Li Zhi-hua, Wang Jin, Chen Chao
Division of Neonatology, Children's Hospital of Fudan University, Shanghai 201102, China.
Zhonghua Er Ke Za Zhi. 2010 Sep;48(9):656-60.
Neonatal isoimmune hemolytic disease is still one of the major causes of neonatal hyperbilirubinemia. The infants with severe hemolysis even need phototherapy and exchange transfusion. Early intravenous immunoglobulin infusion may block hemolysis to some extent. This study aimed to investigate the efficacy and safety of immunoglobulin infusion on neonatal isoimmune hemolytic disease by meta analysis.
All randomized controlled trials on the effect of immunoglobulin infusion on neonatal Rh and ABO incompatible hemolytic disease obtained by searching MEDLINE, Cochrane Library, EMBASE, CNKI and CBM were included. Meta analysis was done by Review Manager 4.2 software.
Six trials with totally 456 neonates were included. There were 109 infants with Rh blood group incompatible hemolysis in 4 studies and 347 infants with ABO blood group incompatible hemolysis in 4 studies. There was no significant difference in gestational age, weight and sex between the immunoglobulin infusion and control groups. Compared with those neonates treated with only phototherapy, the infants treated with immunoglobulin and phototherapy had shorter duration of phototherapy (weighted mean difference, WMD -15.42, 95%CI -29.00 to -1.85), less chance to be given exchange transfusion (RR 0.25, 95%CI 0.17 to 0.39) and shorter duration of hospitalization (WMD -25.44, 95%CI -36.93 to -13.94). While intravenous immunoglobulin could not decrease the maximum serum bilirubin level (WMD -29.91, 95%CI -78.24 to 18.42). There was no significant difference in the incidence of late anemia between the two groups. No adverse reaction was found in neonates who received immunoglobulin.
The results of this meta analysis support that the intravenous immunoglobulin had some therapeutic effect on neonatal isoimmune hemolytic disease. The infants who received immunoglobulin had shorter duration of phototherapy and less chance to be given exchange transfusion. Well designed, double blind and randomized controlled trials with large sample size and long-term follow-up are needed for further evaluation of the efficacy and safety of the immunoglobulin therapy.
新生儿同种免疫溶血病仍是新生儿高胆红素血症的主要病因之一。严重溶血的婴儿甚至需要光疗和换血治疗。早期静脉输注免疫球蛋白在一定程度上可阻断溶血。本研究旨在通过荟萃分析探讨免疫球蛋白输注治疗新生儿同种免疫溶血病的疗效和安全性。
纳入通过检索MEDLINE、Cochrane图书馆、EMBASE、中国知网和中国生物医学文献数据库获得的关于免疫球蛋白输注对新生儿Rh和ABO血型不合溶血病疗效的所有随机对照试验。采用Review Manager 4.2软件进行荟萃分析。
纳入6项试验，共456例新生儿。4项研究中有109例Rh血型不合溶血病婴儿，4项研究中有347例ABO血型不合溶血病婴儿。免疫球蛋白输注组与对照组在胎龄、体重和性别方面无显著差异。与仅接受光疗的新生儿相比，接受免疫球蛋白和光疗的婴儿光疗时间较短（加权均数差，WMD -15.42，95%CI -29.00至-1.85），接受换血治疗的机会较少（RR 0.25，95%CI 0.17至0.39），住院时间较短（WMD -25.44，95%CI -36.93至-13.94）。而静脉注射免疫球蛋白不能降低血清胆红素最高水平（WMD -29.91，95%CI -78.24至18.42）。两组晚期贫血发生率无显著差异。接受免疫球蛋白的新生儿未发现不良反应。
本荟萃分析结果支持静脉注射免疫球蛋白对新生儿同种免疫溶血病有一定治疗作用。接受免疫球蛋白治疗的婴儿光疗时间较短，接受换血治疗的机会较少。需要设计良好、双盲、大样本量且长期随访的随机对照试验来进一步评估免疫球蛋白治疗的疗效和安全性。
