静脉注射丙种球蛋白治疗新生儿溶血症的系统评价

Intravenous Immunoglobulin G for Hemolytic Disease of the Newborn: A Systematic Review

目的评价静脉注射丙种球蛋白(intravenous immunoglobulin G,IVIG)治疗新生儿溶血症的疗效。方法采用Cochrane系统评价方法,检索Cochrane图书馆临床对照试验资料库、MEDLINE(1966～2008.05)、EMbase(1992～2008.05)、中国生物医学文献光盘数据库(1979.11～2008.05)及所获文献的参考文献,筛选所有应用IVIG治疗新生儿溶血症的随机对照试验(RCT)。按照纳入与排除标准由两名评价员独立选择文献、评介质量、提取资料并交叉核对,而后采用RevMan4.2软件进行Meta分析。结果共纳入6个RCT,合计375例患者。Meta分析结果显示:IVIG治疗新生儿溶血症可显著减少换血例数[RR=0.27,95%CI(0.18,0.42)];IVIG组留院时间比单纯光疗组明显减少[WMD=–1.11,95%CI(–1.60,–0.63)],所需光疗时间也显著减少[WMD=–0.82,95%CI(–1.16,–0.47)]。结论在新生儿溶血症治疗中,IVIG能有效减少换血数、光疗时间和留院时间,值得推荐使用。开展有严格的试验设计,多中心、大样本的临床试验有助于进一步明确IVIG在新生儿溶血症治疗中的有效性和安全性。

Objective To assess the effectiveness of intravenous immunoglobulin G （IVIG） in reducing the need for exchange transfusion in neonates with proven haemolytic disease due to Rh and/or ABO incompatibility. To evaluate the effectiveness of IVIG in reducing the duration of phototherapy and hospital stay. Methods We electronically searched CENTRAL, MEDLINE （1966 to May 2008）, EMBASE （1992 to May 2008）, CBMdisc （November 1979 to May 2008）, and also checked the reference lists of all papers identified. According to the Cochrane Handbook for Systematic Reviews of interventions, randomized controlled trials comparing IVIG and phototherapy with phototherapy alone in neonates with Rh and/or ABO incompatibility were identified and analyzed. Results Six RCTs were included. The meta-analysis showed that, IVIG can significantly decrease the requirements of exchange transfusion （RR=0.27, 95%CI 0.18 to 0.42）, the duration of hospitalization （WMD= –1.11, 95%CI –1.60 to –0.63） and the duration of phototherapy （WMD= –0.82, 95%CI –1.16 to –0.47）. Conclusions Intravenous immunoglobulin （IVIG） is recommended for treating hemolytic disease of the newborn because it is effective in decreasing the requirements of exchange transfusion, the duration of hospi-talization and phototherapy. Well designed studies with large sample in multicenter are required for further proving.