从使用磷酸二酯酶-5抑制剂(PDE-5i)的少数相对较小的不同研究中,尚不清楚其在妊娠中的功效和安全性。
评估妊娠期使用PDE-5i的安全性和临床结局。
我们搜索了Embase,PubMed,中部,Prospero和GoogleScholar确定随机对照试验(RCT),报告到2021年9月在怀孕期间使用任何PDE-5i。
RCT报告妊娠期间服用PDE5i的妇女的产科或围产期结局或产妇不良结局。
风险比率(RR),计算95%置信区间(95%CI)和95%预测区间并汇集用于分析。
我们确定了1324条引文,其中包括1090名参与者的10项研究符合纳入标准.据报道,只有他达拉非和西地那非用于妊娠。两项使用他达拉非和八项西地那非的研究。10项研究中有9项被评估为具有低偏倚风险。使用PDE-5i与头痛风险增加相关(RR1.41,95%CI0.97-2.05),潮红(RR2.59,95%CI0.69-9.90)和鼻出血(RR10.53,95%CI1.36-81.3);用于非胎儿生长受限(FGR)适应症的阴道分娩增加(RR1.24,95%CI1.00-1.55),产时胎儿受损的手术分娩风险降低(RR0.58,95%CI0.38-0.88).没有证据表明围产期死亡风险增加(RR0.89,95%CI0.56-1.43)。然而,使用FGR治疗会增加新生儿持续性肺动脉高压(PPHN)的风险(RR2.52,95%CI1.00~6.32).
这项荟萃分析显示,在妊娠期间使用PDE-5i与轻微的母体副作用和降低产时胎儿窘迫的手术分娩风险相关。长期使用FGR治疗可能会增加PPHN的风险。
怀孕期间使用PDE-5i与轻微的母体副作用有关,用于治疗胎儿生长受限时,产时胎儿窘迫的手术分娩率较低,新生儿持续性肺动脉高压可能增加。
The efficacy and safety profile of phosphodiesterase-5 inhibitors (PDE-5i) in pregnancy are unclear from the few relatively small diverse studies that have used them.
To assess the safety profile and clinical outcomes of PDE-5i use in pregnancy.
We searched Embase, PubMed, CENTRAL, Prospero and Google Scholar to identify randomised controlled trials (RCTs) reporting the use of any PDE-5i in pregnancy up to September 2021.
RCTs reporting obstetric or perinatal outcomes or maternal adverse outcomes in women taking PDE5i in pregnancy.
Risk ratios (RR), 95% confidence intervals (95% CI) and 95% prediction intervals were calculated and pooled for analysis.
We identified 1324 citations, of which 10 studies including 1090 participants met the inclusion criteria. Only tadalafil and sildenafil were reported as used in pregnancy. Two studies using tadalafil and eight sildenafil. Nine of ten studies were assessed at having of low risk of bias. PDE-5i use was associated with an increased risk of headaches (RR 1.41, 95% CI 0.97-2.05), flushing (RR 2.59, 95% CI 0.69-9.90) and nasal bleeding (RR 10.53, 95% CI 1.36-81.3); an increase in vaginal birth when used for non-fetal growth restriction (FGR) indications (RR 1.24, 95% CI 1.00-1.55) and a reduction in risk of operative birth for intrapartum fetal compromise (RR 0.58, 95% CI 0.38-0.88). There was no evidence of any increase in risk of perinatal death (RR 0.89, 95% CI 0.56-1.43). However, use for the treatment of FGR increased the risk of persistent pulmonary hypertension of the newborn (PPHN) (RR 2.52, 95% CI 1.00-6.32).
This meta-analysis suggests PDE-5i use in pregnancy is associated with mild maternal side effects and lower risk of operative birth for intrapartum fetal distress. Prolonged use for the treatment of FGR may increase the risk of PPHN.
PDE-5i use in pregnancy is associated with mild maternal side effects, lower operative birth for intrapartum fetal distress and a possible increase in persistent pulmonary hypertension of the newborn when used for the treatment of fetal growth restriction.