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Antithrombin for respiratory distress syndrome in preterm infants

  • Review
  • Intervention

Authors


Abstract

Background

Acquired Antithrombin (AT) deficiency is a common and prognostically important finding in sick preterm infants with respiratory distress syndrome (RDS). It has been hypothesised that AT concentrate may improve clinical outcomes in preterm infants with RDS.

Objectives

To determine the effect of administration of AT concentrate compared with placebo or no treatment on mortality in preterm infants with RDS.

Search methods

An electronic literature search in CENTRAL, MEDLINE, and EMBASE was performed in August 2006. References from identified studies were cross checked for possible additional studies. Experts in the field and pharmaceutical companies were contacted for unpublished data. Abstracts of the American Society of Pediatric Research and European Society of Pediatric Research meetings (1983 to 2005) were searched and authors of relevant studies were contacted to obtain additional information. The electronic search was updated in December 2009.

Selection criteria

Randomized controlled trials comparing any dose and duration of AT therapy with placebo or no treatment in preterm infants with RDS.

Data collection and analysis

Two review authors independently extracted data from included studies. Data for similar outcomes were combined where appropriate, using a fixed-effects model in RevMan 4.

Main results

Two trials consisting of 182 preterm infants fulfilled the inclusion criteria. Mean gestational age of patients included was 28 weeks. In one trial, patients had to be intubated and ventilated for RDS to be eligible for the study. In the other trial, RDS was not mentioned as an inclusion criteria; however, the vast majority of infants in the study received surfactant. No individual trial showed a significant difference in mortality. One of the trials was stopped early because of an increase in deaths in the AT group. The pooled analysis for mortality within the first week of life showed a typical relative risk of 2.67 (95% CI 0.72 to 9.83) in favour of the control group. Only the trial that was stopped early followed the infants long enough to report neonatal mortality. This trial reported 7 deaths (11.5%) in the AT group and two deaths (3.3%) in the placebo group within 28 days of life. Secondary outcomes included days of mechanical ventilation and supplemental oxygen which were only reported in 1 trial. Both outcomes were in favour of the control group and statistically significant (p < 0.05).

Authors' conclusions

Preterm infants with RDS are unlikely to benefit from AT treatment and may be harmed.

摘要

背景

使用抗凝血?(Antithrombin)治療呼吸窘迫症(respiratory distress syndrome)早產兒的效果

後天性抗凝血?缺乏症(Acquired Antithrombin deficiency)對於患有呼吸窘迫症(RDS)的早產兒是一種常見的並影響癒後的重要發現。有假說指出,濃縮後的抗凝血?可改善呼吸窘迫症早產兒的臨床結果。

目標

要決定對於呼吸窘迫症的早產兒,給予濃縮抗凝血?和給予安慰劑或不治療之間死亡率的差別

搜尋策略

電子文獻搜尋:CENTRAL, MEDLINE, and EMBASE was performed in August 2006. 從確切研究資料來的參考資料都經過交叉檢查,來找出可能的進一步研究。 我們向在此領域的專家和藥商公司索取尚未發布的數據資料,並搜尋American Society of Pediatric Research and European Society of Pediatric Research meetings (1983 to 2005)的文摘。此外我們也與相關研究的作者進行聯繫,以獲取更多資料。電子搜尋已於2009年12月更新

選擇標準

隨機對照試驗來比較使用任一的劑量和治療時間的抗凝血?與使用安慰劑或不給藥物治療的呼吸窘迫症的早產兒

資料收集與分析

兩位審查作者獨立地從符合標準的研究中擷取數據。相似結果的數據使用固定效應模型(fixedeffects model)的專用軟體 RevMan4.2.8做適當的合併

主要結論

本次分析包含兩項試驗,共有182名早產兒符合收案標準。嬰兒平均年齡為28周大。其中一個試驗,呼吸窘迫症的病嬰需插管並使用呼吸器才可進行研究。另一個試驗中,呼吸窘迫並未提及是收案條件之一,但絕大多數收案的病嬰有使用表面張力素(surfactant)。這兩個研究在死亡率上無顯著差異。而其中之一的試驗因使用抗凝血?組的死亡增加而提早結束試驗。 第一周死亡率的pooled analysis顯示typical relative risk of 2.67 (95% CI 0.72 to 9.83),故對照組較優。惟獨讓試驗時間已經長到可以報告新生兒死亡率時就提早結束。這項試驗報告在觀察28天中給予抗凝血?組有7例死亡(11.5%),而安慰劑組有兩個例死亡(3.3%)。次級結果包括其中一個試驗中提及的使用呼吸器和氧氣的天數。兩種試驗都顯示不使用抗凝血?組的新生兒死亡率較低且有統計學意義(P < 0.05)。

作者結論

有呼吸窘迫症的早產兒給予抗凝血?治療無益且可能有害

翻譯人

本摘要由臺中榮民總醫院薛榮華翻譯。

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

總結

使用抗凝血?(Antithrombin)治療呼吸窘迫症(respiratory distress syndrome)早產兒的效果: 抗凝血?是由肝臟產生的一種物質,對於控制血液凝固和之後的血塊崩解有重要的作用。病危的新生兒,如因早產使肺部不成熟導致呼吸窘迫,血液中的抗凝血?濃度很低。已有實驗針對給予呼吸窘迫症的早產兒抗凝血?是否有益。但在我們的systematic review發現,給予呼吸窘迫症的早產兒抗凝血?治療,不但無益還可能受到傷害。

Plain language summary

Antithrombin for respiratory distress syndrome in preterm infants

Antithrombin (AT) is a substance that is produced by the liver and that plays an important role in the control of blood clotting and the subsequent breakdown of the clot. Critically ill infants, such as those born prematurely with immature lungs leading to respiratory distress (Respiratory Distress Syndrome; RDS) have low concentrations of AT in the blood. Studies have been conducted to examine whether preterm infants with RDS benefit from the administration of AT. In our systematic review, we found that preterm infants with RDS do not benefit from therapy with AT and may be harmed.

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