Huhle G, Hoffmann U, Hoffmann I, Harenberg J, Heene D L
I. Medizinische Klinik, Fakultät für Klinische Medizin Mannheim, Universität Heidelberg.
Dtsch Med Wochenschr. 2000 Jun 2;125(22):686-91. doi: 10.1055/s-2007-1024437.
Heparin-induced thrombocytopenia (HIT) type II is a severe complication of heparin therapy with a high incidence of thromboembolic events.
The aim of this prospective study was to evaluate efficacy and safety of prophylaxis of thromboembolism with subcutaneous r-hirudin (25 mg twice daily) in patients with HIT type II.
From 01/06/1997 until 01/08/1999, 19 patients were prospectively included into the study. During subcutaneous r-hirudin application (25 mg twice daily) the activated partial thromboplastin time (aPTT) and ecarin clotting time (ECT) were measured twice daily prior to and 2 hours after the morning injection.
Ten patients (mean age: 68 years; two men, eight women) with thromboembolic events were intravenously treated with r-hirudin (mean 19.3 days) with a target aPTT of 1.5 to 2.5 times normal values followed by subcutaneous r-hirudin (mean 22.5 days). Five Patients without thromboembolism immediately received subcutaneous r-hirudin (mean 25.9 days; mean age: 61 jahre; two men, three women) after cessation of heparin. Four patients requiring prophylaxis of thromboembolism received subcutaneous r-hirudin (mean 32 days; mean age: 68 years; four women) because of HIT type II in the past. Mean aPTT-values prior to and 1.5-2.5 hours after the morning injection were 1.2 to 1.7 and 2.0 to 2.3 times normal values, respectively. The ECT was prolonged by 1.2 to 1.7 and 2.3 to 2.5 times the upper normal value, respectively. Thromboembolic or bleeding events were not observed during the study.
The subcutaneous application of r-hirudin provides an alternative for primary and secondary prophylaxis of thromboembolism in HIT type II patients.
Ⅱ型肝素诱导的血小板减少症（HIT）是肝素治疗的一种严重并发症，血栓栓塞事件发生率很高。
这项前瞻性研究的目的是评估皮下注射重组水蛭素（25毫克，每日两次）对Ⅱ型HIT患者预防血栓栓塞的疗效和安全性。
从1997年6月1日至1999年8月1日，前瞻性纳入19例患者进行研究。在皮下注射重组水蛭素期间（25毫克，每日两次），每天上午注射前及注射后2小时测量活化部分凝血活酶时间（aPTT）和蛇静脉酶凝结时间（ECT）两次。
10例发生血栓栓塞事件的患者（平均年龄：68岁；2名男性，8名女性）先静脉注射重组水蛭素（平均19.3天），目标aPTT为正常值的1.5至2.5倍，随后皮下注射重组水蛭素（平均22.5天）。5例未发生血栓栓塞的患者在停用肝素后立即接受皮下注射重组水蛭素（平均25.9天；平均年龄：61岁；2名男性，3名女性）。4例需要预防血栓栓塞的患者因过去的Ⅱ型HIT接受皮下注射重组水蛭素（平均32天；平均年龄：68岁；4名女性）。上午注射前及注射后1.5 - 2.5小时的平均aPTT值分别为正常值的1.2至1.7倍和2.0至2.3倍。ECT分别延长至正常上限值的1.2至1.7倍和2.3至2.5倍。研究期间未观察到血栓栓塞或出血事件。
皮下注射重组水蛭素为Ⅱ型HIT患者原发性和继发性预防血栓栓塞提供了一种替代方法。
