Crombleholme Timothy M, Shera David, Lee Hanmin, Johnson Mark, D'Alton Mary, Porter Flint, Chyu Jacquelyn, Silver Richard, Abuhamad Alfred, Saade George, Shields Laurence, Kauffman David, Stone Joanne, Albanese Craig T, Bahado-Singh Ray, Ball Robert H, Bilaniuk Larissa, Coleman Beverly, Farmer Diana, Feldstein Vickie, Harrison Michael R, Hedrick Holly, Livingston Jeffrey, Lorenz Robert P, Miller David A, Norton Mary E, Polzin William J, Robinson Julian N, Rychik Jack, Sandberg Per L, Seri Istvan, Simon Erin, Simpson Lynn L, Yedigarova Larisa, Wilson R Douglas, Young Bruce
Fetal Care Center of Cincinnati, Division of Pediatric General, Thoracic, and Fetal Surgery, Cincinnati Children's Hospital, MLC #2023, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Am J Obstet Gynecol. 2007 Oct;197(4):396.e1-9. doi: 10.1016/j.ajog.2007.07.020.
The objective of the study was to examine the effect of selective fetoscopic laser photocoagulation (SFLP) vs serial amnioreduction (AR) on perinatal mortality in severe twin-twin transfusion syndrome (TTTS).
This was a 5 year multicenter, prospective, randomized controlled trial. The primary outcome variable was 30 day postnatal survival of donors and recipients.
There was no statistically significant difference in 30-day postnatal survival between SFLP or AR treatment for donors at 55% (11 of 20) vs 55% (11 of 20) (P = 1.0, odds ratio [OR] 1, 95% confidence interval [CI] 0.242 to 4.14) or recipients at 30% (6 of 20) vs 45% (9 of 20) (P = .51, OR 1.88, 95% CI 0.44 to 8.64). There was no difference in 30 day survival of 1 or both twins on a per-pregnancy basis between AR at 75% (15 of 20) and SFLP at 65% (13 of 20) (P = .73, OR 1.62, 95% CI 0.34 to 8.09). Overall survival (newborns divided by the number of fetuses treated) was not statistically significant for AR at 60% (24 of 40) vs SFLP 45% (18 of 40) (P = .18, OR 2.01, 95% CI 0.76 to 5.44). There was a statistically significant increase in fetal recipient mortality in the SFLP arm at 70% (14 of 20) vs the AR arm at 35% (7 of 20) (P = .25, OR 5.31, 95% CI 1.19 to 27.6). This was offset by increased recipient neonatal mortality of 30% (6 of 20) in the AR arm. Echocardiographic abnormality in recipient twin Cardiovascular Profile Score is the most significant predictor of recipient mortality (P = .055, OR 3.025/point) by logistic regression analysis.
The outcome of the trial did not conclusively determine whether AR or SFLP is a superior treatment modality. TTTS cardiomyopathy appears to be an important factor in recipient survival in TTTS.
本研究的目的是探讨选择性胎儿镜激光凝固术(SFLP)与系列羊膜腔穿刺减压术(AR)对重度双胎输血综合征(TTTS)围产期死亡率的影响。
这是一项为期5年的多中心、前瞻性、随机对照试验。主要结局变量是供体和受体出生后30天的存活率。
SFLP组与AR组供体出生后30天存活率无统计学显著差异,分别为55%(20例中的11例)和55%(20例中的11例)(P = 1.0,优势比[OR]1,95%置信区间[CI]0.242至4.14);受体存活率分别为30%(20例中的6例)和45%(20例中的9例)(P = 0.51,OR 1.88,95%CI 0.44至8.64)。基于每次妊娠,AR组1或2个胎儿出生后30天存活率为75%(20例中的15例),SFLP组为65%(20例中的13例),两者无差异(P = 0.73,OR 1.62,95%CI 0.34至8.09)。总体存活率(新生儿数除以接受治疗的胎儿数)方面,AR组为60%(40例中的24例),SFLP组为45%(40例中的18例),无统计学显著差异(P = 0.18,OR 2.01,95%CI 0.76至5.44)。SFLP组胎儿受体死亡率为70%(20例中的14例),显著高于AR组的35%(20例中的7例)(P = 0.25,OR 5.31,95%CI 1.19至27.6)。但AR组受体新生儿死亡率增加30%(20例中的6例)抵消了这一差异。通过逻辑回归分析,受体双胎心血管Profile评分中的超声心动图异常是受体死亡率的最显著预测因素(P = 0.055,OR 3.025/分)。
该试验结果未能最终确定AR或SFLP哪种治疗方式更优。TTTS心肌病似乎是TTTS中受体存活的一个重要因素。