硫酸镁对轻度子痫前期疗效的随机对照临床试验

A randomized controlled trial:effect of magnesium sulfate on mild preeclampsia in women

目的本试验拟研究该药可否控制轻度子痫前期的病情发展。方法选入的轻度子痫前期患者共403例,随机分组。实验组给予硫酸镁治疗,共199例;对照组有204例,给予安慰剂。患者若出现重度子痫前期及子痫的症状和体征、或HELLP综合征的临床表现,则认为有病情的加重。结果两组入选病例的临床特征相似。硫酸镁组有30例(15.1%)、对照组有35例(17.2%)发展为重度子痫前期(RR=0.88;95%CI0.56-1.37;χ2=0.322;P>0.5)。两组病例的剖宫产率、产后出血量,以及新生儿Apgar评分均无显著性差异。结论硫酸镁对轻度子痫前期的病情进展没有显著的影响;其应用似不会提高剖宫产率,对母婴亦没有不利的效应。

Objective To explore whether magnesium sulfate prevents disease progression in women with mild preeclampsia.Methods Total 403 women with mild preeclampsia were randomly divided into two groups：experimental group treated with intravenous magnesium sulfate（n=199）and control group treated with placebo（n=204）.The following outcomes were considered to have disease progression if women developed signs or symptoms of severe preeclampsia,eclampsia,or laboratory abnormalities of full or partial HELLP syndrome.Results Clinical characteristics were similar in two groups.Thirty women（15.1%）in experimental group and 35（17.2%）in control group developed severe preeclampsia（RR=0.88;95%CI 0.56-1.37;χ^2=0.322;P〉0.5）.There was no significant difference in rates of cesarean delivery,postpartum hemorrhage and neonatal outcome between two groups.Conclusion Magnesium sulfate have no significant effect on disease progression in women with mild preeclampsia,and it could not increase rates of cesarean delivery and do harm to mother or baby.