Simpson H K, Baird J, Allison M, Briggs J D, Rowe P A, Welsh M, Macdougall A I, Grant A C, Lowe G D, Rumley A, Wallace M, Menday A P
Renal Unit, Glasgow Royal Infirmary, UK.
Haemostasis. 1996 Mar-Apr;26(2):90-7. doi: 10.1159/000217193.
Fifty-two patients with chronic renal failure undergoing hospital haemodialysis were given a single bolus dose of tinzaparin (Innohep, Leo Laboratories, UK) into the arterial side of the dialyser, for up to 43 consecutive dialyses. The mean tinzaparin dose at the beginning was 2,139 IU anti-Xa and at the end 2,186 IU anti-Xa. Overall, tinzaparin proved a satisfactory anticoagulant for 1,370 (96.0%) out of 1,427 dialyses. Significant clot formation was prevented in 1,326 (92.8%) out of 1,429 dialyses. The clinically effective dose was associated with a mean plasma anti-Xa activity 1 h after dosing of 0.4 IU/ml and suppressed fibrinopeptide A formation for up to 4 h. Bleeding, from the skin or mucous membranes, was recorded at 27 (1.9%) of 1,408 dialyses. Prolonged fistula bleeding on completion of dialysis was recorded on only 20 occasions. Other haemorrhagic events included haematemesis, bruising and subconjunctival haemorrhage (each in 1 patient) and epistaxis (2 patients). Three patients died during the study of causes considered unrelated to tinzaparin therapy, myocardial infarction (2 patients) and multiple myeloma. Other adverse events reported included vomiting (3 patients) and hypotension (3 patients). Three patients ceased treatment due to haematemesis, prolonged bleeding from fistula puncture and thrombosis of the arteriovenous access, respectively. A small, but statistically significant, increase within the normal reference range was recorded in the mean values for aspartate aminotransferase and alanine aminotransferase.
52例接受医院血液透析的慢性肾衰竭患者在透析器动脉端给予单次大剂量替扎肝素(英国利奥实验室生产的Innohep),连续透析多达43次。开始时替扎肝素的平均剂量为抗Xa 2139 IU,结束时为抗Xa 2186 IU。总体而言,在1427次透析中,替扎肝素对1370次(96.0%)透析证明是一种满意的抗凝剂。在1429次透析中,有1326次(92.8%)防止了显著的血栓形成。临床有效剂量与给药后1小时平均血浆抗Xa活性0.4 IU/ml相关,并在长达4小时内抑制纤维蛋白肽A的形成。在1408次透析中有27次(1.9%)记录到皮肤或黏膜出血。透析结束时仅20次记录到瘘管出血延长。其他出血事件包括呕血、瘀斑和结膜下出血(各1例)以及鼻出血(2例)。3例患者在研究期间死于被认为与替扎肝素治疗无关的原因,即心肌梗死(2例)和多发性骨髓瘤。报告的其他不良事件包括呕吐(3例)和低血压(3例)。3例患者分别因呕血、瘘管穿刺出血延长和动静脉通路血栓形成而停止治疗。天冬氨酸转氨酶和丙氨酸转氨酶的平均值在正常参考范围内有小幅但具有统计学意义的升高。