Coccheri Sergio, Scondotto Gaetano, Agnelli Giancarlo, Aloisi Daniele, Palazzini Ernesto, Zamboni Villiam
Department of Angiology and Blood Coagulation, University Hospital S. Orsola-Malpighi, Bologna, Italy.
Thromb Haemost. 2002 Jun;87(6):947-52.
Sulodexide, a highly purified glycosaminoglycan, was investigated for treatment of venous leg ulcers. Patients (n = 235) undergoing local treatment including wound care and compression bandaging, were randomised to receive either sulodexide or matching placebo for three months. Primary study endpoint was complete ulcer healing after 2 months; secondary endpoints were ulcer healing at 3 months and the time-course changes of ulcer areas. The proportion of patients with complete ulcer healing was higher with sulodexide at 2 months (p = 0.018) and 3 months. The "number needed to treat" to obtain one additional patient healed with sulodexide was 7 at 2 months and 5 at 3 months. The changes in ulcer surface area with time were significant for sulodexide only (p = 0.004). Fibrinogen significantly decreased in sulodexide patients (p = 0.006). In conclusion, sulodexide associated with local treatment proved to be effective and well tolerated in the management of venous leg ulcers.
舒洛地希，一种高度纯化的糖胺聚糖，被用于研究治疗下肢静脉溃疡。接受包括伤口护理和加压包扎在内的局部治疗的患者（n = 235）被随机分为两组，分别接受舒洛地希或匹配的安慰剂治疗三个月。主要研究终点是2个月后溃疡完全愈合；次要终点是3个月时溃疡愈合情况以及溃疡面积的时间进程变化。舒洛地希组在2个月（p = 0.018）和3个月时溃疡完全愈合的患者比例更高。使用舒洛地希使一名额外患者愈合所需的“治疗所需人数”在2个月时为7，在3个月时为5。仅舒洛地希组溃疡表面积随时间的变化具有显著性（p = 0.004）。舒洛地希组患者的纤维蛋白原显著降低（p = 0.006）。总之，在下肢静脉溃疡的治疗中，与局部治疗联合使用的舒洛地希被证明是有效且耐受性良好的。
