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针对接受人工流产的 RhD 阴性妇女的靶向 Rh 免疫球蛋白:一项临床初步研究。

Targeted Rhesus immunoglobulin for RhD-negative women undergoing an induced abortion: A clinical pilot study.

机构信息

Fetal Medicine Unit, Department of Obstetrics and Gynecology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.

Laboratory of Blood Genetics, Department of Clinical Immunology, Copenhagen University Hospital Rigshospitalet, Rigshospitalet, Copenhagen, Denmark.

出版信息

Acta Obstet Gynecol Scand. 2019 Sep;98(9):1164-1171. doi: 10.1111/aogs.13606. Epub 2019 Apr 1.

Abstract

INTRODUCTION

The aim of this clinical pilot study was to examine the accuracy of noninvasive fetal RHD genotyping in early pregnancy (8  to 11  weeks) and to clarify whether targeted administration of Rhesus immunoglobulin (RhIg) is possible for women undergoing an induced abortion such that unnecessary injections can be avoided. The study examines the correlation between gestational age and the amount of cell-free fetal DNA in maternal plasma, the fetal fraction of DNA and whether transportation time or body mass index affects these parameters.

MATERIAL AND METHODS

Fifty-two RhD-negative women undergoing a surgically induced abortion were included. A maternal blood sample was collected prior to the abortion and a tissue sample was collected from the placental part of the abortion material after the intervention. Fetal RhD type was determined by PCR analysis of cell-free fetal DNA extracted from maternal plasma and on DNA from the tissue sample, with the latter providing a reference standard. Copies of RHD/mL were determined on RHD-positive samples and the fetal fraction of DNA was calculated.

RESULTS

We demonstrated complete concordance between results from plasma and tissue, with 31 RhD-positive and 21 RhD-negative samples, corresponding to 40% being RhD-negative, specificity 100% [95% confidence interval (CI) 88.8-100] and sensitivity 100% (95% CI 83.9-100). We found no significant correlation between gestational age and the amount or the fraction of cell-free fetal DNA in maternal plasma, nor did we find that transportation time or BMI significantly affected these factors in this setup.

CONCLUSIONS

Fetal RHD genotyping can be accurately performed from the 8th week of gestation and unnecessary injections of RhIg can be avoided for women undergoing an induced abortion. A larger study is needed to determine a more accurate sensitivity for the analysis early in pregnancy.

摘要

简介

本临床初步研究旨在检验非侵入性胎儿 RHD 基因分型在早孕(8 至 11 周)中的准确性,并阐明对于接受人工流产的女性是否可以进行靶向 Rh 免疫球蛋白(RhIg)给药,从而避免不必要的注射。本研究检查了母体外周血浆中游离胎儿 DNA 量、DNA 胎儿分数与妊娠龄之间的相关性,以及运输时间或体重指数是否会影响这些参数。

材料与方法

共纳入 52 名 RhD 阴性行人工流产的女性。在流产前采集一份母体血样,在干预后从流产材料的胎盘部分采集组织样本。通过对从母体外周血浆中提取的游离胎儿 DNA 以及组织样本中的 DNA 进行 PCR 分析来确定胎儿 RhD 型,后者作为参考标准。在 RHD 阳性样本中测定 RHD/mL 的拷贝数,并计算 DNA 胎儿分数。

结果

我们在血浆和组织样本之间展示了完全一致的结果,31 份 RhD 阳性和 21 份 RhD 阴性样本,对应 40%为 RhD 阴性,特异性 100%(95%置信区间[CI] 88.8-100),灵敏度 100%(95% CI 83.9-100)。我们发现妊娠龄与母体外周血浆中游离胎儿 DNA 的量或分数之间无显著相关性,且在该设置中,运输时间或 BMI 也未显著影响这些因素。

结论

可在妊娠第 8 周准确进行胎儿 RHD 基因分型,从而避免对于接受人工流产的女性进行不必要的 RhIg 注射。需要更大的研究来确定在早期妊娠中进行分析的更准确灵敏度。

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