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目的探讨维生素K预防新生儿出血症(HDN)的给药方案。方法采用MEDLINE和CBM检索,选取以新生儿出血症(HDN)发生率和血浆VitK缺乏诱导蛋白(PIVKA_Ⅱ)阳性率为观察指标的相关文献,比较肌注与口服维生素K预防HDN的效果,通过Meta分析估计不同口服次数预防HDN的相对危险度,采用有序变量Logistic模型拟合不同口服次数HDN的发生概率,计算Fisher精确概率比较不同口服次数之间的HDN理论发生频率的差异。结果口服及肌注1次维生素K均能降低PIVKA_Ⅱ阳性率,口服组和肌注组之间差异无显著性;口服1次维生素K的HDN发生率明显高于肌注1次维生素K;随着口服维生素K次数的增加,发生HDN的相对危险度以及HDN的发生概率逐渐下降,口服2次以上的相对危险度趋于平稳,3次与4次以上的HDN的发生概率差异无显著性。结论PIVKA_Ⅱ阳性率能否作为评价维生素K预防新生儿HDN的敏感指标,值得进一步商榷;建议以新生儿出生当天肌注1次或者每周1次连续3周口服维生素K,作为预防HDN的参考方案。
Objective To investigate the dosage regimen of vitamin K for the prevention of neonatal hemorrhagic disease (HDN). Methods MEDLINE and CBM were used to search the relevant literature about the incidence of neonatal hemorrhagic disease (HDN) and the positive rate of plasma VitK deficiency-inducing protein (PIVKA_Ⅱ), and to compare the preventive effects of intramuscular injection and oral vitamin K on HDN. Meta To analyze the relative risk of HDN by different times of oral administration. Logistic model was used to fit the incidence of HDN in different oral times, and Fisher’s exact probability was calculated to compare the frequency of HDN between different oral times. Results Oral and intramuscular injection of vitamin K all can reduce the positive rate of PIVKA Ⅱ, no significant difference between the oral group and the intramuscular injection group; oral HDK incidence of vitamin K was significantly higher than intramuscular injection of vitamin K; with The increase of oral vitamin K, the relative risk of occurrence of HDN and the incidence of HDN gradually decreased. The relative risk of oral administration of more than two times tended to be stable, and there was no significant difference in the incidence of HDN between three and four times. Conclusions The positive rate of PIVKA_Ⅱ can be used as a sensitive index to evaluate the prevention of neonatal HDN by vitamin K. It is worth further discussing that it is recommended to take vitamin K as an intramuscular injection once a day or once a week for 3 weeks as a reference to prevent HDN .