Isheo s.r.l, Rome, Italy.
Vascular Screening and Diagnostic Centre, Nicosia, Cyprus.
Phlebology. 2021 Oct;36(9):695-709. doi: 10.1177/02683555211015020. Epub 2021 May 13.
To assess the clinical efficacy of sulodexide, including a comparison with venoactive drugs (VAD) (micronized purified flavonoid fraction, MPFF; hydroxy-ethyl-rutosides, HR; calcium dobesilate;Ruscus extract combined with hesperidin methyl chalcone and vitamin C, Ruscus+HMC+VitC; horse chestnut seed extract, HCSE) and pentoxifylline in patients with chronic venous disease.
We performed a literature search in MEDLINE, Embase, and Cochrane Library for randomized controlled trials (RCTs) and observational studies. Proportion of patients with complete venous ulcer healing was the primary outcome and lower leg volume, foot volume, ankle circumference and symptoms were the secondary outcomes. Bayesian network meta-analysis (NMA) was perfomed with random effects models using only RCTs. A meta-analysis of observational studies was performed for sulodexide because no RCT could be included in NMA for symptoms or signs.
Forty-five RCTs and eighteen observational studies were identified. Sulodexide was included only in a single NMA for the proportion of patients with complete ulcer healing and it showed to have the highest probability of being the best treatment (48%) compared with pentoxifylline (37%) and MPFF (16%). MPFF was the most effective treatment in reducing lower leg volume, CIVIQ-20 score and pain VAS scale while calcium dobesilate and Ruscus+HMC+VitC were the most effective in reducing foot volume and ankle circumference respectively.Meta-analyses of observational studies for sulodexide showed that it improves significantly the scoring of pain, feeling of swelling, heaviness and parasthesiae measured by Likert scales.
Sulodexide is at least as effective as pentoxifylline and more effective than MPFF in improving the rate of ulcer healing in patients with CVD. VADs are effective in improving venous symptoms and signs, as was also shown by sulodexide in the meta-analysis of observational studies. The relative effectiveness of sulodexide and VADs needs to be evaluated by an RCT in order to better inform clinical practice.
评估舒洛地特的临床疗效，包括与静脉活性药物（VAD）（米诺地尔黄酮、MPFF；羟乙基芦丁、HR；己酮可可碱、钙；鲁斯可提取物联合橙皮苷甲基查尔酮和维生素 C、鲁斯可+HMC+维生素 C；欧洲七叶树种子提取物、HCSE）和己酮可可碱的比较，用于治疗慢性静脉疾病患者。
我们在 MEDLINE、Embase 和 Cochrane Library 中进行了文献检索，以寻找随机对照试验（RCT）和观察性研究。完全静脉性溃疡愈合的患者比例是主要结局，小腿体积、足部体积、踝关节周长和症状是次要结局。仅使用 RCT 进行贝叶斯网络荟萃分析（NMA），使用随机效应模型。由于没有 RCT 可纳入 NMA 用于症状或体征，因此对舒洛地特进行了观察性研究的荟萃分析。
确定了 45 项 RCT 和 18 项观察性研究。舒洛地特仅被纳入一项关于完全溃疡愈合患者比例的 NMA，与己酮可可碱（37%）和 MPFF（16%）相比，它具有成为最佳治疗的最高概率（48%）。MPFF 在降低小腿体积、CIVIQ-20 评分和疼痛 VAS 评分方面最有效，而钙和鲁斯可+HMC+维生素 C 在降低足部体积和踝关节周长方面最有效。舒洛地特的观察性研究荟萃分析表明，它显著改善了 Likert 量表评估的疼痛、肿胀感、沉重感和感觉异常的评分。
舒洛地特在改善 CVD 患者溃疡愈合率方面至少与己酮可可碱一样有效，比 MPFF 更有效。VAD 在改善静脉症状和体征方面同样有效，舒洛地特在观察性研究的荟萃分析中也证明了这一点。为了更好地为临床实践提供信息，需要通过 RCT 来评估舒洛地特和 VAD 的相对有效性。
