Four patients treated with the herbal medicine syo-saiko-to (xiao-chai-hu-tang) exhibited acute drug-induced liver injury. The latent period was one and a half to three months. All of the patients showed a rise in aminotransferases after readministration or challenge test. The liver histology revealed centrilobular confluent necrosis or spotty necrosis, microvesicular fatty change, acidophilic degeneration, and a granuloma. Cholestasis was seen in two patients. The results of the [13C]aminopyrine breath test, performed in one patient, were low before the challenge test and even lower after the challenge. These findings suggest that the herbal medicine syo-saiko-to may induce acute injury or the hepatocellular pattern with variable cholestasis.

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We studied the histological and ultrastructural changes in the liver and alterations in the liver test results before, during, and after treatment with human interferon-beta from five patients with hepatitis B e antigen-positive chronic active hepatitis. A daily dose of 3 x 10(6) to 6 x 10(6) units of interferon-beta was given intravenously for four weeks. The total index of periportal and portal inflammation, intralobular degeneration, and focal necrosis before treatment was decreased significantly six months after treatment (P less than 0.05). Ultrastructurally, the structure of endoplasmic reticulum was irregularly shaped or fragmentally decreased during treatment, but these disappeared six or 12 months after treatment. Glycogen particles diminished greatly during treatment. The alanine aminotransferase concentrations in these patients increased during treatment. Serum albumin and cholinesterase levels decreased significantly at the fourth week of treatment (P less than 0.01) and at the third day (P less than 0.01) to the second week (P less than 0.05) of treatment, respectively. These results suggest that interferon-beta injures endoplasmic reticulum and glycogen areas and damages the cholinesterase activity in the early stage of treatment and protein synthesis in patients with hepatitis B e antigen-positive chronic active hepatitis.

Twenty patients with hepatitis B e antigen (HBeAg) -positive chronic hepatitis, who received 40 mg of prednisolone per day for three weeks followed by withdrawal, were studied for changes in alanine aminotransferase (ALT), triiodothyronine (T3), thyroxine (T4), and hepatitis B virus DNA polymerase (HBV-DNAp) levels determined before and during prednisolone treatment and after its withdrawal. A decreased HBV-DNAp level of less than 100 cpm/ml three to five weeks after withdrawal was considered a sign of efficacy and was shown in 10 patients (50%). Significant differences were found between ALT levels, between T3 levels, and between the T3/T4 ratios assayed in the third and fourth weeks in total (P less than 0.02) and in the group in which efficacy was demonstrated (P less than 0.01). The T3/T4 ratio in the third week in the effectively treated group was significantly less than that in the noneffectively treated group (P less than 0.05). Prednisolone withdrawal effective for HBV-DNAp was shown in the patients with a decreased T3 level and the T3/T4 ratio at the third week and an increase in the ATL level after the withdrawal. The ALT level increased after the T3 level decreased. Changes in the T3 level or the T3/T4 ratio represent a marker for effectiveness of prednisolone withdrawal and for determination of combination therapy after steroid withdrawal.