Institut National de Nutrition, Tunis, Tunisia.
J Nephrol. 2010 Jul-Aug;23(4):415-24.
Diabetic nephropathy (DN) is the single greatest cause of end-stage renal disease (ESRD). Without specific interventions, microalbuminuria (incipient nephropathy) gradually progresses to macroalbuminuria (overt nephropathy) within 10-15 years in about 80% of type 1 and 30% of type 2 diabetic patients, and to ESRD within further 20 years in about 75% and 20%, respectively. A primary alteration in DN consists of decreased concentration of glycosaminoglycans (GAGs) in the glomerular extracellular matrix. This evidence has prompted interest in using exogenous GAGs and specifically sulodexide in DN treatment.
In this uncontrolled multicenter study, diabetic patients with albumin excretion rate (AER) >or=30 mg/24 hours were treated with oral sulodexide 50 mg/day for 6 months, while receiving concomitant medication as required. Two hundred thirty-seven patients (54% males and 46% females, mean age 55 years, mean diabetes duration 11 years) were evaluated; 89% had type 2 and 11% type 1 diabetes mellitus, 67% microalbuminuria and 33% macroalbuminuria.
AER was significantly and progressively reduced during sulodexide treatment (p<0.0001): geometric mean after 3 and 6 months was 63.7% (95% confidence interval [95% CI], 59.3%-68.4%) and 42.7% (95% CI, 37.8%-48.2%) of baseline, respectively. The reduction was similar in type 1 and type 2 diabetes and was slightly greater in macroalbuminuric than in microalbuminuric patients. Blood pressure was slightly lowered, while fasting glucose and glycosylated hemoglobin were moderately reduced. Adverse effects were observed in 5.5% of patients, including gastrointestinal in 3.8%.
Sulodexide therapy was shown to reduce AER in patients with DN.
糖尿病肾病（DN）是终末期肾病（ESRD）的单一最大原因。如果没有特定的干预措施，微量白蛋白尿（初期肾病）在大约 80%的 1 型糖尿病患者和 30%的 2 型糖尿病患者中会在 10-15 年内逐渐进展为大量白蛋白尿（显性肾病），并在进一步的 20 年内分别约有 75%和 20%发展为 ESRD。DN 的主要改变是肾小球细胞外基质中糖胺聚糖（GAG）的浓度降低。这一证据促使人们对使用外源性 GAG 特别是磺达肝癸钠治疗 DN 产生了兴趣。
在这项未对照的多中心研究中，白蛋白排泄率（AER）>或=30mg/24 小时的糖尿病患者接受口服磺达肝癸钠 50mg/天治疗 6 个月，同时根据需要使用伴随药物。共有 237 名患者（54%为男性，46%为女性，平均年龄 55 岁，平均糖尿病病程 11 年）接受了评估；89%为 2 型糖尿病，11%为 1 型糖尿病，67%为微量白蛋白尿，33%为大量白蛋白尿。
磺达肝癸钠治疗期间 AER 显著且持续降低（p<0.0001）：治疗 3 个月和 6 个月后的几何平均值分别为基线的 63.7%（95%置信区间[95%CI]，59.3%-68.4%）和 42.7%（95%CI，37.8%-48.2%）。1 型和 2 型糖尿病的降低情况相似，大量白蛋白尿患者的降低略高于微量白蛋白尿患者。血压略有降低，空腹血糖和糖化血红蛋白中度降低。5.5%的患者出现不良反应，包括 3.8%的胃肠道不良反应。
磺达肝癸钠治疗可降低 DN 患者的 AER。
