STRIDER NZAus：一项关于西地那非治疗早发型胎儿生长受限的多中心随机对照试验。

STRIDER NZAus: a multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction.

机构信息

Liggins Institute, University of Auckland, Auckland, New Zealand.

National Women's Health, Auckland City Hospital, Auckland, New Zealand.

出版信息

BJOG. 2019 Jul;126(8):997-1006. doi: 10.1111/1471-0528.15658. Epub 2019 Mar 14.

DOI:10.1111/1471-0528.15658

PMID:30779295

Abstract

OBJECTIVE

To assess the effect of maternal sildenafil therapy on fetal growth in pregnancies with early-onset fetal growth restriction.

DESIGN

A randomised placebo-controlled trial.

SETTING

Thirteen maternal-fetal medicine units across New Zealand and Australia.

POPULATION

Women with singleton pregnancies affected by fetal growth restriction at 22 to 29 weeks.

METHODS

Women were randomised to oral administration of 25 mg sildenafil citrate or visually matching placebo three times daily until 32 weeks, birth or fetal death (whichever occurred first).

MAIN OUTCOME MEASURES

The primary outcome was the proportion of pregnancies with an increase in fetal growth velocity. Secondary outcomes included live birth, survival to hospital discharge free of major neonatal morbidity and pre-eclampsia.

RESULTS

Sildenafil did not affect the proportion of pregnancies with an increase in fetal growth velocity; 32/61 (52.5%) sildenafil-treated, 39/57 (68.4%) placebo-treated [adjusted odds ratio (OR) 0.49, 95% CI 0.23-1.05] and had no effect on abdominal circumference Z-scores (P = 0.61). Sildenafil use was associated with a lower mean uterine artery pulsatility index after 48 hours of treatment (1.56 versus 1.81; P = 0.02). The live birth rate was 56/63 (88.9%) for sildenafil-treated and 47/59 (79.7%) for placebo-treated (adjusted OR 2.50, 95% CI 0.80-7.79); survival to hospital discharge free of major neonatal morbidity was 42/63 (66.7%) for sildenafil-treated and 33/59 (55.9%) for placebo-treated (adjusted OR 1.93, 95% CI 0.84-4.45); and new-onset pre-eclampsia was 9/51 (17.7%) for sildenafil-treated and 14/55 (25.5%) for placebo-treated (OR 0.67, 95% CI 0.26-1.75).

CONCLUSIONS

Maternal sildenafil use had no effect on fetal growth velocity. Prospectively planned meta-analyses will determine whether sildenafil exerts other effects on maternal and fetal/neonatal wellbeing.

TWEETABLE ABSTRACT

Maternal sildenafil use has no beneficial effect on growth in early-onset FGR, but also no evidence of harm.

摘要

目的

评估母亲西地那非治疗对早发型胎儿生长受限妊娠胎儿生长的影响。

设计

随机安慰剂对照试验。

地点

新西兰和澳大利亚的 13 个母婴医学单位。

人群

妊娠 22 至 29 周时患有胎儿生长受限的单胎妊娠妇女。

方法

将妇女随机分配口服 25mg 西地那非枸橼酸盐或视觉匹配安慰剂，每日 3 次，直至 32 周、分娩或胎儿死亡（以先发生者为准）。

主要结局测量

主要结局是胎儿生长速度增加的妊娠比例。次要结局包括活产、新生儿无主要发病率的存活率出院和子痫前期。

结果

西地那非对胎儿生长速度增加的妊娠比例没有影响；32/61（52.5%）西地那非治疗组，39/57（68.4%）安慰剂治疗组[调整后比值比（OR）0.49，95%CI 0.23-1.05]，对腹围 Z 评分也没有影响（P=0.61）。西地那非治疗 48 小时后，子宫动脉搏动指数均值较低（1.56 对 1.81；P=0.02）。西地那非治疗组的活产率为 56/63（88.9%），安慰剂治疗组为 47/59（79.7%）（调整后 OR 2.50，95%CI 0.80-7.79）；新生儿无主要发病率的存活率出院，西地那非治疗组为 42/63（66.7%），安慰剂治疗组为 33/59（55.9%）（调整后 OR 1.93，95%CI 0.84-4.45）；新发性子痫前期，西地那非治疗组为 9/51（17.7%），安慰剂治疗组为 14/55（25.5%）（OR 0.67，95%CI 0.26-1.75）。