Saccone Gabriele, Suhag Anju, Berghella Vincenzo
Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA.
Am J Obstet Gynecol. 2015 Jul;213(1):16-22. doi: 10.1016/j.ajog.2015.01.054. Epub 2015 Feb 4.
We sought to evaluate the efficacy of maintenance tocolysis with 17-alpha-hydroxyprogesterone caproate (17P) compared to control (either placebo or no treatment) in singleton gestations with arrested preterm labor (PTL), in a metaanalysis of randomized trials. Electronic databases (MEDLINE, OVID, Scopus, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials) were searched from 1966 through July 2014. Key words included "progesterone," "tocolysis," "preterm labor," and "17-alpha-hydroxyprogesterone caproate." We performed a metaanalysis of randomized trials of singleton gestations with arrested PTL and treated with maintenance tocolysis with either 17P or control. Primary outcome was preterm birth (PTB) <37 weeks. This metaanalysis was performed following the Preferred Reporting Items for Systematic Reviews and Metaanalyses (PRISMA) statement. The protocol was registered with PROSPERO (registration no: CRD42014013473). Five randomized trials met inclusion criteria, including 426 women. Women with a singleton gestation who received 17P maintenance tocolysis for arrested PTL had a similar rate of PTB <37 weeks (42% vs 51%; relative risk [RR], 0.78; 95% confidence intervals [CI], 0.50-1.22) and PTB <34 weeks (25% vs 34%; RR, 0.60; 95% CI, 0.28-1.12) compared to controls. Women who received 17P had significantly later gestational age at delivery (mean difference, 2.28 weeks; 95% CI, 1.46-13.51), longer latency (mean difference, 8.36 days; 95% CI, 3.20-13.51), and higher birthweight (mean difference, 224.30 g; 95% CI, 70.81-377.74) as compared to controls. Other secondary outcomes including incidences of recurrent PTL, neonatal death, admission to neonatal intensive care unit, neonatal respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal sepsis were similar in both groups. Maintenance tocolysis with 17P after arrested PTL is not associated with prevention of PTB compared to placebo or no treatment in a metaanalysis of the available randomized trials. As 17P for maintenance tocolysis is associated with a significant prolongation of pregnancy, and significantly higher birthweight, further research is suggested.
在一项随机试验的荟萃分析中，我们试图评估己酸17-α-羟孕酮（17P）与对照组（安慰剂或不治疗）相比，对单胎妊娠且早产临产（PTL）停滞的维持性保胎治疗的疗效。检索了1966年至2014年7月的电子数据库（MEDLINE、OVID、Scopus、ClinicalTrials.gov和Cochrane对照试验中央注册库）。关键词包括“孕酮”“保胎治疗”“早产临产”和“己酸17-α-羟孕酮”。我们对单胎妊娠且PTL停滞并接受17P或对照组维持性保胎治疗的随机试验进行了荟萃分析。主要结局是孕37周前早产（PTB）。该荟萃分析按照系统评价和荟萃分析的首选报告项目（PRISMA）声明进行。该方案已在PROSPERO注册（注册号：CRD42014013473）。五项随机试验符合纳入标准，包括426名女性。与对照组相比，因PTL停滞接受17P维持性保胎治疗的单胎妊娠女性孕37周前PTB发生率相似（42%对51%；相对危险度[RR]，0.78；95%置信区间[CI]，0.50 - 1.22），孕34周前PTB发生率也相似（25%对34%；RR，0.60；95%CI，0.28 - 1.12）。接受17P治疗的女性分娩时孕周显著更晚（平均差，2.28周；95%CI，1.46 - 13.51），潜伏期更长（平均差，8.36天；95%CI，3.20 - 13.51），出生体重更高（平均差，224.30克；95%CI，70.81 - 377.74）。两组的其他次要结局，包括复发性PTL、新生儿死亡、入住新生儿重症监护病房、新生儿呼吸窘迫综合征、支气管肺发育不良、脑室内出血、坏死性小肠结肠炎和新生儿败血症的发生率相似。在现有随机试验的荟萃分析中，与安慰剂或不治疗相比，PTL停滞后用17P进行维持性保胎治疗与预防PTB无关。由于17P用于维持性保胎治疗与妊娠显著延长和出生体重显著增加相关，建议进一步研究。
