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一项针对孕周尚早的HELLP综合征患者延长泼尼松龙给药时间的随机安慰剂对照试验。

A randomised placebo-controlled trial of prolonged prednisolone administration to patients with HELLP syndrome remote from term.

作者信息

van Runnard Heimel Pieter J, Huisjes Anjoke J M, Franx Arie, Koopman Corine, Bots Michiel L, Bruinse Hein W

机构信息

Department of Perinatology and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2006 Sep-Oct;128(1-2):187-93. doi: 10.1016/j.ejogrb.2005.11.041. Epub 2006 Jan 10.

Abstract

OBJECTIVES

To evaluate the effect of prolonged administration of high-dose prednisolone on early onset HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome during expectant management.

STUDY DESIGN

A randomized, double-blind trial was performed in 31 pregnant women with HELLP syndrome with an onset before 30 weeks gestation. Patients received either 50mg prednisolone or placebo intravenously twice a day. Primary outcome measures were the entry-to-delivery interval and the number of recurrent HELLP exacerbations in the antepartum period.

RESULTS

Serious maternal morbidity was considerable, in particular in the placebo group where even on maternal occurred as a consequence of liver rupture. The mean entry-delivery interval did not differ between the prednisolone group (6.9 days) and the placebo group (8.0 days). However, patients in the prednisolone group had a significant lower risk of a recurrent HELLP exacerbation after the initial crisis had subsided, as compared to patients in the placebo group (HR 0.3, with 95% CI 0.3-0.9). Platelet count recovered faster in the prednisolone group as compared to the placebo group (mean 1.7 days versus 6.2 days, P<0.01).

CONCLUSIONS

HELLP syndrome remote from term causes high risk for serious maternal morbidity and mortality. When expectant management is pursued in selected patients with a HELLP syndrome remote from term, prolonged administration of prednisolone reduces the risk of recurrent HELLP syndrome exacerbations.

摘要

目的

评估大剂量泼尼松龙长期给药对期待治疗期间早发型HELLP(溶血、肝酶升高和血小板减少)综合征的影响。

研究设计

对31例孕30周前发病的HELLP综合征孕妇进行了一项随机双盲试验。患者每天静脉注射50mg泼尼松龙或安慰剂两次。主要结局指标是入院至分娩间隔时间和产前复发性HELLP加重的次数。

结果

严重孕产妇发病率相当高,尤其是在安慰剂组,甚至有1例孕产妇因肝破裂死亡。泼尼松龙组(6.9天)和安慰剂组(8.0天)的平均入院至分娩间隔时间无差异。然而,与安慰剂组患者相比,泼尼松龙组患者在初始危机缓解后复发性HELLP加重的风险显著降低(风险比0.3,95%置信区间0.3 - 0.9)。与安慰剂组相比,泼尼松龙组血小板计数恢复更快(平均1.7天对6.2天,P<0.01)。

结论

孕晚期的HELLP综合征会导致严重孕产妇发病和死亡的高风险。对于选定的孕晚期HELLP综合征患者进行期待治疗时,长期给予泼尼松龙可降低复发性HELLP综合征加重的风险。

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