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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×2 W;方案B组42人,采用更昔洛韦5 mg/kg.次,Q12 h×1 W,并采用5mg/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5 mg/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。
Objective To evaluate the curative effect and side effect of ganciclovir in different courses on symptomatic CMV infection in infants and to provide basis for clinical treatment decisions. Methods A randomized controlled clinical trial was designed to collect 128 cases of children diagnosed with CMV symptomatic infection in children hospitalized in Hunan Children’s Hospital and randomly divided into groups and received 3 different ganciclovir regimens. In group A, 42 patients were treated with ganciclovir 5 mg / kg twice a day, and treated with Q1 2h × 2 W for 5 days, with ganciclovir 5 mg / kg, qd × 2 w during the maintenance phase, 42 patients in group B, Using ganciclovir 5 mg / kg. Times, Q12 h × 1 W, and the use of 5mg / kg times, QD × 2W to maintain; program C group 44 people, with ganciclovir 5 mg / kg times, Q12 h, CMV-pp65 negative with 5 mg / kg. times, QD × 2W maintenance, the longest induction of 3 weeks to maintain. Blind collection of various clinical treatment, follow-up curative effect. Results: A group of 40 patients, B group of 39 people, C group 42 patients completed the trial and participate in the evaluation of the efficacy. The results showed that the three programs before and after treatment significantly decreased the amount of virus, have significant antiviral effect. The negative conversion rate of CMV-pp65 between the three groups was statistically significant. At the end of the treatment, CMV-pp65 negative conversion rates were 75.00%, 66.67% and 88.09% respectively. Compared with protocol A, CMV-pp65 had a lower negative conversion rate in protocol B (non-inferiority test, P = 0.357), and CMV-pp65 negative conversion rate in protocol C was higher than that of protocol A. (Noninferiority test P = 0.006, Excellent side test P = 0.068). There was no significant difference in adverse reactions between the three regimens. Conclusion All groups have obvious antiviral effect. In order to obtain a higher PP65 negative conversion rate, this study supported ganciclovir 5 mg / kg on the basis of no adverse reactions, Q12 h and CMV-pp65 up to 3 weeks after induction, then used 5 mg / kg. Times, QD × 2W maintenance treatment program.