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地塞米松治疗不能改善伴有HELLP综合征的女性的预后:一项双盲、安慰剂对照、随机临床试验。

Dexamethasone treatment does not improve the outcome of women with HELLP syndrome: a double-blind, placebo-controlled, randomized clinical trial.

作者信息

Fonseca Javier E, Méndez Fabián, Cataño Claudia, Arias Fernando

机构信息

School of Public Health, Universidad del Valle, Cali, Colombia.

出版信息

Am J Obstet Gynecol. 2005 Nov;193(5):1591-8. doi: 10.1016/j.ajog.2005.07.037.

Abstract

OBJECTIVE

The purpose of this study was to determine the efficacy of dexamethasone for treatment of HELLP (hemolysis, elevated liver enzymes and low platelet count) syndrome.

STUDY DESIGN

A prospective, double-blind clinical trial was conducted among 132 women with HELLP syndrome who were assigned randomly to treatment or placebo groups. Pregnant women in the experimental group received 10-mg doses of dexamethasone intravenously every 12 hours until delivery and 3 additional doses after delivery. Puerperal women received 3 10-mg doses of dexamethasone after delivery. The same schedule was used in the placebo group. The main outcome variable was the duration of hospitalization. In addition, we evaluated treatment effects on the time to recovery of laboratory and clinical parameters and on frequency of complications.

RESULTS

The mean duration of hospitalization of patients who received dexamethasone therapy was shorter than in the placebo group (6.5 vs 8.2 days), but this difference was not statistically significant (P = .37). No significant differences were found in the time to recovery of platelet counts (hazard ratio, 1.2; 95% CI, 0.8-1.8), lactate dehydrogenase (hazard ratio, 0.9; 95% CI, 0.5-1.5), aspartate aminotransferase (hazard ratio, 0.6; 95% CI, 0.4-1.1) and to the development of complications. The results were found in both pregnant and puerperal women.

CONCLUSION

The results of this investigation do not support the use of dexamethasone for treatment of HELLP syndrome.

摘要

目的

本研究旨在确定地塞米松治疗HELLP(溶血、肝酶升高和血小板计数降低)综合征的疗效。

研究设计

对132例HELLP综合征女性进行了一项前瞻性双盲临床试验,她们被随机分配到治疗组或安慰剂组。实验组的孕妇每12小时静脉注射10毫克地塞米松,直至分娩,分娩后再追加3剂。产后妇女在分娩后接受3剂10毫克地塞米松。安慰剂组采用相同的给药方案。主要结局变量是住院时间。此外,我们评估了治疗对实验室和临床参数恢复时间以及并发症发生率的影响。

结果

接受地塞米松治疗的患者平均住院时间比安慰剂组短(6.5天对8.2天),但这一差异无统计学意义(P = 0.37)。血小板计数恢复时间(风险比,1.2;95%可信区间,0.8 - 1.8)、乳酸脱氢酶(风险比,0.9;95%可信区间,0.5 - 1.5)、天冬氨酸转氨酶(风险比,0.6;95%可信区间,0.4 - 1.1)以及并发症发生情况均未发现显著差异。在孕妇和产后妇女中均得到此结果。

结论

本研究结果不支持使用地塞米松治疗HELLP综合征。

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