摘要
目的 对不同疗程的更昔洛韦治疗方案对婴儿CMV症状型感染的疗效、不良反应进行评价,为临床治疗决策提供依据.方法 采用随机对照临床试验设计,收集湖南省儿童医院住院患儿中符合CMV症状性感染诊断患儿128例,随机分组并接受3种不同更昔洛韦治疗方案.方案A组42人,使用更昔洛韦5 mg/kg·次,Q1 2h×2W诱导治疗,维持阶段采用更昔洛韦5 mg/kg·次,QD×2W;方案B组42人,采用更昔洛韦5 mg/kg·次,Q12 h×1W,并采用5 mg/kg·次,QD×2W维持；方案C组44人,采用更昔洛韦5 mg/kg·次,Q12 h,CMV-pp65阴转采用5mg/kg·次,QD×2W维持,最长诱导3周进入维持.盲法收集各种临床治疗,随访近期疗效.结果 方案A组40人,B组39人,方案C组42人完成试验并参加疗效评价.结果表明,三种方案治疗前后病毒量明显下降,均有明显的抗病毒效果.三组之间CMV-pp65阴转率差异有统计学意义,疗程结束时三组的CMV-pp65阴转率分别为75.00％、66.67％和88.09％.与方案A比较,方案B CMV-pp65阴转率较低(非劣效性检验,P=0.357),方案C CMV-pp65阴转率可高于方案A(非劣效性检验P=0.006,优侧检验P=0.068).三种方案的不良反应产生差异无统计学意义.结论 各组治疗均有明显的抗病毒效果.为获得更高的PP65阴转率,在不增加不良反应的基础上,本研究支持更昔洛韦5 mg/kg·次,Q12 h,CMV-pp65最长3周诱导至阴转,然后采用5 mg/kg·次,QD×2W维持治疗的方案.
Abstract
Objective To evaluate the efficacy and side effect of 3 therapeutic regimens of ganciclovir for infants with cytomegalovirus (CMV) infection, and to provide a basis for clinical therapeutic decision-making.Methods A randomized controlled clinical trial (RCT) was conducted, and 128 infants with symptomatic CMV infection were randomly assigned to receive one of 3 therapeutic regimens of ganciclovir.42 infants of group A received ganciclovir 5 mg/kg twice a day for 2 weeks induction therapy and 5 mg/kg once a day for 2 weeks maintenance.42 infants of group B received ganciclovir 5 mg/kg twice a day for 1 week induction therapy and 5 mg/kg once a day for 2 weeks maintenance.44 infants of group C received ganciclovir 5 mg/ kg twice a day induction therapy, and then the infants with CMV-pp65 negative turning received ganciclovir 5 mg/kg once a day for 2 weeks maintenance, with a 3-week-induced cycle.Double blind method was used to collect the clinical treatment data.The short-term therapeutic efficacy and side effect were evaluated.Results Forty infants of group A, 39 infants of group B and 42 infants of group C completed the experiment and the therapeutic efficacy was evaluated.All 3 regimens showed a significant antiviral effect.CMV-pp65 negative converted rates of the three groups were 75.00％, 66.67％ and 88.09％, respectively, and the difference was statistically significant.CMV-pp65 negative converted rate of regimen B was lower compared with regimen A (non inferiority test, P =0.357), while CMV-pp65 negative converted rate of regimen C was higher than that of regimen A (non-inferiority test, P =0.006; superiority test, P =0.068).No statistically significant difference was found in adverse reactions among the three regimens.Conclusions The results of this study suggest that all three regimens show significant antiviral effects, but regimen C presents a higher CMV-pp65 negative converted rate on the basis of same adverse reactions as compared with the other two regimens.
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