Oepkes Dick, Seaward P Gareth, Vandenbussche Frank P H A, Windrim Rory, Kingdom John, Beyene Joseph, Kanhai Humphrey H H, Ohlsson Arne, Ryan Greg
Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
N Engl J Med. 2006 Jul 13;355(2):156-64. doi: 10.1056/NEJMoa052855.
Pregnancies complicated by Rh alloimmunization have been evaluated with the use of serial invasive amniocentesis to determine bilirubin levels by measuring in the amniotic fluid the change in optical density at a wavelength of 450 nm (DeltaOD450); however, this procedure carries risks. Noninvasive Doppler ultrasonographic measurement of the peak velocity of systolic blood flow in the middle cerebral artery also predicts severe fetal anemia, but this test has not been rigorously evaluated in comparison with amniotic-fluid DeltaOD450.
We performed a prospective, international, multicenter study including women with RhD-, Rhc-, RhE-, or Fy(a)-alloimmunized pregnancies with indirect antiglobulin titers of at least 1:64 and antigen-positive fetuses to assess whether Doppler ultrasonographic measurement of the peak systolic velocity of blood flow in the middle cerebral artery was at least as sensitive and accurate as measurement of amniotic-fluid DeltaOD450 for diagnosing severe fetal anemia. The results of the two tests were compared with the incidence of fetal anemia, as determined by measurement of hemoglobin levels in fetal blood.
Of 165 fetuses, 74 had severe anemia. For the detection of severe fetal anemia, Doppler ultrasonography of the middle cerebral artery had a sensitivity of 88 percent (95 percent confidence interval, 78 to 93 percent), a specificity of 82 percent (95 percent confidence interval, 73 to 89 percent), and an accuracy of 85 percent (95 percent confidence interval, 79 to 90 percent). Amniotic-fluid DeltaOD450 had a sensitivity of 76 percent (95 percent confidence interval, 65 to 84 percent), a specificity of 77 percent (95 percent confidence interval, 67 to 84 percent), and an accuracy of 76 percent (95 percent confidence interval, 69 to 82 percent). Doppler ultrasonography was more sensitive, by 12 percentage points (95 percent confidence interval, 0.3 to 24.0), and more accurate, by 9 percentage points (95 percent confidence interval, 1.1 to 15.9), than measurement of amniotic-fluid DeltaOD450.
Doppler measurement of the peak velocity of systolic blood flow in the middle cerebral artery can safely replace invasive testing in the management of Rh-alloimmunized pregnancies. (ClinicalTrials.gov number, NCT00295516.).
对于因Rh血型同种免疫而并发的妊娠，以往通过连续进行侵入性羊膜腔穿刺术来评估，通过测量羊水在450nm波长处的光密度变化（ΔOD450）来确定胆红素水平；然而，该操作存在风险。经颅多普勒超声测量大脑中动脉收缩期血流峰值速度也可预测严重胎儿贫血，但与羊水ΔOD450相比，该检测方法尚未得到严格评估。
我们开展了一项前瞻性、国际性、多中心研究，纳入RhD、Rhc、RhE或Fy(a)血型同种免疫妊娠且间接抗球蛋白效价至少为1:64以及抗原阳性胎儿的孕妇，以评估经颅多普勒超声测量大脑中动脉收缩期血流峰值速度对于诊断严重胎儿贫血是否与测量羊水ΔOD450一样敏感和准确。将这两种检测结果与通过测量胎儿血液血红蛋白水平所确定的胎儿贫血发生率进行比较。
165例胎儿中，74例患有严重贫血。对于严重胎儿贫血的检测，大脑中动脉多普勒超声检查的敏感性为88%（95%置信区间为78%至93%），特异性为82%（95%置信区间为73%至89%），准确性为85%（95%置信区间为79%至90%）。羊水ΔOD450的敏感性为76%（95%置信区间为65%至84%），特异性为77%（95%置信区间为67%至84%），准确性为76%（95%置信区间为69%至82%）。与测量羊水ΔOD450相比，多普勒超声检查的敏感性高12个百分点（95%置信区间为0.3至24.0），准确性高9个百分点（95%置信区间为1.1至15.9）。
大脑中动脉收缩期血流峰值速度的多普勒测量可安全替代侵入性检测用于Rh血型同种免疫妊娠的管理。（临床试验注册号：NCT00295516。）
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