Randomized clinical trial with two doses (100 and 40 ml) of Stronger Neo-Minophagen C in Chinese patients with chronic hepatitis B

Abstract

Stronger Neo-Minophagen C (SNMC) is an intravenous drug with glycyrrhizin as the principal ingredient. The efficacy and safety of SNMC at two doses were evaluated on 194 patients with chronic hepatitis B in nine hospitals in China. They all had serum levels of alanine aminotransferase (ALT) exceeding twice the upper limit of normal (>80 IU/l). SNMC daily 100 and 40 ml were given for 4 weeks to the patients randomized into Group A (N=99) and Group B (N=95), respectively. Thereafter, all patients received oral glycyrrhizin (GLYCYRON Tab) 9 tablets a day for an additional 4 weeks. Primary end-point was ALT<1.5 times the upper limit of normal (60 IU/l) at completion of the 8-week therapy, and it was achieved by 73 patients (74%) in Group A and 74 (79%) patients in Group B; normalization of ALT levels (<40 IU/l) was accomplished in 58 (58%) and 54 (57%) patients in Groups A and B, respectively. SNMC was withdrawn in four (2%) patients due to mild and reversible side effects. Based on these results, SNMC is safe and efficacious in lowering or normalizing ALT levels in patients with chronic hepatitis B in China, and an induction dose of 40 ml daily is efficient in achieving maximal effects.