Department of Pharmaceutical Sciences, School of Specialisation in Hospital Pharmacy, University of Milan, Milano, Italy.
Angiologická Ambulance, Hodonín, Czech Republic.
Adv Ther. 2020 Mar;37(3):1013-1033. doi: 10.1007/s12325-020-01232-1. Epub 2020 Jan 27.
Chronic venous disease (CVD) is a common condition associated with valvular dysfunction, venous hypertension and endothelial inflammation. Sulodexide facilitates the healing of venous ulcers and is frequently used in patients with CVD without ulcer. This review assessed the efficacy and safety of sulodexide for treatment of signs and symptoms of lower extremity CVD.
We searched MEDLINE, EMBASE, CINAHL and AMED as well as the Cochrane Central Register of Controlled Trials and the World Health Organisation (WHO) International Clinical Trials Registry Platform Search Portal. We also manually searched potentially relevant journals, conference proceedings and journal supplements. Any study monitoring any effect of sulodexide in patients with CVD at any stage of the disease, classified or non-classified, was considered. Treatment effects were estimated using standardised mean differences (SMDs), mean differences (MDs) and risk ratios (RRs), as appropriate. We calculated 95% confidence intervals (CIs) and heterogeneity (Q, tau and I).
The search found 64 studies, but only 23 provided data on 7153 participants (mean age 55 years; 68% female). The 13 studies providing extractable quantitative information included 1901 participants (mean age 55.2 years; 65% female). Sulodexide decreased the intensity of pain, cramps, heaviness, oedema and total symptom score and reduced inflammatory mediators in patients with CVD. The risk of adverse events (AEs) was not different between sulodexide and placebo or heparan sulphate (RR 1.31, 95% CI 0.74-2.32; I = 0%; 270 participants). The overall risk of AEs with sulodexide was low: 3% (95% CI 1-4%) estimated from 3656 participants.
Sulodexide was found to have a beneficial venoactive effect on the major signs and symptoms of CVD such as pain, cramps, heaviness and oedema without increasing the risk of AEs. It is also likely to exert a systemic effect on the course of CVD by interfering with inflammatory chemokines.
慢性静脉疾病（CVD）是一种与瓣膜功能障碍、静脉高压和内皮炎症相关的常见病症。舒洛地特有助于静脉溃疡的愈合，并且经常用于没有溃疡的 CVD 患者。本综述评估了舒洛地特治疗下肢 CVD 体征和症状的疗效和安全性。
我们检索了 MEDLINE、EMBASE、CINAHL 和 AMED 以及 Cochrane 中央对照试验注册库和世界卫生组织（WHO）国际临床试验注册平台搜索门户。我们还手动搜索了可能相关的期刊、会议记录和期刊增刊。任何监测 CVD 患者在疾病任何阶段（分类或未分类）的舒洛地特任何影响的研究都被认为是合适的。使用标准化均数差（SMD）、均数差（MD）和风险比（RR）适当估计治疗效果。我们计算了 95%置信区间（CI）和异质性（Q、tau 和 I）。
搜索发现了 64 项研究，但只有 23 项研究提供了 7153 名参与者的数据（平均年龄 55 岁；68%为女性）。提供可提取定量信息的 13 项研究包括 1901 名参与者（平均年龄 55.2 岁；65%为女性）。舒洛地特降低了 CVD 患者的疼痛、痉挛、沉重感、肿胀和总症状评分的强度，并降低了炎症介质。舒洛地特与安慰剂或肝素硫酸盐的不良事件（AE）风险无差异（RR 1.31，95% CI 0.74-2.32；I=0%；270 名参与者）。从 3656 名参与者中估计，舒洛地特的总体 AE 风险较低：3%（95% CI 1-4%）。
舒洛地特对 CVD 的主要体征和症状（如疼痛、痉挛、沉重感和肿胀）具有有益的静脉活性作用，而不会增加 AE 的风险。它还可能通过干扰炎症趋化因子对 CVD 的病程产生系统影响。
