Clinical Research Division, Fresenius Medical Care North America, Waltham, Massachusetts 02451, USA.
Kidney Int. 2013 Sep;84(3):555-61. doi: 10.1038/ki.2013.152. Epub 2013 May 15.
Enoxaparin, a low-molecular-weight form of heparin, is not approved for use in dialysis patients in the United States, because it is eliminated through the kidneys and could therefore accumulate and cause inadvertent bleeding. Accordingly, it is unknown if enoxaparin is as safe to prescribe as subcutaneous heparin for thromboprophylaxis in patients with chronic renal failure. Here we conducted a retrospective comparative effectiveness study in a large population of chronic maintenance dialysis patients initiated with subcutaneous injections of enoxaparin or heparin for thromboprophylaxis. The primary study end point was hospitalization or death related to bleeding, with a secondary end point of venous thromboembolism. Among 7721 dialysis patients started on subcutaneous enoxaparin or heparin at doses for thromboprophylaxis, the crude rate for bleeding requiring hospitalization or resulting in death was 15.2 (95% confidence interval (CI) 12.7-18.2) events per 100 patient-years in the enoxaparin group, which did not differ from the heparin group in which the crude rate was 16.2 (95% CI 14.0-18.7) events per 100 patient-years. In risk factor-adjusted Poisson models, enoxaparin was not associated with more bleeding in comparison to heparin (risk ratio, 0.98; 95% CI 0.78-1.23). The risk of venous thromboembolism was not associatively worse with enoxaparin (risk ratio, 0.77; 95% CI 0.49-1.22). Thus, in dialysis patients, daily enoxaparin for thromboprophylaxis was not associated with increased serious bleeding or less effective compared to subcutaneous heparin.
依诺肝素是肝素的一种低分子形式，未获得美国批准用于透析患者，因为它通过肾脏消除，因此可能会积累并导致意外出血。因此，尚不清楚依诺肝素在预防慢性肾衰竭患者血栓形成方面是否与皮下肝素一样安全。在这里，我们对大量开始皮下注射依诺肝素或肝素进行血栓预防的慢性维持性透析患者进行了回顾性比较有效性研究。主要研究终点是与出血相关的住院或死亡，次要终点是静脉血栓栓塞。在 7721 名开始接受皮下依诺肝素或肝素预防血栓的透析患者中，依诺肝素组的严重出血需要住院或导致死亡的粗发生率为每 100 患者年 15.2 例（95%置信区间[CI] 12.7-18.2），与肝素组的粗发生率 16.2 例（95%CI 14.0-18.7）无差异。在风险因素调整的泊松模型中，与肝素相比，依诺肝素并未导致更多出血（风险比，0.98；95%CI 0.78-1.23）。依诺肝素与静脉血栓栓塞风险无关（风险比，0.77；95%CI 0.49-1.22）。因此，在透析患者中，与皮下肝素相比，每日依诺肝素用于血栓预防与增加严重出血或降低疗效无关。
