Tocolytic effectiveness of nifedipine versus ritodrine and follow-up of newborns: a randomised controlled trial
Tocolytic effectiveness of nifedipine versus ritodrine and follow-up of newborns: a randomised controlled trial
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DOI：
10.1080/00016340801913189
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发表时间：
2008-01-01
影响因子：
4.3
通讯作者：
Oei, S. G.
中科院分区：
文献类型：
--
作者：
De Water, M. Van;Kessel, E. Timmerman-Van;Oei, S. G.
背景几项研究表明硝苯地平的保胎效果优于利托君。只有一项试验对新生儿进行了长期随访，发现心理社会和运动功能没有差异。在一项随机、多中心试验中，我们比较了硝苯地平和利托君的保胎效果，并对2岁后的新生儿进行了长期随访。方法.即将早产的患者被随机分配并接受硝苯地平或利托君治疗。观察不良反应、保胎效果及新生儿结局。儿童的发展进行了研究后，2岁的父母问卷调查。结果共纳入93例患者。利托君组平均推迟4.3周出生，硝苯地平组平均推迟5.0周出生（p=0.4）。与接受硝苯地平治疗的患者相比，接受利托君治疗的患者出现了更多的副作用（29%对4%，p < 0.05）。两组的平均出生体重、1 min后Apgar评分、新生儿重症监护室（NICU）入院情况和新生儿并发症无显著差异。两年后父母问卷的回答率为70%。两组中有三分之二的儿童发育正常。在两组中，只有少数儿童严重弱智（n=4）。两组之间的发育无显著差异。结论.硝苯地平和利托君都被证明是有效的安胎药物，但利托君引起的母体副作用明显更多。新生儿结局和2岁后的长期发育无显著差异。我们倾向于硝苯地平而不是利托君作为安胎药。
Background. Several studies have demonstrated the superior tocolytic effectiveness of nifedipine over ritodrine. Only 1 trial conducted a long-term follow-up of newborns and found no difference in psychosocial and motor functioning. In a randomised, multicentre trial, we compared the tocolytic effectiveness of nifedipine and ritodrine and included a long-term follow-up of the newborns after 2 years of age. Methods. Patients with imminent preterm labour were randomised and received either nifedipine or ritodrine. Side-effects, tocolytic effectiveness and neonatal outcome were studied. Development of the children was studied after the age of 2 years by a parental questionnaire. Results. Ninety-three patients were included. Birth was postponed for an average of 4.3 weeks in the ritodrine group and 5.0 weeks in the nifedipine group (p=0.4). Patients who received ritodrine experienced significantly more side-effects compared to patients who received nifedipine (29 versus 4%, p < 0.05). No significant differences were found in either group for average birth weight, Apgar scores after 1 min, neonatal intensive care unit (NICU) admission and neonatal complications. Parental questionnaires after 2 years had a response rate of 70%. Two-thirds of the children had developed normally in both groups. In both groups, only a few children were severely retarded (n=4). No significant differences in development were found between the 2 groups. Conclusions. Both nifedipine and ritodrine proved effective tocolytic drugs, however ritodrine caused significantly more maternal side-effects. Neonatal outcome and long-term development after 2 years of age were not significantly different. We favour nifedipine over ritodrine as a tocolytic drug.