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常规产前RhD免疫球蛋白预防:一项为期10年的前瞻性研究结果

Routine antenatal Rhesus D immunoglobulin prophylaxis: the results of a prospective 10 year study.

作者信息

MacKenzie I Z, Bowell P, Gregory H, Pratt G, Guest C, Entwistle C C

机构信息

Nuffield Department of Obstetrics and Gynaecology, University of Oxford, John Radcliffe Hospital, UK.

出版信息

Br J Obstet Gynaecol. 1999 May;106(5):492-7. doi: 10.1111/j.1471-0528.1999.tb08304.x.

DOI:10.1111/j.1471-0528.1999.tb08304.x
PMID:10430201
Abstract

OBJECTIVE

To assess the clinical and financial impact, and identify the problems, of providing routine antenatal RhD immunoglobulin prophylaxis for Rhesus D negative nulliparae.

DESIGN

A retrospective (1980-1986) and prospective (1987-1996) comparison between two similar populations, one population with nulliparae offered routine RhD immunoglobulin 500 IU prophylaxis at 28 and 34 weeks of gestation part way through the study period, and the other population not offered prophylaxis at any time.

SETTING

Obstetric units in two counties (three health districts) with similar annual numbers of maternities and the Regional Blood Transfusion Service antenatal serology laboratory.

PARTICIPANTS

Non-sensitised Rhesus D negative pregnant nulliparae.

INTERVENTIONS

Intramuscular RhD immunoglobulin 500 IU at 28 and 34 weeks of gestation to eligible women booked for confinement in one county; the intervention not offered in the other county.

MAIN OUTCOME MEASURES

  1. Rhesus D sensitised second pregnancy rate; 2. success in providing prophylaxis to eligible women; 3. serology laboratory activity changes; 4. potential savings from the prophylaxis programme.

RESULTS

Prophylaxis significantly reduced iso-immunisation in the next pregnancy when compared with historical (OR 0.28, CI 0.14-0.53; P < 0.0001) and contemporary controls (OR 0.43, CI 0.22-0.86; P = 0.02). However, success at achieving comprehensive prophylaxis was disappointing, with only 89% of eligible women receiving the first injection, 74% both injections, and for only 29% were both at the correct gestation. Fifty-two percent of women delivered after 40 weeks of gestation, beyond the period of adequate prophylaxis protection. The savings in antenatal interventions, neonatal care and possible long term ill-health that result from very preterm birth should be considerable.

CONCLUSION

Routine prophylaxis for nulliparae significantly reduces the incidence of sensitised next pregnancies with consequent savings, and its adoption nationwide should be encouraged. A programme offering antenatal prophylaxis for all Rhesus D negative women is unlikely to be economic. Improvement in uptake of prophylaxis is needed; alternative administration strategies should be explored.

摘要

目的

评估对恒河猴D阴性初产妇进行常规产前RhD免疫球蛋白预防的临床和经济影响,并找出其中存在的问题。

设计

对两个相似人群进行回顾性(1980 - 1986年)和前瞻性(1987 - 1996年)比较,一组初产妇在研究期间中途于妊娠28周和34周时接受常规500国际单位RhD免疫球蛋白预防,另一组在任何时候均未接受预防。

地点

两个县(三个卫生区)的产科单位,其每年的产妇数量相近,以及地区输血服务产前血清学实验室。

参与者

未致敏的恒河猴D阴性妊娠初产妇。

干预措施

对预定在一个县分娩的符合条件的妇女在妊娠28周和34周时肌肉注射500国际单位RhD免疫球蛋白;另一个县不提供该干预措施。

主要观察指标

  1. 恒河猴D致敏的第二次妊娠率;2. 为符合条件的妇女提供预防措施的成功率;3. 血清学实验室活动的变化;4. 预防计划可能节省的费用。

结果

与历史对照组(比值比0.28,可信区间0.14 - 0.53;P < 0.0001)和当代对照组(比值比0.43,可信区间0.22 - 0.86;P = 0.02)相比,预防措施显著降低了下一胎的同种免疫发生率。然而,全面预防的成功率令人失望,只有89%的符合条件的妇女接受了第一针注射,74%接受了两针注射,且只有29%的妇女两针注射时间均正确。52%的妇女在妊娠40周后分娩,超出了充分预防保护的时间段。产前干预、新生儿护理以及因极早产可能导致的长期健康问题方面节省的费用应该相当可观。

结论

对初产妇进行常规预防可显著降低下一胎致敏的发生率,从而节省费用,应鼓励在全国范围内采用。为所有恒河猴D阴性妇女提供产前预防的计划不太可能具有经济性。需要提高预防措施的接受率;应探索替代给药策略。

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