Intervention Review

Prophylactic vitamin K for vitamin K deficiency bleeding in neonates

  1. Renee M Puckett,
  2. Martin Offringa*

Editorial Group: Cochrane Neonatal Group

Published Online: 23 OCT 2000

Assessed as up-to-date: 5 AUG 2000

DOI: 10.1002/14651858.CD002776

How to Cite

Puckett RM, Offringa M. Prophylactic vitamin K for vitamin K deficiency bleeding in neonates. Cochrane Database of Systematic Reviews 2000, Issue 4. Art. No.: CD002776. DOI: 10.1002/14651858.CD002776.

Author Information

  1. Academic Medical Center, Pediatrics, H3-144, Amsterdam, Netherlands

*Martin Offringa, Pediatrics, H3-144, Academic Medical Center, P.O. Box 22700, Amsterdam, 1100 DE, Netherlands. m.offringa@amc.uva.nl.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 23 OCT 2000

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Vitamin K deficiency can cause bleeding in an infant in the first weeks of life. This is known as Hemorrhagic Disease of the Newborn (HDN). HDN is divided into three categories: early, classic and late HDN. Early HDN occurs within 24 hours post partum and falls outside the scope of this review. Classic HDN occurs on days one to seven; common bleeding sites are gastrointestinal, cutaneous, nasal and from a circumcision. Late HDN occurs from week 2-12; the most common bleeding sites are intracranial, cutaneous, and gastrointestinal.

Vitamin K is commonly given prophylactically after birth for the prevention of HDN, but the preferred route is uncertain.

Objectives

To review the evidence from randomized trials in order to determine the effectiveness of vitamin K prophylaxis in the prevention of classic and late HDN. Main questions are: Is one dose of vitamin K, given after birth, able to significantly reduce the incidence of classic and late HDN? Is there a significant difference between the oral route and the intramuscular route in preventing classic and late HDN? Are multiple oral doses of vitamin K, given after birth, able to significantly reduce the incidence of classic and late HDN?

Search methods

The standard search strategy of the Cochrane Neonatal Review Group was used.

Selection criteria

All trials using random or quasi-random patient allocation, in which methods of vitamin K prophylaxis in infants were compared to each other, placebo or no treatment, were included.

Data collection and analysis

Data were extracted independently by each author and were analysed with the standard methods of the Cochrane Collaboration and its Neonatal Review Group, using relative risk, risk difference and weighted mean difference.

Main results

Two eligible randomized trials, each comparing a single dose of intramuscular vitamin K with placebo or nothing, assessed effect on clinical bleeding. One dose of vitamin K reduced clinical bleeding at 1-7 days, including bleeding after circumcision, and improved biochemical indices of coagulation status. Eleven additional eligible randomized trials compared either a single oral dose of vitamin K with placebo or nothing, a single oral with a single intramuscular dose of vitamin K, or three oral doses with a single intramuscular dose. None of these trials assessed clinical bleeding. Oral vitamin K improved biochemical indices of coagulation status at 1-7 days. There was no evidence of a difference between the oral and intramuscular route in effects on biochemical indices of coagulation status. A single oral compared with a single intramuscular dose resulted in lower plasma vitamin K levels at two weeks and one month, whereas a 3-dose oral schedule resulted in higher plasma vitamin K levels at two weeks and at two months than did a single intramuscular dose.

Authors' conclusions

A single dose (1.0 mg) of intramuscular vitamin K after birth is effective in the prevention of classic HDN. Either intramuscular or oral (1.0 mg) vitamin K prophylaxis improves biochemical indices of coagulation status at 1-7 days. Neither intramuscular nor oral vitamin K has been tested in randomized trials with respect to effect on late HDN. Oral vitamin K, either single or multiple dose, has not been tested in randomized trials for its effect on either classic or late HDN.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Prophylactic vitamin K for vitamin K deficiency bleeding in neonates

Vitamin K injection can prevent hemorrhagic disease of the newborn. Vitamin K helps the blood to clot but the body's capacity to store it is very low. Hemorrhagic disease of the newborn (HDN) is caused by a deficiency of Vitamin K in newborns and results in life-threatening bleeding in an infant in the first hours to months of life. Classic HDN occurs on days one to seven and late HDN occurs from week two to 12. Some Vitamin K comes from the placenta but it is not always enough. The review of randomized trials found that a single injection of Vitamin K prevents classic HDN.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

預防性維生素K使用於維生素K缺乏之新生兒

維生素K的缺乏會造成嬰兒在出生後一星期內的出血。這又稱之為新生兒的出血疾病 (HDN, Hemorrhagic Disease of the Newborn) 。新生兒的出血疾病又分為三種類型:早期,典型和晚期。出生24小時內發生的出血稱之為早期的新生兒出血疾病,這部份並不在於我們此篇文獻要討論的範圍內。出生後第1天至第7天內發生的出血稱之為典型的新生兒的出血疾病,最常發生的出血處是胃腸道,皮下,鼻子和包皮割除處。出生第2周到第12周內發生的出血稱之為晚期的新生兒出血疾病,最常發生出血的位置是顱內,皮下和胃腸道。出生後我們通常會給予預防性的維生素K來預防新生兒的出血疾病,而給予的最佳途徑為何目前尚無定論。

目標

為了決定預防性的維生素K對於預防典型及晚期的新生兒出血疾病的有效性,我們回顧來自隨機對照研究的證據。我們最想知道的是:在出生之後給予單一劑量的維生素K,是否可以明顯的降低典型及晚期的新生兒出血疾病發生的機率?維生素K的給予路徑是由口服途徑或是肌肉內注射途徑,對於降低典型及晚期的新生兒出血疾病發生機率的效果是否有明顯差異?在出生後給予多次劑量的口服維生素K,是否可以明顯的降低典型及晚期的新生兒出血疾病發生的機率?

搜尋策略

我們利用考科藍新生兒回顧群 (Cochrane Neonatal Review Group) 的標準搜尋策略。

選擇標準

所有的試驗都是使用隨機或半隨機分配病人,研究中比較了各種預防性維生素K給予的方法,並且比較與安慰劑或沒接受治療的差別。

資料收集與分析

每位作者獨立的摘錄數據,且經由考科藍共同研究 (Cochrane Collaboration) 以及它的新生兒回顧群 (Neonatal Review Group) 的標準方法來分析,利用相對危險性 (relative risk) 、危險差 (risk difference) 和加權平均數 (weighted mean difference) 來分析。

主要結論

有2篇符合資格的隨機研究,他們比較單一劑量的肌肉內注射維生素K和安慰劑或什麼都不給對於臨床上出血的影響。發現單一劑量的維生素K可以減少出生後第1天至第7天的出血情況,包括減少割除包皮後的出血和改善生化檢查上的凝血功能。另外還有11個符合資格的隨機研究,比較單一劑量的口服維生素K和安慰劑或什麼都不給,或者是比較單一劑量的口服維生素K和單一劑量的肌肉內注射維生素K,或者是比較3次劑量的口服維生素K和單一劑量的肌肉內注射維生素K。這些研究沒有評估臨床出血的結果。口服維生素改善出生後第1天至第7天生化檢查上的凝血功能。沒有任何證據顯示口服維生素K和單一劑量的肌肉內注射維生素K對於改善生化檢查上的凝血功能有差異。儘管一個3劑量口服療程其2周與2個月血漿濃度高於單一劑量肌肉內注射;不過單一劑量口服與肌肉內注射維他命K相比,其2周與1個月血漿內維他命K濃度較低。

作者結論

在出生後給予單一劑量的肌肉內注射維生素K (0.1mg) 可以有效預防典型的新生兒的出血疾病。預防性的肌肉內注射維生素K與預防性口服維生素K (0.1mg) 可以改善第1天至第7天的生化檢查上的凝血功能。並沒有任何的隨機研究去探討肌肉內注射維生素K或口服維生素K對於晚期的新生兒出血疾病有於影響。並沒有任何的隨機研究去探討單一劑量或多次劑量口服維生素K對於典型或晚期的新生兒出血疾病有於影響。

翻譯人

本摘要由高雄醫學大學附設醫院陳怡瑄翻譯。

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

總結

維生素K的注射可以預防新生兒出血疾病。維生素K可以幫助血液凝結,可是身體內儲存維生素K的能力卻很低。新生兒因缺乏維生素K造成新生兒出血疾病,可能造成嬰兒出生後第1個小時至出生後第一個月的致命性出血。典型的新生兒出血疾病發生在出生後的第1天到第7天,晚期的新生兒出血疾病發生在出生後的第2週到第12週。有些維生素K可從胎盤中獲取,可是量卻不一定足夠。這篇隨機研究的回顧發現單一劑量維生素K的注射可以預防典型的新生兒出血疾病。