Feuring M, Wehling M, Schultz A
Institute of Experimental and Clinical Pharmacology and Toxicology, University of Heidelberg, Germany.
Int J Clin Pharmacol Ther. 2011 Oct;49(10):626-8. doi: 10.5414/cp201542.
The aim of this in-vitro pilot study was to assess the usefulness of the thrombelastograph ROTEM® for determining the anticoagulant activity of lepirudin.
The ROTEM® parameters, clotting-time, clot formation time and maximum clot firmness were measured in the presence of increasing concentrations of lepirudin (10-4 μg/ml - 10 μg/ml). Citrated blood was obtained from 16 healthy male subjects.
Clotting-time increased from 79.1 ± 53.4 s at baseline to 194.1 ± 151.9 s at a drug concentration of 1μg/ml as measured with EXTEM (p < 0.0001). Borderline significance was found for the difference between maximum clot firmness at baseline (60.2 ± 4.3 mm) and after drug application (55.5 ± 6.5 mm).
This pilot investigation shows that the ROTEM® device may be suitable for monitoring lepirudin at low concentrations but the results should be confirmed in a larger study and the ROTEM® device validated against standard methods.
这项体外初步研究的目的是评估血栓弹力图仪ROTEM®在测定来匹卢定抗凝活性方面的实用性。
在来匹卢定浓度不断增加(10⁻⁴μg/ml - 10μg/ml)的情况下,测量ROTEM®参数,即凝血时间、凝血形成时间和最大血凝块硬度。从16名健康男性受试者中采集枸橼酸盐抗凝血。
使用EXTEM测量时,凝血时间从基线时的79.1±53.4秒增加到药物浓度为1μg/ml时的194.1±151.9秒(p<0.0001)。发现基线时最大血凝块硬度(60.2±4.3毫米)与用药后(55.5±6.5毫米)之间的差异具有临界显著性。
这项初步研究表明,ROTEM®设备可能适用于监测低浓度的来匹卢定,但结果应在更大规模的研究中得到证实,并且ROTEM®设备应根据标准方法进行验证。