To evaluate the efficacy and safety of Chinese medicine (CM) in treating infantile cytomegalovirus hepatitis (ICH). A total of 100 infant ICH patients were randomly assigned to two groups

60 in the treatment group and 40 in the control group. Ganciclovir was administered to all patients via intravenous dripping at dose of 5 mg/kg every 12 h for 2 weeks

followed by 5 mg/kg once a day for 5 days every week; the whole treatment course lasted 8 weeks. Besides

the patients in the treatment group were treated with CM of Qinggan Lidan Decoction (清肝利胆汤

QLD) during icteric stage

and Yigan Jiangmei Decoction (益肝降酶汤

YJD) in non-icteric hyper-aminotransferase stage by oral medication

while for those in the control group

glucurolactone 50 mg was given three times per day. The efficacy of treatment was evaluated at the ends of 2nd

4th and 8th weeks

respectively. And a follow-up study was carried out for 6–24 months. The total effective rate was 95.0% (57/60) in the treatment group and 77.5% (31/40) in the control group; the overall curative effect in the former was superior to that in the later

showing a significant difference (P=0.021). Cholestasis and liver function were improved in both groups

and the effect of reducing serum bilirubin level in the treatment group was more rapid and extensive than that in the control group

which could reduce the post-hepatitis cirrhotic risk caused by long-term cholestasis and liver cell damage. The therapeutic efficacy of integrated CM and Western medical drug therapy

by using QLD during icteric stage and YJD in nonicteric hyper-aminotransferase stage

was significantly higher than that of routine Western medical treatment alone; it was an ideal project for the treatment of infantile cytomegalovirus hepatitis.