Dieval J, Morinière P, Roussel B, Bayrou B, Fournier A, Delobel J
Laboratoire d'Hématologie, C.H.R., Amiens.
J Mal Vasc. 1987;12 Suppl B:114-8.
Efficacy of CY 222 for providing anticoagulation during hemodialysis was evaluated in three successive trials by rating quality of blood restitution (degree of coagulum formation in extracorporeal circulation) and by assay of fibrinopeptide A. Its safety was assessed by measurement of manual compression time necessary to ensure hemostasis of puncture points at end of session. Details of the first preliminary study were: 60 sessions in 11 chronic uremia patients; CY 222: 75, 150 and 300 A-Xa IC U/kg + 1,000 A-Xa IC U/h, then 150 and 300 A-Xa IC U/kg without continuous injection, compared with standard heparin (SH) at the usual dosage for each patient (60 +/- 13 IU/kg). Results showed CY 222 at 150 U/kg + 1,000 U/h to possess the same efficacy as SH and to give a shorter compression test time: for 150 U/kg the efficacy was satisfactory, although less than with SH, and compression times were shorter (interest in patients at risk of hemorrhage). For 300 U/kg, efficacy was superior (improved restitution and lower FPA level at end of seance: 6 ng/ml instead of 15 ng/ml.p less than 0.002) and compression times were identical. The second study to evaluate optimal dosage of CY 222 in chronic hemodialysis (CHD) involved: 10 patients; CY 222: 200 A-Xa IC U/kg and 250 A-Xa IC U/kg by single-dose injection. Results failed to demonstrate any significant difference in evolution of FPA levels, but restitution was better at 250 U/kg. In addition, investigation of the effect of rinsing of ECC with standard heparin before the session showed that its suppression did not alter effectiveness but improved tolerance.(ABSTRACT TRUNCATED AT 250 WORDS)
通过评定血液恢复质量(体外循环中凝块形成程度)和检测纤维蛋白肽A,在三项连续试验中评估了CY 222在血液透析期间提供抗凝作用的疗效。通过测量确保透析结束时穿刺点止血所需的手动压迫时间来评估其安全性。第一项初步研究的详细情况如下:11例慢性尿毒症患者进行60次透析;CY 222:75、150和300抗Xa国际单位/千克 + 1000抗Xa国际单位/小时,然后不连续注射150和300抗Xa国际单位/千克,与每位患者常用剂量的标准肝素(SH)(60±13国际单位/千克)作比较。结果显示,150国际单位/千克 + 1000国际单位/小时的CY 222与SH具有相同疗效,且压迫试验时间更短:150国际单位/千克时疗效令人满意,尽管不如SH,但压迫时间更短(对有出血风险的患者有益)。300国际单位/千克时,疗效更佳(透析结束时恢复改善且纤维蛋白肽A水平更低:6纳克/毫升而非15纳克/毫升,p<0.002),且压迫时间相同。第二项评估CY 222在慢性血液透析(CHD)中最佳剂量的研究涉及10例患者;CY 222:单剂量注射200抗Xa国际单位/千克和250抗Xa国际单位/千克。结果未显示纤维蛋白肽A水平变化有任何显著差异,但250国际单位/千克时恢复更好。此外,对透析前用标准肝素冲洗体外循环的效果研究表明,其抑制作用不会改变有效性,但可提高耐受性。(摘要截于250字)