Antithrombin Therapy for Severe Preeclampsia

Masahiro Maki; Takao Kobayashi; Toshihiko Terao; Tsuyomu Ikenoue; Kazuo Satoh; Masao Nakabayashi; Yusuke Sagara; Yayoi Kajiwara; Masao Urata; for BI51.017 Study Group

doi:10.1055/s-0037-1614071

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2000; 84(04): 583-590
DOI: 10.1055/s-0037-1614071

Review Article

Schattauer GmbH

Antithrombin Therapy for Severe Preeclampsia

Results of a Double-blind, Randomized, Placebo-controlled Trial

Authors

Masahiro Maki

¹From the Department of Obstetrics & Gynecology, Akita University School of Medicine, Akita, Japan
Takao Kobayashi

²Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine, Shizuoka, Japan
Toshihiko Terao

²Department of Obstetrics & Gynecology, Hamamatsu University School of Medicine, Shizuoka, Japan
Tsuyomu Ikenoue

³Department of Obstetrics & Gynecology, Miyazaki Medical College, Miyazaki, Japan
Kazuo Satoh

⁴Department of Obstetrics & Gynecology, Nihon University School of Medicine, Tokyo, Japan
Masao Nakabayashi

⁵Department of Obstetrics & Gynecology, Tokyo Women’s Medical University, Tokyo, Japan
Yusuke Sagara

⁶Department of Obstetrics & Gynecology, Kochi Medical School, Kochi
Yayoi Kajiwara

⁷Drug Innovation & Approval, Aventis Pharma, Ltd., Tokyo, Japan
Masao Urata

⁷Drug Innovation & Approval, Aventis Pharma, Ltd., Tokyo, Japan

for BI51.017 Study Group

Abstract

Summary

A double-blind, randomized, placebo-controlled trial was conducted to evaluate whether treatment with Antithrombin (AT) concentrates improved the clinical and perinatal outcome in patients with severe preeclampsia. Severe preeclamptic patients (24 to 35 weeks of gestation, Gestosis Index (GI) > 6 points) were randomized into two groups: 66 received AT and 67 received placebo. There were no statistical differences in the clinical profiles of the two groups. Study drugs were given intravenously once daily for 7 consecutive days. Maternal symptoms were evaluated from the difference of GI between before and after treatment, and fetal findings were evaluated from the changes of the biophysical profile score and the estimated fetal weight gain. Improvement was significantly greater in the AT group for both the GI (p = 0.020) and the estimated fetal weight gain (p = 0.029). The improvement of coagulation parameters was also evaluated. The D-dimer levels increased significantly in the placebo group (p = 0.026), but did not change in the AT group. Gestation was significantly prolonged (p = 0.007), and the number of low-birth weight infants was significantly smaller (p = 0.011) in the AT group. No adverse events related to AT were observed. It is revealed that AT concentrate therapy for preeclampsia is effective and safe, leading to an improved perinatal outcome.

Key words

Preeclampsia - hypercoagulable state - vasoconstriction - antithrombin (AT) concentrate - low-birth weight infant

Full Text

References

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