不同剂量更昔洛韦治疗新生儿先天性巨细胞病毒感染的临床观察

Comparison of therapeutic effect of different doses of ganciclovir for neonatal congenital cytomegalovirus infection

目的更昔洛韦(GCV)是治疗先天性巨细胞病毒(CMV)感染的首选药物,临床疗效是肯定的,但有一定的副作用。该文旨在评价不同剂量GCV治疗先天性CMV感染新生儿的临床疗效和副作用。方法先天性CMV感染新生儿167例分为大剂量治疗组(n=79)和小剂量治疗组(n=88),均给予GCV治疗和其他对症支持治疗。大剂量治疗组给予GCV的剂量为:诱导治疗每次7.5mg/kg,维持治疗每次10mg/kg;小剂量治疗组给予GCV的剂量:诱导治疗每次5mg/kg,维持治疗每次5mg/kg,观察两组的临床疗效和副作用。结果①两种剂量的GCV治疗先天性CMV感染有相同疗效,临床症状明显好转,大剂量治疗组CMV-IgM转阴率93.8%,CMV-DNA转阴率80.8%;小剂量治疗组CMV-IgM转阴率93.1%,CMV-DNA转阴率为86.7%,两组比较差异无显著性(P>0.05);②小剂量GCV治疗先天性CMV感染新生儿的副作用低于大剂量GCV,大剂量治疗组呕吐发生率11.4%,贫血发生率20.3%,中性粒细胞减少发生率16.5%,血小板增加发生率18.9%;小剂量治疗组呕吐发生率2.3%,贫血发生率8.0%,中性粒细胞减少发生率5.7%,血小板增加发生率8.0%,两组比较差异有显著性(P<0.05)。结论小剂量GCV治疗新生儿先天性CMV感染与大剂量有同样的临床疗效,且副作用低于大剂量GCV,更安全,值得临床推广使用。

Objective Ganciclovir is a first-line drug for treatment of cytomegalovirus（CMV）infection.However,some ganciclovir treatment-related side-effects can be found.This study aimed to compare the efficacy and side effects of relatively low and high doses of ganciclovir in the treatment of neonatal congenital CMV infection.Methods One hundred and sixty-seven neonates with congenital CMV infection were randomly assigned to high-dose（n=79）and low-dose ganciclovir groups（n=88）.The high-dose ganciclovir group was injected with ganciclovir of 7.5 mg/kg in the inducement phase and of 10 mg/kg in the maintaining phase.The low-dose ganciclovir group was injected with ganciclovir of 5 mg/kg in the inducement and the maintaining phases.The efficacy and side effects were observed in the two groups.Results After treatment the clinical symptoms and signs were obviously improved in both groups.CMV-IgM became negative in 93.8% of neonates in the high-dose ganciclovir group and 93.1% of neonates in the low-dose ganciclovir group（P〉0.05）.CMV-DNA became negative in 80.8% of neonates in the high-dose ganciclovir group and in 86.7% in the low-dose ganciclovir group（P〉0.05）.The low-dose ganciclovir group had lower incidence of side effects than the high-dose ganciclovir group：vomiting 2.3% vs 11.4%;anemia 8.0% vs 20.3%;reduction of neutrophilic granulocytes 5.7% vs 16.5%;increase in platelet count 8.0% vs 18.9%（P〈0.05）.Conclusions Low-dose ganciclovir has the same clinical efficacy to high-dose ganciclovir for treatment of neonatal congenital CMV infection,but fewer side effects occur in the low-dose group.