[The effect of extract from human tubercle bacilli (SSM) on HBeAg positive type B chronic hepatitis]

The effect on the HBeAg/anti-HBe system of SSM (specific substance Maruyama), an extract from human tubercle bacilli, was evaluated in patients with HBeAg positive type B chronic hepatitis.

Twenty-five (25) HBeAg positive patients with biopsy-proven chronic hepatitis were injected subcutaneously with SSM solution twice a week for two years. Fifteen (15) comparable patients served as untreated controls for one year. HBeAg and anti-HBe were measured by the RIA method.

(1) In the group receiving SSM injections, HBeAg disappeared in 8 out of 25 patients (32.0%) one year after the treatment and in 15 out of 23 (65.2%) within two years. Seroconversion from HBeAg to anti-HBe occurred in 5 of the 25 patients (20.0%) after one year and in 7 out of 23 (30.4%) within two years. Of the 15 untreated controls, HBeAg disappeared in 3 patients (20%), and seroconversion from HBeAg to anti-HBe occurred in 1 (6.7%) within one year. (2) In the SSM group, the HBeAg cut off index decreased significantly (p less than 0.01), from 5.2 +/- 1.9 during the pretreatment period to 2.7 +/- 2.3 twelve months after the treatment. (3) In the SSM group, a transient rise in sGOT and sGPT was observed in some patients three to nine months after starting the treatment. HBeAg disappeared in all these patients. (4) No notable side effects were observed in any of the patients treated with SSM.

These results indicate that SSM treatment improves the HBeAg/anti-HBe system in patients with HBeAg positive chronic hepatitis.