Jiang Qing-Jun, Bai Jun, Jin Jie, Shi Jian, Qu Lefeng
Department of Vascular and Endovascular Surgery, Changzheng Hospital, Second Military Medical University, Shanghai, China.
Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai, China.
Front Pharmacol. 2018 Aug 8;9:876. doi: 10.3389/fphar.2018.00876. eCollection 2018.
Patients with venous thromboembolism have high risk of recurrence after discontinuation of anticoagulant treatment. Extended anticoagulation, such as traditional anticoagulants, can reduce the risk of recurrence but is associated with increased risk of hemorrhage. Sulodexide is a natural glycosaminoglycan mixture which can prevent recurrent venous thromboembolism. However, its clinical efficiency and safety still remain controversial. A systematic search in Medline, EMBASE, Cochrane Library, Web of Science and bibliographies of retrieved articles was performed. Prospective controlled studies reporting the efficacy and safety of sulodexide on the secondary prevention of recurrent venous thromboembolism were included. Two reviewers independently extracted the following data: first author, year of publication, study design, characteristics of patients, data of interventions, doses of sulodexide, overall duration of drug administration, time of follow-up, efficacy and safety outcomes, adverse effects, and the quality of the included studies. The primary efficacy outcomes were recurrent deep vein thrombosis (DVT) or pulmonary embolism. The secondary efficacy outcomes included distal or superficial vein thrombosis and nonfatal or fatal myocardial infarction, stroke, and acute ischemia of the lower limbs. Safety outcome was possible hemorrhagic episodes. Four studies involving 1,461 patients were enrolled in this study. Meta-analysis showed that sulodexide significantly reduced the recurrent venous thromboembolism [RR 0.51, 95 % CI [0.35, 0.74], = 0.0004] and superficial vein thrombosis in the sulodexide group [RR 0.41, 95% CI [0.22, 0.76], = 0.005]. The safety of sulodexide was also reliable. The rate of bleeding was 0.28% in the sulodexide group and 1.60% in the control group, and design of study did not influence these results. Sulodexide could significantly reduce the recurrence of VTE after discontinuation of anticoagulation treatment as compared with placebo.
静脉血栓栓塞患者在停用抗凝治疗后复发风险较高。延长抗凝治疗，如使用传统抗凝剂，可降低复发风险，但会增加出血风险。舒洛地特是一种天然糖胺聚糖混合物，可预防静脉血栓栓塞复发。然而，其临床疗效和安全性仍存在争议。我们在Medline、EMBASE、Cochrane图书馆、科学网以及检索文章的参考文献中进行了系统检索。纳入了报告舒洛地特对复发性静脉血栓栓塞二级预防疗效和安全性的前瞻性对照研究。两名研究者独立提取了以下数据：第一作者、发表年份、研究设计、患者特征、干预数据、舒洛地特剂量、药物给药总时长、随访时间、疗效和安全性结果、不良反应以及纳入研究的质量。主要疗效结果为复发性深静脉血栓形成（DVT）或肺栓塞。次要疗效结果包括远端或浅静脉血栓形成以及非致命或致命性心肌梗死、中风和下肢急性缺血。安全性结果为可能的出血事件。本研究纳入了四项涉及1461例患者的研究。荟萃分析表明，舒洛地特显著降低了复发性静脉血栓栓塞[风险比（RR）0.51，95%置信区间（CI）[0.35，0.74]，P = 0.0004]，舒洛地特组的浅静脉血栓形成也显著降低[RR 0.41，95%CI[0.22，0.76]，P = 0.005]。舒洛地特的安全性也可靠。舒洛地特组的出血率为0.28%，对照组为1.60%，研究设计并未影响这些结果。与安慰剂相比，舒洛地特在停用抗凝治疗后可显著降低静脉血栓栓塞复发率。
