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为什么我们需要针对维生素K进行一项临床试验。

Why we need a clinical trial for vitamin K.

作者信息

Slattery J M

机构信息

Department of Clinical Neurosciences, University of Edinburgh.

出版信息

BMJ. 1994 Apr 2;308(6933):908-10. doi: 10.1136/bmj.308.6933.908.

DOI:10.1136/bmj.308.6933.908
PMID:8173376
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2539847/
Abstract

Vitamin K is given to many babies born in the United Kingdom, but we still do not know if it has substantial hazards. Because the population exposed to vitamin K is very large even quite small hazards would involve many adverse events. It is therefore important to be able to put reasonably close bounds on the potential damage that vitamin K prophylaxis could cause. Past research has not allowed us to do this but a large randomised controlled clinical trial of vitamin K against no vitamin K, enrolling only infants at low risk of haemorrhagic disease, would do so. There is no question that vitamin K is a useful treatment in babies at highest risk of haemorrhagic disease: the question is whether the trend towards use of vitamin K in lower risk babies should be encouraged.

摘要

英国许多新生儿都被注射了维生素K,但我们仍不清楚它是否存在重大危害。由于接触维生素K的人群非常庞大,即便危害很小,也会涉及众多不良事件。因此,能够合理地准确界定维生素K预防性用药可能造成的潜在损害非常重要。过去的研究未能让我们做到这一点,但针对低出血性疾病风险婴儿开展的一项维生素K与不使用维生素K的大型随机对照临床试验将会做到。毫无疑问,维生素K对于出血性疾病风险最高的婴儿是一种有效的治疗方法:问题在于,是否应鼓励在低风险婴儿中使用维生素K的趋势。

相似文献

1
Why we need a clinical trial for vitamin K.为什么我们需要针对维生素K进行一项临床试验。
BMJ. 1994 Apr 2;308(6933):908-10. doi: 10.1136/bmj.308.6933.908.
2
Neonatal vitamin K prophylaxis and childhood cancer.新生儿维生素K预防与儿童癌症
Indian Pediatr. 1998 Jul;35(7):691-3.
3
Ecological studies of relation between hospital policies on neonatal vitamin K administration and subsequent occurrence of childhood cancer.关于新生儿维生素K给药医院政策与儿童期癌症后续发生之间关系的生态学研究。
BMJ. 1998 Jan 17;316(7126):184-9. doi: 10.1136/bmj.316.7126.184.
4
Prevention of vitamin K deficiency bleeding in newborns.预防新生儿维生素K缺乏性出血
Br J Haematol. 1999 Mar;104(3):430-7. doi: 10.1046/j.1365-2141.1999.01104.x.
5
Case-control studies of relation between childhood cancer and neonatal vitamin K administration.儿童癌症与新生儿维生素K给药之间关系的病例对照研究。
BMJ. 1998 Jan 17;316(7126):178-84. doi: 10.1136/bmj.316.7126.178.
6
Vitamin K for neonates: the controversy.新生儿维生素K:争议
BMJ. 1994 Apr 2;308(6933):867-8. doi: 10.1136/bmj.308.6933.867.
7
Weekly oral vitamin K prophylaxis in Denmark.丹麦的每周口服维生素K预防措施。
Acta Paediatr. 2003 Jul;92(7):802-5.
8
The vitamin K controversy.维生素K争议
Birth Gaz. 2000 Spring;16(2):19-21.
9
Vitamin K prophylaxis and vitamin K deficiency bleeding (VKDB) in early infancy.婴儿早期的维生素K预防与维生素K缺乏性出血(VKDB)
Acta Paediatr. 1992 Sep;81(9):655-7. doi: 10.1111/j.1651-2227.1992.tb12326.x.
10
Late vitamin K deficiency bleeding in an infant born at a maternity hospital.一名在妇产医院出生的婴儿发生晚发性维生素K缺乏性出血。
Pediatr Int. 2014 Jun;56(3):436. doi: 10.1111/ped.12346.

引用本文的文献

1
Vitamin K for neonates.新生儿维生素K
BMJ. 1994 Sep 10;309(6955):668-9. doi: 10.1136/bmj.309.6955.668b.
2
Vitamin K for neonates.新生儿维生素K
BMJ. 1994 Jun 18;308(6944):1635. doi: 10.1136/bmj.308.6944.1635a.

本文引用的文献

1
The relation of vitamin K deficiency to hemorrhagic disease of the newborn.维生素K缺乏与新生儿出血性疾病的关系。
Adv Pediatr. 1952 Jan;5:129-53.
2
Observations on the prophylactic use of vitamin Kin the newborn infant.关于新生儿维生素K预防性使用的观察
J Pediatr. 1960 Mar;56:343-6. doi: 10.1016/s0022-3476(60)80185-0.
3
The risk of childhood cancer after neonatal exposure to vitamin K.新生儿接触维生素K后患儿童癌症的风险。
N Engl J Med. 1993 Sep 23;329(13):905-8. doi: 10.1056/NEJM199309233291301.
4
Administration of vitamin K to newborn infants and childhood cancer.给新生儿和儿童癌症患者补充维生素K
BMJ. 1993 Jul 10;307(6896):89-91. doi: 10.1136/bmj.307.6896.89.
5
Hemorrhagic disease of the newborn. Breast feeding as a necessary factor in the pathogenesis.新生儿出血性疾病。母乳喂养作为发病机制中的一个必要因素。
Am J Dis Child. 1967 May;113(5):524-33. doi: 10.1001/archpedi.1967.02090200056003.
6
Vitamin K prophylaxis against haemorrhagic disease of the newborn in the United Kingdom.英国预防新生儿出血性疾病的维生素K应用
BMJ. 1991 Nov 2;303(6810):1109. doi: 10.1136/bmj.303.6810.1109.
7
Haemorrhagic disease of the newborn in the British Isles: two year prospective study.不列颠群岛新生儿出血性疾病:两年前瞻性研究
BMJ. 1991 Nov 2;303(6810):1105-9. doi: 10.1136/bmj.303.6810.1105.
8
Vitamin K and childhood cancer.维生素K与儿童癌症
BMJ. 1992 Oct 24;305(6860):1016. doi: 10.1136/bmj.305.6860.1016-c.
9
Intramuscular vitamin K and childhood cancer.肌肉注射维生素K与儿童癌症
BMJ. 1992 Sep 19;305(6855):709; author reply 710-1. doi: 10.1136/bmj.305.6855.709.
10
Childhood cancer, intramuscular vitamin K, and pethidine given during labour.儿童癌症、肌肉注射维生素K以及分娩期间使用的哌替啶。
BMJ. 1992 Aug 8;305(6849):341-6. doi: 10.1136/bmj.305.6849.341.