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胎儿同种免疫性血小板减少症基于风险治疗的平行随机试验。

Parallel randomized trials of risk-based therapy for fetal alloimmune thrombocytopenia.

作者信息

Berkowitz Richard L, Kolb E Anders, McFarland Janice G, Wissert Megan, Primani Andrea, Lesser Martin, Bussel James B

机构信息

Divison of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia College of Physicians and Surgeons, New York 10032, USA.

出版信息

Obstet Gynecol. 2006 Jan;107(1):91-6. doi: 10.1097/01.AOG.0000192404.25780.68.

DOI:10.1097/01.AOG.0000192404.25780.68
PMID:16394045
Abstract

OBJECTIVE

Antenatal therapy with intravenous immunoglobulin (IVIG) and prednisone has been shown to improve fetal thrombocytopenia and reduce the incidence of intracranial hemorrhage in neonatal alloimmune thrombocytopenia. Optimization of this therapy for individual patients, however, has yet to be achieved.

METHODS

In these parallel, randomized, multicenter studies, 78 patients in 79 pregnancies were stratified to 2 different treatment arms based on the presence of a peripartum intracranial hemorrhage in a previously affected sibling and/or the initial fetal platelet count. Patients with a history of an antenatal intracranial hemorrhage in a prior pregnancy were excluded.

RESULTS

Forty women whose children from a previous birth had a peripartum intracranial hemorrhage or whose current fetus had an initial platelet count less than 20,000/mL3 were randomly assigned to receive IVIG plus prednisone or IVIG alone. The mean increase in fetal platelet counts in the following 3 to 8 weeks was 67,100/mL3 and 17,300/mL3, respectively (P < .001). Thirty-nine patients whose prior affected child did not have an intracranial hemorrhage and whose initial platelet count was more than 20,000/mL3 were randomly assigned to receive IVIG alone or prednisone alone. There were no significant differences, and 33 (85%) had birth platelet counts more than 50,000/mL3. There were 11 (6%) significant complications after a total of 175 fetal blood sampling procedures, 2 of which led to fetal or neonatal deaths.

CONCLUSION

The spectrum of disease severity of alloimmune thrombocytopenia is reflected in the initial fetal platelet count and response to therapy. Fetal blood sampling may be associated with significant fetal/neonatal morbidity and mortality. Empiric therapy sufficient to treat the most severely affected fetuses will overtreat others and is likely to be associated with additional maternal morbidity.

摘要

目的

静脉注射免疫球蛋白(IVIG)和泼尼松进行产前治疗已被证明可改善胎儿血小板减少症,并降低新生儿同种免疫性血小板减少症颅内出血的发生率。然而,针对个体患者优化这种治疗方法尚未实现。

方法

在这些平行、随机、多中心研究中,79例妊娠的78名患者根据先前受影响的同胞中是否存在围产期颅内出血和/或初始胎儿血小板计数,被分层到2个不同的治疗组。既往妊娠有产前颅内出血病史的患者被排除。

结果

40名妇女,其前次分娩的孩子有围产期颅内出血或其当前胎儿的初始血小板计数低于20,000/mL3,被随机分配接受IVIG加泼尼松或单独接受IVIG。在接下来的3至8周内,胎儿血小板计数的平均增加分别为67,100/mL3和17,300/mL3(P <.001)。39名患者,其先前受影响的孩子没有颅内出血且初始血小板计数高于20,000/mL3,被随机分配单独接受IVIG或单独接受泼尼松。没有显著差异,33名(85%)患者出生时血小板计数高于50,000/mL3。在总共175次胎儿血液采样程序后有11例(6%)严重并发症,其中2例导致胎儿或新生儿死亡。

结论

同种免疫性血小板减少症的疾病严重程度范围反映在初始胎儿血小板计数和对治疗的反应中。胎儿血液采样可能与显著的胎儿/新生儿发病率和死亡率相关。足以治疗受影响最严重胎儿的经验性治疗会过度治疗其他胎儿,并且可能与额外的母体发病率相关。

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