OBJECTIVETo observe the clinical effects of Linda Mixture (LM) on cholestatic liver diseases caused by cytomegalovirus (CMV) infection.

METHODSTotally 240 CMV infected cholestatic liver diseases infants, who were hospitalized at the Department of Integrated Traditional Chinese and Western Medicine, Wuhan Children's Hospital from January 2008 to June 2011, were randomly assigned to the treatment group (120 cases) and the control group (120 cases). Patients in the treatment group were treated by LM combined ganciclovir, while those in the control group were treated by ganciclovir alone. The therapeutic course was 2 months. The patients were assigned to 3 sub-groups according to the quantification standards of symptoms and signs, i. e., the No. 1 treatment group (mild, 30 cases), the No. 1 control group (mild, 30 cases), the No. 2 treatment group (moderate, 30 cases), the No. 2 control group (moderate, 30 cases), the No. 3 treatment group (severe, 30 cases), the No. 1 control group (severe, 30 cases). The clinically cured rate and the total effective rate, the jaundice subside time, the retraction time for Gan and Pi, the body weight growth, the indices of the liver function, and lab indices of CMV infection were observed before and after treatment.

RESULTSAfter treatment the cured rate was 77.50% and the total effective rate was 88.33% in the treatment group, while they were 60.83% and 76.67% in the control group. There was statistical difference between the two group (P<0.05, P<0.01). There was some improvement in the jaundice subside time, the retraction time for Gan and Pi, the body weight growth, the indices of the liver function in the two groups. Better results were obtained in the treatment group than in the control group, showing statistical difference (P<0.05, P<0.01). The lab indices of CMV infection showed negative to some degrees. The negative rates of serum IgM (83.54% in the treatment group and 63. 64% in the control group) and the serum CMVDNA (84.52% in the treatment group and 67.47% in the control group) were better in the treatment group than in the control group, showing statistical difference (P<0.01). There was no obvious difference in the negative rate of CMV antigen in urine between the two groups (P>0.05).

CONCLUSIONSLM combined ganciclovir therapy showed definite effects in treating cholestatic liver diseases caused by CMV infection. Early treatment for severe infants might change their prognosis. LM also could alleviate adverse reactions during the therapeutic course.