Cornelissen E A, Kollée L A, De Abreu R A, van Baal J M, Motohara K, Verbruggen B, Monnens L A
Department of Paediatrics, University of Nijmegen, The Netherlands.
Arch Dis Child. 1992 Oct;67(10):1250-4. doi: 10.1136/adc.67.10.1250.
A randomised clinical trial was conducted to establish the effects of oral and intramuscular administration of vitamin K at birth on plasma concentrations of vitamin K1, proteins induced by vitamin K absence (PIVKA-II), and clotting factors. Two groups of about 165 healthy breast fed infants who received at random 1 mg vitamin K1 orally or intramuscularly after birth were studied at 2 weeks and 1 and 3 months of age. Although vitamin K1 concentrations were statistically significantly higher in the intramuscular group, blood coagulability, activities of factors VII and X and PIVKA-II concentrations did not reveal any difference between the two groups. At 2 weeks of age vitamin K1 concentrations were raised compared with reported unsupplemented concentrations and no PIVKA-II was detectable. At 3 months vitamin K1 concentrations were back at unsupplemented values and PIVKA-II was detectable in 11.5% of infants. Therefore, a repeated oral prophylaxis will be necessary to completely prevent (biochemical) vitamin K deficiency beyond the age of 1 month.
进行了一项随机临床试验，以确定出生时口服和肌肉注射维生素K对维生素K1血浆浓度、维生素K缺乏诱导蛋白（PIVKA-II）和凝血因子的影响。对两组各约165名健康母乳喂养婴儿进行了研究，这些婴儿在出生后随机接受1毫克维生素K1口服或肌肉注射，并在2周龄、1月龄和3月龄时进行检测。尽管肌肉注射组的维生素K1浓度在统计学上显著更高，但两组之间的血液凝固性、因子VII和X的活性以及PIVKA-II浓度并无差异。2周龄时，维生素K1浓度比未补充维生素K时的报告浓度有所升高，且未检测到PIVKA-II。3月龄时，维生素K1浓度恢复到未补充时的水平，11.5%的婴儿可检测到PIVKA-II。因此，有必要进行重复口服预防，以完全预防1月龄后（生化）维生素K缺乏。
