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01 August 2010

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

Qing-Feng SunACDEG, Ji-Guang DingABDE, Xiao-Feng WangBCDE, Rong-Quan FuBDF, Jin-Xian YangBFG, Liang HongBF, Xiao-Jia XuBCD, Jun-Rong WangAF, Jin-Guo WuAF, Dao-Zhen XuAF

Med Sci Monit 2010; 16(8): PR9-14 :: ID: 881083

Abstract

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
Material/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.

Keywords: Infant, Newborn, Hepatitis B, Chronic - physiopathology, Health, Glycyrrhetinic Acid - therapeutic use, Glycine - therapeutic use, Follow-Up Studies, Embryonic Development - drug effects, Drug Therapy, Combination, Drug Combinations, Demography, Cysteine - therapeutic use, Aspartate Aminotransferases - blood, Antiviral Agents - therapeutic use, Alanine Transaminase - blood, Injections, Intravenous, Liver Function Tests, Pilot Projects, Pregnancy, S-Adenosylmethionine - therapeutic use

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750