保胎灵联合盐酸利托君治疗先兆早产的临床疗效观察

Curative Effect of Baotailing Combined With Ritodrine Hydrochloride on Preterm Labor

目的探讨保胎灵联合盐酸利托君治疗先兆早产的临床疗效。方法选取2008年7月至2010年12月于本院确诊的198例先兆早产孕妇为研究对象。按照治疗方案将其分为观察组(保胎灵+盐酸利托君,n=96)和对照组(单用盐酸利托君,n=102)。观察两种方案治疗先兆早产的显效时间、治疗时间、住院时间、保胎成功率、延长孕龄时间和保胎至≥35孕周分娩率、产后出血量/率、新生儿预后及不良反应发生率等的作用。两组孕妇年龄、孕周、孕次、产次、宫缩及宫颈扩张情况比较,差异无显著意义(P>0.05)。(本研究遵循的程序符合本院人体试验委员会制定的伦理学标准,得到该委员会批准,分组征得受试对象本人的知情同意,并与之签署临床研究知情同意书)。结果两组显效时间、治疗时间及住院时间比较,差异均有显著意义(P<0.05)。观察组保胎成功率、延长孕龄时间和保胎至≥35孕周分娩率均明显高于对照组,差异有显著意义(P<0.05)。两组产后出血量、产后出血率比较,差异无显著意义(P>0.05)。观察组新生儿预后较对照组好(P<0.05),不良反应发生率低于对照组,差异有显著意义(P<0.05)。结论保胎灵联合盐酸利托君治疗先兆早产可提高盐酸利托君疗效,改善新生儿预后,降低盐酸利托君不良反应,但是否值得临床进一步推广,尚需大样本、多中心的前瞻性随机对照研究证实。

Objective To explore the curative effect of baotailing combined with ritodrine hydrochloride on preterm labor. Methods From July 2008 to December 2010,198 pregnant women with threatened premature labor were included in the study, and divided into observe group（baotailing combined with ritodrine hydrochloride, n = 96） and control group （ritodrine hydrochloride only, n = 102）. Starting therapeutic effectiveness time, treatment time, hospital stays, successful rate of locolysis, prolonging of gestational age and delivery after 35 gestational weeks rate, postpartum blood loss volume/rate, neonatal prognosis and adverse effect were compared between two groups. The study protocol was approved by the Ethical Review Board of Investigation in Cbengdu Women and Children＇s Medical Center. Informed consent was obtained from each parents. There had no significant difference between two groups among maternal age, gestational age,gravidity, parity, uterine contraction and cervical dilatation （P〉0.05）, respectively. Results Starting therapeutic effectiveness time, treatment time and hospital stays in observed group was shorter than those in control group（P〈0.05）. The successful rate of locolysis, prolonging of gestational age and delivery after 35 weeks rate in observe group was obviously higher than those in control group（P〈0.05）. There was no significant difference in postpartum blood loss volume and postpartum hemorrhage rate between two groups （P 〉 0. 05）. Neonatal prognosis of the observe group was significantly better and adverse effect was significantly less than those in control group（P〈0.05）. Conclusion Baotailing combined with ritodrine hydrochloride increases the curative effect of ritodrine hydrochloride, improves neonatal prognosis and reduces adverse effect. But whether to be worth clinical spreading, it is necessary to have large sample, multi-central prospectively randomized controlled trials.