Abstract:

Objective To evaluate the safety of ganciclovir (GCV) in infants with CMV infection. Methods One hundred and eleven infants were collected who were diagnosed as symptomatic CMV infection that had indications to use GCV, and they were treated for 3 courses of GCV in Children's Hospital of Chongqing Medical University from Jan. 2011 to Feb. 2014. Clinic data of adverse effects were collected and analyzed retrospectively. Results Among 111 cases, 70 were boys and 41 were girls. The mean age was 2 m and 29 d (14 d to10 m and 27 d). There were 60 cases with CMV hepatitis, 38 with CMV hepatitis and hearing impairment, 10 with hearing impairment caused by CMV, 2 with CMV encephalitis, 1 was with interstitial pneumonia and hearing impairment caused by CMV. All of them got better after treated with GCV for 3 courses. Before the treatment with GCV, the data of blood routine examination missed in 1 case, liver function examination missed in 2 cases, DB missed in 4 cases and renal function examination missed in 14 cases. The examination of blood routine , liver function and renal function after the GCV treatment of above cases were normal except 2 cases (ALT was 270 U·L－１ in 1 child, DB was 35.3 μmol·L－１ in 1 child). In 2 cases with thrombocytopenia and in 5 cases with renal impairment before using GCV, PLT or renal function was normal after GCV medication. There were 21 cases with granulocytopenia during the GCV treatment. And ANC number was normal one week follow-up later in 15/21 cases after granulocytopenia occurred and other 6/21 cases with granulocytopenia occurred at the end of the third course were not followed-up because patients missed. There were 15 cases with anemia. HB were increased in 13/15 cases and decreased in 1/15 case 1 week later. Anemia in 1/15 case occurred at the end of the third course was not followed-up because patient missed. Liver damage caused by GCV was found in 27 cases. The level of ALT and AST in 24/27 cases decreased after the GCV treatment. The other 3/27 cases with anemia occurred in the third course were not followed-up because patients missed. Transient increase of ALT, AST and/or DB that did not get the criterion of liver damage were found in 54/109（49.6%）, 41/109（37.6%）and 20/107 (18.7%) respectively. Rash was found in 18 cases. WBC reducing, thrombocytopenia and renal damage were not found. And describes about adverse effects of nervous system and gastrointestinal tract were not recorded. Incidence of granulocytopenia in cases whose ANC≤2.00×109·L－１ was higher than those whose ANC>2.00×109·L－１（11/30 vs 10/80, χ2=10.17，P=0.001，R=0.291）. Incidence of anemia in cases whose Hb≤100 g·L－１was higher than those whose Hb>100 g·L-1（11/52 vs 4/58, χ2=4.73，P=0.030，R=0.207）. Conclusion GCV can cause bone marrow suppression, liver function damage and rash in infants with CMV infection. The adverse effects often occur in the induction period of GCV treatment, and are usually mild and reversible.