Berkowitz Richard L, Lesser Martin L, McFarland Janice G, Wissert Megan, Primiani Andrea, Hung Crystal, Bussel James B
Department of Obstetrics and Gynecology, Columbia Presbyterian Medical Center, 622 West 168th Street, New York, NY 10032, USA.
Obstet Gynecol. 2007 Aug;110(2 Pt 1):249-55. doi: 10.1097/01.AOG.0000270302.80336.dd.
To evaluate the effectiveness and safety of two antenatal treatment regimens designed to optimally protect fetuses against intracranial hemorrhage resulting from alloimmune thrombocytopenia while minimizing the risks associated with fetal blood sampling. The study was limited to "standard-risk" patients, who were defined as women with documented alloimmune thrombocytopenia who had not delivered an infant with an intracranial hemorrhage in a prior pregnancy.
In this prospective multicenter study of 73 women with documented alloimmune thrombocytopenia, patients were randomized to receive either intravenous immunoglobulin (IVIG) 2 g/kg/wk (group A) or IVIG 1 g/kg/wk plus prednisone 0.5 mg/kg/d (group B), starting at approximately 20 weeks of gestation. Fetal blood sampling was performed at approximately 32 weeks of gestation, and those with fetal platelet counts less than 30,000/mL(3) were given salvage therapy.
There were two intracranial hemorrhages; neither was due to treatment failure. The average platelet counts at the time of fetal blood sampling were 121,600/mL(3) and 116,100/mL(3), and the average birth platelet counts were 169,400/mL(3) and 134,000/mL(3) for groups A and B, respectively. Twenty-seven percent of patients in group A and 17% in group B received salvage therapy, and only one neonate in each of these subsets had a birth platelet count less than 30,000/mL(3). There were four complications after 79 fetal blood sampling procedures, leading to cesarean deliveries between 32 and 37 weeks. There was a higher incidence of gestational diabetes and a tendency to more fluid retention, mood swings, insomnia, and jitteriness in patients on prednisone and of moderate-to-severe fatigue in those on high-dose IVIG alone.
The outcomes of both treatment groups were excellent and comparable. Early cordocentesis is not necessary when treating alloimmune thrombocytopenia in patients who have not delivered an infant with an intracranial hemorrhage in a prior pregnancy.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00194987
I.
评估两种产前治疗方案的有效性和安全性，这两种方案旨在最佳地保护胎儿免受同种免疫性血小板减少症导致的颅内出血，同时将与胎儿血样采集相关的风险降至最低。该研究仅限于“标准风险”患者，即有记录的同种免疫性血小板减少症且既往妊娠未分娩过颅内出血婴儿的女性。
在这项对73例有记录的同种免疫性血小板减少症女性的前瞻性多中心研究中，患者被随机分为两组，从妊娠约20周开始，分别接受静脉注射免疫球蛋白（IVIG）2 g/kg/周（A组）或IVIG 1 g/kg/周加泼尼松0.5 mg/kg/天（B组）。在妊娠约32周时进行胎儿血样采集，胎儿血小板计数低于30,000/mL³的患者接受挽救治疗。
发生了两例颅内出血；均非治疗失败所致。A组和B组胎儿血样采集时的平均血小板计数分别为121,600/mL³和116,100/mL³，出生时的平均血小板计数分别为169,400/mL³和134,000/mL³。A组27%的患者和B组17%的患者接受了挽救治疗，这些亚组中各只有一名新生儿出生时血小板计数低于30,000/mL³。在79次胎儿血样采集操作后出现了4例并发症，导致在32至37周之间进行剖宫产。泼尼松治疗的患者中妊娠期糖尿病发生率较高，且有更多液体潴留、情绪波动、失眠和易激惹的倾向，单独使用高剂量IVIG的患者有中度至重度疲劳的倾向。
两个治疗组的结果都很好且具有可比性。对于既往妊娠未分娩过颅内出血婴儿的同种免疫性血小板减少症患者，治疗时无需早期进行脐带穿刺术。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00194987
I级
