Ipema Heather J
Drug Information Group, College of Pharmacy, University of Illinois at Chicago, IL, USA.
Ann Pharmacother. 2012 Jun;46(6):879-83. doi: 10.1345/aph.1Q769. Epub 2012 May 22.
To evaluate the literature describing use of oral vitamin K(1) (phytonadione) to prevent late vitamin K deficiency bleeding (VKDB) in neonates when injectable vitamin K preparations are not available.
Articles were retrieved through MEDLINE (1946-February 2012) using the terms vitamin K, vitamin K deficiency bleeding, newborn, neonate, and prophylaxis. Reference citations from publications identified were reviewed.
All articles published in English on the use of prophylactic oral vitamin K in neonates were evaluated. The largest epidemiologic studies discussing the efficacy of continuous oral vitamin K prophylaxis were reviewed. Individual, smaller clinical trials were not reviewed.
For prevention of early, classic, and late VKDB, use of intramuscular vitamin K 1 mg is preferred over oral administration because of superior efficacy. Single oral doses protect against early VKDB, but multiple oral doses are needed for late VKDB prophylaxis, especially in exclusively breast-fed neonates. Continuous oral dosing regimens used in the literature vary; European epidemiologic data suggest the lowest rates of late VKDB with oral vitamin K 1 mg at birth followed by 25 μg daily for 13 weeks, or 2 mg at birth followed by 1 mg weekly for 3 months. Limited data describe the use of oral prophylactic vitamin K in high-risk patients (eg, premature neonates, biliary abnormalities).
While there are data supporting effective oral vitamin K dosing regimens for prevention of late VKBD in exclusively breast-fed neonates, lack of an appropriate oral dosage form prevents routine use of this technique in the US. In times of drug shortage, injectable vitamin K preparations should be reserved for use in neonates. If injectable vitamin K is not available, clinicians should choose the most practical method of administering oral vitamin K based on the oral products available.
评估在无法获得注射用维生素K制剂时,使用口服维生素K(1)(叶绿醌)预防新生儿晚期维生素K缺乏性出血(VKDB)的相关文献。
通过MEDLINE(1946年至2012年2月)检索文章,检索词为维生素K、维生素K缺乏性出血、新生儿、早产儿和预防。对已识别出版物的参考文献进行了审查。
评估了所有以英文发表的关于新生儿预防性口服维生素K使用的文章。审查了讨论连续口服维生素K预防效果的最大规模流行病学研究。未审查个体的、规模较小的临床试验。
对于预防早期、典型和晚期VKDB,由于疗效更佳,肌肉注射1毫克维生素K比口服更可取。单次口服剂量可预防早期VKDB,但预防晚期VKDB需要多次口服剂量,尤其是纯母乳喂养的新生儿。文献中使用的连续口服给药方案各不相同;欧洲流行病学数据表明,出生时口服1毫克维生素K,随后每天25微克持续13周,或出生时口服2毫克,随后每周1毫克持续3个月,晚期VKDB发生率最低。有限的数据描述了口服预防性维生素K在高危患者(如早产儿、胆道异常)中的使用情况。
虽然有数据支持有效的口服维生素K给药方案可预防纯母乳喂养新生儿的晚期VKBD,但缺乏合适的口服剂型阻碍了该技术在美国的常规使用。在药物短缺时期,注射用维生素K制剂应保留用于新生儿。如果没有注射用维生素K,临床医生应根据可用的口服产品选择最实用的口服维生素K给药方法。