Cortey A, Elzaabi M, Waegemans T, Roch B, Aujard Y
Centre national de référence en hémobiologie périnatale (unité clinique), pôle périnatalité, hôpital Trousseau, AP-HP, 26, rue Arnold-Netter, 75012 Paris, France.
LFB biotechnologies SAS, 3, avenue des Tropiques, Les Ulis, 91958 Courtabœuf, France.
Arch Pediatr. 2014 Sep;21(9):976-83. doi: 10.1016/j.arcped.2014.02.005. Epub 2014 Aug 11.
ABO fetomaternal red blood cell incompatibility (ABO FMI) induces an immune hemolysis after fetal transfer of hemolyzing maternal anti-A or anti-B. ABO hemolytic disease (ABO HD) remains the most frequent cause of severe and early jaundice in newborns. High levels of unconjugated hyperbilirubinemia may induce acute and chronic neurological complications. Severe hyperbilirubinemia can be prevented by first-line phototherapy (PT) treatment, but exchange transfusion (ET) is required if treatment is not effective, even if ET is linked with high hemodynamic, infectious, gastrointestinal, and/or biological morbidity. Intravenous human polyclonal immunoglobulins (IVIg) have been proposed in concomitant use with PT in order to avoid the requirement for ET in ABO FMI.
Electronic databases of all published clinical trials in neonatal hyperbilirubinemia due to ABO incompatibility were systematically queried for randomized controlled clinical trials comparing PT alone to PT associated with IVIg based on the requirement for ET. Duration of PT and adverse events were optional criteria. A meta-analysis of the selected data was performed on six selected trials out of 28 found.
IVIg doses ranged from 0.5 to 1.5 g/Kg in one to three administrations. Requirement for ET was lower in the IgIV+PT group, with a relative risk of 0.27 [CI 95% 0.17-0.42; P<0.00001], expressed as a number needed to treat of five neonates to avoid one ET. The mean duration of PT was 4 days in the PT group and association of PT with IVIg significantly reduced the duration of PT treatment by 0.84 days. The tolerance of the IVIg and PT association was good with no reported cases of ulcerative enterocolitis in 265 treated newborns.
IVIG associated with PT reduces the need for ET and the duration of PT in newborns with hyperbilirubinemia due to ABO hemolytic disease. Their efficacy and good tolerance prompt consideration of IVIg as a therapeutic adjuvant to PT in severe hemolytic hyperbilirubinemia due to ABO incompatibility.
ABO 母胎红细胞不相容（ABO FMI）在胎儿接受具有溶血作用的母体抗 A 或抗 B 抗体后会引发免疫性溶血。ABO 溶血病（ABO HD）仍然是新生儿严重早期黄疸最常见的病因。高水平的未结合型高胆红素血症可能会引发急性和慢性神经并发症。一线光疗（PT）治疗可预防严重高胆红素血症，但如果治疗无效则需要进行换血疗法（ET），即便 ET 会带来较高的血流动力学、感染、胃肠道和/或生物学发病率。已有人提出静脉注射人多克隆免疫球蛋白（IVIg）与 PT 联合使用，以避免 ABO FMI 患儿需要进行 ET。
系统检索所有已发表的关于 ABO 血型不合所致新生儿高胆红素血症的临床试验的电子数据库，以查找将单纯 PT 与基于 ET 需求的 PT 联合 IVIg 进行比较的随机对照临床试验。PT 持续时间和不良事件为可选标准。对在 28 项研究中筛选出的 6 项试验的选定数据进行荟萃分析。
IVIg 剂量在 0.5 至 1.5 g/Kg 之间，分 1 至 3 次给药。IgIV + PT 组需要进行 ET 的情况较少，相对风险为 0.27 [95%置信区间 0.17 - 0.42；P < 0.00001]，即每治疗 5 名新生儿可避免 1 次 ET。PT 组的 PT 平均持续时间为 4 天，PT 与 IVIg 联合使用显著缩短了 PT 治疗持续时间 0.84 天。265 例接受治疗的新生儿中未报告溃疡性结肠炎病例，表明 IVIg 与 PT 联合使用耐受性良好。
PT 联合 IVIG 可减少 ABO 溶血病所致高胆红素血症新生儿对 ET 的需求以及 PT 的持续时间。它们的疗效和良好耐受性促使人们考虑将 IVIg 作为 PT 在 ABO 血型不合所致严重溶血性高胆红素血症中的治疗辅助药物。
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