Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, and the Center for Clinical Research and Evidence-Based Medicine, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas.
Obstet Gynecol. 2018 Nov;132(5):1185-1191. doi: 10.1097/AOG.0000000000002941.
To evaluate whether torsemide reduces the rate of persistent postpartum hypertension in women with preeclampsia.
We conducted a randomized, double-blind, placebo-controlled trial of women with preeclampsia at a tertiary center from August 2016 to September 2017. Those with gestational hypertension or renal or cardiopulmonary failure were excluded. Within 24 hours of delivery, women were randomized one to one to oral torsemide, 20 mg/d, or placebo, for 5 days. Our primary outcome was blood pressure greater than or equal to 150 mm Hg systolic or 100 mm Hg diastolic (or both) on two occasions at least 4 hours apart by postpartum day 5 or by the time of hospital discharge. Assuming a 50% rate of persistent hypertension in women with preeclampsia, 118 participants were required to detect a 50% rate reduction. Analyses were by intention to treat.
From August 2016 to September 2017, 118 women were randomized: 59 were allocated to torsemide and 59 to placebo. Overall, 43 (73%) women in the torsemide and 45 (76%) in the placebo group had either preeclampsia with severe features or preeclampsia superimposed on chronic hypertension. The rate of persistent postpartum hypertension was 44% in the torsemide and 58% in the placebo group (relative risk 0.76, 95% CI 0.5-1.1). No differences were seen in rate of hypertension 7-10 days or 6 weeks postpartum, severe hypertension, length of postpartum hospital stay, readmission for hypertension, or adverse events. There were no cases of severe composite morbidity or deaths.
In this trial of women with preeclampsia, a 5-day course of postpartum torsemide did not have a significant effect on the rate of postpartum hypertension.
ClinicalTrials.gov, NCT02813551.
评估托塞米是否能降低子痫前期患者产后持续性高血压的发生率。
我们在 2016 年 8 月至 2017 年 9 月在一家三级中心进行了一项随机、双盲、安慰剂对照试验,纳入子痫前期患者。排除患有妊娠期高血压、肾功能或心肺衰竭的患者。在分娩后 24 小时内,将患者按 1:1 随机分为口服托塞米组(20mg/d)或安慰剂组,治疗 5 天。主要结局是产后第 5 天或出院时,至少两次相隔至少 4 小时,收缩压≥150mmHg 和(或)舒张压≥100mmHg(或两者均有)。假设子痫前期患者持续性高血压发生率为 50%,需要 118 名患者来检测出 50%的发生率降低。分析为意向治疗。
2016 年 8 月至 2017 年 9 月,共 118 名患者随机分组:59 名分配至托塞米组,59 名分配至安慰剂组。总体而言,托塞米组 43 名(73%)患者和安慰剂组 45 名(76%)患者患有重度子痫前期或子痫前期合并慢性高血压。托塞米组产后持续性高血压发生率为 44%,安慰剂组为 58%(相对风险 0.76,95%CI 0.5-1.1)。两组产后 7-10 天或 6 周时高血压发生率、重度高血压、产后住院时间、因高血压再次入院或不良事件均无差异。没有严重复合发病或死亡病例。
在这项子痫前期患者的试验中,产后使用托塞米 5 天对产后高血压的发生率没有显著影响。
ClinicalTrials.gov,NCT02813551。