更昔洛韦治疗先天性巨细胞病毒感染患儿的系统评价

Ganciclovir therapy for congenital cytomegalovirus infection in newborn infants:a meta analysis

目的评价更昔洛韦(GCV)治疗先天性巨细胞病毒(CMV)感染的疗效及安全性。方法计算机检索PubMed(1988.1～2009.1)、EMbase(1988.1～2009.1)、Cochrane图书馆(2003年第3期和2009年第1期)、中国学术期刊全文数据库(1994.1～2009.1)、中国生物医学文献数据库(1994.1～2009.1)、中文生物医学期刊文献数据库(1994.1～2009.1),纳入用GCV治疗及未用GCV治疗先天性CMV感染的随机及半随机对照试验。对研究人群的干预措施及结果进行分析评价及meta分析。结果共纳入10篇文献。meta分析结果表明,GCV治疗后在先天性CMV感染患儿的病情好转率(91.4%vs34.0%,P<0.01)及病毒感染指标转阴率(87.6%vs15.3%,P<0.01)这两方面均明显高于未治疗的对照组。GCV治疗后还可明显降低CMV感染患者的听力障碍发生率(4.7%vs37.2%,P<0.01)。GCV治疗组的不良反应发生率低。结论本系统评价提示,对先天性CMV感染的婴儿,使用GCV治疗可以增加患儿的治疗好转率,增加CMV感染指标的转阴率,减少听力障碍的发生率,而GCV的不良反应发生率低。但因纳入研究的总样本量较小,证据强度有限,需更多高质量研究证实。

Objective To evaluate the efficacy and safety of ganciclovir therapy for congenital cytomegalovirus （CMV） infection in newborn infants. Methods The randomized controlled trials （RCTs） and quasi-RCTs on ganciclovir therapy for congenital CMV were reviewed in the following electronic databases： PubMed （January 1988 to January 2009） , EMbase （January 1988 to January 2009）, the Cochrane library （Issue 3, 2003 and Issue 1, 2009）, the Chinese Journals Full-text Database （January 1994 to January 2009 ）, the Chinese Biological Medical Disc （January 1994 to January 2009） and the Chinese Medical Current Contents （January 1994 to January 2009）. Quality assessment, data extraction, and meta analysis were performed. Results Ten papers were included. Meta analysis showed that the ganciclovir therapy increased the improvement rate （91.4% vs 34.0% ; P 〈0.01 ） and led CMV infection indexes to become negative in more patients （87.6% vs 15.3%; P 〈0.01） and decreased incidence of hearing disturbance （4.7% vs 37.2%; P〈0.01） as compared with the non-ganciclovir therapy control group. The incidence of the ganciclovir-therapy-related side effects was low. Conclusions Ganeiclovir treatment may increase the improvement rate and the rate of CMV infection indexes becoming negative, and decrease incidence of hearing disturbance, with few side effects, in newborn infants with CMV infection. However the supporting evidence is not strong due to few trials and more high-quality research is needed.