Efficacy and safety of intravenous stronger neo-minophagen C and S-adenosyl-L-methionine in treatment of pregnant woman with chronic hepatitis B: a pilot study.
BACKGROUND
There have been no studies evaluating the efficacy and potential risks of stronger neo-minophagen C (SNMC) in pregnant women with chronic hepatitis B CHB.


METHODS
A total of 36 pregnant women with CHB, but without severe complications, were randomized to intravenously receive SNMC or S-adenosyl-L-methionine (SAM) daily for 4 weeks or until birth. Normalization of serum alanine transaminase (ALT) and aspartate transaminase (AST) levels and changes in ALT and AST levels from baseline were determined. All neonates were regularly examined for up to 1 year.


RESULTS
Treatment with SNMC and SAM resulted in normalization of ALT levels at 4 weeks in 64.3% and 21.4% of patients, respectively (OR=6.60, 95% CI: 1.23-35.44, P=0.0540). SNMC and SAM significantly decreased ALT (from 558.28+/-390.24 to 47.07+/-24.94 IU/L, P<0.0001 and from 525.61+/-483.87 to 117.43+/-85.44 IU/L, P=0.0041, respectively) and AST (from 419.72+/-409.49 to 38.14+/-18.87 IU/L, P=0.0016, and from 510.78+/-621.58 to 79.93+/-63.25 IU/L, P=0.0152, respectively) at 4 weeks relative to baseline values. Hypokalemia was observed in 4 SNMC-treated patients and in 2 SAM-treated patients and hypernatremia in 3 SNMC-treated and in 3 SAM-treated patients. Hypertension was observed in 1 SNMC-treated patient. There was no significant difference in the volume of amniotic fluid or meconium between SNMC-treated and SAM-treated groups. All the neonates were physically normal at birth and at the 1-year follow-up examination.


CONCLUSIONS
Both SNMC and SAM improve liver function, with SNMC appearing more effective, in pregnant women with chronic hepatitis B without impact on fetal development.
Sun
Qing-Feng
QF
Department of Infectious Diseases, 3rd Affiliated Hospital of Wenzhou Medical College, Ruian, Zhejiang, P.R. China.
Ding
Ji-Guang
JG
Wang
Xiao-Feng
XF
Fu
Rong-Quan
RQ
Yang
Jin-Xian
JX
Hong
Liang
L
Xu
Xiao-Jia
XJ
Wang
Jun-Rong
JR
Wu
Jin-Guo
JG
Xu
Dao-Zhen
DZ
D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D003545:Cysteine / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003710:Demography; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D047108:Embryonic Development / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D005998:Glycine / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006034:Glycyrrhetinic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D006262:Health; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007231:Infant, Newborn; D007275:Injections, Intravenous; D008111:Liver Function Tests; D010865:Pilot Projects; D011247:Pregnancy; D012436:S-Adenosylmethionine / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D004338:Drug Combinations; D012436:S-Adenosylmethionine; C083319:stronger neominophagen C; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D003545:Cysteine; D006034:Glycyrrhetinic Acid; D005998:Glycine