Department of Clinical and Experimental Medicine, University of Insubria, Varese IRCCS Policlinico S. Matteo Foundation, University of Pavia, Pavia Department of Medical, Oral and Biotechnological Sciences, University 'G.D'Annunzio' of Chieti-Pescara Department of Internal Medicine, Ospedale S. Andrea, La Spezia Department of Internal Medicine, Arcispedale S. Maria Nuova, Reggio Emilia Department of Internal Medicine, Ospedale Sacro Cuore di Gesù, Gallipoli Department of Emergency Medicine, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan Department of Internal Medicine, Ospedale di Rovigo, Rovigo Department of Internal Medicine, University of Turin, Ospedale S. Giovanni, Torino Department of Emergency Medicine, Ospedale di Piacenza, Piacenza, Italy.
J Thromb Haemost. 2012 Nov;10(11):2291-7. doi: 10.1111/j.1538-7836.2012.04908.x.
Renal impairment is common, affecting around 40% of acutely ill medical patients, and is associated with an increased risk of both venous thromboembolism (VTE) and bleeding. The clinical benefit of effective thromboprophylactic strategies may be outweighed in these patients by an excessive rate of hemorrhage.
To assess the safety and efficacy of lower prophylactic doses of fondaparinux in acutely ill medical patients with renal impairment.
PATIENTS/METHODS: We carried out a multicenter, investigator-initiated, prospective cohort study. Patients at risk of VTE with a creatinine clearance between 20 and 50 mL min(-1) were treated with fondaparinux 1.5 mg qd for a minimum of 6 to a maximum of 15 days. The primary outcome was the incidence of major bleeding; secondary outcomes were clinically relevant non-major bleeding (CRNMB) and symptomatic VTE.
We enrolled 206 patients with a mean age of 82 years, mean creatinine clearance of 33 mL min(-1) , and a mean Charlson co-morbidity index of 8.2. One patient had major bleeding (0.49%, 95% confidence interval [CI] 0.03-3.10), eight had CRNMB (3.88%, 95% CI 1.81-7.78) and three developed symptomatic VTE (1.46%, 0.38-4.55). Twenty-three patients (11.17%, 7.36-16.48) died. No independent predictors of bleeding were found at univariate analysis.
The addition of moderate to severe renal impairment to patients with traditional risk factors for VTE identified a population of very elderly acutely ill medical patients potentially at high risk of both VTE and bleeding complications. The recently approved lower prophylactic dose of fondaparinux appears to be a safe and relatively effective strategy in these patients.
肾功能损害很常见，影响大约 40%的急症内科患者，并且与静脉血栓栓塞（VTE）和出血的风险增加相关。在这些患者中，有效的血栓预防策略的临床获益可能因过度出血而被抵消。
评估肾功能损害的急症内科患者使用较低预防剂量的磺达肝癸钠的安全性和疗效。
患者/方法：我们进行了一项多中心、研究者发起的前瞻性队列研究。肌酐清除率在 20 至 50 mL/min 的有 VTE 风险的患者接受磺达肝癸钠 1.5mg qd 治疗，最短 6 天，最长 15 天。主要结局是主要出血的发生率；次要结局是临床相关非主要出血（CRNMB）和有症状的 VTE。
我们纳入了 206 名平均年龄 82 岁、平均肌酐清除率 33 mL/min 和平均 Charlson 合并症指数为 8.2 的患者。1 名患者发生主要出血（0.49%，95%置信区间 [CI] 0.03-3.10），8 名患者发生 CRNMB（3.88%，95% CI 1.81-7.78），3 名患者发生有症状的 VTE（1.46%，0.38-4.55）。23 名患者（11.17%，7.36-16.48）死亡。单变量分析未发现出血的独立预测因素。
将中度至重度肾功能损害与 VTE 的传统危险因素相加，确定了一个非常高龄的急症内科患者群体，他们可能同时面临 VTE 和出血并发症的高风险。最近批准的磺达肝癸钠较低预防剂量在这些患者中似乎是一种安全且相对有效的策略。
