Harrison Michael R, Keller Roberta L, Hawgood Samuel B, Kitterman Joseph A, Sandberg Per L, Farmer Diana L, Lee Hanmin, Filly Roy A, Farrell Jody A, Albanese Craig T
Fetal Treatment Center, University of California, San Francisco, San Francisco, CA 94143-0570, USA.
N Engl J Med. 2003 Nov 13;349(20):1916-24. doi: 10.1056/NEJMoa035005.
Experimental and clinical data suggest that fetal endoscopic tracheal occlusion to induce lung growth may improve the outcome of severe congenital diaphragmatic hernia. We performed a randomized, controlled trial comparing fetal tracheal occlusion with standard postnatal care.
Women carrying fetuses that were between 22 and 27 weeks of gestation and that had severe, left-sided congenital diaphragmatic hernia (liver herniation and a lung-to-head ratio below 1.4), with no other detectable anomalies, were randomly assigned to fetal endoscopic tracheal occlusion or standard care. The primary outcome was survival at the age of 90 days; the secondary outcomes were measures of maternal and neonatal morbidity.
Of 28 women who met the entry criteria, 24 agreed to randomization. Enrollment was stopped after 24 patients had been enrolled because of the unexpectedly high survival rate with standard care and the conclusion of the data safety monitoring board that further recruitment would not result in significant differences between the groups. Eight of 11 fetuses (73 percent) in the tracheal-occlusion group and 10 of 13 (77 percent) in the group that received standard care survived to 90 days of age (P=1.00). The severity of the congenital diaphragmatic hernia at randomization, as measured by the lung-to-head ratio, was inversely related to survival in both groups. Premature rupture of the membranes and preterm delivery were more common in the group receiving the intervention than in the group receiving standard care (mean [+/-SD] gestational age at delivery, 30.8+/-2.0 weeks vs. 37.0+/-1.5 weeks; P<0.001). The rates of neonatal morbidity did not differ between the groups.
Tracheal occlusion did not improve survival or morbidity rates in this cohort of fetuses with congenital diaphragmatic hernia.
实验和临床数据表明，胎儿内镜下气管闭塞以促进肺生长可能会改善严重先天性膈疝的治疗结果。我们进行了一项随机对照试验，比较胎儿气管闭塞与标准产后护理。
孕周在22至27周之间、患有严重左侧先天性膈疝（肝脏疝入且肺头比低于1.4）且无其他可检测到异常的孕妇被随机分配接受胎儿内镜下气管闭塞或标准护理。主要结局是90日龄时的存活率；次要结局是母婴发病率的指标。
在28名符合入选标准的女性中，24名同意随机分组。在24名患者入组后，由于标准护理的存活率出乎意料地高，且数据安全监测委员会得出结论认为进一步招募不会导致两组间出现显著差异，因此停止入组。气管闭塞组11例胎儿中有8例（73%）存活至90日龄，接受标准护理组13例中有10例（77%）存活至90日龄（P = 1.00）。随机分组时通过肺头比测量的先天性膈疝严重程度与两组的存活率均呈负相关。胎膜早破和早产在接受干预的组中比接受标准护理的组更常见（分娩时的平均[±标准差]孕周，30.8±2.0周对37.0±1.5周；P<0.001）。两组间新生儿发病率无差异。
在这组先天性膈疝胎儿中，气管闭塞并未改善存活率或发病率。
