Immunoglobulin infusion for isoimmune haemolytic jaundice in neonates

  • Review
  • Intervention

Authors


Abstract

Background

Exchange transfusion and phototherapy have traditionally been used to treat jaundice and avoid the associated neurological complications. Exchange transfusion is not without risk and intravenous immunoglobulin has been suggested as an alternative therapy for isoimmune haemolytic jaundice to reduce the need for exchange transfusion.

Objectives

To assess whether the use of intravenous immunoglobulin, in newborn infants with isoimmune haemolytic jaundice, is effective in reducing the need for exchange transfusion.

Search methods

The search strategy of the Cochrane Neonatal Review group was used. Searches were made of MEDLINE 1966-2002, EMBASE Drugs and Pharmacology 1990-2002, Cochrane Controlled Trials Register, The Cochrane Library, Issue 1, 2002, expert informants, review articles, cross references, and hand searching of abstracts and conference proceedings of the annual meetings of The Society for Pediatric Research 1990-2001 and The European Society for Paediatric Research 1990-2001.

Selection criteria

All randomised and quasi-randomised controlled trials of the use of intravenous immunoglobulin in the treatment of isoimmune haemolytic disease were considered.

Data collection and analysis

The standard methods of the Cochrane Collaboration and its Neonatal Review Group were used. Studies were assessed for inclusion and quality by two reviewers working independently, with the second reviewer blinded to trial author, institution and journal of publication. Data were extracted independently by the two reviewers. Any differences of opinion were discussed and a consensus reached. Investigators were contacted for additional or missing information. For categorical outcomes, the relative risk (RR), risk difference (RD) and the number needed to treat (NNT) were calculated. For continuous variables, the weighted mean difference (WMD) was calculated.

Main results

Seven studies were identified. Three of these fulfilled the inclusion criteria and included a total of 189 infants. Term and preterm infants and infants with rhesus and ABO incompatibility were included. The use of exchange transfusion decreased significantly in the immunoglobulin treated group (typical RR 0.28, 95% CI 0.17, 0.47; typical RD -0.37, 95% CI -0.49, -0.26; NNT 2.7). The mean number of exchange transfusions per infant was also significantly lower in the immunoglobulin treated group (WMD -0.52, 95% CI -0.70, -0.35). None of the studies assessed long term outcomes.

Authors' conclusions

Although the results show a significant reduction in the need for exchange transfusion in those treated with intravenous immunoglobulin, the applicability of the results is limited. The number of studies and infants included is small and none of the three included studies was of high quality. The protocols of two of the studies mandated the use of early exchange transfusion, limiting the generalizability of the results. Further well designed studies are needed before routine use of intravenous immunoglobulin can be recommended for the treatment of isoimmune haemolytic jaundice.

摘要

背景

免疫球蛋白注射在新生兒同族免疫性溶血性黃疸上的使用

傳統上用換血和照光治療來處理黃疸以避免相關的神經學併發症。換血治療並非沒有危險,所以靜脈注射免疫球蛋白被建議使用於同族免疫性溶血性黃疸來減少換血的需要。

目標

評估在有同族免疫性溶血性黃疸的嬰兒使用靜脈注射免疫球蛋白是否能有效的減少換血治療的需要。

搜尋策略

搜尋的方針是使用Cochrane Neonatal Review group的方法。搜尋包括 MEDLINE 1966 – 2002、EMBASE Drugs and Pharmacology、Cochrane Controlled Trial Register、The Cochrane Library, Issue 1, 2002、專家意見、回顧性文章、交叉參考及The Society for Pediatric Research 1990 – 2001和The European Society for Paedatric Research of 1990 – 2001年度會議的的摘要和會議內容。

選擇標準

所有使用靜脈注射免疫球蛋白來治療同族免疫性溶血性黃疸的隨機或半隨機控制研究都考慮收錄。

資料收集與分析

使用Cochrane Collaboration及其Neonatal Review Group的標準方法。由兩位評論者獨立作業來評估研究的收錄和品質,且第二位評論者完全不知研究的作者、機構和出版處。資料由兩位評論者各自獨立來摘錄。任何不同的意見都會被討論直到意見一致。若需額外的或缺漏的資訊則聯繫研究者。對類別的預後來說,計算其相對危險值 (RR) 、危險差 (RD) 和需治數 (NNT) 。對連續性變項來說,則計算加權平均數 (WMD) 。

主要結論

共有7個研究被搜尋到。其中3個研究共189位嬰兒完全符合收入的標準。足月兒和早產兒有Rh或ABO血型不合的嬰兒都包含在內。以免疫球蛋白治療組明顯的減少換血治療的使用 (typical RR 0.28, 95% CI 0.17, 0.47; typical RD −0.37, 95% CI −0.49, −0.26; NNT 2.7) 。每位嬰兒的平均換血次數在免疫球蛋白治療組是明顯的減少。並沒有任一個研究評估長期的預後。

作者結論

雖然這結果指出用靜脈注射免疫球蛋白來治療會明顯地減少換血的需要,但這結果的適用性有限。研究數目和含括的嬰兒數皆太少,且三個被納入的研究也都並非高品質的研究。兩個研究草案設計使用早期換血,限制了其結果的廣泛性。在常規性的建議使用靜脈注射免疫球蛋白來治療同族免疫溶血性黃疸前,仍需更好設計的研究來證明其價值。

翻譯人

本摘要由馬偕醫院謝雨潤翻譯。

此翻譯計畫由臺灣國家衛生研究院 (National Health Research Institutes, Taiwan) 統籌。

總結

概要未決

Plain language summary

Immunoglobulin infusion for isoimmune haemolytic jaundice in neonates

Plain language summary will be included with future review update.

Ancillary