Steer P A, Flenady V J, Shearman A, Lee T C, Tudehope D I, Charles B G
Centre for Clinical Studies, University of Queensland, Queensland, Australia.
J Paediatr Child Health. 2003 Sep-Oct;39(7):511-5. doi: 10.1046/j.1440-1754.2003.00207.x.
To compare the effectiveness of three dosing regimens of caffeine for preterm infants in the periextubation period.
A randomized double-blind clinical trial of three dosing regimens of caffeine citrate (3, 15 and 30 mg/kg) for periextubation management of ventilated preterm infants was undertaken. Infants born <32 weeks gestation who were ventilated for>48 h were eligible for the study. Caffeine citrate was given as a once daily dose for a period of 6 days commencing 24 h prior to a planned extubation, or within 6 h of an unplanned extubation. The primary outcome measure was extubation failure, defined as neonates who were unable to be extubated within 48 h of caffeine loading or who required reventilation or doxapram dose within 7 days of caffeine loading. Continuous recordings of oxygen saturation and heart rate were undertaken in a subgroup of enrolled infants.
A total of 127 babies were enrolled into the study (42, 40, 45, in the 3, 15, and 30 mg/kg groups, respectively). No statistically significant difference was demonstrated in the incidence of extubation failure between dosing groups (19, 10, and 11 infants in the 3, 15, and 30 mg/kg groups, respectively), however, infants in the two higher dose groups had statistically significantly less documented apnoea than the lowest dose group. Of the 37 neonates with continuous pulse oximetry recordings, those on higher doses of caffeine recorded a statistically significantly higher mean heart rate, oxygen saturations and less time with oxygen saturations <85%.
This trial indicated there were short-term benefits of decreased apnoea in the immediate periextubation period for ventilated infants born <32 weeks gestation receiving higher doses of caffeine. Further studies with larger numbers of infants assessing longer-term outcomes are necessary to determine the optimal dosing regimen of caffeine in preterm infants.
比较三种咖啡因给药方案对早产儿拔管期的有效性。
进行了一项随机双盲临床试验，研究枸橼酸咖啡因的三种给药方案（3、15和30mg/kg）用于机械通气早产儿拔管期的管理。孕周<32周且机械通气>48小时的婴儿符合研究条件。枸橼酸咖啡因在计划拔管前24小时或非计划拔管后6小时内开始，每日给药一次，持续6天。主要结局指标为拔管失败，定义为在咖啡因负荷后48小时内无法拔管或在咖啡因负荷后7天内需要再次通气或使用多沙普仑的新生儿。对部分入选婴儿进行了血氧饱和度和心率的连续记录。
共有127名婴儿纳入研究（3、15和30mg/kg组分别为42、40和45名）。各给药组之间拔管失败发生率无统计学显著差异（3、15和30mg/kg组分别有19、10和11名婴儿），然而，两个较高剂量组的婴儿记录到的呼吸暂停在统计学上显著少于最低剂量组。在37名有连续脉搏血氧饱和度记录的新生儿中，接受较高剂量咖啡因的新生儿记录到的平均心率、血氧饱和度在统计学上显著更高，且血氧饱和度<85%的时间更短。
本试验表明，对于孕周<32周的机械通气婴儿，在拔管期接受较高剂量咖啡因有短期减少呼吸暂停的益处。需要进行更多婴儿参与的进一步研究以评估长期结局，从而确定早产儿咖啡因的最佳给药方案。
