Raso A M, Maggio D, Trogolo M, Rispoli P, Sandrone N, Pezzuto D, Bellan A, Melloni C D
Cattedra e Scuola di Specializzazione in Chirurgia Vascolare, Università degli Studi, Torino.
Minerva Cardioangiol. 1997 Jul-Aug;45(7-8):383-92.
Mesoglycan is a natural glycosaminoglycans preparation, with antithrombotic and pro-fibrinolytic activities, which has been shown to be clinically effective in a number of vascular atherosclerotic disorders with thrombotic risk.
In the present investigation we studied the effect of mesoglycan in patients with acute episodes of relative lower limb ischemia (Stage IIb according to Leriche-Fontaine classification) coming to our observation. Mesoglycan was administered according to the following schedule: a 10-days period of endovenous mesoglycan (90 mg/day), given in day-hospital regimen, followed by a 20-days period of oral mesoglycan (100 mg/day). The treatment schedule was repeated for two months and then patient continued with oral mesoglycan. We present the preliminary results obtained on 36 patients which were followed for a mean period of 12 months.
From February 1995 thirty-six patients, 24 males and 12 females, aged between 45 and 83 years (mean +/- SD: 69.8 +/- 7.5) coming to our observation for acute relative lower limb ischemia were enrolled. At baseline, the diagnosis was Fontaine's IIb stage (walking distance < or = 200 m) in all patients, 17 patients presenting walking distance < 100 m. After 3 and 6 months of mesoglycan treatment a significant improvement of symptoms and signs was observed in all patients but one. At the end of the 6-months period, 29 patients (81% of the study population) became to a Fontaine's IIa degree, with a significant increase in walking distance (in 70% three times their basal value) and improvement of symptoms and recovery time. After treatment, Winsor Index was not significantly modified. Similar results were obtained after 12 months of follow-up. During the study period only one patient included in the trial needed surgical revascularisation. The administration of mesoglycan was well tolerated, with only minor complaints in two patients (one case of headache and one of diarrhea). During the endovenous administration of mesoglycan most patients (81%) presented values of aPTT almost double than baseline, which returned to normal values at the end of the administration.
The present preliminary results show that, in patients with acute episodes of relative lower limb ischemia, mesoglycan (administered according to the described protocol) is an effective and safe agent able to improve symptoms (walking distance, pain, leg appearance) and to possibly delay the need of surgical interventions.
硫酸乙酰肝素是一种天然糖胺聚糖制剂，具有抗血栓形成和促纤溶活性，已被证明在一些有血栓形成风险的血管动脉粥样硬化疾病中具有临床疗效。
在本研究中，我们观察了硫酸乙酰肝素对前来就诊的急性下肢相对缺血发作患者（根据勒里什 - 方丹分类为IIb期）的影响。硫酸乙酰肝素的给药方案如下：先进行为期10天的静脉内硫酸乙酰肝素给药（90毫克/天），采用日间医院治疗方案，随后进行为期20天的口服硫酸乙酰肝素给药（100毫克/天）。该治疗方案重复两个月，然后患者继续口服硫酸乙酰肝素。我们展示了对36例患者获得的初步结果，这些患者平均随访了12个月。
从1995年2月起，纳入了36例因急性下肢相对缺血前来就诊的患者，其中男性24例，女性12例，年龄在45至83岁之间（平均±标准差：69.8±7.5）。基线时，所有患者的诊断均为方丹IIb期（步行距离≤200米），17例患者步行距离＜100米。在硫酸乙酰肝素治疗3个月和6个月后，除1例患者外，所有患者的症状和体征均有显著改善。在6个月期末，29例患者（占研究人群的81%）达到方丹IIa级，步行距离显著增加（70%的患者增加至基线值的三倍），症状改善，恢复时间缩短。治疗后，温莎指数无显著变化。随访12个月后获得了类似结果。在研究期间，试验中仅1例患者需要进行手术血运重建。硫酸乙酰肝素的给药耐受性良好，仅有2例患者有轻微不适（1例头痛，1例腹泻）。在静脉内给予硫酸乙酰肝素期间，大多数患者（81%）的活化部分凝血活酶时间（aPTT）值几乎是基线值的两倍，在给药结束时恢复至正常水平。
目前的初步结果表明，对于急性下肢相对缺血发作的患者，硫酸乙酰肝素（按照所述方案给药）是一种有效且安全的药物，能够改善症状（步行距离、疼痛、腿部外观），并可能延迟手术干预的需求。
