論文種別	原著(症例報告除く)
言語種別	英語
査読の有無	その他(不明)
表題	Randomized Study of Antithrombin in Early-Onset Preeclampsia: KOUNO-TORI Study.
掲載誌名	正式名：Hypertension (Dallas, Tex. : 1979) 略　 称：Hypertension ISSNコード：15244563/0194911X
掲載区分	国外
巻・号・頁	83(6),pp.e25431
著者・共著者	Jun Takeda, Daisuke Tachibana, Atsuo Itakura, Kenichi Takagi, Shoichi Nakami, Hirotaka Mano, Takao Kobayashi, Naohiro Kanayama, Hiroshi Sameshima, Mamoru Morikawa, Haruhiko Sago, Tomoko Adachi, Akihide Ohkuchi, Satoru Takeda, Hisashi Masuyama, Hiroyuki Seki, Shigeru Saito,
発行年月	2026/06
概要	BACKGROUND:In preeclampsia, prolonging pregnancy decreases the risks of fetal morbidity and death. This study aimed to evaluate the efficacy and safety of antithrombin in prolonging pregnancy early-onset severe preeclampsia.METHODS:This was a randomized, double-blind, placebo-controlled study involving women with early-onset preeclampsia from 61 institutions. Participants developed early-onset severe preeclampsia from 24+0 to 31+6 weeks' gestation and had ≤100% antithrombin activity. Two groups were created, with random and blinded assignment of the participants 1:1 to a placebo (saline) group (n=92) or a recombinant human antithrombin-gamma (rhAT-gamma) group (n=90). The number of days from treatment initiation to delivery was recorded in each group, as the primary end point.RESULTS:Pregnancy was prolonged by 13 days (95% CI, 10.4-15.6) in the placebo group and 16.9 days (95% CI, 13.8-20.0) in the rhAT-gamma group (P=0.07). Compared with the placebo group, hemorrhage-related adverse events occurred at a 19.0% higher rate in the rhAT-gamma group (mean difference [95% CI, 4.3%-32.7%]), and anemia occurred at a 16.8% higher rate (mean difference [95% CI, 2.0%-30.6%]).CONCLUSIONS:No significant difference in pregnancy prolongation was found between the placebo and rhAT-gamma participants with early-onset severe preeclampsia. However, compared with the placebo group, the rhAT-gamma group appeared to have higher rates of hemorrhage-related adverse events and anemia.REGISTRATION:URL: https://jrct.niph.go.jp/en-top; Unique identifier: jRCT2080224912. URL: https://clinicaltrials.gov/; Unique identifier: NCT04182373.
DOI	10.1161/HYPERTENSIONAHA.125.25431
PMID	41789451