特布他林与硝苯地平用于产时胎儿宫内复苏:前瞻性随机对照研究

目的初步探索特布他林与硝苯地平用于产时胎儿宫内复苏(intrauterine fetal resuscitation,IUFR)的安全性及有效性。方法本研究采用随机对照方法,前瞻性将2021年1月至2021年4月在广州市妇女儿童医疗中心分娩中出现不可靠胎心监护图形(non-reassuring fetal heart rate tracing,NRFHT)的110例孕产妇随机分为特布他林组(硫酸特布他林0.25 mg皮下注射,n=55)和硝苯地平组(硝苯地平10 mg口服,n=55)。收集2组孕妇使用药物前及用药后5、15、30 min的血压、心率、血氧饱和度等血流动力学变化,以及IUFR的成功率、药物起效时间、产后出血率等指标,采用t检验、χ²检验、Fisher精确概率法及秩和检验对数据进行统计学分析。结果特布他林组和硝苯地平组孕妇用药前后平均动脉压及血氧饱和度比较差异均无统计学意义(P值均>0.05);硝苯地平组孕妇用药前后心率无明显变化(P>0.05),而特布他林组孕妇心率在用药后5、15、30 min均快于用药前(97.0±20.2)、(99.2±13.8)、(91.8±12.6)与(81.7±11.3)次/min,P值均<0.001],但心率增快效应在30 min开始下降,与用药后15 min相比,心率下降了6.4次/min(95%CI:1.5~11.2,P<0.05)。所有孕产妇均未发生需要医疗干预的不良反应。特布他林组有78.2%(43/55)复苏成功,与硝苯地平组的70.9%(39/55)比较差异无统计学意义(χ²=0.77,P=0.381);特布他林组药物起效时间明显快于硝苯地平组2 min(1~6 min)与6 min(1~10 min),U=2348.50,P<0.001]。2组孕产妇因NRFHT行剖宫产及阴道助产、1 h内再次使用宫缩抑制剂等方面比较差异均无统计学意义(P值均>0.05)。2组产后出血量、产后出血率、新生儿低Apgar评分(≤7分)、低脐动脉pH值(pH<7.2)、新生儿窒息率及新生儿重症监护病房入住率等方面差异均无统计学意义(P值均>0.05)。结论特布他林用于产时IUFR暂未发现明显不良反应;其起效速度快,可作为处理产时紧急IUFR的选择方案。

Subcutaneous terbutaline and oral nifedipine for intrapartum fetal resuscitation:a prospective randomized controlled study

Objective To compare the safety and efficacy of terbutaline and nifedipine for acute intrapartum fetal resuscitation(IUFR).Methods This was a prospective randomized controlled study involving 110 pregnant women with non-reassuring fetal heart rate tracings(NRFHT)during delivery at Guangzhou Women and Children's Medical Center between January and April 2021.These women were randomly allocated to receive subcutaneous terbutaline sulphate(0.25 mg,terbutaline group)or oral nifedipine(10 mg,nifedipine group),with 55 subjects in each group.Hemodynamic parameters including blood pressure,heart rate,and oxygen saturation before and 5,15 and 30 min after treatment as well as the success rate of intrapartum resuscitation,the onset time of medication,and the incidence of postpartum hemorrhage were analyzed using t test,Chi-square test or Fisher's exact test.Results Two groups both showed no significant difference in the mean arterial pressure or oxygen saturation before or after treatment(all P>0.05).The heart rate was not affected in nifedipine group at any time points(P>0.05).While the patients treated with terbutaline showed accelerated maternal heart rate 5,15 and 30 min after administration as compared with the baseline(97.0±20.2),(99.2±13.8),(91.8±12.6)vs(81.7±11.3)bpm,all P<0.001],but it began to decrease at 30 min,with a drop of 6.4 bpm compared with that at 15 min(95%CI:1.5-11.2,P<0.05).None of the pregnant women had adverse reactions requiring medical intervention.The rates of successful acute resuscitation were similar in the two groupsterbutaline:78.2%(43/55)vs nifedipine:70.9%(39/55),χ²=0.77,P=0.381].Terbutaline had a shorter onset time than nifedipine in slowing the frequency of contractions and returning fetal heart rate to classⅠcategory2(1-6)vs 6(1-10)min,U=2348.50,P<0.001].No significant difference was found between the two groups in terms of NRFHT-indicated cesarean section,assisted vaginal delivery,or second dose of tocolysis within 1 h(all P>0.05)nor in blood loss volume,postpartum hemorrhage rate,low Apgar score,low umbilical artery pH value(pH<7.2),neonatal asphyxia rate,or neonatal intensive care admission rate(all P>0.05).Conclusion Terbutaline spends less time than nifedipine to take effect and may be an alternative for acute IUFR without significant adverse outcomes.