更昔洛韦联合丙种免疫球蛋白治疗婴儿巨细胞病毒感染的系统评价

摘要

目的：查系统评价更昔洛韦联用丙种免疫球蛋白治疗婴儿巨细胞病毒感染的临床疗效和安全性。方法：计算机检索PubMed、Medline、CNKI、CBM、VIP和万方数据库，同时辅助手工检索相关文献，检索主题为以常规治疗的空白治疗和以在常规治疗基础上加用更昔洛韦为对照组，以更昔洛韦联用丙种人免疫球蛋白为试验组的治疗婴儿CMV感染的随机对照研究，检索年限均为建库开始至2015年5月，对纳入研究进行文献质量评价，采用Rev Man 5.2统计软件对同质性结果进行合并分析。结果：共纳入11项研究，合计617例患者。Meta分析显示，与对照组相比，试验组能显著提高临床疗效(RR=1.50,95%CI：1.34~1.68, P<0.01)和CMV转阴率(RR=1.81,95%CI：1.59~2.05, P<0.01)。ADR发生率大于以常规治疗的空白治疗( RR=9.25，95%CI：3.19~26.83, P<0.01)，但显著小于在常规治疗基础上加用更昔洛韦( RR=0.40,95%CI：0.22~0.72，P<0.01)。倒漏斗图提示本研究偏倚性较小。结论：更昔洛韦联用丙种球蛋白治疗婴儿CMV感染疗效显著，安全性较好。鉴于纳入研究文献质量偏低，准确结果尚需大样本、高质量随机对照研究进一步验证。%Objective:To systematic review clinical efifcacy and safety of ganciclovir combined with intravenous immune globulin (IVIG) in treatment of cytomegalovirus (CMV) infection in infants .Methods: Retrieved from PubMed, Medline, CNKI, VIP, Wangfang database online version until May 2015, relevant articles were searched by auxiliary manual retrieval, and the reference lists of enrolled reports and reviews were looked up. Randomized controlled studies on ganciclovir combined with Intravenous immune globulin (IVIG) in treatment of cytomegalovirus (CMV) infection in infants were selected with conventional therapy and conventional therapy combined with ganciclovir as control groups. Meta-analysis of included trials was performed using Rev Man 5.2 software.Results:A total of 11 studies were included, involving 617 patients. Meta-analysis showed that, compared to control group, test group could signiifcantly improve clinical efifcacy [RR=1.50, 95%CI(1.34-1.68),P<0.01] and the negative rate of CMV [RR=1.81, 95%CI (1.59-2.05), P<0.01]. And the incidence rate of ADR was signiifcantly higher than conventional treatment [RR=9.25, 95%CI (3.19-26.83),P<0.01], but was signiifcantly less than that in the conventional treatment combined with ganciclovir [RR=0.40, 95%CI (0.22-0.72),P<0.01]. The funnel plots indicated that the study bias was small.Conclusion: Ganciclovir combined with intravenous immune globulin in treatment of infant CMV infection achieves signiifcant effect and good safety. Given the low quality of the included literature research, accurate results still need large-scale high-quality randomized controlled study for further veriifcation.