68989National and Kapodistrian University of Athens School of Medicine, Athens, Greece.
Department of Pathology, Yale School of Medicine, New Haven, CT, USA.
Clin Appl Thromb Hemost. 2021 Jan-Dec;27:1076029620979592. doi: 10.1177/1076029620979592.
Low-molecular-weight heparins are approved for primary and secondary venous thromboembolism prevention. Tinzaparin is the low-molecular-weight heparin with the highest average molecular weight. The purpose of this systematic review is to provide an update regarding the safety profile of tinzaparin, prescribed either as a prophylactic or as a therapeutic regimen for venous thromboembolism in special populations, including cancer patients and patients with renal impairment. We identified prospective studies up to August 2020 reporting safety outcomes for cancer patients and patients with renal impairment on tinzaparin regimens. In patients with cancer major bleeding rates fluctuated between 0.8% and 7%. Patients on tinzaparin exhibited significantly lower rates of clinically relevant nonmajor bleeding events in comparison with those on vitamin K antagonists. Bioaccumulation of tinzaparin was not correlated with age, body weight or creatinine clearance. Periodic administration of either prophylactic or therapeutic doses of tinzaparin did not result in bioaccumulation, even in patients with severe renal impairment and creatinine clearance < 20 ml/min. Major bleeding rates for non-cancer patients with renal impairment on prophylactic tinzaparin regimens were 0%. Non-cancer patients with renal impairment on therapeutic tinzaparin regimens exhibited major bleeding in 0 to 3.4% of cases; major bleeding rates were higher for cancer patients with renal impairment on therapeutic tinzaparin regimens (4.3 to 10%). Tinzaparin can be used without dose adjustment in patients with severe renal impairment and creatinine clearance > 20 ml/min. Tinzaparin represents a safe choice for special populations at increased risk for thrombosis and bleeding.
低分子量肝素被批准用于一级和二级静脉血栓栓塞预防。亭扎肝素是平均分子量最高的低分子量肝素。本系统评价的目的是提供关于亭扎肝素安全性概况的最新信息，亭扎肝素可作为预防或治疗特殊人群（包括癌症患者和肾功能损害患者）静脉血栓栓塞的方案。我们确定了截至 2020 年 8 月的前瞻性研究，报告了癌症患者和肾功能损害患者在亭扎肝素方案中的安全性结果。在癌症患者中，大出血发生率在 0.8%至 7%之间波动。与维生素 K 拮抗剂相比，接受亭扎肝素治疗的患者临床相关非大出血事件发生率显著降低。亭扎肝素的生物蓄积与年龄、体重或肌酐清除率无关。定期给予预防或治疗剂量的亭扎肝素不会导致生物蓄积，即使在严重肾功能损害和肌酐清除率<20ml/min 的患者中也是如此。接受预防用亭扎肝素方案的非癌症肾功能损害患者的大出血发生率为 0%。接受治疗用亭扎肝素方案的非癌症肾功能损害患者中有 0%至 3.4%发生大出血；接受治疗用亭扎肝素方案的癌症伴肾功能损害患者的大出血发生率更高（4.3%至 10%）。严重肾功能损害和肌酐清除率>20ml/min 的患者无需调整剂量即可使用亭扎肝素。亭扎肝素是血栓形成和出血风险增加的特殊人群的安全选择。
