醋酸阿托西班与盐酸利托君对双胎妊娠保胎的临床研究

Clinical trial of atosiban acetate and ritodrine hydrochloride for fetal preservation in twin pregnancy

目的探究醋酸阿托西班、盐酸利托君和硫酸镁对双胎妊娠的保胎效果及安全性。方法选取先兆早产的双胎妊娠孕妇,根据使用宫缩抑制药的情况分为阿托西班组(给予醋酸阿托西班)、利托君组(给予盐酸利托君)、硫酸镁组(给予硫酸镁)。比较3组孕妇的保胎成功率、宫缩抑制起效时间、延长妊娠时间、用药时生命体征(心率、呼吸频率、血压)、新生儿围产结局(低体质量儿、新生儿窒息、围产儿死亡)及药物不良反应。结果试验过程中共脱落6例,最终阿托西班组、利托君组和硫酸镁组分别纳入25例、27例和18例。治疗后,阿托西班组、利托君组和硫酸镁组的保胎成功率分别为96.00%(24例/25例)、96.30%(26例/27例)和72.22%(13例/18例),阿托西班组、利托君组与硫酸镁组,差异均有统计学意义(均P<0.05)。阿托西班组、利托君组和硫酸镁组的宫缩抑制起效时间分别为(1.63±0.25)、(1.74±0.33)和(2.61±0.55)h,延长妊娠时间分别为(25.07±3.26)、(24.58±3.07)和(21.98±2.62)d,呼吸频率分别为(18.57±2.32)、(22.16±2.77)和(18.94±2.74)beat·min^(-1),心率分别为(96.04±12.01)、(109.53±13.69)和(97.35±13.42)beat·min^(-1),低体质量儿发生率分别为4.00%、11.11%和38.89%,新生儿窒息发生率分别为4.00%、7.41%和33.33%;上述指标,阿托西班组、利托君组与硫酸镁组比较,差异均有统计学意义(均P<0.05)。用药期间阿托西班组的药物不良反应发生率均低于利托君组与硫酸镁组(均P<0.05)。结论醋酸阿托西班、盐酸利托君对双胎妊娠先兆早产的保胎效果优于硫酸镁,醋酸阿托西班安全性较盐酸利托君高。

Objective To explore fetal-protection effect and safety of atosiban acetate,ritodrine hydrochloride and magnesium sulfate in twin-pregnancy.Methods The twin-pregnancy women with premature delivery during late pregnancy were enrolled.According to the use of different contraction inhibitors,they were divided into atosiban group(atosiban acetate),ritodrine group(ritodrine hydrochloride)and magnesium sulfate group(magnesium sulfate).The success rate of fetal protection,onset time of contraction inhibition,prolonged pregnancy time,vital signs(heart rate,respiratory rate,blood pressure)during medication,perinatal outcomes(low birth weight infants,neonatal asphyxia,perinatal death)and adverse drug reactions in the three groups were compared.Results A total of 6 cases lost during the trial,and there were 25 cases,27 cases and 18 cases in atosiban group,ritodrine group and magnesium sulfate group,respectively.After treatment,success rates of fetal-protection in atosiban group,ritodrine group and magnesium sulfate group were 96.00%(24 cases/25 cases),96.30%(26 cases/27 cases)and 72.22%(13 cases/18 cases);compared atosiban group,ritodrine group with magnesium sulfate group,the difference were statistically significant(all P<0.05).The onset time of contraction inhibition in atosiban group,ritodrine group and magnesium sulfate group were(1.63±0.25),(1.74±0.33)and(2.61±0.55)h;prolonged pregnancy time were(25.07±3.26),(24.58±3.07)and(21.98±2.62)d.After medication,respiratory rates in atosiban group,ritodrine group and magnesium sulfate group were(18.57±2.32),(22.16±2.77)and(18.94±2.74)times·min^(-1),heart rates were(96.04±12.01),(109.53±13.69)and(97.35±13.42)times·min^(-1),and there were significant differences in the above indexes among the three groups(all P<0.05).The incidence of low birth weight infants in atosiban group,ritodrine group and magnesium sulfate group were 4.00%,11.11%and 38.89%,and incidence of neonatal asphyxia were 4.00%,7.41%and 33.33%,and there were significant differences in the above indexes among the three groups(all P<0.05).During medication,incidence of adverse drug reactions in atosiban group was lower than that in ritodrine group and magnesium sulfate group(P<0.05).Conclusion Atosiban acetate and ritodrine hydrochloride have better fetal-protection effect than magnesium sulfate,and atosiban acetate has higher safety than ritodrine hydrochloride in twin-pregnancy women with threatened abortion and premature delivery.