ten Cate H, Henny C P, ten Cate J W, Büller H R, Dabhoiwala N F
Thromb Haemost. 1987 Feb 3;57(1):92-6.
In preparation for an efficacy study, the effect of the low molecular weight heparinoid Org 10172 on postoperative blood loss was assessed in a randomized double-blind, placebo controlled study in patients undergoing transurethral resection of the prostate (TURP). Org 10172 and placebo were given twice daily as i.v. injection for three postoperative days starting one hour preoperatively. Three doses of Org 10172 (800, 1600, and 2400 anti-Xa units b.d.) were evaluated against placebo in three consecutive patient blocks respectively. Each block consisted of 20 patients, 15 receiving Org 10172 and 5 patients placebo. The study was discontinued after 9 patients of the third block had completed the protocol because of excessive urinary blood loss. Data analysis showed a dose-dependent increase in postoperative haemoglobin loss, this was not significant for the 800 anti-Xa units b.d. dosage but was significant in those patients treated with 1600 (p less than 0.05) and 2400 anti-Xa units b.d. (p less than 0.01). It was concluded that the heparinoid Org 10172 caused a dose dependent increase in urinary blood loss following TURP.
在一项疗效研究的准备阶段，在一项针对接受经尿道前列腺切除术（TURP）的患者的随机双盲、安慰剂对照研究中，评估了低分子量类肝素Org 10172对术后失血的影响。Org 10172和安慰剂在术前1小时开始，术后连续3天每天静脉注射2次。分别在三个连续的患者组中，将三剂Org 10172（800、1600和2400抗Xa单位，每日两次）与安慰剂进行评估。每个组由20名患者组成，其中15名接受Org 10172治疗，5名接受安慰剂治疗。由于血尿过多，在第三组的9名患者完成方案后，该研究停止。数据分析显示术后血红蛋白损失呈剂量依赖性增加，对于800抗Xa单位/每日两次的剂量而言，这并不显著，但在接受1600（p小于0.05）和2400抗Xa单位/每日两次治疗的患者中显著（p小于0.01）。得出的结论是，类肝素Org 10172导致TURP术后血尿呈剂量依赖性增加。
