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首页> 外文期刊>BJOG: an international journal of obstetrics and gynaecology >STRIDER NZAus: a multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction
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STRIDER NZAus: a multicentre randomised controlled trial of sildenafil therapy in early-onset fetal growth restriction

机译：Strider nzaus：早期胎儿生长限制的西地尼亚嘧啶治疗的多期式随机对照试验

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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(+0) to 29(+6) weeks. Methods Women were randomised to oral administration of 25 mg sildenafil citrate or visually matching placebo three times daily until 32(+0) 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.
机译：目的探讨母体西地那非治疗对早期胎儿生长限制妊娠胎儿生长的影响。设计随机安慰剂对照试验。在新西兰和澳大利亚设置十三个母体医学单位。人口妇女患有胎儿生长限制的胎儿妊娠的人口妇女在22（+0）至29（+ 6）周内受到影响。方法将妇女随机向口服给予25毫克西地那非的柠檬酸盐或直接匹配安慰剂，每天3次，直到32（+0）周，出生或胎儿死亡（首先发生）。主要结果测量主要结果是怀孕的比例随胎儿生长速度的增加。二次结果包括生存，生存到医院排放的主要新生儿发病率和先兆子痫。结果西地那非不影响胎儿生长速度增加的妊娠比例; 32/61（52.5％）西地那非治疗，39/57（68.4％）安慰剂处理[调整后的差距（或）0.49,95％CI 0.23-1.05]并且对腹周Z分数没有影响（P = 0.61）。在48小时的治疗后，Sildenafil使用与较低的子宫动脉脉动性指数（1.56对1.81; p = 0.02）。 Sildenafil治疗的活率为56/63（88.9％），47/59（79.7％）用于安慰剂处理（调整或2.50,95％CI 0.80-7.79）; Sildenafil治疗和33/59（55.9％）的安慰剂治疗（调整或1.95％CI 0.84-4.45）的Sildenafil治疗和33/59（55.9％）的33/59（55.9％）的生存为42/63（66.7％）;新的新生儿预防预混物为西地那非治疗的9/51（17.7％），14/55（25.5％）用于安慰剂处理（或0.67,95％CI 0.26-1.75）。结论母体西地那非对胎儿生长速度没有影响。潜在计划的荟萃分析将确定西地那非是否对母体和胎儿/新生儿福利施加其他影响。 Twelable摘要母体西地那非对早盘性FGR的增长没有有益的影响，也没有危害的证据。

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