Scondotto G, Aloisi D, Ferrari P, Martini L
ASL città de Bologna, Angiology Service and Day Hospital Mengoli, Italy.
Angiology. 1999 Nov;50(11):883-9. doi: 10.1177/000331979905001102.
Venous ulcers are still today one of the main socioeconomic problems of medical interest in terms of prevalence, morbidity, and costs to the health service. In the past, various studies have been carried out to identify a systemic pharmacologic treatment able to accelerate venous ulcer healing times, but frequently the results have not been satisfactory. The aim of this study was to evaluate the efficacy of sulodexide, a drug with profibrinolytic and antithrombotic activity, in accelerating venous ulcer's healing time. Ninety-four patients (32 men and 62 women), aged 72 years old on average, were randomly distributed between two groups. In the first group ("control group") a standard treatment was applied, which consisted of cleansing by washing with physiological solution and the application of elastic compression with short-extensibility, removable bandages. The second group ("sulodexide group") received the standard treatment plus sulodexide (600 lipoprotein lipase releasing units [LRU] by im route per day for 30 consecutive days, followed by 500 LRU by oral route per day for a further 30 days). After 2 months the venous ulcers were found healed in 15 patients (36%) in the control group and in 30 patients (58%) in the sulodexide group (p = 0.03). The life table showed that the healing times were shorter in the sulodexide group in the first 2 months of treatment. Total healing times amounted to 110 days in the control group and 72 days in the sulodexide group (p = 0.08) and the results were in proportion to the initial severity of the lesion. A significant correlation was noted between ulcer healing times and severity of the initial ulcerous lesion, the duration of the ulcer, and the group the patient belonged to. No correlation was found between age, gender of the patient and the etiology of the ulcer. In conclusion sulodexide was shown effective in the treatment of venous leg ulcers, yielding healing more quickly than the standard treatment.
就患病率、发病率以及对卫生服务造成的成本而言，静脉溃疡至今仍是医学领域主要的社会经济问题之一。过去，人们开展了各种研究，以确定一种能够缩短静脉溃疡愈合时间的全身性药物治疗方法，但结果往往不尽人意。本研究的目的是评估舒洛地昔（一种具有纤溶酶原激活和抗血栓活性的药物）在加速静脉溃疡愈合时间方面的疗效。94名患者（32名男性和62名女性），平均年龄72岁，被随机分为两组。第一组（“对照组”）采用标准治疗，包括用生理盐水清洗以及使用低延展性、可移除的绷带进行弹性加压包扎。第二组（“舒洛地昔组”）接受标准治疗加舒洛地昔（每天通过肌肉注射给予600脂蛋白脂肪酶释放单位[LRU]，连续30天，随后每天通过口服给予500 LRU，持续30天）。2个月后，对照组有15名患者（36%）的静脉溃疡愈合，舒洛地昔组有30名患者（58%）的静脉溃疡愈合（p = 0.03）。生命表显示，在治疗的前2个月，舒洛地昔组的愈合时间更短。对照组的总愈合时间为110天，舒洛地昔组为72天（p = 0.08），结果与病变的初始严重程度成比例。溃疡愈合时间与初始溃疡病变的严重程度、溃疡持续时间以及患者所属组之间存在显著相关性。未发现患者的年龄、性别与溃疡病因之间存在相关性。总之，舒洛地昔在治疗下肢静脉溃疡方面显示出有效性，比标准治疗愈合更快。
