1.06 IU/mL, p=0.002). NK cell function test,The
levels of mTOR phosphorylation of NK cell in combination
treatment group were significantly higher than those in the
ETV monotherapy group at 24 weeks Conclusion: Both
entecavir single drug or GM-CSF combined with HBeAgpositive
chronic hepatitis B have a good effect on inhibiting
HBVDNA replication.The combination of ETV and GM-CSF
appeared beneficial to the clearance of HBsAg in patients with
CHB, and the mechanism may be related to the regulation of
the function of NK cells.Statement :This study is registered
at Clinicaltrials.gov with identification number NCT03164889
and is still in progress.The numbers of patients who had
completed 12th,24th, 48thweek follow-up, we would release
more data as the trial progresses.
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发表于 2018-10-22 17:12