Sannazzari P
Panminerva Med. 1989 Jul-Sep;31(3):127-33.
Ninety patients suffering from chronic venous insufficiency were submitted to subcutaneous treatment with calcium heparin in fixed doses (5000 I.U. t.i.d.) or with different doses of a low molecular weight heparin fraction 7,500 AXaU/day or 15,000 AXaU/day) for thirty days with a double blind random design. On days 0, 15 and 30, clinical parameters were assessed (edema, painfulness, cutaneous trophic lesions, paresthesia) and laboratory tests carried out (fibrinogenemia, plasma viscosity, euglobin lysis time, general tolerance parameters); at the beginning and at the end of the study the plethysmographic indexes of maximum venous flow and venous capacitance were evaluated. Treatment with 15,000 AXaU, of low molecular weight heparin caused modifications of the clinical and instrumental parameters which were on the whole better than those caused by heparin calcium t.i.d. throughout the study. The administration of 7,500 AXaU of low molecular weight heparin was practically equivalent to the control treatment at the end of the study, although at the intermediate assessment it was slightly less effective despite the fact that it had produced significant modifications with respect to the basal values. Treatment with low molecular weight heparin, with both doses used, produced fewer side effects than the reference drug.
90名患有慢性静脉功能不全的患者采用双盲随机设计,接受皮下注射固定剂量(5000国际单位,每日三次)的肝素钙或不同剂量(7500抗Xa国际单位/天或15000抗Xa国际单位/天)的低分子肝素治疗,为期30天。在第0天、第15天和第30天,评估临床参数(水肿、疼痛、皮肤营养性损害、感觉异常)并进行实验室检查(纤维蛋白原血症、血浆粘度、优球蛋白溶解时间、一般耐受性参数);在研究开始和结束时,评估最大静脉血流量和静脉容量的体积描记指数。在整个研究过程中,15000抗Xa国际单位低分子肝素治疗引起的临床和仪器参数变化总体上优于每日三次肝素钙治疗引起的变化。尽管在中期评估时,7500抗Xa国际单位低分子肝素的疗效略逊于对照治疗,但其相对于基线值产生了显著变化,不过在研究结束时,其实际效果与对照治疗相当。使用两种剂量的低分子肝素治疗产生的副作用均少于参比药物。